By Catherine M. Sharkey[*]

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[Editor's Note: This week, we are pleased to present Professor Sharkey's Essay on FDA preemption in light of Riegel v. Medtronic.  Part I appears today.  Part II of this Essay will appear on Thursday.]  

Introduction: Preemption Cases in Search of a Framework

In Riegel v. Medtronic, Inc., the U.S. Supreme Court held that a federal statute governing regulation of medical devices expressly preempts, or displaces, state tort law claims when a device has received FDA premarket approval.[1]  A month after the Court issued this opinion, Justice Scalia inveighed against the news media coverage of Riegel (an opinion that he authored) at a meeting convened by the Food and Drug Law Institute:

Scalia's majority opinion can indeed be fairly characterized as a "narrow, textual interpretation" of the preemption clause of the congressionally enacted Medical Devices Amendments of 1976 (MDA) to the Federal Food Drug and Cosmetics Act (FDCA).[3]  Express preemption cases, at least in theory, can begin and end with statutory text.

But it is rare to find a products liability preemption case where, in Justice Scalia's words, "the statute itself speaks clearly to the point at issue."[4]  Far more typically, disagreements erupt among the Justices over whether statutory language is in fact clear.  Often congressional legislation touches on some aspects of federal regulation of consumer products, motor vehicles, or recreational boats (to name a few examples), without clearly specifying the interrelationship with state common law tort claims.  In such legislation, Congress often creates confusion by including both a preemption clause, which mandates displacement of competing or conflicting state law standards, and a savings clause, which purports not to upend existing state common law liability.[5]

Where the language of the preemption and savings clauses points in opposite directions, or where Congress has been cryptic or silent on the matter, Justice Scalia's ode to text will ring hollow.  Courts will have to decide on the basis of implied conflict preemption (as opposed to express preemption), looking at the entire statutory and regulatory framework to determine whether state laws either "make it 'impossible' for private parties to comply with both state and federal law,"[6] or, more broadly, whether state laws frustrate or "stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress."[7]  Justice Ginsburg's lone dissent in Riegel may well portend the true battleground in implied conflict preemption challenges to come: "In the absence of legislative precision . . . courts may face the task of determining the substance and scope of Congress' displacement of state law."[8] Where statutory text is indeterminate, where are courts to look?

Several options present themselves.  First, courts may resort to the "presumption against preemption" statutory canon to raise the bar against interpretations favoring preemption absent clear language by Congress.[9]  While this approach retains some appeal for judges and academic commentators,[10] it has receded of late in the imagination of the Supreme Court Justices.  In fact, this canon was not even mentioned by the majority in Riegel.[11]

By Catherine M. Sharkey[*]

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[Editor's Note: This week, we are pleased to present Professor Sharkey's Essay on FDA preemption in light of Riegel v. Medtronic.  Part II appears today.]  

II.  Judicial Review

The Riegel majority had little to say about judicial review of agency actions or interpretations, given the primacy and determinacy of statutory text to the question at hand. But what little the Court did have to say may have resolved (at least in dicta) a simmering debate over the appropriate level of deference due to agency views on preemption:

Wrapped up in this quixotic counterfactual musing are two salient doctrinal points: first, that "mere Skidmore" deference—which is meted out according to the agency's "power to persuade" the court, as opposed to unconditionally[47]—is the appropriate level of judicial deference; and second, that agency inconsistency is a salient factor, weighing against an agency's new-found (and by hypothesis, turn-about) position. What is missing is a framework for the Court to undertake judicial review, probing the adequacy of the reasons given by the agency for taking a particular action, as well as for changing tack and taking a different course of action.

By Richard A. Epstein[*]

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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.[1]  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.[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 case scheduled to come before the Supreme Court next year, Wyeth v. Levine.[4]  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.[5]

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[6] 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.