WYETH v. LEVINE

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555 OCTOBER TERM, 2008
Syllabus
WYETH v. LEVINE
certiorari to the supreme court of vermont
No. 06–1249. Argued November 3, 2008—Decided March 4, 2009
Petitioner Wyeth manufactures the antinausea drug Phenergan. After a
clinician injected respondent Levine with Phenergan by the “IV-push”
method, whereby a drug is injected directly into a patient’s vein, the
drug entered Levine’s artery, she developed gangrene, and doctors am
putated her forearm. Levine brought a state-law damages action, al
leging, inter alia, that Wyeth had failed to provide an adequate warning
about the significant risks of administering Phenergan by the IV-push
method. The Vermont jury determined that Levine’s injury would not
have occurred if Phenergan’s label included an adequate warning, and it
awarded damages for her pain and suffering, substantial medical ex
penses, and loss of her livelihood as a professional musician. Declining
to overturn the verdict, the trial court rejected Wyeth’s argument that
Levine’s failure-to-warn claims were pre-empted by federal law because
Phenergan’s labeling had been approved by the federal Food and Drug
Administration (FDA). The Vermont Supreme Court affirmed.
Held: Federal law does not pre-empt Levine’s claim that Phenergan’s label
did not contain an adequate warning about the IV-push method of ad
ministration. Pp. 563–581.
(a) The argument that Levine’s state-law claims are pre-empted be
cause it is impossible for Wyeth to comply with both the state-law duties
underlying those claims and its federal labeling duties is rejected. Al
though a manufacturer generally may change a drug label only after
the FDA approves a supplemental application, the agency’s “changes
being effected” (CBE) regulation permits certain preapproval labeling
changes that add or strengthen a warning to improve drug safety. Pur
suant to the CBE regulation, Wyeth could have unilaterally added a
stronger warning about IV-push administration, and there is no evi
dence that the FDA would ultimately have rejected such a labeling
change. Wyeth’s cramped reading of the CBE regulation and its broad
assertion that unilaterally changing the Phenergan label would have
violated federal law governing unauthorized distribution and misbrand
ing of drugs are based on the fundamental misunderstanding that the
FDA, rather than the manufacturer, bears primary responsibility for
drug labeling. It is a central premise of the Federal Food, Drug, and
Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer
bears responsibility for the content of its label at all times. Pp. 568–573.

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556 WYETH v. LEVINE
Syllabus
(b) Wyeth’s argument that requiring it to comply with a state-law
duty to provide a stronger warning would interfere with Congress’ pur
pose of entrusting an expert agency with drug labeling decisions is mer
itless because it relies on an untenable interpretation of congressional
intent and an overbroad view of an agency’s power to pre-empt state
law. The history of the FDCA shows that Congress did not intend to
pre-empt state-law failure-to-warn actions. In advancing the argument
that the FDA must be presumed to have established a specific labeling
standard that leaves no room for different state-law judgments, Wyeth
relies not on any statement by Congress but on the preamble to a 2006
FDA regulation declaring that state-law failure-to-warn claims threaten
the FDA’s statutorily prescribed role. Although an agency regulation
with the force of law can pre-empt conflicting state requirements, this
case involves no such regulation but merely an agency’s assertion that
state law is an obstacle to achieving its statutory objectives. Where,
as here, Congress has not authorized a federal agency to pre-empt state
law directly, the weight this Court accords the agency’s explanation of
state law’s impact on the federal scheme depends on its thoroughness,
consistency, and persuasiveness. Cf., e. g., Skidmore v. Swift & Co., 323
U. S. 134. Under this standard, the FDA’s 2006 preamble does not
merit deference: It is inherently suspect in light of the FDA’s failure
to offer interested parties notice or opportunity for comment on the
pre-emption question; it is at odds with the available evidence of Con
gress’ purposes; and it reverses the FDA’s own longstanding position
that state law is a complementary form of drug regulation without pro
viding a reasoned explanation. Geier v. American Honda Motor Co.,
529 U. S. 861, is distinguished. Pp. 573–581.
183 Vt. 76, 944 A. 2d 179, affirmed.
Stevens, J., delivered the opinion of the Court, in which Kennedy,
Souter, Ginsburg, and Breyer, JJ., joined. Breyer, J., filed a concur
ring opinion, post, p. 581. Thomas, J., filed an opinion concurring in the
judgment, post, p. 582. Alito, J., filed a dissenting opinion, in which Rob
erts, C. J., and Scalia, J., joined, post, p. 604.
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

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557 Cite as: 555 U. S. 555 (2009)
Counsel
ent, then-Assistant Attorney General Katsas, Daryl Josef
fer, Douglas N. Letter, Peter R. Mai er, and Gerald F.
Masoudi.
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 Ken
neth S. Geller and Andrew E. Tauber; for the Washington Legal Founda
tion 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 Kan
sas, 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 Mis
sissippi, 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 Okla
homa, 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.

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558 WYETH v. LEVINE
Opinion of the Court
Justice Stevens delivered the opinion of the Court.
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
tion we must decide is whether the FDA’s approvals provide
Van Hollen of Wisconsin, and Bruce A. Salzburg of Wyoming; for AARP
et al. by Charles L. Becker, Bruce Vignery, Stacy J. Canan, and Michael
R. Schuster; for the American Association for Justice by Louis M. Bograd,
Francine A. Hochberg, and Les Weisbrod; for the California Medical Asso
ciation by Collyn A. Peddie and Francisco J. Silva; for the Center for
State Enforcement of Antitrust and Consumer Protection Laws, Inc., by
Thomas W. Merrill and Stephen D. Houck; for the Constitutional Account
ability Center by Elizabeth B. Wydra, Sean H. Donahue, and David T.
Goldberg; for Constitutional and Administrative Law Scholars by Ernest
A. Young and Erin Glenn Busby; for the Consumers Union of United
States, Inc., by Mark R. Savage; for DES Action by Aaron M. Levine; for
former FDA Commissioner Dr. Donald Kennedy et al. by David C. Vla
deck; for Members of Congress by Jonathan S. Massey; for the National
Conference of State Legislatures by Elizabeth J. Cabraser; for the New
England Journal of Medicine Editors and Authors by Gerson H. Smoger,
Arthur H. Bryant, and Leslie A. Brueckner; for the Senior Citizens
League by John S. Miles, Herbert W. Titus, and William J. Olson; for the
Texas Medical Association et al. by R. Brent Cooper, Diana L. Faust, Jay
H. Henderson, and Donald P. Wilcox; for Anju Budhwani, M.D., et al. by
Stanley D. Bernstein; for Daniel Paul Carpenter et al. by Gregory S. Cole
man and Christian J. Ward; for Mark P. Gergen et al. by Michael F.
Sturley; for David B. Ross, M.D., Ph.D., et al. by Michael J. Quirk, Mark
R. Cuker, and Esther E. Berezofsky; and for Kim Witczak et al. by Earl
Landers Vickery and W. Mark Lanier.
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.

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Opinion of the Court
Wyeth with a complete defense to Levine’s tort claims. We
conclude that they do not.
I
Phenergan is Wyeth’s brand name for promethazine hydro
chloride, an antihistamine used to treat nausea. The inject
able 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 Phen
ergan. 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 as
sistant administered the drugs by the IV-push method, and
Phenergan entered Levine’s artery, either because the nee
dle penetrated an artery directly or because the drug es
caped from the vein into surrounding tissue (a phenomenon
called “perivascular extravasation”) where it came in contact
with arterial blood. As a result, Levine developed gan
grene, 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 clini
cian, Levine brought an action for damages against Wyeth,
relying on common-law negligence and strict-liability theo
ries. Although Phenergan’s labeling warned of the danger
of gangrene and amputation following inadvertent intra

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Opinion of the Court
arterial injection,1 Levine alleged that the labeling was de
fective because it failed to instruct clinicians to use the IV
drip method of intravenous administration instead of the
higher risk IV-push method. More broadly, she alleged that
Phenergan is not reasonably safe for intravenous administra
tion because the foreseeable risks of gangrene and loss of
limb are great in relation to the drug’s therapeutic benefits.
App. 14–15.
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 con
flict 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
1 The warning for “Inadvertent Intra-arterial Injection” stated: “Due to
the close proximity of arteries and veins in the areas most commonly used
for intravenous injection, extreme care should be exercised to avoid peri
vascular extravasation or inadvertent intra-arterial injection. Reports
compatible with inadvertent intra-arterial injection of Phenergan Injec
tion, usually in conjunction with other drugs intended for intravenous use,
suggest that pain, severe chemical irritation, severe spasm of distal ves
sels, and resultant gangrene requiring amputation are likely under such
circumstances. Intravenous injection was intended in all the cases re
ported but perivascular extravasation or arterial placement of the needle
is now suspect. There is no proven successful management of this condi
tion after it occurs. . . . Aspiration of dark blood does not preclude intra
arterial needle placement, because blood is discolored upon contact with
Phenergan Injection. Use of syringes with rigid plungers or of small
bore needles might obscure typical arterial backflow if this is relied upon
alone. When used intravenously, Phenergan Injection should be given in
a concentration no greater than 25 mg per mL and at a rate not to exceed
25 mg per minute. When 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. In the event
that a patient complains of pain during intended intravenous injection of
Phenergan Injection, the injection should be stopped immediately to pro
vide for evaluation of possible arterial placement or perivascular extrava
sation.” App. 390.

