Attorney Elizabeth Abramson Joins Maglio Christopher & Toale Law Firm

Attorney Elizabeth Abramson Joins Maglio Christopher & Toale Law FIRM

The Maglio Christopher & Toale Law Firm is pleased to announce the addition of attorney Elizabeth Abramson to the Firm’s Vaccine Injury Practice Group.

Previously, Ms. Abramson worked in the Vaccine Injury Compensation Program (VICP) as a federal judicial law clerk to Chief Special Master Brian Corcoran in the United States Court of Federal Claims Office of Special Masters. Her work included extensive research on legal precedent for unique procedural issues and writing memoranda outlining how the Office of Special Masters should rule on those issues.

“I absolutely loved the experience of being a law clerk in the Court of Federal Claims,”  says Abramson. “As an attorney, I enjoyed learning about vaccine injury cases,  about rare medical conditions, and listening to experts from all over the world discuss the relationship between those diseases and vaccination.”

Ms. Abramson is also an adjunct professor of trial advocacy at the Drexel University Thomas R. Kline School of Law, where she earned her law degree with honors.

“We are very excited to have Elizabeth Abramson join us! With her experience working inside the Court of Federal Claims and her passion to advocate for people suffering adverse reactions, she will be a tremendous asset to those who need our help,” says Managing Partner Altom Maglio. Ms. Abramson works out of the Firm’s Washington, DC office.

Elizabeth is originally from Pottsville, Pennsylvania where she grew up on a farm in a small town with a population of fewer than 200 people. She now lives in Philadelphia with her husband and pets. In her time off she enjoys reading, writing, snowboarding, and watching foreign films. She is also an environmental activist and focuses a lot of her attention on promoting a minimal waste lifestyle and sustainability.

About Maglio Christopher & Toale:  Our Firm has more than 20 years of experience litigating in the VICP in the United States Court of Federal Claims. The Firm’s other practice areas include Federal takings claims, government contract litigation, commercial and construction litigation, business law, and other complex civil litigation. Learn more about the Maglio Christopher & Toale Law Firm at www.mctlaw.com

Continue ReadingAttorney Elizabeth Abramson Joins Maglio Christopher & Toale Law Firm

FDA Warns The public About J&J COVID-19 Vaccine for Neurological Complications

This past Monday the U.S. Food and Drug Administration added a new warning to the J&J COVID-19 vaccine fact sheet. This warning indicates an increased risk for an autoimmune disorder called Guillain-Barre syndrome. GBS causes a person’s immune system to attack its own peripheral nervous system.

The FDA suggests that J&J vaccine recipients should seek medical attention if they show symptoms such as weakness or tingling sensations in their legs or arms, have a hard time walking or hard time with facial expressions.

This warning is another setback for the J&J vaccine. It is also linked to a very rare but potentially life threatening blood clot condition. The CDC and FDA determined that the risk of blood clots was low and treatable.

Continue ReadingFDA Warns The public About J&J COVID-19 Vaccine for Neurological Complications

Webinar: A Clearheaded Look at Marijuana as Tribal Enterprise

RECORDED WEBINAR

Cutting Through the Smoke: A Clearheaded Look at Marijuana as Tribal Enterprise
Watch Webinar Now: https://www.youtube.com/watch?v=FuOzfPj5O4w

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Maglio Christopher Toale Law Firm Honored to Represent Sauk-Suiattle Indian Tribe

Maglio Christopher & Toale P.A. is honored to begin its representation of the Sauk-Suiattle Indian Tribe in the State of Washington!  We look forward to working with the Tribe’s leaders and co-counsel on a number of critical matters.  You can learn more about the Sauk-Suiattle Indian Tribe here: www.sauk-suiattle.com

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Attorney Ilyas Sayeg Published in AAJ’s Trial Magazine

Attorney ilyas sayeg's article published in july's issue of aaj's trial magazine

Maglio Christopher & Toale Law Firm | Read attorney Ilyas Sayeg’s recent article “Sharing is the Law”, published in this month’s issue of AAJ’s Trial Magazine. This article explains how sharing provisions helps clients in similar litigations access discovery in an efficient way rather than duplicating the same work. This could apply whether you are negotiating a protective order or challenging an existing one. Click on the link below to read full article.

“Sharing is the Law” by Ilyas Sayeg

Ilyas Sayeg’s legal experience focuses on the intersection of consumer protection law and healthcare. His areas of practice include representing people across the country who are injured by defective medical products, such metal on metal hips. Mr. Sayeg litigates these complex cases in state and federal courts around the United States.

About Maglio Christopher & Toale Law Firm | Our Firm is leading the U.S. litigation against metal on metal hip replacements. The Firm filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating these cases ever since.

Continue ReadingAttorney Ilyas Sayeg Published in AAJ’s Trial Magazine

HHS Walks Back Rules Removing SIRVA, Syncope from Vaccine Injury Table

Health and Human Services (HHS) says it will no longer move forward with removing SIRVA and syncope, or fainting, from the Vaccine Injury Compensation Program.  This is a complete turnaround from the previous administration’s plans to enact this change on February 22nd. 

The rule to strip these claims from the program would have severely limited the number of people who could get compensation. More than half of all claims filed in the Vaccine Injury Compensation Program involve SIRVA or syncope. It also would have triggered increased lawsuits against doctors, nurses, pharmacists, and other providers who vaccinate the public; all at the worst possible time during a pandemic. 

HHS added SIRVA and syncope (fainting) to the VICP in 2017 after a years-long process that included public comment, multiple workgroups, and reviews of medical research. In comparison, the steps to remove SIRVA and fainting happened with unusual speed; proposed in mid-2020, put into effect just 1 day before a change in the government’s administration, and set to take effect on February 22, 2021. 

The Biden administration immediately took steps to freeze the changes to the Vaccine Injury Table and force a review of those new rules. 

The next step in rescinding the rule is to open up the decision for public comment before making it official. Read the official notice to be published in the Federal Register on March 17, 2021: National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table. Notice of proposed withdrawal; request for comments

 

Continue ReadingHHS Walks Back Rules Removing SIRVA, Syncope from Vaccine Injury Table

FDA Approves Third COVID-19 Vaccine

It’s official.  A third COVID-19 vaccine is out for distribution in the United States. This Saturday, the Food and Drug Administration (FDA) authorized Johnson & Johnson’s COVID-19 vaccine. It is the first vaccine to only require one shot for immunization.

An estimated 3.9 million doses of this third vaccine will be distributed across the U.S beginning tomorrow 3/2. Johnson & Johnson stated that they are committed to distribute 100 million doses by June and up to one billion by the end of this year.

Based on clinical trials, J&J claims that as of now this one-dose vaccine is 72% effective against preventing mild/severe COVID-19 disease. Its rivals, Moderna and Pzifer, are both over 90% effective against this virus. Despite the percentage differences, health experts say that all three vaccinations are highly effective.

All three of these vaccines contain basically the same genetic instructions. What distinguishes J&J’s vaccine from the others is the delivery system. Both Moderna and Pfizer are packed in the form of RNA and J&J’s vaccine is in the form of DNA.

Another major difference is that the first two vaccines must be kept in specialized freezers to prevent the RNA from decaying. This third vaccine is fairly stable and can be preserved in refrigerators for months.

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Should I get a Covid Vaccine? What the CDC Says

Americans today have a lot of questions about the COVID-19 vaccine. The most frequently asked question is: “Should I get the vaccine if I’ve had a reaction to other vaccines in the past?” Typically, they’re referring to other vaccines such as the flu shot.

The answer, according to the Centers for Disease Control and Prevention (CDC), is to ask your doctor. If you’ve had an immediate allergic reaction in the past, whether it was minimal or severe, your doctor can help you decide if you should get the COVID-19 vaccine or not.

The CDC also warns people not to get the 2nd COVID-19 vaccine dose if they had a severe allergic reaction to the first one. One of the common reactions to this vaccine is anaphylaxis, a critical allergic reaction in which the body becomes hypersensitive. There are also reports that this vaccine has triggered other reactions such as Bell’s Palsy and Thrombocytopenia.

For those people who have had either Guillain-Barre syndrome (GBS) or Bell’s Palsy in the past, the CDC says that you can still get the vaccine. However, it is best to consult with your doctor before making that decision.

Continue ReadingShould I get a Covid Vaccine? What the CDC Says

Moderna COVID-19 Vaccine Approved

The FDA approves a second COVID-19 vaccine as daily death and infection rates spike across the country.  The CDC voted 11-0 to approve the Moderna vaccine in people 18 and older. Earlier in the week, the FDA gave Moderna an Emergency Use Authorization (EUA) after reviewing clinical trials.

Moderna vaccines will begin shipping out on Sunday, December 20th and people could start getting these shots by Monday the 21st. This vaccine also needs a second dose about a month after the first for full effectiveness.

Side Effects and Reactions to the Moderna COVID-19 Vaccine

Side effects from the Moderna vaccine include fatigue, chills, headaches, arm pain and swelling. More serious vaccine injuries include possible anaphylaxis and Bell’s Palsy. The Pfizer vaccine also had some early indication during trial phases that Bell’s Palsy could be a known reaction. People with a history of allergic reactions are being warned not to get the shots.

COVID-19 and Vaccine Injury Compensation Programs

For people in the United States who experience a severe vaccine injury or reaction after the COVID-19 shot, there are two federal vaccine injury compensation programs: The National Vaccine Injury Compensation Program (VICP) and The Countermeasures Injury Compensation Program (CICP).

The attorneys at Maglio Christopher & Toale, P.A. are reviewing COVID-19 vaccine injury cases across the country. Our attorneys have represented more people in the vaccine injury programs than any other firm and have won hundreds of millions of dollars in compensation for our clients.

Comparison of Pfizer and Moderna COVID-19 Vaccines

The Moderna and Pfizer vaccines are similar to each other, but the Pfizer version is approved for children 16 years up.  Neither immunization gives you a weakened or inactivated version of the virus to build immunity. Instead, the mRNA vaccine injects you with instructions for your immune cells to create a piece of protein that the rest of your body fights off with antibodies. This protein is similar to the COVID-19 strain, so when your immune system deals with the actual coronavirus, it already knows how to fight it off.

Continue ReadingModerna COVID-19 Vaccine Approved

CDC, FDA Approve First COVID-19 Vaccine for U.S.

The first COVID-19 vaccine approved by the CDC will start rolling out on Monday. On Saturday, Dec 12th, the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted 11-0 to approve the Pfizer – BioNTech version of the vaccination. The panel approved the 2-shot vaccine for people 16 years and older.

Hospitals expect to get nearly 3-million doses delivered as soon as this Monday in what’s being called D-Day for the vaccine distribution with assistance from the military.

The CDC says it will monitor the vaccine for signs that it causes Bell’s Palsy as a vaccine injury. Four people in the test phase of Pfizer’s COVID-19 vaccine experienced facial paralysis reaction known as Bell’s Palsy. British drug regulators have warned people with severe allergies not to get the new vaccine after several cases of anaphylaxis in the UK. The FDA is requiring Pfizer to track anaphylactic reactions in the U.S. because of the British cases.

COVID-19 and Vaccine Injury Compensation Programs

For people in the United States who experience a severe vaccine injury or reaction after the COVID-19 shot, there are two federal vaccine injury compensation programs: The National Vaccine Injury Compensation Program (VICP) and The Countermeasures Injury Compensation Program (CICP).

The attorneys at Maglio Christopher & Toale, P.A. are reviewing COVID-19 vaccine injury cases across the country. Our attorneys have represented more people in the vaccine injury programs than any other firm and have won hundreds of millions of dollars in compensation for our clients.

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Jury Awards $20 Million Verdict to Victim of Defective Metal on Metal Hip Replacement

A St. Louis jury sent a $20 million dollar message to Biomet Orthopedics in Federal Court today. The verdict sided clearly in favor of Mary Bayes, who suffered extensive heavy metal poisoning and 6 traumatic hip revision surgeries because of the metal on metal hip replacement.  The trial relied upon testimony and evidence uncovered by the metal on metal hip team at mctlaw.  
 
The legal team at Maglio Christopher & Toale, P.A. spent years investigating metallosis and heavy metal poisoning caused by metal on metal hip replacements. From secret files of hip replacement manufacturers, they were able to determine what the manufacturers knew and when they knew it. This process took years and was accomplished by painstaking document review, continual court battles, and verbal examinations of evasive company employees. Our attorneys have personally questioned under oath dozens of marketing executives, testing engineers, and the CEO’s of some of the largest medical corporations in the world. 
 
“The horrific injuries suffered by Mrs. Bayes are what we have been warning about for years,” says mctlaw attorney Ilyas Sayeg, who attended the St. Louis trial. “People with metal on metal hip replacements are still going about their lives unaware that they have ticking time bombs in their hips.”
 
Despite severe injuries and even deaths from heavy metal poisoning caused by metal on metal hip replacements, the United States Food and Drug Administration continues to stand by and do nothing. While manufacturers stopped selling metal on metal hip replacements in the United States, they have never been required to recall or warn patients of the dangers posed by the hip replacements. In fact, tens of thousands of patients in the United States have metal on metal hip replacements implanted in their bodies but don’t even realize it. They believe that if there was a problem with their hip replacement, the FDA would let them know. Unfortunately, that has not happened.
 
Today’s compelling $20 million dollar verdict shows that juries understand that orthopedic corporations have put profits before the safety of their patients for a very long time. Victims like Mary Bayes are left with a hefty verdict, but she is still horrifically injured and will never recover from what the metal on metal implants did to her body, her health, and her life. But this verdict is not the end of the trial. The next phase will award punitive damages in this case. Punitive damages are considered a financial punishment against the defendant when their actions are found to be in flagrant disregard for the safety of others. 
 
Maglio Christopher & Toale, P.A. is a national law firm with offices in Sarasota, Florida; Washington, DC; and Seattle, Washington. After filing the first metal on metal hip replacement case in 2008, mctlaw has gone on to represent metal hip patients in courts across the country.
Continue ReadingJury Awards $20 Million Verdict to Victim of Defective Metal on Metal Hip Replacement

Research Shows Neurological Issues Linked to COVID-19

A new study shows up to 80% of COVID-19 patients have experienced neurological symptoms. The Northwestern University Feinberg School of Medicine study of 509 patients found the coronavirus can affect more than the respiratory system, with some alarming potential impacts to the brain.

Common symptoms of the virus are loss of smell, fever, fatigue, and respiratory issues. But this study found many patients also experienced muscle aches, headaches, and encephalopathy (defined as a disease in which the functioning of the brain is affected by some agent or condition such as a viral infection or toxins in the blood). Encephalopathy can affect memory, cognitive abilities, personality changes, and cause inflammation of the spinal cord. Not so common are manifestations such as stroke, seizures, and ataxia, which is a drunk-like state.

Other worldwide studies reveal some COVID-19 patients were diagnosed with Guillain-Barre Syndrome. This rare disorder happens when the body’s immune system attacks the nerves, eventually leading to paralysis.  A clinical trial for a COVID-19 vaccine was recently put on hold after triggering a neurological reaction, transverse myelitis, in one of the test participants. 

Scientists say more study is needed on the potential long-term effects of coronavirus on the brain.

Continue ReadingResearch Shows Neurological Issues Linked to COVID-19

COVID-19 Vaccine Injuries Harder to Get Compensation from Government Program

Those who suffer injuries or life-altering conditions from the upcoming COVID-19 vaccine will face difficulties getting vaccine injury payouts. The Wall Street Journal reporting COVID-19 vaccine injuries will be covered by what’s called the countermeasures vaccine injury compensation fund. It was set up 10 years ago to cover injuries from vaccines for a flu pandemic, or drugs to treat an Ebola or Anthrax outbreak.

This countermeasures program makes it harder to file claims than the existing National Vaccine Injury Compensation Program (NVICP). This established program is funded by a vaccine tax, paid by drug companies on each vaccination. Money is awarded to people who suffer an injury from common vaccines recommended for children or pregnant women and recently included conditions related to the seasonal flu vaccine.

People injured by the COVID vaccine who file claims can expect their compensation will be much lower than those paid by the vaccine injury fund (NVICP). Vaccine Injury lawyers and vaccine experts say the average claim under this countermeasures program is $207,000. The vaccine injury fund awards average more than double that at $585,000.

In the rush to develop a vaccine, serious injuries can affect some people in the vaccine trial. Many receiving the COVID-19 vaccines in these trials have experienced side effects like chills, fever, fatigue, and pain where they were injected.  Two vaccine trials were paused in the United States after participants developed illnesses. AstraZeneca/Oxford’s vaccine trial and Johnson & Johnson’s single dose vaccine trial are both still shut down in the U.S. as scientists and regulators investigate.

Continue ReadingCOVID-19 Vaccine Injuries Harder to Get Compensation from Government Program

Another COVID-19 Vaccine Trial Paused After Illness

Another COVID-19 vaccine trial is now on pause after a study participant’s unexplained illness. The Associated Press reports that Johnson & Johnson is investigating if the person’s illness is related to the coronavirus vaccine. Johnson & Johnson joins AstraZeneca/Oxford as the two drugmakers to stop vaccine trials because of side effects. 

No details were released by Johnson & Johnson about the study participant’s illness or their current condition. A woman in the Astra/Zeneca trial developed severe neurological symptoms consistent with transverse myelitis, an inflammation of the spinal cord.

Johnson & Johnson is testing a one-dose vaccine, while the other drugmakers working to create a safe and effective COVID-19 vaccine are working on a 2-dose approach.

Continue ReadingAnother COVID-19 Vaccine Trial Paused After Illness

Covid-19 Vaccine Transverse Myelitis Reaction Investigation Expanded

Reuters reports the US Food and Drug Administration (FDA) has expanded its investigation of a serious vaccine injury in AstraZeneca’s COVID-19 vaccine study. The company’s late-stage US trial has been on hold since September 6th after a study participant in England was diagnosed with transverse myelitis, a rare spinal inflammatory disorder.  Participants in other studies have reported day-long side effects from the COVID-19 test vaccines

AstraZeneca’s effort to come up with a coronavirus vaccine had been one of the most advanced before the FDA began a probe.  President Trump pledged $1.2 billion to support the development of AstraZeneca’s vaccine, but the trial is now on hold.

The FDA will be looking into the data from earlier AstraZeneca trials of similar vaccines developed by the same scientists working on this one. The pharmaceutical company is one of 4 in the United States now in phase 3 Covid-19 vaccine trials, the final stage in developing a safe and effective vaccine. The other trials underway are from Moderna, Pfizer, and Johnson and Johnson.

Source: https://www.reuters.com/article/us-health-coronavirus-vaccine-astrazenec/exclusive-fda-widens-u-s-safety-inquiry-into-astrazeneca-coronavirus-vaccine-sources-idUSKBN26L3TA

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Coronavirus Vaccine Trials Showing Day Long Side Effects

Some coronavirus vaccine trials are showing day-long side effects, but participants say it’s worth it, according to CNBC, reporting on the vaccine trials from Moderna and Pfizer.

Some of those receiving the trial COVID-19 vaccine say they experienced exhaustion, high fever, body aches, and headaches. Participants also said the symptoms were uncomfortable and sometimes intense, but most often, went away within a day.

One participant in the Moderna vaccine trial says he felt under the weather for several days after getting the first dose. About a month later, he received the second dose of the vaccine and says he was bed-bound with a high fever and experienced shakes, chills, headache, and shortness of breath. But after about 12 hours, the participant says he felt back to normal. Other participants have reported similar side effects after getting the 2nd dose of these trial vaccines.

Moderna and Pfizer have admitted their vaccines could have side effects similar to COVID-19 symptoms. Both vaccines are in phase 3 trials where thousands of volunteers get the vaccine and scientists study their effectiveness and safety. A recent coronavirus poll shows that many Americans say they will avoid the vaccine when it’s first released. 

Four U.S. backed vaccine candidates are now in phase 3 trials. It is hoped at least one safe and effective coronavirus vaccine will be ready by the end of the year.

Source: https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html

Continue ReadingCoronavirus Vaccine Trials Showing Day Long Side Effects

Poll: Americans May Avoid COVID-19 Vaccine When First Released

A new poll shows many Americans will not get a first-generation COVID-19 vaccine as soon as it becomes available because they do not trust the pharmaceutical companies to adequately test the immunization. The latest Axios/Ipsos poll reveals 60% will avoid the vaccine when it’s released, while 39% say they will get the vaccine. These poll numbers reveal a growing lack of trust in that still under development first-generation vaccine. This latest poll shows those who say they will get the vaccine has dropped 8 points (47% to 39%) since late August 2020.

Most of those polled don’t expect to pay any out of pocket costs for the vaccine, instead, they’re expecting insurance or the federal government to pay for it. About half only want to spend $50 or less for a vaccine, while another one-third say they are not willing to pay anything for the coronavirus vaccine.

The poll also shows more parents are turning to distance learning after COVID-19 scares in their school districts. 64% say they are using virtual or distance learning for their children. That number continues to rise since the start of the school year.

The poll’s results also show the emotional toll that distance learning is having on students. Since early August, parents of distance learning students are more likely to report a decline in their child’s emotional health. In fact, more than 1 in 3 (37%) say this is the case. That’s higher than the 27% of Americans who say their emotional health is getting worse because of the virus and its impact on our lives.

Experts say that it could be more than a year before the COVID-19 vaccine is available to the general public 

Continue ReadingPoll: Americans May Avoid COVID-19 Vaccine When First Released

What are the Stages of Vaccine Development and Testing?

With so much research happening around the world to come up with a cure for a vaccine for the coronavirus, it’s important to understand how that research happens.  Below we’ve explained the different phases of COVID-19 vaccine development and what each of them means.

PRE-CLINICAL TRIALS

The development of a vaccine for the coronavirus begins in pre-clinical trials, where a potential vaccine is tested in animals and in the lab.

PHASE 1

Once it passes that test, the vaccine moves on to Phase 1, where a small number of healthy people are given a dose. At this point, scientists are assessing the safety and effectiveness of the vaccine.

PHASE 2

In Phase 2, the potential vaccine is tested on hundreds of people, including those who are at a higher risk of illness like the elderly and children. Scientists are looking at the vaccine’s safety and if it can stimulate the immune system.

PHASE 3

The final hurdle for a potential vaccine is Phase 3 trials. Thousands of people will receive a dose of the vaccine. Scientists study how many of them become infected, compared with those who received a placebo. This final phase should also show evidence of any vaccine injuries that may be missed by other studies. The FDA is requiring the vaccine will have to protect at least 50% of those vaccinated, although it is hoped it will be more effective than that.

Once the vaccine is distributed, scientists will continue to monitor its effectiveness and safety.  However, medical experts say a vaccine could take up to a year before the entire US population has access to one.  Even more troubling, recent polls show that a majority of Americans may not feel it’s safe to get the vaccine right away. 

Source: The New York Times

Continue ReadingWhat are the Stages of Vaccine Development and Testing?

COVID-19 Vaccine Likely a Year Away for Most People

The nation’s top expert on COVID-19 says even though a vaccine is expected by early 2021, it will likely be the end of next year before life gets to a pre-pandemic normal. NBC News reports Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, says a COVID-19 vaccine should be approved within the next couple of months. However, it will be several more months before enough doses can be produced and distributed for the general public.

Fauci says the most vulnerable to the coronavirus will be first in line to receive the vaccine. This includes healthcare workers, those with underlying conditions, and the elderly. Dr. Fauci says the vaccine, when ready, will not be 100% effective and that if we’re lucky, the vaccine will be about 70 to 75% effective.

Once the vaccine is distributed, Fauci warns it will not signal the end of the public health measures that have been in place since the pandemic began last spring. Mask wearing and social distancing meant to keep the virus at bay, will allow us to get back to some sort of “normal” sooner.

Several vaccines being developed now in the United States are in the third and final stage of testing. Dr. Fauci expects to know if any of them work by November or December and possibly sooner.

Source: https://www.cidrap.umn.edu/news-perspective/2020/03/fauci-vaccine-least-year-away-covid-19-death-toll-rises-9-seattle

Continue ReadingCOVID-19 Vaccine Likely a Year Away for Most People

mctlaw Welcomes Attorney Jeffrey Nelson

Attorney Jeffrey Nelson Named Assistant Attorney General for Oklahoma Indian Tribe

Jeffrey Nelson was appointed Assistant Attorney General for the United Keetoowah Band of Cherokee Indians in Oklahoma. Mr. Nelson will represent the Tribe in matters involving tribal governance, Indian gaming, and other matters as assigned by the Attorney General. The Tribe’s Attorney General, Klint A. Cowan, stated “The Tribe is excited to have access to Mr. Nelson’s extensive gaming experience and wise legal judgment. We look forward to working with Mr. Nelson and his new Firm.”

Attorney Jeffrey Nelson Headshot
Attorney Jeffrey Nelson

One major area of law where Nelson will assist the Tribe will involve the legal ramifications of the U.S. Supreme Court’s recent ruling in McGirt v. Oklahoma that the Muscogee (Creek) Reservation was never disestablished by Congress, and therefore still exists. Because there are several reservations in Oklahoma that share the same history, the effect of this decision means that much of eastern Oklahoma is within one of several Indian reservations, including the 14-county Cherokee Reservation, shared by the Cherokee Nation of Oklahoma and the United Keetoowah Band of Cherokee Indians. The Supreme Court’s decision brings into question many potential legal issues regarding the Cherokee Reservation.

Mr. Nelson recently joined Maglio Christopher & Toale, P.A. as a firm partner. He brings a wealth of experience to mctlaw, including his time as an Assistant Solicitor at the Department of the Interior and as a Senior Attorney at the National Indian Gaming Commission. “We’re honored to welcome Mr. Nelson to mctlaw as our firm’s practice in the Court of Federal Claims expands,” says Managing Partner Altom Maglio. In addition to his work for the United Keetoowah Band of Cherokee Indians, Nelson will focus his legal practice on other federal Indian law issues and complex civil litigation, including vaccine injury cases.

Continue Readingmctlaw Welcomes Attorney Jeffrey Nelson

ACCV Meeting on Proposed Removal of SIRVA and Syncope from Vaccine Injury Table

Advocacy groups and business industry leaders from across the country gathered on Monday during a governmental meeting to say they are all opposed to removing SIRVA and syncope from the National Vaccine Injury Compensation Program (NVICP).

On Monday, May 18th, the Advisory Committee on Childhood Vaccines (ACCV) met to discuss proposed changes to the Vaccine Injury Table. The Secretary of Health and Human Services proposed removing SIRVA and syncope from the Vaccine Injury Table because these injuries are “depleting the pool of funds available to those injured by vaccine antigens,” which is false.

After hearing from medical doctors, the pharmaceutical industry, vaccine administrators, and vaccine injury attorneys, the ACCV unanimously rejected the removal of SIRVA and syncope from the program. The ACCV is a committee within HHS that advises the Secretary of Health and Human Services (HHS) on issues relating to the NVICP.  No one from HHS showed up to the meeting to support its suggestion that these injuries should be removed from the Vaccine Injury Table. 

Below find relevant excerpts from the many letters presented during the ACCV meeting showing strong support for keeping SIRVA and syncope within the Vaccine Program:

Vaccine Injured Petitioners Bar Association (VIPBar)

The NPRM creates more problems than it attempts to solve, and even a forthright and comprehensive deliberation of the NPRM with individuals regularly involved in the NVICP would highlight the NPRM will only irreversibly damage the NVICP.

National Association of Chain Drug Stores (NACDS)

NACDS urges ACCV to recommend that HRSA not proceed with the NPRM, as the HRSA proposal would likely result in dramatically negative public health consequences by significantly reducing Americans’ access to vaccinations. Especially in this time of nationwide pandemic and associated health care crises, we believe it would be unwise to adopt such a health policy change.Ironically, the HRSA proposal would limit access to vaccinations, which are the only potential preventative treatment that could halt the spread of the coronavirus.

American Pharmacists Association (APhA)

“By seeking to remove vasovagal syncope and SIRVA from the Vaccine Injury Table, HRSA’s NPRM threatens patient access to COVID-19 and other critical vaccinations. Rather than encouraging vaccination, this proposal could severely impact our nation’s ability to research, develop, and widely administer life-saving vaccines due to concerns about potential liability.”

Biotechnology Innovation Organization (BIO)

“The Biotechnology Innovation Organization (“BIO”) is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.”

“We also question whether SIRVA and syncope claims pose a risk of “reducing the funding available for children and others who are injured by vaccine antigens. The fund balance as of January 31, 2020 is greater than $4 billion. It has continued to grow even after SIRVA and syncope were added to the Table. It therefore does not appear that inclusion of SIRVA on the Table, to say nothing of syncope, is putting the fund at risk.”

Dr. Uma Srikumaran MD, MBA, MPH Associate Professor of Orthopaedic Surgery Johns Hopkins School of Medicine

1. The scientific evidence does support a causal relationship between injection of vaccine antigen and SIRVA. SIRVA should remain a table injury and the evidence is summarized above.
2. The policy reasons to remove SIRVA are weak and the policy reasons to keep SIRVA are much stronger, summarized above, and maximize the net benefits related to economic, public health, safety, and equity issues.

Anne Toale, Vaccine Injury Attorney with Maglio Christopher & Toale, P.A.

Our firm also strongly disagrees with the proposal to remove SIRVA and syncope from the NVICP. You can read our complete statement below: 

Continue ReadingACCV Meeting on Proposed Removal of SIRVA and Syncope from Vaccine Injury Table

Guillain-Barré Syndrome in the NVICP

Facebook Live on Guillain-Barré Syndrome in the NVICP

mctlaw attorneys Anne Toale, Danielle Strait, Diana Stadelnikas and Isaiah Kalinowski went live on facebook to discuss GBS in the NVICP. Watch the video here or read the transcript below.

Transcript

Anne Toale: Hi. Welcome to our talk about getting compensation in the vaccine injury compensation program for a rare vaccine reaction known as Guillain-Barré syndrome, or GBS. This is a rare disease, but its association with vaccination is well known. I’m Anne Toale and I’m a partner at mctlaw, a nationwide law firm representing people injured by medical products.

I have been representing people injured by vaccinations for 17 years, day in and day out. I have three of my partners here with me today, and so I’ll let them introduce themselves.

Danielle Strait: Hi, my name is Danielle Strait. I’m an attorney in Maglio Christopher and Toale’s Seattle, Washington office. I’ve been representing people with vaccine related injuries for about eight years now, and for the three years prior to that, I worked as a law clerk at the us court of federal claims, which is the court that hears these cases.

I’m very passionate about the work that we do, and I’m really glad to be with you all today teaching you about the program and about GBS.

Diana Stadelnikas: Hi everybody, my name is Diana. I work in the vaccine team. I’ve been on the vaccine team about 10 years. I work in the Florida office. I come to the practice of law with a background as a pediatric critical care nurse and like my partners, i’m also very passionate about the work that we do and the program that we’re working in.

Isaiah Kalinowski: Hi everyone. My name is Isaiah Kalinowski.  Like Danielle. I worked at the court that hears these cases for about four years. And since 2010 I’ve been in their Washington DC office, which is about two blocks away from that court representing vaccine petitioners every day since then.

Anne Toale: Thanks, Isaiah. So today we’re talking about a specific condition Guillain-Barré syndrome, like I mentioned before, and how we can help you get compensation for GBS. But take a look at our website, mctlaw.com, where we have a list of all kinds of other conditions that can be caused potentially by vaccination.

, and that way you can find out, what other conditions when we might be able to help you with. But GBS basically is an auto immune disorder. And what that means is your body’s immune system gets confused and starts attacking itself. And so this will look like your feet and your hands, your legs and your arms are slowly becoming paralyzed and even your lungs potentially, and you might stop breathing.

So depending on how severe that is, usually you’ll end up in the emergency room. And if you get care right away, and a proper diagnosis, then you can hopefully have a pretty good outcome from your GBS. But other people don’t have such a good outcome and they actually end up in a wheelchair for the rest of their life.

So there’s some variation with that. , Danielle, what are some vaccines that can be associated with GBS?

Danielle Strait: That’s a great question. And so the vaccine injury program itself looks at many different vaccines and vaccine related injuries. As you said, some of those vaccines are going to be influenza or your annual flu shot.

The hep shot hepatitis A, B, MMR. Tetanus shots, which are also called T dap or Dtap, meningococcal, polio, and HPV. But the vaccines that we see most commonly associated with Guillain-Barré and where we represent the most clients are going to be your influenza vaccine. The tetanus and tdap vaccine and also your hepatitis B vaccine.

I think one of the things that is confusing because this isn’t a well known disease until you get it, is that relationship. A lot of my clients end up with their primary care doctor or with urgent care. And while the doctors are taking a history, it comes to light that they’ve had a vaccine shortly before onset of those neurological symptoms.

But a lot of my clients are either told it’s not related to those vaccines or they do Googling. They’re on their own and they find out that there could be a relationship and they contact us. So it’s very important for people who think that there is a relationship between the GBS, that they get a vaccine.

They had. To contact the law firm like ours or get on our website, www.mctlaw.com and check out the information we have for therapy for folks.

Anne Toale: Right? I mean, that’s a good point. And what I see in a lot of my cases involving GBS is that primary care doctors, not so much, but in when people are in the hospital and a neurologist comes to see them and they’re considering what could be wrong with you, because you’re suddenly becoming paralyzed.

And when they start thinking about GBS. Usually neurologist actually will ask how you gotten any vaccines in the past several weeks because it is just, it’s one of the more well known vaccine reactions that can happen and that’s, you know, that’s pretty well established. So

Diana Stadelnikas: I’m sorry, I just want to, one thing to point out too is that it’s not a disease that’s limited just to adults either.

GBS is a disease that also impacts infants and children as well.

Anne Toale: That’s right. We had a really significant GBS case in the firm that, and actually went to trial that involved a baby. , and the defense was, GBS doesn’t happen in babies. , but we won that case and got that kid a very, very sizable, very sizable where it actually, that was life changing for him.

, so Isaiah, I’m going to ask you to talk about earlier, you mentioned that you previously worked in the vaccine court. And so tell us more about that because there is just one court where all the vaccine claims are. Are brought for the whole country. And we, we practice all over the country and meaning we represent people from all over the country.

So, but we all go to that one vaccine court in DC where you worked. And so tell us how that works.

Isaiah Kalinowski: That’s right, Anne. Thanks for, thanks for that. , the court is in, in Washington DC and hears all vaccine cases for the whole country. , the court does travel, as needed sometimes, to where people live, but it is in DC and claims have to be brought to this court.

They cannot be brought in other courts, whether federal or state. , it is administered as a no fault compensation program in which we’re pursuing compensation out of a federal fund that’s funded by vaccines. So it’s no fault. We’re not suing anyone’s doctors. We’re not suing pharmacies. So, you don’t need to worry about that.

And in addition, we don’t require anything from you upfront. , some paperwork, some information, but you do not need to pay anything upfront to us. And at the end of the case, when you’re compensated, we do not take anything from your amount of compensation. , our, our fees are paid after the fact by the court as part of this compensation program.

. But the important thing I want to reiterate and is that we, you must act quickly because the one aspect of this being a federal program is there is a very hard deadline to claims. So if you, a person thinks they’ve experienced the vaccine related, adverse reaction, they need to contact us or someone like us, very soon thereafter.

Anne Toale: That’s right, Isaiah. Diana, I want to ask you about what’s it like representing people with GBS? I mean, firstly, what kinds of, what kinds of ways are people’s lives impacted by having GBS?

Diana Stadelnikas: I could probably talk for hours on that, but I’ll try to be quick.

, I think, you know, our goal is to try to get folks who are severe.

Some, some, some folks are not injured. They recover from GBS fairly quickly. Some folks, I have one client. Gentlemen who in his mid-forties was a breadwinner of the family who was paralyzed from GBS and ended up in a wheelchair unable to work again. , through the program, we were able to get him, recovery.

, the wage replacement, as we talked about before, we were able to get him into, a new residence that’s was accessible for his,

his life, which was now limited to a power scooter, which we also got through the [00:09:40] program. , a modified, accessible, wheelchair van, so that he could get around with his family and also, home health services so that his wife could

get some help with the care that he needed.

Anne Toale: , it sounds like that really made a difference in that person in my family’s lives. , so. Oh, that brings me to the point where a lot of people ask us, you know, right at the beginning, a lot of clients ask what, well, how much is my case worth? Like how much money are you going to be able to get from me?

And obviously the answer to that as well, it depends. It depends how, how severe your injury is. Like you were just saying, Diana, some people recover really well and don’t, don’t really miss out on that much, and other people are, are way worse off than others. So Danielle, what would you, how would you answer that question?

Like what’s my case for it’s how much can I get.

Danielle Strait: You’re right, and that is one of the most common kind of first questions that people ask us. I always think of it as three different buckets of money. One for lost wages because of the vaccine injury, one for out of pocket medical expenses, both past and future.

And then another, some for pain and suffering, which has kept, which we’ll talk about. But I have a client in the Midwest. He was an insurance agent, kind of a middle of the road case, but he had a lot of residual damages because of the GBS. A lot of fatigue and a lot of neuropathic symptoms that the numbness and tingling wasn’t able to get around quite as much.

So he did go out of work, but he was able to return part time. He had great insurance, so no out of pocket medical expenses. So that bucket was really empty for him. But as far as lost wages, he was able to get his past lost wages and also as some for future lost wages, which allowed him to remain part time because of the GBS symptoms he was left with.

And then with the amount for pain and suffering, and he was about a $350,000 case. So a good s of money to get him to a point where, you know, you still have those symptoms, but he’s able to provide for his family and still kind of go on living a happy and fulfilling life. And it was really meaningful.

Anne Toale: Right, right. Isaiah, what, what about a case where someone is, you know, essentially a quadriplegic and they really don’t recover at all? I mean, they, they have insurance, so that’s paying for some things, but, . How can the program help with, you know, home care and future medicals, like for people like that?

Isaiah Kalinowski: Well, that the asset and the, the pro, the act specifically provides for therapies and that includes vocational and occupational therapies as well as home modifications as necessary. And some of those therapies, you know, are sort of, it can be very tailored to the person, equine therapies and water therapies.

And. , and Diana has had a lot of experience with that. , and you know, it, it really depends on the case. And we, we really explore every month we’re representing someone to see what’s going to help them the best

Diana Stadelnikas: I say. I think, I’m sorry. And I think you brought up a good point. I stay at that. The one key about the program and, and the experience that we’ve all brought to the program is that these awards and, and what you can get for the clients to make them bring them back to their new normal, in dealing with it.

With right. Is that it’s so individualized and, and we try to, we try to work, we work with the clients closely to find out what is it that they specifically need to make their new life as normal as possible when dealing with the and variety. It’s very, very individual specific.

Anne Toale: Right? I mean, because some people are so debilitated by this, then they need lifetime care and potentially even near round the clock care.

And that, which is great because that way it takes the burden off the spouse and other family members of having to care for them. And you can have someone like that come into your home and help with bathing and dressing and just everything, all the regular life activities that they’re having a hard time

Isaiah Kalinowski: One thing is we don’t want to encourage, we don’t want to discourage people who don’t have the catastrophic. , I’ll come like that because we can help people who have moderate outcomes as well. It’s worth it. So people kind of asked me, is it even worth it to file a petition? If I have to pay something, it’s going to be a lot of work.

You’re going to take a cut. Why? Why is it even worth it? But because as I said a minute ago, we don’t, we aren’t taking anything out of this. It is worth it. I just had settled a case the other day of someone that was less than a hundred thousand dollars total compensation because they didn’t, they weren’t put on their back. They were, it was a different kind of GBS that affected their face and their, and their eyes more. They had to wear glasses. They had, you know, it was a different type of case and it was a different kind of outcome, but it was still worth it for him to pursue the outcome that we achieved for him.

Anne Toale: Right? I mean, cause it’s a significant injury, you know, for everyone, even if they have a good outcome. So I agree with you. I think people even with milder cases should still contact us and we can get them something and everyone can use that extra money right now. I think so. Okay. Questions are coming in.

So, let’s see. So Danielle, the first question is, can I hire my own lawyer who I know, I know personal injury lawyer and he does injury law.

Danielle Strait: That’s a question that I think our firm, because of the amount of vaccine injury compensation program experience we have, we hear a lot. And often it’s a situation where they have hired a local attorney, someone they know, and when that attorney gets into the program and realizes it’s a very nuanced program, they realized they might be in over their head. I think we would always recommend to find an attorney who’s very well versed in the vaccine injury program. Not only are they the injuries themselves, they can be very complex, but the program, it’s not your typical civil litigation, I’m going to the courthouse in the County kind of work.

So it really pays off to have somebody that’s experienced and, and, and I would always jp on our website, mctlaw.com and you can check out all of the experience that our attorneys have in the vaccine injury compensation program.

Anne Toale: Right. That’s a good point. We, all of our information is on the website and people should look at that and, and definitely look for an attorney like all of us, or someone like us.

But we are only doing vaccine cases. We’re not doing medical malpractice. We’re not doing car crashes. We’re not doing anything else. We literally just specialize in these cases. And so. You probably want to have the advantage of, of, of a specialist for your case. Another question is, I just found out about this program, but my reaction was over five years ago, Diana.

Diana Stadelnikas: Unfortunately, that time is to get the time to bring that claim has passed. , I would call, I would urge someone, if you do think that you’ve had a vaccine injury or you know, someone who might be suffering from a vaccine injury to please contact our firm or another vaccine injured firm and, and talk to them about your case.

There’s a very limited timeframe and there’s, there’s very little ways around that set timeframe to bring your case act quickly.

Anne Toale: That’s right. It’s that getting calls from people who just didn’t know about the vaccine program, it’s not very well publicized. And like I said earlier, not, not a lot of them.

A lot of doctors or lawyers are aware of it, so, so that is unfortunate. , let’s see. Here’s another question. , Isaiah, you touched on this a little earlier, but the question is, what are you guys going to ask me for when I call you on the phone? Like, what, what do you need from me?

Isaiah Kalinowski: That’s a great question.

And thanks for asking that. Why we need a lot of information that pertains to the things we were just talking about. What are your lost earnings? What is the documentation to substantiate that?

But just to start though, and well, just for a bit of background, I think you mentioned this a minute ago, but we do, we will need to collect all these, their medical records, so we’re going to need their medical history.

But this program, the proceedings are private, meaning the, this is not a public proceeding. Someone can’t go to the courthouse and get your file. In these cases, sealed. The only thing that is will give them public information is the court’s decision at the end. , and so that is something there. But everything else, your records, everything you provide to us, we only provide to the court what’s necessary.

And the court only, and the court keeps that sealed as well. So it is a very private and, but there is specific information we asked for. It has to do with financial, the medical, that sort of background information we need to help the person. But initially we really just need to see your vaccine record and some records that show what diagnosis you have.

Anne Toale: Just to get an idea if it’s something we can help with at all.

But Danielle, I got another question that just came in for you and it’s how long is my case going to take? , whether it’s a settlement or to go to trial or just get it, get some money.

Danielle Strait: That’s a great question. It’s another, one of the questions were asked right off the bat with clients.

I would say, you know, with uncomplicated cases right now, from the time that we file them, and until the time that they actually have compensation in hand, it can be anywhere from two to two and a half years, sometimes even three years. But a lot of our clients, because we have so much experience, because we take such complex cases, you know, there’s a lot more process involved.

We do have to go to trial. We have to get experts involved. Cases like that that are more complex can take anywhere from three, five, sometimes even 10 years. So with any government program, it is not a fast process, but we’re here to help people through it and try to make it as painless as possible.

Anne Toale: Right, right.

Thanks for that. Well, that’s almost all the time we have for today. I want to thank everybody for listening in and learning some more about Guillain-Barré, about the vaccine compensation program and about mctlaw. , I just want to remind you, to go visit our website, mctlaw.com, the question about how much money is my case worth.

There’s a lot of information on our site about amounts that we’ve recovered for other clients, and. They’re listed by injury, so you can see what a typical GBS settlement would be like, or other auto immune disorders that we deal with. , so lots of examples there that you can read about. , so I’m going to say good night and thank you for coming in.

Stay safe.

