WYETH v. LEVINE
No. 06-1249
SUPREME COURT OF THE UNITED STATES
Argued November 3, 2008—Decided March 4, 2009
555 U.S. 555
Seth P. Waxman argued the cause for petitioner. With him on the briefs were Paul R. Q. Wolfson, Bert W. Rein, Allan R. Keyes, and R. Joseph O‘Rourke.
Then-Deputy Solicitor General Kneedler argued the cause for the United States as amicus curiae urging reversal. With him on the brief were former Solicitor General Clem-
David C. Frederick argued the cause for respondent. With him on the brief were Scott H. Angstreich, Scott K. Attaway, Brendan J. Crimmins, and Richard I. Rubin.*
*Briefs of amici curiae urging reversal were filed for the Chamber of Commerce of the United States of America by Alan E. Untereiner, Robin S. Conrad, and Amar D. Sarwal; for DRI-The Voice of the Defense Bar by Daniel E. Troy, Rebecca K. Wood, Eamon P. Joyce, and Michael W. Davis; for the Generic Pharmaceutical Association by Jay P. Lefkowitz and Michael D. Shumsky; for PhRMA et al. by Robert A. Long, Jr., and Paul W. Schmidt; for the Product Liability Advisory Council, Inc., by Kenneth S. Geller and Andrew E. Tauber; for the Washington Legal Foundation et al. by Eric G. Lasker, Daniel J. Popeo, and Richard A. Samp; and for John E. Calfee et al. by Joe G. Hollingsworth, Katharine R. Latimer, and Eric G. Lasker.
Briefs of amici curiae urging affirmance were filed for the State of Vermont et al. by William H. Sorrell, Attorney General of Vermont, Kevin O. Leske, Assistant Attorney General, by Dan Schweitzer, and by the Attorneys General for their respective States as follows: Troy King of Alabama, Talis J. Colberg of Alaska, Terry Goddard of Arizona, Dustin McDaniel of Arkansas, Edmund G. Brown, Jr., of California, John W. Suthers of Colorado, Richard Blumenthal of Connecticut, Joseph R. Biden III of Delaware, Bill McCollum of Florida, Thurbert E. Baker of Georgia, Mark J. Bennett of Hawaii, Lawrence G. Wasden of Idaho, Lisa Madigan of Illinois, Steve Carter of Indiana, Tom Miller of Iowa, Steve Six of Kansas, Jack Conway of Kentucky, James D. “Buddy” Caldwell of Louisiana, G. Steven Rowe of Maine, Douglas F. Gansler of Maryland, Martha Coakley of Massachusetts, Lori Swanson of Minnesota, Jim Hood of Mississippi, Jeremiah W. (Jay) Nixon of Missouri, Mike McGrath of Montana, Catherine Cortez Masto of Nevada, Kelly A. Ayotte of New Hampshire, Anne Milgram of New Jersey, Gary K. King of New Mexico, Andrew M. Cuomo of New York, Roy Cooper of North Carolina, Wayne Stenehjem of North Dakota, Nancy Rogers of Ohio, W. A. Drew Edmondson of Oklahoma, Hardy Myers of Oregon, Thomas W. Corbett, Jr., of Pennsylvania, Patrick C. Lynch of Rhode Island, Henry McMaster of South Carolina, Lawrence E. Long of South Dakota, Robert E. Cooper, Jr., of Tennessee, Mark L. Shurtleff of Utah, Robert F. McDonnell of Virginia, Robert M. McKenna of Washington, Darrell V. McGraw, Jr., of West Virginia, J. B.
Briefs of amici curiae were filed for the Citizens Commission on Human Rights by Kendrick L. Moxon; and for the National Coalition Against Censorship by Erwin Chemerinsky and Sharon J. Arkin.
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. The ques-
I
Phenergan is Wyeth‘s brand name for promethazine hydrochloride, an antihistamine used to treat nausea. The injectable form of Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV-push” method, whereby the drug is injected directly into a patient‘s vein, or the “IV-drip” method, whereby the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient‘s vein. The drug is corrosive and causes irreversible gangrene if it enters a patient‘s artery.
Levine‘s injury resulted from an IV-push injection of Phenergan. On April 7, 2000, as on previous visits to her local clinic for treatment of a migraine headache, she received an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Because the combination did not provide relief, she returned later that day and received a second injection of both drugs. This time, the physician assistant administered the drugs by the IV-push method, and Phenergan entered Levine‘s artery, either because the needle penetrated an artery directly or because the drug escaped from the vein into surrounding tissue (a phenomenon called “perivascular extravasation“) where it came in contact with arterial blood. As a result, Levine developed gangrene, and doctors amputated first her right hand and then her entire forearm. In addition to her pain and suffering, Levine incurred substantial medical expenses and the loss of her livelihood as a professional musician.
After settling claims against the health center and clinician, Levine brought an action for damages against Wyeth, relying on common-law negligence and strict-liability theories. Although Phenergan‘s labeling warned of the danger of gangrene and amputation following inadvertent intra-
Wyeth filed a motion for summary judgment, arguing that Levine‘s failure-to-warn claims were pre-empted by federal law. The court found no merit in either Wyeth‘s field pre-emption argument, which it has since abandoned, or its conflict pre-emption argument. With respect to the contention that there was an “actual conflict between a specific FDA order,” id., at 21, and Levine‘s failure-to-warn action, the
The evidence presented during the 5-day jury trial showed that the risk of intra-arterial injection or perivascular extravasation can be almost entirely eliminated through the use of IV-drip, rather than IV-push, administration. An IV drip is started with saline, which will not flow properly if the catheter is not in the vein and fluid is entering an artery or surrounding tissue. See id., at 50-51, 60, 66-68, 75. By contrast, even a careful and experienced clinician using the IV-push method will occasionally expose an artery to Phenergan. See id., at 73, 75-76. While Phenergan‘s labeling warned against intra-arterial injection and perivascular extravasation and advised that “[w]hen administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily,” id., at 390, the labeling did not contain a specific warning about the risks of IV-push administration.