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court reviewed the sparse correspondence between Wyeth
and the FDA about Phenergan’s labeling and found no evi
dence that Wyeth had “earnestly attempted” to strengthen
the intra-arterial injection warning or that the FDA had
“specifically disallowed” stronger language, id., at 23. The
record, as then developed, “lack[ed] any evidence that the
FDA set a ceiling on this matter.” Ibid.
The evidence presented during the 5-day jury trial showed
that the risk of intra-arterial injection or perivascular ex
travasation 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 Phen
ergan. See id., at 73, 75–76. While Phenergan’s labeling
warned against intra-arterial injection and perivascular ex
travasation and advised that “[w]hen administering any irri
tant 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 label
ing 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 applica
tions, 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

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proposed changes. The FDA did not respond. Instead, in
1996, it requested from Wyeth the labeling then in use and,
without addressing Wyeth’s 1988 submission, instructed it to
“[r]etain verbiage in current label” regarding intra-arterial
injection. Id., at 359. After a few further changes to the
labeling not related to intra-arterial injection, the FDA ap
proved Wyeth’s 1981 application in 1998, instructing that
Phenergan’s final printed label “must be identical” to the ap
proved package insert. Id., at 382.
Based on this regulatory history, the trial judge instructed
the jury that it could consider evidence of Wyeth’s compli
ance with FDA requirements but that such compliance did
not establish that the warnings were adequate. He also in
structed, without objection from Wyeth, that FDA regula
tions “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 de
fective product as a result of inadequate warnings and in
structions, and that no intervening cause had broken the
causal connection between the product defects and the plain
tiff ’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 reg
ulations permit strengthened warnings without FDA ap
proval on an interim basis and the record contained evidence

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of at least 20 reports of amputations similar to Levine’s since
the 1960’s. The court also found that state tort liability in
this case would not obstruct the FDA’s work because the
agency had paid no more than passing attention to the ques
tion whether to warn against IV-push administration of Phen
ergan. In addition, the court noted that state law serves a
compensatory function distinct from federal regulation. Id.,
at 249–252.
The Vermont Supreme Court affirmed. It held that the
jury’s verdict “did not conflict with FDA’s labeling require
ments 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 ad
ministration 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 Reib
er’s dissent, persuaded us to grant Wyeth’s petition for cer
tiorari. 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 vio
lating federal law, see Fidelity Fed. Sav. & Loan Assn. v. De
la Cuesta, 458 U. S. 141, 153 (1982), and second, that recogni
tion of Levine’s state tort action creates an unacceptable “ob
stacle to the accomplishment and execution of the full pur

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564 WYETH v. LEVINE
Opinion of the Court
poses 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.
As a preface to our evaluation of these arguments, we iden
tify two factual propositions decided during the trial court
proceedings, emphasize two legal principles that guide our
analysis, and review the history of the controlling federal
statute.
The trial court proceedings established that Levine’s in
jury would not have occurred if Phenergan’s label had in
cluded an adequate warning about the risks of the IV-push
method of administering the drug. The record contains evi
dence that the physician assistant administered a greater
dose than the label prescribed, that she may have inadvert
ently injected the drug into an artery rather than a vein, and
that she continued to inject the drug after Levine com
plained of pain. Nevertheless, the jury rejected Wyeth’s ar
gument 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 lia
ble, the jury also determined that Levine’s injury was fore
seeable. That the inadequate label was both a but-for and
proximate cause of Levine’s injury is supported by the rec
ord 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 ade
quate warning about the risks of IV-push administration.
Levine also offered evidence that the IV-push method should
2 The dissent nonetheless suggests that physician malpractice was the
exclusive cause of Levine’s injury. See, e. g., post, at 605 (opinion of
Alito, J.) (“[I]t is unclear how a ‘stronger’ warning could have helped
respondent”); post, at 619–621 (suggesting that the physician assistant’s
conduct was the sole cause of the injury). The dissent’s frustration with
the jury’s verdict does not put the merits of Levine’s tort claim before
us, nor does it change the question we must decide—whether federal law
pre-empts Levine’s state-law claims.

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Opinion of the Court
be contraindicated and that Phenergan should never be ad
ministered intravenously, even by the IV-drip method. Per
haps for this reason, the dissent incorrectly assumes that the
state-law duty at issue is the duty to contraindicate the IV
push method. See, e. g., post, at 611, 628. But, as the Ver
mont Supreme Court explained, the jury verdict established
only that Phenergan’s warning was insufficient. It did not
mandate a particular replacement warning, nor did it require
contraindicating IV-push administration: “There may have
been any number of ways for [Wyeth] to strengthen the
Phenergan warning without completely eliminating IV-push
administration.” 183 Vt., at 92, n. 2, 944 A. 2d, at 189, n. 2.
We therefore need not decide whether a state rule proscrib
ing intravenous administration would be pre-empted. The
narrower question presented is whether federal law pre
empts Levine’s claim that Phenergan’s label did not contain
an adequate warning about using the IV-push method of
administration.
Our answer to that question must be guided by two cor
nerstones 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 Con
gress 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
3 Wyeth argues that the presumption against pre-emption should not
apply to this case because the Federal Government has regulated drug
labeling for more than a century. That argument misunderstands the
principle: We rely on the presumption because respect for the States as

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566 WYETH v. LEVINE
Opinion of the Court
In order to identify the “purpose of Congress,” it is appro
priate to briefly review the history of federal regulation of
drugs and drug labeling. In 1906, Congress enacted its first
significant public health law, the Federal Food and Drugs
Act, ch. 3915, 34 Stat. 768. The Act, which prohibited the
manufacture or interstate shipment of adulterated or mis
branded drugs, supplemented the protection for consumers
already provided by state regulation and common-law liabil
ity. In the 1930’s, Congress became increasingly concerned
about unsafe drugs and fraudulent marketing, and it enacted
the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675,
52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq. The
FDCA’s most substantial innovation was its provision for
premarket approval of new drugs. It required every manu
facturer to submit a new drug application, including reports
of investigations and specimens of proposed labeling, to the
FDA for review. Until its application became effective, a
manufacturer was prohibited from distributing a drug. The
FDA could reject an application if it determined that the
drug was not safe for use as labeled, though if the agency
failed to act, an application became effective 60 days after
the filing. FDCA, § 505(c), 52 Stat. 1052.
“independent sovereigns in our federal system” leads us to assume that
“Congress does not cavalierly pre-empt state-law causes of action.” Lohr,
518 U. S., at 485. The presumption thus accounts for the historic presence
of state law but does not rely on the absence of federal regulation.
For its part, the dissent argues that the presumption against pre
emption should not apply to claims of implied conflict pre-emption at all,
post, at 623–624, but this Court has long held to the contrary. See, e. g.,
California v. ARC America Corp., 490 U. S. 93, 101–102 (1989); Hills
borough County v. Automated Medical Laboratories, Inc., 471 U. S. 707,
716 (1985); see also Rush Prudential HMO, Inc. v. Moran, 536 U. S. 355,
387 (2002). The dissent’s reliance on Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U. S. 341 (2001), see post, at 624, and n. 14, is especially curi
ous, as that case involved state-law fraud-on-the-agency claims, and the
Court distinguished state regulation of health and safety as matters to
which the presumption does apply. See 531 U. S., at 347–348.

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In 1962, Congress amended the FDCA and shifted the bur
den of proof from the FDA to the manufacturer. Before
1962, the agency had to prove harm to keep a drug out of
the market, but the amendments required the manufacturer
to demonstrate that its drug was “safe for use under the
conditions prescribed, recommended, or suggested in the
proposed labeling” before it could distribute the drug.
§§ 102(c), 104(b), 76 Stat. 781, 784. In addition, the amend
ments required the manufacturer to prove the drug’s effec
tiveness by introducing “substantial evidence that the drug
will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or sug
gested in the proposed labeling.” § 102(c), id., at 781.
As it enlarged the FDA’s powers to “protect the public
health” and “assure the safety, effectiveness, and reliability
of drugs,” id., at 780, Congress took care to preserve state
law. The 1962 amendments added a saving clause, indicat
ing that a provision of state law would only be invalidated
upon a “direct and positive conflict” with the FDCA. § 202,
id., at 793. Consistent with that provision, state common
law suits “continued unabated despite . . . FDA regulation.”
Riegel v. Medtronic, Inc., 552 U. S. 312, 340 (2008) (Gins
burg, J., dissenting); see ibid., n. 11 (collecting state cases).
And when Congress enacted an express pre-emption provi
sion for medical devices in 1976, see § 2, 90 Stat. 574 (codified
at 21 U. S. C. § 360k(a)), it declined to enact such a provision
for prescription drugs.
In 2007, after Levine’s injury and lawsuit, Congress again
amended the FDCA. 121 Stat. 823. For the first time, it
granted the FDA statutory authority to require a manu
facturer to change its drug label based on safety informa
tion that becomes available after a drug’s initial approval.
§ 901(a), id., at 924–926. In doing so, however, Congress did
not enact a provision in the Senate bill that would have re
quired the FDA to preapprove all changes to drug labels.
See S. 1082, 110th Cong., 1st Sess., § 208, pp. 107–114 (2007)

