Split 8th Circuit Panel Affirms Sprint Fidelis Preemption Ruling

Split 8th Circuit Panel Affirms Sprint Fidelis Preemption Ruling

ST. LOUIS - A day after the parties announced a $268 million settlement and an end to the appeal, a split panel of the Eighth Circuit U.S. Court of Appeals on Oct. 15 affirmed that the plaintiffs' claims involving the Medtronic Sprint Fidelis heart device leads are preempted and that the plaintiffs failed to plead that their state law claims parallel federal regulations (In Re:  Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, No. 09-2290, 8th Cir.).

U.S. Judge Richard H. Kyle of the District of Massachusetts last year dismissed claims in which the plaintiffs allege that Medtronic Inc. sold defective lead wires for an implantable cardiac defibrillator (ICD) that fractured and failed to adequately warn doctors and patients or take the defective products off the market.  The plaintiffs appealed.

Circuit Judges James B. Loken and Bobby E. Shepherd agreed that the plaintiffs' failure-to-warn and related claims are expressly preempted by Section 360k of the Medical Device Amendments (MDA) of the Food, Drug and Cosmetic Act.  The two judges said the plaintiffs' citation of the U.S. Supreme Court drug preemption ruling in Wyeth v. Diana Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774) is unavailing because it turned on implied preemption, not express preemption.

The majority said the plaintiffs' claims that Medtronic failed to report adverse events involving the Sprint Fidelis to the Food and Drug Administration are an attempt at private enforcement of the MDA, which is prohibited by the U.S. Supreme Court ruling in Buckman Co. v. Plaintiffs' Legal Committee (531 U.S. 341 [2001]).

The majority said that absent concrete allegations that the leads were not what the FDA approved through the premarket approval (PMA) process, they are not parallel claims that escape preemption under the Supreme Court's medical device preemption ruling in Donna S. Riegel, et al. v. Medtronic, Inc. (No. 06-179, U.S. Sup.; 2008 U.S. LEXIS 2013).  Instead, the judges said the allegations are an attack on the FDA's risk/benefit analysis and are preempted.

The plaintiffs also argued that the court's ruling that they failed to plead their manufacturing defect claim under the Supreme Court's pleading ruling in Bell Atlantic Corp. v. Twombly (550 U.S. 544, 555-56 [2007]) "would have considerable force in a case where a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirements in the PMA prior to commencing the lawsuit."  However, the majority said the plaintiffs specifically disclaimed their need for unredacted information from Medtronic's PMA supplement.

The majority also affirmed the District Court's denial of the plaintiffs' motion to amend their master complaint, finding the motion untimely.

Circuit Judge Michael J. Melloy dissented, saying the District Court and the majority applied Twombly too rigidly without allowing the plaintiffs to see the unredacted PMA supplement to establish a parallel claim.  He disputed the majority's finding that the plaintiffs' motion for discovery into the supplement was untimely, citing record evidence.

[Editor's Note:  Full coverage will be in the Oct.21 issue of Mealey's Emerging Drugs & Devices. In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #28-101021-016Z.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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