The trial record also contains correspondence between Wyeth and the FDA discussing Phenergan‘s label. The FDA first approved injectable Phenergan in 1955. In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency approved after proposing labeling changes. Wyeth submitted a third supplemental application in 1981 in response to a new FDA rule governing drug labels. Over the next 17 years, Wyeth and the FDA intermittently corresponded about Phenergan‘s label. The most notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988, when Wyeth submitted revised labeling incorporating the
Based on this regulatory history, the trial judge instructed the jury that it could consider evidence of Wyeth‘s compliance with FDA requirements but that such compliance did not establish that the warnings were adequate. He also instructed, without objection from Wyeth, that FDA regulations “permit a drug manufacturer to change a product label to add or strengthen a warning about its product without prior FDA approval so long as it later submits the revised warning for review and approval.” Id., at 228.
Answering questions on a special verdict form, the jury found that Wyeth was negligent, that Phenergan was a defective product as a result of inadequate warnings and instructions, and that no intervening cause had broken the causal connection between the product defects and the plaintiff‘s injury. Id., at 233-235. It awarded total damages of $7,400,000, which the court reduced to account for Levine‘s earlier settlement with the health center and clinician. Id., at 235-236.
On August 3, 2004, the trial court filed a comprehensive opinion denying Wyeth‘s motion for judgment as a matter of law. After making findings of fact based on the trial record (supplemented by one letter that Wyeth found after the trial), the court rejected Wyeth‘s pre-emption arguments. It determined that there was no direct conflict between FDA regulations and Levine‘s state-law claims because those regulations permit strengthened warnings without FDA approval on an interim basis and the record contained evidence
The Vermont Supreme Court affirmed. It held that the jury‘s verdict “did not conflict with FDA‘s labeling requirements 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 administration of Phenergan was safe and effective.
The importance of the pre-emption issue, coupled with the fact that the FDA has changed its position on state tort law and now endorses the views expressed in Chief Justice Reiber‘s dissent, persuaded us to grant Wyeth‘s petition for certiorari. 552 U. S. 1161 (2008). The question presented by the petition is whether the FDA‘s drug labeling judgments “preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.” Pet. for Cert. i.
II
Wyeth makes two separate pre-emption arguments: first, that it would have been impossible for it to comply with the state-law duty to modify Phenergan‘s labeling without violating federal law, see Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, 458 U. S. 141, 153 (1982), and second, that recognition of Levine‘s state tort action creates an unacceptable “ob-
The trial court proceedings established that Levine‘s injury would not have occurred if Phenergan‘s label had included an adequate warning about the risks of the IV-push method of administering the drug. The record contains evidence that the physician assistant administered a greater dose than the label prescribed, that she may have inadvertently injected the drug into an artery rather than a vein, and that she continued to inject the drug after Levine complained of pain. Nevertheless, the jury rejected Wyeth‘s argument that the clinician‘s conduct was an intervening cause that absolved it of liability. See App. 234 (jury verdict), 252-254. In finding Wyeth negligent as well as strictly liable, the jury also determinеd that Levine‘s injury was foreseeable. That the inadequate label was both a but-for and proximate cause of Levine‘s injury is supported by the record and no longer challenged by Wyeth.2
The trial court proceedings further established that the critical defect in Phenergan‘s label was the lack of an adequate warning about the risks of IV-push administration. Levine also offered evidence that the IV-push method should
Our answer to that question must be guided by two cornerstones of our pre-emption jurisprudence. First, “the purpose of Congress is the ultimate touchstone in every pre-emption case.” Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U. S. 96, 103 (1963). Second, “[i]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.‘” Lohr, 518 U. S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947)).3
As it enlarged the FDA‘s powers to “protect the public health” and “assure the safety, effectiveness, and reliability of drugs,”
In 2007, after Levine‘s injury and lawsuit, Congress again amended the FDCA.
III
Wyeth first argues that Levine‘s state-law claims are pre-empted because it is impossible for it to comply with both the state-law duties underlying those claims and its federal labeling duties. See De la Cuesta, 458 U. S., at 153. The FDA‘s premarket approval of a new drug application includes the approval of the exact text in the proposed label. See
Wyeth argues that the CBE regulation is not implicated in this case because a 2008 amendment provides that a manufacturer may only change its label “to reflect newly acquired information.” 73 Fed. Reg. 49609. Resting on this language (which Wyeth argues simply reaffirmed the interpretation of the regulation in effect when this case was tried), Wyeth contends that it could have changed Phenergan‘s label only in response to new information that the FDA had not considered. And it maintains that Levine has not pointed to any such information concerning the risks of IV-push administration. Thus, Wyeth insists, it was impossible for it
We need not decide whether the 2008 CBE regulation is consistent with the FDCA and the previous version of the regulation, as Wyeth and the United States urge, because Wyeth could have revised Phenergan‘s label even in accordance with the amended regulation. As the FDA explained in its notice of the final rule, “‘newly acquired information‘” is not limited to new data, but also encompasses “new analyses of previously submitted data.” Id., at 49604. 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 submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to FDA, the sponsor meets the requirement for ‘newly acquired information.‘” Id., at 49607; see also id., at 49606.
