We’ve just learned that the Eighth Circuit as affirmed the preemption-based dismissal of the entire Sprint Fidelis Multidistrict Litigation. This is the first major appellate test of PMA preemption post-Riegel – and we passed. Here’s a copy: Bryant v. Medtronic, slip op. (8th Cir. Oct 15, 2010). Thanks to Ken Geller at Mayer Brown for passing it along.
(1) Express preemption under Riegel and implied preemption under Buckman work in tandem where violation claims are alleged (an argument we’ve been advancing here forever):
“Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).”
Slip op. at 4.
(2) A recall does not preclude preemption. Slip op. at 5 n.4.
(3) “Even if federal law allowed Medtronic to provide additional warnings, as Plaintiffs alleged, any state law imposing an additional requirement is preempted.” Slip op. at 6 (emphasis original).
(4) A failure-to-recall claim is an “additional” requirement that’s preempted. Slip op. at 6 (“as the FDA did not prohibit Medtronic from continuing to sell the unmodified lead, a state requirement to that effect would be ‘different from or in addition to’ the federal requirement and preempted”).
(5) “[A]lleg[ations] that Medtronic failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations . . . are simply an attempt by private parties to enforce the MDA, claims foreclosed by § 337(a) as construed in Buckman.” Slip op. at 6.
(6) Design defect claims also preempted unless there are “concrete” allegations of divergence from federal requirements. Slip op. at 6-7).
(7) TwIqbal requires specific pleading of manufacturing defects involving alleged violation of FDA Good Manufacturing Practices. Slip op. at 9 (“Plaintiffs simply failed to adequately plead that Medtronic violated a federal requirement specific to the FDA’s PMA approval of this Class III device”). A dissent in part on this ground by one member of the panel alleged that the pleading requirement was “insurmountable.” Slip op. at 17-18. The majority did not agree.
(8) Express warranty claims are just as preempted as anything else when they conflict with federal requirements. Slip op. at 10 (“To succeed on the express warranty claim asserted in this case, Plaintiffs must persuade a jury that Sprint Fidelis Leads were not safe and effective, a finding that would be contrary to the FDA’s approval of the PMA Supplement”).
The trial court’s dismissal without leave to amend, and its denial of the plaintiffs’ recusal motion, were also affirmed.