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: 

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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.

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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]

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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

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Statement Against Proposal to Remove Sirva from Vaccine Injury Table

Statement on behalf of mctlaw by Vaccine Injury Attorney Anne Toale over proposed legislation to remove SIRVA and syncope from the National Vaccine Injury Compensation Program:

As a past president of the Vaccine Injured Petitioners Bar Association, I oppose the unprecedented move by the Department of Health and Human Services towards eliminating more than half of all claims filed in the National Vaccine Injury Compensation program.  

HHS aims to remove claims regarding SIRVA (shoulder injury related to vaccine administration) and syncope (fainting) from the Vaccine Injury Table and exclude them from the no-fault compensation program.  Instead, HHS wants these claims to be brought in the civil courts, where plaintiffs would undoubtedly sue both vaccine administrators such as nurses or pharmacists, and vaccine manufacturers like Pfizer and Merck.  This is the exact opposite of what Congress intended when it passed the Vaccine Act in 1986.  The Vaccine Act was designed to shield vaccine manufacturers and administrators from liability to protect the vaccine supply, while at the same time providing a method for relatively quick and easy compensation for unavoidable vaccine injuries.  

The arguments for removing SIRVA and syncope from the National Vaccine Injury Compensation Program are weak – there are numerous claims, but the 4 billion dollar vaccine fund continues to grow and is no danger of being depleted by these claims.  SIRVA claims are serious, I have represented a SIRVA claimant who required three separate shoulder surgeries and is unable to return to their profession.  Rather than deny these deserving claimants of their present route to compensation, a better solution, consistent with congressional intent and basic decency, would be to increase the number of special masters available to hear vaccine injury claims.  The vaccine bar has long advocated for Congress to increase the number of special masters to at least sixteen – presently only eight special masters are available to decide vaccine cases originating from every U.S. state and territory.  

HHS, as the Respondent in Vaccine Act cases, should focus its efforts on supporting the legislation to alleviate the overburdened court instead of selectively removing a large percentage of claims and placing them back in the civil court system where they don’t belong.

Read the proposed legislation to remove SIRVA and syncope from the Vaccine Injury Table

Anne Carrión Toale - Vaccine Injury Lawyer

Anne Carrión Toale
Anne Carrión Toale, Esq. is a vaccine injury attorney at Maglio Christopher & Toale, P.A. Anne helps vaccine injury clients get compensation from the National Vaccine Injury Compensation Program (NVICP) before the Vaccine Court in the United States Court of Federal Claims. Ms. Toale has served as past President of the Vaccine Injured Petitioners Bar Association, where she provided education and assistance to other attorneys throughout the United States practicing in the area of vaccine injury compensation.
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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.

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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

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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.

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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.

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What is the Status of the Biomet Hip Litigation?

mctlaw Attorney Michael Cowgill explains the status of the Zimmer Biomet Litigation. To 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

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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.

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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.

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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.”

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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.

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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

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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.  

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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.

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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.  

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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

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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.

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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. If you are an attorney representing a client with a Johnson & Johnson DePuy metal on metal hip replacement, go to https://www.justice.org/litigation-groups/depuy-metal-metal-hip-implant to join the litigation group.

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.

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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.

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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

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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

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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

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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

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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.

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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.

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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.
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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.”

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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.

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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.”
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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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“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.

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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.

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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.

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.

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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 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.

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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 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.

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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 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.

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~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.

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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 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.

Print Friendly, PDF & Email
Continue Reading Monitor for Cobalt Chromium Levels and Pseudotumors Very Early On