Around the country, dozens of lawsuits have been filed against Biomet Inc. alleging that its M2a Magnum hip replacement caused serious injuries to patients who received the device. These implants have been linked to metal ion poisoning (metallosis) and a high rate of premature failure.
Hip Replacement Complications
The Biomet M2a Magnum hip replacement has been linked to several serious problems, including premature failure and metal ion poisoning (metallosis). These problems are thought to be caused by the device’s metal-on-metal (MOM) design, and its alleged tendency to release toxic metal debris as its components rub together. Elevated levels of cobalt have been found in recipients of metal hip implants like the M2a Magnum, and have been linked to a number of potential health complications including:
- Optic nerve damage
- Peripheral neuropathy
Like other metal implants, the Biomet M2a Magnum hip replacement is made of a metal ball and metal socket. According to lawsuits, these components rub against together, gradually releasing metal debris into the tissue and/or bone nearby. It is believed that these particles can not only increase the recipient’s metal levels, but also cause tissue death, bone loss, swelling and severe pain. These problems can make it difficult to perform revision surgery to replace the devices.
FDA Investigating Safety of Metal Hip Replacements
In response to the mounting concerns over metal hip replacement devices, the U.S. Food & Drug Administration (FDA) called an advisory panel in June 2012 to discuss these issues. The panel determined that there was little reason to continue use of the devices, as evidence has shown that they can fail much earlier than expected and put patients at risk for developing metallosis. To date, FDA has not recalled the implants, but most of the panel members stressed that there were few if any instances in which metal-on-metal hip replacements should be used. The panel recommended that patients with severe pain and other symptoms should get x-rays and blood testing done in order to measure the levels of metal in their blood. Unfortunately, there is no standard diagnostic kit that tests for these highly toxic metals.
Biomet Hip Litigation
In October of 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) announced that all lawsuits involving the Biomet M2a Magnum hip replacement device would be centralized before a single judge in one jurisdiction. JPML determined that all of the hip implant lawsuits contained similar issues regarding alleged design defects, and could therefore be combined as part of a Multidistrict Litigation (MDL). In an MDL, 1 judge manages the pretrial and discovery phase, which includes witness testimony and obtaining documents to be used as evidence. This is intended to speed up the litigation process, and to serve the convenience of all parties involved. This order requires that all pending and future Biomet M2a Magnum hip lawsuits be transferred to the U.S. District Court for the North District of Indiana before Robert L. Miller, Jr. As of February 2014, at least 1,141 Biomet hip implant lawsuits had been included in the MDL.