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II

This Court has determined that there are two categories of conflict pre-emption, both of which Wyeth contends are at issue in this case. First, the Court has found pre-emption “where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 142–143 (1963) . Second, the Court has determined that federal law pre-empts state law when, “under the circumstances of [a] particular case, [state] law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U. S. 52, 67 (1941) .2

A

Wyeth first contends that “it would have been impossible for it to comply with the state-law duty to modify Phenergan’s labeling without violating federal law.” Ante, at 6 (opinion for the Court by Stevens, J.). But, as the majority explains, the text of the relevant federal statutory provisions and the corresponding regulations do not directly conflict with the state-law judgment before us.

This Court has used different formulations of the standard to be used in deciding whether state and federal law conflict, and thus lead to pre-emption, under the “impossibility” doctrine. See, e.g., Geier, supra, at 873 (“a case in which state law penalizes what federal law requires”); American Telephone & Telegraph Co. v. Central Office Telephone, Inc., 524 U. S. 214, 227 (1998) (AT&T) (when state-law claims “directly conflict” with federal law), cited in Geier, supra, at 874 (describing AT&T as a “cas[e] involving impossibility”); Florida Lime & Avocado Growers, supra, at 142–143 (“where compliance with both federal and state regulations is a physical impossibility”). The Court has generally articulated a very narrow “impossibility standard,” see Crosby, 530 U. S., at 372–373 (citing Florida Lime & Avocado Growers, supra, at 142–143); see also Sprietsma v. Mercury Marine, 537 U. S. 51, 64–65 (2002) ; United States v. Locke, 529 U. S. 89, 109 (2000) —in part because the overly broad sweep of the Court’s “purposes and objectives” approach, see infra, at 13–23, has rendered it unnecessary for the Court to rely on “impossibility” pre-emption.

The Court, in fact, has not explained why a narrow “physical impossibility” standard is the best proxy for determining when state and federal laws “directly conflict” for purposes of the Supremacy Clause. There could be instances where it is not “physically impossible” to comply with both state and federal law, even when the state and federal laws give directly conflicting commands. See Nelson, Preemption, 86 Va. L. Rev. 225, 260–261 (2000). For example, if federal law gives an individual the right to engage in certain behavior that state law prohibits, the laws would give contradictory commands notwithstanding the fact that an individual could comply with both by electing to refrain from the covered behavior. Ibid. Therefore, “physical impossibility” may not be the most appropriate standard for determining whether the text of state and federal laws directly conflict. See ibid. (concluding that the Supremacy Clause does not limit direct conflicts to cases with “physically impossible” conflicts and arguing that evidence from the Founding supports a standard of “logical-contradiction”); see also AT&T, supra, at 227 (requiring that the state-law claims “directly conflict” with federal law); 3 Story §1836, at 701 (suggesting instead that a state law is pre-empted by the Supremacy Clause when it is “repugnant to the constitution of the United States” (emphasis added)).

Nonetheless, whatever the precise constitutional contours of implied pre-emption may be, I am satisfied that it does not operate against respondent’s judgment below. The text of the federal laws at issue do not require that the state-court judgment at issue be pre-empted, under either the narrow “physical impossibility” standard, Florida Lime & Avocado Growers, supra, at 142–143, or a more general “direc[t] conflict” standard, AT&T, supra, at 227.

Under the FDA’s “changes being effected” regulation, 21 CFR §314.70(c)(6)(iii), which was promulgated pursuant to the FDA’s statutory authority, it is physically possible for Wyeth to market Phenergan in compliance with federal and Vermont law. As the majority explains, Wyeth could have changed the warning on its label regarding IV-push without violating federal law. See ante, at 11–13. The “changes being effected” regulation allows drug manufacturers to change their labels without the FDA’s preapproval if the changes “add or strengthen a contraindication, warning, precaution, or adverse reaction,” §314.70(c)(6)(iii)(A), or “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” §314.70(c)(6)(iii)(C), in order to “reflect newly acquired information,” including “new analyses of previously submitted data,” 73 Fed. Reg. 49603, 49609. Under the terms of these regulations, after learning of new incidences of gangrene-induced amputation resulting from the IV-push administration of Phenergan, see ante, at 12–13, federal law gave Wyeth the authority to change Phenergan’s label to “strengthen a … warning,” “strengthen a … precaution,” §314.70(c)(6)(iii)(A), or to “strengthen an instruction about … administration [of the IV-push method] … to increase the safe use of the drug product,” §314.70(c)(6)(iii)(C). Thus, it was physically possible for Wyeth to comply with a state-law requirement to provide stronger warnings on Phenergan about the risks of the IV-push administration method while continuing to market Phenergan in compliance with federal law.