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568 WYETH v. LEVINE
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(as passed) (proposing new § 506D). Instead, it adopted a
rule of construction to make it clear that manufacturers re
main responsible for updating their labels. See 121 Stat.
925–926.
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 in
cludes the approval of the exact text in the proposed label.
See 21 U. S. C. § 355; 21 CFR § 314.105(b) (2008). Generally
speaking, a manufacturer may only change a drug label after
the FDA approves a supplemental application. There is,
however, an FDA regulation that permits a manufacturer
to make certain changes to its label before receiving the
agency’s approval. Among other things, this “changes being
effected” (CBE) regulation provides that if a manufacturer
is changing a label to “add or strengthen a contraindication,
warning, precaution, or adverse reaction” or to “add or
strengthen an instruction about dosage and administration
that is intended to increase the safe use of the drug product,”
it may make the labeling change upon filing its supplemental
application with the FDA; it need not wait for FDA ap
proval. §§ 314.70(c)(6)(iii)(A), (C).
Wyeth argues that the CBE regulation is not implicated
in this case because a 2008 amendment provides that a manu
facturer may only change its label “to reflect newly acquired
information.” 73 Fed. Reg. 49609. Resting on this lan
guage (which Wyeth argues simply reaffirmed the interpre
tation 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 ad
ministration. Thus, Wyeth insists, it was impossible for it

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to discharge its state-law obligation to provide a stronger
warning about IV-push administration without violating fed
eral law. Wyeth’s argument misapprehends both the federal
drug regulatory scheme and its burden in establishing a
pre-emption defense.
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 accord
ance 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 analy
ses 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 sub
mits adverse event information to FDA, and then later con
ducts a new analysis of data showing risks of a different type
or of greater severity or frequency than did reports pre
viously submitted to FDA, the sponsor meets the require
ment for ‘newly acquired information.’ ” Id., at 49607; see
also id., at 49606.
The record is limited concerning what newly acquired in
formation 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 re
quired 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 inci
dent came to Wyeth’s attention in 1967, it notified the FDA
and worked with the agency to change Phenergan’s label.
4 Levine also introduced evidence that Pfizer had withdrawn Vistaril,
another antinausea drug, from intravenous use several decades earlier be
cause its intravenous injection had resulted in gangrene and amputations.
See App. 79.

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In later years, as amputations continued to occur, Wyeth
could have analyzed the accumulating data and added a
stronger warning about IV-push administration of the drug.
Wyeth argues that if it had unilaterally added such a warn
ing, it would have violated federal law governing unauthor
ized distribution and misbranding. Its argument that a
change in Phenergan’s labeling would have subjected it to
liability for unauthorized distribution rests on the assump
tion that this labeling change would have rendered Phen
ergan a new drug lacking an effective application. But
strengthening the warning about IV-push administration
would not have made Phenergan a new drug. See 21
U. S. C. § 321(p)(1) (defining “new drug”); 21 CFR § 310.3(h).
Nor would this warning have rendered Phenergan mis
branded. The FDCA does not provide that a drug is mis
branded simply because the manufacturer has altered an
FDA-approved label; instead, the misbranding provision fo
cuses on the substance of the label and, among other things,
proscribes labels that fail to include “adequate warnings.”
21 U. S. C. § 352(f). Moreover, because the statute contem
plates that federal juries will resolve most misbranding
claims, the FDA’s belief that a drug is misbranded is not
conclusive. See §§ 331, 332, 334(a)–(b). And the very idea
that the FDA would bring an enforcement action against a
manufacturer for strengthening a warning pursuant to the
CBE regulation is difficult to accept—neither Wyeth nor the
United States has identified a case in which the FDA has
done so.
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

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sibility for the content of its label at all times. It is charged
both with crafting an adequate label and with ensuring that
its warnings remain adequate as long as the drug is on the
market. See, e. g., 21 CFR § 201.80(e) (requiring a manufac
turer to revise its label “to include a warning as soon as
there is reasonable evidence of an association of a serious
hazard with a drug”); § 314.80(b) (placing responsibility for
postmarketing surveillance on the manufacturer); 73 Fed.
Reg. 49605 (“Manufacturers continue to have a responsibility
under Federal law . . . to maintain their labeling and update
the labeling with new safety information”).
Indeed, prior to 2007, the FDA lacked the authority to
order manufacturers to revise their labels. See 121 Stat.
924–926. When Congress granted the FDA this authority,
it reaffirmed the manufacturer’s obligations and referred
specifically to the CBE regulation, which both reflects the
manufacturer’s ultimate responsibility for its label and pro
vides a mechanism for adding safety information to the label
prior to FDA approval. See id., at 925–926 (stating that a
manufacturer retains the responsibility “to maintain its label
in accordance with existing requirements, including subpart
B of part 201 and sections 314.70 and 601.12 of title 21, Code
of Federal Regulations (or any successor regulations)” (em
phasis added)). Thus, when the risk of gangrene from IV
push injection of Phenergan became apparent, Wyeth had a
duty to provide a warning that adequately described that
risk, and the CBE regulation permitted it to provide such a
warning before receiving the FDA’s approval.
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 re
tains such authority in reviewing all supplemental applica
tions. 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.

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Wyeth has offered no such evidence. It does not argue
that it attempted to give the kind of warning required by
the Vermont jury but was prohibited from doing so by the
FDA.5 See Tr. of Oral Arg. 12–13; see also Brief for United
States as Amicus Curiae 25. And while it does suggest
that the FDA intended to prohibit it from strengthening the
warning about IV-push administration because the agency
deemed such a warning inappropriate in reviewing Phener
gan’s drug applications, both the trial court and the Vermont
Supreme Court rejected this account as a matter of fact. In
its decision on Wyeth’s motion for judgment as a matter of
law, the trial court found “no evidence in this record that
either the FDA or the manufacturer gave more than passing
attention to the issue of ” IV-push versus IV-drip administra
tion. App. 249. The Vermont Supreme Court likewise con
cluded that the FDA had not made an affirmative decision to
preserve the IV-push method or intended to prohibit Wyeth
from strengthening its warning about IV-push administra
tion. 183 Vt., at 91–92, 944 A. 2d, at 188–189. Moreover,
Wyeth does not argue that it supplied the FDA with an eval
5 The record would not, in any event, support such an argument. In
1988, Wyeth did propose different language for Phenergan’s warning about
intra-arterial injection, adapted from revisions the FDA proposed in 1987.
See id., at 339–341, 311–312. When the FDA approved Wyeth’s appli
cation, it instructed Wyeth to retain the wording in its current label.
During the trial court proceedings, Levine indicated that the language
proposed in 1988 would have more strongly warned against IV-push ad
ministration. But the trial court and the Vermont Supreme Court found
that the 1988 warning did not differ in any material respect from the
FDA-approved warning. See 183 Vt. 76, 92, 944 A. 2d 179, 189 (2006)
(“Simply stated, the proposed warning was different, but not stronger. It
was also no longer or more prominent than the original warning . . . ”);
App. 248–250. Indeed, the United States concedes that the FDA did not
regard the proposed warning as substantively different: “[I]t appears the
FDA viewed the change as non-substantive and rejected it for formatting
reasons.” Brief for United States as Amicus Curiae 25; see also 183 Vt.,
at 92–93, 944 A. 2d, at 189.

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uation or analysis concerning the specific dangers posed by
the IV-push method. We accordingly cannot credit Wyeth’s
contention that the FDA would have prevented it from add
ing a stronger warning about the IV-push method of intrave
nous administration.6
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 “Con
gress’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 that the FDCA establishes both a floor
and a ceiling for drug regulation: Once the FDA has ap
6 The dissent’s suggestion that the FDA intended to prohibit Wyeth
from strengthening its warning does not fairly reflect the record. The
dissent creatively paraphrases a few FDA orders—for instance by conflat
ing warnings about IV-push administration and intra-arterial injection,
see, e. g., post, at 612–613, 614–651, 618–619—to suggest greater agency
attention to the question, and it undertakes a study of Phenergan’s label
ing that is more elaborate than any FDA order. But even the dissent’s
account does not support the conclusion that the FDA would have pro
hibited Wyeth from adding a stronger warning pursuant to the CBE
regulation.

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proved a drug’s label, a state-law verdict may not deem the
label inadequate, regardless of whether there is any evidence
that the FDA has considered the stronger warning at issue.
The most glaring problem with this argument is that all evi
dence of Congress’ purposes is to the contrary. Building on
its 1906 Act, Congress enacted the FDCA to bolster con
sumer protection against harmful products. See Kordel v.
United States, 335 U. S. 345, 349 (1948); United States v. Sul
livan, 332 U. S. 689, 696 (1948). Congress did not provide a
federal remedy for consumers harmed by unsafe or ineffec
tive drugs in the 1938 statute or in any subsequent amend
ment. Evidently, it determined that widely available state
rights of action provided appropriate relief for injured
consumers.7 It may also have recognized that state-law
remedies further consumer protection by motivating man
ufacturers to produce safe and effective drugs and to give
adequate warnings.
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 § 2, 90 Stat. 574
(codified at 21 U. S. C. § 360k(a)), Congress has not enacted
such a provision for prescription drugs. See Riegel, 552
U. S., at 327 (“Congress could have applied the pre-emption
clause to the entire FDCA. It did not do so, but instead
wrote a pre-emption clause that applies only to medical de
7 Although the first version of the bill that became the FDCA would
have provided a federal cause of action for damages for injured consumers,
see H. R. 6110, 73d Cong., 1st Sess., § 25 (1933) (as introduced), witnesses
testified that such a right of action was unnecessary because common-law
claims were already available under state law. See Hearings on S. 1944
before a Subcommittee of the Senate Committee on Commerce, 73d Cong.,
2d Sess., 400 (1933) (statement of W. A. Hines); see id., at 403 (statement
of J. A. Ladds) (“This act should not attempt to modify or restate the
common law with respect to personal injuries”).

