The lawsuit alleges that by the time both hip replacement systems were implanted, the Defendants had full knowledge that more than 100 adverse event reports linked to the device had been sent to the U.S. Food and Drug Administration.
New York, New York (PRWEB) October 04, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a South Carolina woman who alleges that her Biomet M2a Magnum metal-on-metal hip replacement system is defective and caused pain and injuries, as well as the need for revision surgery. The suit was filed on Sept. 13, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-952) 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.
According to the Complaint, the Plaintiff was implanted, via separate procedures, in the right hip, followed by the left hip, with Biomet’s M2a Magnum Hip System. The lawsuit alleges that by the time both hip replacement systems were implanted, the Defendants had full knowledge that more than 100 adverse event reports linked to the device had been sent to the U.S. Food and Drug Administration (FDA), yet they failed to disclose this information to the Plaintiff. Instead, the suit alleges, the Defendants misrepresented the implant as safe and efficacious.
The lawsuit alleges that, as a result of the Biomet’s M2a Magnum Hip System’s defective design, the hip replacement system in the Plaintiff’s right hip failed shortly after it was implanted, resulting in severe pain. On Feb. 18, 2011, the Plaintiff was forced to undergo a complex, risky revision surgery to remove and replace the device, according to the Complaint. The suit alleges that revision surgeries are generally more complex than the initial implantation because there is typically less bone to work once the original device is removed. Also, revision surgeries usually take longer to complete than the initial hip surgery and can result in a higher rate of complications.
The Biomet M2a Magnum metal-on-metal hip replacement system is a type of metal-on-metal hip implant. Metal-on-metal hip devices have been recalled worldwide, as the U.S. Food and Drug Administration (FDA) noted in a Jan. 17, 2013, recall update. The FDA itself put the metal-on-metal class of medical devices under increased scrutiny following reports of high failure rates and the release of elevated concentrations of metallic debris into the bloodstream. On January 17, 2013, the FDA released new guidelines for patients who were implanted with all-metal devices. The agency also advised that regular physical examinations, diagnostic imaging, and metal ion testing be conducted in symptomatic patients.
Additionally, new data from Canada suggests that people implanted with metal-on-metal hips are likelier to undergo revision surgery within five years of implantation with the all-metal device, according to a July 18 CBC News report. According to the Canadian Institutes for Health Information study, people implanted with metal-on-metal hips face a 5.9 percent increased risk for revision surgery within five years of original implantation, compared 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, during daily activity—such as walking— the body’s own weight can cause an implant’s metal parts to rub against each other. This rubbing causes metal particles to shed into the person’s surrounding tissue and bloodstream, causing bone and tissue damage—which can lead to a condition called metallosis (metal poisoning), as well as pseudotumors, and the need for early revision surgery.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implant page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636