The record is limited concerning what newly acquired information Wyeth had or should have had about the risks of IV-push administration of Phenergan because Wyeth did not argue before the trial court that such information was required for a CBE labeling change. Levine did, however, present evidence of at least 20 incidents prior to her injury in which a Phenergan injection resulted in gangrene and an amputation. See App. 74, 252.4 After the first such incident came to Wyeth‘s attention in 1967, it notified the FDA and worked with the agency to change Phenergan‘s label.
Wyeth argues that if it had unilaterally added such a warning, it would have violated federal law gоverning unauthorized distribution and misbranding. Its argument that a change in Phenergan‘s labeling would have subjected it to liability for unauthorized distribution rests on the assumption that this labeling change would have rendered Phenergan a new drug lacking an effective application. But strengthening the warning about IV-push administration would not have made Phenergan a new drug. See
Wyeth‘s cramped reading of the CBE regulation and its broad reading of the FDCA‘s misbranding and unauthorized distribution provisions are premised on a more fundamental misunderstanding. Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears respon-
Indeed, prior to 2007, the FDA lacked the authority to order manufacturers to revise their labels. See
Of course, the FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufacturer‘s supplemental application, just as it retains such authority in reviewing all supplemental applications. But absent clear evidence that the FDA would not have approved a change to Phenergan‘s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.
Impossibility pre-emption is a demanding defense. On the record before us, Wyeth has failed to demonstrate that it was impossible for it to comply with both federal and state requirements. The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan‘s label does not establish that it would have prohibited such a change.
IV
Wyeth also argues that requiring it to comply with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation. Levine‘s tort claims, it maintains, are pre-empted because they interfere with “Congress‘s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.” Brief for Petitioner 46. We find no merit in this argument, which relies on an untenable interpretation of congressional intent and an overbroad view of an agency‘s power to pre-empt state law.
Wyeth contends thаt the FDCA establishes both a floor and a ceiling for drug regulation: Once the FDA has ap-
If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA‘s 70-year history. But despite its 1976 enactment of an express pre-emption provision for medical devices, see
Despite this evidence that Congress did not regard state tort litigation as an obstacle to achieving its purposes, Wyeth nonetheless maintains that, because the FDCA requires the FDA to determine that a drug is safe and effective under the conditions set forth in its labeling, the agency must be presumed to have performed a precise balancing of risks and benefits and to have established a specific labeling standard that leaves no room for different state-law judgments. In advancing this argument, Wyeth relies not on any statement by Congress, but instead on the preamble to a 2006 FDA regulation governing the content and format of prescription drug labels. See Brief for Petitioner 8, 11, 42, 45, and 50 (citing 71 Fed. Reg. 3922 (2006)). In that preamble, the FDA declared that the FDCA establishes “both a “floor” and a “ceiling,“” so that “FDA approval of labeling . . . preempts conflicting or contrary State law.” Id., at 3934-3935. It further stated that certain state-law actions, such as those involving failure-to-warn claims, “threaten FDA‘s statutorily
This Court has recognized that an agency regulation with the force of law can pre-empt conflicting state requirements. See, e. g., Geier v. American Honda Motor Co., 529 U. S. 861 (2000); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 713 (1985). In such cases, the Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption. We are faced with no such regulation in this case, but rather with an agency‘s mere assertion that state law is an obstacle to achieving its statutory objectives. Because Congress has not authorized the FDA to pre-empt state law directly, cf.
In prior cases, we have given “some weight” to an agency‘s views about the impact of tort law on federal objectives when “the subject matter is technica[l] and the relevant history and background are complex and extensive.” Geier, 529 U. S., at 883. 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
Under this standard, the FDA‘s 2006 preamble does not merit deference. When the FDA issued its notice of proposed rulemaking in December 2000, it explained that the rule would “not contain policies that have federalism implications or that preempt State law.” 65 Fed. Reg. 81103; see also 71 id., at 3969 (noting that the “proposed rule did not propose to preempt state law“). In 2006, the agency finalized the rule and, without offering States or other interested parties notice or opportunity for comment, articulated a sweeping position on the FDCA‘s pre-emptive effect in the regulatory preamble. The agency‘s views on state law are inherently suspect in light of this procedural failure.
Further, the preamble is at odds with what evidence we have of Congress’ purposes, and it reverses the FDA‘s own longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA‘s regulation of drug labeling during decades of coexistence. The FDA‘s 2006 position plainly does not reflect the agency‘s own view at all times relevant to this litigation. Not once prior to Levine‘s injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission. To the contrary, it cast federal labeling standards as a floor upon which States could build and repeatedly dis-
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 ac-
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 re-quire airbags for all cars. The Department of Transporta-
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” regula-
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.
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 580. State tort law will sometimes help the
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 contraindi-
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.” The Federalist 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.
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. Mor- rison, 529 U. S. 598, 618, 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,
B
In light of these constitutional principles, I have become “increasingly reluctant 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
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 “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 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 “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“);
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, 524 U. S., at 227 (requiring that the state-law claims “directly conflict” with federal law); 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)).
