U.S. Supreme Court Ruling in Riegel v. Medtronic Confirms Preemption for Medical Devices with FDA Premarket Approval

On February 20, 2008, the U.S. Supreme Court ruled that the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA) preempt most state tort claims that challenge the safety or effectiveness of a device marketed in a form that received premarket approval from the Food and Drug Administration (FDA). Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008). The Court concluded that manufacturers cannot be held liable under state common law causes of action that seek to impose requirements with respect to the device that are “different from, or in addition to,” federal requirements governing the device’s safety or efficacy.

The opinion lays to rest more than a decade of debate regarding the effect of the MDA’s so-called “preemption clause” with respect to state product liability suits involving devices that have undergone premarket approval (PMA devices). In concluding that FDA regulation left no room for competing state tort lawsuits, Justice Scalia’s majority opinion focused on the “rigorous” nature of the premarket approval process, noting, for example, that FDA spends an average of 1,200 hours reviewing each application and grants premarket approval only after it finds that there is a “reasonable assurance” of the device’s safety and effectiveness, and that it requires a device that receives premarket approval to be made with almost no deviations from the specifications in its approval application. The Court also cited FDA’s review of proposed device labeling during the premarket approval process and the post-approval reporting obligations imposed on manufacturers as evidence of the comprehensive nature of the federal oversight.

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