New York, New York (PRWEB) December 02, 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 60-year-old Maryland man who alleges that the Biomet M2a Magnum metal-on-metal hip replacement system, which he had implanted on both sides, is defective. The implant in each leg caused him to suffer pain and other injuries, and caused him to undergo two revision surgeries to have the bilateral devices explanted and replaced. The lawsuit was filed on November 6, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-01166 ) 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 received bilateral hip implants—specifically, Biomet’s M2a Magnum Hip System, which has a 38-mm M2a ball-and-socket design with a porous-coated lateralized Taperloc femoral device. The lawsuit alleges that the Plaintiff began to suffer from a number of symptoms, including severe groin pain, elevated metal serum ion levels and other injuries. The lawsuit alleges that the Plaintiff underwent revision surgery to remove and replace the left hip device, which had failed; and thereafter, he underwent revision surgery to remove and replace the failed right hip device.
The lawsuit alleges that by the time the Plaintiff was implanted with the two Biomet devices, the Defendants had full knowledge that more than 100 adverse event reports tied to the device had been sent to the U.S. Food and Drug Administration (FDA); however, the Defendants neglected to advise the plaintiff of this potentially damaging information. Instead, according to the lawsuit’s allegations, the Defendants misrepresented the implant as safe and efficacious.
The lawsuit also notes that the Plaintiff had to undergo two separate revision surgeries to remove the devices, highlighting that revision surgery is costlier, more dangerous, and more painful than the original implantation procedure because there is less bone and tissue to work with after the original device is removed. Revision surgeries also typically require more time to complete than initial hip surgery and can lead to increased complication rates and a greater need for ongoing, future medical care.
The FDA noted in a safety communication on January 17, 2013, that it had placed the entire metal-on-metal class of medical devices under increased scrutiny following mounting reports of high failure rates associated with the all-metal hip devices, as well as reports that they can cause elevated levels of metallic debris in patients’ bloodstreams. The FDA also released new guidelines for patients implanted with all-metal devices and advised that symptomatic patients have regular physical examinations, diagnostic imaging, and metal ion testing.
Meanwhile, recent data from Canada suggests that people implanted with metal-on-metal hips are likelier to require revision surgery within the first five years of implantation, according to a July 18 CBC News report.
In the CBC report, a Canadian Institutes for Health Information study found that patients implanted with metal-on-metal hip face a 5.9 percent increased risk of having to undergo revision surgery within five years following the original implantation, compared to a 2.7 percent rate in people implanted with a metal-on-plastic implant device. The metal-on-metal implant design was intended to provide increased longevity and durability, but has not worked as expected or promised, the CBC News reported. In fact, during daily activities, including walking, rising and sitting, the patient’s own body weight can cause to the implant’s metal components to rub against one another, leading to the shedding of microscopic shards from the metal implant into area tissue and the bloodstream. This metallic shedding can cause bone and tissue damage, metallosis (metal poisoning), the development of 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 the premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact the 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