The Presumption Against Preemption Strikes Back: The Lessons Of Altria Group v. Good and Wyeth v. Levine

Dan Schweitzer, Supreme Court Counsel

Dan Schweitzer, Supreme Court Counsel

In the ongoing preemption wars, February 22, 2008, was the states’ darkest day. The Supreme Court handed down five decisions, three in preemption cases. And the Court found state law preempted in all three. One of those decisions, Rowe v. New Hampshire Motor Transport Association, broadly construed an express preemption provision to nullify a Maine statute that sought to prevent minors from obtaining cigarettes through Internet purchases ― even though a state public health law of that sort was the furthest thing from Congress’ mind when it enacted the federal statute at issue. In another, Riegel v. Medtronic, Inc., the Court drastically limited the ability of consumers injured by Food and Drug Administration (FDA)-approved medical devices to sue the manufacturers ― again, even though no one seriously argued that Congress specifically intended to preempt state tort actions when it added the express preemption provision in 1976. In neither case did the Court so much as mention the presumption against preemption, which supposedly requires courts not to find state laws preempted “unless that was the clear and manifest purpose of Congress.” At the time, commentators leaped over each other to declare the Roberts Court more pro-business than any Court in recent history.

What a difference a year makes.

This Term, the Court has already issued two major opinions holding that state laws are not preempted by federal law. In Altria Group, Inc. v. Good, the Court held that the Federal Cigarette Labeling and Advertising Act does not preempt a state-law action alleging that Philip Morris deceptively advertised “light” cigarettes. More recently, in Wyeth v. Levine, the Court held that federal law does not preempt a state-law tort claim asserting that an FDA-approved label for a drug did not contain an adequate warning. Thorough summaries of those decisions appear in 16 Supreme Court Report 4 (NAAG 2008) and 16 Supreme Court Report 8 (NAAG 2009). Rather than repeating those discussions, what follows is a listing of some of the most important holdings in the two opinions. These holdings ― which involve both express preemption (i.e., where the federal statute includes a provision expressly preempting state law) and implied conflict preemption (i.e., where federal law preempts state law because it is either impossible to comply with both the state and federal law or because the state law stands as an obstacle to the accomplishment of the federal law’s objectives) ― should assist the states in litigating all manner of preemption cases in the lower courts.

The presumption against preemption applies with a vengeance in express preemption cases.

Over the dissent of four Justices, the Court in Altria Group reaffirmed that the presumption against preemption applies when a court is construing an express preemption provision. 129 S. Ct. at 543. Indeed, the Court set forth a Chevron-like rule that, if strictly applied, would dramatically cabin express preemption: ...“when the text of a pre-emption clause is susceptible of more than one plausible reading, courts ordinarily accept the reading that disfavors pre-emption.” Id. (internal quotation marks omitted).

The presumption against preemption applies to fields that have long been subject to federal regulation.

In United States v. Locke, 529 U.S. 89, 108 (2000), the Court held that the presumption “is not triggered when the State regulates in an area where there has been a history of significant federal presence,” for example, maritime commerce. Since then, businesses have asserted that this limitation applies to virtually every field of activity. See, e.g., Brief for Petitioner at 51 n.23, Wyeth v. Levine (arguing that the presumption does not apply because “[r]egulation of drug labeling has now been the domain of the federal government for more than a century”). The Court in Wyeth decisively rejected that argument, stating that “it misunderstands the principle: We rely on the presumption because respect for the states as independent sovereigns in our federal system leads us to assume that Congress does not cavalierly pre-empt state-law causes of action. The presumption thus accounts for the historic presence of state law but does not rely on the absence of federal regulation.” Slip op. at 9 n.3 (internal quotation marks and citation omitted).

The presumption against preemption applies in conflict preemption cases.

In several recent amicus briefs, the Chamber of Commerce and the Product Liability Advisory Council argued that the presumption against preemption does not apply in conflict preemption cases. This is so, they argued, because the Supremacy Clause dictates that any state law that actually conflicts with federal law is preempted; and determining whether state law actually conflicts with federal law requires interpreting the substantive meaning of those laws, which must be done without any thumbs on the scale. The Court in Wyeth definitively rejected that argument, stating that “this Court has long held to the contrary.” Slip op. at 9 n.3 (citing cases); but see id. at 22 n.14 (Alito, J., dissenting) (stating that it “remained an open question ― before today ― whether” the presumption against preemption “applied in conflict preemption cases”).

Congressional intent matters in conflict preemption cases.

A related contention by the pro-preemption forces was that congressional intent to preempt is irrelevant in conflict preemption cases. As Justice Alito put it in his Wyeth dissent, “the sole question is whether there is an ‘actual conflict’ between state and federal law; if so, then pre-emption follows automatically by operation of the Supremacy Clause.” Slip op. at 21. The majority in Wyeth emphatically disagreed. Wyeth had argued that Levine’s action was preempted because requiring it to comply with the state-law duty “would obstruct the purposes and objectives” of the federal drug laws, under which an FDA-approved label operates as both “a floor and a ceiling for drug regulation.” The Court did not deny that state-law verdicts finding labels inadequate might, in some circumstances, frustrate the FDA’s efforts to establish national labeling standards. But that was not the test applied by the Court. Instead, the Court emphasized early on that one of the “cornerstones of our pre-emption jurisprudence” is that “the purpose of Congress is the ultimate touchstone in every pre-emption case.” Slip. op. at 8 (internal quotation marks omitted). Applying that principle, the Court found that “all evidence of Congress’ purposes is . . . contrary” to the proposition that “Congress thought state-law suits posed an obstacle to its objectives.” Id. at 18.

