Court Order in Conserve Hip Device Multidistrict Litigation Sets Stage for Bellwether TrialSep 3, 2015
United States District Judge William S. Duffey Jr., of the Northern District of Georgia, issued a 123-page order in the first of the consolidated MDL cases alleging that the Wright Medical Conserve metal-on-metal hip replacement devices are defective.
The court denied the motion for summary judgment of the plaintiff's claims of defective design, fraudulent misrepresentation and concealment and punitive damages, and also rejected Wright Medical's claim that the Medical Device Amendment to the Food Drug & Cosmetic Act preempted the design-defect claims, according to a news release about the court order.
Wright Medical submitted only a 510(k) short-form clearance application to the Food and Drug Administration (FDA), and the decision not to submit the device via Pre-Market Approval “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." The court also rejected Wright Medical's argument that Comment K to Section 402A of the Restatement of Torts should apply to bar the strict-liability design-defect claims and further held that evidence that the Conserve metal-on-metal hip device was not made as safely as it could have been and that it was not properly marketed precluded Comment K's application.
Although the court held that the surgeon's failure to read the package insert ruled out the defective warnings claims, it also concluded that the evidence demonstrated questions about Wright Medical's active misrepresentations to the plaintiff's surgeon and concealment of material information. The court concluded that whether Wright Medical acted fraudulently is a question for the jury at trial. And it also up to the jury to decide if such fraudulent conduct supports the award of punitive damages.
Judge Duffey also denied the motion for summary judgment from parent company Wright Medical Group, Inc. Wright Medical Group argued that the Court lacked personal jurisdiction and that it had no involvement with the Conserve metal-on-metal hip devices. The "no involvement" argument was based on a hearsay declaration by Wright Medical representative Debbie Daurer that failed to present competent, admissible evidence based on personal knowledge. The court found the submission of Daurer's under-oath declaration to be "troubling”, and concluded that Wright Medical Group's Securities and Exchange Commission filings and other documents detailed Wright Medical Group's involvement with the Conserve metal-on-metal hip device and that the personal-jurisdiction argument was raised too late.
The court order excluded some minor experts in toxicology, biostatistics and wear-volume calculation, but otherwise found that the expert evidence offered by the plaintiff, including her treating physician, another expert orthopedic surgeon, a pathologist, a biomedical engineer, a mechanical engineer, and a regulatory expert were reliable and could be considered by the jury.