Preemption as inverse negligence per se.

• Author: Moreland, Michael P.

Federal preemption of state tort claims has been a controversial and frequently litigated issue over the past decade, arguably constituting the most important, if confusing, development in tort law over that period. Books, (1) law review symposia, (2) and much of a blog (3) are devoted to the topic. But a grand unified theory of preemption doctrine has been elusive, and preemption cases come to wildly unpredictable results. Sometimes statutory text is said to control the outcome of a case, but sometimes statutory text is all but ignored. (4) Sometimes questions of state sovereignty are placed at the forefront of preemption analysis, but other times the demand for a uniform federal scheme of regulation trumps state common law. (5) Sometimes courts defer to an agency's view about the preemptive effect of an agency's own regulations, but other times courts refuse to defer at all. (6) It is little wonder that scholars have described the Supreme Court's preemption jurisprudence as a muddle or as simply a veiled assertion of political power on behalf of either plaintiffs' lawyers or defendant manufacturers. (7) How can we account for the apparently inconsistent and unsatisfying results in preemption cases?

Part of the problem, I suggest, is that federal preemption of state tort claims is particularly susceptible to the tendency to hit every legal nail with a public law hammer. What almost everyone in the preemption debate assumes is that the resolution of preemption cases is primarily a question of public law, involving various aspects of constitutional law, administrative law, and statutory interpretation. My argument here is that this apparent consensus fails to account for the divergent contexts to which preemption doctrine applies. In particular, the preemption of common law tort claims raises specific tort issues that have been largely neglected by courts and scholars. Most assume that common law tort remedies are state "regulations" in the relevant sense and so are subject to review through considerations of agency deference, regulatory competence, or national versus state power. This view obscures the fact that federal preemption, in whatever context, is always an argument about preemption of something--a state law tort claim, a local government's effort to engage in foreign affairs, (8) state regulation of health insurers, (9) or state labor law. (10)

But once the question of whether federal law preempts state tort law has been raised, it does not require--or so I shall argue--that traditional principles of common law adjudication be discarded as well, particularly where the only available substitutes for common law categories are versions of textualist statutory interpretation or freewheeling "purposes and objectives" tests for implied preemption. (11) This Article suggests that the missing element in much of the case law and scholarship on preemption of tort claims is attention to the underlying character of the common law tort claims themselves. Such attention has been neglected party on account of the dominant constitutional and administrative law approaches to preemption, but also on account of the tendency even in tort law to treat products liability as if it were a separate field with its own, quite different set of doctrines. Though such issues are beyond the scope of this Article, the shift in the Restatement (Third) of Torts: Products Liability toward bringing negligence considerations back into design defect claims, (12) arguments for the bearing of negligence factors on failure to warn claims, (13) and recent scholarship on such traditional tort topics as causation in products liability claims (14) suggest that the effort to employ traditional common law tort doctrine in an area touching on products liability is not as odd as it might at first appear. My suggestion in this Article is that preemption analysis in the context of state tort claims would benefit both descriptively and normatively, by invoking the traditional tort doctrine of negligence per se but, in the preemption context, on behalf of defendants--inverse negligence per se.

My argument will proceed in three steps. First, I will summarize the deep confusion around preemption doctrine, most recently on display in a series of cases in the regulation of medical devices, automobile safety, and the labeling of prescription drugs. Second, I will take up the traditional doctrine of negligence per se and reframe preemption of state tort law claims as "inverse negligence per se." Third and finally, I will argue that preemption as inverse negligence per se as applied to recent preemption case law offers a superior descriptive account of the outcomes in recent cases and a superior normative account for understanding federal preemption.

1. THE CONFUSION OF TRADITIONAL PREEMPTION DOCTRINE

   Scholars are frequently tempted to characterize any area they happen to be working in as deeply confused or in need of thorough reworking, but with respect to preemption such characterizations happen to be true. The Supreme Court's preemption jurisprudence traces back to such cases as San Diego Building Trades Council v. Garmon, (15) involving the National Labor Relations Act, and Silkwood v. Kerr-McGee Corporation, (16) in which the Court held that an award of punitive damages was not preempted by the Atomic Energy Act. (17) Courts and scholars struggle to explain why preemption cases come to divergent results, even in regulatory areas that are closely related. State tort claims for design defects in medical devices that have received pre-market approval from the FDA are preempted, (18) but claims that medical devices that were approved based on their similarity to previously approved devices are not. (19) Claims that automobiles without airbags are defectively designed are preempted, (20) but claims that automobiles with lap-only seat belts (instead of lap and shoulder belts) in rear inner seats are not. (21) Design defect claims against manufacturers of routinely administered childhood vaccines (22) and failure to warn claims against manufacturers of generic drugs are preempted, (23) but failure to warn claims for labeling of brand-name prescription drugs are not. (24) Commentators routinely characterize the Supreme Court's preemption case law as a "muddle," (25) turning on narrowly technical discussions of statutory interpretation, agency deference, and federalism. But in recent years the pace of preemption decisions has quickened considerably, particularly cases in which defendants argue that federal law preempts state common law tort claims. (26)

   1. Overview of Preemption Doctrine

      Preemption is the apparently straightforward constitutional doctrine based in the Supremacy Clause that a "state law that conflicts with federal law is 'without effect.'" (27) Preemption is traditionally divided among "express," "conflict," and "field" preemption:

      Congress' intent may be "explicitly stated in the statute's language or implicitly contained in its structure and purpose." In the absence of an express congressional command, state law is preempted if that law actually conflicts with federal law, or if federal law so thoroughly occupies a legislative field "'as to make reasonable the inference that Congress left no room for the States to supplement it.'" (28) Traditional preemption analysis begins with statutory interpretation. (29) If the federal statute contains an express preemption clause, then inconsistent state laws within the scope of the clause are pre-empted. (30) If there is no express preemption clause, courts typically then consider whether state law is impliedly preempted, either because Congress has occupied the relevant regulatory field or because state law would pose an obstacle to federal objectives. (31) Most controversial is consideration of federal "purposes and objectives" in preemption cases, where courts attempt to isolate congressional purposes in enacting a statute and then try to determine whether state law stands in the way of that purpose. (32)

      Though the preemption debate had simmered for many years in such contexts as federal nuclear safety statutes (33) and cigarette warnings, (34) the most recent spate of controversy and litigation began in January 2006 with the FDA's release of a revision to its physician labeling rule for prescription drugs and an accompanying preamble asserting that the rule preempted state common law causes of action. Some states had already enacted statutes that provide measures of protection against liability for pharmaceutical defendants demonstrating compliance with FDA requirements, (35) and I will discuss below the differences between such regulatory compliance arguments and my category of "inverse negligence per se." Preemption at the federal level by the FDA would, of course, have been a much more powerful defense in pharmaceutical products liability litigation than relying on a patchwork of state statutes. The FDA's action, then, represented a newer, more aggressive approach to federal preemption that some termed "silent tort reform." (36)

      As the debate unfolded, five questions were at the heart of the FDA preemption debate that are also pertinent to other regulatory settings. Part of my argument in defending an alternative approach to preemption is that the interminable debates around these questions frustrate progress in adequately understanding preemption. First, where Congress has not expressly preempted state law (or where a statute is ambiguous) how broadly may courts invoke principles of conflict preemption to find state tort claims preempted? Beginning in 2000 with Geier v. American Honda Motor Company, (37) the Supreme Court has decided a series of preemption cases involving statutes that did not expressly preempt state common law claims but in which the Court has occasionally adopted a broader doctrine of implied conflict preemption. Because the FDA labeling cases based on failures to...