Under the FDA‘s “changes being effected” regulation,
In addition, the text of the statutory provisions governing FDA drug labeling, and the regulations promulgated there-under, 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
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.”
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
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 563-564 (majority opinion). 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 587-588. I, therefore, cannot join the majority‘s analysis of this claim, see ante, at 573-581, or its reaffirmation of the Court‘s “purposes and objectives” jurisprudence, ante, at 573-575 (analyzing congressional purposes); ante, at 576-577 (quoting the ““purposes and objectives“” 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 “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
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 “[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 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
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
This Court has repeatedly stated that when statutory language is plain, it must be enforced according to its terms. See Jimenez v. Quarterman, ante, p. 113; 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, 665 (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
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, 529 U. S., 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
3
The majority, while reaching the right conclusion in this case, demonstrates once again how application of “purposes and objectives” pre-emption requires inquiry into matters beyond the scope of proper judicial review. For example, the majority relies heavily on Congress’ failure “during the . . . 70-year history” of the federal
In this case, the majority has concluded from silence that Congress believed state lawsuits pose no obstacle to federal drug approval objectives. See ante, at 574-575. That is the required conclusion, but only because it is compelled by the text of the relevant statutory and regulatory provisions, not judicial suppositions about Congress’ unstated goals. The fact that the Court reaches the proper conclusion does not justify its speculation about the reasons for congressional inaction. In this case, the Court has relied on the perceived congressional policies underlying inaction to find that state law is not pre-empted. But once the Court shows a willingness to guess at the intent underlying congressional inaction, the Court could just as easily rely on its own perceptions regarding congressional inaction to give unduly broad pre-emptive effect to federal law. See, e. g., American Ins. Assn. v. Garamendi, 539 U. S. 396, 401, 405-408, 429 (2003) (finding that Congress’ failure to pass legislation indicating that it disagreed with the President‘s executive agreement supported, at least in part, the Court‘s determination that the agreement pre-empted state law). Either approach is illegitimate. Under the Supremacy Clause, state law is pre-empted only by federal law “made in Pursuance” of the Constitution,
III
The origins of this Court‘s “purposes and objectives” pre-emption jurisprudence in Hines, and its broad application in cases like Geier, illustrate that this brand of the Court‘s pre-emption jurisprudence facilitates freewheeling, extratextual, and broad evaluations of the “purposes and objectives” embodied within federal law. This, in turn, leads to decisions giving improperly broad pre-emptive effect to judicially manufactured policies, rather than to the statutory text enacted by Congress pursuant to the Constitution and the agency actions authorized thereby. Because such a sweeping approach to pre-emption leads to the illegitimate—and thus, unconstitutional—invalidation of state laws, I can no longer assent to a doctrine that pre-empts state laws merely because they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives” of federal law, Hines, 312 U. S., at 67, as perceived by this Court. I therefore respectfully concur only in the judgment.
JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE SCALIA join, dissenting.
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.
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. Ante, at 565. 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.1
More to the point, the question presented by this case is not a “narrow” one, and it does not concern whether Phenergan‘s label should bear a “stronger” warning. Rather, the real issue is whether a state tort jury can countermand the FDA‘s considered judgment that Phenergan‘s FDA-mandated warning label renders its intravenous (IV) use “safe.” Indeed, respondent‘s amended complaint alleged that Phenergan is “not reasonably safe for intravenous administration,” App. 15, ¶ 6; respondent‘s attorney told the jury that Phenergan‘s label should say, “‘Do not use this drug intravenously,‘” id., at 32; respondent‘s expert told the
Federal law, however, does rely on the FDA to make safety determinations like the one it made here. The FDA has long known about the risks associated with IV push in general and its use to administer Phenergan in particular. Whether wisely or not, the FDA has concluded—over the course of extensive, 54-year-long regulatory proceedings—that the drug is “safe” and “effective” when used in accordance with its FDA-mandated labeling. 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.
A
To the extent that “[t]he purpose of Congress is the ultimate touchstone in every pre-emption case,” Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) (internal quotation marks omitted), Congress made its “purpose” plain in authorizing the FDA—not state tort juries—to determine when and under what circumstances a drug is “safe.” “[T]he process for approving new drugs is at least as rigorous as the premarket approval process for medical devices,” Riegel v. Medtronic, Inc., 552 U.S. 312, 343 (2008) (GINSBURG, J., dissenting), and we held that the latter pre-empted a state-law tort suit that conflicted with the FDA‘s determination that a medical device was “safe,” id., at 324-325 (opinion of the Court).
Under the
Thus, a drug‘s warning label “serves as the standard under which the FDA determines whether a product is safe and effective.” 50 Fed. Reg. 7470 (1985). Labeling is “[t]he centerpiece of risk management,” as it “communicates to health care practitioners the agency‘s formal, authoritative conclusions regarding the conditions under which the product can be used safely and effectively.” 71 Fed. Reg. 3934 (2006). The FDA has underscored the importance it places on drug labels by promulgating comprehensive regulations—spanning an entire part of the
1
Where the FDA determines, in accordance with its statutory mandate, that a drug is on balance “safe,” our conflict pre-emption cases prohibit any State from countermanding that determination. See, e. g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U. S. 341, 348 (2001) (after the FDA has struck “a somewhat delicate balance of statutory objectives” and determined that petitioner submitted a valid application to manufacture a medical device, a State may not use common law to negate it); International Paper Co. v. Ouellette, 479 U. S. 481, 494 (1987) (after the Environmental Protection Agency has struck “the balance of public and private interests so carefully addressed by” the federal permitting regime for water pollution, a State may not use nuisance law to “upse[t]” it); Chicago & North Western Transp. Co. v. Kalo Brick & Tile Co., 450 U. S. 311, 321 (1981) (after the Interstate Commerce Commission has struck a “balance” between competing interests in permitting the abandonment of a railroad line, a State may not use statutory or common law to negate it).
