The Biomet M2a Magnum metal-on-metal hip implant device is at the center of yet another lawsuit brought against the device maker over alleged injuries and the need for revision surgery.
According to the complaint, the plaintiff, a North Carolina woman, was implanted with the M2a Magnum system in her left hip on September 27, 2006. By this time, the lawsuit alleges, the defendants knew about over 100 adverse event reports tied to the device, but neglected to disclose this information to the plaintiff. The lawsuit alleges that, instead, the defendants misrepresented the device, touting it as safe and efficacious. Allegations also include that the woman’s surgeon would never have implanted the Biomet M2a Magnum had it not been for the defendants’ misrepresentations.
It was a result of the M2a Magnum’s defective design that the implant failed, the lawsuit alleges, leading the woman to suffer severe pain and necessitating the revision surgery she underwent on August 3, 2011. Revision surgeries, conducted to remove and replace a defective device, are complex, painful, risky, and costly. In fact, the lawsuit alleges that revision surgeries, because there is less bone to work with, are typically more complex than initial implantation surgery; the surgeries take longer and have higher complication rates
The plaintiff is suing for economic damages—including lost wages and medical and hospital expenses—; severe, possibly permanent injuries; pain; suffering; and emotional distress.
Many metal-on-metal hip devices have been recalled worldwide and reports of injuries and lawsuits involving these devices continues to mount. The U.S. Food and Drug Administration (FDA) has put this class of medical device under scrutiny following reports of high failure rates and the devices’ propensity to release high concentrations of metallic debris into the patients’ bloodstream. On January 17, 2013, the FDA released new guidelines for patients implanted with all-metal devices and advised that physical examinations, diagnostic imaging, and metal ion testing in symptomatic patients be routinely conducted.
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. In the United States, metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. These devices were approved using the FDA’s fast-tracked 510(k) approval route, which bypasses clinical testing.
New data from Canadian suggests that individuals implanted with metal-on-metal hips are likelier to require revision surgery within five years, according to CBC News. Specifically, according to the Canadian Institutes for Health Information study, people implanted with metal-on-metal hip implants experienced a 5.9 percent increased likelihood of having to undergo revision surgery in five years, compared to a 2.7 percent rate among patients implanted with metal-on-plastic implants.
The all-metal hip devices were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks and many have criticized device makers for placing profits before patient safety.
The national law firm, Parker Waichman LLP, filed this lawsuit on May 30, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-510). This case is just one of many pending in the multidistrict litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 3:12-md-2391). Biomet, Inc., and Biomet Orthopedics, LLC have been named as defendants.