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Full Opinion
concurring in the judgment.
I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyethâs drug Phenergan does not pre-empt the state-law judgment before the Court. That judgment was based on a jury finding that the label did not adequately warn of the risk involved in administering Phenergan through the IV-push injection method. Under federal law, without prior approval from the FDA, Wyeth could have âadd[ed] or strengthened]ââ information on its label about âa contraindi
I write separately, however, because I cannot join the majorityâs implicit endorsement of far-reaching implied preemption doctrines. In particular, I have become increasingly skeptical of this Courtâs âpurposes and objectivesâ pre-emption jurisprudence. Under this approach, the Court routinely invalidates .state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law. Because implied pre-emption doctrines that wander far from the statutory text are inconsistent with the Constitution, I concur only in the judgment.
I
A
In order âto ensure the protection of our fundamental liberties,â Atascadero State Hospital v. Scanlon, 473 U. S. 234, 242 (1985) (internal quotation marks omitted), the âConstitution establishes a system of dual sovereignty between the States and the Federal Government,â Gregory v. Ashcroft,
Under this federalist system, âthe States possess sovereignty concurrent with that of the Federal Government, subject only to limitations imposed by the Supremacy Clause.â Tafflin v. Levitt, 493 U. S. 455, 458 (1990). In this way, the Supremacy Clause gives the Federal Government âa decided advantage in [a] delicate balanceâ between federal and state sovereigns. Gregory, 501 U. S., at 460. âAs long as it is acting within the powers granted it under the Constitution, Congress may impose its will on the States.â Ibid. That is an âextraordinary power in a federalist system.â Ibid.
Nonetheless, the States retain substantial sovereign authority. U. S. Const., Arndt. 10 (âThe powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the peopleâ); see also Alden v. Maine, 527 U. S. 706, 713 (1999); Printz v. United States, 521 U. S. 898, 918-922 (1997); New York v. United States, 505 U. S. 144, 155-156 (1992); Gregory, supra, at 457-459; Tafflin, supra, at 458. In accordance with the text and structure of the Constitution, â[t]he powers delegated by the proposed constitution to the
As a result, in order to protect the delicate balance of power mandated by the Constitution, the Supremacy Clause must operate only in accordance with its terms. The Clause provides:
âThis Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the Contrary notwithstanding.â Art. VI, cl. 2.
With respect to federal laws, then, the Supremacy Clause gives âsupremeâ status only to those that are âmade in Pursuanceâ of â[t]his Constitution.â Ibid.; see 3 J. Story, Commentaries on the Constitution of the United States §1831, p. 694 (1833) (hereinafter Story) (âIt will be observed, that the supremacy of the laws is attached to those only, which are made in pursuance of the constitutionâ).
Federal laws âmade in Pursuanceâ of the Constitution must comply with two key structural limitations in the Constitution that ensure that the Federal Government does not amass too much power at the expense of the States. The first structural limitation, which the parties have not raised in this case, is âthe Constitutionâs conferral upon Congress of not all governmental powers, but only discrete, enumerated ones.â Printz, supra, at 919; see also United States v. Mor