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vices”).8 Its silence on the issue, coupled with its certain
awareness of the prevalence of state tort litigation, is power
ful evidence that Congress did not intend FDA oversight to
be the exclusive means of ensuring drug safety and effective
ness. As Justice O’Connor explained in her opinion for a
unanimous Court: “The case for federal pre-emption is par
ticularly weak where Congress has indicated its awareness
of the operation of state law in a field of federal interest, and
has nonetheless decided to stand by both concepts and to
tolerate whatever tension there [is] between them.” Bonito
Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 166–
167 (1989) (internal quotation marks omitted); see also supra,
at 565 (discussing the presumption against pre-emption).
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
8 In 1997, Congress pre-empted certain state requirements concerning
over-the-counter medications and cosmetics but expressly preserved prod
uct liability actions. See 21 U. S. C. §§ 379r(e), 379s(d) (“Nothing in this
section shall be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any State”).

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prescribed role as the expert Federal agency responsible for
evaluating and regulating drugs.” Id., at 3935.
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 Labora
tories, 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 as
sertion 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. 21 U. S. C. § 360k (authoriz
ing the FDA to determine the scope of the Medical Devices
Amendments’ pre-emption clause),9 the question is what
weight we should accord the FDA’s opinion.
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 his
tory 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 explana
tion of how state law affects the regulatory scheme. While
9 For similar examples, see 47 U. S. C. §§ 253(a), (d) (2000 ed.) (authoriz
ing the Federal Communications Commission to pre-empt “any [state]
statute, regulation, or legal requirement” that “may prohibit or have the
effect of prohibiting the ability of any entity to provide any interstate
or intrastate telecommunications service”); 30 U. S. C. § 1254(g) (2006 ed.)
(pre-empting any statute that conflicts with “the purposes and the re
quirements of this chapter” and permitting the Secretary of the Interior
to “set forth any State law or regulation which is preempted and su
perseded”); and 49 U. S. C. § 5125(d) (2000 ed. and Supp. V) (authorizing
the Secretary of Transportation to decide whether a state or local statute
that conflicts with the regulation of hazardous waste transportation is
pre-empted).

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agencies have no special authority to pronounce on pre
emption absent delegation by Congress, they do have a
unique understanding of the statutes they administer and an
attendant ability to make informed determinations about
how state requirements may pose an “obstacle to the accom
plishment and execution of the full purposes and objectives
of Congress.” Hines, 312 U. S., at 67; see Geier, 529 U. S.,
at 883; Lohr, 518 U. S., at 495–496. The weight we accord
the agency’s explanation of state law’s impact on the federal
scheme depends on its thoroughness, consistency, and per
suasiveness. Cf. United States v. Mead Corp., 533 U. S. 218,
234–235 (2001); Skidmore v. Swift & Co., 323 U. S. 134, 140
(1944).
Under this standard, the FDA’s 2006 preamble does not
merit deference. When the FDA issued its notice of pro
posed rulemaking in December 2000, it explained that the
rule would “not contain policies that have federalism implica
tions 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 final
ized 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 explana
tion, 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 re
flect the agency’s own view at all times relevant to this litiga
tion. Not once prior to Levine’s injury did the FDA suggest
that state tort law stood as an obstacle to its statutory mis
sion. To the contrary, it cast federal labeling standards as
a floor upon which States could build and repeatedly dis

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claimed any attempt to pre-empt failure-to-warn claims.
For instance, in 1998, the FDA stated that it did “not believe
that the evolution of state tort law [would] cause the develop
ment of standards that would be at odds with the agency’s
regulations.” 63 id., at 66384. It further noted that, in es
tablishing “minimal standards” for drug labels, it did not in
tend “to preclude the states from imposing additional label
ing requirements.” Ibid.10
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 regula
tion. The FDA has limited resources to monitor the 11,000
drugs on the market,11 and manufacturers have superior ac
10 See also 44 Fed. Reg. 37437 (1979) (“It is not the intent of the FDA to
influence the civil tort liability of the manufacturer”); 59 Fed. Reg. 3948
(1994) (“[P]roduct liability plays an important role in consumer protec
tion”); Porter, The Lohr Decision: FDA Perspective and Position, 52
Food & Drug L. J. 7, 10 (1997) (former chief counsel to the FDA stating
that the FDA regarded state law as complementing the agency’s mission
of consumer protection).
11 In 1955, the same year that the agency approved Wyeth’s Phenergan
application, an FDA advisory committee issued a report finding “conclu
sively” that “the budget and staff of the [FDA] are inadequate to permit
the discharge of its existing responsibilities for the protection of the Amer
ican public.” Citizens Advisory Committee on the FDA, Report to the
Secretary of Health, Education, and Welfare, H. R. Doc. No. 227, 84th
Cong., 1st Sess., 53. Three recent studies have reached similar conclu
sions. See FDA Science Board, Report of the Subcommittee on Science
and Technology: FDA Science and Mission at Risk 2, 6 (2007), online at
http://www.fda.gov/ohrms/dockets/ac/07/ briefing/2007-4329b_02_01_FDA%
20Report%20on%20Science%20and%20Technology.pdf (all Internet mate
rials as visited Feb. 23, 2009, and available in Clerk of Court’s case file)
(“[T]he Agency suffers from serious scientific deficiencies and is not
positioned to meet current or emerging regulatory responsibilities”); Na
tional Academies, Institute of Medicine, The Future of Drug Safety: Pro
moting and Protecting the Health of the Public 193–194 (2007) (“The
[FDA] lacks the resources needed to accomplish its large and complex
mission . . . . There is widespread agreement that resources for postmar
keting drug safety work are especially inadequate and that resource limi

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cess to information about their drugs, especially in the post
marketing phase as new risks emerge. State tort suits un
cover unknown drug hazards and provide incentives for drug
manufacturers to disclose safety risks promptly. They
also serve a distinct compensatory function that may mo
tivate 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 pri
mary responsibility for their drug labeling at all times.
Thus, the FDA long maintained that state law offers an addi
tional, and important, layer of consumer protection that com
plements 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 re
quire airbags for all cars. The Department of Transporta
tations have hobbled the agency’s ability to improve and expand this es
sential component of its mission”); GAO, Drug Safety: Improvement
Needed in FDA’s Postmarket Decision-making and Oversight Process 5
(GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf (“FDA
lacks a clear and effective process for making decisions about, and provid
ing management oversight of, postmarket safety issues”); see also House
Committee on Oversight and Government Reform, Majority Staff Re
port, FDA Career Staff Objected to Agency Preemption Policies 4 (2008)
(“[T]he Office of Chief Counsel ignored the warnings from FDA scientists
and career officials that the preemption language [of the 2006 preamble]
was based on erroneous assertions about the ability of the drug approval
process to ensure accurate and up-to-date drug labels”).
12 See generally Brief for Former FDA Commissioners Drs. Donald Ken
nedy and David Kessler as Amici Curiae; see also Kessler & Vladeck, A
Critical Examination of the FDA’s Efforts To Preempt Failure-To-Warn
Claims, 96 Geo. L. J. 461, 463 (2008); Bates v. Dow Agrosciences LLC, 544
U. S. 431, 451 (2005) (noting that state tort suits “can serve as a catalyst”
by aiding in the exposure of new dangers and prompting a manufacturer
or the federal agency to decide that a revised label is required).

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tion (DOT) had promulgated a rule that provided car manu
facturers with a range of choices among passive restraint
devices. Geier, 529 U. S., at 875. Rejecting an “ ‘all air
bag’ ” 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, ex
pressed 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
13 The United States’ amicus brief is similarly undeserving of deference.
Unlike the Government’s brief in Geier v. American Honda Motor Co.,
529 U. S. 861 (2000), which explained the effects of state law on the DOT’s
regulation in a manner consistent with the agency’s prior accounts, see
ibid., the Government’s explanation of federal drug regulation departs
markedly from the FDA’s understanding at all times relevant to this case.

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tory 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 accom
plishment 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
14 Wyeth’s more specific contention—that this case resembles Geier be
cause the FDA determined that no additional warning on IV-push adminis
tration was needed, thereby setting a ceiling on Phenergan’s label—is be
lied by the record. As we have discussed, the FDA did not consider and
reject a stronger warning against IV-push injection of Phenergan. See
also App. 249–250 (“[A] tort case is unlikely to obstruct the regulatory
process when the record shows that the FDA has paid very little attention
to the issues raised by the parties at trial”).

