On August 31, 2015, United States District Judge William S. Duffey Jr., issued a 123-page order in the first bellwether trial for the consolidated Multi-District Litigation alleging that the Wright Medical Conserve metal-on metal hip replacement devices are defective. Wright faces claims in over 2,000 cases now pending between the MDL in the Northern District of Georgia and the concurrent proceeding in Los Angeles Superior Court, JCCP 4710. Christopher P. Yuhl of YUHL CARR, LLP is a member of the leadership group of attorneys spear heading the litigation.
The Court denied Wright’s Motion for Summary Judgment as to Plaintiff Robyn Christiansen’s claims for defective design, fraudulent misrepresentation and concealment and allowed punitive damages for this conduct to remain in the case. The court rejected Wright Medical’s claim that the Medical Device Amendment to the Food Drug & Cosmetic Act preempted the design defect claims. As to the specific device involved, the Conserve metal-on-metal total-hip device, the Court found that Wright’s 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…” Instead, the evidence demonstrated that Wright chose only to submit a 510(k) short form clearance application to the FDA. The Court further rejected Wright’s argument that Comment K to §402A of the Restatement of Torts should apply to bar the plaintiffs strict liability design-defect claims, citing evidence that the Conserve metal-on-metal hip device was not made as safely as it could have been and was not properly marketed.
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 and whether such fraudulent conduct supports an award of punitive damages against Wright Medical remains a question for the jury.
The Court also denied the motion for summary judgment by parent company Wright Medical Group, Inc. which argued that it had no involvement with the Conserve metal-on-metal hip devices and thus the court lacked personal jurisdiction. The Court found this “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 untimely.
As to the multiple Daubert motions directed at Plaintiff’s experts, , the Court found on the whole 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. The Court excluded limited opinions and minor experts in the areas of toxicology, biostatistics and wear-volume calculation only.
Lead Plaintiff’s MDL Counsel Mike McGlamry, of Pope McGlamry, P.C. stated: “Overall, we are very pleased with the Court’s thorough and timely opinion which allows us to move ahead with the trial. Ms. Christiansen looks forward to presenting her case to a jury now that we know Plaintiffs’ claims against the Wright Medical defendants will be considered by the Court.”