Danielle Strait: Yeah. Thanks for being with us. It’s been great being here and talking with you all. And like everybody’s said, if you think that you have a vaccine related injury, give us a call. We’re here to help.

Diana Stadelnikas: Good night, everybody. Thanks for joining us. And again, like everyone said, if you do think you’re injured, please contact us.

This program is really the only mechanism and Avenue for you to get the help that you need and we’re here to help you

Isaiah Kalinowski: Thank you for me as well. I look forward to meeting you. If you do end up contacting us.

Danielle Strait: Good night, everybody.

Anne Toale: Good night. Goodbye.

Continue ReadingGuillain-Barré Syndrome in the NVICP

Grey’s Anatomy FaceBook Live on Dr. Weber’s Failed Metal on Metal Hip Replacement | mctlaw.

On April 9th, 2020, ABC aired is season finale of Grey’s Anatomy and the storyline featured problems with Dr. Webber’s metal on metal hip replacement.    

After viewers finished the episode, they took to google to learn more about metal on metal hips. So mctlaw’s attorneys hosted a Facebook Live event to explain how real life medical problems with metal poisoning inspired the this Grey’s Anatomy episode. You can watch a recording of the Facebook Live event above, and the transcript to the video is below.

Transcript

Grey’s Anatomy FB Live

[00:00:00] Ilyas Sayeg: [00:00:00] Hi everyone. Welcome to mctlaw’s Facebook live presentation on metal on metal hips. The real story behind the drama. My name is Ilyas Sayeg, and uh, this is Malio Christopher and Toale. We are a law firm that has been litigating metal on metal hip [00:00:20] cases for many, many years. So we filed the very first metal on metal hip replacement case, a lawsuit in the country back in 2008 and we had been litigating these cases ever since

Michael Cowgill: [00:00:30]

Hi there everybody, my name is Michael Cowgill.

I’m also a member of the MCT law hip litigation team.

[00:00:40] Michele Stephan: [00:00:40] Hi everybody. My name is Michele and I’m also on the hip litigation team. Um, and we’re here tonight because of an episode of Grey’s Anatomy that aired, uh, earlier this week. Um, if you’re a fan, a fan of Grey’s Anatomy, you’ve seen over the past few weeks that something’s happened to Dr. Webber, he’s had a mystery [00:01:00] illness that nobody could figure out, and a season finale.

It was. It was discovered that his problems were stemming from his metal and metal hip implants. Let’s go ahead and take a look at that clip.

Clip From Grey’s Anatomy

[00:01:20] Grey’s Anatomy Video Playback: [00:01:20] I’d say we should bring in someone who isn’t family.

That person doesn’t exist.

Wait, don’t cut, just stop. I was going over Dr. Weber’s history again, and he got a hip replacement three years ago in Boston. [00:01:40] You need to step away from the sterile field.

Let’s me now. That’s it. You’re done. We need to restart. Listen to me. Okay. She told me to do the [00:02:00] biopsy already. His hip replacement was made out of cobalt. We did a heavy metals test and it came back, negative, right? Not for Cobalt, that test is mercury, arsenic and lead. We wouldn’t see that.

That hip is deteriorating.

Bailey, Cobalt poisoning would explain the dementia, the depression, hallucination, tremors, everything. [00:02:20] Okay. And every second it’s in his body is deteriorating, please trust me.

Change of plans, we need to draw some blood. DeLuca, run this down to the lab. Tell them the chief says this to the front of the line.

Attorney Discussion on Metal Hips

[00:02:40] Michael Cowgill: [00:02:47] Shonda Rhimes knows drama. And that’s, that’s what we got there. Some metal on metal, hip drama. And, uh, you know, after this episode aired last week, we noticed a spike in traffic to our firm’s site. And we realized that, uh, you know, [00:03:00] sometimes fiction and reality collide and that’s kind of what we have here.

So we wanted to take the opportunity to explain to everyone, you know, the real story behind metal on metal, hip replacements.

Ilyas Sayeg: [00:03:12] Thank you, Michael. So really the first question is what is a hip replacement? And what we’re going to do is we’re going to put on the screen a photo of [00:03:20] what a hip replacement looks like.

And what you’re looking at now are the four main components that people typically get when they have a hip replacement. The femoral stem. It’s actually something that an orthopedic surgeon places down into your leg, uh, and the surgeon will attach, typically a metal ball on top of the femoral [00:03:40] stem, so that you can see is labeled as the femoral head.

Your hip, meanwhile, will get a metal cup placed into it, and on the inside of that metal cup will click into place a plastic liner. It’s made of polyethylene, a much harder version of your kitchen countertop cutting board, [00:04:00] uh, but the same type of plastic. So what you typically have is a metal on plastic hip replacement.

This is a tried and true technology. It’s been used since the 60s and used very, very successfully. Most orthopedic surgeons actually discuss a hip replacement like this as the greatest advancement in medical [00:04:20] science in a hundred years. In short, these hip replacements work and they work well. So what happened with metal on metal hips.

Michael Cowgill: [00:04:30] Thanks, Ilyas. Why don’t we go ahead and take a look at a metal on metal hip to show you what was really not a great, so not, not a so great advancement in scientific literature. Uh, [00:04:40] can we bring up that metal on metal hip. So what you’ll see here is very similar, but there’s one key difference. The plastic liner is now out of the picture.

So what you’ve got is the metal head rubbing against the metal cup. So you have a direct metal on metal connection, and maybe in theory that [00:05:00] sounds nice. You know, you’re talking about metal, it’s strong, right? We all know that steel girders and so forth, and maybe that means this thing will last longer.

It’ll, it’ll, it’ll give you more longevity. You’ll get more use out of it. Well, unfortunately, that really hasn’t panned out. And like Ilyas said, you know, the metal and plastic came about in the 60s. Uh, these metal on metal hips were also, [00:05:20] uh, invented in the 60s, and they were only used till 1972 and that’s because of the negative effects of metal wear debris.

Effects of Metal on Metal Hips

Michele Stephan: [00:05:30] Thanks, Michael. I can, I can talk about what metal wear debris is and what it does to the human body. Um, as you saw in, um. [00:05:40] The, the last, uh, diagram when the metal ball rubs against the metal shell, there are tiny metal particles that are emitted into the body right around the hip area. With these metal particles do is they can, um, eat away at your tissue, [00:06:00] at your muscle and at your bone.

Um, people who have these symptoms will sometimes start feeling like their hip implants, you know, might be loose. Uh, they have instability in their leg. They might experience some pain, um, or they may just have a general feeling that their, their leg just doesn’t feel right. Um, and that could [00:06:20] be that these metal particles are eating away at the tissue in the bone that holds that hip implant in place.

Um, they also, um, these particles are so tiny that they can get into your bloodstream and this goes to what you saw on Grey’s anatomy, and when the metal gets into your bloodstream. Um, there had [00:06:40] been reports of what are called systemic injuries. So people lose their hair, they can develop tremors, they get skin rashes.

Um, there have been reports of heart issues, um, and then the cognitive function, like what Dr. Weber had. The, the science, uh, as [00:07:00] it pertains to what these metal particles do to tissue in bone is rather solid. Um, it’s still emerging as to these other systemic injuries. Um, if you find that you have a mysterious illness that you can’t figure out, it may be in your best interest to go see your doctor and tell them that you have a metal on [00:07:20] metal hip implants.

Or if you’re experiencing problems, you know, with your current hip implants, um, to find out if you have heavy metal toxicity, doctors will do a blood test. Uh, when the blood test comes back, they’ll be able to tell the levels of cobalt and chromium in your bloodstream. Um, if [00:07:40] they find that it’s necessary, the doctors may order what’s called a Mars MRI, which is a special type of MRI that can look at the tissue and the bone when you have a metal implant in your body.

Um, often if doctors find that there’s a problem, they’ll indicate or they’ll recommend to you that you have the, uh, metal and metal [00:08:00] implant removed and it’d be replaced with a different type of implant that’s not metal on metal

FDA Product ‘Testing’

Ilyas Sayeg: [00:08:05] Okay. So one, one question and one problem is, is this isn’t a new problem.

As Michael mentioned, these implants had been experimented with in the 60s and were abandoned by 1972 how did they [00:08:20] make their way back onto the market? And we need to discuss how the FDA regulates these medical devices. And what you need to know is that the FDA didn’t begin regulating medical devices until 1976.

And unfortunately, uh, it allowed a way for device manufacturers to put brand new [00:08:40] devices onto the market without ever testing for safety or effectiveness. All they would have to do is compare their new device to something that was already on the market, and they’re even allowed to compare it to these previous devices.

If the devices predate the regulations and if the [00:09:00] devices have a history of failure. And because they were allowed to do that in the early 2000s, all of these manufacturers began to market metal on metal hip implants by comparing these new metal on metal had been plants to the ones that failed and were abandoned by 1972 so in effect, [00:09:20] what they were doing was promising.

You as the, the, the, the public that were buying their implants, that they were going to do a better job with these than they did in the 1970s without ever testing whether, uh, what they were saying was accurate and you all unfortunately became their Guinea pigs. And that’s just [00:09:40] unfortunate.

Michael Cowgill: [00:09:41] Thanks for that, Ilyas.

You know, people might also be wondering, really. What, what is the impact of that FDA loophole? And you know, how has this impacted everyday people and our clients are diverse. We, we’ve got an array of clients and we’ve seen an array of impacts. So, you know, you’ve got people who are dance instructors, construction workers, [00:10:00] people who rely on their bodies for making their livelihood.

And then you’ve got people who are avid recreational list, hikers, bikers, runners, and these middle of middle hips were actually. Targeted toward these people, that it was targeted toward younger, more active patients because the idea was metal would wear at a lower [00:10:20] rate than plastic, and they would last longer.

Unfortunately, that just wasn’t the truth. It wasn’t true in the 1970s and it wasn’t true in the 2000s. Uh, and you know, w. Now we see that people have lost their livelihoods. People can’t return to do the hobbies and the activities that they really love and hold dear. So you have people whose lives have been turned upside down, a [00:10:40] similar to dr Weber’s life.

It’s a, you know, it really impacts you and it can create a significant quality of life decrease.

Michele Stephan: [00:10:48] And you would be thinking. That with our FDA, wouldn’t this product be recalled? And the answer really comes down to the fact that the FDA in the United States doesn’t [00:11:00] have the stringent guidelines or the tracking capability as other governments and other, um, in other countries.

Um, so in the United States, very few of these hip implants have actually been recalled. And the problem that stems from that is that doctors and surgeons relying on the FDA for [00:11:20] guidance in treating their patients. And there may be doctors that are left in the dark because they haven’t been told about the issues that come from these implants.

Um, that’s why it’s important for you. If you are having some type of mysterious symptom to specify to your doctor [00:11:40] that you do have a metal on metal implants. Now, we’ve talked tonight about all of the bad things that can come from these metal and metal implants. Um, I don’t want to spoil, uh, the next episode of Grey’s anatomy.

But what we have seen is that once the, uh, offending [00:12:00] product is taken out of, um, client’s bodies there, there is a degree of recovery. There’s some damage that is longstanding. Um, and that’s going to depend on everybody’s individual circumstance. And that’s why it’s very important if you are having any trouble that you go to your doctor and you started investigating this now.

Filing a Lawsuit Against Metal on Metal Hip Manufacturers

[00:12:20] Michael Cowgill: [00:12:21] So you might be wondering, how do I qualify for, for, you know, any legal action related to a metal on metal hip? Do I have a metal on metal hip? Uh, well, you know, the first thing to do maybe to obtain some medical records and talk to your doctor to see if you in fact have a metal on metal hip. Nonetheless, you should also go to mctlaw.com and [00:12:40] you know, later on, you’ll see on the screen our contact information reach out to us.

Uh, we can help with obtaining medical records, reviewing those records. Seeing if there’s a possible case here.

Ilyas Sayeg: [00:12:52] Another question many people have is, uh, most people have never been part of a lawsuit. They don’t know what to expect. They don’t know whether they should do [00:13:00] it. Uh, and sometimes there’s just a bad connotation that comes with being involved in a lawsuit.

And you shouldn’t feel bad about investigating whether you need to file a lawsuit. Uh, and you shouldn’t feel bad about having to file a lawsuit if one of these manufacturers actually does make a Guinea pig out of you. Uh, give us a call. Uh, we’ll look at your case for you and we’ll try to minimize the impact [00:13:20] on your daily life.

Uh, but what’ll typically happen is, uh, we may be filing a lawsuit for you somewhere. We handle that. Uh, there might be some documents you might have to fill out over the course of a few months. Uh, and, and at some point, you might have to sit for a deposition. Uh, what is a deposition that’s going to be where you sit at a table with one of your attorneys, [00:13:40] one of us sitting right next to you.

And the other side’s attorney asking you some questions about what you went through, uh, what you felt, uh, they might be looking at your medical records and asking you some questions, uh, and, and that’s it. You just answer what you know. Uh, apart from that, what we’re going to be doing potentially for a period of many years is fighting to get the [00:14:00] documents out of that company.

They’re not going to want to part with the documents that show that they were putting profit above safety. And we’re going to be fighting to get those documents. And as we do that, we’re going to build leverage to hopefully get a settlement for you and if we need to go all the way to trial, and that is something that we’ll be prepared to do if we need to.

Audience Questions

[00:14:20] Michele Stephan: [00:14:21] Absolutely, Ilyas. If anybody has any questions, please go ahead. And, um. Uh, write them on your screen. Um, we’ll stay on for a few minutes to answer any questions that you may have. Uh, you can also give a call to the office, um, with any questions.

[00:14:40] So while we’re waiting for questions, uh, we do hope that everybody is keeping themselves safe. Uh, during the COVID19 pandemic, our offices are open. We have offices in Sarasota, Florida, and Seattle, Washington, and also in Washington, D C. [00:15:00] um, we’re fortunate that our technology allows us to all work remotely.

Uh, we do so on a typical normal basis because we travel a lot. I’m handling these cases nationwide, both in federal and state courts.

Ilyas Sayeg: [00:15:16] Michelle, we have a question from one of our viewers and the question is, [00:15:20] how do I know what kind of hip I have? Uh, the way that we’re going to, and, and when people call us, uh, what, what we do is we ask them to go to their, uh, medical provider.

Usually the orthopedic surgeon. Uh, and there’s a very particular medical record that will always identify the hip implant. And it’s, [00:15:40] it’s, uh, comes along with the operative note. That’s the surgical notes the doctor made after performing the surgery. Along with that is something called an operative record.

And, uh, many of you may not know, but what actually ends up happening in most of these surgeries. Is that a sales rep goes into the operating [00:16:00] room with the surgeon. The sales rep brings boxed devices into the O.R. The surgeon will cut the patient up, cut the patient open, uh, and will figure out exactly what size device is needed.

We’ll ask the sales rep, okay, I need a S a size 56, and the sales rep will then get [00:16:20] the box size 56 device, hand it to, uh, a nurse. The nurse will start opening the box. There’ll be a little label inside that box. That label is a sticky label. It gets put on a page. And the sales transaction occurs when that sticker gets put on the page.

The sales representative in the [00:16:40] room, and you didn’t even know that while your surgeon was operating on you. A transaction took place. That document becomes the main way that we identify what type of hip implant that you get. And

Michele Stephan: [00:16:52] Ilyas, I can just add to that. Often, after you’ve had your hip implant, you’re going to get a little card for your [00:17:00] wallets, um, that will identify, uh, the manufacturer of the product, uh, and the type of product that you might have.

Michael Cowgill: [00:17:09] I think we’ve got another question here. Someone asking. You know, do, do we sue your doctors, your, is your doctor someone that needs to be sued in this process? And the answer to that though, the simple answer [00:17:20] is typically no. So, uh, these lawsuits are focused on the manufacturers of the metal and metal hip products.

Uh, you know, as we discussed, or as Michelle said earlier, it’s really. Yes. The FDA has this loophole for approval of these products, uh, and it’s kind of dropped the ball here. So manufacturers have been able to get these through, [00:17:40] and doctors who rely on the FDA aren’t getting the information they need. Um, so it’s not necessarily, you know, a doctor’s fault.

It’s not something that we’re going to bring against a doctor. It’s about the manufacturer who created the product.

Ilyas Sayeg: [00:17:51] Yeah. And, and to be clear, what we don’t do here, we do not pursue these like malpractice claims. And as Michael was saying, we don’t go after the [00:18:00] doctor. Uh, we want the doctor on our side. Uh, so if there’s any type of malpractice element where you believe your doctor may have done something wrong, uh, we can help you go to different attorneys to look at that. But we have a strategy on our side, we do not think it’s worth blaming the doctor when the doctor got duped as well.

[00:18:20] Michael Cowgill: [00:18:20] And Ilyas, so it looks like we’ve got another good question here. Maybe you can field that. So why didn’t the government recall all of these hips?

Ilyas Sayeg: [00:18:28] Sure. Uh, and, and unfortunately, um, the FDA in this country doesn’t do its job. Uh, we should all expect and reasonably, uh, that the [00:18:40] FDA’s sole purpose to exist is to make sure that medical products are safe and effective. Before, people are allowed to sell them to us. They do not do that for devices. Uh, they, they literally do not require devices to be tested for safety or effectiveness before they’re sold in the same way they, they, uh, don’t [00:19:00] have a, uh, required process to test how these products do once they’re on the market.

Uh, it is voluntary for the device manufacturers to report when devices fail. They get to pick, uh, if and when they are or aren’t going to report. So what you have is a [00:19:20] process with the FDA where there’s severe under-reporting. Um, and, and frankly, uh, the FDA is usually headed by somebody who’s been working in the industry.

Uh, I, I think that, um, working on these cases have shown us that unfortunately, Australia is the leader in the world to have a regulator [00:19:40] that actually, uh, prioritizes the safety of patients instead of, um, the priority, the profits of the manufacturers. 

Michele Stephan: [00:19:48] Unfortunately, and as you can see, there’s, there’s been a lot of information that we’ve learned about not only the FDA, um, but about different government’s [00:20:00] tracking systems and also different manufacturers.

These cases are complex. Um, but we’ve been handling them for many, many years and we’re, you know, well-suited and well able. And we are a force against these manufacturers. We hope that the information that we’ve provided to you tonight has been [00:20:20] helpful. Again, if you would like to discuss your case, please, uh, go onto our website, MCT law.com and we’d be happy to help you have a good night, everyone. [00:20:40]

Continue ReadingGrey’s Anatomy FaceBook Live on Dr. Weber’s Failed Metal on Metal Hip Replacement | mctlaw.

Grey’s Anatomy Story Line and The Real Story Behind Metal on Metal Hip Replacements

Once again, problems with metal on metal hip replacements become a major storyline in a medical TV drama.

Last week on the season finale of Grey’s Anatomy, the show revealed that one of the main characters, Doctor Richard Webber, was diagnosed with cobalt poisoning from a metal on metal hip replacement. The dramatic diagnosis came after many episodes of trying to find a cause for Webber’s mysterious medical conditions. The Episode is titled: “DeLuca Makes an Incredible Diagnosis.”

After this Grey’s Anatomy episode aired on Thursday night, mctlaw saw a huge spike in traffic to our website from people searching for information about cobalt poisoning from metal on metal hips.  So we’re taking this opportunity to give you the real story behind the problems with metal on metal hip replacements.

Watch clips from the episode and hear from mctlaw’s metal on metal hip litigation team about the current status of these lawsuits.

Metal on Metal Hips on Medical Drama TV Shows

This is not the first time real-life problems with metal on metal hips made their way into TV dramas.  In 2014, an episode of the TV medical drama, House, helped a German doctor diagnose one of his patients with cobalt poisoning from his hip replacement. The patient and the character on the show both had the same symptoms. 

Click below to watch a clip from this episode of Grey's Anatomy

Continue ReadingGrey’s Anatomy Story Line and The Real Story Behind Metal on Metal Hip Replacements

mctlaw Coronavirus Update

Due to COVID-19,  mctlaw’s entire staff has transitioned to working remotely. Our Firm remains open, but our physical offices in Seattle, Washington; Washington, DC; and Sarasota, Florida are closed. Fortunately, we have planned for this contingency.  The attorneys, paralegals, and operations staff of Maglio Christopher & Toale, P.A. will continue their work with little disruption.

To our clients, rest assured that we continue to actively represent you. You can communicate with us by e-mail and telephone as you have previously. We ask that you also keep us updated about any changes in your contact information.  

Our staff and our attorneys will also continue reviewing new cases from potential clients. You can contact us by phone, webchat or by completing the form on the bottom of our website pages.  We will respond to you within 1 business day, but most likely much sooner than that.

Most importantly, please stay safe during this difficult time.

Continue Readingmctlaw Coronavirus Update

Long Time Seattle Attorney Talis Abolins Joins Maglio Christopher & Toale, P.A.

SEATTLE, WA (March 2, 2020)  — Maglio Christopher & Toale, P.A. welcomes Seattle attorney Talis Abolins to the Firm. Talis is a native Washingtonian with more than 30 years of experience as an attorney. He earned his undergraduate degree from the University of Washington and a law degree from Seattle University School of Law. Talis served as an Assistant Attorney General for the State of Washington for 14 years before moving into private practice.

MCTLaw Attorney Talis Abolins
Attorney Talis Abolins

“Talis is a tireless advocate and steadfast litigator,” says mctlaw Managing Partner Altom Maglio. “He has worked with us as co-counsel on medical product liability cases for years and we’re honored to add his experience and knowledge to our firm’s legal team.”

In addition to representing Washingtonians in personal injury and wrongful death cases, Talis will focus on developing new practice areas for mctlaw. He will also continue his work representing Washington patients in defective metal on metal hip replacement lawsuits and settlements.

Talis comes to mctlaw after years in private practice, most recently with Advocates Law Group in Seattle and before that as a partner at Campbell, Dille, Barnett & Smith from 2005 to 2015. Talis and his wife Marla are dedicated to nonprofit activities supporting the vision of a diverse and livable Mount Baker Town Center. They enjoy time with family, and adventuring on the mountains and waters of the Pacific Northwest and beyond.

About Maglio Christopher & Toale, P.A. 

Maglio Christopher & Toale, P. A. is a national complex litigation firm with offices located in Sarasota, FL, Washington, D.C., and Seattle, WA. The firm’s practice areas include vaccine injury compensation, defective metal on metal hip replacement litigation, construction and commercial law, and federal takings. You can contact us at 888.952.5242 or www.mctlaw.com

Continue ReadingLong Time Seattle Attorney Talis Abolins Joins Maglio Christopher & Toale, P.A.

Judge Orders Biomet Internal Documents to go Public

Internal documents about metal on metal hips that Zimmer Biomet (ZBH) fought hard to keep secret are now public, and some of the contents are troubling.
Recently, a judge ruled in favor of mctlaw demand to unseal dozens of Zimmer Biomet’s internal corporate documents that were kept hidden from the public.
Among the unsealed documents is a memo prioritizing the design and development of the Biomet M2a metal on metal hip as a “money project.”

This is the project that each group should rally around and push to completion as soon as possible. It will have the biggest impact on Biomet’s bottom line.

Dozens of lawsuits against Zimmer Biomet allege that corporate management pressured their development teams to put sales over safety when it came to metal on metal hips. The priority was to make “the most money.” There’s no part of this unsealed memo that mentions patient safety or pre-market testing:

…we want to get the “biggest bang for our development buck.” This would mean that we should prioritize our work and develop the products that will make the most money for Biomet first.

Poor design doomed patients with Zimmer Biomet M2a Magnum hips from the start. The cobalt and chromium metal surfaces of the hip and the socket rub and grind together, releasing microscopic metal debris into the body. That metal has destroyed muscle, bone, and other tissue around a patient’s hips. The metal debris is small enough to enter the bloodstream and cause cobalt-chromium metal poisoning throughout a person’s body.
Essentially, the litigation alleges Zimmer Biomet turned patients into human guinea pigs so they could sell their new metal on metal hip replacement models faster. The formerly secret document states:

When a piece of this project comes into your possession, (drafting, prototypes, regulatory, tooling, production planning, rollout schedule, etc.) do not accept delays…

You can read the entire contents of this newly unsealed Biomet internal memo here. The public can expect to see more damaging internal memos as Zimmer Biomet faces almost 20 jury trials against mctlaw attorneys. The first trial is scheduled for this May in Seattle, WA.

About Maglio Christopher & Toale, P.A. – mctlaw

Maglio Christopher & Toale, P.A. is leading the U.S. litigation against metal on metal hip replacements with clients across the country. The Firm filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating these cases ever since.

Continue ReadingJudge Orders Biomet Internal Documents to go Public

Biomet Reports Show Rising Litigation Liabilities for Metal Hips

JANUARY 17, 2020 (Sarasota, FL)  — Zimmer Biomet Holdings’ (ZBH) most recent quarterly financial report puts the litigation liability for the M2a-Magnum hip at $65.7-million. Since May 2018, the expected cost of litigation from the M2a-Magnum metal on metal hip keeps going up quarter after quarter, based on the company’s financial reports. Litigation liability is an estimate or prediction of how much money a company expects to lose or spend due to current and future litigation. Typically, litigation liability costs should go down over time as individual lawsuits and settlements wind down and fewer cases are left to litigate. However, the Biomet M2a-Magnum litigation liability amount has not gone down over time, as one would expect.  Instead, the predicted costs of litigation have increased over time, sometimes greatly.  In the fall of 2018 alone there was a $20 million spike and estimates since then continue to rise steadily.

RECENT ZIMMER BIOMET LITIGATION LIABILITY AMOUNTS BY QUARTERLY REPORT RELEASE DATE

QUARTERLY REPORT DATELIABILITY AMOUNT
MAY 2018$32.5 million
AUGUST 2018$41.4 million
NOVEMBER 2018$62.1 million
MAY 2019$62.1 million
AUGUST 2019$64.3 million
NOVEMBER 2019$65.7 million

It is not surprising that litigation costs would increase so dramatically for ZBH in late 2018.  That’s when the multi-district litigation (MDL) that consolidated all metal on metal hip lawsuits into one lawsuit in South Bend, Indiana shut down. This sent thousands of plaintiffs back to their local federal courts to try their lawsuits, individually. Suddenly, Zimmer Biomet faced lawsuits in separate locations around the country instead of only in the Indiana MDL.

Underestimating the Future Financial Risk

The litigation liability figure of $65.7 million appears extremely low, given recent jury verdicts in similar metal on metal hip lawsuits.  For example, juries returned verdicts of roughly $500 million, $1 billion, and $240 million in three consecutive multi-plaintiff trials over a similar metal on metal hip manufactured by Johnson & Johnson.

It is highly possible that Zimmer Biomet’s estimate of $65.7 million to set aside for this litigation may not be enough to cover even a single jury verdict.  Of note, Maglio Christopher & Toale, P.A. alone has 19 jury trials scheduled over the next year and a half.

About Maglio Christopher & Toale, P.A. – mctlaw

Maglio Christopher & Toale, P.A. is leading the U.S. litigation against metal on metal hip replacements with clients across the country. The Firm filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating these cases ever since.

Contact: Altom Maglio, Managing Partner, Maglio Christopher & Toale, P.A.
Phone: 888.952.5242
Website: https://www.mctlaw.com/joint-replacement/biomet-hip-implant/
Source: Maglio Christopher & Toale, P.A.

Continue ReadingBiomet Reports Show Rising Litigation Liabilities for Metal Hips

What is the Status of the Biomet Hip Litigation?

mctlaw Attorney Michael Cowgill explains the status of the Zimmer Biomet LitigationTo date, Zimmer Biomet is the only metal on metal hip manufacturer who has yet to face a jury in trial.

“We’re looking forward to finally having our day in court for our clients” says Cowgill.

In May, Maglio Christopher & Toale, P.A. and its’ co-counsel will face Biomet in trial. mctlaw Attorneys have almost 20 trials scheduled for clients throughout the next two years, the first one begins in May 2020 in King County, Washington State

Continue ReadingWhat is the Status of the Biomet Hip Litigation?

Typical Settlement Amount in a Metal on Metal Hip Lawsuit?

Attorney Michael Cowgill discusses metal on metal hip replacement case settlements and why they can vary. It is not possible to give specific details on any settlement amounts, they are confidential. But mctlaw attorneys can say that they work tirelessly to fight for amounts that our clients deserve.

“What I can tell you is that when we attend a settlement negotiation, we’re going to bat for our clients” states Cowgill.

Maglio, Christopher & Toale, P.A. has almost 20 trial dates set to represent our clients against Zimmer Biomet, the manufacturer of the defective Biomet Magnum and M2a-38 metal on metal hip replacements. Zimmer Biomet has not yet faced a jury in a trial over these hips. The first trial starts on May 4th in Washington state.

Continue ReadingTypical Settlement Amount in a Metal on Metal Hip Lawsuit?

Biomet (ZBH) Facing 19 Trials On Metal on Metal Hips

Sarasota, FL — (December 17, 2019) Zimmer Biomet Holdings, Inc. (NYSE:ZBH)  (SWX:ZBH) is facing almost 20 jury trials across the country between 2020 through 2021. The barrage of trials begins May 2020 in Seattle, WA and spans venues across the country. The trials involve patients suffering heavy metal poisoning from Biomet metal on metal hip replacements. The patients in these jury trials are all represented by Maglio Christopher & Toale, P.A., which currently has 140 lawsuits filed against Zimmer Biomet.

Biomet has never faced a trial over its M2a metal-on-metal hip replacements, until now. In 2014, before its merger with Zimmer, Biomet claimed a meager $56 million settlement would make the company’s metal on metal hip replacement litigation liability go away. It did not. As a result, the new company — Zimmer Biomet — is saddled with litigation problems which continue to get worse.

From the beginning, the attorneys at Maglio Christopher & Toale, P.A filed their clients’ cases in state courts around the country instead of the Federal Multi-District Litigation, where most cases were gathered in one court. The independence from the federal MDL allowed them unique access to millions of pages of additional documents as well as many witnesses. “We believe the jury will see that these documents show a shocking disregard for patient safety in the pursuit of profit,” says Managing Partner, Altom Maglio. Those documents are currently sealed but will become public during the upcoming trials.

Portions of the case against Zimmer Biomet include:

  • Damaging and incriminating internal company documents.
  • Surgeons warnings to Biomet which went ignored.
  • The company’s decision to recall the metal on metal hip replacements in Australia and Europe, but not in the United States.

The attorneys at Maglio Christopher & Toale, PA will have 19 opportunities across the country to present the case against Zimmer Biomet for the public to hear and a jury to decide. For Zimmer Biomet, this represents an immense financial and credibility problem, especially given repeated missed opportunities to resolve these cases.

About Maglio Christopher & Toale, P.A. – mctlaw

Maglio Christopher & Toale, P.A. is leading the U.S. litigation against metal on metal hip replacements with clients across the country. The Firm filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating these cases ever since.

Continue ReadingBiomet (ZBH) Facing 19 Trials On Metal on Metal Hips

Ilyas Sayeg Promoted to Partner at Maglio Christopher & Toale, P.A.

Attorney Ilyas Sayeg promoted to partner at Maglio Christopher & Toale, P.A. 

The announcement came during the annual law firm meeting, held at the law firm’s new Washington, DC office. Managing partner Altom Maglio presented Sayeg with the honor, speaking about his belief in holding himself and others to high ethical standards in the practice of law, his commitment to clients, and the atmosphere of teamwork Sayeg brings to the firm.

Mr. Sayeg, a complex litigation attorney, represents clients who suffer devastating injuries from defective metal on metal hip replacements. He started at the firm in 2012 and has been an integral part of its growth and leadership in the national metal on metal hip litigation.

Sayeg is Maglio, Christopher, & Toale’s lead trial attorney in upcoming high profile trials against Zimmer Biomet, scheduled to begin in May of 2020.

“Ilyas always puts his clients’ best interests first,” says managing partner Altom Maglio, on naming Mr. Sayeg a firm partner. “He aggressively fights on their behalf in high profile cases against corporations like Johnson & Johnson and Zimmer-Biomet, but it’s his dedication to doing what’s right for his clients that make him such an accomplished attorney.”

Mr. Sayeg is active with the Sarasota County Bar Association (SCBA), where he served on the executive board of the Young Lawyers Division and presently serves on the executive board of the Council for Diversity and Inclusion. Mr. Sayeg received the SCBA’s President’s Award for outstanding leadership in the creation of the Council for Diversity and Inclusion. He serves on the board of directors for My Warrior’s Place, a retreat providing hope and healing for veterans and their families, and he mentors students in Booker High School’s law academy.

“It’s an honor to be named partner,” says Mr. Sayeg. “I’m proud to earn this accomplishment and proud of this firm’s commitment to ethics on behalf of our clients.”

Continue ReadingIlyas Sayeg Promoted to Partner at Maglio Christopher & Toale, P.A.

Almost 50 Vaccine Injury Decisions and Settlements Added

This week mctlaw posted nearly 50 new vaccine injury decisions and settlement amounts to its case results page at www.mctlaw.com.  This table shows how much money our attorneys recovered for clients with severe reactions through the National Vaccine Injury Compensation Program.  You can read through the entire table of our Vaccine Injury Case Results here. Some of the recently posted results include:

The table lists the filing date, vaccine, diagnosis, and a link to the redacted court decision. There are almost 700 injury cases listed that were represented by the attorneys at mctlaw.  This case results table is updated multiple times a year.

The Vaccine Court is a no-fault compensation program. People who suffer debilitating reactions to vaccines can file a claim for compensation through the program. At Maglio Christopher & Toale, P.A., there are nine attorneys working exclusively within the National Vaccine Injury Compensation Program.

  • Our attorneys have recovered more than $300 million dollars for vaccine-injured clients.
  • mctlaw obtained the highest single compensation award in the Vaccine Act history on behalf of one of our clients.
  • NO part of a clients’ financial award is taken by our law firm.
  • There is NEVER a contingency fee paid by the client in vaccine cases in the United States Court of Federal Claims
  • Our clients keep 100% of their settlements because our legal fees are paid directly by the Court.

The program, which operates within the US Court of Federal Claims, distributes compensation from a trust fund. The fund is supported by a $.75 excise tax on every vaccine dose administered in the United States. 

Maglio Christopher & Toale, P.A. has more than 2o years of experience representing clients in the Federal Vaccine Injury Compensation Program. If you think you may have a severe vaccine injury,  contact us for a free case evaluation here or call 888.952.5242.

Continue ReadingAlmost 50 Vaccine Injury Decisions and Settlements Added

See mctlaw’s New Washington, DC Office

WASHINGTON, DC — (December 2, 2019)  mctlaw opened the doors to a new and larger Washington, D.C. law office today.  mctlaw is now located in a tech-forward office building at 1015 15th Street, NW in Suite 1125. The firm is still in the heart of the nation’s Capitol and remains only 3 blocks away from the United States Court of Federal Claims.  Nearby landmarks include McPherson Square and K Street.

“This new and much larger space gives us room to grow and it also accommodates attorneys from our Seattle and Florida offices when they travel to Washington, D.C. for trials,” says Managing Partner Altom Maglio. “I also believe this expansion is a sign of the trust and confidence that our clients have in our attorneys and staff.”  mctlaw has a long-established reputation as a leader within the US Court of Federal Claims and as a national trial law firm. “Our commitment to set down firm roots in the Washington, D.C. legal community is strengthened by this firm expansion,” says Maglio.

The new address for the Maglio Christopher & Toale, P.A. Washington, D.C. office is:

1015 15th Street, NW
Suite 1125
Washington, DC  20005
(888) 952-5242

Take a Look Inside mctlaw's New Office Expansion

Continue ReadingSee mctlaw’s New Washington, DC Office

Attorney Anne Toale Honored by VIP Bar Assoc.

Anne Toale receiving an award from the VIP Bar Association
Attorney Anne Toale (pictured to the right)
Anne Toale Award for her service as the 2017-2018 VIP Bar President
Presented to Anne Toale for your service as the President of the Vaccine Injured Petitioners Bar Association 2017-2018

mctlaw attorney Anne Toale honored today by the members of the Vaccine Injury Petitioners Bar Association.  The award recognizes her accomplishments leading the VIP Bar Association from 2017-2018 and was presented to her during the national conference held in Washington DC this week. 

Ms. Toale has more than 15 years of experience as a vaccine injury attorney working in the US Court of Federal Claims.  She’s represented hundreds of people in the Vaccine Court and negotiated a $61 million settlement for a child who experienced a severe reaction to the DTaP vaccine.  

Anne’s other honors include “Vaccine Injury Lawyer of the Year” by Finance Monthly and the 2018 Lawyer Monthy Women in Law award.  

Continue ReadingAttorney Anne Toale Honored by VIP Bar Assoc.

mctlaw Attorneys Involved in VIP Bar Conference

Every year a select group of attorneys from around the country gather in Washington, DC for the annual Vaccine Injured Petitioners Bar Conference.  mctlaw is highly involved in the VIP Bar Association and takes an active leadership role each year.

Attorneys Altom Maglio, Jessica Olins, Isaiah Kalinowski, Anne Toale, Jennifer Maglio, and Diana Stadelnikas all led presentations and discussion before the members of the Vaccine Injured Petitioners Bar Association this week.

The VIP Bar Association is a group of experts in the National Vaccine Injury Compensation Program providing advice and ideas on specific challenges facing vaccine attorneys. There are currently 109  attorneys listed as members of this exclusive legal group from across the country.  Every vaccine injury attorney at mctlaw is an active member and all of our vaccine injury attorneys and paralegals participate in this conference every year.  No other vaccine injury law firm in the country sends as many representatives to this event as Maglio Christopher & Toale, P.A.

Continue Readingmctlaw Attorneys Involved in VIP Bar Conference

mctlaw Helps Train New Vaccine Injury Attorneys

mctlaw attorneys Altom Maglio, Anne Toale and Jessica Olins training new vaccine injury attorneys this week in Washington, DC. at the Vaccine Injured Petitioner’s Boot Camp. 

Every year our entire staff travels to this national conference to teach, present, and lead workshops about representing people in the Vaccine Court. 

Anne Toale’s presentation focused on the differences between “on-table” and “off-table” vaccine injuries.  Jessica Olins discussed the process to file for attorney fees.  mctlaw managing partner Altom Maglio closed the “Vaccine Injury Boot Camp” with his final remarks and advice for attorneys who are new to this extremely complex practice area.  

Continue Readingmctlaw Helps Train New Vaccine Injury Attorneys

Storyline About MoM Hips Featured on NBC Show New Amsterdam

NBC’s newest medical drama, New Amsterdam, took on the metal on metal hip crisis in one of its storylines this week.  The season 3, episode 3 show is titled “Revision”  and follows a construction worker named Vincent who comes to the hospital for symptoms of a heart attack, but it turns out to be cobalt blood poisoning.  

As the doctors try to figure out how he was exposed to such high cobalt metal levels, he tells them he had a hip replacement.  Dr. Helen Sharpe uses a long syringe to remove fluid from Vincent’s hip and discover a mixture of black sludge instead of blood or clear fluid. She instantly knows he’s being poisoned by his own metal on metal hip replacement.  The only cure for his problem is ANOTHER hip replacement to remove the metal parts that are making him sick. 

The next scene pits Vincent and Dr. Sharpe against a group of men in suits from the hip replacement company.  They demand the company pays for Vincent’s medical bills, surgery costs, lost wages, and the cost of a newer, more expensive ceramic hip.  Dr. Sharpe even pushes the hip manufacturers to cover these costs for ALL patients dealing with metal poisoning from their bad hips.  Of course, the orthopedic company officials refuse these terms and the doctor threatens to expose their product on national television. 

Dr. Sharpe’s colleague warns her the powerful medical device company could crush her future as a physician if she takes them on.  During her interview on live national TV, Dr. Sharpe threatens to name the hip manufacturer specifically.  However, after a commercial break, the doctor instead blames the FDA for letting hip replacement companies, in general, get away with selling medical products with almost no testing or government oversight. She calls on the general public to call their representatives and demand change. 

To see the entire episode of New Amsterdam, click on the video below. 

Reality Stranger than Fiction in Metal Hip Cases

Sometimes reality is stranger than fiction.  Thousands of people across the country are in the same position as the fictional character Vincent in this episode.  Hip makers like Zimmer Biomet and Johnson & Johnson with their Pinnacle hips follow a similar script by not taking responsibility for making and selling an implant that can and has poisoned thousands of people.   

That’s why mctlaw attorneys feel compelled to represent people hurt by metal on metal hips.  To learn more about which metal on metal hip makers we are currently litigating against click HERE.

Talk to us about problems with your metal on metal hip replacement

Continue ReadingStoryline About MoM Hips Featured on NBC Show New Amsterdam

10 Signs your Metal on Metal Hip May be Going Bad

If you have a Metal-on-Metal (MoM) hip implant, you may have heard the term “revision surgery” before. But what is revision surgery, and how can you tell if you need it?

Revision surgery is a procedure in which a broken, worn out, or unsafe hip implant is removed and replaced (in whole or in part) by a new implant. Because Metal-on-Metal hip implants have such high rates of failure, hip revisions are a relatively common procedure.

Here, we’ve put together a list of some of the top 10 most common signs that you may need hip revision surgery. If you’ve experienced any of these symptoms of implant failure, you should speak to your doctor and request to get your blood metal ion levels measured as soon as possible.

You feel pain in your hip or pelvic area.

This one might seem obvious, but people often underestimate the importance of listening to your body when it is in pain. Your hip implant should not cause you pain if it is working correctly. If you’re suddenly experiencing pain in your hip or pelvic area during everyday activities, it’s a sign that something could be wrong with your hip replacement. Pain is a symptom of many metal-on-metal implant side effects, such as dislocation, bone damage, muscle damage, pseudotumors, or infection.

You hear squeaking, popping, or clicking in your hip.

In short – anything in your hip that doesn’t feel quite right in your hip is a sign that you might need a new one. You really shouldn’t be able to feel (or hear) your implant. If it is working correctly, it should be a seamless part of your body, just like any other joint. Talk to your doctor if you have any concerns about your hip replacement. Pain, squeaking, popping, or clicking in your hip could be signs that your implant has dislocated, caused bone loss, destroyed muscle tissue, developed a pseudotumor, or some other serious side-effect of metal-on-metal hip implants.

You experience difficulty walking or bearing weight on your hip.

Do you find yourself walking, standing, or leaning in an unusual way to avoid feeling pain in your hip during everyday activities? This is something to bring up to your doctor to see if revision surgery is an option. Problems caused by metal-on-metal hips, like pseudotumors, ALVAL, or infection, make bearing weight on your replaced hip more painful.

You sometimes get a metallic taste in your mouth, particularly in the mornings.

Metal-on-metal hips are made up of multiple metal components, which rub against each other when you walk or move your leg. As this happens, tiny metal particles flake off into your body and bloodstream. If enough metal particles enter your body, serious side effects can occur, such as a type of metal poisoning called metallosis. A symptom of metallosis is a metal taste in your mouth.

You’re experiencing blurry vision and/or color-blindness.

The metal particles released into the body by metal-on-metal hip replacements can have many adverse effects on the body. One of these possible effects is on your vision. Vision loss or color-blindness are both reactions to metal in the blood from a metal on metal hip replacement.

Your hearing has gotten worse, and/or you hear ringing in your ears.

Similar to the vision loss and metallic taste, hearing loss and tinnitus (ringing in the ears) can be caused by excessive metal in the bloodstream.

You’re showing symptoms of dementia or cognitive impairment.

Metal particles in the blood can wreak havoc on the body when levels are high enough to cause metal poisoning. One of the results of metal poisoning due to a metal-on-metal hip is dementia, memory problems, and cognitive impairment. Revision surgery may help stop the progression, so if you show these signs it is best to speak to a doctor about your possibly faulty hip replacement.

Your blood metal ions are high.

Leading orthopedic surgeons recommend that patients with metal-on-metal hip replacements get their blood tested for metal ions every three months. If your levels are too high, it could lead to issues like the ones listed above. If your levels are too high, you should speak to your doctor about revision surgery and if it is right for your situation.

You’re experiencing any or all of the symptoms above.

If you have a metal-on-metal hip replacement and have experienced any of the symptoms above, you should speak with a doctor about revision surgery and if it is an option for your situation.

