In Riegel v. Medtronic, 2008 WL 440744 (No. 06-179), the Court held 8-1 that the Medical Device Amendments of 1978 (MDA) preempted state tort claims regarding the safety and efficacy of medical devices given premarket approval by the FDA. Justice Scalia wrote for the Court, with Justice Stevens concurring in part and in the judgment, and Justice Ginsburg dissenting. And in Rowe v. New Hampshire Motor Transport Association, 2008 WL 440686 (No. 06-457), the Court held unanimously that a preemption provision in the Federal Aviation Administration Authorization Act of 1994 preempted a Maine law requiring carrier companies to verify age for tobacco deliveries. Justice Breyer wrote for the Court, with Justices Ginsburg and Scalia writing concurring opinions.

                The Riegels alleged that Charles Riegel was seriously injured by a balloon catheter device made by Medtronic. The MDA preempts any “requirement” of state law that is “different from, or in addition to, any requirement” of federal law, and that “relates to the safety or effectiveness of [a medical] device or to any other matter included in a requirement” of federal law. 21 U.S.C. § 360k(a). In Medtronic v. Lohr, 518 U.S. 470 (1996), the Court held that the MDA did not preempt state tort claims based on defective medical devices that were on the market prior to MDA. The Court distinguished Lohr, holding that FDA premarket approval standards are “requirements” under the MDA, and that tort claims of negligence, strict product liability, and breach of warranty fell within the MDA’s preemption clause.

                A few things to note about Riegel: First, the Court held that common law duties are “requirements” just like state statutes. To extent that other federal preemption clauses use the term “requirements,” they therefore are likely to preempt the common law. Stevens, however, pointed out that under the Court’s precedents not all common law claims are necessarily “requirements.”

                Second, neither Scalia’s nor (strangely) Stevens’s opinion mentioned the presumption against preemption, usually trumpeted by Stevens in cases where traditional state remedies are at issue. This presumption was a major focus of Ginsburg’s dissent. In fact, Scalia appears to invoke a presumption in favor of preempting tort law; he says that because tort law is applied by a jury, who “sees only the cost of a more dangerous design, and is not concerned with its benefits,”  it may be “less deserving of protection” than a statute. (Stevens pointed out that it is in fact judges, not juries, who define common law duties.)

                Third, the decision raises several questions to be decided in later cases. The Court states that the MDA does not preempt state claims that “parallel” the MDA. This issue may be explored further in Warner-Lambert v. Kent (06-1498), to be argued on February 25, concerning product liability claims alleging that a device manufacturer falsified its application to the FDA. As noted in the dissent, the Court also did not address claims based on safety hazards that came to light after FDA approval. The dissent also indicated that, while lower courts have held that product liability suits regarding prescription drugs are not preempted per se, defendants could still argue that an individual plaintiff’s theory of the case conflicts with FDA requirements. Prescription drug preemption will be addressed later this term in Levine v. Wyeth (06-1249).

                In Rowe, the Maine tobacco statute was held preempted under 49 U.S.C. § 14501(c)(1), which preempts any state law “related to a price, route, or service of any motor carrier.” The Court followed its very broad application of a similar preemption clause in Morales v. Trans World Airlines, 504 U.S. 374 (1992). It stated that the Maine law had a “direct ‘connection with’ motor carrier services” because it imposed specific verification duties on them. It also stated that the state law’s impact on carriers was “significant” because it mandated certain services. The Court dismissed Maine’s argument that the impact was insignificant because its economic impact would be minimal. While Maine characterized its law as a public health measure, the Court stated that the federal clause had no “public health exception,” and did not mention the presumption against preemption that the Court has previously applied to state health and safety laws. Justice Scalia wrote a short concurrence criticizing (once again) the Court’s reliance on legislative history.

                Both Justice Stevens’s concurrence in Riegel and Justice Ginsburg’s concurrence in Rowe took the view that preemption was required by the Court’s precedents, even though Congress had not intended to preempt these protections for consumers. Such regretful concurrences are becoming a staple of the Court’s preemption jurisprudence. See Aetna Health Inc. v. Davila, 542 U.S. 200, 222 (2004) (Ginsburg and Breyer, J.J., concurring in preemption of suits against health plan administrators).

                In a third case, Preston v. Ferrer, 2008 WL 440670 (No. 06-1463), the Court held 8-1 the Federal Arbitration Act preempted a state law under which a state administrative agency would conduct an initial review of disputes before they were submitted to arbitration. Justice Ginsberg wrote for the Court that the California law violated the FAA’s “national policy in favor of arbitration” by granting primary jurisdiction to a non-arbitral tribunal where the parties had previously agreed to arbitration. Justice Thomas dissented, solely on the ground that he believed the FAA never applied to state court proceedings.