Article excerpt


Catherine Sharkey's essay, What Riegel Portends for FDA Preemption of State Law Product Liability Claims, represents an ingenious effort to work between the horns of the most pressing dilemma in today's law of federal preemption with her "agency reference model" of preemption.1 This issue is hot today because the Supreme Court recently held in Riegel v. Medtronic, Inc. that the Medical Devices Act preempted a plaintiffs state product liability claims alleging defective design of a balloon catheter after plaintiff suffered grievous injuries when the device ruptured inside his right coronary artery.2 It is worthy of note that here the treating physician made two controversial decisions: (1) he used the catheter on a patient whom FDA warnings classified as unfit for the treatment, and (2) he overinflated the catheter.3

The problem of FDA preemption also arises in the context of a drug manufacturer's duty to warn in a closely watched case recently argued before the Supreme Court, Wyeth v. Levine? In that case, the Vermont Supreme Court upheld a damage award on the ground that Wyeth should have warned the plaintiff against using its drug, Phenergan, in a risky procedure that the FDA had explicitly authorized. More specifically, the FDAapproved warning label allowed Phenergan to be injected intravenously by a so-called "IV push," or rapid injection into a vein by syringe, so long as physicians were alert of the risk of hitting an artery instead of a vein. The plaintiff suffered gangrene and consequent loss of a limb when the IV needle mistakenly punctured the artery. Plaintiff argued that Wyeth's label "should not have allowed IV push" - period?

To understand the legal issues raised by these two cases, it is useful to set the background with a thumbnail sketch of the modern law of preemption. All parties agree that some principles of interpretation are needed to work out the interrelationships between federal and state law, broadly conceived, that covers the same sphere of action. It is understood as well that the law of preemption divides itself into two halves. The first half deals with express preemption, which holds that if the federal government makes it clear - itself a term that turns out often to be unclear - that its statute preempts the state law, then the issue is over. Under the Supremacy Clause6 of the United States Constitution, the lowliest federal action trumps the most granthose state pronouncement. Conversely, if the federal statute makes it clear that the state law may peacefully coexist with it, a system of dual enforcement is appropriate.

In many cases, of course, the question of preemption is not resolved by express preemption, at which point the common view holds that there are three possible grounds for implied preemption. The strictest standard allows for preemption only in cases of actual conflict, such that there must be a clear inconsistency between what the federal government and the state government each allow or require. Second, it is often stated that the preemption in question only arises in those cases where the imposition of the state liability will frustrate the ends of the federal statute. Finally, a third form of preemption argues that preemption does not require this form of explicit conflict, but is satisfied if it appears that the federal statute has occupied the field, blocking state efforts to impose sanctions within that field even if there is no explicit conflict. For our purposes, the first and third forms of preemption are the most relevant ones. Drug cases are more problematic than device cases because the Medical Devices Act does contain an explicit preemption provisions for medical devices, in contrast to drug cases, which are subject to no explicit form of preemption.7

Professor Sharkey's distinctive contribution to this debate is her careful elaboration of the "agency reference model" of preemption, which enriches the debate over preemption by consciously incorporating administrative law principles resting on the twin pillars of Chevron U. …