Professor of Law, William Mitchell College of Law; Of Counsel, Larson  King

Professor J. David Prince analyzes the U.S. Supreme Court’s recent decision upholding federal preemption in Riegel v. Medtronic. The Court held that state-law tort claims against a manufacturer of an allegedly defective medical device, which had received premarket approval from the FDA, were preempted by the Medical Device Amendments of 1976. Reviewing the Court's ruling and discussing its impact on future actions involving allegedly defective medical devices, Professor Prince writes:

 In its first significant preemption ruling of 2008, the United States Supreme Court in Riegel v. Medtronic voted 8-1 in favor of upholding federal preemption. The Supreme Court’s ruling resolved a question that has divided the lower courts for more than a decade: Does the preemption clause in the Medical Device Amendments of 1976 (MDA) bar state common-law tort claims that challenge the safety and effectiveness of a medical device that received premarket approval from the U.S. Food and Drug Administration (FDA)?

Answering in the affirmative, the Supreme Court held that “[s]tate tort law that requires a manufacturer's [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.” In tracing the path of federal regulation over medical devices, the Supreme Court noted that the premarket approval process adopted in 1976 under the MDA “imposed a regime of detailed federal oversight” that is “specific to individual devices” and “is in no sense an exemption from federal safety review—it is federal safety review.” The Court pointed out that “the FDA may grant premarket approval only after it determines a device offers a reasonable assurance of safety and effectiveness.” Allowing Riegel to proceed with his state common-law tort claims would impose on Medtronic “different” or “additional” requirements from those imposed by the FDA premarket approval process and would disrupt the federal regulatory scheme. Thus, the Supreme Court held that Riegel’s claims were properly barred by the federal preemption provision in § 360k(a) of the MDA.

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The result in Riegel will not eliminate all product liability claims against medical device manufacturers. If a medical device is not manufactured in accordance with the specifications, including the proposed labeling, approved by the FDA, a state common-law claim that the device was defective would not be preempted. And the court’s holding does not resolve the question of whether § 360k(a) preempts post-sale defect claims – claims that the device is defective due to information that comes to light only after the device receives the FDA’s premarket approval. footnotes omitted.)

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