Companies that market Class III medical devices subject to premarket approval are shielded from state law claims that would impose requirements different from or in addition to those imposed by FDA. The decision may have implications for two FDA preemption cases involving new drugs that are still pending before the Supreme Court.

A premarket approval application (PMA) for Medtronic’s Evergreen© Balloon Catheter was approved by the U.S. Food and Drug Administration (FDA) in 1994 under the provisions in the Medical Device Amendments of 1976 (MDA) applicable to Class III medical devices. Class III medical devices subject to PMA requirements are those (a) intended “for a use in supporting or sustaining human life,” (b) “of substantial importance in preventing impairment of human health,” or (c) that “present[ ] an unreasonable risk of illness or injury.” When it approved the PMA, FDA specifically reviewed and approved the product’s design specifications and label. In particular, the FDA approved label stated that the device was contraindicated for patients with “diffuse or calcified stenoses.” The label also warned against inflating the catheter beyond its rated burst pressure. Despite the fact that he suffered from diffuse and calcified stenosis, Charles Riegel underwent an angioplasty procedure in 1996 using the Evergreen Balloon Catheter. During the procedure, the catheter ruptured as a result of over inflation by Mr. Riegel’s doctor. Sadly, Mr. Riegel later died as a consequence of the rupture. An action was thereafter brought against Medtronic under New York state law claiming that the Evergreen Balloon Catheter was defective because, among other things, it was defectively designed and labeled. The U.S. District Court for the Northern District of New York dismissed the action on the basis of the MDA’s express preemption provision. This prohibits a state from “establish[ing]” “any requirement” that “relates to the safety or effectiveness” of a device and that is “different from, or in addition to, any requirement” imposed by FDA. The U.S. Court of Appeals for the Second Circuit affirmed the dismissal.

On these facts, an 8–1 majority of the United States Supreme Court, in a pointed opinion written by Justice Scalia, held that the Riegel’s state law tort action against Medtronic was preempted by the MDA’s express preemption provision. Riegel v. Medtronic, Inc., No. 06-179 (February 20, 2008), available at  http://www.law.cornell.edu/supct/html/06-179.ZS.html . Indeed, Justice Scalia had little difficulty in according the express language in the MDA’s express preemption provision its express meaning. Thus, he said, a judgment imposing liability on Medtronic in this case would amount to a “requirement” relating to the device’s “safety or effectiveness” that is “different from, or in addition to” a “requirement” imposed on the device by FDA and hence is preempted. Here, the FDA “requirement” is imposed as a consequence of the intensive and comprehensive design review and label approval that culminates, and is reflected, in the approved PMA. In this respect, Justice Scalia differentiated the PMA safety and effectiveness review process applicable to Class III devices from the “substantial equivalence” process that applies under §510(k) of the Federal Food, Drug, and Cosmetic Act. The §510(k) process focuses on equivalence, not on the device’s underlying safety or effectiveness, which, according to Justice Scalia, was the primary reason why the Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), declined to accord preemptive effect to a device “clearance” obtained under that section. By contrast, review under a PMA “is federal safety review” (emphasis in original) and “FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application” because “FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.”

In her thoughtful dissenting opinion, Justice Ginsburg proposed an interpretation of the MDA’s express preemption provision based on its legislative history and purpose. According to her, Congress’s purpose in enacting the MDA’s express preemption provision was to displace conflicting state device approval regimes, such as the one enacted in California in the early 1970s, and not to displace state product liability law. In an opinion concurring with the majority, Justice Stevens agreed with Justice Ginsburg’s analysis of legislative history and purpose, but nevertheless sided with Justice Scalia’s interpretation of the MDA’s express preemption provision on the theory that “it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed” (quoting, Oncale v. Sundowner Offshore Services, Inc., 523 U.S. 75, 79-80 (1998)).

The primary policy justification for finding federal preemption in Riegel was the majority’s conclusion that “[s]tate tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law.” This disruption is primarily a consequence of the differing risk versus benefit balance that an adverse state tort judgment would represent from the benefit versus risk trade-off that FDA made in approving the PMA and thereby allowing the device onto the market in the first instance. Of course, “disruption” of the federal scheme is not a distinct element of the express statutory preemption standard in the MDA. On the contrary, it is more akin to the question presented in implied conflict preemption cases, where the issue is whether the state law stands as an “obstacle” to the accomplishment of the full purposes and objectives of Congress. In this respect, then, the decision in Riegel may be relevant to two other closely watched FDA preemption cases that involve FDA’s new drug approval process, which lacks an express preemption provision. The cases have also been accepted for review by the Supreme Court. For more information, see McDermott Will & Emery On the Subject “FDA Issues Proposed Regulations on Supplemental Applications for Labeling Changes,” published January 22, 2008, available at  http://www.mwe.com/info/news/ots0108e.htm .

Of course, the decision in this case may not be the final word on express preemption under the MDA. Several members of Congress, including Senator Edward Kennedy and Congressman Henry Waxman, are reported to be considering legislation that would overturn the result here. Stay tuned.