Wyeth v. Levine

Supreme Court of United States
129 S.Ct. 1187 (2009)

ELI5:

Rule of Law:

Federal approval of a prescription drug's labeling by the Food and Drug Administration (FDA) does not preempt state-law tort claims that the label provided an inadequate warning of the drug's risks.

Facts:

Diana Levine sought treatment at a clinic for a migraine headache and associated nausea.
A physician assistant administered the anti-nausea drug Phenergan, manufactured by Wyeth, using the 'IV-push' method, which involves direct injection into a vein.
During the IV-push injection, some of the corrosive drug entered Levine's artery, leading to irreversible gangrene.
As a result of the gangrene, doctors were forced to amputate Levine's right hand and forearm.
Phenergan's label warned of the general risk of gangrene from inadvertent intra-arterial injection.
However, the label did not specifically instruct clinicians to use the safer IV-drip method instead of the higher-risk IV-push method, despite Wyeth being aware of numerous similar amputation incidents.

Procedural Posture:

Diana Levine sued Wyeth in a Vermont state trial court, alleging negligence and strict liability for failure to provide an adequate warning.
The trial court denied Wyeth's motion for summary judgment, which argued that federal law preempted Levine's claims.
A jury returned a verdict in favor of Levine and awarded damages.
The trial court denied Wyeth's post-trial motion for judgment as a matter of law.
Wyeth, as appellant, appealed the judgment to the Vermont Supreme Court.
The Vermont Supreme Court affirmed the trial court's judgment, holding that Levine's claims were not preempted.
The United States Supreme Court granted Wyeth's petition for a writ of certiorari.

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Issue:

Does the Food, Drug, and Cosmetic Act preempt state-law tort claims alleging that a drug manufacturer provided an inadequate warning on its product's label, even though the Food and Drug Administration approved that label?

Opinions:

Majority - Justice Stevens

No, federal law does not preempt Levine's state-law failure-to-warn claims. The Court's reasoning is twofold. First, it rejects impossibility preemption, holding that Wyeth failed to show it was impossible to comply with both state and federal law. Under the FDA's 'changes being effected' (CBE) regulation, a manufacturer can unilaterally strengthen a drug's warning label to reflect newly acquired safety information without waiting for prior FDA approval. Wyeth could have and should have strengthened its warning about the dangers of the IV-push method as evidence of amputations accumulated. Second, the Court rejects obstacle preemption, finding that state tort suits do not obstruct Congress's purposes. Congress chose not to include an express preemption provision for prescription drugs and has long been aware of the coexistence of state tort law and federal regulation. State law serves as a complementary layer of consumer protection, and the FDA's 2006 preamble asserting preemptive authority is not entitled to deference due to its procedural failings and its reversal of the agency's long-standing position.

Dissenting - Justice Alito

Yes, federal law should preempt Levine's state-law claims. This case is governed by the principles of conflict preemption established in Geier v. American Honda Motor Co. The FDA, as the expert agency, is charged by Congress with balancing a drug's risks and benefits to determine whether it is safe and effective, and the label reflects this expert judgment. Allowing a lay jury to second-guess the FDA's determination and effectively require a different warning creates a direct conflict that undermines the federal regulatory scheme. The FDA had been aware of and had specifically regulated the warnings related to IV-push administration for decades, concluding that it was a safe method when used according to the approved label. A state tort verdict that contradicts this considered federal judgment should be preempted by the Supremacy Clause.

Concurring - Justice Breyer

I concur with the majority's judgment but write to emphasize its narrowness. The Court correctly holds that there is no preemption in this specific case, particularly because the FDA has not issued a specific regulation, with the force of law, stating that its labeling requirements are intended to be a ceiling as well as a floor. It is possible that in other circumstances, state tort law could interfere with the FDA's objectives. An agency could issue such a specific regulation, and if it did, that regulation might have preemptive effect, but that is not the situation presented here.

Concurring - Justice Thomas

I concur in the judgment only. The case should be resolved on the simple ground of impossibility preemption. The FDA's 'changes being effected' regulation explicitly permitted Wyeth to strengthen its warning label without prior FDA approval. Therefore, it was not impossible for Wyeth to comply with both its state-law duties and federal law, and there is no direct conflict. I reject the majority's and dissent's reliance on 'purposes and objectives' or 'obstacle' preemption, as this doctrine is an unconstitutional, freewheeling judicial inquiry into legislative history and congressional purposes that are not grounded in the enacted statutory text.

Analysis:

This decision significantly limits the scope of federal preemption in the context of prescription drug labeling, affirming a robust role for state tort law. It establishes that FDA approval sets a 'floor,' not a 'ceiling,' for drug safety warnings, placing the ongoing responsibility on manufacturers to monitor their products and update labels as new risks become known. The ruling makes it much more difficult for pharmaceutical companies to use FDA approval as a shield against failure-to-warn lawsuits. Furthermore, it curtails the power of federal agencies to preempt state law through informal statements, such as regulatory preambles, that have not gone through formal notice-and-comment rulemaking.

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