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Food and Drug Administration (FDA) “uncover unknown
drug hazards and [encourage] drug manufacturers to disclose
safety risks.” Ante, at 579. 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 concur
ring 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 regu
lations 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 Hills
borough 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.
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

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cation, warning, precaution, or adverse reaction,” 21 CFR
§ 314.70(c)(6)(iii)(A) (2008), or “about dosage and administra
tion that is intended to increase the safe use of the drug
product,” § 314.70(c)(6)(iii)(C), in order to “reflect newly ac
quired information,” including “new analyses of previously
submitted data,” about the dangers of IV-push administra
tion of Phenergan, 73 Fed. 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 ap
proved 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 judg
ment 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 ma
jority’s implicit endorsement of far-reaching implied pre
emption doctrines. In particular, I have become increas
ingly 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 lib
erties,” Atascadero State Hospital v. Scanlon, 473 U. S. 234,
242 (1985) (internal quotation marks omitted), the “Constitu
tion establishes a system of dual sovereignty between the
States and the Federal Government,” Gregory v. Ashcroft,

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501 U. S. 452, 457 (1991). The Framers adopted this “ ‘con
stitutionally 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 advan
tages,” such as “a decentralized government that will be
more sensitive to the diverse needs of a heterogeneous soci
ety” and “increase[d] opportunity for citizen involvement in
democratic processes,” Gregory, supra, at 458. Further
more, 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 sepa
rate departments.” The Federalist No. 51, p. 266 (M. Beloff
ed., 2d ed. 1987).
Under this federalist system, “the States possess sover
eignty concurrent with that of the Federal Government, sub
ject 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 au
thority. 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 ac
cordance with the text and structure of the Constitution,
“[t]he powers delegated by the proposed constitution to the

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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, 7 Wall. 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 Trea
ties 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 Pur
suance” of “[t]his Constitution.” Ibid.; see 3 J. Story, Com
mentaries 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 Con
stitution 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

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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 pro
cedures 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 Bi
cameral and Presentment Clauses, Art. I, § 7, cls. 2–3, which
“prescribe and define the respective functions of the Con
gress and of the Executive in the legislative process”).
“[T]he Framers were acutely conscious that the bicameral
requirement and the Presentment Clauses would serve es
sential constitutional functions,” Chadha, 462 U. S., at 951,
by allowing the passage of legislation only after it has pro
ceeded through “a step-by-step, deliberate and deliberative
process,” id., at 959, that was “finely wrought and exhaus
tively considered” by the Framers, id., at 951. The Suprem
acy Clause thus requires that pre-emptive effect be given
only to those federal standards and policies that are set forth
in, or necessarily follow from, the statutory text that was
produced through the constitutionally required bicameral
and presentment procedures. See Story § 1831, at 694 (Ac
tions 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
1 This structural limitation may be implicated in a pre-emption case if
the federal law at issue is beyond the scope of Congress’ enumerated
powers. Expansion of congressional power through an “increasingly
generous . . . interpretation of the commerce power of Congress,” for ex
ample, creates “a real risk that Congress will gradually erase the diffusion
of power between State and Nation on which the Framers based their
faith in the efficiency and vitality of our Republic.” Garcia v. San Anto
nio Metropolitan Transit Authority, 469 U. S. 528, 583–584 (1985) (O’Con
nor, J., dissenting); see also Marbury v. Madison, 1 Cranch 137, 176 (1803)
(“The powers of the legislature are defined, and limited; and that those
limits may not be mistaken, or forgotten, the constitution is written”).

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supreme law of the land. They will be merely acts of usur
pation, 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 objec
tives” pre-emption jurisprudence, has increased my concerns
that implied pre-emption doctrines have not always been
constitutionally applied. Under the vague and “potenti
ally 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 ob
vious 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 Article I, § 7, requirements for enactment of federal law
and, therefore, do not pre-empt state law under the Suprem

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588 WYETH v. LEVINE
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acy Clause. When analyzing the pre-emptive effect of fed
eral 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 congressionally
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) (inter
nal quotation marks and citation omitted); see also Geier,
supra, at 911 (Stevens, J., dissenting) (“[P]re-emption anal
ysis 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.
II
This Court has determined that there are two categories
of conflict pre-emption, both of which Wyeth contends are at

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issue in this case. First, the Court has found pre-emption
“where compliance with both federal and state regulations is
a physical impossibility for one engaged in interstate com
merce.” Florida Lime & Avocado Growers, Inc. v. Paul,
373 U. S. 132, 142–143 (1963). Second, the Court has deter
mined that federal law pre-empts state law when, “under the
circumstances of [a] particular case, [state] law stands as an
obstacle to the accomplishment and execution of the full pur
poses and objectives of Congress.” Hines v. Davidowitz,
312 U. S. 52, 67 (1941).2
A
Wyeth first contends that “it would have been impossible
for it to comply with the state-law duty to modify Phener
gan’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” doc
trine. See, e. g., Geier, supra, at 873 (“a case in which state
law penalizes what federal law requires”); American Tele
phone & 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 (de
scribing AT&T as a “cas[e] involving impossibility”); Florida
2 The majority’s pre-emption analysis relies in part on a presumption
against pre-emption. Ante, at 565, and n. 3 (opinion of Stevens, J.). Be
cause it is evident from the text of the relevant federal statutes and regu
lations themselves that the state-law judgment below is not pre-empted,
it is not necessary to decide whether, or to what extent, the presumption
should apply in a case such as this one, where Congress has not enacted
an express pre-emption clause. Cf. Altria Group, Inc. v. Good, ante, at
99–103 (Thomas, J., dissenting) (rejecting the use of a presumption against
pre-emption in express pre-emption cases).

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Lime & Avocado Growers, supra, at 142–143 (“where compli
ance with both federal and state regulations is a physical
impossibility”). The Court has generally articulated a very
narrow “impossibility standard,” see Crosby, 530 U. S., at
372–373 (citing Florida Lime & Avocado Growers, supra, at
142–143); see also Sprietsma v. Mercury Marine, 537 U. S.
51, 64–65 (2002); United States v. Locke, 529 U. S. 89, 109
(2000)—in part because the overly broad sweep of the
Court’s “purposes and objectives” approach, see infra, at
594–604, has rendered it unnecessary for the Court to rely
on “impossibility” pre-emption.
The Court, in fact, has not explained why a narrow “physi
cal 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 sup
ports a standard of “logical-contradiction”); see also AT&T,
supra, 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)).

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Nonetheless, whatever the precise constitutional contours
of implied pre-emption may be, I am satisfied that it does not
operate against respondent’s judgment below. The text of
the federal laws at issue do not require that the state-court
judgment at issue be pre-empted, under either the narrow
“physical impossibility” standard, Florida Lime & Avocado
Growers, supra, at 142–143, or a more general “direc[t] con
flict” standard, AT&T, supra, at 227.
Under the FDA’s “changes being effected” regulation, 21
CFR § 314.70(c)(6)(iii), which was promulgated pursuant to
the FDA’s statutory authority, it is physically possible for
Wyeth to market Phenergan in compliance with federal and
Vermont law. As the majority explains, Wyeth could have
changed the warning on its label regarding IV-push without
violating federal law. See ante, at 568–570. The “changes
being effected” regulation allows drug manufacturers to
change their labels without the FDA’s preapproval if the
changes “add or strengthen a contraindication, warning, pre
caution, or adverse reaction,” § 314.70(c)(6)(iii)(A), or “add or
strengthen an instruction about dosage and administration
that is intended to increase the safe use of the drug product,”
§ 314.70(c)(6)(iii)(C), in order to “reflect newly acquired infor
mation,” including “new analyses of previously submitted
data,” 73 Fed. Reg. 49603, 49609. Under the terms of these
regulations, after learning of new incidences of gangrene
induced amputation resulting from the IV-push administra
tion of Phenergan, see ante, at 569–570, federal law
gave Wyeth the authority to change Phenergan’s label to
“strengthen a . . . warning,” “strengthen a . . . precau
tion,” § 314.70(c)(6)(iii)(A), or to “strengthen an instruction
about . . . administration [of the IV-push method] . . . to in
crease the safe use of the drug product,” § 314.70(c)(6)(iii)(C).
Thus, it was physically possible for Wyeth to comply with a
state-law requirement to provide stronger warnings on Phen
ergan about the risks of the IV-push administration method

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while continuing to market Phenergan in compliance with
federal law.
In addition, the text of the statutory provisions governing
FDA drug labeling, and the regulations promulgated 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 21 U. S. C. § 355(a) (“No person shall intro
duce or deliver for introduction into interstate commerce any
new drug, unless an approval of an application filed pursuant
to subsection (b) or ( j) of this section is effective with respect
to such drug” (emphasis added)). To say, as the statute
does, that Wyeth may not market a drug without federal
approval (i. e., without an FDA-approved label) is not to say
that federal approval gives Wyeth the unfettered right, for
all time, to market its drug with the specific label that was
federally approved. Initial approval of a label amounts to a
finding by the FDA that the label is safe for purposes of
gaining federal approval to market the drug. It does not
represent a finding that the drug, as labeled, can never be
deemed unsafe by later federal action, or as in this case, the
application of state law.
Instead, FDA regulations require a drug manufacturer—
after initial federal approval of a drug’s label—to revise the
federally approved label “to include a warning as soon as
there is reasonable evidence of an association of a serious
hazard with a drug.” 21 CFR § 201.80(e). Drug manufac
turers are also required to “establish and maintain records
and make reports” to the FDA about “[a]ny adverse event
associated with the use of a drug in humans, whether or not
considered drug related,” after it has received federal ap
proval. §§ 314.80(a), (c), ( j). In addition, the manufacturer
must make periodic reports about “adverse drug experi