The Court pointed out that Congress enacted the Food, Drug, and Cosmetic Act in 1938 “to bolster consumer protection against harmful products”; and that Congress has failed to enact an express preemption provision for FDA-approved drugs, even though in 1976 Congress added an express preemption provision for medical devices. The Court found that Congress’ “silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Slip op. at 18; see also Brief of Vermont, et al. as Amici Curiae Supporting Respondent at 16, Wyeth (“The Supremacy Clause tells us that if Congress intended to displace state laws when they frustrate the achievement of certain federal objectives, that federal command controls. The Clause does not, however, answer the predicate question whether Congress so intended. That issue is a matter of statutory construction.”).

State laws protecting consumers can coexist with federal regulatory regimes.

Supporters of preemption frequently contend that a state tort regime is incompatible with a federal regulatory regime in which an expert agency determines what products should be allowed on the market and with what warnings. The Court’s decision Riegel gave force to that argument, observing that Congress may have wanted to preempt state tort claims against manufacturers of medical devices because of Congress’ “solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.” 128 S. Ct. at 1009. And, added the Court in Riegel, “[s]tate tort law that requires a manufacturer’s [medical device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.” Id. at 1008. Not surprisingly, Wyeth relied on precisely those arguments in asserting that state-law actions against drug manufacturers conflict with the federal regime just as much as state-law actions against medical-device manufacturers. The Court in Wyeth disagreed.

The Court did not deny that state tort suits against drug manufacturers might frustrate full achievement of certain federal objectives. But, found the Court, Congress had ample countervailing reasons to permit state tort suits against drug manufacturers. For example, the “FDA has limited resources to monitor the 11,000 drugs on the market”; “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly”; and state torts suits “serve a distinct compensatory function that may motivate injured persons to come forward with information.” Slip op. at 22, 23. The critical point is not that the Court concluded the plaintiffs have the better of the policy argument. It is that reasonable policy arguments can be made both for and against allowing state tort actions to proceed. In that situation, it is for Congress to make that policy choice. And, as discussed just above, the Court found numerous reasons to conclude that Congress made the policy choice to allow state tort actions against drug manufacturers to proceed.

Agency assertions of preemption in preambles to federal regulations are not entitled to deference.

One of the most prominent trends in preemption law has been federal agencies asserting that state law is preempted. The agencies have done this through a variety of means, including amicus briefs, adoption of rules expressly preempting state law, adoption of rules construing express preemption provisions, and adoption of rules establishing substantive federal law that displaces conflicting state law. Wyeth addressed still another method by which federal agencies have purported to preempt state law, namely, the assertion in a preamble to a notice-and-comment rule that certain state laws are preempted. In a preamble to a 2006 FDA regulation regarding the content and format of prescription drug labels, the FDA stated that FDA-approved labels constitute both a “floor” and a “ceiling” and that state-law failure-to-warn suits “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.” The Court in Wyeth held that “the FDA’s 2006 preamble does not merit deference.” Slip op. at 20. The Court reasoned that the FDA failed to give interested parties notice and an opportunity to comment on its preamble; the preamble “is at odds with what evidence we have of Congress’ purposes[;] and it reverses the FDA’s longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA’s regulation of drug labeling during decades of coexistence.” Id. at 21.

The Court added that it was not deciding “the pre-emptive effect of a specific agency regulation bearing the force of law.” Slip op. at 24. The Court may resolve that issue in Cuomo v. Clearing House Association, which will be argued in late April. The case addresses the validity of an Office of the Comptroller of the Currency (OCC) regulation that construes the National Bank Act to preempt efforts by New York to enforce its non-preempted fair housing laws against national banks. The second question presented in the case is whether the OCC regulation is entitled to Chevron deference.

US Supreme Court Justice Clarence Thomas

Justice Thomas will always reject claims of “purposes and objectives” preemption.

In several prior opinions, Justice Thomas had expressed skepticism about the doctrine of implied preemption. In an opinion concurring in the judgment in Wyeth, Justice Thomas went where his logic took him, and concluded that the Court should altogether abandon the concept of “purposes and objectives” preemption. He explained that the cases finding implied preemption based on a conflict with a federal statute’s purposes and objectives “improperly rely on legislative history, broad atextual notions of congressional purpose, and even congressional inaction in order to pre-empt state law.” Slip op. at 13 (Thomas, J.). The consequence of a “freewheeling” implied preemption doctrine is “giving improperly broad pre-emptive effect to judicially manufactured policies, rather than to the statutory text enacted by Congress.” Id. at 23. Accordingly, absent an express preemption provision, Justice Thomas will not find a state statute preempted unless it is “impossible” to comply with both state and federal law. This approach to implied conflict preemption closely resembles the position advocated in the 47-state amicus brief filed in Wyeth. See Brief of Vermont, et al. as Amici Curiae Supporting Respondent at 11-28, Wyeth.

All told, it has been a very good Term so far for state law. The Court’s reasoning in its preemption decisions not only preserves state-law actions challenging “light” cigarette advertisements and drug labels; it should also assist states in defending myriad state laws against federal preemption challenges in the lower courts.

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