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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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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