Does the fact that the FDA has approved a drug’s label preempt a state law claim that an addition to the label was necessary to make the drug reasonably safe for use? On March 4, 2009, in Wyeth v. Levine, the Supreme Court considered that question, and held that such a claim is not preempted by federal law – in what may prove to be an important decision reflecting the Court’s view of preemption generally. While some commentators had previously suggested that the Roberts Court was likely to be sympathetic to business claims that a federal regulation preempts state and local laws, Wyeth – like December’s decision in Altria v. Good – may suggest that the Court’s approach to the Supremacy Clause is more sophisticated, and more sympathetic to state and local interests. It may also suggest that, where Congress acts in a field where states and localities have traditionally had strong, independent regulatory roles, the Court will be reluctant to preempt state and local requirements except where the law expressly provides for preemption. In today’s environment, when federal regulatory agencies are asserting broad rights to preempt state and local laws with very little express statutory authority, the case could prove quite significant…particularly if the reasoning in Justice Thomas’ concurrence is adopted in future cases.
Like many tort cases, the facts of Wyeth are difficult. On April 7, 2000, Diana Levine visited a local clinic for treatment of a migraine headache. When the physician assistant administered Phenergan an anti-nausea medication, using the IV-push method, the drug entered Levine’s artery and came in contact with arterial blood. As a result, Levine developed gangrene, and doctors were ultimately forced to amputate her forearm. In addition to her pain and suffering, Levine incurred substantial medical expenses and the loss of her livelihood as a professional musician.
Levine filed suit against Wyeth, the manufacturer of the drug. A jury found that Wyeth was negligent and that Phenergan was a defective product as a result of inadequate warnings and instructions regarding IV-push administration of the drug. Wyeth claimed that the suit was preempted by federal law – based on the fact that the FDA had approved Phenergan’s label. The trial court and Vermont Supreme Court disagreed, upholding a jury award of damages to Levine.
In a 6-3 decision, the Supreme Court affirmed. The Court began its analysis by recognizing that “the historic police powers of the States [are] not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Slip op. 8 (citing Medtronic v. Lohr, 518 U.S. 470, 485 (1996)). First, the Court rejected the claim that it was “impossible” for Wyeth to comply with the state-law duty to modify Phenergan’s labeling without violating federal law. Id. at 12. The Court ruled that federal rules allowed Wyeth to add “newly acquired information” to a label. Id. In addition, the Court rejected the claim that requiring Wyeth to provide a stronger warning about IV-push administration of the drug would “obstruct the purposes and objectives of federal drug labeling regulation.” Id. at 17. The Court found no evidence that Congress had intended to establish “a ceiling” on drug regulation. Indeed, while Congress had enacted an express pre-emption provision for medical devices, 21 U.S.C. § 360k(a), it did not do so with respect to prescription drugs, despite its “certain awareness” of state tort litigation. As the Court put it, “The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them.” Id. at 18.
Finally, the Court recognized an important principle of administrative law with respect to preemption. Wyeth had contended that a preamble to an FDA regulation indicated that federal law establishes both a “floor and a ceiling” to drug labeling regulation. Id. at 19. The Court recognized that while an agency regulation with the “force of law” can preempt state requirements, the Court “has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption.” Id. (emphasis added). In this case, because Congress did not empower the FDA to preempt state law directly in this context, the Court examined what level of deference it owed the FDA. The Court concluded it did not owe the FDA any such deference because the preamble was not the product of public comment, and because it is at odds with other evidence regarding Congress’s purposes. Id. at 21. In his concurrence, Justice Breyer indicated that “it is possible that [lawful specific regulations] would have pre-emptive effect.” Opinion of J. Breyer at 2.
Justice Thomas’s concurrence is especially notable. He stresses that because our federalist system is one of dual sovereignty, the Court’s preemption analysis should focus more closely on the statutory text. As he puts it, “This Court’s entire body of ‘purposes and objectives’ preemption jurisprudence is inherently flawed.” Opinion of J. Thomas at 13. As he explains, “[T]he majority has concluded from silence that Congress believed state lawsuits pose no obstacle to federal drug-approval objectives. That is the required conclusion, but only because it is compelled by the text of the relevant statutory provisions, not judicial suppositions about Congress’ unstated goals.” Id. at 22. Any other approach, in his view, leads to “the illegitimate – and thus, unconstitutional – invalidation of state laws.” Id. At 24.