The lawsuit alleges that by the time she underwent this implant surgery, the Defendants were already aware of over 100 adverse event reports linked to the device.
New York, New York (PRWEB) August 06, 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 Tennessee woman who alleges that her Biomet M2a Magnum hip implant device is defective and caused her injuries, as well as the need to undergo revision surgery. The suit was filed 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.
According to the Complaint, the Plaintiff was implanted in her left hip with the M2a Magnum system on April 13, 2009. The lawsuit alleges that by the time she underwent this implant surgery, the Defendants were already aware of over 100 adverse event reports linked to the device, yet they failed to disclose this information to the Plaintiff. Instead, the suit alleges, the Defendants misrepresented the M2a Magnum implant as safe and efficacious. Allegedly, the Plaintiff’s surgeon would not have implanted the M2a Magnum had it not been for the misrepresentations made by the Defendants.
The lawsuit 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. As a result of this, she underwent a complex, risky revision surgery to explant, or remove the device, and be re-implanted with a replacement hip device. The suit alleges that revision surgeries are generally more complex than initial implantation because there is typically less bone to work with when the original device is removed from the body. Revision surgeries usually take longer to complete than the original hip surgery and have a higher rate of complications. The Plaintiff is suing for economic damages, including lost wages, as well as medical and hospital expenses; severe and possibly permanent injuries; pain; suffering; and emotional distress.
The Biomet M2a Magnum is a type of metal-on-metal hip implant. The U.S. Food and Drug Administration (FDA) has 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 have 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 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 to remove and replace the hip with implantation of another device.
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