Wyeth v. Levine,
555 U.S. 555 (2009)

Annotate this Case




certiorari to the supreme court of vermont

No. 06–1249. Argued November 3, 2008—Decided March 4, 2009

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the “IV-push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling had been approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.

Held: Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration. Pp. 6–25.

   (a) The argument that Levine’s state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency’s “changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, and there is no evidence that the FDA would ultimately have rejected such a labeling change. Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer bears responsibility for the content of its label at all times. Pp. 11–16.

   (b) Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law. The history of the FDCA shows that Congress did not intend to pre-empt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA’s statutorily prescribed role. Although an agency regulation with the force of law can pre-empt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, the weight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Cf., e.g., Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the pre-emption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation. Geier v. American Honda Motor Co., 529 U. S. 861, is distinguished. Pp. 17–25.

___ Vt. ___, 944 A. 2d 179, affirmed.

   Stevens, J., delivered the opinion of the Court, in which Kennedy, Souter, Ginsburg, and Breyer, JJ., joined. Breyer, J., filed a concurring opinion. Thomas, J., filed an opinion concurring in the judgment. Alito, J., filed a dissenting opinion, in which Roberts, C. J., and Scalia, J., joined.

Primary Holding

State tort law claims are not preempted by the FDCA with regard to prescription drugs, but they are an additional level of safeguards for consumers that complements the goals of the FDA.


The federal Food and Drug Administration (FDA) approved Wyeth's drug application for the anti-nausea medication Phenergan, finding its warnings sufficient. The FDA also later approved changes to the labeling of the drug . A patient named Levine was injected with Phenergan by the IV-push method, which released the drug directly into her vein. Levine developed gangrene and suffered the amputation of her forearm after the drug entered her artery.

Bringing a negligence and strict liability claim against Wyeth under state law, Levine argued that the manufacturer had failed to provide an adequate warning about the risks of using it through the IV-push method. While the labeling did warn that an intra-arterial injection could cause gangrene and amputation, she claimed that Wyeth should have told clinicians to use the IV-drip rather than the IV-push method, which was riskier. Levine also asserted that the risks associated with the drug meant that it was not safe for use through any IV method because the risks were too significant in relation to Phenergan's benefits.

After the jury found for Levine, the state Supreme Court affirmed. Wyeth appealed on the grounds that federal regulations preempted state law in this area.



  • John Paul Stevens (Author)
  • Anthony M. Kennedy
  • David H. Souter
  • Ruth Bader Ginsburg
  • Stephen G. Breyer

Stevens was not persuaded by the manufacturer's claim that it would be impossible to comply with duties imposed by state tort law and the federal labeling regulations simultaneously. The changes being effected regulation under the FDA allows labeling changes prior to its approval that promote consumer safety. Wyeth could have added this type of warning about the IV-push administration, and it is not clear that the FDA would have rejected it later. Manufacturers have primary responsibility for drug labeling, rather than the FDA.

Wyeth's view of a federal agency's power to pre-empt state law is overly broad in that Congress could not have intended to give the FDA decision-making authority on drug labeling that would forestall all related tort actions. The legislative history of the law that created the FDA, the Food, Drug, and Cosmetic Act, shows that Congress did not intend to pre-empt claims based on the failure to warn. The manufacturer improperly relied on the preamble to a 2006 FDA regulation rather than a statement by Congress, which would trump any assertion by the agency. No deference is due to a statement that conflicts with legislative history relating to the purpose of the Act, and the statement even conflicts with the agency's own long-standing policy.


  • Samuel A. Alito, Jr. (Author)
  • John G. Roberts, Jr.
  • Antonin Scalia

The FDA has had plenty of opportunities to require the manufacturer to change the contents of its warning label. Its decision not to do so suggests that the warnings on the label were sufficient and that the IV use of the drug was safe. The FDA clearly knew about the risks associated with the IV-push method, and its decision that these risks do not require more detailed warnings should negate a state tort claim based on the failure to warn.

The truly negligent parties in this case were the health care providers who administered the drug to the patient, ignoring the warnings on the label. This action should be based on medical malpractice rather than product liability, and maintaining it under the latter theory conflicts with the Supremacy Clause of the Constitution. Allowing a tort claim to proceed in these circumstances gives rise to impermissible conflict pre-emption because the agency performed as Congress required. Juries in state courts should not have the authority to issue their own determinations of a drug's safety that may clash with the FDA's conclusions. They lack the expertise of the agency, cannot take the more beneficial long-term perspective, and could reach a host of different outcomes that undermine the uniformity of the agency's decisions on safety.


  • Stephen G. Breyer (Author)


  • Clarence Thomas (Author)

Case Commentary

Preemption cases require balancing the goals of Congress against the sovereign authority of states in protecting their citizens. An express statement by Congress, rather than a federal agency, is required for a federal law to preempt a long-standing body of state common law in an area, and in this instance it appeared that Congress had recognized state common law as offering an additional protection to consumers.

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