Bellwether Case in Wright Medical Conserve Hip Device Multidistrict Litigation Can Go to Trial

In a 123-page order, United States District Judge William S. Duffey Jr., of the Northern District of Georgia, ruled that the first of the consolidated multidistrict litigation (MDL) cases alleging that the Wright Medical Conserve metal-on-metal hip replacement devices are defective can go to trial.

The court denied the plaintiff’s motion for summary judgment for 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.In seeking Food and Drug Administration (FDA) device approval, Wright Medical submitted a 510(k) short-form clearance application and did not submit the device via Pre-Market Approval. This action “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,” according to court documents. 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 the question of whether Wright Medical acted fraudulently should be decided at trial. And a jury should also decide if such fraudulent conduct supports the award of punitive damages.

Judge Duffey denied the motion for summary judgment from the 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.  But the “no involvement” argument was based on a hearsay declaration by a Wright Medical representative that failed to present competent, admissible evidence based on personal knowledge, and the court called the submission of the under-oath declaration to be “troubling.” Wright Medical Group’s filings with the Securities and Exchange Commission filings and other documents showed Wright Medical Group’s involvement with the Conserve metal-on-metal hip device. The personal-jurisdiction argument was raised too late, the judge said.

The court order excluded some minor expert witnesses in toxicology, biostatistics and wear-volume calculation, but otherwise the judge 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.

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