>Parker Waichman LLP just filed a lawsuit on behalf of an Indiana man who was surgically implanted with the Biomet M2a Magnum™ hip system. The lawsuit alleges that the metal-on-metal hip replacement is defective and caused severe pain and loosening in the man, which led to a complex and risky revision surgery.
The national law firm filed the lawsuit on January 18, 2013, in the Marion County Circuit Court (Case No. 49005 13 01 CT 002323). Biomet, Inc., Biomet Orthopedics, LLC, Biomet U.S. Reconstruction, LLC, LVB Acquisition, Inc., LVB Acquisition Holding LLC, and LVB Acquisition Merger Sub, Inc. have been named as defendants in the case.
According to the complaint, the Indiana man was implanted with the Biomet M2a Magnum™ device in his left hip. As an alleged result of using the implant, the man suffered from severe pain and loosening of the Biomet M2a Magnum™ device and these complications led to his having to undergo a complex, risky, and painful revision surgery to have the allegedly defective implant removed.
The lawsuit also alleges that, at this time, more than 100 reports of adverse events had been filed with the U.S. Food and Drug Administration (FDA) about this device and that the defendants knew the implant was defective. The lawsuit further alleges that Biomet refused to disclose this information to the plaintiff, his doctor, and the public; instead, the defendants continued to misrepresent the Biomet M2a Magnum™ as safe and effective.
As we have long explained, revision surgeries usually take longer than the initial implantation surgeries, and have a higher risk of complications. Going through this invasive procedure has allegedly placed the plaintiff at greater risk of future complications, such as dislocation, according to the lawsuit.
The Biomet M2a Magnum™ device is a type of metal-on-metal hip implant. According to the lawsuit, the Biomet M2a Magnum™ uses a co-called “monoblock” system, which does not permit the device to be constructed with a plastic acetabular liner. Because of this, the lawsuit alleges, the implant forces metal to rub against metal with the full weight of the body. This rubbing can lead to the shedding of excess levels of cobalt and chromium ions into the body, which may lead to metallosis, bone and tissue damage, pseudotumors, and the need for early revision surgery.
Last week, the FDA issued new guidelines for patients with metal-on-metal hip implants. The guidelines warned that the devices can cause bone and tissue damage due to the release of metal ions. The guidelines also advise that patients who experience pain; swelling; a change in their ability to walk; or who hear noises emanating from the hip, such as popping, squeaking, and grinding, should speak with their physicians. These symptomatic patients should also be considered for metal ion testing, the agency said. The FDA also recommended that metal-on-metal hip implant patients undergo regular physical examinations, routine radiographs, and diagnostic imaging for ongoing assessment of the patient reaction to metal-on-metal devices.
As we’ve mentioned, from a legal standpoint, these changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.
The plaintiff is suing for severe, and possibly permanent, injuries; pain; suffering; emotional distress; and economic damages that include lost wages and medical expenses.