Even if you aren’t experiencing any of these signs & symptoms – you should still talk to your doctor.

Some people with bad metal-on-metal hip replacements have been recommended to get revision surgeries even when they have not experienced any pain or side effects at all. This is why many leading orthopedic surgeons recommend people with metal-on-metal hip replacements get testing for metal levels in their blood every three months.

Learn more about defective metal on metal hip replacements and the problems they can cause.  If you have a metal on metal hip replacement and believe it may be defective, you should talk to your doctor. Then, contact an attorney about your potential claim against defective hip manufacturers. mctlaw is highly experienced with metal on metal hip cases. Our attorneys filed the FIRST lawsuit in the US against a metal on metal hip manufacturer. Let us review your case at no cost. Call us at 888.952.5242 or get an online case review here.

Continue Reading10 Signs your Metal on Metal Hip May be Going Bad

Maglio to Lead Pinnacle/ASR Attorney Group

Attorney Altom M. Maglio was elected to lead a group focused on the ongoing litigation against Johnson & Johnson over the company’s Pinnacle and ASR metal on metal hip replacements.

The American Association for Justice (AAJ), the primary organization for plaintiffs’ trial lawyers in the United States, recently elected Mr. Maglio Chairman of the DePuy Metal on Metal Hip Implant Litigation Group. Mr. Maglio will help coordinate strategy for AAJ attorneys who are filing lawsuits against J&J’s metal on metal hips.

In 2008 Mr. Maglio filed the first lawsuit in the United States over a defective metal on metal hip replacement. He’s been involved at the highest levels of these cases ever since and brings that experience and knowledge of the medical device industry to the AAJ group.

Johnson & Johnson faces legal pressure over the Pinnacle metal on metal hip implant, despite a 2018 settlement deal. Over the past 10 years, J&J paid out billions of dollars to settle lawsuits involving the recalled DePuy ASR metal on metal hip system, which is similar to the Pinnacle hip.

Maglio’s own national law firm, Maglio Christopher & Toale, P.A. is aggressively pursuing Pinnacle metal on metal hip cases and filing Pinnacle MoM hip lawsuits across the U.S. on behalf of our clients.

The AAJ DePuy Metal on Metal Implant Litigation group will assist attorneys facing Pinnacle and ASR lawsuits with the resources and information they need to effectively represent their clients. 

ABOUT MAGLIO CHRISTOPHER & TOALE
mctlaw is a national medical product liability law firm with offices in Sarasota, FL, Seattle, WA, and Washington, DC.  It filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008. Additionally, mctlaw’s highly experienced trial attorneys continue to litigate metal on metal hip replacement cases across the country. The Firm represents patients suffering from the effects of heavy metal poisoning from metal on metal hip replacements.

Continue ReadingMaglio to Lead Pinnacle/ASR Attorney Group

mctlaw Attorney Christina Unkel a FIFA Rules Expert

mctlaw’s Christina Unkel is taking a high profile role as a FIFA rules expert on Fox Sports this month.  She’s part of the Women’s World Cup broadcasting team and reports on the sometimes complex rules of the game.  In addition to her position as an attorney at Maglio Christopher & Toale, P.A., Unkel is also an international FIFA referee.  She’s gotten positive reviews for her knowledge and analysis during the World Cup coverage on topics like the Video Assistant Referee (VAR) and predicting the outcome of some controversial calls.

You can watch Christina during World Cup coverage on Fox Sports.

Ms. Unkel practices in the following areas:  Commercial and Construction Litigation, Federal Takings, Rails to Trails conversions.  She is also leading up litigation over the Plantation Golf and Country Club equity memberships.

Continue Readingmctlaw Attorney Christina Unkel a FIFA Rules Expert

Vaccines Could be Stored at Room Temperatures

Vaccines, like many medicines, are finicky.  To stay safe, they need to be stored in very specific conditions.  Give them too much heat or too much light, and they can become ineffective.  The current need to refrigerate vaccines makes them difficult to safely transport and distribute.  Because of this, areas with improper health infrastructure see drastically lower vaccination rates.

In an attempt to make vaccines safer and more accessible, a team of researchers at McMaster University came up with a cheap and effective method for storing vaccines at room temperature.  By preserving the vaccination in something called a “sugar film,” vaccines survive as long as three months at 104 degrees Fahrenheit!

The researchers were thrilled to find that, while testing the higher-temperature “sugar film” treated vaccines on mice, they were just as effective as the refrigerated vaccines.

The McMaster scientists are only one of many groups trying to make vaccines safer, cheaper, and more accessible to people around the world.  For example, last year, a group of researchers managed to genetically engineer a vaccine that naturally kept itself safe at higher temperatures without adding any other chemicals.

Meanwhile, other groups have tried to identify affordable and efficient preservatives that increase the shelf-life of vaccines.  What makes the McMaster research promising, though, is the fact that its ingredients are cheap and already FDA-approved.  This means their “sugar-film” method could be a lot more affordable and easier to implement in the near future.

Source

https://www.vox.com/future-perfect/2019/6/5/18647563/vaccines-cold-chain-public-health-lives

Continue ReadingVaccines Could be Stored at Room Temperatures

Study: Vaccine Reduced Disease Rates in Kenyan Community

A recently-published long-term study that measured the efficacy of a pneumococcal vaccine in Kenya shows how widespread vaccination can improve public health.

In 2011, Kenya introduced a new pneumococcal vaccine to its child immunization program: PCV10 (or Synflorix).  Prior to the introduction of PCV10, Kenya did not require nor provide children with any sort of pneumococcal immunization.  This newly added childhood vaccine protects individuals from contracting 10 major strains of S. pneumoniae.

This new study observed the population of a coastal Kenyan town called Kilifi and its surrounding communities.  It compared the rates of pneumococcal disease in a time period before the vaccine’s introduction (1990-2010) to the community’s pneumococcal disease rates after the implementation of PCV10 (form 2012 to 2016).

Overall, the study found that serious pneumococcal disease cases caused by any of the 10 strains targeted by PCV10 dropped by 92% among infants under five years old.  Before the introduction of PCV10, the area in and around Kilifi experienced about 25 cases of pneumococcal disease (caused by PCV10 strains) annually.  Cases of pneumococcal disease caused by strains not covered by PCV10 did not increase either.

Another interesting finding from the study has to do with a phenomenon called “herd immunity.”  Her immunity is a positive spill-over effect that occurs when a large percentage of a community’s population is vaccinated against a particular disease.  When there are very high rates of immunization, those who are not vaccinated are less likely to contract a disease because they are less likely to catch it from someone else.

The Kilifi study found evidence of herd immunity, particularly among children and infants: babies less than two months old (who are too young to receive the PCV10 vaccine) were 173% less likely to contract a pneumococcal disease despite not yet having the vaccination.

Overall, the Kilifi study comparing the pneumococcal disease rates before and after the introduction of PCV10 found that the implementation of the vaccine in the country’s childhood immunity program – and, more broadly, the widespread distribution of PCV10 – had a positive effect on the community’s public health outcomes.

Sources

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)33005-8/fulltext

https://www.sciencedaily.com/releases/2019/04/190416131522.htm

Continue ReadingStudy: Vaccine Reduced Disease Rates in Kenyan Community

Future of Medicine: “Needle-Free” Hep B Vaccine

Hepatitis B is an incredibly common – and deadly – infection that affects hundreds of thousands of people each year.  Children in developing countries are especially prone to contract and die from hepatitis B.

High rates of infection in developing countries are partially due to the fact that it is difficult to safely store intravenous vaccines.  For this reason, researchers around the world have been hard at work to develop a form of the hepatitis B vaccine that can be administered orally.

Oral vaccines are challenging to create because our digestive system is designed to break down anything that enters it.  Oral vaccines can be easily destroyed before making the body immune.

However, a recent partnership among researchers from the University of Sao Paulo, the Butantan Institute, and the Neils Bohr Institute shed new light on how we might develop an oral vaccine that can survive the conditions of the digestive system.  This remarkable collaboration brought together experts from vastly different fields, from physicists to biologists to virologists.

For years now, the Sao Paulo-based researchers have known that a particular silica-based material called SBA-15 can be used to encapsulate the oral hepatitis B vaccine and protect them in the digestive system.  However, the results were not consistent – the SBA-15 shell was only effective some of the time.

With the help of a group of physicists, they are now closer to perfecting the oral hepatitis B vaccine.  With a state-of-the-art three-dimensional imaging technique, the physicists were able to produce a highly accurate picture of the capsule and observe the behavior of the vaccine inside of the capsule.  The researchers were able to observe the vaccine’s behavior at a microscopic level.

An effective oral hepatitis B vaccine that can be mass-produced would save lives, while also being cost-effective and easier to administer at a large scale in developing countries, where children face the greatest hepatitis B threat.

Currently, this same research team is developing a combination oral vaccine that immunizes people against diphtheria and tetanus.  However, their ultimate goal is to create a single oral vaccine that guards against whooping cough, diphtheria, hepatitis B, tetanus, polio, and Hib.

Sources

https://www.sciencedaily.com/releases/2019/05/190503100808.htm

https://www.nature.com/articles/s41598-019-42645-5

Continue ReadingFuture of Medicine: “Needle-Free” Hep B Vaccine

Researchers Developing Room Temp-Stored Vaccine

It is no secret that medicines have very specific storage needs.  Think about all of the medications you’ve handled in your life.  Some need opaque bottles, others need clear bottles.  Some have to be stored in the freezer next to your pizza rolls, while others can safely add to the clutter in your purse without losing any efficacy.  And we’ve all kept antibiotics in the little butter compartment of our refrigerator door.  Vaccines, however, almost always need to be stored at cold temperatures, or else they’ll become ineffective.

The temperature needs of vaccines have long posed a challenge for public health, which strives to make vaccines as widely available as possible.  The University of Texas Medical Branch (UTMB) at Galveston has been working to solve this problem – and save money too!

UTMB researchers figured out that if they could get rid of cell culture, eggs, (a common vaccine ingredient), and cold storage, they could revolutionize the vaccine production process.  Their answer? Genetically engineering a Zika vaccine that can stabilize itself without any additives.

The vaccine is essentially in DNA form, and once it enters the body, it releases the vaccine and creates immunity.  This innovative vaccine requires no cell culture, eggs, or cold temperatures!  This means the vaccine can be safely kept at room temperature for many years.

The UTMB researchers found that this new method can also be used with other common vaccines, and it cuts production costs significantly.  In fact, their DNA-vaccine method slashes 80% of vaccine production and storage costs.

Sources

https://www.sciencedaily.com/releases/2018/10/181005130824.htm

https://www.ebiomedicine.com/article/S2352-3964(18)30349-9/fulltext

Continue ReadingResearchers Developing Room Temp-Stored Vaccine

Injured Patients Motion for Status Conference

On behalf of our clients, Maglio Christopher & Toale, P.A. filed a “Motion and Incorporated Brief for Case Management Conference” with the Court overseeing lawsuits involving Johnson & Johnson’s DePuy Pinnacle metal on metal hip replacements.

The motion requests that the judge overseeing the national litigation, Judge Ed Kinkeade, “schedule a case management conference to provide for an update on the status of the MDL and to accept questions and input from all parties.”

The motion explains that such a case management conference would help ensure transparency.  It states that patients injured by Pinnacle metal on metal hip replacements are desperate for information about their cases.  Desired information includes settlement prospects for these cases.

Additionally, plaintiffs want to know when litigation will resume for cases where no settlement is reached.  Maglio Christopher & Toale, P.A. filed the motion on June 14th.

Media and online comments from injured patients reflect their frustration.  Comments focus on how J&J failed to warn patients of heavy metal poisoning from Pinnacle metal on metal hip replacements.

However, for patients faced with tissue death and bone loss from the Pinnacle metal on metal hip replacement, rather than providing compensation, Johnson & Johnson instead conducted scorched earth litigation.

Additionally, injured patients are expressing severe discontent with the proposed settlement terms from Johnson & Johnson.  Finally, patients question how they can intelligently make a decision to settle or not settle without more information.

A copy of mctlaw’s motion on behalf of its clients can be found HERE.

About Maglio Christopher & Toale, P.A.

mctlaw is a national medical product liability law firm with offices in Sarasota, FL, Seattle, WA, and Washington, DC.  It filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008. Additionally, mctlaw continues to litigate metal on metal hip replacement with its’ highly experienced attorneys.  The Firm represents patients across the US suffering the effects of heavy metal poisoning from metal on metal hip replacements.

Continue ReadingInjured Patients Motion for Status Conference

Investigating FDA’s Hidden Reports

Kaiser Health News recently released an article that reveals a secret FDA reporting avenue that is not accessible to the public. Most doctors and healthcare providers don’t even know about it, which limits their search for any known problems or defects with medical devices they may use.  mctlaw Attorney Ilyas Sayeg explains why our Metal on Metal Hip Replacement team is currently investigating.

Video Transcript:

Recently, we learned through some strong investigative journalism from Kaiser Health News that some device manufacturers have been using a secret reporting mechanism to let the FDA know of some problems with their devices. We’ve taken this information and we’re now currently investigating whether any of the device manufacturers that we’re litigating with have also been using this secret mechanism. What this can result in, potentially, is an under-reporting of publicly available issues of problems and we need to know whether the products that our clients have had secret problems because if they’re secret than the public needs to know.

Worldwide Medical Device Safety Fails

An article by The Implant Files investigates worldwide governments failing at protecting people from defective devices due to unsafe approval processes.  Just in the United States alone, the article states that “In the last ten years, there have been more than 83,000 deaths and 1.7 million injuries associated with medical devices.” The Implant Files is “the first-ever global examination of the medical device industry.”  They also provide the International Medical Devices Database, a database that contains information on worldwide medical device recalls, safety alerts, and more.  This investigative journalism and the database are great resources in the fight to keep patients safe from defective medical devices, like metal on metal hip replacements.

Continue ReadingInvestigating FDA’s Hidden Reports

Women Possibly At Higher Risk for Medical Device Failures?

“Are women more likely to be harmed by medical device failures?”

By: Ben Hallman

https://www.icij.org/blog/2018/12/are-women-more-likely-to-be-harmed-by-medical-device-failures/

For the last year, the International Consortium of Investigative Journalists has been investigating the medical device industry around the world. They found that there are very relaxed regulations in the implant industry, which allows dangerous products, like metal on metal hip replacements, to be implanted into millions of patients.

The investigators were particularly shocked at the number of dangerous devices that were marketed towards women. After their extensive investigation into the implant world, they found that  “women were disproportionately harmed in many of the scandals that have plagued the industry.”

Women are now banding together into interest groups and demanding that regulators do more to protect them from dangerous devices because women are more likely to experience complications from medical devices than men.

The authors discuss the shockingly high failure rates of female-specific implants. However, the authors found that women face more complications than men using the same exact implants.

This is especially true for hip replacements. For instance, the failure rate for hip implants in women is 29% higher than that of men. Additionally, women are more likely to suffer from hypersensitivity to metal used in hip implants.

This, according to the authors, happens for many reasons. First, clinical trials don’t include enough women. Second, doctors don’t always believe women who claim their devices are harming them. The authors discuss several stories where women expressed that they believed their implants were causing them problems, but their doctors did not believe them.

Continue ReadingWomen Possibly At Higher Risk for Medical Device Failures?

Victims & Medical Professionals Not Warned of Product Failures

Article link: https://www.icij.org/investigations/implant-files/hidden-dangers-patients-doctors-not-informed-of-defective-implants/

Article title: Hidden Dangers: patients, doctors not informed of defective implants

By Spencer Woodman

This article begins with the story of Vijay Vojhala, an Indian man who received a Johnson & Johnson metal-on-metal hip in 2008. Vojhala’s implant was the DePuy Orthopaedics ASR hip system.

In 2011, Vojhala went to a medical product conference and found out that his hip replacement had been recalled in a handful of countries, including the U.S., over a year ago.

Soon after, Vojhala found out that his implant had shed metal particles that infiltrated his bloodstream. Vojhala now has a limp and cannot work. His implant has a failure rate over 50 percent.

The article explains that the problem Vojhala had was due to the fact that, in many cases, medical implants are recalled or even banned in some countries, but they remain on the market in other countries. Additionally, it is very difficult for hospitals to locate patients who have received recalled implants.

After Vojhala’s hip was recalled around the world, it took India’s health authorities over three years to notify hospitals. By that point, Johnson & Johnson and India’s hospitals had lost track of who had received the hazardous implant.

Johnson & Johnson claimed that patient privacy laws prevented them from directly reaching out to patients who received their metal-on-metal hips.

Johnson & Johnson also claimed that they posted recall information on their website and hired third-party companies to tell patients that their implant had been recalled.

The article then goes on to explain that, when medical products are recalled, the process for notifying the public is not always effective. Sometimes a recall only requires labeling changes, and other times, a recall might require a product to be completely removed from the shelves. In other cases, manufacturers will stop sales after a recall but won’t admit any wrongdoing. Governments can also ban the sale of certain devices without even recalling them.

The author’s investigation found that there was no global database to search for device recalls, so the journalists of the ICIJ made one. ICIJ’s database shows any implant that has been recalled or deemed dangerous in any country. They hope this resource will make it easier for patients to find out when their medical devices have been recalled in other places around the world.

A major problem the ICIJ found is that sometimes a product will be recalled in some countries but not others. One example of this is a metal-on-metal hip produced by Biomet. After studies found that Biomet’s implant was causing metallosis – a type of metal poisoning that affects internal tissue – Biomet notified doctors in Australia, the UK, and other countries in Europe. But they did not notify any doctors in Canada or the US. The authors state that if the FDA had tried to recall the implant, American doctors would have known about the recall too.

The investigators interviewed a 43-year-old American man named Andrew Chappell, who had a Biomet metal-on-metal hip implant. At a doctor’s appointment, Andrew found out that his implant was injuring his bones. The implant eroded his bones so much that his femur cracked during a surgery he received in 2018, three years after Biomet’s implant was recalled in other countries.

Zimmer Biomet (the new official name for Biomet) did not respond to the journalist’s questions about the global recalls. The company simply stated that they “adhere to strict regulatory standards” and are “commit[ted] to operating a first-rate quality management system” around the world. They also stated that they work closely with the FDA.

When the journalists asked the FDA why they hadn’t recalled the Biomet hip even though other countries recalled it, the FDA said that they posted a general safety notification about metal-on-metal hips on their website in 2011. They said that, because they posted that notice online, they didn’t have to recall the Biomet hip.

Could we somehow fix the worldwide gaps in medical device recalls? It turns out there are efforts around the world to streamline and improve how patients are notified of implant recalls.

The investigators interviewed Harold Paz, the vice president of Aetna, a major US health insurance company. Paz is advocating for a system that would track patients who are implanted with medical devices like metal-on-metal implants. This would make it easier to inform patients when their devices are recalled. Paz believes that if automobile manufacturers can keep track of their owners, then medical providers should be able to keep track of patients who receive medical implants.

They also interviewed Carl Heneghan, a health researcher in the UK. He said that databases to track joint replacements have taken off much faster than databases for other types of medical devices, most likely because of the high failure rate of joint implants like metal-on-metal hips.

However, this is really only true for the UK and Canada. The US and India, for example, have not really taken steps to track joint implants through device registries. However, after the Johnson & Johnson hip implant scandal, the Indian government “is considering implementing its own implant registry.”

On that same note, the authors spoke with Dr. Henrick Malchau, an orthopedic surgeon from Sweden who has been pushing to create worldwide implant registries. He said Australia’s implant database was the reason government health agencies figured out that Johnson & Johnson’s hip implant was dangerous. The information from the database was also instrumental in notifying patients and doctors of the device’s hazards. Because the database tracked all the patients who received implants, it was easy to let them know that the metal-on-metal hip was dangerous.

In closing the article, the authors revisit the story of Vojhala, who received the hazardous Johnson & Johnson hip implant in India. He says that better systems to notify patients about implant problems are “badly needed.” To this day, Vojhala suffers from decreased mobility, vision problems, and heart problems because of his implant. These health complications have left him unemployed. He says that if he had known about the recall when it first happened, he could have avoided the complications and “a lot of pain.”

Continue ReadingVictims & Medical Professionals Not Warned of Product Failures

European Lobbying Impeded on Safety of Medical Devices

Article Link: https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/

Article Title: How lobbying blocked European safety checks for dangerous medical implants

By Simon Bowers

In recent years, there have been two major attempts to increase safety regulations for medical implants in the European Union. However, lobbyists have shot down both of these reform attempts by misleading policymakers about their products.

Public health spokespeople criticize the European Union for its lax regulations and speedy approvals of medical implant devices. As proof of this, they point to the fact that “the EU has borne the brunt of many of the world’s worst implant scandals,” which have caused patients to suffer and even die because of their implants.

The Implant Files is a year-long investigation that involved over 250 journalists around the world. Their extensive investigation found that medical technology has advanced very quickly, but the laws surrounding them have not kept up. As a result, patients with medical implants have suffered from faulty devices entering the market too quickly.

Experts have found that the time it takes to approve medical products in the US has gotten shorter and shorter, which has created massive profits for medical device companies.

It’s even easier and quicker to get products approved in Europe, which has “some of the lightest regulations in the developed world.” Medical device lobbyists based out of Europe have encouraged other countries, including the United States, to adopt Europe’s relaxed policies.

These trends apply to all sorts of medical devices, including metal-on-metal hip implants, which have been some of the most controversial medical products to hit the market in recent decades.

Jurgen’s hip

Because the laws are so relaxed in Europe, medical device manufacturers like to introduce their products in Europe first. Once their products have been approved in Europe — which acts as a stamp of approval for the rest of the world — it is much easier to get them marked as safe for consumption in other countries.

The article tells the story of Jurgen Thoma, who was 48 when he received a metal-on-metal hip implant in Germany. His implant, manufactured by Zimmer Biomet, had not been approved by the FDA when he received it in 2005.

Europe legally classified Zimmer Biomet’s product as “safe for use” two years before Jurgen’s surgery, in 2003, despite not having a single human study testing its product. European laws did not require Biomet to test their implant on humans before marking it safe for consumption.

Thoma said that the hip implant quickly became painful. In 2009, just four years after getting his implant, Thoma had to get a revision surgery to replace his device. The surgeons found that the implant was shedding metal debris. As a result, his bone became spongey, soft, and grey. Thoma said his bone looked like Swiss cheese.

Thoma said that, because of Europe’s poor safety standards, he felt he had become the “guinea pig” for the product.

He decided to sue Zimmer Biomet in 2010. In 2018, a judge in Germany declared that the Zimmer implant “should not have been put on the market,” and Thoma received only $28,600 for his injuries at the end of the eight-year legal battle. Zimmer has since denied any problems with their product and appealed the court’s decision.

That being said, the article states that Thoma is relatively lucky because European laws tend to protect manufacturers over consumers.

Scandals and Loopholes

The article goes on to talk about a 2010 scandal involving metal-on-metal implants. Many metal-on-metal implants were pulled from the market as people began to realize that they were failing at extremely high rates.

As the scandal unraveled, a group of journalists went undercover, posing as metal-on-metal hip device manufacturers, and visited EVPU. EVPU is a Slovakian firm that the government has put in charge of testing whether products are safe for use in the European Union.

The journalists presented the EVPU with a mock-up drawing for a fake metal-on-metal hip implant, which was designed to be identical to a hip implant that had already been recalled. The EVPU approved the fake hip design. The exchange exposed blatant corruption and carelessness in medical device regulation.

Continue ReadingEuropean Lobbying Impeded on Safety of Medical Devices

Victim Hope Fluctuating

Article Link: https://www.icij.org/investigations/implant-files/patient-hopes-rise-and-fall-as-an-industry-balances-progress-and-profit/

Article Title: Patient Hopes Rise and Fall as An Industry Balances Progress and Profit

By Dean Starkman and Delphine Reuter
The article starts with a description of a 2008 sales meeting for DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. The sales gathering was more of a party than a meeting: sales executives were dressed up in costumes, music was blaring, and people were cheering, hooting and hollering. The reason for the celebration? DePuy Orthopaedics had just made one billion dollars selling the DePuy Pinnacle, a hugely popular metal-on-metal hip implant. At the gathering, Pinnacle inventor and celebrated orthopedic surgeon Thomas Schmalzreid stood on stage, proudly calling his device a “billion-dollar baby” and “the market leader.” Schmalzreid continued boasting about the product’s success to a crowd of cheering Pinnacle salesmen, “Did you know that the first billion is the hardest? Billion here, billion there. Pretty soon it adds up to some real money.” It was later found that DePuy was not necessarily making an honest living from the Pinnacle device and its sister model, the ASR XL. In fact, the huge profits were driven by intense marketing and “bribes to surgeons.” Between the Pinnacle and the ASR XL, DePuy made a jaw-dropping $5 billion in sales in 2008. But the company’s profits came at a huge cost to its consumers. The authors state that, prior to hitting the market, the Pinnacle and the ASR XL had never been tested on a human. This is typical in the medical device industry. As a result of the lack of testing, DePuy’s ASR XL and ASR systems were both recalled in 2010. Additionally, DePuy received so many lawsuits for the Pinnacle device that it was completely removed from the market. The authors note that DePuy was far from the only metal-on-metal implant company to face a huge backlash for its dangerous product. Other metal-on-metal manufacturers that pulled their products from the market include Zimmer Biomet, Smith & Nephew, Wright Medical, and Stryker. The companies pulled their products after reports from around the world found that the implants were poisoning their patients and “turn[ing] surrounding tissue to a liquefied black sludge.” Despite the report, Johnson & Johnson and other metal-on-metal implant manufacturers say they stand by their products. The authors interviewed Diana Zuckerman, who is in charge of the National Center for Health Research. She said the scandal with metal-on-metal implants is the result of underlying problems with the medical device industry and its poor regulations. There are lots of loopholes, shady connections between regulators and manufacturers, and an overall anti-regulation sentiment, which has let bad devices enter and stay in the market. Zuckerman said the metal-on-metal controversy “was almost a perfect storm.” The metal-on-metal hip scandal shows that, overall, the medical device industry is extremely profitable yet highly corrupt. And profits are even greater in developing countries, where there is poor regulation but increasing wealth. Even though medical devices like hip implants have done amazing things for people, it is far too easy to shove a flawed product into the market. Implants can be approved with very little research to back them, and this research is often paid for by the industry itself. After they are approved, manufacturers persuade doctors and hospitals to use them “in ways that push – or break – legal and ethical barriers.”
Continue ReadingVictim Hope Fluctuating

Medical Devices Cause Unexpected Issues in Patients

Article link: https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/

Article Title: Medical Devices Harm Patients Worldwide as Governments Fail on Safety

By ICIJ

This article is the result of an extensive study involving over 250 journalists across 36 countries. The investigation found that, in recent decades, medical implants have caused patients a great deal of harm because governments have approved them as “safe for use” with little or no human testing.

The investigation also found that it is common for devices to be recalled and pulled from the market in some countries but remain on the market in others.

In the last ten years, there have been more than 83,000 deaths and 1.7 million injuries associated with medical devices — such as metal-on-metal hip implants — in the United States alone.

The article tells the story of Vijay Vojhala, who received a metal-on-metal hip implant from Johnson & Johnson’s subsidiary, DePuy Orthopaedics, Inc. Due to his implant, Vojhala now has vision problems, heart problems, and difficulty walking.

The implant Vojhala received has since been found to poison patients, as have other metal-on-metal hip implant models.

The authors note that over half a million people have received metal-on-metal hip implants, but most models have been recalled or pulled from the market.

Later on, the article mentions that, since 2015, Johnson & Johnson has been ordered to pay $4.3 billion to Americans who have been injured by their medical products, including their metal-on-metal hips.

Additionally, the authors discuss the fact that the medical device industry can be extremely profitable for manufacturers, even when their devices are complete failures.

For instance, orthopaedic surgeon Thomas Schmalzried has made almost $30 million for designing two of DePuy Orthopaedics’ most dangerous metal-on-metal hip implants: the Pinnacle and the ASR XL. One of his devices was recalled worldwide, and both of them have been removed from the market because they have been found to cause metal poisoning.

Furthermore, the authors find that there are gaps in the way that medical device recalls are issued worldwide. As an example, the authors talk about one of Zimmer Biomet’s metal-on-metal hip implants.

After Biomet’s implant was linked to “flesh-rotting metallosis,” the company stopped selling it. And because the implant was formally recalled in Australia and some European countries, Biomet had to send alerts to surgeons in those countries, informing them about the product’s hazards.

However, because the FDA did not attempt to recall the device in the United States, Biomet did not have to issue such notifications to doctors in the US.

Finally, the article discusses attempts to correct the broken system that makes it difficult to trace the impact of medical implants. The authors interview Stephen Graves, a surgeon from Australia.

In the 1990s, Graves started a registry that tracks almost all hip and knee replacements in Australia. He has since found that hip and knee devices cause many problems to patients.

Graves’ database was a key piece of evidence in the fight to recall the ASR XL implant in 2009. His database has identified over 150 faulty joint implant models.

Continue ReadingMedical Devices Cause Unexpected Issues in Patients

Defective Medical Device Victims Speak Out

Article Link: https://www.icij.org/investigations/implant-files/patients-fight-for-answers-as-broken-implants-cause-unseen-agony/

Article title: Patients Fight For Answers as Broken Implants Cause Unseen Agony.

By: Spencer Woodman

This article highlights the heartbreaking stories of patients around the world who received faulty medical device implants.

In doing so, they interviewed Jeong Sang-Ho, a 47-year-old from Seoul, South Korea, who is currently embroiled in a years-long lawsuit against Johnson & Johnson over a faulty implant he received in 2008. Jeong originally received Johnson & Johnson’s ASR metal-on-metal hip system in 2008.

Jeong experienced great suffering as a result of his ASR hip implant. The implant dissolved inside of his body, which led to a number of devastating consequences, each one worse than the other. Jeong recalls that, as the implant began to disintegrate inside of him, “the device [pierced] into [his] thigh, which caused [him] to bleed a lot, and it felt like there were a thousand needles poking into [his] leg.”

In 2010, Jeong went in for a hip revision surgery, where his broken implant was replaced with a new ASR implant. Two months after his surgery, Jeong’s new implant was recalled, but he did not find out about the recall until 2013.

As a result of the ASR implants, Jeong is disabled and lost his job. He has spent the last few years fighting Johnson & Johnson in court, but he has only received a meager $600 of compensation from the company through Johnson & Johnson’s ASR Reimbursement Program.

In 2016, a United States federal judge ruled that Johnson & Johnson had to pay $1 billion to Americans who received one of Johnson & Johnson’s other faulty metal-on-metal implants. However, being in South Korea, Jeong is not entitled to the same compensation as Americans.

To this day, Jeong still has the ASR system in his body. Johnson & Johnson has also appealed the 2016 ruling requiring it to pay $1 billion to patients injured by the ASR system.

In a video embedded in the article, Jeong states, “This device ruined my life. I lost my job. I have great limits in exercising every day. I can’t lift up heavy things or even hold up my baby.”

———-

The article also tells the story of Connie Hill, a 72-year-old American woman who received a Zimmer Biomet metal-on-metal hip implant.

In 2015, Biomet issued a safety warning for the implant in Australia and later published similar warnings in countries throughout Europe. Biomet issued the warning after doctors found it was causing “an array of disabling complications.” However, Biomet never published a safety warning in the United States, so Connie and her doctor were never notified of the Biomet device’s hazards.

Connie had no idea there was anything wrong with her implant until late 2017 when her doctor noticed that the bone around her implant was starting to dissolve, and she had very high levels of cobalt and chromium in her blood.

The authors of the article point out that the FDA published a “generalized safety communication” about Biomet hip implants in 2011, but the FDA never directly reached out to doctors and patients who had worked with or received the implants.

Connie’s implant had to be replaced. Before she went into surgery, the doctors warned her that she could suffer a variety of debilitating complications, including death. Thankfully, Connie’s revision surgery went smoothly.

The authors of the article suggest that Connie’s experience was a result of a larger problem in the medical device industry: medical device companies sometimes send out safety alerts in some countries, but not others.

————

A video embedded in the article also tells the story of Vijay Vojhala. Vojhala lives in India, and he received metal-on-metal hip implant in 2008. His implant was recalled in 2010 after it “poison[ed] thousands of patients.”

As a result of the implant, Vojhala had to remove all of his dentures, is deaf in one ear, and has a myalgia problem. He states that, when he tried to talk to the surgeon who gave him the faulty implant, the doctor had no idea the product had been recalled.

Continue ReadingDefective Medical Device Victims Speak Out

Both Sides Close to a Deal in Pinnacle Hip Implant Cases

Good News for Potential Pinnacle Hip Lawsuit Settlements

A global settlement may come soon in Pinnacle hip implant lawsuits across the country.  One of the attorneys working on the deal announced that both sides reached a tentative agreement. The deal would resolve most of the 10,000 lawsuits currently filed against Johnson & Johnson and the DePuy hip maker.

Federal Trial in Pinnacle Hip Cases Ends Suddenly

At the moment, there are no details about a potential settlement. However, a federal court in Dallas suddenly released a jury from a Pinnacle re-trial after news broke of a possible settlement. That retrial was in response to a 2016 verdict awarding five DePuy Pinnacle hip replacement patients a $500 million verdict against Johnson & Johnson. DePuy’s spokeswoman refused to comment on any settlement deal details.  Lawsuits aimed at DePuy’s failed Pinnacle metal on metal hips began back in 2010. Since then, Johnson & Johnson faced several massive jury verdicts against them, including a $1 Billion verdict against the hip maker.

J&J Settles with US States for $120 Million

Two weeks ago J&J agreed to pay $120 million to states over deceptive marketing practices in how they sold the Pinnacle metal-on-mngine.com/metal-hip/pinnacle/pinnacletal hips.  Attorney Generals from 46 states said DePuy misled consumers about how long their metal on metal hip implants would last.

Early Settlements Reached in 3,300 Pinnacle Hip Cases

In December 2018 news sources reported that Johnson & Johnson settled about 3,300 individual cases for approximately $125,000 each.

One of our highly experienced attorneys can review your case for free.

Complications from Metal on Metal Hips

Continue ReadingBoth Sides Close to a Deal in Pinnacle Hip Implant Cases

J&J To Pay $120 Million to Settle False DePuy Marketing Claims

Johnson & Johnson agrees to a pay $120-million settlement.  The attorneys general of 46 states announced the victory today.  They sued J&J over deceptive and misleading marketing practices. The states claimed Depuy told patients the ASR XL and Pinnacle Ultamet hips would last at least 5 years.  In reality, European health regulators reported that 95% of these hips never made it to the 5-year mark.  Patients often needed another hip surgery to remove and replace the ASR XL and Pinnacle Ultamet implants.

The settlement forces Depuy to change how they market their hip implants.  They also have to closely monitor, track, and report on complaints about these hips. Depuy says the settlement does not imply any admission of liability or misconduct. New York Attorney General Letitia James says in her statement that “companies should never be allowed to freely mislead the public, especially when there are health concerns involved.”

Timeline of Johnson & Johnson Metal on Metal Hip Trials and Settlements

mctlaw Defective Metal on Metal Hip Litigation

The defective joint replacement team at Maglio Christopher & Toale, P.A. have extensive experience in representing clients who suffered injuries from defective Metal on Metal Hip Replacements.  Our attorneys were the first to file a claim against Biomet for their M2a and Magnum metal on metal hip replacements.

Continue ReadingJ&J To Pay $120 Million to Settle False DePuy Marketing Claims

Kentucky Patients – Infections from Flu Shots & Other Vaccines

A warning to adults in Kentucky who got vaccinated between September 1 and December 31, 2018:  Patients and doctors report a number of serious adverse vaccine reactions coming from vaccine clinics held at Kentucky businesses during those dates. The reactions include swelling, hard knots, pain, redness, abscesses, and lumps.

According to WKYT, the problems originated with Location Vaccination, a company that sends out staff to vaccinate people at local businesses.  That company has since stopped vaccinating, so there are no further risks.

It looks like the problem is with how these shots were given, meaning injection safety and not a reaction to the vaccine itself. The Kentucky Department for Public Health believes the problems stem from improper storage and handling of the vaccines.

People who got a hep A, TDaP, pneumococcal, or seasonal flu shot from Location Vaccination between September 1, 2018 and December 31, 2018 should be alert.  Reactions can happen up to 8 weeks after getting the vaccination.

The Kentucky Department for Public Health (KDPH) sent out a statewide health alert asking for information about anyone experiencing a serious reaction to vaccinations given between those dates.

Our highly experienced vaccine attorneys are reviewing Kentucky vaccine injury cases now.

You may be eligible for the federal Vaccine Injury Compensation Program (VICP)

Recent Client Award Amounts

See a listing of MCTLaw's client awards. The entire dollar amount shown goes directly to our clients because our legal fees are paid separately by the Federal Court

About the National Vaccine Injury Compensation Program

Currently, there is more than $3 billion available in a federal trust fund to compensate people with vaccine injuries. Americans with vaccine injuries have already received more than $2 billion in compensation since 1988.  Find out more about how the program works and if you qualify.

How to File a Vaccine Injury Compensation Claim

Filing a vaccine claim is a complicated and adversarial process. Vaccine Cases are NOT typical personal injury cases. Your vaccine lawyer needs to be a member Court of Federal Claims Bar and should be highly experienced in litigating vaccine injury cases before the Vaccine Court.

Continue ReadingKentucky Patients – Infections from Flu Shots & Other Vaccines

Attorney Michael J. Cowgill Joins MCT Law

(December 12, 2018 — Sarasota, FL)  Maglio Christopher & Toale, P.A. is pleased to announce the addition of attorney Michael J. Cowgill to its complex litigation practice, including the firm’s national metal on metal hip litigation team.
Mr. Cowgill comes to the mctlaw Sarasota office from Portland, Oregon, where he co-founded his own firm, Meadowlark Immigration PC. Cowgill represented clients before the Executive Office of Immigration Review and the 9th Circuit Court of Appeals in asylum and deportation proceedings. Cowgill also worked as a law clerk on contract law and environmental law issues with in-house counsel at Iberdrola Renewables (now Avangrid), an international utility corporation.
Before attending law school, Cowgill was a legal researcher at Maglio Christopher & Toale, P.A. Now, years later, he’s returned to the Firm’s Sarasota office as an accomplished attorney focusing on high profile metal on metal hip replacement litigation.

“No one should ever feel like the odds are against them when the law is on their side,” says Mr. Cowgill. “I’ve always represented people who need someone to speak up for them against huge government institutions and profit-driven corporations.”

Mr. Cowgill graduated from Lewis & Clark Law School in Portland, OR where he was also a legal writing teaching fellow.  He earned his Bachelors Degree from New College of Florida, the state’s highly competitive honors college. Michael was born and raised in Miami, FL and is a native Spanish speaker.

About Maglio Christopher & Toale, P.A. 

Maglio Christopher & Toale, P. A. is a national complex litigation firm with 18 attorneys and offices located in Sarasota, FL, Washington, D.C., and Seattle, WA. The firm’s practice areas include vaccine injury compensation, defective metal on metal hip replacement litigation, construction and commercial law, qui tam, and federal takings. For more information, you can contact us at 888.952.5242 or www.mctlaw.com.

Continue ReadingAttorney Michael J. Cowgill Joins MCT Law

NBC Biomet Report Features Patient Represented by MCTLaw

NBC News investigative reporters sat down with Andrew Chappell to speak about his Biomet M2a hip replacement nightmare. Reporters wonder why seven nations, including Australia and Germany, knew about serious problems with the Biomet M2a hip implant and issued warnings, but neither Biomet nor the FDA warned American patients like Andrew.

“Throughout the extensive litigation, it’s still not clear why Biomet decided not to issue a recall in the U.S. According to Chappell’s attorney, Altom Maglio, it’s because no one was forcing them to.”  -Excerpt from NBC News Investigative Report on Biomet M2a Hip Replacements

Andrew’s Biomet nightmare required two unnecessary surgeries to remove and replace the Biomet M2a implants in both of his hips.  Despite the surgeries, he was left with extensive damage to his muscles, tissue, and bones. Blood tests came back positive for heavy metal poisoning, the result of toxic heavy metals from the hip implant spreading through Andrew’s body.  When Andrew’s surgeon opened up the hip cavity, he found a grisly mess of disintegrated bone, gray-green fluid, metallic-stained tissue, and a cavity filled with metallic debris. Andrew is not alone. There are thousands of people in the United States with metal on metal hip replacements like the Biomet M2a and Magnum hip implants. NBC News worked with the International Consortium of Investigative Journalists to uncover how medical devices like Biomet metal on metal hip implants are “tested, approved, marketed, and monitored.”  The results of their investigation are terrifying for anyone living with a medical device like the Biomet M2a hip.

Continue ReadingNBC Biomet Report Features Patient Represented by MCTLaw

DePuy Allegedly in Process to Settle Pinnacle MoM Hip Cases

According to court documents released on Monday, November 26th, 2018, DePuy, the manufacturer of the Pinnacle hip, appears to be in the process of settling thousands of their Metal on Metal hip cases within the Multi-District Litigation.  Typically, court documents that talk of the payment terms for attorneys are produced when the settlement process begins. So far no formal announcement of any settlements has been made.

The metal liner of the Pinnacle device creates friction between the cup and the ball-shaped head of the thigh bone. This can cause the hip parts to prematurely wear down and release microscopic metal ion particles into a patient’s body. The patient may experience metal poisoning, short-term side effects, and unknown long-term health problems. Some patients don’t realize that they are being poisoned until a blood test shows unsafe levels of heavy metals in their body or an MRI or CT shows tissue destruction or bone loss.

 

DePuy discontinued sales of the Pinnacle metal liner in mid-2013 but has not issued any recalls.

If you have a defective metal hip replacement, contact MCT Law by calling 888.952.5242 or filling out a form below for a free case review.

Continue ReadingDePuy Allegedly in Process to Settle Pinnacle MoM Hip Cases

FDA to Overhaul of System that Approved Defective Metal Hips

On Monday, the Food and Drug Administration (FDA) announced that it will overhaul the way medical devices are tested and approved. The changes will force device makers to design their newest devices on more updated and recent technology. The FDA’s sudden announcement came just one day after a worldwide investigative report into medical device safety, led by the International Consortium of Investigative Journalists (ICIJ). The news report is called the “Implant Files” and holds the US government and device makers accountable for “1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices (that) had been reported to the U.S. Food and Drug Administration over a 10-year period.”  Those staggering numbers are the result of the FDA’s 510(k) process of getting medical devices approved by basing their design on outdated and decades-old testing and research. Orthopedic companies like Zimmer Biomet and Johnson & Johnson used designs from the 1970s to get their new metal on metal hip replacements approved, even though the older hip designs were scrapped because of severe patient reactions to metal wear.  Those same problems with heavy metal poisoning from hip implants like the Biomet Magnum and Pinnacle are now haunting millions of patients facing serious health risks. The change in the 510(k) system is welcome, but the reforms won’t happen soon or fast enough.  The Associated Press reports that it “could take years to implement, in some cases requiring new guidelines and regulations for manufacturers. And the most substantive changes could require action by Congress.”

About MCT Law

Maglio Christopher & Toale, P.A. continues to aggressively lead the national fight for patient’s rights in the metal on metal hip replacement disaster.  Our Firm filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases since that time.  Maglio Christopher & Toale, P.A. is currently representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet M2a-38 and M2a-Magnum hip replacements, as well as other brands of MoM hips. Read the FDA’s press release about the new medical device safety overhaul here.
Continue ReadingFDA to Overhaul of System that Approved Defective Metal Hips

CA Lawsuit Claims Biomet Misleading with False Info

(Sacramento, CA – November 23, 2018)  Three California residents filed a lawsuit in Sacramento County Court against Biomet Orthopaedics.  The suit says that Biomet sold defective Magnum metal on metal hip replacements to these patients, who all experienced heavy metal poisoning which destroyed muscle, tissue, and bone in their bodies.  The lawsuit also details how Biomet has posted false and misleading data on its website to reassure surgeons and patients that there’s nothing wrong with the Magnum implant, even though evidence exists that Biomet Magnum hips have serious problems.

