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The decision in Riera v. Somatics, LLC, 2018 WL 6242154 (C.D. Cal. Sept. 14, 2108), comes from California, a place in which private plaintiffs bring claims against medical device companies for violations of the FDCA all the time, despite the fact that the FDCA prohibits that very kind of thing. We won’t—yet again—get into how that came about or why negligence per se claims are allowed at all. We’ll take the Riera decision as it stands and focus on its rulings.

Doctors treated two plaintiffs for severe psychological problems, ultimately employing defendant’s Thymatron System IV to perform electroconvulsive therapy. Plaintiffs claimed that, as a result, they suffered brain trauma, memory loss and other brain-related injuries. They filed product liability claims based, in the main, on the manufacturer’s alleged failure to report adverse events. The decision in Riera addressed summary judgment motions, ones filed by both the plaintiffs and the defendant. You don’t ordinarily see summary judgment motions by plaintiffs, and Riera is an example of why.

Plaintiffs sought only partial summary judgment, asking the court to rule that the manufacturer violated FDA regulations by not maintaining written procedures for evaluating adverse events and by not reporting them. Id. at *4-*7. The Court denied the motions. The court held that there was an issue of fact as to whether the manufacturer’s written procedures were insufficient under FDA regulations, particularly given that the FDA never sent a warning letter or started an enforcement action. Id. at *5. Separately, the court held that plaintiffs were not entitled to a judgment that the manufacturer failed to report adverse events. In one instance, the alleged adverse event was immaterial because it was unrelated to the injury suffered by plaintiffs. In other instances, there were fact issues as to whether the events constituted a reportable adverse event. Id. at *6.

Defendant had some success on its motions, but by no means ran the table. On plaintiffs’ negligence per se claims, defendant got a split decision. The court granted summary judgment against plaintiffs’ negligence per se claims for misbranding, rejecting plaintiffs’ theory that, if defendant had reported the alleged adverse events, the Thymatron would never have entered the stream of commerce and injured plaintiffs. Id. at *8. Nothing in the record suggested that the FDA would have recalled Thymatron if the events were reported. Id. In fact, the FDA already knew of those alleged adverse events and took no action. Id. (This same causation failure also doomed plaintiff’s strict liability misbranding claim. Id. at *10.) On the other hand, the court, denied defendant’s motion on plaintiffs’ negligence per se claim that asserted a failure to investigate and report adverse events. The court found an issue of fact on whether the adverse events, if reported, would have reached plaintiffs’ doctors, who would then have warned plaintiffs. Id. at *8.

Finally, the court denied defendant’s motion for summary judgment on plaintiffs’ (ordinary) negligence claim for failure to warn of potential brain damage and memory loss. There was an issue of fact as to whether the science supported a stronger warning. Id. at *9-*10. For this same reasons, the Court allowed plaintiffs’ two strict liability failure to warn claims to go forward. Id. at *10-11.

And so it was a mixed bag. Some claims get to go to trial, and some don’t. But it’s a bit of a wonder that any would. They each read exactly like efforts by private plaintiffs to enforce the FDCA and FDA regulations, the very thing that the FDCA explicitly prohibits.