February 22, 2008
On February 20, the Supreme Court of the United States issued an 8-1 decision in Riegel v. Medtronic, Inc., which held that federal law preempts state-law products liability claims challenging the design and labeling of medical devices that the federal Food and Drug Administration ("FDA") has found to be safe and effective. The decision ensures that juries applying state law will not be able to second-guess the FDA’s expert determinations regarding the safety and effectiveness of complex medical devices.
Charles Riegel’s suit alleged that he had been injured when the Medtronic balloon catheter used to treat a clogged artery during an angioplasty procedure burst, and that Medtronic was liable under New York law for negligently designing and labeling the balloon catheter. Before that device entered the market, the FDA had found it to be safe and effective pursuant to its rigorous premarket approval ("PMA") process. That process entails more than 1,200 hours of substantive review by the agency and provides that a manufacturer may not deviate from the design and labeling specifications approved by the FDA. Affirming a decision of the U.S. Court of Appeals for the Second Circuit, the Supreme Court held that state-law products liability claims challenging the design and labeling of PMA-approved devices are preempted by the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, which prohibits States from establishing "with respect to a [medical] device . . . any requirement which is different from, or in addition to, any requirement" imposed by federal law. The Court explained that the design and labeling "requirements" embodied in state-law products liability claims would be "different from" the FDA-approved requirements and would "disrupt[ ] the federal scheme" for regulating the safety and effectiveness of medical devices.
In holding that Mr. Riegel’s claims were preempted, the Court distinguished its earlier decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which had held that federal law does not preempt state-law claims challenging the design and labeling of devices that have entered the market through the comparatively streamlined § 510(k) process. The Court explained that § 510(k) clearance grants an exemption to manufacturers that market a device that is "substantially equivalent" to certain pre-existing devices, and thus "is focused on equivalence, not safety." The premarket approval process, in contrast, is "focused on safety" and imposes federal requirements regarding the design and labeling of medical devices.
The Court alerted Congress that, in future cases construing federal preemption provisions, it will interpret a statute’s reference to state-law "requirement[s]" to include common-law duties, absent a contrary indication. It further emphasized that, in order to be preempted, a state common-law duty need not "apply only to the relevant device, or only to medical devices." Federal law preempts general common-law duties, the Court explained, whenever a jury’s application of those general duties would result in state-law design and labeling requirements for a device that are different from the applicable federal requirements.
The Court’s opinion recognizes that Congress has vested the experts of the FDA—not lay juries—with the responsibility for determining the safety and effectiveness of complex medical devices. In so doing, the Court’s decision ensures that the development of life-saving medical devices will not be stifled by the potential imposition of state-law liability.
Gibson Dunn’s Theodore B. Olson, Matthew D. McGill, Amir C. Tayrani, and Dace A. Caldwell briefed the case on behalf of Medtronic. Theodore B. Olson presented oral argument in the Supreme Court.
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