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.
According to Mass Device, 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 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.
Source: Mass Device