555 U.S. 555 (2009)
Diana Levine, a professional musician, was treated for a migraine headache at a Vermont clinic on April 7, 2000.1 She received an intramuscular injection of Demerol and Phenergan that provided no relief, so she returned later that day and received a second injection of both drugs administered by the IV-push method.2 The injection entered an artery, either because the needle penetrated an artery directly or because of perivascular extravasation, and Levine developed gangrene that required amputation of her right hand and then her entire forearm.3
Levine settled claims against the health center and clinician before bringing a product liability action against Wyeth in Vermont state court.4 She alleged that Phenergan's labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher-risk IV-push method.5 After a five-day jury trial, the jury found Wyeth negligent and that Phenergan was a defective product as a result of inadequate warnings and instructions, awarding total damages of $7,400,000 that the court reduced to account for the prior settlement.
Wyeth manufactures Phenergan, an antihistamine used to treat nausea that the FDA first approved in 1955.6 The injectable form can be administered intramuscularly or intravenously, either by the IV-push method of injecting the drug directly into a vein or by the IV-drip method of introducing it into a saline solution in a hanging intravenous bag.7 The drug is corrosive and causes irreversible gangrene if it enters a patient's artery.8
The FDA-approved labeling warned of the danger of gangrene and amputation following inadvertent intra-arterial injection but did not contain a specific warning about the risks of IV-push administration. The trial record contained correspondence between Wyeth and the FDA about Phenergan's label spanning from the 1955 approval through a 1981 supplemental application that the FDA finally approved in 1998.9 In 1987 the FDA suggested different warnings about the risk of arterial exposure, and Wyeth submitted revised labeling in 1988, but the FDA did not respond and in 1996 instructed Wyeth to retain the verbiage in the current label regarding intra-arterial injection.10 The record also showed at least twenty incidents prior to Levine's injury in which a Phenergan injection resulted in gangrene and amputation.11
The trial court denied Wyeth's motion for summary judgment asserting federal preemption.12 The Vermont Supreme Court affirmed the jury verdict.13 The Supreme Court of the United States granted certiorari to decide whether the FDA's approvals of Wyeth's drug label precluded Levine from bringing her claim.14
Whether the FDA's approvals of Wyeth's drug label precluded Levine from bringing her state-law failure-to-warn claim?15
Federal law preempts a state-law failure-to-warn claim only if it is impossible for a manufacturer to comply with both federal labeling requirements and state-law duties or if the state claim stands as an obstacle to federal objectives.16 A strong presumption against preemption applies in traditional state fields such as health and safety regulation.17
No. The established facts establish that Diana Levine suffered gangrene and forearm amputation after an IV-push injection of Phenergan entered an artery.18 The Vermont jury determined that the FDA-approved label was inadequate because it failed to direct clinicians to the safer IV-drip method.19 At least twenty prior incidents of similar amputations had occurred.20 Wyeth could have used the changes-being-effected regulation to strengthen the warning without prior FDA approval.21
The FDA had never specifically rejected such a strengthened warning during decades of label correspondence.22
The FDA approvals therefore do not preclude Levine's state-law claim.23
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Justice Thomas concurred in the judgment.24 He agreed that the FDA approval did not preempt the state-law judgment because the CBE regulation permitted Wyeth to strengthen the warning without prior FDA approval.25 He wrote separately to explain his view that the Supremacy Clause requires a direct conflict between federal and state law before preemption can occur.26
In his view, the Court's implied preemption jurisprudence relying on broad purposes and objectives has become too expansive and inconsistent with constitutional principles.27 He would limit preemption to cases of actual textual conflict.28 He concluded that the FDA's approval did not create an unconditional right for Wyeth to market Phenergan with the initial label at all times.29
Whether it was impossible for Wyeth to comply with both federal labeling requirements and a state-law duty to provide stronger warnings about IV-push administration?30
No. The established facts show that Wyeth had received reports of at least twenty gangrene amputations before Levine's injury.33 The CBE regulation expressly allowed label changes to add or strengthen warnings about dosage and administration without prior FDA approval.34 The FDA's 1998 approval of the 1981 supplemental application did not prohibit such changes.35 Wyeth never attempted to add the warning the Vermont jury required.36
Compliance with both federal and state duties was therefore possible.37
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Justice Breyer concurred separately.38 He emphasized that the Court left open whether a specific regulation with the force of law could preempt state claims in a future case.39 He noted that state tort law can sometimes assist the FDA in uncovering unknown drug hazards.40
He also noted that state tort law can encourage drug manufacturers to disclose safety risks promptly.41 He observed that the FDA may seek to determine in future regulations when state tort law acts as a help or hindrance to achieving safe drug-related medical care.42
Whether recognition of Levine's state tort action creates an unacceptable obstacle to the accomplishment of federal drug regulation objectives?43
Obstacle preemption requires that state law stand as an obstacle to the full purposes and objectives of Congress.44 Congressional silence on express preemption for prescription drugs, combined with the FDCA savings clause and the FDA's historical treatment of state tort suits as complementary, defeats any claim of obstacle preemption.45
No. The established facts demonstrate that Congress has never enacted an express preemption provision for prescription-drug labeling despite doing so for medical devices.46 The FDA has long viewed state tort suits as providing additional incentives for safety.47 The agency had paid only passing attention to the specific IV-push risk in its decades of correspondence with Wyeth.48
Levine's claim therefore creates no unacceptable obstacle to federal objectives.49
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Joined by Chief Justice Roberts And Justice Scalia
Justice Alito dissented.50 He argued that the FDA's considered judgment that Phenergan's label rendered IV use safe should preempt conflicting state tort claims.51 He contended that allowing juries to second-guess the agency's cost-benefit balance would undermine the federal regulatory scheme.52
He also contended that such suits would produce inconsistent labeling requirements across states.53 He maintained that the FDA devoted substantial resources to evaluating drug safety and that its approval after considering the very risks at issue should control.54