This Symposium was convened to explore the state of the civil justice system in the United States. At the time, Wyeth v. Levine (1) was pending before the United States Supreme Court, and a decision was not anticipated until the end of the Term. My project was to comment on the state of the Court' s jurisprudence in regulatory implied conflict preemption cases. These are cases in which federal regulatory action is said to pre-empt state tort or products liability law because the application of state law is alleged to obstruct the fulfillment of federal regulatory objectives. The issue is important, not just because the disposition of Wyeth would decide whether failure-to-warn cases against drug companies are preempted, but also because Wyeth was seen as a test case for President George W. Bush's campaign to use regulatory implied conflict preemption to provide businesses insulation from state tort and products liability cases. From 2002 through 2008, each of the nation's key federal health and safety regulatory agencies--including the Food and Drug Administration (FDA), the National Highway Traffic Safety Administration (NHTSA), the Consumer Product Safety Commission (CPSC), and the Federal Railroad Administration (FRA)--took the position that virtually any regulatory action taken by the agency, including statements in regulatory preambles and obscure references on agency web-sites, had the effect of wiping away state law. If that position were upheld by the courts, Americans injured through no fault of their own by everyday consumer products might find themselves without any remedy at all.
As discussed below, the Court's recent ruling in Wyeth emphatically rejects the FDA's argument that its approval of a drug's label preempts state failure-to-warn claims. The decision also clarifies and, in my view, narrows considerably the doctrine of regulatory implied conflict preemption, and does so in a way that likely consigns the Bush Administration's pro-preemption efforts to repudiation by the courts.
Before turning to Wyeth, it is useful to explore the critique of the Court's regulatory implied preemption jurisprudence before Wyeth, which helps explain why the Bush Administration thought it could reshape tort law through implied regulatory preemption and why many commentators predicted a big win for Wyeth. The Essay then turns to discuss the background for the Wyeth litigation and the possibly far-reaching implications of the Court's decision.
THE PRE-WYETH CRITIQUE
The analysis courts apply in preemption cases is, at least as a matter of structure, well settled. Courts are instructed first to examine whether Congress has included in the relevant statute an express preemption provision that specifically forecloses the state law, regulation, requirement, or other state-mandate under attack. (2)
Difficult interpretative questions often arise about the reach of express preemption provisions. (3) But in express preemption cases, the Court's first focus is on the meaning of the preemption provision Congress drafted, an inquiry guided by well-settled tools of statutory construction. (4)
More complicated analytical questions arise if there is no express preemption provision that forecloses the state action. Courts then must undertake field, conflict, and implied conflict preemption analysis. (5) The inquiry is to determine whether, although Congress did not say so explicitly, circumstances compel the conclusion that Congress intended to displace state law, because Congress wanted a federal regulatory regime to occupy the field or because state law either actually conflicts with federal dictates or would frustrate the attainment of federal objectives. (6) As the Court has repeatedly driven home, "'"[t]he purpose of Congress is the ultimate touchstone" in every pre-emption case.'" (7)
As I have written elsewhere, this analytical structure has led courts to hold far more state law--especially state tort and damages law-preempted than Congress intended or is necessary to the achievement of federal goals. (8) Adding to the confusion is that the justifications courts invoke for non-express preemption--field, conflict, and implied conflict preemption--are imprecise, overlapping, and inconsistently applied, which leads to uncertainty about when state law will be set aside. (9) This lack of analytic clarity is a problem not simply for regulated entities, those injured by products made by regulated entities, and the courts, but it is also a serious problem for Congress and state legislatures trying to reach sensible accommodations about the allocation of regulatory power. (10)
But the point of this brief Essay is not to launch a broad-sided attack on conventional preemption analysis. There has already been a tank car's worth of ink spilled doing just that. (11) Rather, this Essay focuses solely on the Court's regulatory implied conflict preemption analysis--that is, the analytical path the Court follows where a party (generally backed by a federal regulatory agency) claims that application of state law will frustrate the attainment of federal goals, even where it is possible to comply simultaneously with both federal and state dictates. The Court has ruled that state law may be ousted in such circumstances, notwithstanding the fact that there is (a) no express preemption provision, (b) no direct conflict between federal and state law, and (c) no indication that Congress wanted to foreclose all state regulation in a given field. (12) Some Justices have expressed discomfit with the very idea that courts can displace state law in these circumstances. (13) But because the implied preemption doctrine is by now embedded deeply in the Court's preemption jurisprudence, this Essay does not call for its reevaluation.