In addition, the text of the statutory provisions governing FDA drug labeling, and the regulations promulgated thereunder, do not give drug manufacturers an unconditional right to market their federally approved drug at all times with the precise label initially approved by the FDA. Thus, there is no “direct conflict” between the federal labeling law and the state-court judgment. The statute prohibits the interstate marketing of any drug, except for those that are federally approved. See 21 U. S. C. §355(a) (“No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug” (emphasis added)). To say, as the statute does, that Wyeth may not market a drug without federal approval (i.e., without an FDA-approved label) is not to say that federal approval gives Wyeth the unfettered right, for all time, to market its drug with the specific label that was federally approved. Initial approval of a label amounts to a finding by the FDA that the label is safe for purposes of gaining federal approval to market the drug. It does not represent a finding that the drug, as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.

Instead, FDA regulations require a drug manufacturer—after initial federal approval of a drug’s label—to revise the federally approved label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” 21 CFR §201.80(e). Drug manufacturers are also required to “establish and maintain records and make reports” to the FDA about “[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug related,” after it has received federal approval. §§314.80(a), (c), (j). In addition, the manufacturer must make periodic reports about “adverse drug experience[s]” associated with its drug and include “a history of actions taken since the last report because of adverse drug experiences (for example, labeling changes or studies initiated).” §§314.80(c)(2)(i)–(ii). When such records and reports are not made, the FDA can withdraw its approval of the drug. §314.80(j); see also 21 U. S. C. §355(e) (“The Secretary may … withdraw the approval of an application … if the Secretary finds … that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports”). The FDA may also determine that a drug is no longer safe for use based on “clinical or other experience, tests, or other scientific data.” Ibid. (approval may be withdrawn if “the Secretary finds … that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved”).

The text of the statutory provisions and the accompanying regulatory scheme governing the FDA drug approval process, therefore, establish that the FDA’s initial approval of a drug is not a guarantee that the drug’s label will never need to be changed. And nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.

In sum, the relevant federal law did not give Wyeth a right that the state-law judgment took away, and it was possible for Wyeth to comply with both federal law and the Vermont-law judgment at issue here. The federal statute and regulations neither prohibited the stronger warning label required by the state judgment, nor insulated Wyeth from the risk of state-law liability. With no “direct conflict” between the federal and state law, then, the state-law judgment is not pre-empted. Cf. AT&T, 524 U. S., at 221–226 (finding pre-emption where federal law forbade common carriers from extending communications privileges requested by state-law claims); Foster, 522 U. S., at 68–69 (finding pre-emption where the federal statute required congressional elections on a particular date different from that provided by state statute).

B

Wyeth also contends that state and federal law conflict because “recognition of [this] state tort action creates an unacceptable ‘obstacle to the accomplishment and execution of the full purposes and objectives of Congress,’ Hines v. Davidowitz, 312 U. S. 52, 67 (1941) , because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA.” Ante, at 6–7. This Court’s entire body of “purposes and objectives” pre-emption jurisprudence is inherently flawed. The cases improperly rely on legislative history, broad atextual notions of congressional purpose, and even congressional inaction in order to pre-empt state law. See supra, at 5–7. I, therefore, cannot join the majority’s analysis of this claim, see ante, at 17–25, or its reaffirmation of the Court’s “purposes and objectives” jurisprudence, ante, at 17–18 (analyzing congressional purposes); ante, at 20 (quoting the “ ‘purposes and objectives’ ” pre-emption standard from Hines v. Davidowitz, 312 U. S. 52, 67 (1941) , and Geier, 529 U. S., at 883); ante, at 23–24, and nn. 13–14 (analyzing this case in light of Geier, 529 U. S. 861 ).

1

The Court first formulated its current “purposes and objectives” pre-emption standard in Hines when it considered whether the federal Alien Registration Act pre-empted an Alien Registration Act adopted by the Commonwealth of Pennsylvania. The Court did not find that the two statutes, by their terms, directly conflicted. See Hines, supra, at 59–60, and n. 1 (citing Pa. Stat. Ann., Tit. 35, §§1801–1806 (Purdon Supp. 1940)); 312 U. S., at 60, and n. 5 (citing Act of June 28, 1940, 54 Stat. 670); 312 U. S., at 69–74 (analyzing numerous extratextual sources and finding pre-emption without concluding that the terms of the federal and state laws directly conflict); see also id., at 78 (noting that “[i]t is conceded that the federal act in operation does not at any point conflict with the state statute” (Stone, J., dissenting)).3 Nonetheless, the Court determined that it was not confined to considering merely the terms of the relevant federal law in conducting its pre-emption analysis. Rather, it went on to ask whether the state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id., at 67.

