PHILADELPHIA - (Mealey's) The Third Circuit U.S. Court of Appeals on July 30 affirmed that manufacturing defect and breach of warranty claims involving the Vagus Nerve Stimulation (VNS) Therapy System made by Cyberonics Inc. are expressly preempted (Diane M. Williams, et al. v. Cyberonics, Inc., No. 09-3800, 3rd Cir.).
Diane M. Williams, Keith M. Williams and Audrey Knight in 2006 filed a class action complaint in the U.S. District Court for the Eastern District of Pennsylvania, alleging injury from the VNS device.
The device uses electrodes implanted in the vagus nerves in the neck and connected to a pacemaker-like electronic device to deliver electrical impulses to treat epilepsy and major depression. It is a Class III medical device (bearing the most regulatory controls) and was approved through the premarket approval (PMA) process by the Food and Drug Administration.
In September 2009, Judge Anita B. Brody found that the plaintiffs' claims are preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. The plaintiffs appealed the preemption ruling.
In a non-precedential opinion, the Third Circuit panel said, "Appellant's allegations of strict products liability based on manufacturing defect and breach of warranty are pre-empted by the MDA. Generalized common law theories of liability, such as those advanced in appellants' complaint, are precisely the type of claims the MDA sought to preempt."
"Success on appellants' breach of warranty claims would require them to show that the VNS Therapy System device was unsafe or ineffective despite the PMA process, thereby interfering with the requirements already established by the MDA, which has preempted safety and effectiveness determinations for a device," the panel wrote.
The panel said the plaintiffs' theory of manufacturing defect based on the "malfunction theory" would allow a trier of fact to infer a defect from an alleged malfunction. "Although it is alleged that the VNS Therapy System stopped working for the Williamses and malfunctioned for Knight, appellants fail to explain how the device deviated from the FDA requirements," the panel said.
"Rather, appellants seek to ground Cyberonics' liability on requirements that go beyond those established by the MDA. Accordingly, appellants' claims are preempted," it said.
[Editor's Note: Full coverage will be in the Aug. 2 issue of Mealey's Emerging Drugs & Devices. In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Document #28-100805-024Z. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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