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
