After over 450 adverse reports were reported to the FDA regarding the Biomet M2A Magnum hip implant system, the lawsuits began. The current pending cases against Biomet have been transferred and consolidated to the U.S. District Court of the Northern District of Indiana and it is expected the number of cases will continue to grow. The current lawsuits allege that Biomet manufactured a negligent hip implant design which can lead to early failure rates and potentially serious health risks. Biomet’s response to the consolidation of the lawsuits is to argue that, unlike other metal-on-metal hip implants, 1) their M2A Magnum hip implant has not been recalled, 2) several other cases involving this implant have been resolved, and 3) this particular device has caused fewer problems than their competitor’s similar hip implants.
History of Biomet
Biomet contends that because they have successfully defended and settled cases regarding the M2a Magnum in the past, they should be given that opportunity once more rather than have the current lawsuits consolidated. In the objection filed in response to the MDL (Case OHS/2:12-cv-00396) Biomet argues that the litigation is distinguishable from other metal-on-metal hip litigation because the Magnum product contains a broad array of components as compared to other MOM implants whose complaints center on the acetabular cup. Biomet also states the M2a Magnum has been available for eight years in the United States making it “as a whole, more mature and procedurally more diverse,” than other MOM lawsuits.
The Construction of the Biomet M2A Magnum Hip Implant
The Biomet M2A Magnum hip replacement system is made up of a metal cup combined with a large diameter cobalt and chromium modular head. All-metal hip implants have been linked to a wide range of adverse effects including metal toxicity, pseudo-tumors, tissue death, loss of bone mass, neurological, cardiovascular and thyroid problems. The number of adverse event reports has escalated in the past year; in 2009 there were only eleven adverse reports, however by 2011 there were eighty reports during the year. In the first five months of 2012, the FDA received 159 reports of adverse events from recipients of Biomet’s M2A Magnum hip implant system. Despite over 16,000 adverse event reports for all metal-on-metal hip implants from 2000-2011, the FDA has yet to ban the sale of these implants.
In March of 2012, the National Joint Registry of England concluded there was “unequivocal evidence” showing all-metal hip implants are associated with much higher failure rates as well as evidence the metal ions which shear away during activity can be toxic to many organs. Although Biomet manufactures a variety of hip implants—some of them made of ceramic or polyethylene—the M2A Magnum is comprised of a cobalt and chromium acetabular monoblock design which comes with the liner, cup and ball in one piece. This particular implant does not rely on screws or a locking mechanism to hold it in place rather the porous coating on the exterior of the implant is meant to encourage bone growth. It was believed that with fewer moving parts to this design there would be less metal debris buildup, however the larger femoral head may lead to greater surface wear, therefore a greater risk of metal ions being released into the body.
M2A Magnum FDA Approval
Like many of its counterparts, the M2A Magnum gained FDA approval through the 510(k) system meaning the manufacturer was not required to conduct clinical trials or perform extensive safety testing prior to the release of the implant. Under the 510(k) system the manufacturer must only prove their medical device is substantially similar to a product which is already on the market. The Biomet M2A Magnum gained FDA approval in 2004 and appeared to be without significant problems for a few years following the first implants.
Getting Medical and Legal Help
If you are unsure of what type of hip implant you have, generally the best source of information are the notes from your operation which should include the manufacturer’s sticker for your particular implant. Once you are sure that you have a Biomet M2A Magnum hip implant in your body you will want to consult a medical professional to have your levels of cobalt and chromium tested as well as having x-rays and any other tests your doctor advises to determine whether the M2A Magnum has caused health problems.
If you have already undergone a revision surgery or if your doctor determines you may have significant health problems due to the M2A Magnum you may want to contact an experienced Sullo & Sullo attorney to discuss your options. Statutes of limitations limit the time you have to file a legal claim. It’s important that you not wait until the last minute to try and file a lawsuit and our attorneys can assess the facts of your case and determine the best way to proceed. The attorneys of Sullo & Sullo are understanding of your situation and will fight hard to help you protect your future.