On August 31, 2015, United States District Judge William S. Duffey, Jr., 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 as to Plaintiff Robyn Christiansen’s claims for defective design, fraudulent misrepresentation and concealment and punitive damages. The Court flatly rejected Wright Medical’s claim that the Medical Device Amendment to the Food Drug & Cosmetic Act preempted the design-defect claims. As to the Conserve total-hip device, Wright Medical submitted only a 510(k) short-form clearance application to the United States Food and Drug Administration, 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 Defendants’ argument that Comment K to § 402A of the Restatement of Torts should apply to bar the strict-liability design-defect claims. The Court 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.
Lead Plaintiff’s MDL Counsel Mike McGlamry, of Pope McGlamry, P.C. stated: “Although we do not agree with all aspects of the Order, overall we are very pleased with the Court’s thorough and timely opinion. Ms. Christiansen looks forward to presenting her case to a jury and setting the stage for the Court’s consideration of all Plaintiffs’ claims against the Wright Medical defendants.”
Although the Court held that the implanting surgeon’s failure to read the package insert ruled out the defective warnings claims, it also concluded that the evidence demonstrated questions as to Wright Medical’s active misrepresentations to and concealment of material information from the implanting surgeon. Thus, whether Wright Medical acted fraudulently is a question for the jury at trial. Likewise, whether such fraudulent conduct supports an award of punitive damages against Wright Medical is a question for the jury.
The Court also denied the motion for summary judgment by 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 Court denied the motion. The “no involvement” argument was based entirely 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 Ms. Daurer’s under-oath declaration to be “troubling.” It concluded that Wright Medical Group’s SEC 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.
Daubert Motions at Plantiff’s Experts
As to the multiple Daubert motions directed at Plaintiff’s experts, the Court excluded a few opinions and minor experts in the areas of toxicology, biostatistics and wear-volume calculation. Otherwise, the Court found that the expert evidence proffered 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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