09/08/2015 // JusticeNewsFlash // (press release)
U.S. – An order has been issued by United States District Judge William S. Duffrey, Jr. in a consolidated multidistrict litigation (MDL) case involving metal-on-metal hip implants manufactured by Wright Medical. News Inferno reported that the 123-page order was issued on August 31, and rejected the company’s argument that design-defect claims by the plaintiffs were deterred by the Medical Device Amendment to the Food Drug & Cosmetic Act.
The Court also denied a summary judgment motion in connection with the plaintiff’s claims regarding “defective design, fraudulent misrepresentation, concealment and punitive damages” News Inferno reported.
The plaintiffs in the case allege that the Conserve hip implant’s metal-on-metal design is linked to serious injuries. The implants are stated to pose risks to patients as a result of the possible shedding metal particles into the bloodstream or tissues, resulting in a range of health complications such as metal lead poisoning.
The order noted that Wright Medical had not undergone the more rigorous process for getting the device approved, submitting only the short-form clearance application to the FDA, stating that going this route “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 …”
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News Inferno Story Link: http://www.newsinferno.com/judge-issues-order-in-conserve-hip-implant-bellwether-case/