Samuel Alito

“ Indeed, as recently as last Term, we held that the Supremacy Clause pre- [p622] empts a " [s] tate tort law that requires a manufacturer's catheters to be safer, but hence less effective, than the model the FDA has approved . . . ." Riegel, 552 U.S., at 325. It did not matter there that the State stopped short of altogether prohibiting the use of FDA-approved catheters – just as it does not matter here that Vermont stopped short of altogether prohibiting an FDA-approved method for administer ing Phenergan. ”

“ And the record contains ample evidence that the FDA specifically considered and reconsidered the strength of Phenergan's IV-push-related warnings in light of new scientific and medical data. The majority's factual assertions to the contrary are mistaken.
1 The FDA's focus on IV push as a means of administering Phenergan dates back at least to 1975. In August of that year, several representatives from both the FDA and Wyeth met to discuss Phenergan's warning label. At that meeting, the FDA specifically proposed "that Phenergan Injection should not be used in Tubex®." ”

“ The unfortunate fact that respondent's healthcare providers ignored Phenergan's labeling may make this an ideal medical-malpractice case. [3] But turning a common-law tort suit into a "frontal assault" on the FDA's regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict pre-emption jurisprudence. Brief for United States as Amicus Curiae 21.
II A [p607] To the extent that " [t] he purpose of Congress is the ultimate touchstone in every pre-emption case," Medtronic, Inc. ”

“ But that ignores the antecedent question of who – the FDA or a jury in Vermont – has the authority and responsibility for determining the "adequacy" of Phenergan's warnings. Moreover, it is unclear how a "stronger" warning could have helped respondent, see ante, at 573; after all, the physician's assistant who treated her disregarded at least six separate warnings that are already on Phenergan's labeling, so respondent would be hard pressed to prove that a seventh would have made a difference. ”

“ Phenergan's label also directs medical practitioners to choose veins wisely when using IV push:
"Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, ex- [p619] treme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. ”

“ See also Haas, Correspondence, 33 Anesthesia Progress 281 (1986) (" [Hydroxyzine's] restriction does not lie with the medicine itself, but in the practice and malpractice of intravenous techniques. Unfortunately, the practitioner who knows how to treat injection technique problems is usually not the practitioner with the intravenous technique problems") . ”

“ The problem is well illustrated by the labels borne by "vesicant" drugs, many of which are used for chemotherapy. As a class, vesicants are much more dangerous than drugs like Phenergan, [15] but the vast majority of vesicant labels – like Phenergan's – either allow or do not disallow IV push. See Appendix, infra. Because vesicant extravasation can have devastating consequences, and because the potentially life saving benefits of these drugs offer hollow solace to the vic- [p627] tim of such a tragedy, a jury's cost-benefit analysis in a particular case may well differ from the FDA's. ”

“ Acting pursuant to that statutory mandate, the Secretary of Transportation promulgated Federal Motor Vehicle Safety Standard 208, which required car manufacturers to include passive restraint systems (i.e., devices that work automatically to protect occupants from injury during a collision) in a certain percentage of their cars built in or after 1987. ”

“ This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA) , is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U.S. 861 (2000) , or general principles of conflict pre-emption. I respectfully dissent.
I [p605] The Court frames the question presented as a "narro [w] " one – namely, whether Wyeth has a duty to provide "an adequate warning about using the IV-push method" to administer Phenergan. ”

“ Medical attention should be sought immediately. Contaminated clothing should be destroyed." [17]
Yet when it comes to administering this highly toxic drug, the label provides that "the drug may be injected directly into any suitable vein, [but] it is injected preferably into the rubber or plastic tubing of a flowing intravenous infusion set. This reduces the possibility of severe local reactions due to extravasation or high concentration of the drug." ”

“ The FDA required Wyeth to include Hager and Wilson's observations on Phenergan's label. See App. 311 (requiring the label to warn that "' [t] he first sign [of an intra-arterial injection] may be the patient's reaction to a sensation of fiery burning'" pain and "' [b] lanching'") .
↑ See Enloe 427 (discussing hydroxyzine – an antihistamine with chemi cal properties similar to those of Phenergan – and suggesting its "temporary" benefits can never outweigh the risks of intra-arterial injection) ”

“ De la Cuesta, 458 U.S. 141, 155 (1982) ("The conflict does not evaporate because the [agency's] regulation simply permits, but does not compel," the action forbidden by state law) . If anything, a finding of pre-emption is even more appropriate here be cause the FDCA – unlike the National Traffic and Motor Safety Vehicle Act – contains no evidence that Congress in- [p612] tended the FDA to set only "minimum standards," and the FDCA does not contain a saving clause. [4] See also ante, at 575 (majority opinion) (conceding Congress' "silence" on the issue) . ”

“ See supra, at 614–617; see also The Lippincott Manual of Nursing Practice 99 (7th ed. 2001) (noting, in a red-text "NURSING ALERT," that the antecubital fossa is "not recommended" for administering dangerous drugs, "due to [the] potential for extravasation") . [13] According to the physician's assistant who injured respondent, however, " [i] t never crossed my mind" that an antecubital injection of Phenergan could hit an artery. App. 110 ”