On March 4, 2009, the U.S. Supreme Court delivered its highly anticipated decision in Wyeth v. Levine, upholding the plaintiff's $7.4 million product liability verdict over a challenge that her claims were preempted by U.S. Food and Drug Administration (FDA) labeling regulations.
In 2000, Donna Levine was injected with Wyeth's medication, Phenergan, by "IV push" administration. The placement of the IV was incorrect and medication entered Levine's artery, resulting in gangrene and the eventual amputation of Levine's forearm. Levine brought claims against Wyeth, arguing that the medication's label was defective because it failed to instruct clinicians to use IV-drip, rather than IV push, to administer Phenergan. A jury found in Levine's favor. The Vermont trial court, appellate court, and supreme court upheld the verdict and denied Wyeth's argument that Levine's failure-to-warn claim was preempted by the FDA's approval of the drug's label.
The Supreme Court agreed. Justice Stevens, writing for the majority, rejected both of Wyeth's theories for conflict preemption. The Court determined that it was not "impossible" for Wyeth to comply with both FDA labeling regulations and Vermont common-law standards for product warnings, since the FDA's "changes being effected" or "CBE" regulations would have allowed Wyeth to revise the label without rendering the drug misbranded. The 2008 changes to the CBE regulations, which limit CBE changes to "newly acquired information," did not affect the Court's conclusion because "newly acquired information" can include "new analysis of previously submitted data." The Court found it unlikely that the FDA would have rejected a label change providing more prominent risk information about IV push administration. In general, the Court was not convinced there was a real conflict between Vermont common-law and the FDA's past approvals of the Phenergan label, since the agency did not appear to have given much thought to the risks and benefits of IV push administration.
The Court further held that claims like Ms. Levine's do not "obstruct the purposes and objectives of federal labeling regulation" or interfere with "Congress's purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives." It cited legislative history suggesting that the Federal Food, Drug and Cosmetic Act (FDCA) contains no provision for patient remedies because legislators expected those claims to be resolved in the courts. The Court also dismissed the idea that Congress's intent in passing the 1938 FDCA and the 1962 amendments was to preempt pharmaceutical product liability claims, since the 1976 medical device amendments expressly preempted state regulation of medical devices but left prescription drugs untouched.
The Court pointedly criticized the FDA's preamble to its 2006 regulations for "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," 71 Fed. Reg. 3922 (Jan. 24, 2006). The agency's statements to the effect that approval sets both a "ceiling and a floor" for labeling requirements were disregarded as lacking the force of law because they were not subjected to public notice and comment. This procedural shortcoming, along with the fact that the agency had said six years earlier that the proposed regulations would not be preemptive, led the Court to conclude that the views staked out in the preamble were "inherently suspect."
Levine does not foreclose the preemption defense in all pharmaceutical cases. The majority, concurring, and dissenting opinions leave room for preemption under different facts. In particular, Justice Breyer, who voted with the majority, suggests in his concurrence that he would still favor preemption in cases where the FDA has clearly considered and rejected the warning that the plaintiff's lawsuit seeks to impose.
What is clear, however, is that the grounds for preemption are far more limited after Levine, which should lead defendants to be selective in bringing future preemption motions. Circumstances where a preemption motion might succeed post-Levine could include:
(1) Claims that a specific route of administration or use of the drug should have been contraindicated. The majority was careful to distinguish the claim in Levine which was that the IV-push warning was inadequate, from a state-law requirement that IV push be contraindicated. This would obviously put the state-law claim in more direct conflict with the FDA's decision to allow the practice.
(2) Claims where there is "clear evidence that the FDA would not have approved a change." The majority suggested that this could support an "impossibility" defense.
(3) Claims that would more clearly "frustrate the achievement of congressional objectives." This is, admittedly, a vague concept that may (or may not) be fleshed out in future litigation.
(4) Claims that would conflict with actual legislation or agency rulemaking. Express Congressional intent and agency decisions "with the force of law"—i.e. those adopted after notice and comment—will continue to be preemptive. Of course, any proposed regulation or legislation preempting personal injury claims will face stiff political resistance.
Two other nuggets from Levine merit brief mention. The Court emphasized that a pharmaceutical manufacturer bears the responsibility for its label "at all times"—a phrase that will undoubtedly find its way into future plaintiffs' briefing. But the Court also recognized that "risk information accumulates over time," and "the same data may take on a different meaning in light of subsequent developments"—in other words, not all risks can be foreseen. This acknowledgement may prove useful in defending future failure-to-warn claims.
In sum, Levine did not result in the broad preemption that Wyeth argued for, but it leaves room for the defense to prevail where a product liability verdict would clearly conflict with the FDA's specific and considered evaluation of the risk at issue.
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