Thus, as the Court itself recognizes, it is irrelevant in conflict pre-emption cases whether Congress “enacted an express pre-emption provision at some point during the FDCA‘s 70-year history.” Ante, at 574; see also Geier, 529 U. S., at 869 (holding the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles“). Rather, the ordinary principles of conflict pre-emption turn solely on whether a State has upset the regulatory balance struck by the federal agency. Id., at 884-885; see also Chicago & North Western Transp. Co., supra, at 317 (describing conflict pre-emption as “a two-step process of first ascertaining the construction of the [federal and state laws] and then determining the constitutional ques-
2
A faithful application of this Court‘s conflict pre-emption cases compels the conclusion that the FDA‘s 40-year-long effort to regulate the safety and efficacy of Phenergan pre-empts respondent‘s tort suit. Indeed, that result follows directly from our conclusion in Geier.
Geier arose under the
Alexis Geier drove her 1987 Honda Accord into a tree, and although she was wearing her seatbelt, she nonetheless suffered serious injuries. She then sued Honda under state tort law, alleging that her car was negligently and defectively designed because it lacked a driver‘s-side airbag. She argued that Congress had empowered the Secretary to set only “minimum standard[s]” for vehicle safety.
Notwithstanding the statute‘s saving clause, and notwithstanding the fact that Congress gave the Secretary authority to set only “minimum” safety standards, we held Gеier‘s state tort suit pre-empted. In reaching that result, we relied heavily on the view of the Secretary of Transportation—expressed in an amicus brief—that Standard 208 “‘embodies 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.‘” 529 U. S., at 881 (quoting Brief for United States as Amicus Curiae, O. T. 1999, No. 98-1811, p. 25). Because the Secretary determined that a menu of alternative technologies was “safe,” the doctrine of conflict pre-emption barred Geier‘s efforts to deem some of those federally approved alternatives “unsafe” under state tort law.
The same rationale applies here. Through Phenergan‘s label, the FDA offered medical professionals a menu of federally approved, “safe” and “effective” alternatives—including IV push—for administering the drug. Through a state tort suit, respondent attempted to deem IV push “unsafe” and “ineffective.” To be sure, federal law does not prohibit Wyeth from contraindicating IV push, just as federal law did not prohibit Honda from installing airbags in all its cars. But just as we held that States may not compel the latter, so, too, are States precluded from compelling the former. See also Fidelity Fed. Sav. & Loan Assn. v. 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 because the FDCA—unlike the National Traffic and Motor Safety Vehicle Act—contains no evidence that Congress in-
III
In its attempt to evade Geier‘s applicability to this case, the Court commits both factual and legal errors. First, as a factual matter, it is demonstrably untrue that the FDA failed to consider (and strike a “balance” between) the specific costs and benefits associated with IV push. Second, as a legal matter, Geier does not stand for the legal propositions espoused by the dissenters (and specifically rejected by the majority) in that case. Third, drug labeling by jury verdict undermines both our broader pre-emption jurisprudence and the broader workability of the federal drug-labeling regime.
A
Phenergan‘s warning label has been subject to the FDA‘s strict regulatory oversight since the 1950‘s. For at least the last 34 years, the FDA has focused specifically on whether IV-push administration of Phenergan is “safe” and “effective” when performed in accordance with Phenergan‘s label. The agency‘s ultimate decision—to retain IV push as one
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®.” 2 Record 583, 586 (Plaintiff‘s Trial Exh. 17, Internal Correspondence from W. E. Langeland to File (Sept. 5, 1975) (hereinafter 1975 Memo)). “Tubex” is a syringe system used exclusively for IV push. See App. 43. An FDA official explained that the agency‘s concerns arose from medical-malpractice lawsuits involving IV push of the drug, see 1975 Memo 586, and that the FDA was aware of “5 cases involving amputation where the drug had been administered by Tubex together with several additional cases involving necrosis,” id., at 586-587. Rather than contraindicating Phenergan for IV push, however, the agency and Wyeth agreed “that there was a need for better instruction regarding the problems of intraarterial injection.” Id., at 587.
The next year, the FDA convened an advisory committee to study, among other things, the risks associated with the Tubex system and IV push. App. 294. At the conclusion of its study, the committee recommended an additional IV-push-specific warning for Phenergan‘s label, see ibid., but did not recommend eliminating IV push from the drug label altogether. In response to the committee‘s recommendations, the FDA instructed Wyeth to make several changes to
In 1987, the FDA directed Wyeth to amend its label to include the following text:
“[1] When used intravenously, [Phenergan] should be given in a concentration no greater than 25 mg/ml and at a rate not to exceed 25 mg/minute. [2] Injection through a properly running intravenous infusion may enhance the possibility of detecting arterial placement.” Id., at 311-312.
The first of the two quoted sentences refers specifically to IV push; as respondent‘s medical expert testified at trial, the label‘s recommended rate of administration (not to exceed 25 mg per minute) refers to “IV push, as opposed to say being in a bag and dripped over a couple of hours.” Id., at 52. The second of the two quoted sentences refers to IV drip. See id., at 15-16 (emphasizing that a “running IV” is the same thing as “IV drip“).