The second structural limitation is the complex set of procedures that Congress and the President must follow to enact âLaws of the United States.â See INS v. Chadha, 462 U. S. 919, 945-946 (1983) (setting forth the Constitutionâs Bicameral and Presentment Clauses, Art. I, § 7, els. 2-3, which âprescribe and define the respective functions of the Congress and of the Executive in the legislative processâ). â[T]he Framers were acutely conscious that the bicameral requirement and the Presentment Clauses would serve essential constitutional functions,â Chadha, 462 U. S., at 951, by allowing the passage of legislation only after it has proceeded through âa step-by-step, deliberate and deliberative process,â id., at 959, that was âfinely wrought and exhaustively consideredâ by the Framers, id., at 951. The Supremacy Clause thus requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentment procedures. See Story § 1831, at 694 (Actions of the Federal Government âwhich are not pursuant to its constitutional powers, but which are invasions of the residuary authorities of the smaller societies,â are not âthe
B
In light of these constitutional principles, I have become âincreasing[ly] reluetan[t] to expand federal statutes beyond their terms through doctrines of implied pre-emption.â Bates v. Dow Agrosciences LLC, 544 U. S. 431, 459 (2005) (Thomas, J., concurring in judgment in part and dissenting in part). My review of this Courtâs broad implied preemption precedents, particularly its âpurposes and objectivesâ pre-emption jurisprudence, has increased my concerns that implied pre-emption doctrines have not always been constitutionally applied. Under the vague and âpotentially boundlessâ doctrine of âpurposes and objectivesâ preemption, Geier v. American Honda Motor Co., 529 U. S. 861, 907 (2000) (Stevens, J., dissenting), for example, the Court has pre-empted state law based on its interpretation of broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not contained within the text of federal law. See, e. g., Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U. S. 644, 678 (2003) (Thomas, J., concurring in judgment) (referring to the âconcomitant danger of invoking obstacle pre-emption based on the arbitrary selection of one purpose to the exclusion of othersâ); Crosby v. National Foreign Trade Council, 530 U. S. 363, 388-391 (2000) (Scalia, J., concurring in judgment) (criticizing the majorityâs reliance on legislative history to discern statutory intent when that intent was âperfectly obvious on the face of th[e] statuteâ); Geier, supra, at 874-883 (relying on regulatory history, agency comments, and the Governmentâs litigating position to determine that federal law pre-empted state law).
Congressional and agency musings, however, do not satisfy the Article I, § 7, requirements for enactment of federal law and, therefore, do not pre-empt state law under the Suprem
II
This Court has determined that there are two categories of conflict pre-emption, both of which Wyeth contends are at
A
Wyeth first contends that âit would have been impossible for it to comply with the state-law duty to modify Phenerganâs labeling without violating federal law.â Ante, at 563 (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 âimpossibilityâ doctrine. See, e. g., Geier, supra, at 873 (âa case in which state law penalizes what federal law requiresâ); American Telephone & Telegraph Co. v. Central Office Telephone, Inc., 524 U. S. 214, 227 (1998) (AT&T) (when state-law claims âdirectly conflictâ with federal law), cited in Geier, supra, at 874 (describing AT&T as a âcas[e] involving impossibilityâ); Florida
The Court, in fact, has not explained why a narrow âphysical impossibilityâ standard is the best proxy for determining when state and federal laws âdirectly conflictâ for purposes of the Supremacy Clause. There could be instances where it is not âphysically impossibleâ 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, âphysical impossibilityâ 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 âphysically impossibleâ conflicts and arguing that evidence from the founding supports a standard of âlogical-contradictionâ); see also AT&T, supra, at 227 (requiring that the state-law claims âdirectly conflictâ with federal law); Story § 1836, at 701 (suggesting instead that a state law is pre-empted by the Supremacy Clause when it is ârepugnant to the constitution of the United Statesâ (emphasis added)).
