Wyeth v. Levine

LOCATION: Wyeth Pharmaceuticals

DOCKET NO.: 06-1249
DECIDED BY: Roberts Court (2006-2009)
LOWER COURT: Vermont Supreme Court

CITATION: 555 US (2009)
GRANTED: Jan 18, 2008
ARGUED: Nov 03, 2008
DECIDED: Mar 04, 2009

David C. Frederick – argued the cause for the respondent
Edwin S. Kneedler – Deputy Solicitor General, argued the cause for the United States, as amicus curiae, supporting the petitioner
Seth P. Waxman – argued the cause for the petitioner

Facts of the case

Diana Levine filed this personal injury action against Wyeth, the drug manufacturer, in state court in Vermont. Ms. Levine had intravenously injected Phenergan, a drug made by Wyeth and used to prevent allergies and motion sickness, into her arm, and complications arising from the injection eventually led to the amputation of her arm. Ms. Levine brought this claim asserting that Wyeth had failed to include a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because their warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The Superior Court of Vermont found in favor of Ms. Levine and denied Wyeth’s motion for a new trial.

The Supreme Court of Vermont affirmed this ruling on appeal, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. Therefore, states are free to create more stringent labeling requirements than federal law provides.


Does federal law preempt state law in a personal injury action against a drug manufacturer for failing to include an appropriate warning label where the drug in question met the labeling requirements of the Food and Drug Administration?

Media for Wyeth v. Levine

Audio Transcription for Oral Argument – November 03, 2008 in Wyeth v. Levine

Audio Transcription for Opinion Announcement – March 04, 2009 in Wyeth v. Levine

John G. Roberts, Jr.:

Justice Stevens has the opinion of the Court today in case 06-1249, Wyeth versus Levine.

John Paul Stevens:

In April 2000, Diana Levine sought treatment for a migraine headache at her local health center.

A clinician gave her a direct injection of Phenergan, an antinausea drug manufactured by Wyeth.

After the drug entered her artery, Levine developed gangrene and doctors amputated her forearm.

Levine brought a state law damages action alleging that Wyeth had failed to provide an adequate warning about the risk of directly injecting Phenergan into a patient’s vein.

The Vermont jury found that Levine’s injury would have not occurred if Phenergan’s label included an adequate warning and had awarded her damages.

Wyeth then sought a judgment notwithstanding the verdict arguing that Levine’s claims were preempted by federal law because Phenergan’s labeling had been approved by the federal Food and Drug Administration.

The trial court rejected Wyeth’s presumption argument and the Vermont Supreme Court affirmed.

We granted certiorari to consider Wyeth’s argument that the FDA’s approval of Phenergan’s label preempts Levine’s state law claims.

We now affirm the judgment of the Vermont Supreme Court.

We reject Wyeth’s argument that it is impossible for it to comply with both the state law duties underlying Levine’s claims and its federal labeling duties.

Generally, a manufacturer may only change its drug label after receiving the FDA’s approval.

But the agency has a regulation that permits manufacturers to make certain unilateral labeling changes to enhance drug safety.

Under this regulation, Wyeth could have added a stronger warning about direct injection of Phenergan and thereby complied with both its state law and federal law duties.

We also reject Wyeth’s argument that Levine’s state law claims posed an obstacle to Congress’ purpose of entrusting an expert agency with drug labeling decisions.

The history of the Food, Drug and Cosmetic Act shows that Congress did not intend to preempt state law failure to warn actions and Wyeth’s reliance under a preamble to a 2006 FDA regulation is unpersuasive.

This preamble is not an agency regulation with the force of law.

And Congress has not expressly authorized the FDA to preempt state law.

We do not defer to the FDA’s mere assertion that state law is an obstacle to achieving its statutory objections.

Among other problems, the 2006 preamble does not sufficiently explain FDA’s departure from its longstanding position that state law is a complementary form of federal — of drug regulation.

We therefore hold the FDA’s approval of Phenergan’s labeling does not preempt Levine’s state law failure to warn claim.

Justice Thomas has filed an opinion concurring in the judgment.

Justice Alito has filed a dissenting opinion in which the Chief Justice and Justice Scalia have joined.