In its 1987 labeling order, the FDA cited voluminous materials to “suppor[t]” its new and stronger warnings related to IV push and the preferability of IV drip.5 Id., at 313. One of those articles specifically discussed the relative advantages and disadvantages of IV drip compared to IV push, as
“Because of the numerous superficial positions the ulnar artery might occupy, it has often been entered during attempted venipuncture [of the antecubital fossa]. . . . However, the brachial and the radial arteries might also be quite superficial in the elbow region. . . . The arterial variations of the arm, especially in and about the cubital fossa, are common and numerous. If venipuncture must be performed in this area, a higher index of suspicion must be maintained to forestall misdirected injections.” Stone & Donnelly, The Accidental Intra-arterial Injection of Thiopental, 22 Anesthesiol-
ogy 995, 996 (1961) (footnote omitted; cited in App. 315, no. 20).10
Based on this and other research, the FDA ordered Wyeth to include a specific warning related to the use of the antecubital space for IV push.11
2
When respondent was injured in 2000, Phenergan‘s label specifically addressed IV push in several passages (sometimes in lieu of and sometimes in addition to those discussed above). For example, the label warned of the risks of intra-arterial injection associated with “aspiration,” which is a technique used only in conjunction with IV push.12 The
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-
treme care should be exercised to avoid perivascular 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.” Ibid.
Thus, it is demonstrably untrue that, as of 2000, Phenergan‘s “labeling did not contain a specific warning about the risks of IV-push administration.” Ante, at 561 (majority opinion). And whatever else might be said about the extensive medical authorities and case reports that the FDA cited in “support” of its approval of IV-push administration of Phenergan, it cannot be said that the FDA “paid no more than passing attention to” IV push, ante, at 563 (majority opinion); nor can it be said that the FDA failed to weigh its costs and benefits, Brief for Respondent 50.
3
For her part, respondent does not dispute the FDA‘s conclusion that IV push has certain benefits. At trial, her medical practitioners testified that they used IV push in order to help her “in a swift and timely way” when she showed up at the hospital for the second time in one day complaining of “intractable” migraines, “terrible pain,” inability to “bear light or sound,” sleeplessness, hours-long spasms of “retching” and “vomiting,” and when “every possible” alternative treatment had “failed.” App. 40 (testimony of Dr. John Matthew); id., at 103, 106, 109 (testimony of physician‘s assistant Jessica Fisch).
Rather than disputing the benefits of IV push, respondent complains that the FDA and Wyeth underestimated its costs (and hence did not provide sufficient warnings regarding its risks). But when the FDA mandated that Phenergan‘s label read, “INADVERTENT INTRA-ARTERIAL INJECTION
As noted above, when the FDA approved Phenergan‘s label, it was textbook medical knowledge that the “antecubital fossa” creates a high risk of inadvertent intra-arterial injection, given the close proximity of veins and arteries. 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; see also ibid. (“[It] just wasn‘t something that I was aware of at the time“). Oblivious to the risks emphasized in Phenergan‘s warnings, the physician‘s assistant pushed a double dose of the drug into an antecubital artery over the course of “[p]robably about three to four minutes,” id., at 111; id., at 105, notwithstanding re-
B
Given the “balance” that the FDA struck between the costs and benefits of administering Phenergan via IV push, Geier compels the pre-emption of tort suits (like this one) that would upset that balance. The contrary conclusion requires turning yesterday‘s dissent into today‘s majority opinion.
First, the Court denies the existence of a federal-state conflict in this case because Vermont merely countermanded the FDA‘s determination that IV push is “safe” when performed in accordance with Phenergan‘s warning label; the Court concludes that there is no conflict because Vermont did not “mandate a particular” label as a “replacement” for the one that the jury nullified, and because the State stopped short of altogether “contraindicating IV-push administration.” Ante, at 525. But as we emphasized in Geier (over the dissent‘s assertions to the contrary), the degree of a State‘s intrusion upon federal law is irrelevant—the Supremacy Clause applies with equal force to a state tort law that merely countermands a federal safety determination and to a state law that altogether prohibits car manufacturers from selling cars without airbags. Compare 529 U.S., at 881-882, with id., at 902 (STEVENS, J., dissenting). Indeed, as recently as last Term, we held that the Supremacy Clause pre-
Second, the Court today distinguishes Geier because the FDA articulated its pre-emptive intent “without offering States or other interested parties notice or opportunity for comment.” Ante, at 577; see also ante, at 580. But the Geier Court specifically rejected the argument (again made by the dissenters in that case) that conflict pre-emption is appropriate only where the agency expresses its pre-emptive intent through notice-and-comment rulemaking. Compare 529 U.S., at 885 (“To insist on a specific expression of agency intent to pre-empt, made after notice-and-comment rulemaking, would be in certain cases to tolerate conflicts that an agency, and therefore Congress, is most unlikely to have intended. The dissent, as we have said, apparently welcomes that result. . . . We do not“), with id., at 908-910 (STEVENS, J., dissenting) (emphasizing that “we generally expect an administrative regulation to declare any intention to pre-empt state law with some specificity,” and that “[t]his expectation . . . serves to ensure that States will be able to have a dialog with agencies regarding pre-emption decisions ex ante through the normal notice-and-comment procedures of the Administrative Procedure Act” (internal quotation marks omitted)). Indeed, pre-emption is arguably more appropriate here than in Geier because the FDA (unlike the DOT) declared its pre-emptive intent in the Federal Regis-
Third, the Court distinguishes Geier because the DOT‘s regulation “bear[s] the force of law,” whereas the FDA‘s preamble does not. Ante, at 580; see also ante, at 576. But it is irrelevant that the FDA‘s preamble does not “bear the force of law” because the FDA‘s labeling decisions surely do. See
Fourth, the Court sandwiches its discussion of Geier between the “presumption against pre-emption,” ante, at 575, and heavy emphasis on “the longstanding coexistence of state and federal law and the FDA‘s traditional recognition of state-law remedies,” ante, at 581. But the Geier Court specifically rejected the argument (again made by the dis-
Geier does not countenance the use of state tort suits to second-guess the FDA‘s labeling decisions. And the Court‘s contrary conclusion has potentially far-reaching consequences.