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ence[s]” associated with its drug and include “a history of
actions taken since the last report because of adverse drug
experiences (for example, labeling changes or studies initi
ated).” §§ 314.80(c)(2)(i)–(ii). When such records and re
ports are not made, the FDA can withdraw its approval of
the drug. § 314.80( j); see also 21 U. S. C. § 355(e) (“The Sec
retary may . . . withdraw the approval of an application . . .
if the Secretary finds . . . that the applicant has failed to
establish a system for maintaining required records, or has
repeatedly or deliberately failed to maintain such records or
to make required reports”). The FDA may also determine
that a drug is no longer safe for use based on “clinical or
other experience, tests, or other scientific data.” Ibid. (ap
proval may be withdrawn if “the Secretary finds . . . that
clinical or other experience, tests, or other scientific data
show that such drug is unsafe for use under the conditions of
use upon the basis of which the application was approved”).
The text of the statutory provisions and the accompanying
regulatory scheme governing the FDA drug approval proc
ess, 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 par
ticular 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 regula
tions 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

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claims); Foster, 522 U. S., at 68–69 (finding pre-emption
where the federal statute required congressional elections on
a particular date different from that provided by state
statute).
B
Wyeth also contends that state and federal law conflict be
cause “recognition of [this] state tort action creates an unac
ceptable ‘obstacle to the accomplishment and execution of
the full purposes and objectives of Congress,’ Hines v. Da
vidowitz, 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 congres
sional 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 con
gressional purposes); ante, at 576–577 (quoting the “ ‘pur
poses 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 ob
jectives” 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 (Pur
don 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 numer
ous extratextual sources and finding pre-emption without

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concluding that the terms of the federal and state laws di
rectly conflict); see also id., at 78 (Stone, J., dissenting) (not
ing that “[i]t is conceded that the federal act in operation
does not at any point conflict with the state statute”).3
Nonetheless, the Court determined that it was not confined
to considering merely the terms of the relevant federal law
in conducting its pre-emption analysis. Rather, it went on
to ask whether the state law “stands as an obstacle to the
accomplishment and execution of the full purposes and objec
tives of Congress.” Id., at 67.
In so doing, the Court looked far beyond the relevant fed
eral 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
3 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 identifi
cation card 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 fail
ure 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 informa
tion specified by the Act, plus ‘such additional matters as may be pre
scribed 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.

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tions imposed by the law.” Id., at 70. To do so, the Court
looked in part to public sentiment, noting that “[o]pposition
to laws . . . singling out aliens as particularly dangerous and
undesirable groups, is deep-seated in this country.” Ibid.
The Court also relied on statements by particular Members
of Congress and on congressional inaction, finding it perti
nent that numerous bills with requirements similar to Penn
sylvania’s law had failed to garner enough votes in Congress
to become law. Id., at 71–73, and nn. 32–34. Concluding
that these sources revealed a federal purpose to “protect the
personal liberties of law-abiding aliens through one uniform
national registration system,” the Court held that the Penn
sylvania law was pre-empted. Id., at 74.
Justice Stone, in dissent, questioned the majority’s deci
sion 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 resi
dents and of recording their whereabouts.” Id., at 78. Yet,
the Hines majority employed pre-emption to override nu
merous 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
4 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 Con
gress’ 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

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2
The consequences of this Court’s broad approach to “pur
poses and objectives” pre-emption are exemplified in this
Court’s decision in Geier, which both the majority and the
dissent incorporate into their analysis today. See ante, at
579–581, and nn. 13–14; post, at 609–612 (opinion of Alito,
J.). In Geier, pursuant to the National Traffic and Motor
Vehicle Safety Act of 1966 (Safety Act), 80 Stat. 718, 15
U. S. C. § 1381 et seq. (1988 ed.), the Department of Transpor
tation (DOT) had promulgated a Federal Motor Vehicle
Safety Standard that “required auto manufacturers to equip
some but not all of their 1987 vehicles with passive re
straints.” 529 U. S., at 864–865. The case required this
Court to decide whether the Safety Act pre-empted a state
common-law tort action in which the plaintiff claimed that
an auto manufacturer, though in compliance with the federal
standard, should nonetheless have equipped a 1987 automo
bile with airbags. Id., at 865. The Court first concluded
that the Safety Act’s express pre-emption provision and its
saving clause, read together, did not expressly pre-empt
state common-law claims. See id., at 867–868.5 The Court
least as applied in the absence of a congressional command that a particu
lar field be pre-empted”).
5 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.” 15 U. S. C. § 1392(d) (1988 ed.).
The Safety Act also included a saving clause, which stated: “Compliance
with any Federal motor vehicle safety standard issued under this subchap
ter does not exempt any person from any liability under common law.”
§ 1397(k). The majority and dissent in Geier v. American Honda Motor
Co., 529 U. S. 861 (2000), agreed that the import of the express pre-emption
provision and the saving clause, read together, was that by its terms, the
Safety Act did not expressly pre-empt state common-law actions. See id.,
at 867–868; id., at 895–898 (Stevens, J., dissenting).

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then proceeded to consider whether the state action was
nonetheless pre-empted as an “obstacle” to the purposes of
the federal law. The Court held that the state tort claim
was pre-empted, relying in large part on comments that DOT
made when promulgating its regulation, statements that the
Government made in its brief to the Court, and regulatory
history that related to the federal regulation of passive
restraints. See id., at 874–886.
In particular, the majority found that DOT intended to
“deliberately provid[e] the manufacturer[s] with a range of
choices among different passive restraint devices” and to
“bring about a mix of different devices introduced gradually
over time,” based on comments that DOT made when prom
ulgating 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 pro
moted if manufacturers installed alternative protection sys
tems 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 posi
tion and inferences from regulatory history and final com
mentary,” 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 ob
jectives” pre-emption based on agency comments, regulatory

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history, and agency litigating positions was especially flawed,
given that it conflicted with the plain statutory text of the
saving clause within the Safety Act, which explicitly pre
served state common-law actions by providing that “[c]om
pliance with any Federal motor vehicle safety standard is
sued under this subchapter does not exempt any person from
any liability under common law,” 15 U. S. C. § 1397(k) (1988
ed.).6 See Engine Mfrs. Assn. v. South Coast Air Quality
Management Dist., 541 U. S. 246, 252 (2004) (“Statutory con
struction must begin with the language employed by Con
gress and the assumption that the ordinary meaning of that
language accurately expresses the legislative purpose” (in
ternal quotation marks omitted)); West Virginia Univ. Hos
pitals, Inc. v. Casey, 499 U. S. 83, 98 (1991) (“The best evi
dence of th[e] purpose [of a statute] is the statutory text
adopted by both Houses of Congress and submitted to the
President”). In addition, the Court’s reliance on its divined
purpose of the federal law—to gradually phase in a mix of
6 In addition to the impropriety of looking beyond the plain text of the
saving clause to regulatory history, DOT comments, 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 pur
pose 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 15 U. S. C.
§ 1381 (1988 ed.)). On its face, that goal is of course consistent with a
state-law judgment that a particular vehicle needed a passive restraint
system that would better protect persons from death and injury during
traffic accidents. Furthermore, the dissent observed that “by definition
all of the standards established under the Safety Act . . . impose minimum,
rather than fixed or maximum, requirements.” 529 U. S., at 903 (citing 15
U. S. C. § 1391(2)). Thus, in the dissent’s view, the requirements of the
DOT regulation were not ceilings, and it was “obvious that the Secretary
favored a more rapid increase” than required by the regulations. 529
U. S., at 903. That goal also would be consistent with a state-law judg
ment finding that a manufacturer acted negligently when it failed to in
clude an airbag in a particular car. See id., at 903–904.

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passive restraint systems—in order to invalidate a State’s
imposition of a greater safety standard was contrary to the
more general express statutory goal of the Safety Act “to
reduce traffic accidents and deaths and injuries to persons
resulting from traffic accidents,” 15 U. S. C. § 1381 (1988 ed.).
This Court has repeatedly stated that when statutory lan
guage 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 Under
writers 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 alterna
tive conclusion.
Applying “purposes and objectives” pre-emption in Geier,
as in any case, allowed this Court to vacate a judgment is
sued by another sovereign based on nothing more than
assumptions and goals that were untethered from the con
stitutionally enacted federal law authorizing the federal
regulatory standard that was before the Court. See Wat
ters v. Wachovia Bank, N. A., 550 U. S. 1, 44 (2007) (Ste
vens, J., dissenting) (noting that pre-emption “affects the
allocation of powers among sovereigns”). “ ‘[A]n agency lit
erally 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 Lou
isiana 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

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intentions not found within or authorized by the statutory
text. See supra, at 587–588.
The Court’s “purposes and objectives” pre-emption juris
prudence 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 inevita
bly 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., dissent
ing) (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 Rags
dale v. Wolverine World Wide, Inc., 535 U. S. 81, 93–94
(2002). Thus, a statute’s text might reflect a compromise
between parties who wanted to pursue a particular goal to
different extents. See, e. g., ibid. (noting that the Family
and Medical Leave Act’s provision of only 12 workweeks of
yearly leave “was the result of compromise” that must be
given effect by courts); Silkwood v. Kerr-McGee Corp., 464
U. S. 238, 257 (1984) (finding that a state law was not pre
empted though it allegedly frustrated a primary purpose of
the Atomic Energy Act because the Act provided that its
purpose was to be furthered only “to the extent it is consist
ent ‘with the health and safety of the public’ ” (quoting 42
U. S. C. § 2013(d) (1982 ed.))); see also Manning, What Divides
Textualists from Purposivists? 106 Colum. L. Rev. 70, 104
(2006) (“Legislators may compromise on a statute that does
not fully address a perceived mischief, accepting half a loaf to

