The following post is by Anna Neill, a student in the Stanford Supreme Court Litigation Clinic.

On February 20, 2008, the Supreme Court affirmed the Second Circuit decision in Riegel v. Medtronic, Inc., holding that the preemption clause of the Medical Device Amendments of 1976 (21 U.S.C. § 360k(a)) bars common-law claims challenging the safety or efficacy of a medical device marketed in a form that has received pre-market approval from the FDA (more on the background of the case can be found here at SCOTUSwiki). Justice Scalia wrote the opinion of the Court, joined in full by six other justices. Justice Stevens joined the majority opinion except with respect to two parts, and also filed an opinion concurring in part and concurring in the judgment. Justice Ginsburg filed a dissenting opinion.

Because § 360k(a) prohibits the imposition of “requirements” that are either different from or in addition to those established by the federal government, the first question the Court addressed was whether the FDA pre-market approval (PMA) process for medical devices establishes “requirements.” Distinguishing the 1996 case of Medtronic v. Lohr, in which preemption was not found for devices that had been approved under a grandfathering process, the Court found that the PMA process constitutes a “rigorous” review “specific to individual devices,” thereby imposing federal “requirements” on the devices so approved. Finding that the PMA had imposed requirements on the device at issue, the Court then turned to the question whether the Riegels’ common-law tort claims relied on “any requirement” that was different from or in addition to the PMA requirements. Adhering to the view of five Justices in Lohr that common-law negligence and strict liability claims do impose “requirements,” the Court explained that a state tort law requiring a device to be safer than the model approved by the FDA would disrupt the federal regulatory scheme, and that the state “requirements” were thereby preempted.

Addressing the dissent’s view that Congress in enacting § 360k(a) did not intend to preempt state tort remedies, the majority emphasized that “[i]t is not our job to speculate on Congressional motives,” and that barring state tort claims is exactly what the preemption clause does by its terms. Finally, the Court declined to address the Riegels’ argument, raised for the first time in their merits brief in this case, that the state requirements here were not different from or in addition to federal requirements, but rather were parallel to such requirements.

Justice Stevens, while agreeing with Justice Ginsburg that Congress did not intend to achieve the result the Court found here, nonetheless read the text of § 360k(a) to require preemption in this case. But he declined to join the opinion of the Court insofar as it expressed a view that Congress intended to preempt state tort law claims to protect the federal regulatory scheme.

Justice Ginsburg dissented from what she viewed as a “constriction of state authority” that Congress never intended. Discussing at length the history of the Medical Device Amendments (MDA) and their purpose to “protect consumer safety,” she found both the failure of the MDA to establish a federal compensatory remedy and the lack of a similar preemption provision in federal pharmaceutical regulation to indicate that Congress did not intend to bar state tort claims for medical devices. Finally, Justice Ginsburg pointed out that failing to find preemption here would not render the FDA PMA process irrelevant – it would still be relevant to the question of possible conflict preemption as well as other affirmative defenses.

Posted in Riegel v. Medtronic, Everything Else