By their very nature, juries are ill equipped to perform the FDA‘s cost-benefit-balancing function. As we explained in Riegel, juries tend to focus on the risk of a particular product‘s design or warning label that arguably contributed to a particular plaintiff‘s injury, not on the overall benefits of that design or label; “the patients who reaped those benefits are not represented in court.” 552 U.S., at 325. Indeed, patients like respondent are the only ones whom tort juries ever see, and for a patient like respondent—who has already suffered a tragic accident—Phenergan‘s risks are no longer a matter of probabilities and potentialities.
In contrast, the FDA has the benefit of the long view. Its drug-approval determinations consider the interests of all potential users of a drug, including “those who would suffer without new medical [products]” if juries in all 50 States were free to contradict the FDA‘s expert determinations. Id., at 326. And the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones. After today‘s ruling, however, parochialism may prevail.
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-
For example, consider Mustargen (mechlorethamine HCl)—the injectable form of mustard gas—which can be used as an anticancer drug. Mustargen‘s FDA-approved label warns in several places that “This drug is HIGHLY TOXIC.”16 Indeed, the drug is so highly toxic:
“Should accidental eye contact occur, copious irrigation for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt ophthalmologic consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water, for at least 15 minutes while removing contaminated clothing and shoes, followed by 2% sodium thiosulfate solution. 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.” (Emphasis added.) Similarly, the FDA-approved labels for other powerful chemotherapeutic vesicants—including Dactinomycin, Oxaliplatin, Vinblastine, and Vincristine—specifically allow IV push, notwithstanding their devastating effects when extravasated.
* * *
To be sure, state tort suits can peacefully coexist with the FDA‘s labeling regime, and they have done so for decades. Ante, at 573-575 (majority opinion). But this case is far from peaceful coexistence. The FDA told Wyeth that Phenergan‘s label renders its use “safe.” But the State of Vermont, through its tort law, said: “Not so.”
The state-law rule at issue here is squarely pre-empted. Therefore, I would reverse the judgment of the Supreme Court of Vermont.
| Vesicant ¹ | IV Push ² |
|---|---|
| Dactinomycin | Specifically allowed |
| Mechlorethamine (Mustargen) | Specifically allowed |
| Oxaliplatin | Specifically allowed |
| Vinblastine | Specifically allowed |
| Vincristine | Specifically allowed |
| Bleomycin | Neither mentioned nor prohibited |
| Carboplatin | Neither mentioned nor prohibited |
| Dacarbazine | Neither mentioned nor prohibited |
| Mitomycin | Neither mentioned nor prohibited |
| Carmustine | Not prohibited; IV drip recommended |
| Cisplatin | Not prohibited; IV drip recommended |
| Epirubicin | Not prohibited; IV drip recommended |
| Etoposide | Not prohibited; IV drip recommended |
| Ifosfamide | Not prohibited; IV drip recommended |
| Mitoxantrone | Not prohibited; IV drip recommended |
| Paclitaxel | Not prohibited; IV drip recommended |
| Teniposide | Not prohibited; IV drip recommended |
| Vinorelbine | Not prohibited; IV drip recommended |
| Daunorubicin | Prohibited |
| Doxorubicin | Prohibited |
¹ Wilkes & Barton-Burke, 2008 Oncology Nursing Drug Handbook 27-33 (2008) (Table 1.6).
² IV-push information is derived from the “dosage and administration” sections of individual drug labels (available in Clerk of Court‘s case file).
Notes
Indeed, respondent conceded below that Wyeth did propose an adequate warning of Phenergan‘s risks. See Plaintiff Diana Levine‘s Memorandum in Opposition to Wyeth‘s Motion for Summary Judgment in Levine v. American Home Products Corp. (now Wyeth), No. 670-12-01 Wnev (Super. Ct. Washington Cty., Vt.), ¶ 7, p. 26. Specifically, respondent noted: “In 1988, Wyeth proposed language that would have prevented this accident by requiring a running IV and explaining why a running IV will address and reduce the risk [of intra-arterial injection].” Ibid. See also id., at 24 (“Although not strong enough, this improved labeling instruction, if followed, would have prevented the inadvertent administration of Phenergan into an artery . . .“). The FDA rejected Wyeth‘s proposal. See App. 359.
Moreover, in the trial judge‘s final charge, he told the jury that “the critical factual issue which you must decide” is whether Phenergan‘s FDA-mandated label reflects a proper balance between “the risks and benefits of intravenous administration and the potential for injury to patients.” Id., at 220. See also 183 Vt. 76, 82, 944 A. 2d 179, 182 (2006) (recognizing that respondent‘s argument is that Phenergan‘s “label should not have allowed IV push as a means of administration“).