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Thomas, J., concurring in judgment
facilitate a law’s enactment”). Therefore, there is no factual
basis for the assumption underlying the Court’s “purposes
and objectives” pre-emption jurisprudence that every policy
seemingly consistent with federal statutory text has neces
sarily been authorized by Congress and warrants pre
emptive effect. Instead, our federal system in general, and
the Supremacy Clause in particular, accords pre-emptive ef
fect to only those policies that are actually authorized by and
effectuated through the statutory text.
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 Food, Drug, and Cos
metic Act to enact an express pre-emption provision that
addresses approval of a drug label by the FDA. Ante, at 574.
That “silence on the issue, coupled with [Congress’] certain
awareness of the prevalence of state tort litigation,” the ma
jority reasons, is evidence that Congress did not intend for
federal approval of drug labels to pre-empt state tort judg
ments. Ante, at 575; see also ante, at 574 (construing from
inaction that Congress “[e]vidently [had] determined that
widely available state rights of action provided appropriate
relief ”). Certainly, the absence of a statutory provision
pre-empting all state tort suits related to approved federal
drug labels is pertinent to a finding that such lawsuits are
not pre-empted. But the relevance is in the fact that no
statute explicitly pre-empts the lawsuits, and not in any in
ferences that the Court may draw from congressional silence
about the motivations or policies underlying Congress’ fail
ure to act. See Brown v. Gardner, 513 U. S. 115, 121 (1994)
(“[C]ongressional silence lacks persuasive significance” (in

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Thomas, J., concurring in judgment
ternal quotation marks omitted)); O’Melveny & Myers v.
FDIC, 512 U. S. 79, 85 (1994) (“[M]atters left unaddressed in
[a comprehensive and detailed federal] scheme are presum
ably left subject to the disposition provided by state law”);
Camps Newfound, 520 U. S., at 616 (“[O]ur pre-emption
jurisprudence explicitly rejects the notion that mere con
gressional silence on a particular issue may be read as pre
empting state law”).
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 willing
ness 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, Art. VI, cl. 2—not by extratextual considera
tions of the purposes underlying congressional inaction.
See Hoffman v. Connecticut Dept. of Income Maintenance,
492 U. S. 96, 104 (1989) (plurality opinion) (finding that policy
arguments that “are not based in the text of the statute . . .

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Alito, J., dissenting
are not helpful”); TVA v. Hill, 437 U. S. 153, 194 (1978) (“Our
individual appraisal of the wisdom or unwisdom of a particu
lar course consciously selected by the Congress is to be put
aside in the process of interpreting a statute”). Our role,
then, is merely “to interpret the language of the statute[s]
enacted by Congress.” Barnhart v. Sigmon Coal Co., 534
U. S. 438, 461 (2002).
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, extra
textual, and broad evaluations of the “purposes and objec
tives” embodied within federal law. This, in turn, leads to
decisions giving improperly broad pre-emptive effect to judi
cially 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 accom
plishment and execution of the full purposes and objec
tives” 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 Jus
tice 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 re
sult cannot be reconciled with Geier v. American Honda
Motor Co., 529 U. S. 861 (2000), or general principles of con
flict pre-emption. I respectfully dissent.

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I
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 ad
minister Phenergan. Ante, at 565. But that ignores the
antecedent question of who—the FDA or a jury in Ver
mont—has the authority and responsibility for determining
the “adequacy” of Phenergan’s warnings. Moreover, it is
unclear how a “stronger” warning could have helped re
spondent, 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 Phener
gan’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 ad
ministration,” 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
1 Indeed, respondent conceded below that Wyeth did propose an ade
quate warning of Phenergan’s risks. See Plaintiff Diana Levine’s Memo
randum in Opposition to Wyeth’s Motion for Summary Judgment in Levine
v. American Home Products Corp. (now Wyeth), No. 670–12–01 Wncv
(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 Phen
ergan into an artery . . . ”). The FDA rejected Wyeth’s proposal. See
App. 359.

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Alito, J., dissenting
jury, “I think the drug should be labeled ‘Not for IV use,’ ”
id., at 59; and during his closing argument, respondent’s at
torney told the jury, “Thank God we don’t rely on the FDA
to . . . make the safe[ty] decision. You will make the deci
sion. . . . The FDA doesn’t make the decision, you do,”
id., at 211–212.2
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 gen
eral 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 accord
ance 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 con
flict pre-emption jurisprudence. Brief for United States as
Amicus Curiae 21.
2 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 ben
efits of intravenous administration and the potential for injury to pa
tients.” 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”).
3 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 “ ‘responsibil
ity’ ” for her injury and expressed his “ ‘profoun[d] regre[t]’ ” and “ ‘re
mors[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 assist
ant 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 tes
tify on respondent’s behalf in her suit against Wyeth.

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II
A
To the extent that “[t]he purpose of Congress is the ulti
mate 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 Federal Food, Drug, and Cosmetic Act (FDCA),
a drug manufacturer may not market a new drug before first
submitting a new drug application (NDA) to the FDA and
receiving the agency’s approval. See 21 U. S. C. § 355(a).
An NDA must contain, among other things, “the labeling
proposed to be used for such drug,” § 355(b)(1)(F), “full re
ports of investigations which have been made to show
whether or not such drug is safe for use and whether such
drug is effective in use,” § 355(b)(1)(A), and “a discussion of
why the benefits exceed the risks [of the drug] under the
conditions stated in the labeling,” 21 CFR § 314.50(d)(5)(viii)
(2008). The FDA will approve an NDA only if the agency
finds, among other things, that the drug is “safe for use
under the conditions prescribed, recommended, or suggested
in the proposed labeling thereof,” there is “substantial evi
dence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling
thereof,” and the proposed labeling is not “false or mislead
ing in any particular.” 21 U. S. C. § 355(d).

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608 WYETH v. LEVINE
Alito, J., dissenting
After the FDA approves a drug, the manufacturer remains
under an obligation to investigate and report any adverse
events associated with the drug, see 21 CFR § 314.80, and
must periodically submit any new information that may af
fect the FDA’s previous conclusions about the safety, effec
tiveness, or labeling of the drug, 21 U. S. C. § 355(k). If the
FDA finds that the drug is not “safe” when used in accord
ance with its labeling, the agency “shall” withdraw its ap
proval of the drug. § 355(e). The FDA also “shall” deem a
drug “misbranded” if “it is dangerous to health when used
in the dosage or manner, or with the frequency or dura
tion prescribed, recommended, or suggested in the labeling
thereof.” § 352( j).
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 prod
uct 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 Code of Federal Regulations,
see 21 CFR pt. 201, with seven subparts and 70 separate
sections—that set forth drug manufacturers’ labeling obliga
tions. Under those regulations, the FDA must be satisfied
that a drug’s warning label contains, among other things,
“a summary of the essential scientific information needed for
the safe and effective use of the drug,” § 201.56(1), including
a description of “clinically significant adverse reactions,”
“other potential safety hazards,” “limitations in use imposed
by them . . . , and steps that should be taken if they occur,”
§ 201.57(c)(6)(i). Neither the FDCA nor its implementing
regulations suggest that juries may second-guess the FDA’s
labeling decisions.

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B
1
Where the FDA determines, in accordance with its statu
tory 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 com
mon 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 inter
ests so carefully addressed by” the federal permitting re
gime 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 Inter
state Commerce Commission has struck a “balance” between
competing interests in permitting the abandonment of a rail
road line, a State may not use statutory or common law to
negate it).
Thus, as the Court itself recognizes, it is irrelevant in con
flict pre-emption cases whether Congress “enacted an ex
press 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

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610 WYETH v. LEVINE
Alito, J., dissenting
tion whether they are actually in conflict” (internal quotation
marks omitted)).
2
A faithful application of this Court’s conflict pre-emption
cases compels the conclusion that the FDA’s 40-year-long ef
fort to regulate the safety and efficacy of Phenergan pre
empts respondent’s tort suit. Indeed, that result follows di
rectly from our conclusion in Geier.
Geier arose under the National Traffic and Motor Safety
Vehicle Act of 1966, which directs the Secretary of the De
partment of Transportation (DOT) to “establish by order . . .
motor vehicle safety standards,” 15 U. S. C. § 1392(a) (1988
ed.), which are defined as “minimum standard[s] for motor
vehicle performance, or motor vehicle equipment perform
ance,” § 1391(2). Acting pursuant to that statutory man
date, the Secretary of Transportation promulgated Federal
Motor Vehicle Safety Standard 208, which required car man
ufacturers to include passive restraint systems (i. e., devices
that work automatically to protect occupants from injury
during a collision) in a certain percentage of their cars built
in or after 1987. See 49 CFR § 571.208 (1999). Standard
208 did not require installation of any particular type of pas
sive restraint; instead, it gave manufacturers the option to
install automatic seatbelts, airbags, or any other suitable
technology that they might develop, provided the restraint(s)
met the performance requirements specified in the rule.
Ibid.
Alexis Geier drove her 1987 Honda Accord into a tree, and
although she was wearing her seatbelt, she nonetheless suf
fered serious injuries. She then sued Honda under state
tort law, alleging that her car was negligently and defec
tively 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. 15 U. S. C.
§ 1391(2). She also emphasized that the National Traffic and
Motor Safety Vehicle Act contains a saving clause, which

