Motion to Dismiss Biomet Hip Lawsuit Denied by Judge
A federal judge has refused a request from the manufacturer to dismiss a Biomet hip lawsuit on the grounds of federal preemption. The complaint was brought by a man forced to undergo multiple revision surgeries after his hip replacement failed, allegedly causing bone and tissue damage. The device in question is the Biomet ReCap Femoral Resurfacing System, a metal-on-metal hip replacement system that is causing increasing alarm among the medical community due to its high failure rate.
Biomet claimed the case should be dismissed because at the time the plaintiff received the implant it had FDA approval and had undergone a clinical trial known as an investigational device exemption (IDE). Biomet argued that the IDE inured them from prosecution because federal law supercedes claims made at state level.
But in an order issued on August 21, U.S. District Judge Robert Miller, Jr. denied the motion on the grounds that the plaintiff had not participated in the trial. Judge Miller stated:
“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… 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 attempted to argue for preemption based on the implant’s inclusion of specific components from an IDE-approved device, the M2A-Magnum metal-on-metal system. This argument was also rejected by Judge Miller who ruled that the plaintiff could go ahead with his Biomet hip lawsuit. Judge Miller stated:
“I can’t agree with Biomet’s argument that the law affords different preemption status to individual parts of a total system or, as in this case, coupling one component (the M2a-Magnum PF Cup) of an IDE –approved device (the ReCap System) with other components (the Taperloc femoral stem and the M2a-Magnum Modular Head) to create a different system… converts the second system’s status to IDE status for preemption purposes.”
Biomet hip lawsuit cases centralized
Judge Miller is currently overseeing all federal product liability lawsuits relating to Biomet’s M2A-Magnum metal-on-metal hip replacement system. The U.S. Judicial Panel on Multidistrict Litigation (JPML) recently centralized the cases for pretrial proceedings in the Northern District of Indiana.
The Biomet M2A Magnum hip replacement has been linked to numerous reports of loosening in situ, a condition that causes microscopic metal debris to be released into the blood stream resulting in metallosis (metal poisoning).
According to the latest court dockets, there are at least 587 Biomet cases pending. Though there has been no Biomet hip replacement recall as yet, the allegations bear a striking similarity to those made against the recalled DePuy ASR hip replacement, which is currently at the center of nearly 8,000 lawsuits.
FDA issues new guidelines for metal-on-metal implants
In January 2012, the FDA published a new set of guidelines for metal-on-metal hip devices. The guidelines advise surgeons to avoid implanting metal-on-metal hip replacements unless there was no alternative. Additionally, the FDA called for manufacturers to prove their products were safe or face recalls. All metal-on-metal implant makers will have to undergo clinical trials in future.
- FDA, Safety Communication: Metal-on-Metal Hip Implants http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm