Wyeth v. Levine, 555 U. S. ____ (2009)

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In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market,11 and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. 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.

Largely based on the FDA’s new position, Wyeth argues that this case presents a conflict between state and federal law analogous to the one at issue in Geier. There, we held that state tort claims premised on Honda’s failure to install airbags conflicted with a federal regulation that did not require airbags for all cars. The Department of Transportation (DOT) had promulgated a rule that provided car manufacturers with a range of choices among passive restraint devices. Geier, 529 U. S., at 875. Rejecting an “ ‘all airbag’ ” standard, the agency had called for a gradual phase-in of a mix of passive restraints in order to spur technological development and win consumer acceptance. Id., at 879. Because the plaintiff’s claim was that car manufacturers had a duty to install airbags, it presented an obstacle to achieving “the variety and mix of devices that the federal regulation sought.” Id., at 881.

Wyeth and the dissent contend that the regulatory scheme in this case is nearly identical, but, as we have described, it is quite different. In Geier, the DOT conducted a formal rulemaking and then adopted a plan to phase in a mix of passive restraint devices. Examining the rule itself and the DOT’s contemporaneous record, which revealed the factors the agency had weighed and the balance it had struck, we determined that state tort suits presented an obstacle to the federal scheme. After conducting our own pre-emption analysis, we considered the agency’s explanation of how state law interfered with its regulation, regarding it as further support for our independent conclusion that the plaintiff’s tort claim obstructed the federal regime.

By contrast, we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law. And the FDA’s newfound opinion, expressed in its 2006 preamble, that state law “frustrate[s] the agency’s implementation of its statutory mandate,” 71 Fed. Reg. 3934, does not merit deference for the reasons we have explained.13 Indeed, the “complex and extensive” regulatory history and background relevant to this case, Geier, 529 U. S., at 883, undercut the FDA’s recent pronouncements of pre-emption, as they reveal the longstanding coexistence of state and federal law and the FDA’s traditional recognition of state-law remedies—a recognition in place each time the agency reviewed Wyeth’s Phenergan label.14

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. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.

V

We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed.

It is so ordered.

555 U. S. ____ (2009)

SUPREME COURT OF THE UNITED STATES

WYETH, PETITIONER v. DIANA LEVINE
on writ of certiorari to the supreme court ofvermont
[March 4, 2009]

Justice Breyer, concurring.

I write separately to emphasize the Court’s statement that “we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law.” Ante, at 24. State tort law will sometimes help the Food and Drug Administration (FDA) “uncover unknown drug hazards and [encourage] drug manufacturers to disclose safety risks.” Ante, at 23. But it is also possible that state tort law will sometimes interfere with the FDA’s desire to create a drug label containing a specific set of cautions and instructions. I also note that some have argued that state tort law can sometimes raise prices to the point where those who are sick are unable to obtain the drugs they need. See Lasagna, The Chilling Effect of Product Liability on New Drug Development, in The Liability Maze 334, 335–336 (P. Huber & R. Litan eds. 1991). The FDA may seek to determine whether and when state tort law acts as a help or a hindrance to achieving the safe drug-related medical care that Congress sought. Medtronic, Inc. v. Lohr, 518 U. S. 470, 506 (1996) (Breyer, J., concurring in part and concurring in judgment); cf. Bates v. Dow Agrosciences LLC, 544 U. S. 431, 454–455 (2005) (Breyer, J., concurring). It may seek to embody those determinations in lawful specific regulations describing, for example, when labeling requirements serve as a ceiling as well as a floor. And it is possible that such determinations would have pre-emptive effect. See Lohr, supra, at 505 (opinion of Breyer, J.) (citing Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707 (1985) ). I agree with the Court, however, that such a regulation is not at issue in this case.

Thomas, J., concurring in judgment

SUPREME COURT OF THE UNITED STATES

WYETH, PETITIONER v. DIANA LEVINE
on writ of certiorari to the supreme court ofvermont
[March 4, 2009]

Justice Thomas, concurring in the judgment.

I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyeth’s 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 “add[ed] or strengthen[ed]” information on its label about “a contraindication, warning, precaution, or adverse reaction,” 21 CFR §314.70(c)(6)(iii)(A) (2008), or “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,” about the dangers of IV-push administration of Phenergan, 73Fed. Reg. 49603, 49609 (2008). It thus was possible for Wyeth to label and market Phenergan in compliance with federal law while also providing additional warning information on its label beyond that previously approved by the FDA. In addition, federal law does 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. The Vermont court’s judgment in this case, therefore, did not directly conflict with federal law and is not pre-empted.

I write separately, however, because I cannot join the majority’s implicit endorsement of far-reaching implied pre-emption doctrines. In particular, I have become increasingly skeptical of this Court’s “purposes and objectives” 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 “to ensure the protection of our fundamental liberties,” Atascadero State Hospital v. Scanlon, 473 U. S. 234, 242 (1985) (internal quotation marks omitted), the “Constitution establishes a system of dual sovereignty between the States and the Federal Government.” Gregory v. Ashcroft, 501 U. S. 452, 457 (1991) . The Framers adopted this “ ‘constitutionally mandated balance of power,’ ” Atascadero State Hospital, supra, at 242, to “reduce the risk of tyranny and abuse from either front,” because a “federalist structure of joint sovereigns preserves to the people numerous advantages,” such as “a decentralized government that will be more sensitive to the diverse needs of a heterogeneous society” and “increase[d] opportunity for citizen involvement in democratic processes,” Gregory, supra, at 458. Furthermore, as the Framers observed, the “compound republic of America” provides “a double security … to the rights of the people” because “the power surrendered by the people is first divided between two distinct governments, and then the portion allotted to each subdivided among distinct and separate departments.” TheFederalist No. 51, p. 266 (M. Beloff ed., 2d ed. 1987).

Under this federalist system, “the States possess sovereignty concurrent with that of the Federal Government, subject only to limitations imposed by the Supremacy Clause.” Tafflin v. Levitt, 493 U. S. 455, 458 (1990) . In this way, the Supremacy Clause gives the Federal Government “a decided advantage in [a] delicate balance” between federal and state sovereigns. Gregory, 501 U. S., at 460. “As long as it is acting within the powers granted it under the Constitution, Congress may impose its will on the States.” Ibid. That is an “extraordinary power in a federalist system.” Ibid.

Nonetheless, the States retain substantial sovereign authority. U. S. Const., Amdt. 10 (“The 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 people”); 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, “[t]he powers delegated by the proposed constitution to the federal government, are few and defined” and “[t]hose which are to remain in the state governments, are numerous and indefinite.” The Federalist No. 45, at 237–238. Indeed, in protecting our constitutional government, “the preservation of the States, and the maintenance of their governments, are as much within the design and care of the Constitution as the preservation of the Union and the maintenance of the National government.” Texas v. White, 7Wall. 700, 725 (1869), quoted in New York v. United States, supra, at 162.

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:

“This 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.” Art. VI, cl. 2.

With respect to federal laws, then, the Supremacy Clause gives “supreme” status only to those that are “made in Pursuance” of “[t]his Constitution.” Ibid.; see 3 J. Story, Commentaries on the Constitution of the United States §1831, p. 694 (1833) (hereinafter Story) (“It will be observed, that the supremacy of the laws is attached to those only, which are made in pursuance of the constitution”).

