[The FDA] noted that the metal-on-metal class of medical devices – which includes Biomet’s M2a Magnum – was under increased scrutiny following reports of high failure rates and the release of elevated concentrations of metallic debris into the blood.
New York, New York (PRWEB) September 03, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that a lawsuit on behalf of Leslie and Allison Caccia against Biomet will proceed, as U.S. District Judge Robert Miller Jr., in an Aug. 21 Order*, rejected Biomet's preemption argument to obtain dismissal. (Leslie Caccia and Allison Caccia vs. Biomet Inc., et al, Case No.: 3:2013-cv-00073). That lawsuit, filed in the U.S. District Court for the Northern District of Indiana, South Bend Division, is one of many composing the multidistrict litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 2391). Biomet, Inc. and Biomet Orthopedics, LLC have been named as Defendants.
The judge blocked Biomet’s preemption argument because the device maker's metal-on-metal implant had been approved for use in a clinical trial; therefore, the company couldn’t avail itself of preemption protection, the judge noted in court documents. Caccia did not participate in the study; in his complaint, he alleges that the Biomet hip implant caused him to suffer bone loss and tissue damage, which required several revision surgeries.
"I'm not persuaded that a manufacturer that obtains IDE [Investigational Device Exemption] status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from liability for use of that device outside the clinical trial," Judge Robert Miller Jr. noted in court documents.
The U.S. Food and Drug Administration (FDA), in a Jan. 17, 2013 safety communication, noted that the metal-on-metal class of medical devices – which includes Biomet’s M2a Magnum – was under increased scrutiny following reports of high failure rates and the release of elevated concentrations of metallic debris into the bloodstream. The FDA also included in the communication new guidelines for patients implanted with all-metal devices. Moreover, the agency 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 require revision surgery within five years of implantation of the all-metal device, according to a July 18, 2013,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