In so doing, the Court looked far beyond the relevant federal statutory text and instead embarked on its own freeranging speculation about what the purposes of the federal law must have been. See id., at 69–74. In addition to the meaning of the relevant federal text, the Court attempted to discern “[t]he nature of the power exerted by Congress, the object sought to be attained, and the character of the obligations imposed by the law.” Id., at 70. To do so, the Court looked in part to public sentiment, noting that “[o]pposition to laws … singling out aliens as particularly dangerous and undesirable groups, is deep-seated in this country.” Ibid. The Court also relied on statements by particular Members of Congress and on congressional inaction, finding it pertinent that numerous bills with requirements similar to Pennsylvania’s law had failed to garner enough votes in Congress to become law. Id., at 71–73, and nn. 32–34. Concluding that these sources revealed a federal purpose to “protect the personal liberties of law-abiding aliens through one uniform national registration system,” the Court held that the Pennsylvania law was pre-empted. Id., at 74.

Justice Stone, in dissent, questioned the majority’s decision to read an exclusive registration system for aliens into a statute that did not specifically provide such exclusivity. See id., at 75. He noted his concern that state power would be improperly diminished through a pre-emption doctrine driven by the Court’s “own conceptions of a policy which Congress ha[d] not expressed and which is not plainly to be inferred from the legislation which it ha[d] enacted.” Ibid. In his view, nothing that Congress enacted had “denie[d] the states the practicable means of identifying their alien residents and of recording their whereabouts.” Id., at 78. Yet, the Hines majority employed pre-emption to override numerous state alien-registration laws even though enacted federal law “at no point conflict[ed] with the state legislation and [was] harmonious with it.” Id., at 79.4

2

The consequences of this Court’s broad approach to “purposes and objectives” pre-emption are exemplified in this Court’s decision in Geier, which both the majority and the dissent incorporate into their analysis today. See ante, at 23–24, and nn. 13–14; post, at 6–9 (opinion of Alito, J.). In Geier, pursuant to the National Traffic and Motor Vehicle Safety Act of 1966 (Safety Act), 80 Stat. 718, 15 U. S. C. §1381 et seq. (1988 ed.), the Department of Transportation (DOT) had promulgated a Federal Motor Vehicle Safety Standard that “required auto manufacturers to equip some but not all of their 1987 vehicles with passive restraints.” 529 U. S., at 864–865. The case required this Court to decide whether the Safety Act pre-empted a state common-law tort action in which the plaintiff claimed that an auto manufacturer, though in compliance with the federal standard, should nonetheless have equipped a 1987 automobile with airbags. Id., at 865. The Court first concluded that the Safety Act’s express pre-emption provision and its saving clause, read together, did not expressly pre-empt state common-law claims. See id., at 867–868.5 The Court then proceeded to consider whether the state action was nonetheless pre-empted as an “obstacle” to the purposes of the federal law. The Court held that the state tort claim was pre-empted, relying in large part on comments that DOT made when promulgating its regulation, statements that the Government made in its brief to the Court, and regulatory history that related to the federal regulation of passive restraints. See id., at 874–886.

In particular, the majority found that DOT intended to “deliberately provid[e] the manufacturer[s] with a range of choices among different passive restraint devices” and to “bring about a mix of different devices introduced gradually over time,” based on comments that DOT made when promulgating its regulation, rather than the Safety Act’s text. Id., at 875. The majority also embarked on a judicial inquiry into “why and how DOT sought these objectives,” ibid., by considering regulatory history and the Government’s brief, which described DOT’s safety standard as “ ‘embod[ying] the Secretary’s policy judgment that safety would best be promoted if manufacturers installed alternative protection systems in their fleets rather than one particular system in every car,’ ” id., at 881 (quoting Brief for United States as Amicus Curiae in Geier v. American Honda Motor Co., O. T. 1999, No. 98–1811, p. 25); see also 529 U. S., at 883–884. Based on this “ex post administrative litigating position and inferences from regulatory history and final commentary,” id., at 910–911 (Stevens., J., dissenting), the Court found that the state action was pre-empted because it would have required manufacturers of all cars similar to that in which the plaintiff was injured to “install airbags rather than other passive restraint systems” and would have, therefore, “presented an obstacle to the variety and mix of devices that the federal regulation sought” to phase in gradually, id., at 881.

