What Riegel Portends for FDA Preemption of State Law Products Liability Claims (Part II)

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:

In the case before us, the FDA has supported the position taken by our opinion with regard to the meaning of the statute. We have found it unnecessary to rely upon that agency view because we think the statute itself speaks clearly to the point at issue. If, however, we had found the statute ambiguous and had accorded the agency’s current position deference, the dissent is correct that—inasmuch as mere Skidmore deference would seemingly be at issue—the degree of deference might be reduced by the fact that the agency’s earlier position was different.[46]

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.

What Riegel Portends for FDA Preemption of State Law Products Liability Claims

By Catherine M. Sharkey[*]

[download pdf]

[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 said news organizations often fail to focus on the text of the laws the Court interprets . . . . The media often make it appear as though the court is reaching policy judgments on its own rather than basing its decisions on the text of the law at issue in a case . . . . In some instances, said Scalia, the news media leave the impression that no ruling based on the text of a law “is even possible.”[2]

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]