The Patient’s Stories

In 2007 surgeons implanted two Biomet Magnum hip replacements in Denise Derosa. Since then, the Magnum implants have silently released poisonous metals into her body, killing the muscle, ligaments, and bone around her hip joint. Surgeries to remove the implants have not worked because of the extensive damage caused by the Biomet Magnum. Today Ms. Derosa’s hips frequently dislocate from their sockets and she’s gone through many painful surgical procedures to put the hip sockets back in place.

Robert Greenlee underwent two Biomet Magnum hip replacement surgeries in 2008. The Magnum hips poisoned him by releasing extreme levels of toxic cobalt and chromium metals into his bloodstream.  Mr. Greenlee now needs to go through excruciating surgeries to remove and replace both Biomet Magnum hips.

John Woods got his Biomet Magnum hip replacement implants in 2011. They were supposed to last a lifetime, but seven years later Mr. Woods had hip surgery once again, this time to replace the toxic Magnum hips. The heavy metal poisoning from the metal on metal implants triggered a cascade of severe medical problems including dead tissue, necrotic muscle, and dead bone in and around his hip joint.

Inaccurate and Outdated Information Still Posted on Biomet’s Website

The Sacramento, California complaint states that Biomet has posted false information on their website meant to reassure surgeons and patients about the safety of Magnum metal on metal hip implants. The webpage is filled with tables showing how well the Magnum hips have performed compared to other hips.  Biomet posted this “letter to surgeons” online in 2012 and has kept it online and discoverable with a simple search ever since.

The three California plaintiffs allege that this online information is misleading. Biomet cites data from joint registries in Australia and England showing better than average revision rates for the Magnum.  Since the time this letter was published, both the Australian Joint Registry and the England and Wales Joint Registry have uncovered much higher than normal revision rates for the Biomet Magnum hips.  In fact, the Biomet Magnum Hip was essentially recalled in Australia with the release of an official Hazard Alert about the Biomet Magnum implant in 2015.

The Lawsuits Against Zimmer Biomet

Maglio Christopher & Toale, P.A. is leading the U.S. litigation against Zimmer Biomet with clients across the entire United States.  The firm has filed lawsuits in San Francisco, Seattle, Florida, New Jersey, Illinois, Indiana, Louisiana, and Missouri, with more filings pending across the country. The case filed in Sacramento is Derosa vs. Biomet Inc., Case Number 34-2018-00244214.

About Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Seattle, WA, Washington, DC, and Sarasota, FL.  Maglio Christopher & Toale, P.A. filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases ever since.  The Firm is representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet M2a-38 and M2a-Magnum hip replacements.

Continue ReadingCA Lawsuit Claims Biomet Misleading with False Info

“The Bleeding Edge” Documentary and Problems with FDA

You may have seen or read about the recently released documentary The Bleeding Edge. If not, it is presently available on Netflix. The documentary discusses the problems with the FDA regulation of medical devices and metal on metal hip replacements in particular.

The Bleeding Edge is a great example of what strong journalism can do. The Essure birth implant device, which was the main device chronicled in the documentary, was just pulled from the market by Johnson and Johnson days before the release of the movie. We believe this was a direct result of the release of the documentary.

We are fully aware of the issues discussed in this documentary relating to metal on metal hips (MoM hips). Some of the professionals interviewed in the documentary are already involved with our law firm regarding our metal on metal litigations.

There continues to be research into how the body reacts to metal debris from implants. This includes local damage around the hip joint as well as what we call “systemic” damage caused by metal traveling through the bloodstream to different body systems.  As you saw in the documentary, Dr. Tower is particularly investigating issues affecting the brain.  If you suspect you have “systemic” issues that may be related to your implant, your priority should be to discuss those issues with your doctors.

We strongly encourage you to share this documentary with your friends and, especially, your doctors.  We agree with the documentary that many medical professionals are unaware of the loose FDA regulations regarding how these devices make it onto the market. This documentary is an excellent way to present that information to your surgeons.

As always, it is our honor to represent people across the country dealing with the aftermath of metal on metal hip replacements. We will continue to fight on their behalf in pursuit of justice.  If you have any questions, please do not hesitate to reach out.

Thank you,

Altom M. Maglio, Esq.
Managing Partner, Maglio Christopher & Toale, P.A.

Defective Metal on Metal Hip Replacement?

Contact MCT Law at 888.952.5242 or fill out a form below for a free Case Review.

Continue Reading“The Bleeding Edge” Documentary and Problems with FDA

6/13/18 Punitive Damages Allowed-Biomet Knew of Metal Hip Flaws

A Florida judge allows the attorneys at Maglio Christopher & Toale, P.A. to go after punitive damages against Zimmer Biomet as part of three Florida residents’ lawsuit in Fort Lauderdale.

Punitive damages are a type of financial punishment against a company for intentionally bad behavior or misconduct. The standard for punitive damages in civil court is similar to the standard in criminal court for manslaughter. In order to include punitive damages in their lawsuit, these Florida plaintiffs (the patients injured by the Biomet hip implant) had to show that Zimmer Biomet ignored serious health risks with the M2a metal on metal hip and sold it for financial gain, anyway.

Attorney Ilyas Sayeg presented a motion for permission to add a claim for punitive damages in the lawsuit during a recent proceeding. Judge Henning reviewed the evidence and decided the case had enough merit to add punitive damages in the lawsuit against Zimmer Biomet.  Below is a partial transcript of Judge Henning’s ruling during the proceeding:

“I think that there is sufficient showing at this time regarding the knowledge that Biomet had regarding the toxicity of the… metal on metal, that they alleged…the damage as far back as 1995 and the testing that was done then, the culture of the company in suggesting that they, once the information was known, not presenting it to the doctors and the surgeons that were using it and trying to avoid subject matter and… even as they showed discussing that having metal in your body is a normal body function and that it would be in there in any event… So, I think at least at this point, there is a sufficient showing for them to be able to allege the claim.”

Punitive Damage Amounts in other Metal on Metal Trials

Juries in three recent “Pinnacle” metal on metal hip trials have awarded $168-million, $360-million and $1-billion in punitive damages against that device’s manufacturers, Johnson & Johnson and DePuy Orthopaedics. Punitive damages are separate from compensatory damages, which is money awarded to a plaintiff to “compensate” them for their expenses and the other costs of their injury. Punitive damages, meanwhile, are meant to provide a jury an additional means to send a message if they believe the conduct was so bad that compensatory damages will not be enough to deter the bad conduct in the future. Each state has complex laws regarding punitive damages and in some cases, punitive damage awards may not be allowed.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Washington, DC, Sarasota, FL, and Seattle, WA.  Maglio Christopher & Toale, P.A. filed the first metal on metal hip replacement lawsuit in the United States in 2008.  Our team of experienced attorneys has been continuously litigating metal on metal hip replacement cases ever since.  Maglio Christopher & Toale, P.A. represents patients across the country with Biomet M2a-38 and M2a-Magnum hip replacements who are now suffering from the effects of metal poisoning.

Continue Reading6/13/18 Punitive Damages Allowed-Biomet Knew of Metal Hip Flaws

Higher Wear Rates for Biomet Hips than Other MoM Hips

Title: Explant Analysis of the Biomet Magnum/ReCap metal-on-metal hip joint

Abstract

Metal-on-Metal (MoM) hip resurfacing implants and MoM total hip arthroplasty (THA) implants have recently been questioned by the medical community because of their high revision rates. Understanding the reasons for failure can provide insight into how implants can be improved. Furthermore, looking at the wear (amount of material lost) on implant devices can help us determined why they failed.

The authors of this study used a special 3D scanner called a Coordinate Measuring Machine to measure the wear on five failed Biomet M2a-Magnum/Recap/Taperloc large-head MoM THAs and one Biomet ReCap resurfacing implant.

Of the 6 devices tested, the average amount of material lost was 6.1 mm3 per year, which is higher than the wear rates known to cause implant failure in similar metal-on-metal hips. In addition, the average wear rate of the tapers in the Magnum tapers was .054 mm3/year. The taper is a cylindrical piece of titanium at the tip of the implant stem, and it connects to the head.

The authors of this study conclude that patients with Biomet hip implants should be monitored closely by their doctors, regardless of whether they have a MoM THA device or a resurfacing device.

Introduction

MoM implants were popular from the 1990s through the mid-2000s. They were supposed to offer many benefits, such as increased range of motion and lower rates of failure. Young, active patients often received these types of implants. MoM implants come in two forms: hip resurfacing and total hip replacement.

However, some hip implant brands, such as the DePuy Articular Surface Replacement (ASR) and the ASR XL THA device have very high rates of wear and revision, which caused a lot of concern about whether MoM implants are actually beneficial.

A lot of these implants failed due to a set of conditions called adverse reaction to metal debris, or ARMD. ARMD is caused when the implant’s components rub against each other and shed metal debris, primarily cobalt and chromium, into the surrounding tissue. Symptoms of ARMD include pain, dead tissue, metal poisoning, and fluid accumulations around the hip joint.

However, the DePuy ASR and ASR XL THA implants are not the only MoM devices with high revision rates; studies have reported high failure rates among brands like Zimmer Durom and Birmingham Hip Resurfacing (BHR). Because MoM THAs fail at such high rates, they have become a lot less common, but they are still in use.

The authors of this study believe that all patients with MoM implants should be monitored closely in order to understand which implants are working well and which ones are not.

One way to asses the performance of hip implants that have already been removed is to measure the amount of wear they experienced (or how much material rubbed off of the implant). This is measured in cubic millimeters (mm3).

A previous study found that MoM wear rates higher than 2.3 mm3 per year can cause implant failure and require revision. Another study found that wear rates above just 1 mm3 per year can lead to dangerously high metal ion levels in the blood. High metal ion levels can lead to a number of health consequences, ranging from fatal heart disease to dementia.

Importantly, a previous study stated that “the Biomet ReCap and Magnum components are not susceptible to the same design problems” that caused high failure rates among the Durom and ASR hip implants. The authors of this study wanted to test this statement and see if Biomet implants actually functioned better than others.

Patients and Methods

This study examines 5 Biomet M2a-Magnum/Recap/Taperloc MoM implant systems, and one Biomet ReCap resurfacing device. These implants were all extracted during revision surgery after the implant failed.

Reasons for revision were pain, ARMD, and/or dangerously high blood metal ion levels. Blood tests showed that two patients had metal ion levels above what is considered safe (7 µg/l). Additionally, four of the patients had symptoms of ARMD.

Results

The total wear for each implant device was between 30 mm3 and 57.3 mm3. This means that each device shed between 30 mm3 and 57.3 mm3 of metal. The average wear rate for the implant devices was 6.1 mm3 per year.

In all of the implants, the femoral head experienced much more wear than the other components.

Magnum devices have an extra component called a taper, which is made out of titanium. On average, each taper lost about .38 mm3 of material in total. The average wear rate for the tapers was .054 mm3 per year

Discussion

The authors found that the inclination angles — or the way in which the implant components were positioned — did not cause the high wear rates. In other words, the high wear rates were not caused by doctors positioning the implants incorrectly during implantation surgery; rather, the wear rates were the result of the implant design. However, they did find that the implant with the lowest inclination angle had the highest wear rate and produced the highest metal ion levels.

A previous study found that a wear rate of just 2.3 mm3 per year could be enough to cause implant failure. A 2003 study found that a wear rate as low as .55 mm3 per year could cause wear-related failure. The Biomet implants in this study all had wear rates significantly higher than these, as the lowest wear rate in this study was 4.1 mm3 per year and the average was 6.1 mm3.

In 2016, the National Joint Registry (NJR) reported that the probability of failure for the ReCap implant was 7.79% in the first seven years, which is much higher than BHR’s 5.47% but lower than ASR’s 20.88%. In contrast, the Australian Orthopaedic Association (AOA) found that the seven-year failure rate of the ReCap device was 12.2%.

For the Magnum THA system, the AOA found that its revision rate was 8.6% in the first seven years, which is slightly higher than the BHR THA device’s revision rate at seven years.

The NJR found that. in general, revision rates for MoM THAs were higher than revision rates for MoM resurfacings. Some studies concluded that the reason for the higher revision rates in THAs was primarily taper wear, which is why the authors of this study also measured the wear rates of the Magnum tapers.

This study found that, on average, the wear rate for the Magnum taper was .054 mm3 per year, which is relatively low compared to the wear rates of other tapers. The authors believe the reason for the relatively low taper wear is that the Magnum taper is made out of titanium, which has proven to shed less. However, the authors warn that titanium tapers should not be seen as the solution to implant wear because titanium tapers have their own problems. For instance, they are known to weld themselves to other implant components, which can cause complications during revision surgery.

To summarize, the authors conclude that the wear rates for the 6 Biomet devices they studied were higher than the rate known to cause wear-related failures (which is generally considered to be 2.3 mm3 per year). Finally, the authors state that all patients with Biomet implants should be monitored closely by their doctors.

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Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

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Continue ReadingHigher Wear Rates for Biomet Hips than Other MoM Hips

Biomet M2a Magnum Hip is Hard to Revise

Title: Modular to Monoblock: Difficulties of Detaching the M2a-Magnum Head Are Common in Metal on Metal Revisions

Where Are We Now?

Metal-on-Metal total hip arthroplasty (MoM THA) implants consist of many metal parts that rub together over the course of normal use. The medical community used to think that corrosion — which is essentially rusting — didn’t affect metal on metal THAs very much. However, we now know that corrosion is quite common, and it causes complications during revision surgery.

During MoM revision, the implant head needs to be removed from the stem. However, in implants where the head and stem are joined by a titanium taper, there can be so much corrosion that the components of the implant get welded together, making it very difficult to remove the head during revision. The failure rate of MoM implants is already extremely high — sometimes as high as 49% at 6 years – but corrosion could make this rate even higher.

Some MoM implants are more susceptible to this problem than others. A recent study published by Mantyamaki and colleagues demonstrates that Biomet M2a-Magnum devices are frequently hard to revise because it is surprisingly common for the head to get stuck to the stem.

Where Do We Need to Go?

Many studies have shown that removing the implant head can damage the trunnion (which is the tip of the stem that attaches to the head). Mardones, the author of this article, thinks that instead of removing the whole stem during revision, doctors could just place a protective sleeve over the damaged trunnion, and then place a new head.

Alternatively, in cases where the head or taper cannot be removed at all — or if the trunnion is damaged during revision — Mardones believes the stem must be removed at all costs, even if it is very stuck. Mardones also recommends that doctors have a variety of tools available before going into revision surgery so they can deal with any complications that might come up.

How Do We Get There?

Mardones believes doctors need to develop standard skills and tools to remove implant heads without causing damage to the trunnion. Another idea he suggests is creating a replacement trunnion that has a new head attached to it. He notes that this type of implant should be one single structure without interchangeable parts; this is in contrast to most MoM implants, which are made up of many interchangeable parts and are therefore vulnerable to corrosion.

Mardones warns that doctors must be prepared to encounter serious corrosion during revision, so they should always have a variety of skills and tools available during surgery. This way, they can minimize the amount of bone and tissue damage that occurs during revision. Some examples of useful revision tools are a corkscrew head extractor, a diamond saw, cables, and revision stems.

Mardones believes MoM THAs that are composed of many interchangeable parts are mostly looked down upon now. However, he thinks that THA implants could be saved if we can reduce the number of parts they have. He suggests creating one, continuous large-head MoM device could reduce fretting, corrosion, and cold-welding. Mardones concludes that if we cannot develop a MoM THA device with fewer parts, we should discontinue the use of MoM THAs altogether.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingBiomet M2a Magnum Hip is Hard to Revise

Study: Biomet M2a Magnum Heads Greatly Increase Risks

Title: Modular to Monoblock: Difficulties of Detaching the M2a-Magnum Head Are Common in Metal-on-metal Revisions

Abstract

Metal-on-Metal total hip arthroplasty (MoM THA) implants are made up of a variety of components. One common component is the modular head; it is supposed to be easy to remove during revision surgery. However, it can actually be incredibly difficult – sometimes impossible – to remove because it can get welded to other components over time. This happens frequently in implant devices that have a titanium sleeve between the head and stem. The authors of this study have had a lot of difficulties removing the titanium sleeve adapter in the Biomet M2a Magnum hips. These difficulties have been reported to the FDA, but the frequency and complications of these difficulties are unknown.

This study analyzes the results of 124 Metal-on-Metal THA revision surgeries, all of them involving Biomet devices.

The authors of this study wanted to answer two questions. First, are Biomet M2a-Magnum implants more difficult to revise than the Biomet M2a-38? Second, in cases where the M2a-Magnum was harder to revise because of problems with the modular head, were there more surgical complications (such as operative time, bleeding, a risk of fracture, or joint infection)?

In response to their first question, the authors found that, yes, Biomet M2a-Magnum implants are more difficult to revise than Biomet M2a-38 devices. In response to their second question, the authors found that difficult revisions did result in longer operative times, more bleeding, and a higher risk of bone fracture and joint infection after surgery.

Introduction

MoM THAs often fail and require revision surgery. The survival rate of large-diameter MoM THA implants can be as low as 51% after 6 years. Revisions occur because of pseudotumors (which are enlarged masses of tissue that resemble tumors), dislocations, bone fractures around the implant, and infections. Although the use of MoM THAs has gone down, many people still have them and will require revisions in the future, so it is important to understand what might happen during revision.

One common MoM device is the Biomet M2a-Magnum, which is made up of several components: a cup, a femoral head, a titanium taper adapter, and a stem. Another Biomet device, the M2a-38, is similar to the M2a-Magnum, but one key difference is that it does not have a separate titanium taper like the M2a-Magnum.

Usually, during revision surgery, it is not necessary to remove the stem, and the modular head can be removed easily by using a punch and a mallet. However, with the Biomet M2a Magnum device, there is so much grinding and corrosion that occurs between the head and the titanium adapter that the two can get stuck together. This makes it very difficult to remove the head during revision.

Materials and Methods

This study looks at 124 MoM THA implants that underwent revision surgery. 70 of them were M2a-Magnum heads, and 54 of them were M2a-38 heads.  Additionally, all patients had Biomet-brand stems.

The authors of this study measured the difficulty of removing the femoral head based on how many special tools they had to use. The authors also measured operation time, blood loss, infection,  bone fractures, and any health complications after revision surgery.

The authors then compared the results of the M2a-Magnum group to the M2a-38 group.

Results

The authors did not experience difficulties removing any of the M2a-38 heads. However, the authors experienced difficulties in 29% of the M2a-Magnum revisions and had to use special tools to extract the heads. Additionally, 17% of the Magnum hips needed unplanned stem revisions because of the difficulties experienced during head removal. This means that the patients received a more invasive surgery than they had initially planned.

For the M2a Magnum revisions that had removal difficulties, operation time and amount of bleeding increased. Additionally, 9 of the M2a-Magnum patients experienced health complications one year after revision, including 6 infections and 3 bone fractures around the implant.

Discussion

MoM THA implants have been known to cause a number of problems. Patients with M2a-Magnum MoM implants may experience additional problems because this brand of implant is difficult to revise, as this study shows.

The authors note that their study faced some limitations. For instance, they only measured metal ion levels for 68% of the patients. Therefore, they can’t reach a definite conclusion about the relationship between head removal difficulties and metal ion levels. However, their data showed higher average metal ion levels for patients who didn’t experience difficulties, which suggests there may not be any relationship between head-removal problems and metal ion levels.

As mentioned earlier, all of the difficulties were experienced in the M2a-Magnum heads. These heads are larger than the M2a-38 heads, but it is not clear whether the size of the head is the cause of the difficulties. Cold welding – or the joining of two metal pieces without the use of heat – seems to happen a lot in MoM THA implants. However, it is not yet clear how this cold welding occurs.

This study found that the titanium-titanium taper can be difficult to separate during revision surgery. If doctors don’t anticipate these difficulties, this can result in complicated revision surgeries in patients with M2a-Magnum devices. These difficulties can occur even if implantation occurred recently, and even if the patient has low metal ion levels.

Importantly, the authors note that these difficulties might occur in more sensitive cases, such as emergency revisions due to infections. For these cases, it is especially important that patients and physicians be prepared for challenging revisions.

Doctors should inform their patients that their revision surgeries may be longer and more complicated — and may even require bone-cutting — if they have M2a-Magnum devices because of the high rate of difficulties reported by this study.

Additionally, doctors revising M2a-Magnum devices should go into surgery with special tools like femoral head extraction tools and diamond saws.

A previous study found that the use of titanium sleeves is increasing, but this study shows that these sleeves can cause problems. The authors believe more research is needed about titanium sleeves.

Reference

Mantymaki, H., Makela, K., Vahlberg, T., Hirviniemi, J., Niinimaki T. “Modular to Monoblock: Difficulties of Detaching the
M2a-MagnumTM Head Are Common in Metal-on-metal Revisions.” Clin Orthop Relat Res (2016) 474:1999–2005.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingStudy: Biomet M2a Magnum Heads Greatly Increase Risks

Study: Metal Hips Cause Higher Metal Ion Levels than Resurfacing

Title: Higher Blood Cobalt and Chromium Levels in Patients with unilateral metal-on-metal total hip arthroplasties compared to hip resurfacing

Abstract

High cobalt and chromium levels in the blood are known to cause negative side-effects in patients with metal on metal hip replacements. This study discusses the risk factors and the overall likelihood that that people with MoM implants are more likely to experience high cobalt and chromium levels.

This study looks at the blood cobalt and chromium levels of 1,748 patients. 692 of these had hip resurfacings and 1,056 of them had total hip replacements, also known as total hip arthroplasties (THA). In this study, “high” levels of metal ions means greater than 7 ppb.

This study found that patients with THA were more likely to have high metal ion levels than patients with hip resurfacings.

This study also found that these risk factors make hip resurfacing patients more likely to experience high metal ion levels:

  • Small femoral head
  • A high acetabular inclination angle
  • Young age.

These risk factors make MoM THA patients more likely to experience high metal ion levels:

  • Being female
  • Longer time between surgery
  • Ion measurement
  • Large femoral head size

The authors conclude that all large diameter MoM THA implants should definitely be supervised closely.

Introduction

MoM hip replacements have very high revision rates, largely because they cause a set of complications known as adverse reactions to metal debris (ARMD). The amount of cobalt and chromium metal ions in patients’ blood samples are often used to determine whether a metal on metal implant is wearing down because they shed tiny metal particles into patients’ bodies over time.

Because of these problems, guidelines have been put in place to monitor the health of patients with MoM implants. However, some experts believe the existing guidelines don’t do enough to predict whether an implant is failing.

Past studies have shown that large-diameter THA devices are more likely to fail, and some MoM brands are considered more dangerous because they fail way too often.

The authors believe there is only one other study that has compared the metal ion levels associated with different MoM brands.

Additionally, although blood metal ion levels are definitely related to implant failure, there is some debate about what amount of metal should be considered dangerous or “too high.”

The authors of this study tried to answer two questions: First, how common is it for MoM patients to experience blood metal ion levels greater than 7 parts per billion (ppb)? Second, what risk factors make patients with MoM hip implants more likely to experience high metal ion levels?

Patients and Methods

This study analyzed the blood metal ion levels of 1,928 patients with unilateral MoM hip implants (meaning only one of their hips had an implant). Of those patients, 751 of them had hip resurfacings, and 1,177 of them had large-diameter head total hip replacements (THR). Additionally, most of the resurfacing patients were relatively young (89% of them were 65 or younger).

Results

In the hip resurfacing group, 48 of the implants were Biomet ReCap devices. In the THA group, 67 of the implants were Biomet M2a devices.

Patients with THA implants were much more likely to have high metal ions than patients with resurfacing implants. Out of the 7 THA brands analyzed, 5 of them caused high metal ion levels in over 20% of their patients, including Biomet. Meanwhile, less than 10% of all resurfacing patients had high metal ion levels.

In the resurfacing group, there was a lower risk of high metal ions for patients that had BHR and Durom devices than patients with ASR implants. Other factors that increased risk in the resurfacing group were female gender, young age, high acetabular inclination angle, and small femoral head size.

In the THA group, patients with ASR devices had the highest risk for high metal ions. Other risk factors in the THA group were female gender, large femoral head size, and length of time since implantation.

In the resurfacing group, 4.7% patients with Biomet ReCap devices had high metal ion levels. In the THA group, 21.6% patients with Biomet M2a devices had high metal ion levels.

Discussion

This study, which is the largest of its kind, confirms that MoM THAs are more likely to cause increased metal ions than MoM resurfacings. This study also contributes important information about how metal ion levels vary across the different implant brands.

The authors recognize that their study had some limitations. For instance, some brands were more represented in this study than others, which could cause some error in the risk reporting. Second, not all blood samples were taken at the same time. This is important because metal ion levels increase over time, especially for THAs. Third, the medical community still isn’t sure what exact amount of metal in the blood indicates implant failure — different medical institutions have different standards. This study used 7 ppb as its cutoff value for “too much” metal, which is actually the highest standard cutoff value in the medical community. Therefore, this study somewhat understates the link between MoM implants and high metal ion levels.

Two other studies have found that MoM THAs produce higher blood metal ion levels than MoM resurfacings. Experts believe the main reason for higher metal ions in THAs is that the taper wears down. Importantly, this study found that Biomet MoM THAs with titanium sleeves produce lower cobalt levels in the blood. However, the authors believe more research is needed to determine the amount of wear caused by the contact between the titanium sleeve and the femoral head in Biomet implants. Additionally, because titanium sleeves often make revision surgery difficult, the authors cannot say whether a titanium sleeve is actually beneficial in the long run. Finally, although this study found relatively low blood levels of cobalt and chromium in patients with Biomet ReCap devices, other studies have actually found that ReCap implants cause high metal ion levels in a large percentage of patients.

Conclusion

This study presents important data based on the results of a large group of patients. Clearly, some brands of MoM implants pose a higher risk than others. Because high metal ion levels are very common among MoM patients, more studies are needed to determine the effects of high cobalt and chromium levels, especially because many patients with high metal ion levels don’t present any symptoms but could still be at risk of health problems.

Reference

Lainaiala, O. Moilanen, T., Hart, A., Huhtala, H., Sabah, S., Eskelinen, A. “Higher Blood Cobalt and Chromium Levels in Patients With Unilateral Metal-on-Metal Total Hip Arthroplasties Compared to Hip Resurfacings.” The Journal of Arthroplasty 31 (2016) 1261e1266.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingStudy: Metal Hips Cause Higher Metal Ion Levels than Resurfacing

~9% Chance of Pseudotumors 5 Years After Biomet Magnum M2a Hip

Title: A 5-year survival analysis of 160 Biomet Magnum M2a metal-on-metal total hip prostheses

Abstract

Large-head metal-on-metal (MoM) total hip arthroplasties (THA), or hip implants, have high failure rates. This study looks at the conditions of 160 hip devices 5 years after implantation in order to determine their failure rate; all 160 devices were Biomet Magnum M2 large-head MoM total hip articulations.

Overall, a total of 13 implants – or 8.1% – failed and had to be revised. Additionally, this study found that 14 – or 8.75% – of the implants caused pseudotumors in their patients. Pseudotumors are enlarged masses of tissue that resemble tumors, and they’re a known side-effect of MoM implants. Pseudotumors were the leading reason for revision in this study.

The authors of this study conclude that doctors need a rigorous follow-up strategy for MoM THA patients in order to identify and treat implant failure early on.

Introduction

When MoM THA implants were first introduced, they were thought to have a lot of benefits and quickly became popular. However, multiple studies have shown that MoM devices shed metal debris into patients’ bodies, causing many painful and dangerous complications such as pseudotumors and elevated levels of metal ions (cobalt and chromium) in the blood and serum.

Pseudotumor formations can lead to the early failure of hip implants, and there are many risk factors that make people more likely to develop pseudotumors, ranging from the positioning of the implant to the gender of the patient. Because of the well-documented negative consequences of MoM hip implants, the Netherlands recalled these devices and ordered active follow-ups of all patients who received them. This study analyzes the patients who came for follow-ups after the recall.

Materials and Methods

All patients received the Biomet Magnum (M2a-Magnum) prostheses with Recap cup and Taperloc (Taperloc®Hip Stem) or Mallory stem (Mallory®).

All patients had their cobalt and chromium blood levels tested; normal cobalt levels were considered to be below 40 nmol/l. Patients were also asked to complete the Harris Hip Score (HHS) survey. The HHS asks a series of questions that are intended to measure how well an implant is working; after answering these questions, the patient is given a score ranging from 0-100 to rank how well the implant is working. In addition to these examinations, the patients got X-rays, MARS-MRI scans, and CT scans.

Results

In total, this study looked at 160 MoM implants from 150 patients; 10 patients had bilateral MoM implants (meaning they had implants on both hips).

From this group of 160 hips, a total of 15 implants (9.4%) had to be revised. Revisions occurred, on average, 3.7 years after implantation, but some revisions occurred in as little as 6 months after implantation.

Seven of the revision patients experienced groin pain, but 21 of the non-revised patients also experienced groin pain. Additionally, two revisions were conducted due to the loosening of the implant device. Finally, a total of 14 implants developed pseudotumors.

All patient statistics considered, the authors conclude that the survival rate of the large-head Biomet MoM THA device at 5 years is 93.1%.

The patients with revised implants had an average HHS score between 70-80, which is considered “fair.”

The X-rays did not show any bone loss, bone resorption, or fracture. An important finding in this study is that patients with pseudotumors had much higher levels of cobalt in their blood.  Finally, 26 patients had abnormal fluid around their joints.

Discussion

Many studies have shown that large-head MoM THA devices fail early on, develop pseudotumors, and have high revision rates. For instance, one study showed that Biomet implants tend to fail specifically because of their cup, which is a component in the device that’s implanted in the pelvis. Another study found that the Biomet M2a-Magnum had a survival rate of 88% after 3.6 years.

When it comes to pseudotumors, there is some confusion in the literature. Some authors believe that any patient with a pseudotumor should undergo revision surgery, while other authors believe that a pseudotumor alone is not a sufficient reason to revise an implant. It is also unclear whether pain in the hip always indicates the presence of a pseudotumor.

In this study, a total of 14 hips developed pseudotumors after 6.1 years, meaning that patients had an 8.75% chance of developing pseudotumors. Some warning signs of pseudotumors include pain and discomfort in the groin, deafness, fear, and dizziness.

This study also found that patients with pseudotumors experienced more pain in the groin and had lower HHS scores. However, the authors note that they may have missed pseudotumors in patients who did not show any pseudotumor symptoms because some patients did not receive CT scans.

The authors of this study also found that pseudotumors are linked to higher levels of cobalt and chromium in the blood.

The authors believe that large-head MoM devices and high inclination angles are more likely to result in elevated cobalt and chromium blood levels because they cause the implants to shed metal debris more quickly.

The effects of metal debris on the body are not completely understood yet. Some studies have shown that women are more likely to develop pseudotumors than men, and they tend to have higher serum levels of cobalt and chromium.

The authors end their study with multiple recommendations. First, they conclude that doctors should follow up with their patients frequently and measure their metal ion levels each time because these are useful in determining the presence of pseudotumors. They also recommend that patients with pseudotumors undergo revision surgery in order to prevent future complications. Additionally, the authors state that doctors should follow-up very closely with patients who are experiencing pain. Next, they recommend close follow-ups for patients with non-MoM hip devices because those can also have negative side-effects. Finally, they discourage the use of MoM implants outside of a research setting.

Reference

Koper M., Mathijssen N., Vehmeijer, S. “A 5-year survival analysis of 160 Biomet Magnum M2 metal-on-metal total hip prostheses.” Hip Int 2016; 26(1): 50-56.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue Reading~9% Chance of Pseudotumors 5 Years After Biomet Magnum M2a Hip

Monitor for Cobalt Chromium Levels and Pseudotumors Very Early On

Title: Clinical and Wear Analyses of 9 Large Metal-on-Metal Total Hip Prostheses

Abstract

All patients in this study had the Biomet Magnum (M2a-Magnum™) hip implant with a Recap cup and Taperloc (Taperloc1 Hip Stem) or Mallory stem.

This study attempts to figure out the underlying reasons for implant failure by looking at the wear analyses and clinical symptoms of 9 patients with revised Metal-on-Metal (MoM) total hip arthroplasty (THA) implants.

The authors conclude that is very important for doctors to monitor the indicators of implant failure very early on; these include pain, decreased range of motion, and high levels of cobalt and chromium in the blood. The long-term effects of keeping failed implants in place can seriously decrease a patient’s quality of life.

Introduction

All MoM hip implants were recalled in 2011 in the Netherlands. This decision was made after many studies showed MoM THA implants had high rates of revision and caused pseudotumors. Despite this, MoM hip implants remained quite popular in the United States and England.

MoM THA implants shed metal debris into the body, which in turn can lead to high levels of cobalt and chromium in the blood. This can also lead to the formation of pseudotumors around the implant. Pseudotumors are enlargements of tissue that resemble tumors.

The positioning of the implant can impact the amount of wear suffered by implants. For instance, cup inclination angles greater than 55 degrees are known to increase wear due to edge loading. Edge loading occurs when the cup is malpositioned on the head, causing excessive stress and friction, which leads to higher rates of wear.

The wear rates of MoM bearings in this study varied a lot. The authors of this study tried to relate each bearing’s wear rate to its patient’s symptoms in order to understand the underlying mechanisms of implant failure.

Materials and Methods

Of the 9 implants in this study, 7 were revised due to pseudotumor formation. Two of them were revised because of increasing pain. Six of the patients were female, and the average age of the patients was 57.

This study had two main parts: patient examinations and implant wear analysis.

The patient exams consisted of X-rays, MARS-MRI scans, CT scans, ultrasounds, cobalt and chromium serum measurements, and the Harris Hip Score (HHS) survey. The HHS has a series of questions that are intended to measure the performance of an implant; after answering these questions, the patient is given a score from 0-100 to describe how well an implant is working.

Implant wear analysis involved studying the implants themselves after they were removed from the patients in order to determine how much metal was lost by each component of the implant.

Results

The patients’ average HHS score was “fair” (in the 70-80 range). Patients whose implants were revised due to pain had lower HHS scores (in the 60-70 range). Seven patients experienced groin pain, and 2 patients noticed their hip joint was swollen. None of the patients had any neurological problems, deafness, or dizziness.

Four of the patients with pseudotumors experienced groin pain, while three of the patients with pseudotumors (all females) did not experience any groin pain.

According to the X-ray scans, only two patients appeared to have loose cups. Additionally, no patients suffered from bone loss, bone resorption, or fractures. The median inclination angle of the implant cup was 41.2 degrees. However, for the patients with pseudotumors, the median inclination angle of the implant cup was much higher at 47.7.

Moreover, eight patients received ultrasounds. Pseudotumors were visible in 2 ultrasounds. Liquid accumulations in the hip joint were visible in 4 ultrasounds.

In this study, the median cobalt levels were 24.8 nmol/l, and median chromium levels were 47.3 nmol/l. However, patients with pseudotumors had median cobalt levels of 53.8 nmol/l and median chromium levels of 63.0 nmol/l.

A total of 6 MARS-MRIs and CT scans were obtained. Two CT scans showed possible pseudotumors. Five MARS-MRI scans showed possible pseudotumors.

In addition to assessing the patients, the authors of this study also looked at the implants themselves in order to measure the level of wear in each implant. Wear indicates the amount of metal that was shed from a particular component of an implant. Overall, the amount of wear differed a lot from one bearing to another, ranging from 0 mm³ to 24.424 mm³ in the heads, and 0 mm³ to 20.575 mm³ in the cups, and 0 mm³ to .172 mm³ in the tapers. Severe wear was seen in only one bearing.

Discussion

Large-head MoM THAs frequently lead to early failures and pseudotumor formations. However, wear rates and pseudotumor formations vary widely. A better understanding of the relationship between wear rates and pseudotumor formations is needed in order to predict the outcome of MoM THAs in the future.

Some studies have found a link between high wear, patient’s metal sensitivity, and the appearance of pseudotumors. However, other studies have found that pseudotumors can still occur without a lot of wear. In these patients, it is possible that a hypersensitivity to metal caused the implant failure. In hypersensitive patients, reducing the amount of wear experienced by their implant could possibly prevent the implant from failing.

The most important predictor of a bearing’s wear rate is a type of wear called edge loading. Edge loading is caused by a lot of factors, the most significant of which is high cup inclination.

The effects of metal wear particulars and elevated levels of cobalt and chromium have been documented, but they are still not completely understood.

This study did not find a clear relationship between serum metal ion levels and wear rates. However, this study did show a correlation between high cup inclination and increased metal ion levels. For instance, two patients had a cup inclination angle over 55 degrees, and these patients also had the highest amount of wear in their cups.

The patients with the highest amount of head wear also had increased levels of cobalt and chromium in their serum. These findings show that implant positioning is very important in preventing high metal ion levels.

All patients had high levels of cobalt and chromium in their serum. Two patients also had very elevated levels of titanium in their serum. Elevated titanium levels indicate the presence of trunniosis, which is wear of the femoral head–neck interface. It is only seen in large-diameter head bearings. Trunniosis is typically only seen in head bearings larger than 40mm in diameter.

The exact causes of implant failure and pseudotumor formation are not yet known. They could be caused by high cup inclination, edge loading, trunniosis, patient characteristics, or a combination of all of these factors.

The authors provide some recommendations to doctors who treat people with MoM hip implants. They first recommend very close and frequent monitoring of patients with MoM implants. Doctors should not just ask the patient questions to determine if their implant is working; they should also measure patients’ cobalt, chromium, and titanium levels, take X-rays, and conduct MARS-MRI scans. More information is needed to understand the relationships between failed implants, metal ion levels, pseudotumor formations, and patient symptoms.

Reference

Koper, M.C., Mathijssen, N.M.C., Witt, F., Morlock, M.M., Vehmeijer, S.B.W. Clinical and Wear Analyses of 9 Large Metal-on-Metal Total Hip Prostheses. PLoS ONE 11(10):e0163438. doi:10.1371/journal.pone.0163438 (2016).

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingMonitor for Cobalt Chromium Levels and Pseudotumors Very Early On

FL Biomet Hip Lawsuit: Metal Poisoning, Loopholes, etc.

(Ft. Lauderdale, FL – May 3, 2018)  Maglio Christopher & Toale, P.A. files yet another lawsuit against Biomet Orthopedics on behalf of 3 Florida patients who all had to undergo traumatic hip revision surgery because of their defective Biomet Magnum hip implants.

Patients Facing Medical Crises from their Biomet Magnum Hip Implants

Robert Bloom’s Biomet Magnum hip revision surgery turned into an even bigger nightmare than anyone expected.  While removing the Magnum, the orthopedic surgeon found and removed an extremely large pseudotumor from Mr. Bloom’s hip joint before replacing it with a different type of hip implant.  Unfortunately, the hip became infected and Mr. Bloom had to undergo a THIRD hip replacement surgery.

Raymond Moore experienced severe pain, burning, and extremely high levels of metal in his bloodstream from his Biomet Magnum hip implant.  Moore’s orthopedic surgeon had to remove the Magnum hip and cut out the surrounding hip tissue because of the extensive physical damage left behind.

Robert Quinn’s Biomet Magnum hip implant caused metallosis, which is a type of metal poisoning commonly caused by metal on metal hip implants. When Mr. Quinn’s surgeon opened the hip area, he found significant amounts of metal debris and fluid surrounding the hip muscle and tissues.  As with both Mr. Bloom and Mr. Moore, Mr. Quinn also suffered from a long and difficult recovery because of the Biomet Magnum hip implant.

All three patients are represented by the attorneys at Maglio Christopher & Toale, P.A., in partnership with the Nash & Franciskato Law Firm. Unfortunately, there are tens of thousands of other Biomet metal on metal hip patients across the US who may not know their implant may be a ticking time-bomb. Worse still, these victims are probably also unaware of the suspicious methods Biomet used to market and sell this defective hip.

Using a Loophole to Avoid Safety Testing of Biomet Magnum Hips

In 2004, Biomet began selling the Magnum hip to patients in the United States.  One of the defendants in the suit, John Cuckler, M.D., an orthopedic surgeon, worked with Biomet for years to design the Magnum hip implant.  Their design was based on similar metal on metal hips from the 1970s that failed miserably in large part because of metal poisoning. Despite knowing how dangerous metal on metal hips are, the lawsuit indicates that Biomet and Dr. Cuckler used a loophole in the FDA’s approval process to rush the Magnum to the market without ever once being tested in human beings to make sure it was safe.

Secret Marketing Campaign to Boost Biomet Magnum Hip Sales and Profits

The complaint filed by Maglio Christopher & Toale, P.A. states that Biomet and Dr. Cuckler then conducted a secret marketing campaign for the Magnum hip in exchange for millions of dollars in payment.

Around the time the Magnum went on the market, Dr. Cuckler began making speeches and writing scholarly articles promoting the Magnum hip replacement and the safety of metal on metal hip implants.  At the same time, Biomet was paying Cuckler a percentage of all Magnum implant sales but did NOT disclose this information to patients or in the articles he wrote for the orthopedic community.

The more Cuckler promoted the Magnum, the more money he could earn from Biomet. This type of financial relationship creates an obvious conflict of interest because it can prioritize sales over safety.   This financial relationship between Biomet and Cuckler helped trigger an investigation by the US Department of Justice.  That investigation actually resulted in criminal charges against Biomet for these types of financial agreements with the medical community.  In an effort to avoid convictions on those charges, Biomet entered what was called a “deferred prosecution agreement” with the government.

The attorneys at Maglio Christopher & Toale, P.A. are the only lawyers in the country who have questioned Dr. John Cuckler under oath about the Biomet Magnum hips.  Likewise, they are the only attorneys in the country who have questioned Biomet under oath regarding their metal on metal hips and the “deferred prosecution agreement.”

Multiple Trials Set for Biomet Hip Lawsuits by Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is set for the first trial in the United States involving a Biomet metal on metal hip.  That trial date is in September 2018 in Ft. Lauderdale, Florida. Our attorneys have also filed lawsuits in multiple states across the country and are preparing for a series of trials against Biomet.

About Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Seattle, WA, Washington, DC, and Sarasota, FL.  Maglio Christopher & Toale, P.A. filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases ever since.  The Firm is representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet M2a-38 and M2a-Magnum hip replacements.

 
 
 
 
Continue ReadingFL Biomet Hip Lawsuit: Metal Poisoning, Loopholes, etc.

Attorney Theodore J. Hong Joins mctlaw

SARASOTA, FL — (April 17, 2018) – Maglio Christopher & Toale, P.A. welcomes the addition of attorney Theodore J. Hong, Esq. to the Firm’s vaccine injury compensation and metal-on-metal hip replacement litigation practices.  Mr. Hong will be based in the Firm’s Seattle, WA office.

Ted Hong Attorney Maglio Christopher & Toale
Attorney Theodore Hong Joins Firm

Prior to joining the Firm, Mr. Hong served as the law clerk in the King County Superior Court for Judge Carol Schapira, ret., and Judge Hollis Hill, ret.  He received his undergraduate degree from the University of Washington and his Juris Doctor degree from the Lewis & Clark Law School.

Mr. Hong understands the importance of community fellowship and the many benefits it produces, so in his free time he actively participates in mentoring programs and serves as guest speaker/panelist at local schools.

About Maglio Christopher & Toale, P. A.

Maglio Christopher & Toale, P. A. is a national complex litigation firm with 17 attorneys and offices located in Sarasota, FL, Washington, D.C., and Seattle, WA.  The firm’s practice areas include vaccine injury compensation, defective metal on metal hip replacement litigation, construction and commercial law, qui tam and federal takings.

Continue ReadingAttorney Theodore J. Hong Joins mctlaw

Heavy Metal Poisoning from Biomet Metal Hip Destroys Patient’s Pelvis

(San Francisco, CA – April 26, 2018) A team of attorneys led by Maglio Christopher & Toale, P.A. has filed a lawsuit in San Francisco, CA against Biomet Orthopedics on behalf of a patient who suffered horrific injuries from a Biomet M2a metal on metal hip implant.

