The first of the consolidated multidistrict litigation (MDL) cases over Wright Medical Conserve metal-on-metal hip implants continues to move forward. United States District Judge William S. Duffrey, Jr. issued a 123-page order in the case on August 31. Wright Medical had claimed that the design-defect claims were preempted by the Medical Device Amendment to the Food Drug & Cosmetic Act, but this argument was rejected by the Court. The Court also denied motion for summary judgement related to the plaintiff’s claims for defective design, fraudulent misrepresentation, concealment and punitive damages.
Plaintiffs in the MDL allege that Wright’s Conserve hip implant caused serious injuries as a result of its metal-on-metal design. All-metal hip implants have come under increased scrutiny in recent years in light of multiple recalls and high failure rates. The devices were first marketed as being more suitable for younger, more active patients. However, the implants have a risk of shedding or fretting metal particles into the bloodstream and nearby tissues when the surfaces of the implant rub together. This can lead to a host of complications, including metal poisoning. In some patients, it was necessary to perform a revision surgery to remove and replace the implant.
The Order pointed out that Wright Medical only submitted a 510(k) short-form clearance application to the U.S. Food and Drug Administration (FDA) to get the device approved, instead of the more stringent pre-market approval. Devices approved through 510(k) essentially circumvent clinical testing by showing that the device is “substantially equivalent” to an older product. By choosing this route, Wright “denied the FDA the opportunity to determine if the Conserve implant provided a ‘reasonable assurance of safety and effectiveness,’ and denied the FDA the opportunity to scrutinize and evaluate the device …”
Additionally, the Court rejected Wright’s argument that strict-liability design-defect claims should be barred by Comment K to Section 402A of the Restatement of Torts. Comment K’s application was also precluded by evidence that the Conserve metal-on-metal hip implant was not made as safely as possible and that it was improperly marketed, the Court stated. Parent company Wright Medical Group, Inc.’s motion for summary judgment was also denied, with the Court rejecting the argument that it had no involvement with the metal hip implants.