The US Court of Appeals for the Eighth Circuit has affirmed the dismissal of a suit brought against the manufacturer of the Sprint Fidelis Lead, a medical device that transmits electrical signals between an implantable cardiac defibrillator and the heart. See In re: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, __ F.3d __, 2010 WL 4026802 (8th Cir. Oct. 15, 2010). The Eighth Circuit agreed with Medtronic, Inc., the manufacturer of the leads, that the plaintiffs’ claims were preempted by federal law.1

The decision is significant because, among other things, it is the first published opinion by a federal appellate court to analyze at length the Supreme Court’s landmark preemption decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

The Sprint Fidelis Lead is a Class III medical device that was approved by the Food and Drug Administration pursuant to that agency’s premarket approval (PMA) process. In Riegel, the Supreme Court held that the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA) preempts state-law claims that would impose on a medical device with PMA any requirement that is “different from or in addition to” the requirements imposed by the FDA as part of the PMA process. In a prior decision, the Supreme Court had already concluded that a different provision of the FDCA, through implied preemption, bars suits by private litigants “for noncompliance with the medical device provisions.”

In the case at bar—a consolidated multidistrict litigation (MDL) proceeding involving more than 1200 individual claimants who had been implanted with Sprint Fidelis Leads—the plaintiffs alleged that the leads were defective and sought damages against Medtronic. Medtronic argued, and the district court agreed, that the plaintiffs’ claims had to be dismissed because they necessarily would impose different or additional requirements with respect to the leads. In order to prevail, the plaintiffs would have to convince a jury that the leads should have been designed, manufactured, or labeled differently from the manner approved by the FDA.

Affirming the district court’s dismissal of the plaintiffs’ claims, the Eighth Circuit explained that, “[r]ead together[,] Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape … 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).” Thus, the “crucial question” presented in the appeal was whether the plaintiffs had alleged genuinely “parallel” claims that avoided preemption—that is, claims arising out of state law but that did not impose state-law requirements that were “different from or in addition to” the federal requirements established by PMA for the leads.

The court held that the plaintiffs failed to satisfy this standard. To begin with, the court rejected the plaintiffs’ arguments that the recall of the leads meant that they were no longer subject to federal requirements or that federal preemption was categorically inapplicable.

The Eighth Circuit then explained why each of the claims that the plaintiffs defended on appeal was preempted:

  • The failure to warn and related claims imposed “precisely the type of state requirement that is ‘different from or in addition to’ the federal requirement.” Even if (as the plaintiffs contended) federal law did not forbid Medtronic to provide additional warnings or to take other measures, “any state law imposing an additional requirement” of this nature was preempted.
  • The design defect claims were preempted because they were “attacks on the risk/benefit analysis that led the FDA to approve” the leads as designed.
  • The breach of express warranty claim was preempted because it would require a jury to find “that Sprint Fidelis Leads were not safe and effective, a finding that would be contrary” to the leads’ PMA approval.
  • The manufacturing defect claim was preempted because the plaintiffs failed to plead a parallel manufacturing defect claim with the factual elaboration required under Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). The plaintiffs did not identify any specific federal requirement in the PMA approval from which the leads-as-manufactured had allegedly deviated. One judge dissented from the majority’s treatment of the manufacturing defect claim, and would have allowed the plaintiffs to pursue very limited discovery.

Finally, the Eighth Circuit affirmed the district court’s denial of the plaintiffs’ post-dismissal motion for leave to file an amended complaint and the district court’s denial of the plaintiffs’ untimely recusal motion.

If you have any questions or require specific advice on any matter discussed in this Legal Update, please contact Kenneth S. Geller at +1 202 263 3225.

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1. Mayer Brown represented Medtronic in this litigation in both the district court and the Eighth Circuit.