The Court’s decision in Geier to apply “purposes and objectives” pre-emption based on agency comments, regulatory history, and agency litigating positions was especially flawed, given that it conflicted with the plain statutory text of the saving clause within the Safety Act, which explicitly preserved state common-law actions by providing that “[c]ompliance with any Federal motor vehicle safety standard issued under this subchapter does not exempt any person from any liability under common law,” 15 U. S. C. §1397(k) (1988 ed.).6 See Engine Mfrs. Assn. v. South Coast Air Quality Management Dist., 541 U. S. 246, 252 (2004) (“Statutory construction must begin with the language employed by Congress and the assumption that the ordinary meaning of that language accurately expresses the legislative purpose” (internal quotation marks omitted)); West Virginia Univ. Hospitals, Inc. v. Casey, 499 U. S. 83, 98 (1991) (“The best evidence of th[e] purpose [of a statute] is the statutory text adopted by both Houses of Congress and submitted to the President”). In addition, the Court’s reliance on its divined purpose of the federal law—to gradually phase in a mix of passive restraint systems—in order to invalidate a State’s imposition of a greater safety standard was contrary to the more general express statutory goal of the Safety Act “to reduce traffic accidents and deaths and injuries to persons resulting from traffic accidents,” 15 U. S. C. §1381 (1988 ed.). This Court has repeatedly stated that when statutory language is plain, it must be enforced according to its terms. See Jimenez v. Quarterman, 555 U. S. ___ (2009); see also, e.g., Dodd v. United States, 545 U. S. 353, 359 (2005) ; Lamie v. United States Trustee, 540 U. S. 526, 534 (2004) ; Hartford Underwriters Ins. Co. v. Union Planters Bank, N. A., 530 U. S. 1, 6 (2000) . The text in Geier “directly addressed the precise question at issue” before the Court, so that should have been “the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.” National Assn. of Home Builders v. Defenders of Wildlife, 551 U. S. 644 , ___ (2007) (slip op., at 18) (2007) (internal quotation marks omitted). With text that allowed state actions like the one at issue in Geier, the Court had no authority to comb through agency commentaries to find a basis for an alternative conclusion.

Applying “purposes and objectives” pre-emption in Geier, as in any case, allowed this Court to vacate a judgment issued by another sovereign based on nothing more than assumptions and goals that were untethered from the constitutionally enacted federal law authorizing the federal regulatory standard that was before the Court. See Watters v. Wachovia Bank, N. A., 550 U. S. 1, 44 (2007) (Stevens, J., dissenting) (noting that pre-emption “affects the allocation of powers among sovereigns”). “ ‘[A]n agency literally has no power to act, let alone pre-empt the [law] of a sovereign State, unless and until Congress confers power upon it.’ ” New York v. FERC, 535 U. S., at 18 (quoting Louisiana Pub. Serv. Comm’n v. FCC, 476 U. S. 355, 374 (1986) ). Thus, no agency or individual Member of Congress can pre-empt a State’s judgment by merely musing about goals or intentions not found within or authorized by the statutory text. See supra, at 5–7.

The Court’s “purposes and objectives” pre-emption jurisprudence is also problematic because it encourages an overly expansive reading of statutory text. The Court’s desire to divine the broader purposes of the statute before it inevitably leads it to assume that Congress wanted to pursue those policies “at all costs”—even when the text reflects a different balance. See Geier, supra, at 904 (Stevens, J., dissenting) (finding no evidence to support the notion that the DOT Secretary intended to advance the purposes of the safety standard “at all costs”); Nelson, 86 Va. L. Rev., at 279–280. As this Court has repeatedly noted, “ ‘it frustrates rather than effectuates legislative intent simplistically to assume that whatever furthers the statute’s primary objective must be the law.’ ” E.g., Norfolk Southern R. Co. v. Sorrell, 549 U. S. 158, 171 (2007) (quoting Rodriguez v. United States, 480 U. S. 522, 526 (1987) (per curiam)). Federal legislation is often the result of compromise between legislators and “groups with marked but divergent interests.” See Ragsdale v. Wolverine World Wide, Inc., 535 U. S. 81, 93–94 (2002) . Thus, a statute’s text might reflect a compromise between parties who wanted to pursue a particular goal to different extents. See, e.g., ibid. (noting that the Family and Medical Leave Act’s provision of only 12 workweeks of yearly leave “was the result of compromise” that must be given effect by courts); Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 257 (1984) (finding that a state law was not pre-empted though it allegedly frustrated a primary purpose of the Atomic Energy Act because the Act provided that its purpose was to be furthered only “to the extent it is consistent ‘with the health and safety of the public’ ” (quoting 42 U. S. C. §2013(d) (1982 ed.))); see also Manning, What Divides Textualists from Purposivists? 106 Colum. L. Rev. 70, 104 (2006) (“Legislators may compromise on a statute that does not fully address a perceived mischief, accepting half a loaf to facilitate a law’s enactment”). Therefore, there is no factual basis for the assumption underlying the Court’s “purposes and objectives” pre-emption jurisprudence that every policy seemingly consistent with federal statutory text has necessarily been authorized by Congress and warrants pre-emptive effect. Instead, our federal system in general, and the Supremacy Clause in particular, accords pre-emptive effect to only those policies that are actually authorized by and effectuated through the statutory text.
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