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On February 20, 2008, the U.S. Supreme Court issued its most important decision in a decade concerning pre-emption of common law claims for alleged product defect against medical device manufacturers. The Court held that a New York plaintiff could not pursue claims for negligence, strict liability and breach of warranty against Medtronic (manufacturer of the Class III heart catheter at issue) because the claims were based upon state law requirements that are "different from or in addition" to applicable federal law.
Plaintiff Charles Riegel filed a complaint in the U.S. District Court, Northern District of New York, alleging that a Medtronic heart catheter was defectively designed, labeled and manufactured in violation of New York common law. The catheter ruptured during Riegel's surgery, and he claimed resulting injury. The District Court held that the Medical Device Amendments of 1976, 21 U.S.C. Section 360k, pre-empted Riegel's claims for strict liability, breach of implied warranty and negligence in the design, labeling and sale of the device, and plaintiff Donna Riegel's claim for loss of consortium. The U.S. Court of Appeals, Second Circuit, affirmed.
The Supreme Court's opinion, written by Justice Scalia (J. Stevens concurring and J. Ginsburg dissenting), concluded that (1) the Federal Government had established requirements, through the MDA, which were applicable to the subject catheter; and (2) the plaintiffs' common law claims were based upon New York requirements that were "different from or in addition to" federal law, and that related to the device's safety and effectiveness.
Critical to the Court's decision was that the Medtronic device had been approved by the Food and Drug Administration following a "premarket approval" (PMA) application, and was a Class III device subject to the most stringent level of FDA scrutiny. The Court noted that PMA approved devices must undergo rigorous review by the FDA, involving on average 1,200 hours of review.
The Court distinguished its earlier decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which involved a different Medtronic device that had not undergone premarket approval.
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