Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules.
The plaintiff, Leslie Caccia, sued Biomet for a supposedly defective metal-on-metal hip implant in what is now part of a larger multi-district litigation. Biomet argued that the case qualifies for preemption, a controversial rule that protects manufacturers from tort claims surrounding FDA-cleared products.
The judge ruled that because Biomet’s implant had been approved for investigational device use in a clinical trial, the company did not qualify for the preemption rules. Caccia, who did not participate in the study, alleges that he suffered bone loss and tissue damage that required him to undergo numerous revision surgeries because of the Biomet implant.
"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 liability for use of that device outside the clinical trial," said Judge Robert Miller, Jr. in court documents.
Biomet faces close to 600 lawsuits over alleged failure of the M2a Magnum hip implant, according to court documents. The FDA has recognized serious concerns surrounding metal on metal hip implants, which have been shown to fragment, sending particles into the blood stream and to grind down bone and tissue around the metal.
Biomet’s M2A Magnum implant has been the subject of numerous personal injury lawsuits, despite the fact that the device has not undergone a wide recall akin to the DePuy Orthopaedics action that effectively got the ball rolling against metal-on-metal hips.