Federal laws “made in Pursuance” 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 “the Constitution’s conferral upon Congress of not all governmental powers, but only discrete, enumerated ones.” Printz, supra, at 919; see also United States v. Morrison, 529 U. S. 598 , n. 8 (2000); New York v. United States, supra, at 155–157; McCulloch v. Maryland, 4 Wheat. 316, 405 (1819) (“This government is acknowledged by all to be one of enumerated powers”).1

The second structural limitation is the complex set of procedures that Congress and the President must follow to enact “Laws of the United States.” See INS v. Chadha, 462 U. S. 919, 945–946 (1983) (setting forth the Constitution’s Bicameral and Presentment Clauses, Art. I, §7, cls. 2–3, which “prescribe and define the respective functions of the Congress and of the Executive in the legislative process”). “[T]he Framers were acutely conscious that the bicameral requirement and the Presentment Clauses would serve essential constitutional functions,” Chadha, 462 U. S., at 951, by allowing the passage of legislation only after it has proceeded through “a step-by-step, deliberate and deliberative process,” id., at 959, that was “finely wrought and exhaustively considered” by the Framers, id., at 951. The Supremacy Clause thus requires that pre-emptive effect be given only those to 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 3 J. Story §1831, at 694 (Actions of the Federal Government “which are not pursuant to its constitutional powers, but which are invasions of the residuary authorities of the smaller societies,” are not “the supreme law of the land. They will be merely acts of usurpation, and will deserve to be treated as such”).

B

In light of these constitutional principles, I have become “increasing[ly] reluctan[t] to expand federal statutes beyond their terms through doctrines of implied pre-emption.” 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 Court’s broad implied pre-emption precedents, particularly its “purposes and objectives” pre-emption jurisprudence, has increased my concerns that implied pre-emption doctrines have not always been constitutionally applied. Under the vague and “potentially boundless” doctrine of “purposes and objectives” pre-emption, 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 “concomitant danger of invoking obstacle pre-emption based on the arbitrary selection of one purpose to the exclusion of others”); Crosby v. National Foreign Trade Council, 530 U. S. 363, 388–391 (2000) (Scalia, J., concurring in judgment) (criticizing the majority’s reliance on legislative history to discern statutory intent when that intent was “perfectly obvious on the face of th[e] statute”); Geier, supra, at 874–883 (relying on regulatory history, agency comments, and the Government’s litigating position to determine that federal law pre-empted state law).
Congressional and agency musings, however, do not satisfy the Art. I, §7 requirements for enactment of federal law and, therefore, do not pre-empt state law under the Supremacy Clause. When analyzing the pre-emptive effect of federal statutes or regulations validly promulgated thereunder, “[e]vidence of pre-emptive purpose [must be] sought in the text and structure of the [provision] at issue” to comply with the Constitution. CSX Transp., Inc. v. Easterwood, 507 U. S. 658, 664 (1993) ; see also New York v. FERC, 535 U. S. 1, 18 (2002) (“[A] federal agency may pre-empt state law only when and if it is acting within the scope of its congressional delegated authority … [for] an agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it” (internal quotation marks omitted; second alteration in original)); Camps Newfound/Owatonna, Inc. v. Town of Harrison, 520 U. S. 564, 617 (1997) (Thomas, J., dissenting) (noting that “treating unenacted congressional intent as if it were law would be constitutionally dubious”). Pre-emption analysis should not be “a freewheeling judicial inquiry into whether a state statute is in tension with federal objectives, but an inquiry into whether the ordinary meanings of state and federal law conflict.” Bates, supra, at 459 (Thomas, J., concurring in judgment in part and dissenting in part) (internal quotation marks and citation omitted); see also Geier, supra, at 911 (Stevens., J., dissenting) (“[P]re-emption analysis is, or at least should be, a matter of precise statutory [or regulatory] construction rather than an exercise in free-form judicial policymaking” (internal quotation marks omitted)). Pre-emption must turn on whether state law conflicts with the text of the relevant federal statute or with the federal regulations authorized by that text. See Foster v. Love, 522 U. S. 67, 71 (1997) (finding that conflict pre-emption question “turn[ed] entirely on the meaning of the state and federal statutes” at issue before the Court); see also New York v. FERC, supra, at 19.
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