Another lawsuit has been filed alleging that the Biomet M2a Magnum™ hip implant caused pain and the need for revision surgery. The lawsuit was brought by a New York woman who alleges that not only is the Biomet M2a Magnum’s™ metal-on-metal design defective, the device releases a toxic amount of metal ions into the body.
The complaint states that the woman was implanted with the M2a Magnum™ hip system on May 26, 2009 and that, by this time, the makers of the device knew about more than 100 adverse event reports linked to the device, but failed to disclose that information to the woman. Instead, the lawsuit alleges, the manufacturers of the Biomet M2a Magnum™ misrepresented the device as safe and effective. The lawsuit also alleges that the woman’s surgeon would not have implanted the device if not for the misrepresentations made by the device maker.
The lawsuit also alleges that, due to the M2a Magnum’s™ defective design, the plaintiff’s hip implant failed, causing her severe pain, which resulted in her undergoing a revision surgery in the her right hip last February to remove and replace device. The plaintiff is suing for severe and possibly permanent injuries, pain, suffering, and emotional distress.
The lawsuit alleges that revision surgeries are generally more complex than initial implantation, typically because there is less bone to work with; revisions usually take longer than the original hip surgery and have a higher rate of complications. As we’ve previously explained, revision surgery is a painful, complex procedure in which a faulty device must be surgically removed and replaced with a different device. The two surgical procedures must often be handled separately, leaving patients bed-bound in the interim.
The Biomet M2a Magnum™ is a type of metal-on-metal hip implant in a class of medical devices that has come under fire over increasing injury reports, high failure rates, and reports that the devices release high concentrations of metallic debris.
In January, the U.S. Food and Drug Administration (FDA) released new guidelines for patients implanted with all-metal devices advising physical examinations, diagnostic imaging, and metal ion testing in symptomatic patients.
The FDA is also proposing stricter regulations that would require manufacturers to prove their metal hip implants are safe and effective before selling them. Currently, hip makers receive approval simply by showing that their implant is sufficiently similar to a previously approved device.
This lawsuit was filed by national law firm, Parker Waichman LLP, on March 26, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-230). The lawsuit is one of many cases pending in the multidistrict litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 3:12-md-2391).