The patient, Mickey Reed, had no idea the Biomet M2a hip implant in his body was releasing toxic heavy metals and poisoning him. There were no warnings from Biomet or obvious symptoms until it was too late. The metallosis slowly ate away and killed the tissue, muscle, and bone surrounding the M2a implant until there was nothing left of his hip.  The M2a destroyed the entire structure of Mickey Reed’s pelvis.  Surgeons could NOT replace the M2a with another hip implant because there was nowhere left to attach it. Today Reed lives without a hip joint. He can no longer walk or use his leg.  He is in constant agony.

The Warning Signs Were Clear, but Biomet Pushed Sales Instead of Safety

The complaint shows one medical study after another warning that Biomet M2a metal on metal implants caused traumatic complications like pseudotumors, metallosis, tissue death, and higher than normal revision rates.  Biomet responded by publishing counter articles saying there were “no adverse physiological effects” to metal on metal hips implants.

In 2010, Johnson & Johnson issued a worldwide voluntary recall for an almost identical metal on metal hip causing higher than expected complications and revision surgeries. Biomet’s response: a promotional push to sell M2a implants and capture market lost by Johnson & Johnson due to their voluntary recall.

Patients like Mickey Reed were left with ticking time bombs in their bodies. The consequences of Biomet’s profit-driven behavior have left Mr. Reed crippled forever.  Tragically, according to the Complaint, he is just one of the thousands of patients in California and across the country suffering from Biomet’s indifference.

Patients Left with Ticking Time Bombs in the Bodies

According to the complaint, at NO point has Biomet warned US surgeons about problems with the M2a or Magnum implants. At NO point did it tell US surgeons to test patients for elevated cobalt and chromium levels, or to undergo MRI or CT scans to look for silent pseudotumors. These early warnings could have changed Mickey Reed’s life.

The case is Mickey Reed vs. Biomet, Inc. et al filed in Superior Court of California, County of San Francisco, case number CGC-18-565909 (Click Here to Read Complaint)

How Maglio Christopher & Toale, P.A. is Litigating Biomet M2a Hip Cases

Maglio Christopher & Toale, P.A. is aggressively leading the litigation of these cases across the United States, with the first trial involving a Biomet metal on metal hip set for September 2018 in Ft. Lauderdale, Florida.

About Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Seattle, WA, Washington, DC, and Sarasota, FL.  Maglio Christopher & Toale, P.A. filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases ever since.  The Firm is representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet M2a-38 and M2a-Magnum hip replacements.

Continue ReadingHeavy Metal Poisoning from Biomet Metal Hip Destroys Patient’s Pelvis

Metal Hips Cause Levels 26x Cobalt Increase and 15x Chromium Increase

Title: The Effect of Different Bearing Surfaces on Metal Ion Levels in Urine Following 28mm Metal-on-Metal and 28mm Metal-on-Polyethylene Total Hip Arthroplasty

Abstract

Total hip arthroplasty (THA), or hip replacement surgery, is known to increase levels of metal ions in the body. This is because the implant devices can shed metal particles into the body. This can have many negative effects on THA patients.

One way to measure the levels of metal ions in the body is to test patients’ urine. This study compares two different types of THA devices to see which one produces higher metal ion levels, as measured by patients’ urine. The two types of implants they compare are metal-on-metal (MoM) bearings and metal-on-polyethylene (MoP) bearings.

This study looks at 92 hip replacement patients; some of them had MoM implants and others had MoP implants. It measures the amount of cobalt, chromium, and molybdenum ions in their urine one year after getting their implants and two years post-surgery.

The patients with MoP implants had only a slight increase in cobalt and chromium levels two years post-surgery. For the patients with MoM devices, chromium levels were 15 times greater two years after surgery, and cobalt levels had increased by 26 times.

The authors conclude MoM devices cause very high cobalt and chromium levels; they are higher than those allowed for on-the-job exposure in Finland, where this study was conducted.

Introduction

Metal-on-metal hip implant devices that are made out of cobalt and chromium became really popular because they were thought to be more durable. Many improvements have been made since the first generation of MoM devices came out in the 1970s. However, there are still many health problems associated with these devices, such as adverse reactions to metal debris (ARMD). ARMD is a type of hip implant failure that results in pseudotumors and fluid collections around the hip implant. ARMD is caused by metal particles rubbing off of the implant device and into the body.

Patients and Methods

92 patients were divided into two groups, those who had hip replacements with MoM implants and those who had MoP implants. All of the patients had Biomet hip implants with 28-mm head diameters.

The authors collected urine samples from the patients before their hip replacement surgery, one-year post-surgery, and two years post-surgery.

Results

X-rays taken two years after surgery showed that none of the patients’ implants had moved or been misplaced since surgery. Only 5 implants had fractured, and they were fixed.

Before hip replacement surgery, average chromium levels for both MoM and MoP patients were less than .01 µmol/L. One year after surgery, average chromium levels had risen to .12 µmol/L for MoM patients but were still .01 µmol/L for MoP patients. Two years after surgery, average chromium levels rose to .15 µmol/L for MoM patients and .02 µmol/L for MoP patients. Essentially, chromium levels increased a lot more for MoM patients than they did for patients with MoP devices.

Average cobalt levels before hip replacement surgery were 21 nmol/L for MoM patients and 19 nmol/L for MoP patients. One year after surgery, average cobalt levels had risen to 417 nmol/L for MoM patients but only 33 nmol/L for MoP patients. Two years after surgery, cobalt levels had risen to 538 nmol/L for MoM patients and 57 for MoP patients. In sum, cobalt levels were dramatically higher for MoM patients than they were for MoP patients.

Molybdenum levels were also measured for all patients, but there were no significant changes in molybdenum levels.

Overall there was a much greater increase in cobalt and chromium levels for MoM patients than there was for MoP patients. Cobalt and chromium levels for MoM patients ended up being much higher than what is considered safe in Finland.

Discussion

The authors found that 28-mm MoM bearings in THA patients yield chromium and cobalt concentrations in urine that are higher than those recommended for workplace exposure.

The authors used urine samples because metal ion levels in urine are a good indicator of the levels of metal ions in the entire body.

Although cobalt is necessary for the body, excessive amounts of it can cause goiter and heart failure.

Ever since MoM implants were introduced, there have been concerns about their possible link to cancer; in animal studies, high levels of cobalt and chromium particles produced cancer cells in the animals. Recent studies have also suggested that hip implants (MoM and non-MoM) can cause changes to patients’ DNA and chromosomes.

There is also concern about the effects that MoM implants could have on the fetuses of patients who become pregnant because cobalt and chromium can cross the placenta; this could cause developmental problems in fetuses.

In theory, people who have THA surgery should face higher metal ion levels than people who receive hip resurfacing (HRA) surgery. However, the studies on this subject show conflicting results. One study showed that cobalt and chromium levels for patients who received HRA were higher than those who got THA surgery.

Another study found that cobalt and chromium levels in HRA patients and small-diameter head THA patients were significantly higher than in large-diameter head THA patients 6 months after surgery. However, this same study found that one-year post-surgery, all of the patients’ cobalt and chromium levels were more or less the same.

Some studies have shown that MoM implants often wear down very quickly in the first one to two years after surgery. After this initial period, they enter what the authors call a “steady-state” of wear for many years, which means the implants shed metal particles at a much lower rate.

MoP devices seem to be safer than MoM devices when it comes to metal ion levels.

**It is important to note that this study was funded and sponsored by Biomet UK Limited, a company that manufactures MoM devices.

Reference

Tiusanen, H., Makela, K., Kiilunen, M., Sarantsin, P., Sipola, E., Pesola, M. Scandinavian Journal of Surgery 102: 197-203, 2013.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingMetal Hips Cause Levels 26x Cobalt Increase and 15x Chromium Increase

MCT Law Welcomes Attorney Michele Stephan to the Firm

Michele Stephan Attorney Maglio Christopher & Toale
Michele S. Stephan Joins Maglio Christopher & Toale, P.A.

SARASOTA, FL — (April 19, 2018) – Maglio Christopher & Toale, P.A. welcomes the addition of attorney Michele S. Stephan, Esq. to the Firm’s metal on metal hip litigation and complex litigation practices.  Ms. Stephan will work out of the firm’s Sarasota, Florida office.

Ms. Stephan has represented clients in civil litigation for over 20 years.  Her experience includes litigating cases involving defective products, defective medical devices, personal injury, violation of nursing home resident’s rights, federal civil rights violations, international child abduction under The Hague Convention, and international law matters involving civil theft and fraud.

Stephan is active in the legal community as a member of the Twelfth Judicial Circuit Pro Bono Committee, a current board member and past president of the Sarasota County Chapter of the Florida Association for Women Lawyers, a Master Emeritus of the Judge John M. Scheb American Inn of Court, and a member of the Sarasota County Bar Association.  She also serves as a volunteer judge for Teen Court of Sarasota County, is a board member of the Friends of the Selby Public Library and runs a weekly legal clinic at the Resurrection House day shelter in Sarasota, Florida offering legal services to the homeless.

About Maglio Christopher & Toale, P. A.

Maglio Christopher & Toale, P. A. is a national complex litigation firm with 17 attorneys and offices located in Sarasota, FL, Washington, D.C., and Seattle, WA.  The firm’s practice areas include vaccine injury compensation, defective metal on metal hip replacement litigation, construction and commercial law, qui tam and federal takings.  For more information, you can contact us at 888.952.5242.

Continue ReadingMCT Law Welcomes Attorney Michele Stephan to the Firm

2/21/18 Biomet Leaders Forced into Depositions with MCT Law Attorneys

Maglio Christopher & Toale, P.A. is the only law firm in the country allowed to question Biomet representatives under oath about the connection between alleged unethical business practices and their M2a metal on metal hip implants.

In a courtroom hearing, our legal team won the ability to force Biomet to sit for depositions.  During these interviews, top Biomet staff will have to answer our questions about giving financial kickbacks to the surgeons, including those who designed the M2a hip implant.  By using unethical payment practices, Biomet gave those doctors a dangerous incentive to support the use of M2a products, even if they were unsafe.  This business arrangement put Biomet’s profits ahead of patient safety.

A History of Kickbacks at Biomet

In 2007 the Department of Justice (DOJ) pursued Biomet for using illegal financial incentives in marketing its products within the USA, including giving illegal kickbacks to orthopedic surgeons. Kickbacks create a conflict of interest which motivate individuals to mask bad outcomes in favor of financial gain.  Biomet agreed to enter into what’s called a “Deferred Prosecution Agreement” (DPA). The DPA required Biomet to correct its business practices under the supervision of a government-appointed monitor.  Importantly, at the time Biomet designed and initially marketed its M2a implants, it was doing business in accordance with the business model that violated the DPA.  Supposedly, Biomet satisfied the requirements of this DPA in 2009.

While claiming it cleaned up its act, the Department of Justice hit Biomet AGAIN with another DPA for doing the same thing. This time the DPA focused on Biomet’s international conduct, particularly illegal payments to surgeons in Brazil, Argentina, and China. Biomet entered into DPA 2 to correct their international business contract with orthopedic design surgeons.  However, the Department of Justice found that Biomet was not living up to its side of the bargain.  Zimmer Biomet, which now owns Biomet, was forced to pay millions of dollars because, as the Department of Justice states, “Zimmer Biomet had the opportunity to avoid criminal charges but its misconduct allowed the bribes to continue.”

Until Maglio Christopher & Toale, P.A.’s recent courtroom victory, it has been impossible for attorneys to review the documents related to these Deferred Prosecution Agreements.  Now our attorneys will be able to depose Biomet regarding the 2007 DPA and how that’s connected to their design, development, and sales of the M2a metal on metal hip.

Patients across the country may have gotten a Biomet M2a hip that was good for Biomet’s bottom line, but not for their health.

Continue Reading2/21/18 Biomet Leaders Forced into Depositions with MCT Law Attorneys

1/31/18 Documents Find Bad Quality Control at M2a Production Plant

Maglio Christopher & Toale, P.A., and its partner Nash & Franciskato are the ONLY law firms in the country to demand and get access to internal Biomet documents showing dangerous quality control issues at the plant where Biomet made the M2a Hips.

Uncovering the Full FDA Inspection Report of Biomet’s Warsaw Facility

In the fall of 2016, the FDA released a site inspection report of the Biomet facility in Warsaw, Indiana where all M2a metal on metal hip replacements were made. The FDA refers to this type of report as a “Form 483” report.

Where Form 483 reports are typically somewhere between 1-4 pages, the FDA’s Form 483 report based on its’ Fall 2016 inspection was historic in length.  It was 58 pages long.  It detailed serious problems with how Biomet handled product complaints and the internal investigation procedures for those complaints.

It also listed disturbing shortcomings in the design of the plant as well as poor air and water quality issues.  As one example, the design of “clean rooms” (where employees would need to be gowned in order to work in a germ-free environment) requires employees coming to work in their street clothes to walk through the clean room in order to access the gowning area.

In certain areas, the only border between a clean area and a non-clean area was a piece of tape on the ground used as a marker.   Workers were observed in street clothes walking within feet of items intended to be in a clean environment.

A heavily redacted version of this report is publicly available below.

Zimmer Biomet’s Response to the FDA’s Inspection

Even more disturbing than the FDA’s observations was Biomet’s 287-page response to the observations.  Now owned by Zimmer and operating under the new company name of “Zimmer Biomet,” the first two pages of this response letter admits the existence of “systemic issues” at the facility, including issues affecting the “quality culture” at the facility.

Zimmer Biomet explained that at the time Zimmer purchased Biomet, it performed certain investigations of its own before the FDA’s inspection of the site.  Zimmer Biomet claims that the internal investigations it conducted “self-identified major compliance-related issues in areas such as design controls, sterile packaging, complaint handling, nonconforming material, and CAPAs.”   CAPA stands for “Corrective Action Preventive Action” and is a set of protocols companies take in order to address any potential problems with their products (hopefully before they result in safety concerns for patients).

The effect of the FDA’s Form 483 observations at the Biomet immediately resulted in Zimmer Biomet shutting down activities at the plant.  A small number of employees were fired in order to make an example of those employees.  Those employees thereafter filed wrongful termination lawsuits against Zimmer Biomet.  As a result of the allegations in those wrongful termination lawsuits, certain Zimmer Biomet investors then filed “investor fraud” lawsuits against Zimmer Biomet.  They claimed that the corporate leadership of Zimmer Biomet lied to the investors about just how bad the conditions at the plant were.   Following the investor fraud lawsuits, Zimmer Biomet replaced its CEO.

Maglio Christopher & Toale, P.A. Forces Biomet to Turn Over Internal Investigation Documents

Maglio Christopher & Toale, P.A. is aggressively pursuing all documents related to Zimmer Biomet’s internal investigations regarding the Biomet plant where the M2a products were made and where complaints regarding M2a products were processed.   As part of this pursuit, we requested that Biomet produce unredacted versions of the FDA inspection report, Zimmer Biomet’s response letter, and all internal investigations cited in the 287-page letter to the FDA.  Biomet fought hard not to produce any of these documents.  However, the Court issued an order wholly agreeing with our clients and forced Biomet to hand over these very important documents.

If not for Maglio Christopher & Toale’s aggressive investigation, this information would remain hidden from the world.

Click Here to Read the “Motion to Compel” Order

Continue Reading1/31/18 Documents Find Bad Quality Control at M2a Production Plant

1/11/18 – MCT Law Forces Biomet to Produce Internal Sales Training

Losing patience with Biomet, the Court forces Biomet to produce its internal communications with its sales representatives and to explain what efforts it actually took to find the requested communications.

Read Order Forcing Biomet to Produce Internal Communications

Defective Metal on Metal Hip Replacement?

Contact MCT Law for a free case review by calling 888.952.5242 or filling out a form below.

Continue Reading1/11/18 – MCT Law Forces Biomet to Produce Internal Sales Training

06/17 Biomet Forced to Produce Documents with Electronic Search

In extensive arguments with Biomet, Maglio Christopher and Toale, P.A., convinced the court that Biomet’s search protocols for the MDL documents were so poor that they resulted in the production of a large number of useless and irrelevant documents.

These only served to confuse the issues and make more difficult the job of proving Biomet’s bad conduct.  Scoring a critical victory, Biomet was forced to adopt new search protocols authored by Maglio Christopher & Toale, P.A. in order to produce entire document sets from four previously unsearched employee files.

Read Order Forcing Biomet to Use New Electronic Search Protocols

Defective Metal on Metal Hip Replacement?

Contact MCT Law for a free case review by calling 888.952.5242 or fill out a form below.

Continue Reading06/17 Biomet Forced to Produce Documents with Electronic Search

4/16 Court Forces Biomet to Produce Audio/Video Files in M2a Lawsuit

Upset that Biomet has seemingly sat on its hands for nearly a year, the court forced Biomet to produce to our clients all audio and video files responsive to the request.

The court also warns Biomet to stop using its inferior production of documents in the MDL as an excuse to not produce documents to plaintiffs in state court.  The judge wrote in the order, “Biomet cannot utilize its ‘confusion’ or its production of discovery materials from the MDL litigations a smokescreen for failing to respond to the Plaintiffs’ discovery requests in this action.”

Read Order Forcing Biomet to Produce Audio Visual Files in M2a Hip Lawsuit

Contact MCT Law For a Free Case Review

If you have a defective metal on metal hip replacement, call 888.952.5242 or fill out a form below for a free case review.

Continue Reading4/16 Court Forces Biomet to Produce Audio/Video Files in M2a Lawsuit

Attorneys Ready for First US Trial Against Biomet Over M2a Hips

(Sarasota, FL – March 20, 2018) The first Biomet M2a metal on metal hip replacement trial in the United States is set for September 2018 in Ft. Lauderdale, Florida.  It is a significant legal challenge to Biomet Orthopedics since the company has not yet faced a single trial over their M2a-38 and M2a-Magnum hips.

The injured patients represented by Maglio Christopher & Toale, P.A. suffered from severe pseudotumors as well as tissue and muscle death from their Biomet M2a hip implants.  Surgeons for all 3 victims had to remove the defective Biomet M2a hip replacements, surgically cut out the pseudotumors, and dead tissue, and then put in a different type of hip implant.

In addition to the Ft. Lauderdale lawsuit, Maglio Christopher & Toale, P.A. has filed complaints and is preparing for multiple trials against Biomet in state courts around the country.

US Patients Not Adequately Warned of Dangers

“This is a ticking time bomb for thousands of patients in the United States who don’t know they have a very dangerous device in their bodies,” says lead attorney Altom M. Maglio. “Biomet has not warned U.S. patients or surgeons about the serious health consequences of these dangerous hips and we don’t understand why.  Failing to warn people is only making the problem worse.”

Biomet recalled the M2a-38mm hip replacement device throughout the United Kingdom, Europe, and Australia, but has not recalled the same hip in the United States.  In April 2016 the company sent warning letters to European surgeons admitting higher than expected failure rates for the hip implant.  In 2011 Biomet stopped all sales of the M2a-38mm and Magnum hip replacements in Australia, and in 2015 issued a Hazard Alert for higher than expected failure rates in Australia.

But in the United States, Biomet has not warned tens of thousands of patients or their doctors about the life-threatening complications from the identical hip implant.

Litigation Strategy in First Biomet M2a Metal on Metal Hip Trial

The litigation strategy of Maglio Christopher & Toale, P.A. and partner firm, Nash & Franciskato, gives their Biomet M2a clients options not available to others across the country. “By filing our clients’ Biomet metal on metal cases in state courts, we have been able to uncover millions of additional documents that help prove that these are defective hip replacements and that Biomet has known about it for years,” says Maglio. That same evidence was denied to attorneys litigating Biomet cases in Federal court.  “We have also taken over 30 depositions of Biomet executives, aggressively questioning them about the defective M2a hips.” Recently parties on all sides of the federal litigation indicated a desire to send all cases back to their individual attorneys to prepare for trial.

Recent Metal on Metal Hip Verdicts

Other metal on metal hip manufacturers have faced jaw-dropping verdicts against them. Juries in 3 separate trials ordered Johnson & Johnson subsidiary, DePuy Orthopaedics, to pay a $1-billion verdict to six plaintiffs in California, a $502 million-dollar verdict to 5 plaintiffs in Texas, and a $247-million verdict to six injured plaintiffs in New York.

In 2014 Biomet agreed to a $56 million-dollar settlement over the M2a-38 and Magnum hips, but it only applied to a very small number of U.S. patients and came with many strings attached, leaving out thousands of people with M2a hips.

The Biomet M2a-38 was introduced to the global market in 2001. Since then, patients with M2a hip replacements have reportedly developed complications from heavy metal poisoning, tissue death, pseudotumors, bone loss, heart problems, vision loss, and death.

About Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Seattle, WA., Washington, DC, and Sarasota, FL.  Maglio Christopher & Toale, P.A. filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases since that time.  The Firm is presently representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet M2a-38 and M2a-Magnum hip replacements.

Contact:

 Altom M. Maglio of Maglio Christopher & Toale, P.A. is available to discuss this case.

Phone: 888.952.5242

Continue ReadingAttorneys Ready for First US Trial Against Biomet Over M2a Hips

11/15 Biomet Forced to Produce Documents On Old Version of M2a Magnum

As Maglio Christopher & Toale, P.A. turned up the heat on Biomet requesting documents related to their M2a metal on metal hips, Biomet fought back by adopting a “scorched earth” strategy of multiple objections to every single request for documents by our clients.

In November 2015, a state court in Florida ruled for our clients and forced Biomet to produce documents relating not only to the M2a Magnum metal on metal hip implant but the M2a “38” metal on metal hip implant, as well.   The M2a 38 was a “predicate” device for the Magnum.  This means that Biomet told the FDA the Magnum and 38 are “substantially equivalent” devices.

Read Order Forcing Biomet to Produce M2a Magnum and M2a 38 Documents

Do You Have a Defective Metal Hip?

Contact MCT Law at 888.952.5242 for a case review, or fill out the form at the bottom of this page.

Continue Reading11/15 Biomet Forced to Produce Documents On Old Version of M2a Magnum

Metal on Metal Hips Linked to Early Onset Dementia and Depression

Title: “Neuropsychiatric symptoms following metal-on-metal implant failure with cobalt and chromium toxicity”

Abstract

Many metal-on-metal (MoM) total hip replacement implants have been recalled due to high failure rates. This study assesses the mental health of 10 patients who underwent revision surgery for failed MoM implants. The authors believe this is the first study to find a correlation between mental health complications and implant-caused cobalt and chromium poisoning.

Before undergoing revision surgery, 9 patients had toxic levels of chromium and cobalt in their blood. The authors diagnosed all 9 patients with depression; 3 of them were already being treated for depression. 7 out of 9 patients showed short-term memory loss and possible dementia.

The authors found a high incidence of cognitive disability and depression among patients who suffered from implant-caused metal poisoning (metallosis).

Background

MoM implants, which have a metal ball and socket, have been very popular in total hip replacement and hip resurfacing surgeries. When the components of MoM implants rub together over time, they release metal debris into patients’ bodies; this can lead to cobalt and chromium metal poisoning and require patients to undergo revision surgery.

High cobalt and chromium levels in the blood have been known to damage the way that visual stimulation is transmitted to the brain, among other disastrous effects.

Neurological problems, such as changes in brain structure and function, have been associated with high levels of cobalt and chromium in the blood following MoM hip replacement surgery.

Although some papers describe the physical effects of implant-caused cobalt and chromium poisoning, the authors believe this is the first paper to carefully describe the psychiatric problems associated with MoM implants.

Methods

This study looked at patients who received their original MoM implants between 2005 and 2009. All 10 patients underwent revision surgeries between 2008 and 2012 and were assessed for mental health in 2014 and 2015.

All patients received DePuy ASR hip implants; specifically, they received the acetabular implant, the taper sleeve adaptor, and unipolar femoral implants.

Patients’ brain function (or cognition) was evaluated using the Mini-Mental State Examination (MMSE) questionnaire. This exam gives a maximum score of 30, and most people up to age 85 have an average score of 28. A score of 25 or less in patients aged over 65 indicates cognitive disability and possible dementia.

Patients’ moods were evaluated using a questionnaire called the Beck Depression Inventory (BDI). A BDI score above 12 is high enough to diagnose depression.

The patients’ average age was 60.5 years. Six patients were female, four were male. On average, patients received the implants at age 52.5 and had them for an average of 4.44 years before undergoing revision.

Results

Observed metallosis:  Nine patients’ bloodwork was analyzed prior to undergoing revision surgery, and they all had toxic levels of cobalt and chromium in their blood. Their average chromium levels were 338 nmol/l; normal chromium levels are below 134.5 nmol/l. Their average cobalt levels were 669.4 nmol/l; normal cobalt levels are below 119 nmol/l.

The authors received the post-revision surgery bloodwork for only 3 patients. Two of these patients had acceptable metal levels in their blood. One patient still had toxic metal levels in his blood; his cobalt levels were normal, but his chromium levels were still high at 173 nmol/l.

Observed mood and cognitive function: The patients had moderately severe depression with an average BDI score of 27.6. Such high rates of depression are unusual.

There were significant cognitive abnormalities among the patients; their average MMSE score was 24.2. Seven out of 10 patients had short-term memory loss. This means that 70% of the patients showed signs of early-onset dementia, which is extremely unusual because only .00081% of the general population suffers from early-onset dementia. Additionally, some patients suffered from disorientation, concentration issues, and difficulty finding words.

The patient with the highest pre-revision surgery levels of chromium (664 nmol/l) and cobalt (2470 nmol/l) had the lowest MMSE score.

Patient vignettes: The authors provide more detail on 4 of the 9 patients, who will be referred to as Ms. X, Mr. Y, Mrs. Z, and Mrs. A.

Ms. X felt anxious, guilty, was tearful, had an unstable mood, and had a lowered self-esteem. She had a perfect dementia score (30), but a very high depression score (33) even though she was being treated for depression.

Mr. Y complained of social withdrawal, poor concentration, memory loss, and increased irritability, among other problems. His dementia score was lower than average (26), and his depression score was also very high (30) even after being treated for depression.

Mrs. Z complained of low mood, emotional instability, forgetfulness, a tendency to repeat herself, and inability to feel pleasure, among many other things. She was disoriented in person. She had a very low dementia score (17) and a significantly high depression score (38) even after being treated for depression.

Mrs. A had the highest pre-revision surgery metal levels (664 nmol/l of chromium and 2470 nmol/l of cobalt). She complained of chronic pain, low mood, low self-confidence, difficulty recalling words, inability to feel pleasure, and anxiety, among other things. She was unable to spell the word “world” backwards. She had significant cognitive abnormalities, a very low dementia score (18) and a very high depression score (33).

Discussion

This study finds a strong connection between depression, cognitive problems, and cobalt and chromium poisoning following a failed MoM implant.

Depression might be caused by the psychological impact of undergoing revision. Patients frequently reported fear of the need for further surgery and insecurity about pain and mobility.

Chromium and cobalt toxicity may have caused permanent but unchanging brain damage in the patients, which in turn may have caused the cognitive problems. Alternatively, metal poisoning may have triggered early onset dementia in these patients.

Conclusions

All doctors should assess the mental health of patients who received metal on metal implants. Additionally, patients who show signs of cognitive impairment should have their chromium and cobalt levels tested.

The authors urge that patients undergo revision surgery immediately after metal poisoning is detected, as this is the only way to fix elevated cobalt and chromium levels.

This study’s findings suggest that, in the future, patients with metal on metal implants might require care for dementia caused by cobalt poisoning. The authors recognize that public safety is jeopardized by MoM implants.

Reference

Green et al. BMC Psychiatry (2017) 17:33.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingMetal on Metal Hips Linked to Early Onset Dementia and Depression

Pseudotumor in a Patient with a Biomet Hip Implant

Research Title: Pseudotumor in Large-Diameter Metal-on-Metal Total Hip Articulation

Abstract

This case study focuses on a patient who experienced pain in her hip following a large-diameter metal-on-metal (MoM) hip replacement. She also developed a pseudotumor, which is an abnormal swelling of tissue that resembles a tumor.

Intro

MoM hip implants are thought to be more stable and durable than metal-on-plastic implants, so they’ve become a popular choice for patients undergoing total hip replacement or hip resurfacing surgery in the United States.

However, MoM implants can cause conditions like an adverse reaction to metal debris (ARMD) and metallosis. ARMD is a form of implant failure that happens when the device sheds metal debris and causes negative effects like pseudotumors and collections of fluid around the implant. Metallosis is a type of metal poisoning that occurs when the implant’s metal debris raises the amount of metal in a patient’s blood.

This patient developed a pseudotumor five months after receiving a Biomet Magnum device with the Taperloc femoral stem. Her complications have been observed in other cases.

Case Report

A 39-year-old woman came to the authors with a 2-year history of hip pain. She had previously experienced bone tissue death in her left femur (a condition called avascular necrosis) but did not have any other medical problems. Prior to developing avascular necrosis, she was very physically active. She underwent total hip replacement surgery and received a Biomet Magnum device with the Taperloc femoral stem.

Right after her surgery, she made a full recovery, reported no pain, had full strength in her hip, and had a full range of motion in her hip. Three months after surgery, she began to feel pain in her left leg. Four months after surgery, she felt squeaking and popping in her hip.

Five months after surgery, she had such severe pain in her left hip, groin, and buttocks that she used crutches and could not go to work. She had swelling in her left hip and thigh. Her hip was weak and had impaired mobility. X-Rays revealed that her implant was not loose and had not moved. Her device’s femoral stem had an angle of 11.3 degrees, and the shell had an angle of 9.7 degrees. Blood tests indicated that she was experiencing inflammation but no infection.

The doctors took a sample of fluid from her left hip and found a liquid that looked like coconut milk with some yellow grains in it, but it had no signs of infection. Analysis showed that the fluid had chromium levels of 707.6 μg/L of chromium, titanium levels of 60 μg/L, and cobalt levels of 1068 μg/L. These levels are much higher than what is considered acceptable or healthy.

The patient underwent revision surgery because of these unusual and painful symptoms. During the surgery, doctors found a pseudotumor surrounding the implant and removed it. The doctors also found a type of dead tissue that resembled cheese. This tissue was sent for analysis but showed no sign of infection. Another tissue sample appeared to have an impaired blood supply and scarring. An analysis of the tissue surrounding the implant also showed impaired blood supply and scarring.

The patient received a metal-on-plastic implant during revision. The components were the Converge titanium acetabular shell, the Durasul Polyethylene insert, and the Biomet head. Two years after revision surgery, the patient had no negative symptoms other than occasional severe sharp pain in her left hip groin.

Discussion

This patient’s Biomet implant failed because of its metal on metal bearing surface. The levels of chromium and cobalt in the fluid surrounding her hip joint were extremely high.

Pseudotumors are caused by implants shedding metal debris into patients’ bodies as they wear down. The release of metal debris might be related to the positioning of the implant’s components, implant devices rubbing together abnormally, the types of metal in the implant, the thickness of the implant components, and other factors.

The doctors believe the device failed because the femoral neck of the implant was excessively rotated forward (21 degrees). They believe this positioning caused the implant to wear down rapidly and shed metal particles.

This patient’s chromium levels were 18 times higher than the average measurements of other reports, and her cobalt levels were 13 times higher.

One of the authors has stopped using large-diameter MoM implants as his go-to device for hip replacement patients because he has seen way too many complications from the implants. The author has had to revise 25 implants because the implants failed to attach to the patients’ bone and caused the patients severe pain. None of the implants the author has given have dislocated. The author now only uses one brand of implant for MoM hip replacements because he has not experienced any complications with it.

Doctors need to monitor MoM implant patients very carefully, and they need to be very mindful of the way they position the implant because it can mean the difference between failure and success. Additionally, cup inclination should not exceed 50 degrees sideways and 20 degrees forward. The author also believes that large-diameter MoM hip replacement could still be used to treat degenerative hip diseases, but doctors must be very mindful of their implant choice and surgical techniques to prevent failure.

Reference

Shahrdar, C. The Journal of Arthroplasty, Vol. 26 No. 4 2011.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingPseudotumor in a Patient with a Biomet Hip Implant

Vision Loss from Cobalt Poisoning of the Eye from MoM Hip Replacement

Title: Cobalt-Chromium Metallosis With Normal Electroretinogram

Background:

The popularity of Metal-on-Metal (MoM) hip implants, which are typically made out of cobalt and chromium, has made cobalt poisoning of the eye more common. This condition is called ocular cobalt toxicity. This study focuses on a 66-year-old-man whose vision was damaged because he got cobalt poisoning from a MoM hip implant. The authors tried to determine if his vision loss was caused by damage to the optic nerve, the retina, or both.

Methods:

The authors used multiple types of eye exams, including the Humphrey Visual Field (VF) exam, an electroretinogram (ERG), a multifocal electroretinogram (mfERG), multifocal visual evoked potentials (mfVEP), and an optical coherence tomography (OCT) scan.

Results:

The patient had blurred vision, poor color vision, and a type of abnormal blind spot called cecocentral scotoma. Because he had problems with his right eye since childhood, only the test results from his left eye were considered in the study. His ERG results were normal, his mfERG results were normal, and his mfVEP results were normal. However, his mfVEP exam showed a type of visual malfunction called decreased central amplitudes. The OCT scans also appeared to be fully normal.

Conclusion:

Decreased color vision and blind spots are indicators of nerve damage caused by chemical poisoning. Additionally, decreased central amplitudes are also a sign of nerve damage due to chemical poisoning. Therefore, the doctors believe the patient had an early stage of optic nerve poisoning that could not yet be detected by looking at the retina through an OCT scan.

Introduction:

It is not yet known how exactly a failed MoM implant causes eye damage. Cobalt and chromium leak into the bloodstream and the tissue surrounding the implant, causing high levels of metal in the blood. Typically, within 2 years, these patients develop hearing loss, visual loss, hypothyroidism, and heart disease.

Among other visual impairments, patients with cobalt poisoning have experienced damage to the optic nerve and problems with blood flow in the retina. Additionally, these patients’ ERGs usually yield abnormal results. An ERG is an eye exam that measures how the retina responds to light stimulation.

Case Report:

A 66-year-old man received a ceramic-on-ceramic hip replacement. Three years later, his implant broke and was replaced with a metal on metal hip. Nine months later, he realized that traffic lights looked orange to him. He had a hard time seeing at a distance and close-up, and he had to get a hearing aid. He also had swelling in his abdomen, ankle swelling, left hip pain, pale diarrhea, a rash, poor coordination, and a loss of mental clarity.

One year after his revision surgery, vision in his left eye was 20/30. He could not correctly identify any colors, but a funduscopy (an examination of the inner structure of the eye) showed that everything about his physical eye structure was normal.

Many tests and scans were performed on the patient. OCT and ERG scans all showed normal results. However, the mfVEP exam showed a type of visual impairment called central depression of amplitudes. Testing of his visual field showed another type of visual impairment called cecocentral depression.

The patient’s cobalt levels in his blood were 1,078 μg/L; acceptable levels are less than .3 μg/L. He received another revision surgery for his hip implant because he evidently had cobalt poisoning. During surgery, the doctors found ceramic fragments in his joints, and there was significant wear on the implant. The cobalt levels around his joint were above the maximum recordable level of 1,000.0 μg/L.

Following this revision surgery, the patient’s cobalt levels got progressively lower, and his vision continually improved until going back to normal.

Discussion:

This case is different from other reports of cobalt toxicity in the retina. In other cases, abnormalities were detected in the ERG scans. However, this patient had normal ERG and OCT results.

It is unclear whether the patient’s problem was fundamentally caused by the retina or the optic nerve. It is possible that the patient was experiencing poisoning of his retina that could not yet be detected by ERG scans. On the other hand, some of his symptoms suggest that his optic nerve was damaged due to cobalt poisoning.

In conclusion, the authors believe they may have detected a type of optic nerve poisoning that could not yet be physically detected on an OCT scan. Therefore, just because a patient with a metal on metal hip implant has normal ERG results does not mean he or she does not have cobalt poisoning, especially when other symptoms are present. Other symptoms to look out for include ringing in the ears (tinnitus), deafness, poor coordination, depression, heart failure, and hypothyroidism. It is important that eye doctors perform various types of tests and scans on patients with suspected cobalt poisoning.

Reference

Grillo, L., Nguyen, H., Tsang, S., Hood, D., Odel, J. Journal of Neuro-Opthalmology 2016;36:383-388.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingVision Loss from Cobalt Poisoning of the Eye from MoM Hip Replacement

Check for Metal Hip Issues if Patient has Cobalt-Related Heart Concern

Title: Unusual Case of Congestive Heart Failure:  Cardiac Magnetic Resonance Imaging and Histopathologic Findings in Cobalt Cardiomyopathy

Summary

A 69-year-old woman came to the authors with symptoms of congestive heart failure, a heart condition that leads to buildups of fluid in the lungs. She had a history of hypertension, mild kidney problems, and hip replacements on both hips. An ultrasound showed her heart’s left ventricle was pumping blood at a rate of 25% to 30% (a normal rate is 55% or higher). The left ventricle is a chamber in the heart responsible for pumping most of our blood. The ultrasound also revealed some fluid around the patient’s heart. Doctors tested the fluid and found no infection or malignant cells.

Over the next four months, the patient’s heart function declined rapidly, leading to many hospitalizations for congestive heart failure and low blood pressure.

An MRI of her heart revealed that her left ventricle had a normal size and thickness, but it was pumping blood at a severely low rate (14%). Her right ventricle was also a normal size, but it was also not pumping blood adequately. Several areas of her heart (specifically, the subepicardial lateral walls, left atrial wall and the right atrial wall) were enlarged.

The patient mentioned that her Depuy metal on metal hip implant had been squeaking for two years and that she planned to have it removed because it had been recalled. She had high cobalt and chromium levels in her blood.

Because of the concerning heart images and her high cobalt and chromium levels, the doctors performed what is called a right-heart catheterization, an operation where a small tube is inserted into the right side of the heart. This tube then carries blood to the lungs. The doctors also tested a sample of her heart tissue.

Lab tests found that the cells of her heart muscles were enlarged and had some scarring and inflammation. They also found symptoms of dilated cardiomyopathy (DCM), a condition where the heart’s ability to pump blood is decreased because the left ventricle is enlarged and weakened, probably because of the patient’s high cobalt levels. Additionally, they found signs of cobalt cardiomyopathy, a type of heart disease caused by cobalt poisoning. However, the levels of cobalt in the patient’s heart muscles could not be obtained.

The patient’s condition then deteriorated until she went into cardiogenic shock, a condition where the heart cannot pump enough blood to meet the body’s needs. She had to receive advanced heart failure support, have her hip implant removed, and was diagnosed with cobalt-caused heart disease. After having her metal-on-metal (MoM) hip implant replaced with a ceramic implant, she had a stroke and died.

Recently, there have been many reports of cobalt-caused heart disease due to MoM hip implants failing. When this occurs, the heart disease can usually be reversed by removing the hip implant.

Other reports of cobalt-caused heart disease have shown similar heart malfunction symptoms, such as the buildup of fluid around the heart and decreased blood-pumping ability.

Conclusion

The authors feel that fluid around the heart and significant inflammation of the heart walls might indicate cobalt-caused heart disease in future cases. Thus, the authors suggest that, when cobalt-caused cardiomyopathy is suspected, doctors should find out what kind of MoM implant the patient has, test the cobalt levels in the patient’s blood, perform heart ultrasounds and MRIs, and also test the cobalt levels of the heart muscles if possible.

Reference

Khan, A., Verma, R., Bajpai, A.,, Mackey-Bojack, S. Circ Cardiovas Imaging. 2015;8: doi: 10.1161/CIRCIMAGING.115.003352

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingCheck for Metal Hip Issues if Patient has Cobalt-Related Heart Concern

Cobalt Toxicity from Metal Hip Causes Vision Damage

Title: Hip ­Implant Related Chorio-­Retinal Cobalt Toxicity

Abstract

A 39-year-old female with high levels of cobalt in her blood (a side-effect of her two hip implants) came to the doctors with complaints that her left eye had been blurry for three weeks. Eye imaging revealed that the light-sensitive portion of the patient’s retina (called the photoreceptor-RPE complex) was degenerating.

The authors believe this patient experienced damage to the choroid region of her retina due to cobalt poisoning from her hip implants; this is a condition called implant-related chorio-retinal cobalt toxicity.

Introduction

Cobalt poisoning is rare, but it has become more common due to the high number of people opting for Metal-on-Metal hip replacement implants. These implants can increase levels of cobalt in the blood to toxic levels. Many health problems, including vision loss, have been associated with elevated cobalt levels in the blood. However, the doctors believe this is the first time a human’s retina has been damaged due to implant-caused cobalt poisoning.

Case Report

The patient received the ASR™ Hip System implant in each of her hips. She replaced one hip 2 years prior to coming to the doctors and the other 5 years prior. She complained of having blurry vision in her left eye and discomfort in both of her eyes for 3 weeks. She also sometimes experienced a metallic taste in her mouth and nausea in the morning. She had a normal medical history. Her brand of implants had recently been recalled because of its high rate of failure.

The patient had 20/16 vision and normal fluid pressure inside both of her eyes. The front-most part of her eyes (called the anterior) appeared normal, as did the interior back wall of her eyes (called the fundi). However, an optical coherence tomography (OCT) scan revealed several lesions in the patient’s retina. The lesions were located in a portion of the retina called the RPE complex and the photoreceptors, which are the parts of the eye that are sensitive to light. Additionally, eye imaging showed the patient’s macula – an oval-shaped area near the center of the retina – was thicker than normal.

Multiple types of technology-aided eye exams, called electrophysiology tests, were performed on the patient. Almost all of the electrophysiology tests yielded normal results for both eyes.

However, while the Arden index for the right eye was normal at 2.9, the Arden index for the left eye was just borderline normal at 1.9. The Arden index measures the ratio of light and dark sensed by the eye. A score lower than 1.8 is indicative of an eye malfunction.

Lab tests showed high levels of cobalt and chromium in the patient’s blood. Normal cobalt levels are between 0 and 20 nmol/L, but the patient’s cobalt levels were at 757 nmol/L. Normal chromium levels are between 10 and 200 nmol/L, but the patient’s chromium levels were at 595 nmol/L.

The doctors diagnosed the patient with chorio-retinal degeneration, which occurs when the choroid region of the retina has been damaged. They attributed the cause to the toxic levels of cobalt in the patient’s blood, which were caused by her hip implants.

The patient was advised to monitor her eyesight, and she had two follow-up appointments where no new damage was noted. The patient’s orthopedic surgeon found that her implants were well-functioning, and her cobalt and chromium levels did not increase or decrease. Because the patient has not gotten worse, revision surgery has not yet been considered necessary.

Discussion

The retina requires a large amount of oxygen in order to function. The choroid region of the retina is responsible for supplying most of the oxygen-filled blood to the retina. So a lack of blood in the choroid region will lead to a lack of oxygen in the retina, causing damage to the parts of the retina that are sensitive to light; these are called photoreceptors.

When there is an excess of cobalt in the bloodstream, it is as if the retina’s oxygen supply is diminished. Therefore, the authors believe high cobalt levels in humans damage the photoreceptors in the retina. This pattern has been observed in several animal studies.

OCT scans showed the patient’s photoreceptor-RPE complex was damaged. Additionally, another kind of eye imaging called ICG angiography suggested that the choroid region of the patient’s eye had a diminished blood supply. Examinations showed the photoreceptors in the left eye were more damaged and dysfunctional than those in the right eye.

Blood can pass through the choroids of different eyes at different rates, which may explain why the patient only experienced problems with her left eye. Cases where patients experience problems with only one eye have been observed in instances of lead poisoning.

The doctors believe this is the first case where an implant led to cobalt poisoning and caused damage to the retina.

Reference

Ng S. Ebneter A, Gilhotra J. “Hip-Implant Related Chorio-Retinal Cobalt Toxicity,” Indian J Ophthalmol. 2013 Jan: 61(1): 35–37.

