Federal pre-emption in a medical-device case.
Plaintiff used Defendant’s infusion pump, an implanted medical device. It allegedly malfunctioned; he sued under the usual products liability theories. Defendant moved to dismiss arguing that the federal pre-marketing approval process — which the product had passed — pre-empts state law. The trial court granted the motion.
The Court of Appeals affirms in part. The Medical Device Amendments to the Food, Drug, and Cosmetic Act prohibit state regulation that is different from or in addition to federal law. The court holds that strict-liability and warranty claims are barred because they would involve arguing that the product is defective or unsafe when the FDA’s approval process found otherwise.
But the court reverses on failure to warn. Plaintiff alleged that Defendant hadn’t reported certain adverse events to the FDA as required by federal law. The Ninth Circuit examined this issue in Stengal (2013) (also involving one of Defendant’s infusion pumps) and held that Arizona failure-to-warn law parallels the disclosure requirements of the FDCA and is therefore not preempted. This assumes that the Arizona duty to warn can be satisfied by giving notice to a third party such as the FDA. The Court of Appeals agrees that it can, treating the FDA as a learned intermediary because it “could have notified [Plaintiff’s] doctor.” (Whether that would actually have happened, and how the process actually works, the court does not discuss.) Claims that Defendant should have warned Plaintiff or his doctor directly are, however, pre-empted.
For similar reasons the court holds that negligence claims are barred except for negligent failure to report things to the FDA.
Plaintiff argued that this, as a statutory violation, is negligence per se. The court says it could be, invites Plaintiff to ask the trial court to so rule, points out which paragraphs of which case to look at, and then says ‘we express no opinion . . . on the trial court’s ultimate resolution of that issue.” There are ways for a court to opine on issues not before it that are rather less ham-handed than that.