According to the Court, the Pennsylvania Act required: “every alien 18 years or over, with certain exceptions, to register once each year; provide such information as is required by the statute, plus any ‘other information and details’ that the Department of Labor and Industry may direct; pay $1 as an annual registration fee; receive an alien identification cаrd and carry it at all times; show the card whenever it may be demanded by any police officer or any agent of the Department of Labor and Industry; and exhibit the card as a condition precedent to registering a motor vehicle in his name or obtaining a license to operate one. . . . Nonexempt aliens who fail to register are subject to a fine . . . or imprisonment . . . . For failure to carry an identification card or for failure to show it upon proper demand, the punishment is a fine . . . or imprisonment . . . .” Hines, 312 U. S., at 59-60 (footnote omitted).
The Court explained that the federal Alien Registration Act required: “a single registration of aliens 14 years of age and over; detailed information specified by the Act, plus ‘such additional matters as may be prescribed by the Commissioner, with the approval of the Attorney General‘; finger-printing of all registrants; and secrecy of the federal files. . . . No requirement that aliens carry a registration card to be exhibited to police or others is embodied in the law, and only the wilful failure to register is made a criminal offense . . . .” Id., at 60-61.
Respondent sued her physician, physician‘s assistant, and hospital for malpractice. After the parties settled that suit for an undisclosed sum, respondent‘s physician sent her a letter in which he admitted “responsibility” for her injury and expressed his “‘profoun[d] regre[t]‘” and “‘remors[e]‘” for his actions. 1 Tr. 178-179 (Mar. 8, 2004) (testimony of Dr. John Matthew); see also App. 102-103 (testimony of physician‘s assistant Jessica Fisch) (noting that her “sense of grief” was so “great” that she “would have gladly cut off [her own] arm” and given it to respondent). Thereafter, both the physician and the physician‘s assistant agreed to testify on respondent‘s behalf in her suit against Wyeth.
According to Justice Stone, the Hines majority‘s analysis resembled an inquiry into whether the federal Act “occupied the field,” rather than an application of simple conflict pre-emption principles. Id., at 78 (dissenting opinion). Regardless of whether Hines involved field or conflict pre-emption, the dissent accurately observed that in assessing the boundaries of the federal law—i. e., the scope of its pre-emptive effect—the Court should look to the federal statute itself, rather than speculate about Congress’ unstated intentions. Id., at 78-79. See also Camps Newfound/Owatonna, Inc. v. Town of Harrison, 520 U.S. 564, 616-617 (1997) (THOMAS, J., dissenting) (noting that “field pre-emption is itself suspect, at
To be sure, Congress recognized the principles of conflict pre-emption in the FDCA. See Drug Amendments of 1962, § 202, 76 Stat. 793 (“Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law . . . unless there is a direct and positive conflict between such amendments and such provision of State law“). But a provision that simply recognizes the background principles of conflict pre-emption is not a traditional “saving clause,” and even if it were, it would not displace our conflict pre-emption analysis. See Geier v. American Honda Motor Co., 529 U. S. 861, 869 (2000) (“[T]he saving clause . . . does not bar the ordinary working of conflict pre-emption principles“); id., at 873-874 (“The Court has . . . refused to read general ‘saving’ provisions to tolerate actual conflict both in cases involving impossibility and in ‘frustration-of-purpose’ cases” (emphasis deleted; citation omitted)).
The Safety Act‘s express pre-emption provision stated in part: “Whenever a Federal motor vehicle safety standard established under this subchapter is in effect, no State . . . shall have any authority either to establish, or to continue in effect, with respect to any motor vehicle or item of motor vehicle equipment[,] any safety standard applicable to the same aspect of performance of such vehicle or item of equipment which is not identical to the Federal standard.”
The FDA cited numerous articles that generally discuss the costs and benefits associated with IV push. See, e. g., Nahrwold & Phelps, Inadvertent Intra-Arterial Injection of Mephentermine, 7 Rocky Mountain Medical J. 38 (Sept. 1973) (cited in App. 314, no. 14); Albo, Cheung, Ruth, Snyder, & Reemtsma, Effect of Intra-Arterial Injections of Barbiturates, 120 Am. J. of Surgery 676 (1970) (cited in App. 314, no. 12); Corser, Masey, Jacob, Kernoff, & Browne, Ischaemia Following Self-administered Intra-arterial Injection of Methylphenidate and Diamorphine, 40 Anaesthesia 51 (1985) (cited in App. 314, no. 9); Correspondence Regarding Thiopental and Thiamylal (3 letters), 59 Anesthesiology 153-155 (1983) (cited in App. 314, no. 11); Miller, Arthur, & Stratigos, Intra-arterial Injection of a Barbiturate, 23 Anesthesia Progress 25 (1976) (cited in App. 315, no. 19).
In addition to the impropriety of looking beyond the plain text of the saving clause to regulatory history, DOT сomments, and an administrative litigating position to evaluate the Safety Act‘s pre-emptive effect, it is unclear that the Court in Geier accurately assessed the federal objectives of the relevant federal law. As the dissent in Geier pointed out, the purpose of the Safety Act, as stated by Congress, was generally “to reduce traffic accidents and deaths and injuries to persons resulting from traffic accidents.” Id., at 888-889 (opinion of STEVENS, J.) (quoting