By Richard A. Epstein[*]
Introduction: Preemption in Flux
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. This issue is hot today because the Supreme Court recently held in Riegel v. Medtronic, Inc. that the Medical Devices Act preempted a plaintiff’s 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. 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. The problem of FDA preemption also arises in the context of a drug manufacturer’s duty to warn in a case scheduled to come before the Supreme Court next year, 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 FDA-approved 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 action 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 Clause of the United States Constitution, the lowliest federal action trumps the most grandiose 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.