Products Liability Law Reporter

The Arizona Supreme Court held that the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §301 et seq., impliedly preempt a patient’s failure-to-warn claim based on a manufacturer’s failure to submit adverse event reports to the FDA.

Here, Raymond Conklin suffered injury caused by drug over-infusion from his continued use of an implanted Medtronic SynchroMed II 40 ml infusion pump and catheter. He and his wife sued Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc., which designed, manufactured, marketed, and sold the pain pump, alleging, among other claims, that the defendants failed to report postmarket approval (PMA) adverse events to the FDA in violation of federal law, giving rise to liability under Arizona common law. The trial court granted the defendants’ motion to dismiss. An intermediate appellate court affirmed in part but vacated the trial court’s dismissal of the plaintiffs’ failure to warn claim.

Affirming the trial court’s decision, the state high court found that once a device has received PMA, the MDA precludes a manufacturer from changing design specifications or any other attribute affecting a device’s safety or effectiveness. Citing case law, the court found that to avoid MDA preemption, a claim must concern conduct that violates a federal requirement but relate to other state law violations as well. Here, the court said, the plaintiffs cite no authority supporting their assertion that Arizona law requires a manufacturer to warn a federal agency of adverse events. Only federal law imposes this duty on the defendants, the court found, concluding that, absent an independent reporting requirement, the plaintiffs’ failure to warn claim was impliedly preempted by the MDA. 

The court added that although Arizona law recognizes a claim for failure to provide an adequate warning to a patient through his or her health care providers, this does not lead to recognition of a claim for failing to provide adverse event reports to a government agency that has no obligation to send that information to a patient..

Citation: Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018).