Biomet Hip Replacement Products
Biomet manufactured the M2 Magnum Hip Replacement and obtained approval for this replacement joint system in 2004 using the FDA’s expedited 501(K) clearance process. This means the M2 Magnum came to the market with little or no pre-market testing to determine the impact the product would have on patient health.
The Biomet M2 Magnum is a metal-on-metal hip implant system that was advertised as improving stability and providing a greater resistance to wear and tear. These claims, if true, would make the M2a Magnum ideal for younger people. Unfortunately, the M2a not only failed to live up to its marketing promises, but also quickly began causing patients serious complications that necessitated revision surgery.
Patients filed lawsuits and a multidistrict litigation (MDL) was created in 2012 to deal with pending federal claims against Biomet from across the country. A total of eight pending cases moved to a U.S. District Court in the Northern District of Indiana and future plaintiffs would have their cases transferred as well. Multidistrict litigations, or MDLs, let plaintiffs keep their own independent cases unlike class action lawsuits. However, the judge is able to hear arguments applicable to all cases and decide on common pre-trial issues. For help with a multidistrict litigation or other case against Biomet or a defective hip manufacturer, call the Law Offices of Jeffrey Glassman today.Biomet M2 Magnum Defects
Study after study has confirmed dangers associated with metal-on-metal hip joints. A February 2012 article in British Medical Journal recommended annual monitoring for metallosis for as long as the patient has a metal hip implanted. Health Canada issued a warning related to metal hip replacements in May 2012, and the Lancer Medical Journal advised against the use of MoM products because of serious risks. The Food and Drug Administration (FDA) received about 17,000 adverse events reports related to metal-on-metal products between 2000 and 2011. With the high numbers of complaints, the FDA convened an expert panel in 2012 and advocates spoke out against metal hip replacement safety.
The Biomet M2a Magnum is a classic metal-on-metal product, with a metal replacement joint that sits atop the head of the femur, as well as a metal cup or socket that fits into the acetabulum in the pelvis. The cup and the replacement joint can rub against each other and release metal ions into the body. This can lead to the formation of pseudo-tumors as well as to complications including blindness; vertigo, headaches, tinnitus, hypothyroidism, and limited mobility.
Many patients experiencing symptoms have filed a lawsuit, which was centralized as part of the MDL in October of 2012. In February of 2014, Biomet agreed to settle outstanding federal lawsuits. The company paid approximately $56 million, with the base award for each plaintiff set around $200,000.
In addition to federal cases, Biomet is also facing state court claims. It is up to victims to determine whether to settle, sue as part of an MDL, or file a lawsuit. An experienced attorney at the Law Office of Jeffrey Glassman can review your case and help determine the best course of action.