A doctor implanted a pain pump into a patient. The patient was injured and sued the manufacturer of the pump, alleging various state law claims. The patient alleged that the manufacturer’s failure to report adverse events to the FDA gave rise to liability. The pain pump was a medical device, approved and regulated by the FDA. The trial court granted a motion to dismiss all counts based on federal preemption.
The Court of Appeals held that some, but not all, medical-device related claims are expressly or impliedly preempted by federal law. It affirmed the dismissal of the product liability, breach of express warranty, and negligence causes of action because federal law preempts those claims. However it held that federal law does not preempt claims of failure to warn, loss of consortium, and punitive damages.
The federal Medical Device Act (MDA) contains a provision expressly preempting state law where: (1) the federal government is already regulating the device and (2) a plaintiff’s common-law claims would impose different or additional requirements. The MDA also impliedly preempts any action to enforce or restrict violations of the Food, Drug, and Cosmetic Act. “Parallel claims” under state law are not preempted if they are based on state requirements that are equal or substantially similar to the requirements of federal law. State-law claims for damages based on violation of FDA regulations are not preempted.
There was no dispute that the pain pump was a regulated device, satisfying the first element of express preemption. The product liability and breach of express warranty claims in this case both attempted to impose additional requirements, satisfying the second element for express preemption. The negligence per se claim was impliedly preempted as an attempt to enforce the MDA.
Following the result in a similar Ninth Circuit case, the Court of Appeals found that the failure to warn claim was not preempted. That is because the plaintiff’s theory was based on the failure to warn the FDA as already required under the MDA and not on an additional duty to directly warn the consumer. Loss of consortium is a derivative claim that could also proceed. The punitive damages claim also survived because there is no special pleading obligation to allege an “evil mind.”
Presiding Judge Howe authored the opinion; Judges Winthrop and Thompson concurred. Conklin.pdf
Posted by: Brian K. Mosley