New York, New York (PRWEB) July 07, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit naming Biomet Orthopedics, LLC, Biomet, Inc., and Biomet, LLC as Defendants on behalf of an Oregon woman who suffered pain and revision surgery, allegedly due to her defective Biomet M2a Magnum metal-on-metal hip implant. The lawsuit was filed on July 2 in the U.S. District Court for the Northern District of California. (Case No. 3:12-cv-3476)
According to the Complaint, the Plaintiff, a resident of Portland, Oregon, underwent a surgical procedure on April 29, 2008, to implant the M2a Magnum Hip System in her hip. The lawsuit alleges that by this time, more than 100 reports of adverse events associated with the M2a Magnum had been reported to the U.S. Food & Drug Administration (FDA), and Biomet knew that the product was defective. The complaint alleges that due to the defective design, manufacture and composition of the M2a Magnum Hip System, the Plaintiff's hip implant failed, causing her severe pain. On July 5, 2010, the Plaintiff underwent revision surgery, a complex, risky, and painful procedure to remove the failed implant.
The lawsuit claims that the M2a Magnum Hip System suffers from a design or manufacturing defect that causes excessive amounts of cobalt and chromium to wear and corrode from device. This leads to rejection of the implant, which manifests with symptoms of pain, looseness, dislocation, and squeaking and popping sounds. Inside the hip joint, the metal reaction often causes fluids to accumulate and soft tissues and bone to die. Among other things, the lawsuit alleges that that the Biomet hip replacement was not adequately tested before being sold, and that company continued to sell the device even after receiving hundreds of complaints that it had failed, forcing patients to undergo painful and risky revision surgeries. According to the lawsuit, more than 350 reports of adverse events associated with the M2a Magnum Hip System have been filed with the FDA to date.
Metal-on-metal hip replacement devices such as the M2a Magnum hip have been the subject of growing safety concerns since the August 2010 worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System. Last month, an FDA report revealed that the agency's review of recent data suggests that metal-on-metal hip replacement systems are likelier to fail than other hip implant devices. According to the agency, metal-on-metal hip replacement devices were associated with some 16,800 adverse event reports from 2000 to 2011. The vast majority of those reports, more than 14,000, involved revision surgery to remove a failing metal-on-metal hip implant. In 2011, metal-on-metal hip implant complaints made to the FDA totaled 12,137, compared with only 6,332 associated with other types of hip replacement systems.
Last week, the FDA convened a two-day meeting of its Orthopaedic and Rehabilitation Devices Panel to examine the safety of metal-on-metal hip implants, amid concerns that they have the potential to expose patients to dangerous levels of metallic debris. According to a report from the Associated Press, experts on the 18-member panel stated that they could see few reasons to continue using metal-on-metal hip replacement devices. The panel recommended that metal-on-metal hip implant recipients who were experiencing pain and other symptoms should get regular X-rays and blood testing for their metal levels. They further recommended that all patients with the devices undergo annual X-rays to monitor their implants, regardless of symptoms.
According to a report published in the British Medical Journal (BMJ), the panel also urged the FDA to see that the public, including those considering hip replacement surgery, as well as those fitted with all-metal devices, are provided with more information, including additional warning notices on their labels.
According to the BMJ report, one of the advisors, Scott Evans, a clinical trials statistician at Harvard University, noted that while there are ample data on hip implants, they are primarily from observational studies and registries “with high levels of uncertainties.” Evans maintained that there exists a need for appropriately designed prospective studies to answer the remaining questions about the safety of all-metal hip implants, otherwise “we are going to continue to dance around the true answers.”
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 Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding DePuy, Zimmer, Biomet and Smith & Nephew metal-on-metal hip implant lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney