On March 4, 2009, the Supreme Court decided a case that has profound implications regarding the rights of consumers to sue prescription drug manufacturers for failing to properly warn of dangers of prescription drugs. In Wyeth v. Levine, ___ U.S. ___, 2009 U.S. LEXIS 1774 (U.S. Mar. 4, 2009) the Supreme Court ruled 6-3 that FDA approval of a prescription drug warning label does not always pre-empt state tort suits regarding the adequacy of such warnings. The decision comes as somewhat of a surprise because just last year, in Riegel v. Medtronic, 552 U.S. ___ (2008), the Supreme Court ruled 8-1 that FDA pre-market approval of Class III medical devices pre-empts state law negligence claims that challenge the safety or effectiveness of FDA-approved devices. The difference in outcome between Wyeth and Riegel is explained by an understanding of the different ways that Congressional actions can pre-empt state law.

Pre-emption

Under our federalist system, which recognizes concurrent sovereignty between the Federal Government and the States, the Supremacy Clause permits the Congress to pre-empt state law as long as Congress is acting within the scope of its enumerated powers under the Constitution. Thus, Congress may clearly impose its will on the States by enacting express pre-emption provisions in its statutes.

The Supreme Court complicated this doctrine through a series of decisions holding that even in the absence of an express pre-emption provision, an intention to pre-empt state law can be implied from the language of a Congressional statute. The two implied pre-emption doctrines relevant here are “impossibility pre-emption”, which applies when it is impossible to comply with both State and Federal law, and “purposes and objectives pre-emption”, which applies when a competing state law would frustrate the purposes and objectives of a Federal statute or regulation.

Riegel is an express pre-emption case. In 1976, Congress passed an amendment to the Federal Food, Drug and Cosmetic Act (called the Medical Device Amendments of 1976) that included an express pre-emption provision that barred a “State or political subdivision” from imposing or enforcing “any requirement” with respect to a medical device “which is different from, or in addition to, any requirement applicable under this chapter” and that “relates to the safety or effectiveness of the device…” 21 U.S.C. § 360K(a). According to eight members of the Supreme Court (Justice Ginsberg was the lone dissent), that provision barred the Riegels’ state law negligence and product liability claims for a medical device that had received FDA pre-market approval under the Medical Device Amendments.

The Medical Device Amendments apply only to medical devices and not to prescription drugs. Furthermore, there is no express pre-emption provision in the Food, Drug and Cosmetic Act or any of its amendments that applies to prescription drugs. So even after the Supreme Court’s decision in Riegel, there remained a question of whether and to what extent FDA action regarding prescription drugs could be found to have impliedly pre-empted state tort law. That question was explicitly raised and resolved in Wyeth.

Wyeth v. Levine Facts

Diana Levine lost her right foreman and hand to gangrene after the Wyeth drug Phenergan was administered intravenously using the IV-push method, which injects a drug directly into a patient’s vein. It is well known that Phenergan is corrosive and causes irreversible gangrene if it comes in contact with arterial blood. It is equally clear that the IV-push method created a higher risk of inadvertent intra-arterial contamination than did the IV-drip method. Although the Phenergan warning disclosed the risk of gangrene and amputation following intra-arterial injection, the label lacked any explicit instruction against the IV-push method.

Levine filed an action in Vermont state court alleging that Wyeth’s label was defective because it failed to specifically instruct health care providers to use only the IV-drip method of administration. A Vermont jury determined that Phenergan’s label was inadequate and that as such, the drug was defective and Wyeth was negligent. It awarded Levine $7,400,000.

In a pre-trial motion for summary judgment and again in post-trial motions, Wyeth asserted two implied pre-emption arguments. First, Wyeth argued that it was impossible for it to comply with both the FDA labeling requirements and the Vermont jury verdict. Second, it argued that requiring Wyeth to comply with the State law duty obstructed the purposes and objectives of federal drug labeling requirements. Both arguments were based on the FDA’s decision to approve the Phenergan label in 1955, the FDA’s failure to respond to a Wyeth request in 1988 to strengthen the Phenergan warning regarding the IV-push method, and a 1996 FDA instruction to Wyeth to retain the “current verbiage” on the label regarding inter-arterial injection, which Wyeth interpreted as a specific rejection of the stronger language. The trial judge rejected Wyeth’s implied pre-emption arguments, as did the Vermont Supreme Court.

The United States Supreme Court granted certiorari because of the importance of the pre-emption issues and because the FDA under the Bush Administration had changed its position on the role of state tort law in FDA actions. The Supreme Court ruled that Levine’s Vermont state law claims against Wyeth were not pre-empted.

The Majority Opinion

With regard to Wyeth’s “impossibility pre-emption” argument, the Court noted that there is a specific FDA regulation permitting a drug company to make changes to an FDA-approved warning label to “add or strengthen a contraindication, warning, precaution, or adverse reaction.” 21 CFR § 314.70 (c)(6)(iii). Thus, as a matter of fact, Wyeth did not need prior FDA approval to strengthen its Phenergan warning to caution against use of the IV-push method of administration. The majority rejected Wyeth’s argument that it would have been subject to an FDA enforcement action regarding misbranded drugs had it altered its warning without FDA approval in the manner required by the Vermont jury, stating:

And the very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning…is difficult to accept-neither Wyeth nor the United States has identified a case in which the FDA has done so. Wyeth, at *13-*14.

The majority was equally dismissive of Wyeth’s “purposes and objectives pre-emption” argument, finding it to be based “on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law.” Id. at *17. The majority noted that if Congress thought that state tort suits were an obstacle to FDA objectives, it could have enacted an express pre-emption provision like the one it enacted for medical devices.

But the real key to the majority opinion was its rejection of the FDA’s attempt, during the Bush Administration, to pre-empt state law not through proper regulatory rule-making, but rather by executive fiat through an amendment to the regulatory preamble that changed the agency’s longstanding policy on state tort suits.

The Supreme Court has held that federal agency regulations which have the force of law, even in the absence of Congressional action, can pre-empt conflicting state requirements. Geier v. American Honda, 529 U.S. 861 (2000). In determining whether an agency’s rulemaking pre-empts state law, the Supreme Court has accorded “some weight” to an agency’s views about the impact of state tort law on an agency’s federally-mandated objectives.

Recognizing this precedent, in 2006 the Bush Administration amended the preamble to an FDA regulation pertaining to the content and format of drug labels to state that “FDA approval of labeling…pre-empts conflicting or contrary State law.” Wyeth’s “purposes and objectives” pre-emption argument was predicated entirely on this regulatory preamble, rather than any Congressional action that expressly or impliedly pre-empted state tort law.

The Wyeth majority rejected this argument, holding that the FDA’s 2006 regulatory preamble did not merit any deference for a number of reasons. First, the agency had enacted a sweeping regulatory change without following the formal rulemaking procedures that included offering the States and other interested parties notice and an opportunity to be heard, rendering the agency’s views on state tort law “inherently suspect in light of this procedural failure.” Wyeth, at *21. Second, the FDA’s 2006 action conflicted with “evidence we have of Congress’ purposes” and with the FDA’s own longstanding position on state tort law, which was that it helped rather than hindered the FDA’s mission. As a result, the majority concluded that the 2006 FDA regulation did not carry the force of law and had no pre-emptive effect.

The Concurring Opinions

 Justice Breyer and Justice Thomas both agreed with the majority that Levine’s state tort law verdict was not pre-empted by Federal law, but wrote separately to make two contrasting points. Justice Breyer wrote separately to express his view that the FDA has the power to pre-empt State tort law through a proper regulatory process and that even in the absence of such a process, certain FDA actions could pre-empt conflicting state law. Justice Thomas’ concurrence was really an indictment of the Supreme Court’s line of implied pre-emption jurisprudence, which he believes has gone too far and relies too much on assumptions that run far afield of the Congress’ statutory text.

The Dissent

The position of the three dissenters, Justice Alito, Chief Justice Roberts and Justice Scalia, is cogently summarized in the first paragraph of Justice Alito’s opinion:

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather that the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs. Wyeth, at *85.

What follows is not a principled discussion of the law of pre-emption, but a rambling criticism of the Vermont jury’s verdict that includes Justice Alito’s factual disagreement with that verdict and his belief that the actual warning was adequate. What is surprising is that the three dissenting Justices are ardent federalists whose judicial philosophy is more in line with Justice Thomas’s concurrence. It is hard to reconcile that philosophy with a dissenting opinion that attacks state law and its role in a federal system.

Conclusion

It is important not to over-read the Wyeth v. Levine decision. It does not stand for the proposition that FDA actions regarding prescription drug warnings can never pre-empt state tort law. However, it is an important victory for those who have been injured by defective prescription drugs. If the dissenting opinion had carried the day, most if not all state tort suits regarding the adequacy of prescription drug warnings would have been pre-empted if the FDA had approved the warning. For now, the Court has affirmed that state tort law plays and important and complementary role to the FDA’s regulatory action.