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A federal judge has denied a motion to dismiss a product liability lawsuit brought over problems with a Biomet metal hip replacement, rejecting a request by the manufacturer to bar the complaint on the grounds of federal preemption.
The case involved a complaint brought by Leslie Caccia, who had to undergo multiple revision surgeries after his Biomet ReCap Femoral Resurfacing System and M2A-Magnum metal-on-metal hip replacement system allegedly caused damage to bone and tissue.
Biomet argued that the case should be dismissed because at the time Caccia received the implant it was approved by the FDA as part of a clinical trial, known as an investigational device exemption (IDE). The manufacturer therefore argued that it should not be held liable for design defects that may be associated with the device, arguing that federal law preempts any state law claims.
In an order (PDF) issued on August 21, U.S. District Judge Robert Miller, Jr. denied the motion and pointed out that Caccia was not part of that study.
“The FDA approved Biomet’s ReCap System under the IDE process for use in a specific clinical trial to determine the device’s safety and effectiveness,” the Judge wrote. “Use of the ReCap System outside the controlled study, i.e., without proper monitoring, record-keeping, and FDA oversight, wouldn’t advance the aims of the clinical trial. I’m not persuaded that a manufacturer that obtains IDE status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from the liability for use of that device outside the clinical trial.”
Biomet also tried to argue for preemption based on the fact that Caccia’s system was made of components of inside of a M2A-Magnum shell, but the judge rejected those arguments as well.
Biomet M2A-Magnum Litigation
Judge Miller is currently presiding over all product liability lawsuits filed throughout the federal court system involving the Biomet M2A-Magnum metal-on-metal hip replacement system. The U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized the cases for pretrial proceedings before Judge Miller in the Northern District of Indiana.
The Biomet M2A Magnum is a metal-on-metal hip replacement system, which has been linked to reports of loosening and early failure. All of the complaints involve similar allegations that plaintiffs suffered complications caused by problems with the design of the Biomet hip, where microscopic metal debris may be released as the metal parts rub against each other during normal use,resulting in metallosis or metal blood poisoning.
According to an updated case list (PDF) released by the U.S. JPML on August 15, there are currently at least 587 cases pending before Judge Miller. Such centralization is common in complex product liability litigation to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, the witnesses and the courts.
In addition to lawsuits over Biomet metal hips, at least three other federal multidistrict litigations (MDLs) have been established for complaints filed over other metal-on-metal hip implants, which have been linked to similar problems. There are currently at least 7,860 DePuy ASR hip lawsuits, 4,278 DePuy Pinnacle hip lawsuits and about 46 Wright Conserve hip lawsuits pending in the federal court system.