Another lawsuit has been filed over the Biomet metal-on-metal M2a Magnum hip replacement device system. The plaintiff, a woman from Tennessee, underwent hip implantation with the device on her left hip on April 13, 2009. The lawsuit alleges that by the time she underwent this surgery, the defendants were already aware of over 100 adverse event reports linked to the device, yet failed to disclose this information. Instead, the suit alleges, the defendants misrepresented the M2a Magnum implant as safe and efficacious. Allegedly, the woman’s surgeon would not have implanted the M2a Magnum had it not been for the defendants’ misrepresentations.
The lawsuit also alleges that, as a result of the M2a Magnum’s defective design, the plaintiff’s hip implant failed, causing her severe pain, and resulting in her suffering from elevated metal ion levels. Because of this, she underwent a complex, risky revision surgery to explant, or remove, the device, and be re-implanted with a replacement hip device. Also, according to the lawsuit’s allegations, revision surgeries are generally more complex than initial implant surgery as there is usually less bone to work with when the original device is removed. Revision surgeries tend to take longer to complete than original hip surgery and tend to have a higher complication rate. The plaintiff is suing for economic damages, including lost wages and medical and hospital expenses; severe, potentially 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 placed 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.
New data from Canada suggests that people implanted with all-metal hips are likelier to undergo revision surgery within five years of implantation, according to a CBC News report. The Canadian Institutes for Health Information study revealed that people who have received metal-on-metal implants face a 5.9 percent increased likelihood of having to undergo device replacement within five years of original implantation; this, in comparison to a 2.7 percent rate among people who received metal-on-plastic implants.
The all-metal implant design did not work as expected, CBC News reported. In fact, under the body’s weight during daily activity—such as walking—the implant’s metal parts rub against each other. This rubbing causes metal particles to shed into the person’s surrounding tissue and bloodstream, causing bone and tissue damage due to metallosis (metal poisoning), as well as pseudotumors and the need for early revision surgery.
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.
This lawsuit was filed by Parker Waichman LLP on May 30, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-508) and 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). Biomet, Inc. and Biomet Orthopedics, LLC have been named as defendants.