John Paul Stevens

“ Directly injecting the drug Phenergan into a patient's vein creates a significant risk of catastrophic consequences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an adequate warning of that risk and awarded damages to respondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan's label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth's new drug application in 1955 and when it later approved changes in the drug's labeling. ”

“ They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation. [12] The agency's 2006 preamble represents a dramatic change in position. ”

“ In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. ”

“ It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market. See, e.g., 21 CFR § 201.80 (e) (requiring a manufacturer to revise its label "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug") ; § 314.80 (b) (placing responsibility for postmarketing surveillance on the manufacturer) ; 73 Fed. Reg. 49605 ("Manufacturers continue to have a responsibility under Federal law . . . to maintain their labeling and update the labeling with new safety information") . ”

“ Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid peri vascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. ”

“ FDA Perspective and Position, 52 Food & Drug L.J. 7, 10 (1997) (former chief counsel to the FDA stating that the FDA regarded state law as complementing the agency's mission of consumer protection) .
↑ In 1955, the same year that the agency approved Wyeth's Phenergan application, an FDA advisory committee issued a report finding "conclusively" that "the budget and staff of the [FDA] are inadequate to permit the discharge of its existing responsibilities for the protection of the American public." ”

“ Even in such cases, however, we have not deferred to an agency's conclusion that state law is pre-empted. Rather, we have attended to an agency's explanation of how state law affects the regulatory scheme. While [p577] agencies have no special authority to pronounce on pre-emption absent delegation by Congress, they do have a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an "obstacle to the accom plishment and execution of the full purposes and objectives of Congress." ”

“ The Vermont Supreme Court affirmed. It held that the jury's verdict "did not conflict with FDA's labeling require ments for Phenergan because [Wyeth] could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation." 183 Vt. 76, 84, 944 A.2d 179, 184 (2006) . In dissent, Chief Justice Reiber argued that the jury's verdict conflicted with federal law because it was inconsistent with the FDA's conclusion that intravenous ad ministration of Phenergan was safe and effective. ”

“ American Honda Motor Co., 529 U.S. 861 (2000) , which explained the effects of state law on the DOT's regulation in a manner consistent with the agency's prior accounts, see ibid., the Government's explanation of federal drug regulation departs markedly from the FDA's understanding at all times relevant to this case.
↑ Wyeth's more specific contention – that this case resembles Geier be cause the FDA determined that no additional warning on IV-push administration was needed, thereby setting a ceiling on Phenergan's label – is belied by the record. ”

“ The rule accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments: " [I] f the sponsor sub mits adverse event information to FDA, and then later con ducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports pre viously submitted to FDA, the sponsor meets the require ment for 'newly acquired information.'" Id., at 49607 ”

“ V) (authorizing the Secretary of Transportation to decide whether a state or local statute that conflicts with the regulation of hazardous waste transportation is pre-empted) .
↑ See also 44 Fed. Reg. 37437 (1979) ("It is not the intent of the FDA to influence the civil tort liability of the manufacturer") ; 59 Fed. Reg. 3948 (1994) (" [P] roduct liability plays an important role in consumer protection") ”