California Appellate Court Erodes Preemption Defense for Medical Device Makers
California’s Second Appellate District Court on January 27 held that a negligence claim against a medical-device manufacturer, based on state law duties that parallel requirements under federal law, was not preempted by federal law.
In Coleman v. Medtronic, the plaintiff experienced complications from back surgery, which included the use of a medical device manufactured by Medtronic. The Medtronic device had been approved by the federal Food and Drug Administration (FDA) but was used in Coleman’s surgery in an “off-label” manner. In his complaint, Coleman alleged seven separate claims that included strict failure to warn based on a theory of Medtronic’s failure to warn the FDA, negligence, and design defect.
At trial, Medtronic argued that all of Coleman’s claims were preempted by federal law and the court agreed. Coleman appealed and the appellate court reversed in part, holding that certain negligence claims were not preempted.
In the appellate decision written by Judge Sandy Kriegler, the court ruled that while Coleman’s general negligence claim for failure to warn was expressly preempted, to the extent it was based on the idea that Medtronic should give additional warnings than those required by the FDA, a strict liability claim for failure to warn could proceed. The court deciphered the two claims because, it said, Medtronic had a duty to warn the FDA of adverse effects that the manufacturer learned about after the device was approved.
Under California law, a company is liable if it does not adequately warn of a particular risk that was known or was knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. The appellate court also pointed to nonbinding federal law where state claims pertaining to failure to file adverse event reports with the FDA were allowed to proceed. The court held that “because Coleman‘s negligence claim based on Medtronic‘s failure to file adverse event reports is cognizable under California law and is parallel to federal requirements, he may proceed on this theory.” Coleman at 20.
The Court remanded the case back to the lower court and the plaintiff’s suit will go forward. But regardless of the facts and outcome of this particular case, the appellate ruling is likely to invite a slew of additional state-law claims against various makers and their devices, which, up until now, had been preempted by FDA approvals. Such liability-expanding decisions help make California’s civil courts, collectively, the #1 Judicial Hellhole in the land.