A federal judge has refused a request from Warsaw, Ind.-based Biomet Inc. to dismiss a hip lawsuit on the grounds of federal preemption.
The privately held firm is being sued by a patient who underwent 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. Metal-on-metal hip systems have come under an enormous amount of scrutiny recently.
Biomet claimed the case should be dismissed because at the time the plaintiff received the implant it had U.S. Food and Drug Administration (FDA) approval and had undergone a investigational device exemption (IDE) clinical trial. Biomet argued that the IDE protected 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.
Biomet pointed to rulings from Tennessee and New York federal courts in the 1990s that found a preemption analysis should focus on the FDA requirements for an IDE-study device, rather than whether a plaintiff was part of the study. Miller, however, said the decisions were not binding and unpersuasive.
According to the judge:
“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.
“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," Miller wrote.
Miller currently oversees 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 pre-trial proceedings in the Northern District of Indiana.
The Biomet M2A Magnum hip replacement has been reported to loosen, a condition that can cause microscopic metal debris to be released into the blood stream, which could lead to metal poisoning.
According to the latest court dockets, there are nearly 600 Biomet cases pending. Though there has been no Biomet hip replacement recall, the allegations are similar to those made against the recalled ASR hips made by Johnson & Johnson's DePuy orthopedic division, which is currently at the center of nearly 8,000 lawsuits.
In January last year, 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 is no alternative.