Read the Original Research Here

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingCobalt Toxicity from Metal Hip Causes Vision Damage

7/14 – MCT Law Scores A Critical Victory For Biomet M2a Hip Plaintiffs

In the American court system, federal and state courts operate completely independently of each other.   Biomet’s victories up until this point all occurred in the Multi-District Litigation (MDL), which is part of the federal court system.

Suspicious that the MDL may not be the best place to litigate our cases at this early stage of the fight against Biomet, Maglio Christopher & Toale, P.A. instead chose to file our clients’ cases in state court, out of reach of the MDL.   Up until July of 2014, Biomet was taking every case we filed in state court and “removing” them to federal court, where they would then be under the control of the MDL.

In July 2014 Maglio Christopher & Toale scored the first major victory in the fight against Biomet;  one that would have long-ranging consequences for people all over the country implanted with Biomet’s M2a hips and who hoped for a change in momentum in the litigation.   Judge Hernandez-Covington, a federal judge in the Middle District of Florida (Tampa), recognized that Biomet was “removing” to federal court cases which were validly being filed in state court by our firm.  Not willing to rubber stamp a transfer of her case into the MDL, she ordered our firm as well as Biomet to submit legal briefs on the question of whether state or federal courts had jurisdiction over the case.

After reviewing both sides’ arguments, Judge Hernandez-Covington agreed with Maglio Christopher & Toale, P.A.: these cases belong in state court.  The significance: our clients were no longer bound by the MDL’s orders.  Most importantly, our clients could now ask for documents in state court that were not allowed in federal court.

Read 2014 Biomet Remand Order Here

After achieving a “remand” to state court, Maglio Christopher & Toale, P.A. was then able to pursue many cases in state court.  Each of these cases amped up the pressure on Biomet given that none of these plaintiffs was subject to the MDL’s limitation on which Biomet documents could be accessed to prove the case.   With new courts and judges deciding the issues, we began aggressively pursuing the documents necessary to prove our clients’ case.

Defective Metal on Metal Hip?

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Continue Reading7/14 – MCT Law Scores A Critical Victory For Biomet M2a Hip Plaintiffs

1/31/14 – Biomet Announces $56 Million Settlement for M2a Hips

The threat of a trial is typically a very strong bargaining chip to help sides reach a settlement in a case.   For plaintiffs, the bargaining chip is that a trial will ensure that bad behavior of the defendant becomes public and the company may end up having a large jury verdict against it.

Without the documents to prove their claim though, Biomet recognized that the plaintiffs in the MDL were in a weak bargaining position.  Taking advantage of this scenario, Biomet agreed to resolve many cases in the MDL through a settlement program that was very bad for most plaintiffs.

On the surface, the settlement program appeared to be a $56 million program that could offer the average person $200,000.   However, once Biomet actually started to resolve cases, they were only willing to settle cases for a mere fraction of that amount.

Unfortunately, Biomet felt it had the leverage to be able to offer such low amounts because the MDL court agreed with Biomet regarding “discovery” and limited the documents available to plaintiffs.   With little hope that they could actually prove their cases, many plaintiffs took very little money to resolve their cases.

Some people refused to take the low settlements, however.  Many more were simply ineligible for any settlement offers based on Biomet’s eligibility criteria.  Therefore, the settlement program offered no hope to many thousands of Biomet M2a patients.

Maglio Christopher & Toale, P.A. is one of the few law firms in the country taking cases that did NOT qualify for the settlement and actively litigating them in state courts around the United States instead of through the federal MDL. 

Read Biomet M2a Magnum $52 Million Settlement Agreement

Defective Metal on Metal Hip Replacement?

Contact MCT Law for a free case review at 888.952.5242 or by filling out a form below.

Continue Reading1/31/14 – Biomet Announces $56 Million Settlement for M2a Hips

4/18/13 Biomet Hip MDL Plaintiffs Face Limits in Electronic Discovery

During the “discovery” phase of a case, the patients suing Biomet are allowed to request documents and depositions (interviews) from Biomet in order to “discover” evidence for their eventual trial.  Unfortunately, the plaintiffs (patients suing Biomet) in the MDL faced a huge setback in this process early on in this litigation.

The Problem with the Biomet MDL Discovery

Typically, documents will be produced in a case only after they are requested.  Especially when there is a lawsuit against a large corporation with tons of electronic documents,  the parties to a case typically work together to come up with ways to efficiently search many millions of electronic documents for the information requested.

In the Biomet MDL, Biomet jumped the gun:  they didn’t wait for any requests and they certainly did not work together with plaintiffs.  Before the litigation began, they started searching their documents on their own, and used electronic search methods Biomet alone came up with.   Unsurprisingly this resulted in many millions of highly relevant and important documents being hidden from the MDL plaintiffs.

Unfortunately, the MDL judge, in two separate orders, sided with Biomet and stated to the victims that they will need to make do with whatever meager documents Biomet already produced.  In essence, Biomet took rules which were meant to serve as a shield to protect parties against abusive discovery strategies and used those rules as a sword. 

By jumping the gun and spending many millions of dollars before anyone requested documents, Biomet was able to argue to the court that it should not have to spend more money to uncover additional documents after the requests were made.   Unfortunately, these orders derailed litigation in the MDL. Without access to the documents to prove their claims, the plaintiffs in the MDL were seriously hamstrung and lost almost all leverage in the case.

You can read the original copy of those orders below.

Continue Reading4/18/13 Biomet Hip MDL Plaintiffs Face Limits in Electronic Discovery

10/12/12 – Biomet Hip MDL is Created

In October of 2012, a federal judicial panel consolidated lawsuits across the United States involving the Biomet M2a Magnum hip replacements into one federal court.  This move created Multi-District Litigation (MDL) No. 2391.

What is an MDL?

The point of multidistrict litigation (MDL) is to help a lot of similar cases efficiently handle pre-trial issues (such as evidence-gathering) that may be shared between the cases.  While they may seem alike at first glance, an MDL is NOT a class action lawsuit.  In a class-action lawsuit, many cases are thrown together into one lawsuit and there is 1 single trial for EVERYONE involved in the litigation.  In an MDL, once the pre-trial issues are taken care of, collectively, each person still has the ability to have their own, individual trial.  MDLs only exist in federal court (as opposed to state courts) and the particular MDL handling Biomet metal on metal hip replacement claims is located in the Northern District of Indiana (South Bend).

Read Pretrial Order 1: Creation of Biomet Hip MDL 2391

Continue Reading10/12/12 – Biomet Hip MDL is Created

Biomet Magnum Hips and Heart Problems from High Cobalt Ion Levels

Research Title: Progressive Cardiomyopathy in a Patient with Elevated Cobalt Ion Levels and Bilateral Metal-on-Metal Hip Arthroplasties

Abstract:

Cobalt poisoning, which is also referred to as cobalt toxicity or cobalt disease, is caused by excessive levels of cobalt in the body. It is a rare but serious possible side effect of Metal-on-Metal (MoM) total hip replacements. This study focuses on one patient who received MoM hip replacements on both hips and suffered from worsening cardiomyopathy – a type of heart muscle disease – as a result. The authors believe this is the first-ever case where an MRI detected cardiomyopathy resulting from cobalt disease. Even after the MoM THA implant was removed, the patient did not make a full recovery.

Introduction:

Cobalt poisoning has occurred in patients with hip implants that are part metal and part ceramic; it has also occurred in patients with MoM hip implants. Cobalt poisoning has even occurred in patients who received revision surgeries to remove the broken ceramic components in their hip implants.

In four reported cases, patients developed cardiomyopathy after showing high cobalt levels in their blood; one of those cases resulted in death.

MoM hip replacements have also resulted in numerous complications due to the implants shedding metal debris inside of patients’ bodies. Up to 59% of MoM patients have experienced negative reactions to these metal debris in the tissue surrounding their implants. However, there are not as many cases where MoM implants have led to complications that spread throughout the entire body, as was the case with this patient.

This study presents the case of a patient who experienced cardiomyopathy after showing signs of cobalt poisoning from a MoM hip implant. Even after removing the MoM device, the patient’s heart problems continued to deteriorate so much that he had to get a heart transplant to avoid certain death.

Case Report:

This 54-year-old patient was quite healthy. He claimed no history of diabetes, tobacco, alcohol, steroid, or recreational drug use. He also said he had no complaints about either of his hip implants, which were Biomet M2a-Magnum MoM devices. The authors of the study met the patient 6 years after getting his left hip replacement surgery, and 5 years after his right hip replacement surgery.

11 months before the patient came to the doctors, he started feeling chest pressure, fatigue, and sweating when he went through his regular daily activities. He also complained of losing some feeling in both of his feet. He did not, however, have any vision loss or ringing in his ears.

After getting a heart ultrasound (echocardiogram), the patient was found to have several problems. First, he had mitral regurgitation, which is a leakage of blood in one of the heart valves. He also had stage II diastolic dysfunction, which is a type of heart failure where blood collects in the lower half of the heart.

When the patient first came to the doctors, he did not show any of the typical signs of hip implant failure. He said he was not experiencing any pain in his hip or groin. He was walking normally, had a full range of motion, and had no signs of any abnormal fluid or tissue formations around his hip implants.

However, metal ion blood tests showed his cobalt level had risen to 189 ppb and his chromium level was at 71 ppb. High cobalt and chromium levels are a common sign that MoM implants are negatively affecting the patient. Because of this, the patient agreed to undergo revision surgery for his hip implants.

Leading up to his surgery, the doctors were not yet sure what was causing his heart problems. An MRI showed that both of his heart ventricles were failing (this is a condition called biventricular dysfunction). The doctors then performed a particular MRI technique called delayed contrast imaging, and the doctors concluded that the image could be evidence of cobalt infiltration into the heart, even though there were no reported cases of an MRI being able to detect cobalt-caused cardiomyopathy.

Further tests concluded that the patient’s cardiac health was deteriorating. He also showed some signs of kidney failure. The kidney failure was most likely not directly caused by the high cobalt levels in the blood, but it was probably a complication associated with his heart failure.

The doctors took a sample of his tissue for analysis, which showed many concerning signs. The tissue showed, among other things, an increase in the size of the heart muscle cells (myocyte hypertrophy) and inflammation and scarring of the heart tissue (interstitial fibrosis). Although these findings are not unique to cobalt-caused cardiomyopathy, they can be evidence of it.

Overall, the patient’s diagnosis with cobalt-caused cardiomyopathy was based on an analysis of his heart tissue, MRI findings, cobalt levels, the patient’s symptoms, and findings during surgery.

Moreover, during the revision surgery, doctors found evidence of pseudotumors (enlarged tissues that resemble tumors) in the tissue surrounding the hip implants. They also found an abundant brown, creamy fluid that appeared metallic.

The only part of the implant that showed signs of wear was the femur implant (called a femoral head). None of the components were out of place.  The femoral heads were removed replaced with metal-on-polyethylene devices called Biolox Option Ceramics (CeramTec). Tissue samples from the operation showed signs of chronic inflammation and some tissue death (fibrinoid necrosis).

Nine months after the surgery, the patient’s cobalt levels had declined to 16 ppb and his chromium levels had declined to 32 ppb, but normal levels of chromium and cobalt are less than 1 ppb.

Despite the lower cobalt levels, the patient’s cardiac health continued to worsen. The patient was eventually admitted to the hospital with congestive heart failure and received an LVAD implant, which is only given to patients with very advanced heart failure. He has since had a heart transplant and is doing well.

Discussion:

To the authors’ knowledge, this is the very first reported case of cardiomyopathy in a patient with high cobalt levels and a Biomet M2a-Magnum hip implant. This is also the first case where an MRI was able to detect cobalt-caused cardiomyopathy.

This patient’s cobalt levels were similar to those of other patients who got systemic cobalt poisoning from other MoM implants. Cobalt poisoning has been seen in patients who received total hip replacement and surface hip replacement.

The heart problems caused by cobalt toxicity in this patient present a frightening consequence of getting a MoM implant because MoM hip replacements have repeatedly been shown to lead to increased cobalt and chromium levels.

What is unique about this case is that the patient’s heart problems did not improve after removing the MoM implant. He sustained permanent damage to his heart muscles, and his cardiac health continued to decline despite the removal of the implant.

Conclusion:

This case focuses on a patient who received MoM hip replacements on both hips. He experienced mild kidney failure and had cobalt levels greater than 60 ppb. His heart failure was so severe that he required an LVAD implant to keep him alive until he could get a heart transplant. These factors have been associated with reversible heart damage. However, doctors must recognize that certain hip implants can lead to irreversible heart failure.

Reference

Mosier, B., Maynard, L., Sotereanos, N., Sewecke, J. “Progressive Cardiomyopathy in a Patient with Elevated Cobalt Ion Levels and Bilateral Metal on Metal Hip Arthroplasties,” The American Journal of Orthopedics. March/April 2016.

Learn More About the Research

Tell Us About Your Metal on Metal Hip Situation

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip liability lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingBiomet Magnum Hips and Heart Problems from High Cobalt Ion Levels

Adverse Reaction to Metal Debris from Biomet Metal Hip Arthroplasty

Research Title: Adverse Reaction to Metal Debris after ReCap-M2A-Magnum Large-Diameter Head Metal on Metal Total Hip Arthroplasty

Background and Purpose:

Adverse reaction to metal debris (ARMD) is a type of implant failure that can occur after metal-on-metal hip replacements. The symptoms of ARMD failure may include fluid collections around the hip, a build-up of soft tissue around the hip, and gluteal muscle necrosis (a condition where the cells of the gluteal muscles decompose, often causing a build-up of dead tissue).

The Biomet ReCap M2a Magnum was a very popular hip implant for patients receiving metal-on-metal total hip replacements between 2005 and 2012. This study aims to answer two questions: what are the warning signs that the ReCap-M2a-Magnum device might be failing due to ARMD? And how common it is for this device to fail?

Methods:

This study focused on 74 patients (80 hips total) who received the Biomet ReCap-M2a-Magnum device between 2005 and 2006 in order to assess how common it is for this device to fail and what symptoms might indicate its failure. On average, patients were examined 6 years after receiving the implant. The researchers examined the patients by taking MRI scans, measuring levels of chromium and cobalt in the blood, filling out the Oxford hip score questionnaire, and conducting basic clinical examinations. Based on these measurements, implant failure was considered definite if chromium or cobalt levels were above 10 µg/L and/or if there was a solid mass or fluid collection greater than or equal to 50 mm on the MRI scan. Implant failure due to ARMD was considered probable or possible if chromium or cobalt blood levels were above 5 µg/L or if the MRI revealed any collection of fluid or tissue.

Results:

In total, the implant had a definite failure in 11 of the 80 hips; three of the patients with definite failure required a revision operation. Another 32 hips were determined to have a probable or possible failure. This means that, overall, there was some degree of failure in 43 of the hips studied, and only 37 hips did not show symptoms of implant failure.

MRI scans also showed that 46 hips had developed a soft tissue mass or a collection of fluid.

Common symptoms or warning signs associated with definite implant failure include clicking in the hip, swelling of the hip, and a feeling that the hip is dislocated.

Interpretation:

Failure of the ReCap-M2a-Magnum is common, and the researchers discourage doctors and patients from using this device.

Implant failure due to ARMD has many potential warning signs. Patients with definite failure experience clicking, swelling, and a feeling that the hip is dislocated. Another indicator of implant failure is a high level of chromium and cobalt in the patient’s blood. Additionally, MRIs may reveal fluid collections surrounding the hip, build-ups of soft tissue surrounding the hip, and gluteal muscle necrosis (a condition where the cells of the gluteal muscles decompose, often causing a collection of dead tissue) in patients with probable to definite failure. Patients who show small fluid collections in their MRI scans may not need a revision surgery immediately, but they should be followed up closely, even if they do not show any other symptoms of hip implant failure. In order to detect and diagnose implant failure, physicians must be sure to optimize the MRI scanner to reduce image distortions by metallic implants.

Discussion:

There is a lot of concern over the high failure rates of large-diameter head metal-on-metal total hip replacement implants like the ReCap-M2a-Magnum.

It is hard to tell when, exactly, revision surgery is needed. However, at the absolute latest, revision surgery should be performed before the gluteal muscle cells start to deteriorate (before gluteal muscle necrosis occurs).

Patients with normal cobalt and chromium levels in their blood could still have ARMD, and high cobalt and chromium levels alone are not sufficient to diagnose implant failure due to ARMD. Therefore, screenings for ARMD must include more than just cobalt and chromium measurements.

ARMD is definite among patients with a soft tissue mass of any size. ARMD is either probable or definite in patients with fluid collections greater than or equal to 50 mm.

Reference

Mokka J, Junnila M Seppanen M Virolainen P, Polonen T, Vahlberg T, Matilla K, Tuominen E, Rantakokko J, Aarimaa V, Kukkonen J, Makela K.  Adverse reaction to metal debris after ReCap-M2A-Magnum large-diameter-head metal-on-metal total hip arthroplasty. Acta Orthopaedica 2013; 84 (6): 549-554

More Info About the Research

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in defective Biomet metal on metal hip lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have litigated against almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingAdverse Reaction to Metal Debris from Biomet Metal Hip Arthroplasty

Blood Tests to Diagnose Tissue Death from Metal Hip Problems

Research Title: Adverse Local Tissue Reaction After a Metal-on-Metal Total Hip Prosthesis Without Elevated Serum Metal Ion Levels

Background

Recent studies show a correlation between high cobalt and chromium levels and failed metal on metal hip (MoM)  implants. Typically a MoM hip patient with cobalt blood levels above 7 parts per billion (ppb) requires follow-up testing to make sure they’re not experiencing tissue death or other metal ion reactions.

Case Report

This study focuses on a 70-year old man whose blood work showed NO elevated metal ion levels.  The man had gone through 3 hip revision surgeries because of fixation problems and infection.  During the 3rd surgery, performed in 2006, doctors used a metal on metal 58mm Biomet Magnum head and acetabular component with a Taperloc stem.

In March 2017 the man went to the ER for pain in his left flank, which doctors thought was a kidney problem.  A CT scan unexpectedly showed fluid collection in the hip and pelvis area.  The patient did report swelling in his left hip over the previous 6 months.

X-rays uncovered bone loss (osteolysis) in the femur and pelvis.  An MRI showed a 16cm fluid collection in the buttocks, hamstring, and pushing up against the sciatic nerve.   When doctors performed another metal ion blood test, it once again turned up a panel of completely normal results, which is unusual for the type of tissue and bone damage discovered.

The patient had yet another hip revision surgery to remove the metal on metal parts.  When surgeons opened up the area, they found a large amount of brownish fluid and inflamed tissue with a brown rubbery appearance.  They replaced the MoM hip bearing with a metal on polyethylene hip implant. 6 weeks after the operation, the patient walked without help and said he felt no pain on the revised left hip.

Discussion

Metal on metal hip implants popular in the early 2000’s are known to shed metal debris and cause massive soft tissue and muscle damage in patients.  Surgeons use a common set of symptoms and test results to find out if a MoM hip is causing internal damage. Those diagnostic tools include x-rays, blood tests, testing for infection, ultrasound, MRI, and patient reports of pain or swelling.

One of the most useful tools to diagnose tissue damage from a metal on metal hip implant is a simple blood test for elevated metal ion levels.  However, this study shows that blood testing alone may not be enough.  The authors believe this is the first reported case of a failed MoM hip implant WITHOUT elevated metal blood levels.

Conclusion

Doctors need to look at the whole picture when treating a patient with a metal on metal hip, including a review of the patient’s demographics, symptoms, implant history, x-rays, blood test, CT scans and other diagnostic tools.

Reference

Tetreault M, Jacobs J, Mahmud W, Nam D. Adverse Local Tissue Reaction After a Metal-on-Metal Total Hip Prosthesis Without Elevated Serum Metal Ion Levels. Orthopedics. Dec 2017; 19:1-4.

Contact Us Now to Discuss Your Metal on Metal Hip Case

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip replacement lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Call us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue ReadingBlood Tests to Diagnose Tissue Death from Metal Hip Problems

Article by MCT Attorneys Published in the NC Bar Journal

 
Jessica Olins Attorney

The North Carolina Bar Journal published an article co-written by attorneys Cecelia Stultz and Jessica Olins in the Winter edition of this prestigious law publication.  Stultz and Olins wrote about the complex process of the Vaccine Injury Compensation program.  The pointed out the very focused nature of vaccine injury litigation (only about 100 attorneys practice in this area full time nationwide) and why it’s important for inexperienced lawyers to do their homework or refer these cases out.

You can read the entire article by clicking the image below and scrolling to page 14:

Continue ReadingArticle by MCT Attorneys Published in the NC Bar Journal

Ticking Time-Bombs Implanted in the Hips of Thousands of WA Patients

(Seattle, WA – November 28, 2017) – Three patients suffering heavy metal poisoning from a metal on metal hip replacement filed a lawsuit Tuesday in Seattle against Biomet Orthopaedics. The three patients experienced heavy metal poisoning, tissue and muscle necrosis, pseudotumors, and unnecessary revision surgeries because of the defective Biomet Magnum hip replacement, as alleged in the attached complaint. Thousands of other Washington citizens have this same hip implant and Biomet has failed to warn them or their surgeons of this serious problem.

The lawsuit says Biomet sold the Magnum hip replacement without conducting any clinical testing before putting them into patients’ bodies.  Biomet then never warned patients and doctors when faced with compelling evidence that these hips were harming people.  “According to Washington orthopedic surgeons I’ve met with, there are currently thousands of patients in the state who have a Magnum hip in their bodies,” says lead attorney Altom Maglio.  “Our fear is that they don’t know about this possible ticking time bomb inside of them.”

Yellow Turbid Fluid Filled Cyst

Ellen Pardee of Seattle was implanted with a Biomet Magnum hip replacement in 2010.  In 2017 doctors diagnosed her with a large pseudocyst and severe tissue damage around the Magnum implant.  When surgeons opened her up, they found that “a large amount of turbid yellow fluid came out from a cystic structure.”  They also discovered a large tumor surrounding her IT band “with yellowish-brown caseating lining.”  The damage left behind was devastating. Ms. Pardee’s Biomet Magnum hip destroyed her iliotibial band and damaged her hip abductor tendon, along with all the muscles behind the Magnum implant.  She may never walk normally again.

Two Magnum Hips Go In, Only One Comes Out

James Millard had two Magnum hips put in:  One in 2009 and the other in 2012.  By 2017 doctors told Millard that both Magnums had to come out immediately and diagnosed him with extremely high levels of heavy metal poisoning. Tragically, Mr. Millard still has one of the defective Magnum hips inside his body today. Surgeons tried to remove it for 45 minutes by “pounding on to the stem to loosen it,” but they couldn’t get it out without fracturing his right femur. Now Mr. Millard faces a lifetime of worry that the cobalt and chromium heavy metals being released by the Magnum will continue to poison him.

Gruesome Surgery

Alan Rossi, MD is a medical doctor, but he is also a patient and victim of his Biomet Magnum hip. He ended up with a huge fluid-filled cyst in his hip and dangerously high heavy metal levels in his bloodstream.  When surgeons tried to remove the Magnum implant, the stem and adapter were “welded in place.”  The orthopedic surgeon had to rip open the femur to remove the stem and then wire the fractured bones back together around a new stem.  On an X-ray, it looks like barbed wire holds the bone together.

The Problems with Biomet Magnum Hips

Biomet hired Olympic gold medal gymnast Mary Lou Retton to sell the Magnum hip. Biomet aggressively promoted Retton as a Magnum hip replacement success story.  Unfortunately, Retton’s Magnum hip failed, and she had to have it surgically removed. Mary Lou Retton has had to file her own lawsuit against Biomet.  Strangely, Biomet continues to use Retton’s image and story to promote the success of the Magnum hip.

Biomet kept selling the Magnum hip in the United States until 2014, even after worldwide recalls four years earlier for very similar hips implants.  In 2015, the Australian government forced Biomet to recall the Magnum because of higher than expected revision rate.  However, Biomet continues to claim that the identical product sold in the United States is not defective.

To this day, Biomet has still not warned patients or orthopedic surgeons in the United States of the Australian recall or to screen for heavy metal poisoning.  Most people and their doctors are unaware of Magnum-specific research studies showing incredibly high rates of pseudotumors and tissue death caused by heavy metal poisoning from the Magnum.  “This is a huge health crisis in Washington,” says Maglio. “Magnum patients should be receiving careful orthopedic screening and monitoring, but neither they nor their surgeons know of the risk of heavy metal poisoning from these hips.”

The case is Rossi v. Biomet, Inc. filed in King County Superior Court, case number 17-2-30517-1 SEA.

About Maglio Christopher & Toale, P.A.

Maglio Christopher & Toale, P.A. is a national medical product liability law firm with offices in Seattle, WA, Washington, DC, and Sarasota, FL.  Maglio Christopher & Toale, P.A. filed the first metal on metal (MoM) hip replacement lawsuit in the United States in 2008 and has been continuously litigating metal on metal hip replacement cases since that time.  The Firm is presently representing patients across the United States who have suffered the effects of heavy metal poisoning from Biomet Magnum hip replacements.

CONTACT:

Altom M. Maglio of Maglio Christopher & Toale, P.A. is available to discuss this case.  888.952.5242

Continue ReadingTicking Time-Bombs Implanted in the Hips of Thousands of WA Patients

$247 Million Verdict Against J&J in DePuy Pinnacle Hip Trial

A Dallas Federal jury issued a $247 million dollar verdict against Johnson & Johnson and DePuy Orthopedics today. The jury reached their unanimous verdict in favor of 6 hip replacement patients who were seriously hurt by Pinnacle metal on metal hip implants.

Today, the Dallas jury decided J&J was guilty of negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, intentional misrepresentation to the surgeons who performed the initial hip implant surgeries on the plaintiffs, fraudulent concealment from the plaintiffs and from the surgeons, and deceptive business practices as to the plaintiffs and the surgeons.

Previous Pinnacle Trial Verdicts

These trials are what are called “bellwether trials.”  They’re conducted by a judge who oversees the entire litigation, where more than 9,700 cases are filed.  Once this judge conducts enough bellwether trials to lay down a template for future judges, the remaining cases will then be tried, individually, by other judges in the particular jurisdictions where the cases originate.

This was the fourth bellwether trial. Johnson & Johnson and Depuy actually won the first bellwether trial regarding their Pinnacle metal-on-metal implant.  That trial was for a single plaintiff who had a defective Pinnacle implant in each hip.  Unfortunately, the jury in that case was not swayed by her arguments.

Since then, however, the judge overseeing this litigation decided that the remaining bellwether trials will be “multiple-plaintiff” trials.  Instead of hearing only one plaintiff’s story, this guarantees that the same jury will hear from multiple people who each had the same implant and suffered similar injuries.   As you can imagine, this makes the plaintiffs’ arguments much stronger.

Johnson & Johnson and DePuy are now struggling to defend these cases. This is the 3rd multi-million (or billion) dollar verdict in a row against Johnson & Johnson and Depuy Orthopedics for selling defectively designed Pinnacle hips.

  • In March 2016, the jury in the second bellwether trial awarded 5 severely injured hip replacement patients a $500 million verdict against J&J and Depuy.  The court later reduced the award to $150 million, finding that the jury award exceeded certain limits set by law.
  • Then in March of 2017, in the third bellwether trial, the jury sided with 6 patients handing down a stunning $1 billion jury verdict in their favor. The court thereafter found that his award exceeded certain limits and reduced the jury verdict to $543 million.

This verdict pattern is a good sign for all patients suffering from the side effects of metal on metal hip implants, but it’s bad news for a company facing more than 9,700 Pinnacle lawsuits.

November 2017 Dallas Federal Bellwether Trial Facts:

The jury deliberated for 14 hours to reach a verdict.

The trial took 2 months from opening statements through today’s verdict.

The jury says the company knew about major problems with their Pinnacle hip implants but did not warn patients about the risks involved with the hips.

Patients in the case say they’ve had tissue damage, muscle loss, excruciating pain, difficulty walking, and walking with a limp among other side effects.

The cause of their problems stemmed from the metal surfaces of the cup and head rubbing together and shed microscopic metal parts that spread through their entire bodies causing horrific side effects.

Depuy stopped selling the Pinnacle Metal on Metal hips in 2013 but never issued a recall.

Johnson & Johnson is facing at least 9,700 lawsuits over the Pinnacle metal on metal hip implants.

What to Do If You Have a Metal on Metal Hip Replacement

You should contact your orthopedic doctor immediately, even if you’re not having symptoms. Orthopedic surgeons say patients with MoM hips should get a blood test for metal ion levels every 3 months for as long as they have the metal on metal hip in their bodies. Often there are no symptoms even if a patient has extremely high metal levels.

Pinnacle is one of many brands of metal on metal hips causing severe side effects.  No matter what type of MoM hip you have, you should be in regular contact with your doctor or surgeon.

About our extensive experience with metal on metal hip lawsuits

Maglio Christopher & Toale, P.A. filed the FIRST metal on metal hip lawsuit in the United States.  Our attorneys are leaders in the nationwide litigations over MoM hips.  We actively and aggressively represent our clients throughout their case in both state and federal courts. With over a decade of experience in metal on metal hip lawsuits, and we are not afraid to go to trial against these orthopedic corporations.

If you have questions about your situation, call our office at 888.952.5242 or complete the form below and we’ll contact you.

Continue Reading$247 Million Verdict Against J&J in DePuy Pinnacle Hip Trial

Radio Interview about Metal on Metal Hip Problems

Nationally recognized medical journalist, Heidi Godman, invited Attorney Ilyas Sayeg on her radio show to discuss problems with metal on metal hip implants.  Mr. Sayeg explains what’s going wrong with MoM hips and what patients can do to stay informed.

The FDA in the United States has not recalled ALL brands of MoM hips, such as the Biomet M2a Magnum, even though health authorities in countries across Europe and Australia have issued warnings or completely taken these hips off the market.

Sayeg says hip manufacturers like Biomet have never admitted there’s anything wrong with their Magnum M2a line of hip implants.  In addition, Biomet has NOT given enough information to U.S. surgeons about problems in other countries with these same hip implants.

“If you’re going to put something out there that’s going into a human body, you better have tested for safety and effectiveness, and know that that thing is safe. And if it’s not, you’ve got to be held accountable for that.”  – Attorney Ilyas Sayeg – Radio interview

 

Click below to hear the entire radio interview.

Heidi Godman is a health reporter for U.S. News and serves as the executive editor of the Harvard Health Letter. Her work has appeared in dozens of online and print publications, including the Chicago Tribune, Baltimore Sun, Orlando Sentinel and Cleveland Clinic Heart Advisor. Heidi also spent more than 20 years as a TV news anchor and health reporter. She’s interviewed surgeons in operating rooms, scientists in laboratories, and patients in all phases of treatment. Heidi has earned numerous awards for outstanding health reporting and was the first TV broadcaster in the nation to be named a journalism fellow of the American Academy of Neurology.

Defective Metal on Metal Hip Replacement?

Contact us at 888.952.5242 or fill out a form below for a FREE Case Review.

Continue ReadingRadio Interview about Metal on Metal Hip Problems

Boeing Sues Biomet Over Defective M2a Magnum Hip

(August 1, 2017) Boeing, the world’s largest aerospace company, and leading jetliner manufacturer sued Zimmer Biomet over the defective M2a Magnum hip implant. Boeing says one of its employees suffered an industrial injury that was directly caused by the failed Biomet M2a Magnum metal-on-metal hip system. After undergoing hip replacement surgery, the Boeing employee began experiencing extreme pain and persistent squeaking of the hip. The Boeing employee had to undergo revision hip surgery to replace the defective Biomet hip.

Boeing filed the lawsuit on behalf of William Eklund who is receiving benefits from Boeing because of the severity of his injury. Boeing says the M2a Magnum hip system “suffers from a design or manufacturing defect that causes excessive amounts of cobalt and chromium to wear and corrode…” which in turn causes the device to fail and the surrounding tissue and bone to die.

“The M2a Hip System forces metal to rub against metal with the full weight and pressure of the human body. Because of Biomet’s defective design of the M2a Hip System, hundreds of patients – including Mr. Eklund – have been forced to undergo surgeries to replace the failed hip implants.”

Despite being aware of numerous and serious complaints with the M2a system, Biomet told orthopedic surgeons that the M2a Magnum was safe and the best product on the market, Boeing maintains. “Biomet knew or should have known that use of the device created a risk of serious bodily injury in patients.”

This is a significant development in the Biomet M2a metal-on-metal hip litigation and marks the first time a large international corporation has sued Zimmer Biomet on behalf of an employee. Boeing is likely looking to recoup the high costs of providing medical and other benefits to its injured employee and believes Biomet is directly responsible for those injuries caused by its defective M2a Magnum hip.

Defective Metal on Metal Hip Replacement?

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Continue ReadingBoeing Sues Biomet Over Defective M2a Magnum Hip

Biomet Pays $17.4 Million Criminal Penalty for Corruption

(January 12, 2017) Zimmer Biomet agreed to pay a $17.4 million criminal penalty in connection with a scheme to bribe South American, Mexican and Chinese doctors to use the company’s products. According to the Justice Department, “Phony invoices were used to justify the payments, and the bribes were falsely recorded as “consulting fees” or “commissions” in Biomet’s books and records.”

Zimmer Biomet had been in breach of a 2012 deferred prosecution agreement (DPA) with the Department resolving an earlier investigation into FCPA violations committed by Biomet Inc., which became part of Zimmer Biomet in 2015.

Read the entire Department of Justice press release.

Defective Metal on Metal Hip Replacement?

Contact MCT Law by calling 888.952.5242 or filling out a form below for a FREE Case Review.

Continue ReadingBiomet Pays $17.4 Million Criminal Penalty for Corruption

Judge Says Sales Rep Can Be Held Liable in State Court

(August 3, 2017) A Federal Judge says a Missouri man injured by a defective M2a Magnum hip replacement can sue a sales representative who was present at his surgery.  The judge removed the case from an Indiana Multi-District Litigation (MDL) and sent it back to a Missouri state court for trial.

Biomet claimed the sales representative, Jake Weible, could not be held liable since he was just a seller in the “stream of commerce.”  However, the Judge ruled that Weible could be held liable because he was in the operating room during the surgery, had a role in the installation of the implant, and didn’t warn the surgeon about the risks of metal shavings from the M2a.

Defective Metal on Metal Hip Replacement?

Contact MCT Law at 888.952.5242 or fill out a form below for a FREE Case Review.

Continue ReadingJudge Says Sales Rep Can Be Held Liable in State Court

Review of Recent Cases; Entitlement; Fees & Costs Decisions

FACT DECISIONS

Factual determination that SIRVA injury more likely caused by influenza vaccine than uncovered vaccine

In this SIRVA case, the petitioner received an uncovered pneumococcal vaccine and a covered influenza vaccine in the same arm at the same time.   The court concluded that there was preponderant evidence for a finding that the petitioner’s right shoulder injuries resulted from the influenza vaccination and not the pneumococcal vaccination. At the time of the fact hearing, the petitioner was no longer able to recall which vaccination he received first or where each vaccination was given.  However, the chief special master relied on four contemporaneous reports by petitioner to various medical providers that his pain began after getting the flu vaccine too high in his arm. Zebofsky v. HHS, (Fed. Cl. Spec. Mstr. Dec. 15, 2016) (Dorsey, CSM)

ENTITLEMENT DECISIONS

Ruling on the record, finding in favor of entitlement, in a case involving autoimmune NMDA encephalitis following Gardasil vaccine

Petitioner’s immunology expert applied the eight Miller elements to determine whether the evidence supported vaccine causality. This is the second decision in which I’ve seen this criterion successfully used recently. They are:

  1. Temporal association consistent with known biologic effects.
  2. Lack of likely alternative explanations.
  3. Dechallenge – did the defining aspects of the disorder disappear or improve when the exposure was removed.
  4. Rechallenge – did the disorder reappear or worsen when the exposure was reintroduced.
  5. Biologic plausibility-is the disorder plausible based upon the known in vivo or in vitro effects of the exposure. Id.

The secondary elements are:

  1. Analogy- are there prior published or unpublished reports of a similar disorder developing after the exposure in question or after a similar exposure
  2. Dose responsiveness- is there evidence that the dose or extent of the exposure is related to the likelihood of developing the disorder or to the disorder’s severity.
  3. Specificity- are the defining symptoms, signs, and laboratory features of the disorder the same as those seen in previous cases after exposure to the same environmental agent.

This reminds me of a bit of the Stevens criteria, which were previously promulgated in the program by judicial fiat, and ultimately determined to have created too high a bar for petitioners in the Althen case, which set the evidentiary standard we still use today.  But, I suppose if your expert is able to make an argument that these criteria are satisfied then that’s obviously helpful for your case.  But let’s be sure that these criteria are not used against petitioners in an unlawful way, by elevating the burden.

Ultimately, the special master concluded that the petitioner’s proposed causation theory, epitope spreading, was “not particularly robust but it has just enough validity and reliability from a legal standpoint to meet the relatively lenient preponderance standard applied in Program cases.”  It was also quite helpful that there was a treating physician report.

This case also features one of my favorite excerpts from the IOM report which supports short onset cases and ironically had been cited by respondent’s expert “[d]ue to the development of memory B and T cells during the primary immune response, the latency between subsequent exposure to the antigen and development of the immune response will usually be shorter. The lag phase is generally 1 to 3 days; the logarithmic phase of the secondary antibody response occurs over the next 3 to 5 days.”

The special master recognized that close calls are to be resolved in favor of injured claimants.  Al-Uffi v. HHS, Fed. Cl. Spec,. Mstr. Feb. 22, 2017) (Corcoran, SM)

Denial of entitlement in a case alleging pneumococcal pneumonia caused by MMR vaccine

In a drastic departure from the norm, the respondent’s expert conceded, in this case, that the MMR vaccine is immunosuppressive for a period of weeks, in the same way as wild measles infection.  However, the court found that the MMR vaccine does not alter the effectiveness of the innate immune system, thus the ability to produce antibodies against pneumococcus, and could not have contributed to the development of pneumonia.  Two lessons to be learned from this case are 1) murine models do not necessarily apply to humans because mice are not people, and, 2) an immunologist beats a pulmonologist where the dispute is over immunology. DePena v. HHS¸ (Fed. Cl. Spec. Mstr. Feb, 22, 2017) (Moran, SM)

Ruling in favor of entitlement in a case alleging HLH and death in a newborn caused by Hepatitis B vaccine

HLH is hemophagocytic lymphohistiocytosis, which is essentially an immune attack on the entire body leading to death. One of the primary issues in the case, whether the HLH existed in utero, was resolved in the petitioner’s favor.  With respect to prong one, the special master found that it was more likely than not that hepatitis B vaccine could activate the innate immune system, causing a release of proinflammatory cytokines, triggering a cytokine storm and resulting in the development and/or triggering of HLH.  Petitioner prevailed on prongs two and three as well.  Finally, the special master held that respondent did not meet its burden of showing an alternative cause in contending that the HLH was present in utero. Although any infectious agent, bacteria, fungi, virus can cause HLH, there was no evidence that the child suffered from any of these conditions in utero or after birth. Respondent essentially proffered a theory that the HLH was idiopathic or a disease of unknown cause, and this is legally insufficient to constitute a “factor unrelated” defense under the Vaccine Act. Sajbel v. HHS, (Fed. Cl. Spec. Mstr. Mar. 31, 2017) (Roth, SM)

Denial of entitlement in case alleging afebrile seizures caused by HPV vaccine

Petitioner did not prevail on any of the Althen prongs.  The special master noted that petitioner’s expert, a general neurologist, was ill-qualified to testify regarding immunological concepts. K.L. v. HHS, (Fed. Cl. Spec. Mstr. Mar. 17, 2017) (Corcoran, SM)

Denial of entitlement in a case alleging ITP caused by HPV vaccine – onset- molecular mimicry

Petitioner’s claim failed because of the inability to establish the onset of the ITP, there were never any symptoms of ITP, only an abnormal platelet count discovered incidentally, post-vaccine.  Discovery of the condition did not equate to proof of onset of the condition.  The special master did find that petitioner would otherwise have prevailed on Althen prong one, by proposing molecular mimicry, even though that theory is more often utilized with MMR in ITP cases.  Importantly, the special master noted that it was unnecessary for petitioner to show exactly which antigen would be involved in the proposed cross-reactivity process, or to offer any studies showing molecular mimicry could happen between ITP and HPV, because that would impermissibly heighten the burden of proof (not every SM agrees).  Johnson v. HHS, (Fed. Cl. Spec. Mstr. Jan. 6, 2017) (Corcoran, SM)

Motion for review granted; entitlement found by reviewing court in case alleging seizures, autoimmune encephalopathy, and cognitive and motor decline post-MMR vaccine   

This case has a long procedural history and had previously been all the way to the Federal Circuit.  The Circuit had remanded the case to the special master with instructions to reconsider certain parts of the record.  On remand, the special master changed his mind and found that prong one had been proven, but again found that petitioners had failed to prove prong two. Petitioners filed their second motion for review, and the court concluded:

…instead of following the Federal Circuit’s direction, the special master prepared a 60-page, single-spaced decision finding that Petitioners had failed to satisfy prong two of the Althen test. Indeed, the special master explained away or dismissed virtually every argument offered in Petitioner’s favor. In performing this analysis, the special master imposed too great of a burden on Petitioners that could not reasonably or possibly be met. Even if this case could be regarded as a “close call,” the Federal Circuit has held that “close calls regarding causation are resolved in favor of injured claimants.” Althen, at 1280, citing Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994). Application of this principle results in Petitioners’ recovery. Moriarty v. HHS, (Fed. Cl. Feb. 10, 2017) (Wheeler, J)

Denial of entitlement in a post-MMR mitochondrial autism case

Following the trend of all post-OAP cases alleging the existence of a mitochondrial disease or dysfunction, the special master found none to exist, a necessary prerequisite to the medical theory.  Moreover, the special master found that none of the Althen prongs were satisfied. Anderson v. HHS, (Fed. Cl. Spec, Mstr. Nov. 1, 2016) (Corcoran, SM), aff’d  (Fed. Cl. May 5, 2017) (Braden, CJ)

Denial of entitlement in a post-MMR mitochondrial autism case with a genetic mutation

This case presented an interesting twist on the mitochondrial autism theme, in that the child had a mutation in a calcium channel gene which purportedly created a susceptibility factor in addition to his mitochondrial dysfunction. The claim failed because the special master found that the child did not suffer from mitochondrial dysfunction, that his mutation was not a susceptibility factor, and that none of the Althen prongs had been satisfied. Dempsey v. HHS, (Fed. Cl. Spec. Mstr. Feb. 23, 2017) (Hastings, SM)

ATTORNEYS FEES AND COSTS DECISIONS

Hourly rates and billing judgment

In this fees case, the special master ordered the law firm to follow the Guidelines and, in the future, identify paralegals by names or initials and provide information about their qualifications and experience, so that the court could properly assess the reasonableness of the hourly rate charged.  This is so even if the firm charges the same hourly rate for every paralegal.

The court also held that it was unreasonable to bill .1 hours each for drafting an email, reading its response, and replying and that these three tasks should have been combined into one entry. Floyd v. HHS, (Fed. Cl. Spec. Mstr. Mar. 2, 2017) (Moran, SM)

Reasonable basis

Denial of fees and costs, no reasonable basis in a case alleging headaches post HPV vaccine

This case contains a very detailed explanation of the development of reasonable basis law over the years and where it currently stands. There are two cases currently on appeal to the Federal Circuit which will hopefully set forth a more definitive test for what amount of evidence is needed to establish a reasonable basis for a claim, and whether other circumstances, such as statute of limitations, are properly considered in the reasonable basis analysis or not. Cottingham v. HHS, (Fed. Cl. Spec. Mstr. Mar. 30, 2017) (Moran, SM)

Denial of interim fees and costs request, in part due to reasonable basis concerns

The special master observed that she did not expect to know whether the case had a reasonable basis until after the case was triedPurvis v. HHS, (Fed. Cl. Spec. Mstr. Feb. 28, 2017) (Millman, SM)

Expert Costs

In this interim fees proceeding, petitioner requested compensation for a pediatric pulmonologist at an hourly rate of $500, for 221 hours. In the context of discussing whether or not these hours were excessive, the special master suggested that the HHS expert’s timesheets be submitted.  HHS opposed doing so.  The special master noted that “[a]t first glance, this amount of time shockingly exceeds the amount of time that experts usually spend on a case that included two days of hearing.”  Yet, after considering that the expert had summarized the medical records, written six expert reports, (likely most were at the special master’s behest), reviewed more than 70 articles, reviewed respondent’s expert reports and prepared for and attended two days of hearing, the special master concluded that the hours were reasonably spent.  This rendered moot the issue of whether respondent’s expert’s invoices should be sought by the court.

Further, the expert’s hourly rate was reduced to $325 per hour, because he was a first-time vaccine program expert, thus inefficient; his expertise did not match the relevant subject matter; and his credentials were not particularly impressive in that he did not have a significant teaching position, was not conducting research and was not an editor of any journals.

Finally, the expert’s $900 first-class plane ticket was reduced by 50%. DePena v. HHS¸ (Fed. Cl. Spec. Mstr. Mar. 30, 2017) (Moran, SM)

Continue ReadingReview of Recent Cases; Entitlement; Fees & Costs Decisions

MCT Law Opens Seattle, WA Office to Serve West Coast Clients

SEATTLE, WA— (March 7, 2017) Maglio Christopher & Toale, P.A., a national leader in complex litigation, including: Vaccine injuries, defective failed metal on metal hip replacements, defective medical products, and other civil litigation, announces the opening of a West Coast office in downtown Seattle, Washington.  The firm’s new office is located on the 35th floor of the landmark Columbia Center building, which is the tallest skyscraper in the Seattle skyline.

“Opening the Seattle office is a natural evolution in the growth of our nationwide litigation practice,” says managing partner Altom Maglio.  The new expansion allows our Firm to represent our west coast clients with the high level of service they expect from our firm.”  The downtown Seattle office joins Maglio Christopher & Toale, P.A offices located in Washington, DC and Sarasota, Florida.

About Maglio Christopher & Toale, P.A.

Our firm represents people across the country injured by defective medical products.  The Firm’s practice includes litigating defective orthopedic hip replacement cases in state and federal courts throughout the country and representing people with vaccination injuries before the United States Court of Federal Claims.  Other practice areas include pharmaceutical litigation, medical whistleblower litigation, federal takings litigation, and other complex civil litigation.

The new address for the Seattle, WA office is:

Maglio Christopher & Toale, P.A.
Columbia Center
701 5th Avenue
Suite 3505
Seattle, WA 98104
(888) 952-5242

www.mctlaw.com

Continue ReadingMCT Law Opens Seattle, WA Office to Serve West Coast Clients

Review of Recent Cases – Attorney Fees; Entitlements; Damages

Attorney Fees

Reasonable Basis

Alicock v. HHS, (Fed. Cl. Nov. 9, 2016) (Wheeler, J)

Denial of motion for review filed by HHS.  SM had awarded fees and costs in a claim for significant aggravation of developmental delay. According to mom, treating physician told her there was encephalopathy possibly caused by vaccination.  Medical records included encephalopathy diagnosis, but no attribution to vaccine.  Petitioner promptly dismissed claim shortly after medical records were filed and after SM noted that reasonable basis was in doubt at a status conference.  On review, the judge found the SM decision was not clearly erroneous and not an abuse of discretion. HHS is appealing to the Circuit.

Simmons v. HHS, (Fed. Cl. Oct. 10, 2016) (Firestone, J)

CFC granted HHS’ motion for review of a finding of reasonable basis.  Petitioner first retained firm in 2011 with a flu/GBS case.  Petitioner then disappeared and was discharged by the firm after 20 attempts to contact the client.  Petitioner resurfaced 9 days before the expiration of the SOL and agreed to comply with firm.  The firm filed a bare bones petition with no records and Petitioner was never heard from again.  The case was dismissed for lack of prosecution. SM awarded fees and costs noting it would have been unethical not to file petition. Judge Firestone held that the SM erred, as no evidence was ever produced in support of the claim.  She reasoned that reasonable basis requires that petitioners and counsel make some effort to establish the fact of vaccination and an injury linked to the vaccine. The short SOL did not excuse counsel’s obligation to show some evidence for the claim beyond a conversation with Petitioner.  This case is also on appeal to the Circuit.

Foxx v. HHS, (Fed. Cl. Spec. Mstr. Dec. 21, 2016) (Roth, SM)

Reasonable basis existed where counsel substituted in for pro se petitioner several months after case had been filed, requested and filed outstanding medical records and promptly dismissed the claim one month later after realizing the records did not support the claim.  The SM noted that counsel’s involvement helped all parties in the case and sped the resolution of the claim.

Hourly Rates

Anthony v. HHS, (Fed. Cl. Spec. Mstr. Dec. 15, 2016) (Moran, SM)

Cheyenne, WY attorney not entitled to McCulloch rates under Davis exception, because difference in rates of 50% was “very significant.”  Local rates awarded.  SM used BLS inflation rate of 2.6% instead of RRR used in McCulloch.

Entitlement

L.A.M. v. HHS, (Fed. Cl. Spec. Mstr. Jan 31, 2017) (Millman, SM)

In this Gardasil-POTS/CFS/UCTD case, Petitioner had filed the expert report of Yehuda Shoenfeld espousing his ASIA causation theory.  In response, HHS filed FIVE expert reports: immunology, toxicology, pediatric rheumatology, pediatric neurology and pediatrics/immunology.

The Court found that the vast majority of Petitioner’s symptoms were conversion, but all agreed that she had been correctly diagnosed with POTS.  The Court held there was no proof that Gardasil could cause non-autoimmune POTS and, in any event, the onset was too long.  The Court reached the same conclusions with regard to CFS.

The Court considered Petitioner’s UCTD diagnosis, and held that all three Althen prongs were not satisfied.  In particular, the court emphasized a study which found that people who develop autoimmune disorders typically have autoantibodies for many years before they develop symptoms.

Escalera v. HHS, (Fed. Cl. Spec. Mstr. Nov. 23, 2016) (Hamilton-Fieldman, SM)

Ruling on the record (agreed to by both parties) finding entitlement in a DTaP/Hib – celiac case.  Interesting decision discussing the “Miller criteria” to establish the plausibility of an environmental exposure as the cause of a disease.

D’Tiole v. HHS, (Fed. Cl. Spec. Mstr. Nov. 28, 2016) (Corcoran, SM)

SM granted HHS’ motion for ruling on record and denied entitlement in a flu/narcolepsy case.  The case was decided without a hearing over Petitioner’s objection.  The Vaccine Act and Rules not only contemplate but encourage special masters to decide petitions on the papers rather than via evidentiary hearing, where (in the exercise of their discretion) they conclude that the former means of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d).  Moreover, the medical theory was not sufficiently reliable where premised on the European version of the vaccine which, although associated with narcolepsy, was significantly different in its composition.

K.O. v. HHS, Fed. Cl. Spec. Mstr.  Jan. 3, 2017) (Moran, SM)

Denial of entitlement in Pneumococcal/OMS case.  SM held that molecular mimicry theory was not automatically persuasive merely because it holds true for some vaccines and some conditions, noting that Petitioner could have closed the analytical gap in his theory by presenting evidence of homology between the PCV vaccine and brain proteins.

Damages

Day v. HHS, (Fed. Cl. Dec. 7, 2106) (Wolski, J)

CFC denied HHS’ motion for review of an interim damages decision.  HHS agreed that Petitioner should be awarded $250,000 pain and suffering, but disagreed that interim damages are permissible under the Act.  The reviewing judge held that the CSM had reasonably interpreted the Vaccine Act to allow for an award of interim damages.  Although HHS initially appealed this decision to the Circuit, the Secretary dismissed the appeal prior to briefing.

Continue ReadingReview of Recent Cases – Attorney Fees; Entitlements; Damages

Judge Slashes Billion Dollar Pinnacle Verdict in Half

A Texas judge slashes a $1 billion dollar verdict by $500 million dollars in the most recent Pinnacle hip replacement trial.  Judge Ed Kinkeade based his decision on “constitutional considerations that limit the amount a plaintiff may recover in punitive damages,” according to Reuters.  In December a jury originally ordered Johnson & Johnson, the manufacturer of the Pinnacle metal on metal hip, to pay over $1 billion to six California plaintiffs who experienced tissue death and bone erosion from their hip implant. The judge upheld the jury’s findings that Johnson & Johnson designed a defective implant and failed to warn doctors and patients of the risks.

There are still almost 9,000 court cases pending, accusing Johnson & Johnson of marketing the hips with known flaws. The Pinnacle was taken off the market in 2013 when the Federal Food and Drug Administration tightened up regulations regarding replacement hips. That same year, the manufacturer paid $2.5 billion to settle over 7,000 lawsuits related to another one of its metal-on-metal hip devices, the DePuy ASR.

MCT Law Defective Hip Litigation

Maglio Christopher & Toale, P.A. has focused its practice on defective hip replacement cases for over a decade.  In 2008 our law firm filed the first lawsuit in the United States involving a modern generation metal on metal hip replacement. If you think you have a defective metal-on-metal hip replacement, please contact us for a free evaluation of your case at 888-952-5242 or fill out the form below.

Continue ReadingJudge Slashes Billion Dollar Pinnacle Verdict in Half

Review of Recent Cases Involving Attorney’s Fees & Costs

Supplemental Costs Post-Fee Judgment

SM granted an unopposed request for supplemental expert costs inadvertently omitted from original fees and costs determination, which had been settled by stipulation.  Judgment had issued on the original fees and costs decision.  However, the 180 day period in which to requests fees and costs had not yet expired.  Brasher v. HHS, (Fed. Cl. Spec. Mstr. No. 4, 2016) (Gowen, SM)

Excessive hours

File Review- Routine monthly file review, at either .5 or 1 hours, is unreasonable without further explanation, especially if counsel is actively involved in the case.  Florence v. HHS, (Fed. Cl. Spec. Mstr. Oct. 6, 2016) (Moran, SM)

Calls with Client- Eleven hours of attorney time spent in phone calls with petitioner, discussing medical records and case status, was excessive considering the petition had not yet been filed.  Laney v. HHS, (Fed. Cl. Spec. Mstr. Oct. 18, 2016) (Roth, SM)

Billing Specificity- Privileged Communications

Detailed contemporaneous time records are required in Vaccine Act cases even for client communications.  The Federal Circuit, in an EAJA case, has held that to  “adequately identif[y] the purpose of the activities” does “not in most cases invade the attorney-client privilege when applied to client communications.” Florence v. HHS, (Fed. Cl. Spec. Mstr. Oct. 6, 2016) (Moran, SM)

Travel Costs- Ruth’s Chris Steakhouse, Charter Flights and Limousines

A $5500 charter flight to a LCP site visit and an accompanying $600 limo ride were disallowed as excessive (but associated costs were only reduced by 50%!).   Raymo v. HHS, (Fed. Cl. Spec. Mstr. Nov. 2, 2016) (Dorsey, CSM)

Dinner at Ruth’s Chris steakhouse was allowed where lesser meal costs incurred during travel were not billed, thus total meals costs were less than federal per diem.  $50 rental car upgrade not warranted.  Hoehner v. HHS, (Fed. Cl. Spec. Mstr. Nov. 7, 2016) (Hamilton-Fieldman, SM)

Case Funding Costs

Unreasonable to charge $29,554.58 in case funding loan interest to Vaccine Program.  Raymo v. HHS, (Fed. Cl. Spec. Mstr. Nov. 2, 2016) (Dorsey, CSM)

Reasonable Basis

Pro se petitioner entitled to litigation costs associated with filing petition and obtaining medical records, where records contained notation “Please do not administer influenza vaccine due to prior reaction to vaccine that patient is currently still being treated for.”   Heyer v. HHS, (Fed. Cl. Spec. Mstr. Nov. 10, 2016) (Hamilton-Fieldman, SM)

Unreasonable to take on representation of petitioner in case where experienced vaccine counsel was previously unsuccessful in his numerous attempts to obtain supportive expert opinion.  Although not per se unreasonable to take on case as second attorney, “further investigation” than usual is warranted.  Rehn v. HHS, (Fed. Cl. Spec. Mstr. Oct. 31, 2016) (Millman, SM)

Continue ReadingReview of Recent Cases Involving Attorney’s Fees & Costs

$1 Billion Dollar Jury Award in Pinnacle Hip Trial

Jurors announced a record $1 billion dollar verdict against Johnson & Johnson in the most recent Pinnacle metal on metal hip trial.  It took jurors only one day of deliberations to come back with their astounding award.

How Much Was Awarded to Each Pinnacle Hip Plaintiff?

Harris Martin Publishing sources say the verdict total is more than $1.041 billion.  The trial took place in Dallas, Texas. Six individual cases were consolidated into this single trial. That means 6 people claiming injuries from DePuy’s defective Pinnacle Metal on Metal hip replacements went to trial at one time because of the similarities of their cases. Here’s the breakdown of how much the jury awarded each of the six plaintiffs:
  • $4 million per person with a single hip implant.  There are a total of 6 plaintiffs in this bellwether trial.
  • $6 million per person with two hip replacements, or bilateral implants.
  • $1 million for each spouse of those 6 plaintiffs.
  • $84 million per plaintiff in punitive damages against DePuy.
  • $84 million per plaintiff in punitive damages against Johnson & Johnson.
  • $125,000 for each spouse in punitive damages against DePuy.
  • $125,000 for each spouse in punitive damages against Johnson & Johnson.
  • $125,000 for each spouse in punitive damages against DePuy.

About the Pinnacle Hip Trial

The trial started on October 3rd and lasted 31 days.  Yesterday lawyers for Depuy and J&J asked for a mistrial before the jury began deliberating.  The judge denied the motion and gave the case to the jury on Wednesday, November 30th. By the end of the day on Thursday, the jury had made their decision.

What Can Other Injured Pinnacle Hip Patients Expect Now?

This is the second time a jury gave a multimillion-dollar award to injured Pinnacle hip replacement patients.In March another jury awarded $502 million to 5 plaintiffs injured by Pinnacle metal on metal hips.
The pressure is now on Johnson & Johnson to start compensating people for their defective hip implant.
“Hopefully the stockholders will wake up and demand that Johnson & Johnson start settling these cases before facing anymore record-breaking plaintiff’s awards,” says Managing Partner Altom Maglio.  Maglio is a national leader in metal hip litigation, filing the first-ever metal on metal hip lawsuit over the Zimmer Durom hip in 2008.

Maglio Christopher & Toale’s Extensive Experience in Metal on Metal Hip Litigation

➨ Our attorneys have personally questioned under oath dozens of high profile DePuy and Johnson & Johnson employees, including:
  • J&J CEO Alex Gorski
  • DePuy Orthopedics CEO Andrew Ekdahl
  • DePuy Vice President of Clinical Research Pam Plouhar
  • Pinnacle Co-Designer, orthopedic surgeon Dr. Thomas Schmalzried
➨ Our law firm is a national leader in the defective metal on metal hip litigation, filing the first metal on metal hip lawsuit in the United States. ➨ We have deep contacts within the orthopedic community and extensive medical and technical knowledge about defective orthopedic hip replacements. ➨ Maglio Christopher & Toale, P.A. is aggressively and actively litigating metal on metal hip cases through the U.S. state and federal court systems.

CONTACT US NOW TO TALK ABOUT YOUR DEFECTIVE HIP REPLACEMENT

Let our Defective Hip Replacement Attorneys review the details of your case at no cost.

Call: 888.952.5242

Continue Reading$1 Billion Dollar Jury Award in Pinnacle Hip Trial

Attorney’s Fees and Costs Rulings

Attorneys’ Fees Check Payee

Special master granted relief from judgment where counsel was unable to contact petitioner to endorse the fees and costs check.  This satisfied the “narrow circumstances” where a fees award should be payable directly to counsel.  The court noted that counsel did have other remedies against his client, however because the case was eight years old the interests of justice weighed in favor of granting relief. (Editor’s Note: this situation can be avoided by having your client execute a POA with the retainer agreement). Watson v. HHS, (Fed. Cl. Spec. Mstr. Jul. 25, 2016) (Corcoran, SM) –

Reasonable Fees

  • SM held that Respondent’s recommended fee range was unpersuasive where not tailored to lawyer or firm in question and cases cited for range were not factually congruent. 100% of fees and costs awarded.  Auer v. HHS, (Fed. Cl. Spec. Mstr. Aug. 24, 2016) (Corcoran, SM).
  • SM held that recommended range was not helpful, each case is different even if they have a similar procedural history or involve the same injury. Coker v. HHS, (Fed. Cl. Sep. 9, 2016) (Millman, SM).
  • Recommended range of $16-21,000 in SIRVA case rejected and full amount of request ($64,000) awarded where case required a life care plan and was otherwise more complicated than usual. Taylor v. HHS, (Fed. Cl. Spec. Mstr. Sep. 2, 2016) (Millman, SM).
  • 32.10 hours to review a 16-page expert report and 16 articles, (which totaled 178 pages), was unreasonable and reduced by 75%.  Coker v. HHS, (Fed. Cl. Sep. 9, 2016) (Millman, SM).
  • Hours billed in Federal Circuit appeal of fee decision reduced where appeal proceeded inefficiently, perhaps due to inexperience with appellate process, and only 11 pages of 50-page brief constituted “fresh work.”  Improper to bill again for prior work which was reused.  D’Angiolini v. HHS, (Fed. Cl. Spec Mstr. Sep. 13, 2016) (Moran, SM).
  • 17.2 hours spent collaborating with expert in preparation of initial expert reduced by 50%.   Dezern v. HHS, (Fed. Cl. Spec. Mstr. Oct. 14, 2016) (Corcoran, SM)
  • A client visit, with or without a life care planner, at a point in a case where a potential resolution or assessment of damages must be made, is appropriate.  Collaboration by multiple attorneys bring unique views and strengths, which are of great benefit to clients, thus not unreasonable.  Manis v. HHS, (Fed. Cl. Spec. Mstr. Apr. 12, 2016) (Roth, SM)

Reasonable Basis:

  • Reasonable basis existed to enter an appearance in a pro se case where, based on the petition and medical records, medical articles, a social security disability decision, and an affidavit, where the court itself was “unable to rule out the possibility that petitioner could establish entitlement to compensation.”  Neither the fact that petitioner did not have a clear diagnosis nor that the treating physician did not attribute causation to vaccines obviated a reasonable basis for the claim.  Theory of autoimmune etiology was sufficiently plausible to make case worth investigating to a certain point.  Finally, the court noted that taking on a pro se case was different from an initial filing, and that counsel performed a service for both petitioner and the court by investigating the case and then convincing petitioner to dismiss after an expert concluded the case was not viable.  A reasonable basis existed until after the expert reviewLewis v. HHS, (Fed. Cl. Spec. Mstr. Sep. 15, 2016) (Gowen, SM)
  • Duty to investigate claim prior to filing was fulfilled where counsel collected medical records and spoke with petitioner and family members regarding claim.  Where records suggested a viable claim existed, reasonable basis established, considering that the symptoms were similar to those of a demyelinating disorder.  The special master rejected Respondent’s position that counsel had an obligation to seek a pre-filing expert report in the 1.5 years counsel had the case before filing.  “This would effectively raise the bar for filing from ‘reasonable basis’ to ‘likelihood of success’.”  The court noted that petitioners are discouraged from retaining experts in demyelinating cases and may not even be paid for this expense if deemed premature or unnecessary.  (Ed. Note – this holding may not apply in a non-demyelinating case; there are other decisions that hold a pre-filing investigation includes consulting your expert pre-filing, on your own dime, and not the Program’s, should the case prove unviable).  Hinojosa v. HHS, (Fed. Cl. Spec. Mstr. Jul. 20, 2016) (Roth, SM)
  • Against the backdrop of the OAP, it was reasonable to file a mitochondrial autism case, but unreasonable once decision was made to proceed with an unqualified expert and an extremely defective claim.  To incur the expense of defective expert reports, then push the case forward to an evidentiary hearing on the basis of frivolous theories was simply not reasonable.  Expert, (counsel’s mother, who was certified only in family medicine), was unqualified to opine on table encephalopathy or mitochondrial disorders and expert reports were based on a serious misreading or disregard of the medical records.  Moreover, table injury claim was completely contradicted by the medical records, and completely devoid of merit.  Prior decisions in other cases had warned that this was an underqualified and unpersuasive expert and many decisions had been issued in the instant case warning counsel of the serious defects with the claim. $7600 of $42,000 awarded.  Hardy v. HHS, (Fed. Cl. Spec. Mstr. Aug 16, 2016) (Hastings, SM)
  • Reasonable basis for filing the petition and pursuing it somewhat past the point where OAP “test cases” were denied.  Once determined that the claim was time-barred, no longer reasonable to pursue claim.  Also unreasonable to alternatively pursue significant aggravation claim where records strongly contradicted such a claim.  Hashi v. HHS, (Fed. Cl. Spec. Mstr. Aug. 25, 2016) (Hastings, SM)

Interim Fees

  • SM held interim fees were warranted where case was pending for 2.5 years and trial was scheduled for following year thus imposing hardship on counsel if not paid prior to that.  Carda v. HHS, (Fed. Cl. Spec. Mstr. Aug. 19, 2016) (Corcoran, SM)

Hourly Rates

  • CFC affirmed SM’s award of interim fees where SM awarded the median forum rate of $387.50 per hour (range $350-$425) for 20+ year attorney from Idaho.  Garrison v. HHS, (Sep. 8, 2016) (Kaplan, J)
  • Sarasota, FL attorney (23 years) awarded forum rate of $356 where Sarasota rates not significantly different from forum and rate requested was at low end of range for years of practice ($350-425).  Dezern v. HHS, (Fed. Cl. Spec. Mstr. Oct. 14, 2016) (Corcoran, SM)

Interim Expert Costs

  • Factors compelling a 50% award of expert fees included that counsel had already paid them, total amount, (more than 20k), was sufficiently “costly” under Avera, and some of the costs were incurred preparing supplemental expert reports at the SM’s direction.  After trial, court would consider whether experts “were useful and/or necessary in establishing Petitioners’ claim” warranting additional fees.  Carda v. HHS, (Fed. Cl. Spec. Mstr. Aug. 19, 2016) (Corcoran, SM)

Expert Hourly Rates

  • Two experts awarded $400 hourly rates where $500 rates requested for one expert had been denied in other cases and neither’s rate was “substantiated.”  Carda v. HHS, (Fed. Cl. Spec. Mstr. Aug. 19, 2016) (Corcoran, SM)

Reasonable Costs

  • 6.5% sales tax on legal services awarded over objection where state law required collection of this tax and local federal courts routinely awarded sales tax on fees in that district.  Carda v. HHS, (Fed. Cl. Spec. Mstr. Aug. 19, 2016) (Corcoran, SM)
  • Special master disagreed that a SIRVA case, or any case, was “garden variety” given that petitioners with similar injuries would not experience pain or disability in the same way, thus each petitioner deserves the facts of their case reviewed individually.  Life care plan expenses were reasonable to incur, however the amount was deemed excessive and reduced by 50%.  Manis v. HHS, (Fed. Cl. Spec. Mstr. Apr. 12, 2016) (Roth, SM)

*Full decisions are available on the CFC website at http://www.uscfc.uscourts.gov/

Continue ReadingAttorney’s Fees and Costs Rulings

Substantive Decisions – MMR and Gardasil Vaccines

  • Entitlement denied in a case alleging MMR-caused Myoclonic-Astatic Epilepsy (also known as “Doose Syndrome”).   Analytical gaps between medical literature and expert’s theory were too great and too numerous to persuade.  Although molecular mimicry was a valid theory to explain some vaccine reactions, simply explaining how theory of molecular mimicry works with other diseases and purporting to show a connection between the MMR vaccination and the disease is insufficient to meet burden.  K.T. v. HHS, (Fed. Cl. Spec. Mstr. Sep. 8, 2016) (Hamilton-Fieldman, SM)
  • Special master correctly determined that “sensory dysesthesias” and “idiosyncratic severe reaction to vaccination” did not meet the Vaccine Act requirement of a “defined and recognized injury,” thus dismissal was appropriate.  Lasnetski v. HHS, (Fed. Cl. Sep. 9, 2016) (Horn, J)
  • Denial of entitlement in case alleging SLE post-Gardasil vaccine where expert theory was “overbroad, generalized, and vague, to the point that it could apply to virtually everyone in the world who has received a vaccine containing an adjuvant and then at some time in their lives developed an autoimmune disease.”  Further, no explanation was given to favor a temporally remote vaccine over a well-known environmental trigger.  Johnson v. HHS, (Fed. Cl. Spec. Mstr. Aug.18, 2016) (Hamilton-Fieldman, SM)

*Full decisions are available on the CFC website at http://www.uscfc.uscourts.gov/

Adverse Reaction to a Vaccine Injury

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Polio-like Illness Paralyzing Children

The Centers for Disease Control (CDC) is reporting a sudden spike in cases of Acute Flaccid Myelitis (AFM).  At least half of the states in the U.S. have reported cases of this mysterious disease.  Vaccination may play a role in triggering this Polio-like illness.

A January 2015 article in The BMJ suggested that vaccines may play a role in the increased numbers of AFM.  It’s called Paralytic Polio and can be triggered after intramuscular injections of vaccines.   It’s also related to “provocation poliomyelitis” or “provocation paralysis.”

Participants attending the Child Neurology Society’s annual meeting in October suggest that Acute Flaccid Myelitis may have been misdiagnosed as Transverse Myelitis for several years.

What is Acute Flaccid Myelitis?

Acute Flaccid Myelitis is a relatively rare syndrome that affects children primarily between the ages of 1 and 18 years old.  Most patients suffer from the sudden onset of limb and facial weakness similar to polio.  In most cases, the onset is very rapid.  Tests have revealed lesions on the spinal cord and brain stem.

What Causes Acute Flaccid Myelitis?

While the exact cause is still unknown, there are several suspected sources.  Most physicians point to a viral infection known as Enterovirus 68.  However, other potentials are:

What are the symptoms of Acute Flaccid Myelitis?

At least 80% of the confirmed cases of Acute Flaccid Myelitis through the CDC reported a respiratory illness prior to developing AFM and 75% also reported a fever. Diagnosing AFM requires a complete medical history review, MRI imaging, and the elimination of both Guillain-Barre Syndrome and Transverse Myelitis. Symptoms of AFM include:

  • Facial Drooping
  • Facial Weakness
  • Limb Weakness
  • Loss of Muscle Tone
  • Loss of Reflexes
  • Drooping Eyelids
  • Slurred Speech
  • Difficulty Swallowing
  • Difficulty Moving the Eyes
Continue ReadingPolio-like Illness Paralyzing Children

Attorney’s Fees and Costs Rulings by Topic

Non-Forum Rates

Glaser v. HHS, (Fed. Cl. Spec. Mstr. Jun. 6, 2016) (Corcoran, SM). VT attorney only entitled to non-forum rates under Davis exception to McCulloch; prior decisions involving same attorney established VT rates were substantially lower than forum and changed circumstances were not established here.  Awarded rates of $225 to $238.

JB v. HHS, (Fed. Cl. Spec. Mstr. Jul 8, 2016) (Dorsey, CSM).  Hershey, PA attorney only entitled to non-forum rates; Court awarded rates generally consistent with local federal district court decision, $250 and $350.  The Court did note that “the [good] quality of the attorney work” is a relevant factor.

Number of Hours

Glaser, supra.  Number of hours reduced by 10% due to “lack of diligence” in prosecuting case notwithstanding that there was no overbilling – to the contrary the special master held that counsel should have billed more hours to the file earlier on and concluded the case more expeditiously.

JB, supra.  Number of hours reduced by 20% due to vague billing descriptions and block billing.  All time entries characterized as simply “review” file” denied.  Excessive client communication reduced by 50%.

Loving v. HHS, (Fed. Cl. Spec. Mstr. Jul 7, 2016) (Moran, SM).  Number of hours spent on litigation over $282K expert invoice reduced.  Two-thirds of the expert fees had previously been awarded and petitioner sought $8,362.50 in additional attorney’s fees but was awarded $2,090.63 because counsel’s lack of oversight of expert fees fundamentally caused the dispute over expert fees and counsel’s contributions to resolve the dispute over attorneys’ fees were largely ineffective.

Nichols v. HHS, (Fed. Cl. Spec. Mstr. Jun 22, 2016) (Corcoran, SM).  Number of hours incurred after filing of claim reduced by 50% “to account for counsel’s failure to act diligently and thoroughly in addressing underlying problems with the claim that could have been identified sooner.”  Fees for fees also reduced by 50% where fees incurred in fee litigation should not equate to 1/3 of the total fees sought in a case with barely a reasonable basis.

Whitney v. HHS, (Fed. Cl. Spec. Mstr. Jul. 27, 2016) (Moran, SM).  Number of hours reduced to the extent that multiple associates billed to a file for simple tasks and where partner billed a higher rate for work the assigned associate could have performed.

Reasonable Basis

Mounts v. HHS, (Fed. Cl. Spec. Mstr. Jul. 27, 2016) (Hamilton-Fieldman, SM).  Reasonable basis for bringing the claim did not exist where actual onset of symptoms was many months after the vaccine and the purported onset was supported by no more than Petitioner’s representations, which ran directly contrary to her medical records.

Nichols, supra.  Reasonable basis for claim “barely enough” through the time of dismissal after failure to secure an expert.  Asserting a rechallenge theory was not facially unreasonable, in light of other program cases, even though a rechallenge theory had never previously succeeded in an autism case.  The court noted that there was no time pressure to file the claim before a full investigation of the merits and warned that next time fees would likely not be awarded if a claim were filed prematurely.  The court also noted dismay that experienced counsel continue to file claims related to developmental regression.

Smith v. HHS, (Fed. Cl. Spec. Mstr. Jun. 22, 2016) (Corcoran, SM).  Reasonable basis for claim did not exist, given the totality of circumstances, where brain lesions of MS were identified two years after vaccination, and counsel could have determined the claim’s viability in light of the onset issue long before the petition was filed.

Varela v. HHS, (Fed. Cl. Spec. Mstr. Jun, 22 2016) (Corcoran, SM).  Reasonable basis did not exist where dismissed case turned on a factual matter that could easily have been investigated, and resolved, by counsel well before the action was filed.  Specifically, whether “overvaccination” had caused this child harm.

Interim Fees

KL v. HHS, (Fed. Cl. Spec. Mstr. Dec. 8, 2014) (Corcoran, SM).  Interim fees and costs denied – “to repeatedly delay a case and then ask for fees expressly on account of the case’s excessive age is the essence of chutzpah.”  The case had been pending two years, fees were below $50K and expert costs were only $3500.

Fees and Costs

JB, supra.  Highest SPU fees and costs award to date had previously been $64,000.  High damages SPU cases are not necessarily more complex, thus 1.5 million SIRVA case not entitled to requested $195K in fees and costs, but awarded $93K.

Glaser, supra.  Time spent monitoring case after withdrawing nonbillable.

Guardianship costs of $9254.50 reduced by 10% because they exceeded the accepted range of $1750-$8500 and Petitioner failed to establish reasonableness of CA attorney’s hourly rate of $415.  Glaser, supra.

Expert Rates

Glaser, supra.  Expert rate of $400 for unspecified type of expert reasonable.

Glaser, supra.  Expert rate of $450 for a non-testifying, consulting expert was excessive and not reasonable.  Reduced to $350 per hour.

Whitney, supra.  Expert rates of $350 and $500 for neurologist, and $500 for an immunologist, approved.  Only 10 of 18 hours spent preparing a three-page expert report awarded.

Whitney, supra. Flat expert/treater rate of $6000 for day of testimony denied after trial cancelled.  Two-day notice of cancellation warranted some compensation to expert, but he was awarded only $1575.  He had been scheduled to testify at 8:30 a.m. and the parties expected his testimony to last 1.5 hours.   Adding an hour for chart review, and assuming the treater would have been tied up until noon, warranted payment of 4.5 hours at his rate of $350.

Glaser, supra.  Voc rehab expert rate of $325 deemed reasonable.

Glaser, supra.  LCP expert costs of $23,780.51 awarded in full (billed at rate of $200 in that case but noting a rate increase to $225 approved in another case).

JB, supra.  Nonrefundable LCP expert costs of $2500 approved where parties had agreed to engage LCP services but case settled before actually used.

*Full decisions are available on the CFC website at http://www.uscfc.uscourts.gov/

 

Continue ReadingAttorney’s Fees and Costs Rulings by Topic

Procedural Decisions – Motion for Review

Procedural Decisions

Valle v. HHS. (Fed. Cl. Aug. 6, 2016) (Lettow, J).  Thirty-day time limit to file a motion for review under section 300aa-12(e)(1) is jurisdictional, notwithstanding that it is notably rigid and out of step with other statutes and rules relating to the time for seeking review or appeal.

*Full decisions are available on the CFC website at http://www.uscfc.uscourts.gov/

 

Continue ReadingProcedural Decisions – Motion for Review

Substantive Decisions – Denial of Entitlement

Substantive Decisions

Rus v. HHS, (Fed. Cl. Spec. Mstr. Jun. 23, 2016) (Gowen, SM).  Denial of entitlement in case alleging DTaP caused nephrotic syndrome.  The proffered mechanisms were (1) a “specific” T-cell response, and (2) an inflammatory cytokine response to the vaccination that alters an “unspecific” pathway, involving angiopoietin-like 4.  Although Petitioner’s expert “labored valiantly to propose a credible theory to explain this case, and may well have touched upon a theory that proves meritorious in the future . . .he candidly acknowledged that there remains great mystery in the understanding of the causation of this disease.”  Thus, Althen prong 1 failed.  

Cunningham v. HHS (Fed. Cl. Spec. Mstr. Aug. 1, 2016) (Hastings, SM).  Denial of entitlement in case alleging ASD post MMR.  The claim failed because the special master found the ASD predated the vaccine, because Respondent’s expert was far more qualified to opine concerning the causation of autism, and was a much more persuasive witness, and because Petitioner’s expert failed to demonstrate in general that the MMR vaccination can result in autoimmunity or that there was any evidence of autoimmunity or abnormal immune system activity in this specific case.  Finally, there was no validity to the alternative “significant aggravation” argument.

*Full decisions are available on the CFC website at http://www.uscfc.uscourts.gov/

Continue ReadingSubstantive Decisions – Denial of Entitlement

Vaccines and the Risk of Febrile Seizures in Children

Children given the flu shot along with other common childhood vaccines are more likely to suffer from a febrile seizure

A recent study, funded by the Center for Disease Control, looks at connections between childhood vaccines and febrile seizures.  The American Academy of Pediatrics published this study in its July newsletter, citing research conducted by several doctors.  The study found an increased risk of febrile seizure in children between 6 months and 23 months old who get the flu vaccine at the same as the PCV or DTaP vaccines.  The CDC noted that there was not an increased risk of seizure when the flu shot was administered on a different day than other vaccines.  The study only looked at children up to one day after vaccination.

Febrile seizures are seizures that happen to children between 6 months and 5 years old. While most febrile seizures are not permanently harmful, they are very scary to kids and parents. They cause a child with a fever to have “spasms” or jerky movements.  These seizures normally last a minute or two and usually occur when a child has a fever over 102 degrees.

Filing a Vaccine Injury Claim

Febrile seizures typically resolve quickly after the fever passes.  However, some children and adults experience severe and life-threatening reactions to vaccines, such as Guillain-Barré Syndrome, Intussusception, encephalopathy, and other auto-immune related reactions.  In those cases, our attorneys may be able to help you file a vaccine injury compensation claim.

Fill out the online form at the bottom of this page for more information or call our office at (888) 952-5242 to speak directly with someone.

Continue ReadingVaccines and the Risk of Febrile Seizures in Children

Statute of Limitations – Premature Ovarian Failure

Premature Ovarian Failure Mini Omnibus

This group of cases has been attempting to resolve when the first symptom or manifestation of onset occurs in POF, for purposes of the SOL. The court held that for petitioners who were eighteen years old or younger at the time the condition arose, if the condition qualifies for evaluation on the ACOG chart, it constitutes a symptom for purposes of the Vaccine Act. For petitioners who were over eighteen years old at the time the condition arose, the chart also applies, except that periods that should be evaluated include those that occur more frequently than every 21 days or less frequently than every 34 days.

The ACOG chart is an opinion from the Committee on Adolescent Healthcare at the American College of Obstetricians and Gynecologists, together with the American Academy of Pediatrics, entitled “Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign.

Different onset rules were developed for women using contraceptives, depending on the type of contraceptive used.

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Attorney’s Fees – Hourly Rates

Stanford v. HHS, (Fed. Cl. Spec. Mstr. May 16, 2016) (Moran, SM)

20+ year MD/.JD, with relatively little vaccine program experience, requested $525 per hour, but was awarded $400 (McCulloch range $300-425). A 5-year MBA/JD requested $385 per hour, but was awarded $260 (McCulloch range $225-300). Although not mentioned in the analysis, the attorneys were from California; McCulloch generally has been applied to most of California.

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Continue ReadingAttorney’s Fees – Hourly Rates

Attorney’s Fees – Hourly Rates, Expert Costs

Pentchelov v. HHS, (Fed. Cl. Spec. Mstr. April 29, 2016) (Corcoran, SM)

The Court approved a $400 hourly rate for a 40-year attorney from Beverly Hills, ($350-$425 McCulloch range). The Court cited a previous decision holding that LA area attorneys were entitled to “forum” rates in the program. The court awarded $235 per hour, rather than the $250 requested, ($150-225 McCulloch range), for a 2-year associate, who had additional years as a law clerk at her firm working on vaccine cases. A paralegal/former attorney was awarded $145, although McCulloch provided that the highest paralegal rate was $135.

With respect to expert rates, the court awarded $500 for Dr. Steinman, which had already been awarded that rate in other cases, as well as the requested rates for a hematologist ($475) and an expert in microbiology, immunology and molecular genetics ($393). The court did reduce one of the expert’s costs by 30% where he spent more than 100 hours in 2 reports.

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Continue ReadingAttorney’s Fees – Hourly Rates, Expert Costs

Denial of Entitlement – SIDS Death – Triple Risk Model

Copenhaver v. HHS, (Fed. Cl. Spec. Mstr. May 31, 2016) (Moran, SM)

This case is very similar to several recent SIDS cases, all involving the same theory and the same experts, and previous denials such as this one have been affirmed on appeal, e.g. Cozart. The specific reasons petitioner lost in this case were characterized this way: “First, the Secretary’s expert, Dr. McCusker, was much better qualified to discuss cytokines. Second, the articles do not support the opinions Dr. Miller and Dr. Axelrod expressed. Third, there are gaps in the medical record for Nicholas that Dr. Miller fills with assumptions.

The Court expressed some concern about Petitioner’s immunologist, David Axelrod, who had solicited the petitioner’s bar, and apparently also HHS, and also advertised his vaccine expert services on the Internet. Ultimately, the court found that he sincerely held his opinions. However, the court also determined that the field of cytokines was outside the bounds of Dr. Axelrod’s expertise.

One helpful quote, for petitioners, was included in the decision: “When the treating doctors do not know about the vaccination, any lack of connection between the vaccination and injury should not be held against the petitioners.

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Continue ReadingDenial of Entitlement – SIDS Death – Triple Risk Model

Entitlement Ruling – Seizures/Infantile Spasms due to DTaP

Reilly v. HHS, (Fed. Cl. Spec. Mstr. May 31, 2016) (Hamilton-Fieldman, SM)

After a brain biopsy, it was determined that the child had a focal cortical dysplasia, and Petitioner’s expert testified that this was a predisposition which caused the seizure disorder once triggered by DTaP. Respondent argued that the brain anomaly itself was a sufficient explanation for the development of seizures, i.e., they were inevitable.

Based on petitioner’s literature, the court concluded some insult, or second hit, is necessary in some cases of cortical dysplasia to trigger the inherent potential into the actuality of infantile spasms. Further, the court held, the pertussis component of the DTaP vaccine can act as that second hit.

Prongs 2 and 3 were not significantly disputed. The court was careful to note that her ruling that DTaP can cause infantile spasms should be limited to the unique facts of this case, i.e. the preexisting cortical dysplasia.

Continue ReadingEntitlement Ruling – Seizures/Infantile Spasms due to DTaP

Interim Damages – Pain and Suffering $250,000

Day v. HHS, (Fed. Cl. Spec. Mstr. May 21, 2016) (Dorsey, CSM)

(Ed. Note – this was my case, and HHS has appealed)

An entitlement decision had been issued in this neuromyelitis optica post Gardasil case, involving a very significantly disabled teenager. The life care planning process was ongoing, but the family circumstances were desperate: divorce, bankruptcy, loss of housing, difficulty supporting four children, and the child’s impending age of majority and need to be self-supporting, for ADA housing, for a wheelchair vehicle, etc.

I moved for interim damages, and requested that the full lost wage award be made, as this number was not in dispute. DOJ would not take a position on pain and suffering, but I suggested $250,000 was appropriate.

The court agreed and awarded the $250,000. She did not award the lost wages, even though the amount was not in dispute, because this amount would not be recoverable if the child were to die before the entry of judgment.

Respondent argued that the language of the Vaccine Act does not permit special masters to award interim damages, and they cannot be analogized to interim fee awards. There is only one other decision awarding interim damages in the history of the program (Heinzelman). The Court disagreed and found that the Act does implicitly allow interim damage awards.

In awarding interim damages, the court cautioned that this decision does not contemplate that interim damages would be routinely or even frequently awarded, but in this case, petitioners have made a persuasive case that there is extreme hardship and that accordingly, the purpose of the Vaccine Act is better fulfilled by making the interim award.

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Continue ReadingInterim Damages – Pain and Suffering $250,000

Denial of Interim Fees – Litigation not Protracted, No Undue Hardship

Bourche v. HHS, (Fed. Cl. Spec. Mstr. June 24, 2016) (Moran, SM)

The court denied the interim fees request, noting that interim fees are typically only granted when a case has been pending for several years, which would meet the definition of protracted under Avera. Waiting until the end of a case to be paid may be a hardship, but it is not “undue” because it is what is expected. The court also took this opportunity to make a statement to the bar about interim fees generally:

the undersigned wishes to advise attorneys representing petitioners in future cases that they need to justify an interim award with more than a conclusory argument that they are entitled to such an award. More than four years ago, the undersigned anticipated that interim awards would be the rule, not the exception. See Hibbard v. Secʼy of Health & Human Servs., No. 07-446V, 2011 WL 1135894 (Fed. Cl. Spec. Mstr. Mar. 7, 2011). The ensuing four years of experience, a period in which Vaccine Program cases have increased dramatically, has led to a reconsideration of this view. Interim awards remain appropriate in some cases, but interim awards should not be requested routinely.

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Continue ReadingDenial of Interim Fees – Litigation not Protracted, No Undue Hardship

Damages – Supplemental Attendant Care in Nursing Home

Barone v. HHS, (Fed. Cl. Spec. Mstr. Jun. 12, 2016) (Corcoran, SM)

Petitioner was wheelchair dependent, suffered from quadriparesis, and was vision and cognition-impaired. She was unable to be cared for at home due to family dynamics. The parties’ life care planners had reached an agreement on most life care plan items, including moving petitioner to a smaller, higher quality nursing home. The one remaining issue for judicial resolution was whether petitioner was entitled to one-on-one attendant care while in the nursing home, and, if so, how many hours. Petitioner had asked for 40 hours per week.

The court held that the Act’s “reasonably necessary” standard does not permit an award in an amount sufficient to “optimize” a party’s quality of life, thus the court could not award 40 hours per week. However, the court found that some supplemental attendant care was warranted under the circumstances – enough to meet some of petitioner’s “basic needs,” while not “optimizing” her quality of life on a daily basis. The fact that petitioner could not be cared for at home, and was estranged from family members that might otherwise provide home assistance, suggested a need for a modicum of additional, one-on-one care that even a top-of-the line skilled nursing care facility cannot consistently provide. Because the minimum time offered for the requested care was four hours per day, the court awarded that amount.