Prior to the Court's ruling in Wyeth v. Levine, my claim would have been that the Court's approach in implied preemption cases--exemplified in the Court's 5-4 ruling in Geier v. American Honda Motor Co. (14)--pushed courts to find preemption in cases in which the displacement of state law actually subverts the attainment of goals articulated in the federal statutes. (15) The theory of preemption, of course, is that the Supremacy Clause of the Constitution requires state law to yield when it interferes with the attainment of goals Congress set in the legitimate exercise of its powers, generally under the Commerce Clause. (16)
Before Wyeth, the failure of courts to consider whether federal regulatory efforts, on their own, are adequate to fulfill Congress's objectives threatened to stand the purpose of implied preemption analysis on its head. Where a finding of preemption removes a market discipline imposed by state law, and that market discipline in fact serves to advance Congress' goals (even indirectly), then a finding of implied preemption may undermine rather than advance federal objectives. There are two reasons often related for why federal regulatory efforts may not satisfactorily advance federal goals; first, the agency may lack the competence to do its job effectively, generally because it lacks needed resources or statutory authority; or, second, the agency may be "captured" or unduly influenced by the industry it is charged with regulating. In either case, a ruling that federal action--no matter how ineffectual--preempts state law may result in thwarting federal objectives.
As noted, Geier was, prior to Wyeth, the Court's main pronouncement on regulatory implied preemption. Geier involved a claim by Alexis Geier, a young woman who was seriously injured when her 1987 Honda, equipped with just a shoulder harness and a lap belt, crashed into a tree. She sued, claiming that cars lacking air bags were defectively designed. But the Court held, 5-4, that her claim was preempted because a standard promulgated by NHTSA gave manufacturers a choice of installing air bags or non-detachable belts.
Congress established NHTSA in 1966 to set safety standards that are "practicable" and that "meet the need for motor vehicle safety." (17) When Congress wrote the Motor Vehicle Safety Act ("Safety Act")--the legislation creating NHTSA--it included an express preemption provision that said no state may "prescribe or continue in effect a standard applicable to the same aspect of performance" that is not "identical" to the federal standard. (18) But Congress went on to add a "savings clause" that provides that "[c]ompliance with" a NHTSA standard "does not exempt a person from liability at common law." (19)
Geier called on the Court to decide whether NHTSA's "occupant protection" (passive restraint) standard preempted state tort law. (20) The standard, first adopted in 1967, initially required manufacturers to install lap and shoulder belts, but NHTSA soon found that many occupants did not bother fastening their belts. (21) Consumer groups urged NHTSA to require a new technology--air bags--that operated automatically. (22) NHTSA revised the standard in 1971 to require either air bags or automatic seatbelts for front seat occupants by 1975. (23)
But the auto industry objected. Henry Ford and Ford President Lee Iacocca met secretly with President Nixon to urge that the standard be scrapped. (24) After the meeting, Nixon called Secretary of Transportation John Volpe and told him to rescind the rule, which he did. (25) NHTSA then adopted the industry's proposal to mandate the use of "ignition interlock" devices that prevented the car from starting until front-seat occupants had buckled up. (26) The public hated the hard-to-use interlock devices, and Congress soon amended the Safety Act to forbid their uses. (27)
It was not until the Carter Administration that NHTSA revived the passive-restraint standard. In 1977 the agency gave the industry until model year 1982 to install air bags or automatic belts, but the Reagan Administration rescinded the standard in 1981. (28) Insurance companies and consumer groups sued NHTSA...