The mature product preemption doctrine: the unitary standard and the paradox of consumer protection.

• Author: Eggen, Jean Macchiaroli

INTRODUCTION

The product preemption doctrine (1) is reaching maturity with all the awkwardness of a hundred-year-old adolescent. (2) The history of modern product preemption doctrine has been characterized by inconsistency and paradox, (3) and attorneys anticipate each new decision of the United States Supreme Court with a mixture of hope for a definitive test and preparedness for new battles in an increasingly confusing landscape. (4) To date, the Supreme Court's product preemption jurisprudence has failed to produce an optimal level of certainty and predictability in an area of the law dedicated to consumer protection.

An important segment of the Court's product preemption jurisprudence has involved medical devices and drugs regulated under the Food, Drug, and Cosmetic Act (FDCA). (5) In fact, two of the Court's three important preemption decisions in 2008 and 2009 have involved aspects of regulation under the FDCA. Products generally, and medical devices and drugs in particular, involve a complex set of policies relating to public health and safety, areas traditionally within the police power of the states. Federal product regulation also overlaps with state common law. One has only to look at the recent Vioxx debacle to see the problems that can result when a resource-stressed Food and Drug Administration (FDA) is hindered in providing necessary product oversight. (6) In the thousands of lawsuits that alleged illness or death associated with Vioxx use, the manufacturer, Merck & Co., argued that the plaintiffs' tort claims were preempted because the FDA approved the drug for marketing. (7) The delicate balance between these kinds of product liability claims, which ultimately establish standards of conduct, and FDA regulation, which serves other goals as well, (8) presents a special challenge in preemption analysis. Focusing on cases involving the FDCA, therefore, provides insight into the most pressing problems raised by the Court's product preemption doctrine.

Now that the product preemption doctrine is entering its maturity with the recent triad of Supreme Court decisions, (9) it is useful to reassess the doctrine. This Article undertakes that task and reaches some disappointing conclusions from the perspective of consumer safety. In an earlier article, I argued that the Court's product preemption doctrine embodies certain norms and rules, including the value of consumer protection. (10) As the doctrine has matured, however, there is a disconnect between those goals and the analytical process by which the Court reaches its decisions on preemption. The mature doctrine is not easily discernible from the collection of individual cases. Rather, it must be understood as a kind of gestalt, which presents itself as something other than the sum of its individual parts. Thus, even in cases in which the result reached by the Court on preemption advances consumer protection goals, the underlying process used by the Court may establish a precedent that will jeopardize those goals in future cases. The doctrine is a double-edged sword, wielded in the interest of consumer protection, but just as capable of mortally wounding that goal in a broad sweep.

Part I of this Article begins by briefly reviewing some of the decisions that defined the Supreme Court's product preemption doctrine prior to 2008. This section focuses primarily on the often irreconcilable inconsistencies among the cases and the resulting confusion over the standards they embody. Part II considers the overriding concerns of product safety and consumer protection that form the basis of most of product law, both in regulation and in the common law. Particular attention is given to the challenges faced by the FDA in making accurate decisions on the safety and effectiveness of drugs and medical devices as the agency struggles with insufficient resources and increasing demands. Part III of this Article presents a critical analysis of the triad of product preemption cases that the Court decided in 2008 and 2009, and demonstrates what these decisions add to the development of the doctrine. Armed with this new information, I argue in Part IV that the mature product preemption doctrine has become a unitary standard, merging previously discrete analytical elements into a single process. Finally, Part V argues that the unitary standard poses a threat to the health and safety goals of product liability law, particularly in an era when the FDA is unable to fully and effectively execute its role in product safety. This Article concludes that although consumer interests may have been served in many of the Court's preemption cases, the potential for arbitrary and policy-laden decisions is great.

1. THE DEVELOPMENT OF THE PRODUCT PREEMPTION DOCTRINE: CASES AND CONFUSION

   Prior to 2008, the United States Supreme Court issued a number of important decisions on the product preemption doctrine. I do not intend to survey these decisions in any detail, as they have been thoroughly surveyed in the past. (11) Rather, in this section I identify and elucidate the concepts that are significant in the mature doctrine and demonstrate how the confusion over the analytical standards has arisen. The doctrine of preemption is derived from the Supremacy Clause (12) of the United States Constitution. (13) The United States Supreme Court has consistently recognized several types of preemption, which have fallen into the two broad categories of express preemption and implied preemption. Express preemption of state laws may arise when the federal statute or a regulation promulgated by a federal agency within its statutory authority (14) contains a preemption provision that sets forth the circumstances under which state rules will be barred. (15) Implied preemption may occur in several ways. First, Congress may have intended a particular statutory scheme to "occupy the field" on the subject in question. If so, "[t]he scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it." (16) Second, state laws may be preempted because there is an actual conflict between them and the federal statute in one of two ways. (17) Conflict preemption may occur when it is impossible to comply with both the federal statute or regulation and the state-law rules (18) or when state law is an obstacle to the achievement of the goals of the federal scheme. (19)

   Another fixture in the preemption landscape has been the so-called presumption against preemption. This presumption, which derives from the Supremacy Clause, holds that "the historic police powers of the States [are] not to be superseded by the Federal Act unless that [is] the clear and manifest purpose of Congress." (20) This definition of the presumption against preemption is particularly apt in the context of products involving health and safety issues. What has not been clear from the Supreme Court's jurisprudence, however, is why the presumption is rejected--or ignored--in some cases where it would otherwise seem applicable. (21)

   The perceived dichotomy between express preemption and implied preemption--and the notions that they are invoked under different circumstances and involve different analytical processes--has driven much of the legal system's understanding of product preemption. To be sure, the Supreme Court has typically dealt with express preemption and implied preemption as separate processes. But these processes have often seemed at cross purposes, and the rules the Court has followed have appeared inconsistent. In particular, the relationship between express preemption and implied preemption, and the extent to which either or both are involved in a given case, have often flummoxed Court observers and confounded courts attempting to apply the doctrines.

   Comparing several Supreme Court cases demonstrates the breadth of this problem. In Cipollone v. Liggett Group, Inc., (22) the Court was called upon to interpret the language in the express preemption provisions of two federal cigarette labeling statutes establishing mandatory health warnings on cigarette packages and elsewhere. (23) The underlying action was a product liability suit brought by the estate of a smoker. (24) The Cipollone Court conducted a detailed examination of the scope of the preemption provisions in the two statutes. The Court first held that the language in the 1965 preemption provision was not intended to preempt state common-law suits, and then further held that Congress intended the provision in the 1969 Act to preempt at least some state tort claims. (25) The Court's analysis centered around the intent of Congress in changing the language of the 1969 provision to bar state-law "requirements" based upon the advertising and promotion of cigarettes. (26) The Court held that Congress intended the term "requirements" to include at least some common-law claims. (27) In a plurality opinion written by Justice Stevens--a frequent author of subsequent product preemption decisions for the Court--the Court ultimately held that the failure-to-warn claims were preempted, but that the breach of express warranty claim and the misrepresentation claims based upon a general duty not to deceive under state law were not preempted. (28)

   The Cipollone Court suggested that because the cigarette labeling acts contained express preemption provisions, only express preemption analysis was appropriate. Thus, the Court stated: "In our opinion, the pre-emptive scope of the 1965 Act and the 1969 Act is governed entirely by the express language" therein. (29) Furthermore, the Court reasoned that when an express preemption provision "provides a 'reliable indicium of congressional intent with respect to state authority'"--in other words, where Congress clearly indicated what kinds of state rules were barred--the provision absolutely governs on matters of preemption. (30)

   In 1996, in Medtronic, Inc. v. Lohr...