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Continue ReadingDamages – Supplemental Attendant Care in Nursing Home

Motion for Review Denial

Bean-Sasser v. HHS, (Fed. Cl. Jun. 26, 2016) (Yock, SJ) 

The reviewing court held it was not arbitrary and capricious to find that Petitioner’s RA was pre-existing at the time of the vaccines, given the RF antibody. Further, it was within his discretion to find that Respondent’s expert was more persuasive, especially given his more recent experience treating RA.

With respect to the Federal Circuit’s fact-specific finding in Capizzano regarding RA and the hepatitis B vaccine, the reviewing court noted that one of the studies relied upon in that case had not been filed in this case and that a new epidemiological study was published after Capizzano that was filed.

In summary, the reviewing judge held that the Special Master carefully and thoroughly weighed the evidence before him, and there was no reason why the reviewing judge should repeat that process.

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Continue ReadingMotion for Review Denial

Attorney’s Fees – Reasonable Basis

Miller v. HHS, (Fed. Cl. Spec. Mstr. Jun. 3, 2016) (Hastings, SM)

The court denied most of the fees and costs requested, finding it was not reasonable for Petitioners to take to trial their very weak case alleging that autism was vaccine-related. The Court awarded fees for the original participation in the OAP, however, the reasonable basis for the claim ended at the point where petitioner could find no expert to support the case but counsel’s own mother, a family practitioner, and expert whose previous vaccine program performance had been harshly criticized.

The court held “[t]he only reasonable course for Petitioners’ counsel at that time, given the facts in the medical record, and if the only expert that he could obtain was Dr. Cave, was either to persuade Petitioners to abandon their claim, or, failing that, to withdraw from the case. For Mr. Cave to incur the expense of Dr. Cave’s defective reports, then to push this case forward to an evidentiary hearing on the basis of theories that were so unpersuasive, and so contrary to the actual medical records of A.H.M., was simply not reasonable.” Ultimately the court characterized the case as frivolous.

The court warned, once again, that cases that have proceeded out of the OAP risk denial of fees and costs on reasonable basis grounds. Petitioners have tried to avoid the conclusions of the OAP test cases by alleging that a child suffered a vaccine-caused “encephalopathy” that resulted in “autistic-like features,” or that a child had an underlying “mitochondrial disorder” that somehow made the child more vulnerable to injuries by vaccines. These cases, the court observed, have typically involved expert witnesses who were quite underqualified to opine on the vaccine-causation issues at hand, and/or presented theories with no substantial scientific merit, and/or disregarded the facts contained in the medical records of the case.

Adverse Reaction to a Vaccine?

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Continue ReadingAttorney’s Fees – Reasonable Basis

Denial of Compensation – Mitochondrial Autism/Autoimmune Encephalitis

RV v. HHS, (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (Corcoran, SM)

In this case, similar to previous cases, petitioner argued that an underlying, preexisting mitochondrial disease was exacerbated by receipt of a vaccine, resulting in autism. An alternative causation theory was offered – molecular mimicry causing an autoimmune encephalopathy.

The Court found that a preponderance of evidence did not support a conclusion that the child had an underlying mitochondrial disorder or disease. Thus, the Loving analysis did not need to be applied to that theory. However, the court noted that petitioner’s had not shown a critical piece of the Loving analysis – how the child’s preexisting condition would have been better but for the vaccination.

The court also found that there was no evidence to support that the child actually suffered from an encephalopathy. With respect to both causation theories, the court found no evidence of a severe or acute regression post-vaccine, but rather, found that the regression preceded the vaccines.

Adverse Reaction to a Vaccine?

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Continue ReadingDenial of Compensation – Mitochondrial Autism/Autoimmune Encephalitis

Denial of Interim Attorney’s Fees – Reasonable Basis

Reiling v. HHS, (Fed. Cl. Spec. Mstr. Jun 24, 2016) (Moran, SM)

Counsel sought an award of interim fees and costs after withdrawing as counsel. The Court ultimately held that reasonable basis had not been demonstrated as of yet, although it could be later as the petitioner was proceeding pro se. Thus, an interim fee award could not be made. The legal standard applied was that “some” evidence, albeit not preponderant evidence, has to exist in support of the claim. (Ed. Note – a totality of circumstances analysis was not applied).

Reasoning

Multiple factors were considered on the issue of reasonable basis. The petition had alleged a latex allergy resulted in injury, however, no latex allergy existed. An expert report was later filed asserting that Tdap vaccine exacerbated an underlying traumatic brain injury. This theory was problematic because there was little to no evidence that petitioner suffered from a traumatic brain injury. Even if she had, the expert report did not indicate how her condition would have progressed any differently absent the vaccine. Also likely important to the Court’s analysis was the observation that the expert was a doctor of osteopathic medicine who previously specialized in AIDS/HIV but since 2010 was the medical director of a weight loss clinic and consultative practice involving has centered on the diagnosis and treatment of autonomic-related disorders such as traumatic brain injury and concussion, POTS, chronic fatigue, migraine headaches, orthostasis, poor memory and concentration, and irritable bowel syndrome.

Continue ReadingDenial of Interim Attorney’s Fees – Reasonable Basis

Interim Attorney’s Fees, Forum Rates

Auch v. HHS, (Fed. Cl. Spec. Mstr. May 20, 2016) (Corcoran, SM)

The court held that a three-year proceeding was sufficiently protracted to warrant an interim award of fees, and it was not required that Petitioner show that all three Avera factors are met for interim fee awards.

With respect to hourly rates, counsel sought to raise his hourly rates from those previously sought in the program, to rates based on McCulloch. The Court held that the difference in hourly rates between the forum, DC, and Wyoming was “very significant,” thus the Davis exception applied and non-forum/local rates applied. As a general rule of thumb, the court held, any difference over 25 percent meets the very significant standard.

The Court rejected an overstaffing argument, holding that additional attorneys can ensure the overall quality of work performed is better. Ultimately, the test is whether it is “reasonable” to have multiple attorneys on a file, such as whether they unnecessarily duplicated effort or worked in a coordinated manner.

Most tasks paralegal tasks were awarded over objections that the tasks were secretarial in nature. Tasks approved for paralegal billing included “review medical records, bates stamp, print, and put documents in a binder,” although copying the same binder for an expert was deemed secretarial. Organizing and scanning records was also allowed as paralegal time.

The Court held that an interim costs award for $8000 in expert costs was not warranted, and reserved ruling on that item until after the hearing.

Adverse Reaction to a Vaccine?

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Continue ReadingInterim Attorney’s Fees, Forum Rates

GBS Case – Damages, Future Lost Wages, Growth Rate, Discount Rate

Petronelli v. HHS, (Ct. Fed. Cl. Spec. Mstr. May 12, 2016) (Gowen, SM)

In this GBS case, the Court accepted the testimony of Petitioner’s vocational expert that a former corporate attorney was unable to return to work. The Court found Respondent’s expert unreliable, as he “mischaracterized the record.” Although Petitioner was not working at the time of the vaccine due to family obligations, the Court found that she likely would have re-entered the work force at the twenty-fifth percentile or earnings or $75,000. This number would have increased to $125,000, the median salary, over the next five years, and continued through her 13-year work life expectancy. The work life expectancy was calculated by determining the number of years Petitioner would have worked until age 64.5. (Ed. note: this is contrary to Respondent’s formula for wage calculations, which essentially utilize a total work life expectancy of 30 years in most cases based on older case law).

Calculations

The differing methodologies to calculate wage growth and discount rate are discussed in great detail in the opinion. Ultimately the court applied a 3.7% rate for corporate attorney wage growth and a 1% discount rate. Fringe benefits of 10% were also awarded.

The Court awarded the entire award in a lump sum, per Petitioner’s request, which the Court found “reasonable as petitioner is an adult woman with professional experience as a corporate attorney, and thus reasonably capable of making an informed decision.

Finally, the Court awarded past pain and suffering of $250,000. Other notable items were an award of funds for massage and acupuncture (Ed. Note – these are items not always agreed to by HHS).

*HHS will not utilize the methodology from this case in litigative risk settlement because they do not agree with the holding.

Continue ReadingGBS Case – Damages, Future Lost Wages, Growth Rate, Discount Rate

Guillain-Barre Syndrome and H1N1: What You Need to Know

A study outlined in the Journal of the American Medical Association links the H1N1 Flu vaccine with a small increased risk of developing Guillain-Barre Syndrome.  Reuters Health reported on a research study conducted at Laval University in Quebec City which tracks newly-diagnosed cases of Guillain-Barre in the six months after H1N1 vaccination began in Quebec.  Their findings indicated that there is a correlation between the H1N1 flu shot and people over the age of 50 developing Guillain-Barre.

Dr. Claudia Vellozzi, deputy director of the Immunization Safety Office at the U.S. Centers for Disease Control and Prevention said that those findings were similar to other studies in the United States after the 2009 H1N1 vaccination campaign.

Guillain-Barré Syndrome (GBS) is a disorder where a patient’s immune system goes haywire and attacks the peripheral nervous system. The symptoms of Guillain-Barre Syndrome can begin anywhere from one day to several weeks after a vaccination but usually peak around one to two weeks after the shot is given.  The chronic version of GBS is known as Chronic Inflammatory Demyelinating Polyneuropathy or CIDP. Researchers continue to monitor any correlation between the vaccine and the development of Guillain-Barre Syndrome.

Guillain-Barre Syndrome related vaccine cases are some of the most common that our Firm sees. To review some of the more recent decisions through the United States Court of Federal Claims awarding compensation to our clients, please click here.

Read more information on: how to file a vaccine injury claim.

Continue ReadingGuillain-Barre Syndrome and H1N1: What You Need to Know

Entitlement – Multiple Sclerosis Caused by Hep B Vaccination

Valle v. HHS, (Fed. Cl. Spec. Mstr. Apr. 18, 2016) (Gowen, SM)

This case involved a major dispute as to the timing of onset of Petitioner’s MS.  Petitioner contended that her MS began between 4 and 42 days after the third dose of Hepatitis B vaccine; Respondent argued that her MS preceded the vaccine.  The special master held that the onset issue was a close call, and resolved that issue in favor of the petitioner.

With regard to Althen prong one, the court observed that the issue of Hepatitis B causing demyelinating disorders such as MS had been extensively litigated in the program in a prior omnibus proceeding.  In those cases, the court found that the Hepatitis B vaccine could cause MS, along with GBS, TM, and CIDP. The court commented that the medical understanding of the cause of MS is much the same today.

Hep B Vaccine Can Act As Environmental Trigger to MS

The court rejected Respondent’s expert’s argument on prong one, which was largely based on epidemiology.  The Court held that Petitioner’s expert had presented a scientifically reasonable theory of how the Hepatitis B vaccine can act as the environmental trigger of MS through the mechanism of molecular mimicry, particularly with myelin oligodendrocyte protein (MOG) [as opposed to MBP].  It cannot be determined from the decision the degree of homology that was demonstrated between the Hepatitis B vaccine and MOG or whether evidence of cross-reactivity was available.

Prong two was relatively easy to establish, once the timing issues were resolved in petitioner’s favor, since she gradually developed a clinical picture of MS after the third Hepatitis B vaccination and there were no other triggers.  Petitioner’s proposed time frame for onset of symptoms, between 4 and 42 days, was found to be an appropriate temporal interval under prong three.

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Dismissal of Petition – No Equitable Tolling

Smith v. HHS, (Fed. Cl. Spec. Mstr. Apr. 8, 2016) (Hamilton-Fieldman, SM)

Petitioners argued that equitable tolling should be applied because the child’s doctors had failed to recognize that her injuries might be vaccine related, and that this failure should be considered an extraordinary circumstance that warranted equitable tolling.  More specifically, the argument focused on the fact that the child’s lack of majority precluded her from determining that the information being provided to her or her mother was incorrect.  The special master noted that the Federal Circuit had already declined to create a discovery rule for Vaccine Act cases.  The fact that the child was minor did not change the analysis, where Congress failed to include a minority tolling provision.

Continue ReadingDismissal of Petition – No Equitable Tolling

Attorney’s Fees and Costs – Reasonable Basis

Cooper v. HHS, (Fed. Cl. Spec. Mstr. Apr. 25, 2016) (Gowen, SM)

In this case alleging anaphylaxis and seizures caused by Hepatitis B vaccination, counsel for Petitioner indicated they no longer wished to proceed with the case and the case was ultimately dismissed.  Respondent argued there was no “factual basis [for the claim] in the medical records provided,” thus no reasonable basis to award fees and costs.

The special master noted that the totality of circumstances test governs the analysis of reasonable basis controversies.  Further, the court explained that reasonable basis looks at the feasibility of the claim, rather than the likelihood of success.

The court held there was a reasonable basis based on the medical records, including a pediatric visit which stated that the child had a possible allergy to the Hepatitis B vaccine and included a plan to hold additional doses “for now.”  Additionally, an allergist had determined that had a vaccine reaction had occurred and recommended avoiding future doses.   Finally, the court noted that an expert opinion on causation was not necessary for a reasonable basis.

The court did not award 56 hours of paralegal time requested, having determined that an earlier review by a more senior attorney, as opposed to four associates, would have resulted in the case’s dismissal much sooner.  The general order #9 requirement of a signed client statement regarding costs was satisfied by paralegal affidavits outlining good faith efforts to communicate with a client who was unresponsive to both the attorneys and to the court.

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Continue ReadingAttorney’s Fees and Costs – Reasonable Basis

Motion for Reconsideration Denial – Attorney’s Fees Objection Waived

Bundrick v. HHS, (Fed. Cl. Spec. Mstr. Apr. 27, 2016) (Roth, SM)

Petitioner requested fees and costs in the amount of $16,632.57; Respondent countered that a reasonable range was 12,000-14,000.  The special master awarded the fees and costs requested, plus an amount incurred litigating fees, noting that Respondent had no specific objection to the rates or time billed.  The court also noted that she had reviewed the billing and found it reasonable.

Motion for Reconsideration

Respondent filed a motion for reconsideration, contending that the court improperly required her to file a detailed fee position and that the court abused its discretion by failing to independently review the fee application.  The motion was denied as Respondent did not demonstrate that the interests of justice required a reduction of the fees and costs awarded.  Moreover, Respondent “fundamentally and inaccurately mischaracterized” the court’s ruling.  As stated in the decision, the court had reviewed the billing independently and found it reasonable.  Respondent provided no support for the “range” suggested and offered no specific objections.  This constituted a waiver of any objections.

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Vaccine Court Remains Relatively Unknown

There is help available for people hurt after having a severe and debilitating vaccine reaction.  Unfortunately, many people never know about the Vaccine Injury Compensation Program because it’s not widely publicized.

The Vaccine Court “establishes the Vaccine Program as a no-fault compensation program whereby petitions for monetary compensation may be brought by or on behalf of persons allegedly suffering injury or death as a result of the administration of certain compulsory childhood vaccines,” according to their website. Unfortunately, the existence of the Vaccine Court is not widely known, leaving many vaccine injured people to fend for themselves.  Even if you know about the Vaccine Court, most attorneys are not admitted to practice in this court.  NPR recently aired a story about a woman who came down with Guillain-Barre Syndrome (GBS) after getting the flu vaccine.  The report ends by wondering why more people are not aware of the Vaccine Court’s existence.

The vaccine lawyers at Maglio Christopher & Toale, P.A. have helped many people suffering from vaccine injuries get compensation. Find out more on our here.

Continue ReadingVaccine Court Remains Relatively Unknown

May is Guillain-Barre Syndrome Awareness Month

May is International Guillain-Barre Syndrome (GBS) Awareness Month.  Guillain-Barre Syndrome is a rare disorder where your body’s immune system attacks your nerves.  It can spread very quickly, paralyzing your entire body. It is a serious medical condition that requires hospitalization in most cases.  The exact cause of GBS, and a similar condition, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), is unknown, but it has been linked to several vaccines, namely Flu, Menactra, Hepatitis, HPV, Tetanus, DtaP, Tdap, and others.

While there is no cure for Guillain-Barre Syndrome, there is help available.  The GDS/CIDP Foundation provides information, meetings, and other support for people battling GBS.  More information about the Foundation, as well as information about their annual Symposium in September can be found on their site, http://www.gbs-cidp.org/.

If you or someone you know has GBS and believes it was triggered by a vaccine, there is financial help available.  The vaccine injury attorneys Maglio Christopher & Toale, P.A. have helped survivors of GBS get compensation through the Vaccine Court in the United States Court of Federal Claims.  Click here to view a list of our recent GBS cases and the amount of compensation received by our clients.  You can contact us by filling out the form at the bottom of this page or call us at 1-888-952-5242 to speak with someone immediately about your situation.

Continue ReadingMay is Guillain-Barre Syndrome Awareness Month

Zimmer Biomet Admits High MoM Hip Failure Rate for M2a 38mm Implants

(Washington, D.C. – May 2, 2016) Zimmer Biomet is warning European surgeons about problems with the M2a 38mm metal on metal hip implants but has NOT issued any warnings in the United States for patients with the same hip implant.

On April 12th, Zimmer Biomet sent letters to surgeons in Europe admitting the M2a 38mm Acetabular System has a higher than expected revision rate.   The warning also called a Field Safety Corrective Action (FSCA), is based on data collected by the National Joint Registry for England, Wales, and Northern Ireland.   The letter calls on surgeons to follow patient care guidelines established back in 2012 by the Medicines & Healthcare Products Regulatory Agency (MHRA).  The MHRA is the British version of the Federal Drug Administration (FDA) in the United States.  The MHRA guidelines include annual patient exams, MARS MRI or ultrasound testing, blood metal ion level tests, and possible revision surgery.  These follow-up guidelines are unique to metal on metal hip replacement patients because of health concerns.

Read the Biomet Field Safety Notice Here

“There are thousands of patients in the United States with the same medical complications and high revision rates due to the M2a 38mm hip implant. Don’t they deserve to know from the manufacturer if their health is at risk, too?” –Altom Maglio, Managing Partner, Maglio Christopher & Toale, P.A.

Zimmer Biomet has NOT yet issued ANY similar warnings in the United States aimed at doctors, consumers, or patients implanted with the M2a 38mm Acetabular System. Maglio Christopher & Toale, P.A. discovered copies of the April 2016 Field Safety Notice (FSCA20160307) distributed in Italian, German, Danish, and English.  However, the Field Safety Notice does not apply to the U.S.  Last year, Zimmer Biomet stopped all supply and sales of the M2a in Australia and issued a Hazard Alert because data from the Australian Orthopaedic Association showed higher than expected revision rates. Again, Zimmer Biomet did not issue a Hazard Alert or other safety warnings in the U.S.

“Zimmer Biomet has not told any of our U.S. clients or their surgeons about the serious medical issues with the M2a,” says Altom Maglio, Managing Partner of Maglio Christopher & Toale, P.A.  “Why only issue a Field Action Warning in Europe and a Hazard Alert in Australia?  There are thousands of patients in the United States with the same medical complications and high revision rates due to the M2a 38mm hip implant. Don’t they deserve to know from the manufacturer if their health is at risk, too?,” says Mr. Maglio.

The M2a 38mm implant was introduced in the global market in 2001.  Soon after patients started reporting problems with these metal on metal hip replacements.  Many developed complications from metal debris, high metal ions in their blood, tissue necrosis, pseudotumors, and other systemic medical problems.  In 2014 Biomet agreed to a settlement over the M2a and M2a Magnum hips. The attorneys at Maglio Christopher & Toale, P.A. are aggressively litigating on behalf of clients with these hip replacements.  “We encourage anyone having problems with their Biomet M2a hip to contact us so we can evaluate your situation and give you preliminary advice about your case,” says Maglio.

Defective Metal on Metal Hip Replacement?

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Continue ReadingZimmer Biomet Admits High MoM Hip Failure Rate for M2a 38mm Implants

Failure of Proof of Vaccine Causing SIDS

Cozart v. HHS, (Fed. Cl. Mar. 25, 2016) (Smith, SJ)

In the trial court, Petitioner failed to prove that vaccines could be an extrinsic risk factor, for purposes of the Triple-Risk Model of SIDS: vulnerable infant, critical development period and exogenous stressor(s).  The underlying theory had been that cytokines released in response to vaccines provoke an abnormal brainstem serotonin response, resulting in the suppression of arousal in the face of elevated CO2 levels.  The Special Master also held that there was no need to consider a speculative risk factor (vaccines) where the baby had many other risk factors for SIDS: male gender, peak age for SIDS death (2-4 months) and prone position.

On appeal, the court found that the Special Master’s determination that Respondent’s expert was more persuasive on the medical theory was not wholly implausible.  The Court also affirmed a finding that, in essence, required the Petitioner to prove the Daubert element that looks for objective evidence, e.g. brain findings, that the medical theory advanced actually played out in the case.  Other fact findings were affirmed as not arbitrary or capricious.  Finally, the court disagreed that the Special Masters elevated the burden of proof.

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Denial of Motion for Review; No Jurisdiction


JT v. HHS, (Fed. Cl. Feb. 1, 2016) (Bruggink, J)

In this conceded case, there was a significant dispute between the parties on the underlying methodology that should be used to calculate Petitioners’s lost wages.  Respondent moved the court to decide the issue of whether Petitioner’s future business ventures should be included in the wage computation (but not an amount to award).  The Special Master resolved that issue against Petitioner, finding that these future wages were too speculative.  The issue of how much wages to award was not reached.  Petitioner moved for review of that decision.  Because this was not a decision on compensation, i.e. awarding compensation, the matter was not yet ripe for review.

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Continue ReadingDenial of Motion for Review; No Jurisdiction

Reasonableness of Expert Fees

Loving v. HHS, (Fed. Cl. Spec. Mstr. Dec. 15, 2015) (Moran, SM)

In this infamous case that set forth the six-part test for significant aggravation claims, the court awarded 189k in fees, where 284k was requested.  Respondent had originally suggested 80k but later moved to 149k.  The case involved one expert but lasted for ten years.  There were multiple hearings.  The Special Master ordered the Petitioner to created a spreadsheet detailing the expert’s charges and then ordered Respondent to respond, line by line.  The expert’s hourly rate of $250 was not in dispute.

The Special Master had several criticisms of the expert’s billing practices, lumping into poorly described entries, redundant work, and administrative tasks.  Some entries included no task information at all.  The Special Master even asked for the invoices to be amended.  For these reasons, the court reduced the fees by one-third.

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Attorney’s Fees and Costs: Forum Rate, Excessive Billing

Watson v. HHS. (Fed. CL. Spec. Mstr. Mar. 7, 2016) (Corcoran, SM)

In this fee decision, the Special Master reduced the requested hourly rate from $600 to $375, under McCulloch, for this 40+ NYC attorney. Under that framework, 20+ year attorneys in the vaccine program receive a range of $350-$425 (for work in 2014), depending upon the application of enumerated factors.  The higher-end is awarded to those with significant vaccine program experience.  This attorney only had 2 vaccine cases and his billing records showed he spent hours researching the vaccine program.

The court did not find the Davis exception, for attorneys from a higher-paying forum, applicable, because there was no showing that the attorney possessed special expertise, or that no other counsel was available.  CPI adjustments were made for years prior to 2014, down to $340.  The attorney had requested payment for only 35% of the time billed, which the Special Master found commendable, and in line with what he would have awarded anyway.

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Denial of HHS Appeal of Interim Fees; Reasonable Basis

Rehn v. HHS, (Fed. Cl. Mar. 30, 2016) (Lettow, J)

The special master had awarded interim fees to withdrawing counsel.  Respondent had challenged reasonable basis.  On appeal, the judge affirmed the applicability of the “totality of circumstances” test for reasonable basis.  Apparently, these circumstances included voluminous records, a complex medical situation following flu vaccination and illness shortly after the vaccination.  Respondent argued that no reasonable basis existed without an expert opinion, and it was unreasonable to rely on Petitioner’s assertion that his treaters supported causation.  At the very least, reasonable basis was lost when a physician assistant from the practice declined to opine on causation.

The reviewing judge acknowledged that Petitioner’s attorney has a duty to actively investigate a case before filing, however the attorney had gathered extensive medical records and had “formed a view” of how Petitioner’s circumstances fit within the framework of the vaccine program.  He then engaged in an effort to obtain a more definitive diagnosis and a medical opinion.  It was not unreasonable to keep looking for one even after the treater declined to provide an opinion.  There was no clear error in the Special Master’s finding of reasonable basis.  Respondent also failed to convince the judge that it was an abuse of discretion to award fees to a withdrawing attorney, rather than make him wait until the conclusion of the case.

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Continue ReadingDenial of HHS Appeal of Interim Fees; Reasonable Basis

Attorney’s fees; Waiver by HHS

Dorego v. HHS, (Fed. Cl. Spec. Mstr. Apr. 4, 2016) (Moran, SM)

In response to Petitioner’s fee application, Respondent “defer[red] to the special master’s discretion in determining a reasonable fee award.”  Respondent contended that this did not constitute a waiver or failure to object, but the special master held that it did.  Contrary to HHS’ present position, the court further held that Respondent is required to file a response to a fee application under Rule 20 because a fee application is treated as a motion.  Further, the special master implied that the failure to do so might even be a failure of Respondent’s duty to the interests of the US. Petitioner was awarded all of the fees and costs requested.  Practice tip: just because you state in a pleading that something should not be construed as, for example, a waiver, doesn’t mean it will not be.

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Interim Fees: Hourly Expert Rates, Multiple Attorneys

Culligan v. HHS, (Fed. Cl. Spec. Mstr. Mar. 31, 2016) (Hamilton-Fieldman, SM)

In this interim fee decision, the Special Master approved of two attorneys trying the case, where there were multiple experts and fact witnesses, the case was complex and Respondent had two attorneys at the hearing. The court held that $400 per hour ($200 for travel) for Petitioner’s expert was reasonable, and that it was reasonable to bring in an expert from abroad without a showing of special need.  The court did hold that the expert’s billing was not sufficiently detailed.

With regard to a second expert, who charged $500 per hour for most tasks, the court approved this rate.  The court did not approve a higher rate of $650 per hour for report preparation or a flat fee trial rate of $9500 per day, and those hours were compensated at $500.

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Continue ReadingInterim Fees: Hourly Expert Rates, Multiple Attorneys

Claim that Liver Failure Caused by FluMist

Agnew v. HHS, (Fed. Cl. Spec. Mstr. Mar. 30, 2016) (Millman, SM)

Petitioner’s theory was that FluMist, which ordinarily causes a subclinical infection, activated his immune system which was misdirected into entering his liver. Within 10 days of vaccination, he had abdominal pain, nausea, increasing yellow color of his skin, a rise in enzymes showing destruction of hepatic cells, overwhelming liver failure (hepatitis), necessitating a liver transplant.  Processes, including molecular mimicry, innocent bystander injury, and polyclonal expansion of the immune system, caused his immune system to be not only directed against FluMist vaccine but also against his liver.

Petitioner’s expert explained he was not describing typical autoimmune hepatitis, but rather a vaccine immune-activated induced reaction to a live attenuated vaccine, generating cell-mediated injury.  By analogy, the same process could result from live influenza infection.

Respondent’s expert testified it was possible that FluMist escaped the mucosa, but if it had attacked the liver, there should have been evidence of it in the liver.  Only very mild inflammatory periportal infiltrate was seen, while he would have expected to see inflammatory mediators such as complement.  Petitioner’s expert countered that the presence of inflammatory cells is not required or characteristic of apoptotic cell death which natural killer cells or CD-8 cells mediate.

Important for practitioners to note is the following: Petitioner’s expert “admitted there is no direct proof of this process, but he testified that he and other doctors use deductive reasoning based on their education and experience to reach an understanding, imperfect though it may be, of how the immune system works and how it malfunctions.” This is a good counter to the Daubert factor that asks for evidence showing that a particular process actually took place in the person.

The special master found the Petitioner’s theory credible and found in favor of Petitioners.

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Denial of Entitlement; RA Following Hepatitis B Vaccination

Bean-Sasser v. HHS (Fed. Cl. Spec. Mstr. Apr. 5, 2016) (Moran, SM)

In this case, the special master denied entitlement for two reasons: 1) Petitioner’s theory under Althen prong 1 was not persuasive, and 2) Petitioner’s rheumatoid arthritis was preexisting.  Petitioner was asymptomatic at the time of the vaccine, although she had a history of carpal tunnel, which can be a presenting symptom.  Environmental factors are relevant in RA, Petitioner was a smoker which doubles the risk and is by far the most relevant environmental factor.  RA has a preclinical stage where people test positive for biomarkers of the disease.  Petitioner tested positive for RF antibodies, implicated in RA, 5 days after the vaccine, which was determined to be preexisting.  Although it was not guaranteed that Petitioner would develop RA, it was more likely than not.  Thus, Petitioner’s claim failed because her RA was preexisting.  A significant aggravation claim was not pursued.

Petitioner’s medical theory originally was that hepatitis B vaccine can cause immune complexes, also known as a Gel and Combs type III reaction.  At hearing, Petitioner’s expert opined that the hepatitis B vaccine can stimulate a part of the innate immune system, toll-like receptors, to produce pro-inflammatory cytokines that lead to RA.  The Special Master found that this theory was not reliable or persuasive.  There was no evidence that the theory was tested, that the theory was consistent with articles from peer-reviewed journals, or that the theory was generally accepted among immunologists or rheumatologists.  Moreover, epidemiological evidence undermined the persuasiveness.  Even if the theory were viable, Petitioner’s risk of developing RA from her other risk factors, genetics, and smoking, was much greater.

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Stimulating Different Antibodies Could Improve Success of Flu Vaccines

A recent study by the National Institute for Allergy and Infectious Diseases (NIAID) indicates changes could make flu vaccines more effective.  Every year, the World Health Organization (WHO) figures out which strains of the flu virus should be targeted, based on information that it gets from laboratories throughout the world.  The flu vaccination for each year is developed to target those specific strains.  Because viruses can mutate quickly, this strategy is not always effective. In 2014, the vaccine was about 23% effective in protecting people from the flu, according to the study.

Flu vaccines work by stimulating antibodies to fight the virus.  Viruses are made up of Hemagglutinin (H) and Neuraminidase (N), hence the development of names like the H1N1 and H3N2 forms of the virus. Currently, scientists focus on stimulating higher levels of Hemagglutinin Antibodies (HA) to instill immunity.  But new research suggests higher levels of Neuraminidase antibodies (NA) might be more effective.

If you believe you’ve experienced a vaccine injury, contact Maglio Christopher & Toale, P.A. by filling out the form at the bottom of this page. Or call 888-952-5242.

Adverse Reaction to a Vaccine?

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Denial of Entitlement; SIDS

Lord v. HHS, (Fed. Cl. Spec. Mstr. Feb. 9, 2016) (Dorsey, CSM)

This is another case finding that petitioner failed to show preponderant evidence that vaccines are an exogenous stressor for purposes of the Triple Risk Model of SIDS.  The petitioner also failed to show that recognized extrinsic risk factors, and URIs in particular, act as neurochemical rather than mechanical risk factors.  The Court discussed important similarities and differences between the immune response to infections and an immune response to vaccinations.  First, cytokine production in response to vaccination is localized and does not generate significant systemic signaling.  An infection, on the other hand, is a live organism that infects a cell directly and has the ability to replicate in the body and cause a significant immune reaction.  The vaccines at issue were composed of particulate killed organisms, which, administered alone, would not elicit much of an immune response beyond a local reaction, requiring the addition of an adjuvant.

The Court acknowledged that cytokines are released in response to vaccination. However, petitioner failed to show that cytokines produce an abnormal brainstem serotonin response or otherwise act in a manner that causes or contributes to SIDS.  The Court found that the brain regularly produces pro-inflammatory cytokines as part of a normal, regulatory process, which signals the occurrence of a pathologic event and does not themselves cause a pathologic event.  Thus, the evidence failed on Althen prong 1.

The court also found that prong 2 was not satisfied because the baby had several known extrinsic risk factors for the Triple Risk Model of SIDS, thus there was no need to consider a speculative risk factor. Petitioners did, however, meet their burden on prong 3.

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Interim Fees-Review

Mostovoy v. HHS, (Fed. Cl. Spec. Mstr. Feb. 4, 2016) (Dorsey, CSM)

In this omnibus proceeding, the court awarded the highest hourly rate requested, under McCulloch. However, petitioner’s interim fees were reduced by about 1/3. The Court held there were four basic reasons for the reductions. First, counsel billed for multiple hours of administrative work, including filing documents on CM/ECF, mailing letters, and scheduling phone calls. Second, counsel’s time sheets were extremely vague and in some instances constituted block billing. Additionally, counsel failed to adequately explain how some of his billable hours were relevant. Third, counsel billed time for multiple hours spent fundraising, and many of the entries were so vague that the Court could not understand their purpose. Finally, counsel requested compensation at his full hourly rate of pay for time spent traveling.

This is an example of billing deemed inadequate as vague, excessive, and block billing:
“March 12 (“[r]eview theory and statements w/ TD”; April 6 (“[c]ontinue research on motion reply”); April 9 (“[m]otion reply”); April 10 (“[c]ontinue drafting reply”); April 10 (“[c]ontinue reply research, articles history”); April 10 (“[c]ontinue reply research”); April 10 (“[m]otion”); April 11 (“[m]otion, obtain articles cited in articles and drafting”); April 16 (“[r]eview file-orders (HS)”); May 14 (“[r]esearch on safety testing done”); May 14 (“[r]eview 5/16/2001 minutes”); May 14 (“[m]otion to allow subpoenas reply”); July 11 (“[c]ontinue reply); July 11 (“[r]eply to reply”); July 12 (“[e]dit reply draft”); July 13 (“[e]dit reply”); July 13 (“[r]eply on motion to compel”); October 1 (“Mostovoy-Penzi Deisher dec. [sic] Varicella [sic] stats”); November 2 (“[m]otion to supplement the record motion [sic]”); November 3 (“[m]otion to supplement the record”); November 8 (“[r]eview powerpoint; obtain literature”); and November 8 (“[r]eview graph and data”).”

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Order Affirmance on Redaction of Petitioner – Parent Names

R.K. v. HHS, (Fed. Cl. Feb. 29, 2016) (Braden, J)

The special master had ruled that both the minor child’s name and the parents’ names would be changed to initials but declined to redact the case number.  On appeal, petitioner argued that the use of Jane Doe and John Doe provides better privacy protection than the use of initials.

The Court analyzed the Vaccine Act’s exemption from disclosure of “medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy.”  Because this language is also used in FOIA, the court considered cases interpreting the analogous provision.  The US Supreme Court has held that redaction of individual names is appropriate under Section 552(b)(6) of FOIA when the names “would be linked publicly with . . . personal information.”  Thus, the names were properly redacted.  There was no requirement that John Doe be utilized rather than initials, in place of the redacted names.  This case is a departure from current court practice and rules under which, normally, only minor children’s names are redacted, and not those of their parents or adult petitioners.

The Court also affirmed the special master’s refusal to redact the case number noting that RCFC 79(a)(2) requires the clerk to include the case number.  Also, the court appropriately balanced privacy concerns with the importance of the public interest in disclosure.

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HPV Vaccination Held to Have Caused Urticaria

Waterman v. HHS, (Fed. Cl. Spec. Mstr. Feb. 5, 2016) (Hamilton-Fieldman, SM)

The Court resolved an onset issue in favor of petitioner, who did not seek treatment for her urticaria for two months.  The special master found in favor of causation, holding that this was a classic case of challenge-rechallenge.  Petitioner had developed a rash three weeks to a month after the first vaccine, worsening hives and welts approximately one month after the second vaccine and the third, most virulent, chronic urticaria, and the joint pain, approximately three to four weeks after the final vaccine. The court concluded that this evidence constituted such strong proof of causality that it was unnecessary to determine the mechanism of causation—it is understood to be occurring, which satisfied prong one.  Prong two was satisfied by the same evidence. Prong three was also satisfied by the challenge-rechallenge evidence and the medical theory posed by petitioner’s expert.

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Death After HPV Vaccine; Molecular Mimicry–Requirements

Tarsell v. HHS, (Fed. Cl. Spec. Mstr. Feb. 16, 2016) (Moran, SM)

The theory of the case was that the decedent developed an arrhythmia from Gardasil which caused her death.  Petitioner brought an immunologist and a cardiologist to hearing.  The mechanism proposed was that the HPV vaccine causes the body to produce antibodies that are misdirected against a part of the heart, known as an L1 calcium channel, and the cumulative damage to the L1 calcium channel impairs the heart’s functioning leading to arrhythmia and death.

The primary reason Petitioner lost was that the special master found she failed to establish that the onset of her arrhythmia was post-vaccinal.  This was a foundational element of the claim.  Moreover, the proposed theory contained too many leaps and unsupported assumptions to be persuasive.  Finally, heart tissue examined by pathologists at CDC showed that the decedent did not experience damage in the way her experts’ theories predicted (a Daubert factor).

The special master reviewed the epidemiological evidence submitted noting that either the HPV vaccine has not increased the rate of deaths, or if the HPV vaccine is increasing the rate of death, then the increase happens so rarely that multiple studies have not found it.

Additionally, the special master held that there was no persuasive evidence of when the arrhythmia began.  The fact that doctors had failed to detect an irregular rhythm previously was not conclusive because arrhythmias come and go.  Thus, because there was no proof of onset, petitioner could not prevail.

Petitioner’s theory also failed the Althen prongs.  For the first proposed mechanism, the special master found no reliable evidence that the HPV vaccine causes the body to produce antibodies to the beta-adrenergic receptors in the heart.  The second proposed mechanism involved molecular mimicry as well.  Notably, the special master stated: “To some [special masters], Dr. Shoenfeld’s invocation of molecular mimicry plus an identified homology would constitute a persuasive medical theory.”  (Editors note: See Day, McCulloch (entitlement decisions).  However, he found that the evidence persuasively showed that the LQAGL homology Kanduc discovered in 2009 is not an adequate basis for finding that a cross-reaction actually occurs, resulting in autoimmunity.

In this case, unlike most, the parties agreed that there was sequence homology, of five peptides, between the HPV vaccine and the calcium channel of the heart.  The dispute was whether this was meaningful, i.e., does homology always or necessarily lead to cross-reactivity resulting in AI disease.  Pentamer level homologies are common and this could be a mere coincidence.  Even if cross-reactivity occurred, there was no evidence that AI damage to the calcium channel would resemble the petitioner’s clinical presentation.  Thus, petitioner’s theory was not persuasive.

With regard to prong two, if there had been an autoimmune attack on some part of the heart, either the Beta-adrenergic receptors or the L1 calcium channel, one would expect to see inflammatory cell infiltrates on autopsy, but there were none.  Petitioner provided no argument with respect to this discrepancy, thus could not prove that the proposed theory played out in this case.

Editorial comment:

This decision provides information to petitioners’ counsel intending to advance a molecular mimicry theory in the future.  Importantly, the decision implies that a petitioner would need to put on evidence of dose-response curves, or whether sufficient antibody production occurs to cause damage if Respondent were to raise this issue in future cases.

Another potential pitfall for petitioners could arise if the proposed homologous region in the body is intracellular – is it certain that the antibodies can reach this region, perhaps through the process of endocytosis.

These are topics that have not previously played a major role in past decisions involving molecular mimicry.  It used to be that establishing sequence homology was sufficient to prevail on a mimicry theory.  It has become much more complicated over the past decade to prove a case based on homology alone; homologous sequences must be sufficiently lengthy and there must be an explanation why homology leads to cross-reactivity.  At the same time, there are scientific arguments that have been made in several of my cases as to why no sequence homology evidence is even needed for a mimicry theory to be persuasive.  These cases are scheduled for upcoming hearings.  Additionally, the case reported here is on appeal.  Please feel free to contact me if you have a case where the medical theory is mimicry if you’d like to discuss the evolution of the theory and the differing viewpoints of the special masters on this issue.

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Compensation Denial–SCN1A Mutation, Dravet’s Syndrome–Aggravation

Faoro v. HHS, (Fed. Cl. Spec. Mstr. Jan. 29, 2016) (Dorsey, CSM)

This case differed from all of the prior SCN1A cases, in which compensation was denied because the child, in this case, did not have a de novo mutation.  Rather, the mutation was shared by the mother, who was healthy.  The mutation involved a stop codon and was predicted to be disease-causing.  Petitioners argued that the mutation was a susceptibility factor, and vaccines were the environmental trigger that caused Dravet’s in the child. Respondent argued that mosaicism explained why the mother was asymptomatic, i.e., only some of her cells contained the mutation.

The Court reached the same conclusion as the prior SCN1A cases –  vaccination does not affect the prognosis or severity of Dravet syndrome.  The Court also found that mosaicism was the best explanation for the asymptomatic parent. Interestingly the Court held that it was not proven that the vaccine caused the initial seizure.

In analyzing whether a significant aggravation case had been proven, the Court held that Loving prong 3, asks not whether the petitioner was worse after the vaccines than before, but whether the petitioner’s clinical course and the outcome were any different than it would have been without the vaccination.  Because the child’s clinical course was consistent with Dravet, there was no significant aggravation.  The Court observed that, since there was no way to predict what might have been had the vaccine not been given, it was impossible to show that the vaccine resulted in a worse outcome.

Finally, the court held that Respondent had proven that a factor unrelated, the mutation, was the sole cause of the child’s Dravet.

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Jury Awards Nearly $500 Million Verdict in 2016 J&J Pinnacle Trial

(Thursday, March 17, 2016) —  Today a Dallas, TX jury awarded an astounding $497.6 million dollar verdict over the defective Pinnacle metal-on-metal hip replacements made and sold by DePuy Orthopaedics and Johnson & Jonnson.  This is a huge victory for the 5 patients in this case who all suffer from similar debilitating health problems because of their implants, including inflammation around the hip joint tissue, bone erosion, and metallosis.

The jury held both DePuy and J&J liable over claims of failure-to-warn and design defects of the MoM hips.  According to reports in Law360, the verdict included $360 million in punitive damages and $140 million in compensatory damages.  The $140 million will be divided among the 5 patients based on the severity and impact of their injuries.

You can read the entire Pinnacle trial verdict form here.  This document includes juror instructions, definitions and explanations of the questions, how the jurors responded to each claim and shows the breakdown of damages the jurors assessed for each of the plaintiffs.   

Jury selection began on January 8th and opening arguments took place on January 11th.  The jury heard 37 days of testimony before spending 4 days in deliberations to reach their verdict.  This is the 2nd bellwether trial in this Multi-District Litigation (MDL).  The first MDL trial took place in October 2014 and resulted in a verdict in favor of Johnson and Johnson on all counts.

“This is a resounding victory for all victims of defective metal on metal hip replacements, says Altom M. Maglio, Managing Partner of Maglio Christopher & Toale, P.A.  “This verdict sends a message to orthopedic companies that they will be held accountable if they fail to put their patients ahead of their profits.  Mr. Maglio has spent years litigating against all the major hip device manufacturers and filed the first metal on metal hip replacement lawsuit in the United States.

There are currently more than 8,000 cases in the MDL involving Pinnacle hip implants.  Attorneys for J&J and DePuy say they will appeal this verdict.

Do You Have a Defective Metal on Metal Hip Replacement?

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Interim Fees; Reasonable Basis; Excessive Time

Sanchez v. HHS,  (Fed. Cl. Spec. Mstr. Feb. 17, 2016) (Moran, SM)

Petitioner moved for interim fees pre-hearing.  The special master found that a reasonable basis existed at least through the point in time where genetic testing was obtained on the child, and awarded fees through that date. Respondent challenged reasonable basis notwithstanding that Petitioner had multiple experts and was ready to try the case.

What this case adds to the law of reasonable basis is this: Respondent now characterizes the showing required for reasonable basis as “petitioners must show that they filed a claim that was supported by the medical records [meaning a treater opinion on causation] or by a medical [expert] opinion.”  This is based on the “some evidence” test announced by Special Master Moran in Graham, but not (yet?) followed by other special masters.  The alternate totality of circumstances test crafted in Chuisano is not mentioned in this opinion.

Here, Respondent argued that not even the expert opinion supported reasonable basis, because it relied on factual information from the parties’ affidavits that was disput