Under the FDAâs âchanges being effectedâ regulation, 21 CFR § 314.70(e)(6)(iii), which was promulgated pursuant to the FDAâs 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 568-570. The âchanges being effectedâ regulation allows drug manufacturers to change their labels without the FDAâs preapproval if the changes âadd or strengthen a contraindication, warning, precaution, or adverse reaction,â § 314.70(c)(6)(iii)(A), or âadd or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,â § 314.70(c)(6)(iii)(C), in order to âreflect newly acquired information,â including ânew analyses of previously submitted data,â 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 569-570, federal law gave Wyeth the authority to change Phenerganâs label to âstrengthen a . . . warning,â âstrengthen a . . . precaution,â § 314.70(c)(6)(iii)(A), or to âstrengthen an instruction about . . . administration [of the IV-push method] ... to increase the safe use of the drug product,â § 314.70(c)(6)(iii)(C). Thus, it was physically possible for Wyeth to comply with a â˘state-law requirement to provide stronger warnings on Phenergan about the risks of the IV-push administration method
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 âdirect conflictâ 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) (âNo 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 drugâ (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 manufacturerâ after initial federal approval of a drugâs label â to revise the federally approved label âto include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.â 21 CFR § 201.80(e). Drug manufacturers are also required to âestablish and maintain records and make reportsâ to the FDA about â[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug related,â after it has received federal approval. §§ 314.80(a), (c), (j). In addition, the manufacturer must make periodic reports about âadverse drug experi
The text of the statutory provisions and the accompanying regulatory scheme governing the FDA drug approval process, therefore, establish that the FDAâs initial approval of a drug is not a guarantee that the drugâs 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 âdirect conflictâ 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 preemption where federal law forbade common carriers from extending communications privileges requested by state-law
B
Wyeth also contends that state and federal law conflict because ârecognition of [this] state tort action creates an unacceptable âobstacle 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 juryâs decision about drug labeling for the expert judgment of the FDA.â Ante, at 563-564 (majority opinion). This Courtâs entire body of âpurposes and objectivesâ 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 587-588. I, therefore, cannot join the majorityâs analysis of this claim, see ante, at 573-581, or its reaffirmation of the Courtâs âpurposes and objectivesâ jurisprudence, ante, at 573-575 (analyzing congressional purposes); ante, at 576-577 (quoting the ââpurposes and objectivesâ â pre-emption standard from Hines, 312 U. S., at 67, and Geier, 529 U. S., at 883); ante, at 579-581, and nn. 13-14 (analyzing this case in light of Geier, supra).
1
The Court first formulated its current âpurposes and objectivesâ 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
In so doing, the Court looked far beyond the relevant federal statutory text and instead embarked on its own free-ranging 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 â[t]he nature of the power exerted by Congress, the object sought to be attained, and the character of the obliga
Justice Stone, in dissent, questioned the majorityâs 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 Courtâs âown 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.â Ibid. In his view, nothing that Congress enacted had âdenie[d] the states the practicable means of identifying their alien residents and of recording their whereabouts.â Id., at 78. Yet, the Hines majority employed pre-emption to override numerous state alien-registration laws even though enacted federal law âat no point conflicted] with the state legislation and [was] harmonious with it.â Id., at 79.
The consequences of this Courtâs broad approach to âpurposes and objectivesâ pre-emption are exemplified in this Courtâs decision in Geier, which both the majority and the dissent incorporate into their analysis today. See ante, at 579-581, and nn. 13-14; post, at 609-612 (opinion of Auto, 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 ârequired auto manufacturers to equip some but not all of their 1987 vehicles with passive restraints.â 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 Actâs express pre-emption provision and its saving clause, read together, did not expressly pre-empt state common-law claims. See id., at 86T-868.
In particular, the majority found that DOT intended to âdeliberately provid[e] the manufacturer^] with a range of choices among different passive restraint devicesâ and to âbring about a mix of different devices introduced gradually over time,â based on comments that DOT made when promulgating its regulation, rather than the Safety Actâs text. Id., at 875. The majority also embarked on a judicial inquiry into âwhy and how DOT sought these objectives,â ibid., by considering regulatory history and the Governmentâs brief, which described DOTâs safety standard as â âembod[ying] the Secretaryâs 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,ââ 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 âex post administrative litigating position and inferences from regulatory history and final commentary,â 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 âinstall airbags rather than other passive restraint systemsâ and would have, therefore, âpresented an obstacle to the variety and mix of devices that the federal regulation soughtâ to phase in gradually, id., at 881.
The Courtâs decision in Geier to apply âpurposes and objectivesâ pre-emption based on agency comments, regulatory
Applying âpurposes and objectivesâ 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 âaffects the allocation of powers among sovereignsâ). â â[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.â â New York v. FERC, 535 U.