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611 Cite as: 555 U. S. 555 (2009)
Alito, J., dissenting
provides that “[c]ompliance with any Federal motor vehicle
safety standard issued under this subchapter does not ex
empt any person from any liability under common law.”
§ 1397(k).
Notwithstanding the statute’s saving clause, and notwith
standing the fact that Congress gave the Secretary authority
to set only “minimum” safety standards, we held Geier’s
state tort suit pre-empted. In reaching that result, we re
lied 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 ap
proved alternatives “unsafe” under state tort law.
The same rationale applies here. Through Phenergan’s
label, the FDA offered medical professionals a menu of feder
ally 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 be
cause the FDCA—unlike the National Traffic and Motor
Safety Vehicle Act—contains no evidence that Congress in

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612 WYETH v. LEVINE
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tended the FDA to set only “minimum standards,” and the
FDCA does not contain a saving clause.4 See also ante, at
575 (majority opinion) (conceding Congress’ “silence” on the
issue).
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 spe
cific 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 “effec
tive” when performed in accordance with Phenergan’s label.
The agency’s ultimate decision—to retain IV push as one
4 To be sure, Congress recognized the principles of conflict pre-emption
in the FDCA. See Drug Amendments of 1962, § 202, 76 Stat. 793 (“Noth
ing 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 amend
ments and such provision of State law”). But a provision that simply
recognizes the background principles of conflict pre-emption is not a tradi
tional “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” (em
phasis deleted; citation omitted)).

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Alito, J., dissenting
means for administering Phenergan, albeit subject to strin
gent warnings—is reflected in the plain text of Phenergan’s
label (sometimes in boldfaced font and all-capital letters).
And the record contains ample evidence that the FDA spe
cifically considered and reconsidered the strength of Phener
gan’s IV-push-related warnings in light of new scientific and
medical data. The majority’s factual assertions to the con
trary are mistaken.
1
The FDA’s focus on IV push as a means of administering
Phenergan dates back at least to 1975. In August of that
year, several representatives from both the FDA and Wyeth
met to discuss Phenergan’s warning label. At that meeting,
the FDA specifically proposed “that Phenergan Injection
should not be used in Tubex®.” 2 Record 583, 586 (Plain
tiff ’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 addi
tional 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 injec
tion.” 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 alto
gether. In response to the committee’s recommendations,
the FDA instructed Wyeth to make several changes to

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614 WYETH v. LEVINE
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strengthen Phenergan’s label, including the addition of up
percase warnings related to IV push. See id., at 279–280,
282–283.
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 place
ment.’ ” 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 mate
rials 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 advan
tages and disadvantages of IV drip compared to IV push, as
5 The FDA cited numerous articles that generally discuss the costs and
benefits associated with IV push. See, e. g., Nahrwold & Phelps, Inadver
tent Intra-Arterial Injection of Mephenteramine, 70 Rocky Mountain Med
ical J. 38 (Sept. 1973) (cited in App. 314, no. 14); Albo, Cheung, Ruth, Sny
der, & 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 Barbitu
rate, 23 Anesthesia Progress 25 (1976) (cited in App. 315, no. 19).

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Alito, J., dissenting
well as the costs and benefits of administering Phenergan via
IV push.6 The FDA also cited published case reports from
the 1960’s of gangrene caused by the intra-arterial injection
of Phenergan,7 and the FDA instructed Wyeth to amend
Phenergan’s label in accordance with the latest medical re
search.8 The FDA also studied drugs similar to Phenergan
and cited numerous cautionary articles—one of which urged
the agency to consider contraindicating such drugs for IV
use altogether.9
6 See Webb & Lampert, Accidental Arterial Injections, 101 Am. J. Ob
stetrics & Gynecology 365 (1968) (cited in App. 313, no. 5).
7 See Hager & Wilson, Gangrene of the Hand Following Intra-arterial
Injection, 94 Archives of Surgery 86 (1967) (cited in App. 313, no. 7); Enloe,
Sylvester, & Morris, Hazards of Intra-Arterial Injection of Hydroxyzine,
16 Canadian Anaesthetists’ Society J. 425 (1969) (hereinafter Enloe) (not
ing “recent reports” of “the occurrence of severe necrosis and gangrene
following [administration of] promethazine (Phenergan®)” (cited in App.
314, no. 15)). See also Mostafavi & Samimi, Accidental Intra-arterial In
jection of Promethazine HCl During General Anesthesia, 35 Anesthesiol
ogy 645 (1971) (reporting a case of gangrene, which required partial ampu
tation of three fingers, after Phenergan was inadvertently pushed into an
artery in the “antecubital” area); Promethazine, p. 7, in Clinical Pharma
cology (Gold Standard Multimedia Inc. CD–ROM, version 1.16 (1998)) (not
ing that “[i]nadvertent intra-arterial injection [of Phenergan] can result in
arteriospasm . . . and development of gangrene”).
8 Hager and Wilson noted that the most common reactions to intra
arterial injections of drugs like Phenergan include “[i]mmediate, severe,
burning pain,” as well as “blanching.” 94 Archives of Surgery, at 87–88.
The FDA required Wyeth to include Hager and Wilson’s observations on
Phenergan’s label. See App. 311 (requiring the label to warn that “ ‘[t]he
first sign [of an intra-arterial injection] may be the patient’s reaction to a
sensation of fiery burning’ ” pain and “ ‘[b]lanching’ ”).
9 See Enloe 427 (discussing hydroxyzine—an antihistamine with chemi
cal properties similar to those of Phenergan—and suggesting its “tempo
rary” benefits can never outweigh the risks of intra-arterial injection); see
also Goldsmith & Trieger, Accidental Intra-Arterial Injection: A Medical
Emergency, 22 Anesthesia Progress 180 (1975) (noting the risks of intra
arterial administration of hydroxyzine) (cited in App. 315, no. 18); Klatte,
Brooks, & Rhamy, Toxicity of Intra-Arterial Barbiturates and Tranquilizing
Drugs, 92 Radiology 700 (1969) (same) (cited in App. 314, no. 13). With

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616 WYETH v. LEVINE
Alito, J., dissenting
In “support” of its labeling order, the FDA also cited nu
merous articles that singled out the inner crook of the
elbow—known as the “antecubital fossa” in the medical com
munity—which is both a commonly used injection site, see
id., at 70 (noting that respondent’s injection was pushed into
“the antecubital space”), and a universally recognized high
risk area for inadvertent intra-arterial injections. One of
the articles explained:
“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 misdi
rected injections.” Stone & Donnelly, The Accidental
Intra-arterial Injection of Thiopental, 22 Anesthesiol
full knowledge of those risks, the FDA retained IV push for Phenergan,
although the agency required Wyeth to incorporate observations from the
Enloe article into Phenergan’s label. Compare Enloe 427 (arguing that
“every precaution should be taken to avoid inadvertent intra-arterial in
jection,” including the use of “an obviously well-functioning venoclysis”)
with App. 312 (the FDA’s 1987 changes to Phenergan’s label). In contrast,
at some time around 1970, the FDA prohibited all intravenous use of hy
droxyzine. See id., at 79 (testimony of Dr. Harold Green). The FDA’s
decision to regulate the two drugs differently—notwithstanding (1) the
agency’s knowledge of the risks associated with both drugs and (2) the
agency’s recognition of the relevance of hydroxyzine-related articles and
case reports in its regulation of Phenergan—further demonstrates that
the FDA intentionally preserved IV-push administration for Phenergan.
See also Haas, Correspondence, 33 Anesthesia Progress 281 (1986) (“[Hy
droxyzine’s] restriction does not lie with the medicine itself, but in the
practice and malpractice of intravenous techniques. Unfortunately, the
practitioner who knows how to treat injection technique problems is usu
ally not the practitioner with the intravenous technique problems”).

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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 antecu
bital space for IV push.11
2
When respondent was injured in 2000, Phenergan’s label
specifically addressed IV push in several passages (some
times 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
10 See also Engler, Freeman, Kanavage, Ogden, & Moretz, Production of
Gangrenous Extremities by Intra-Arterial Injections, 30 Am. Surgeon 602
(1964) (“Accidental arterial injection most often occurs in the antecubital
region because this is a favorite site for venopuncture and in this area the
ulnar and brachial arteries are superficial and easily entered” (cited in
App. 313, no. 6)); Engler et al., Gangrenous Extremities Resulting from
Intra-arterial Injections, 94 Archives of Surgery 644 (1966) (similar) (cited
in App. 314, no. 16); Lynas & Bisset, Intra-arterial Thiopentone, 24 Anaes
thesia 257 (1969) (“Most [anesthesiologists] agree that injections on the
medial aspect of the antecubital fossa are best avoided” (cited in App. 314,
no. 8)); Waters, Intra-arterial Thiopentone, 21 Anaesthesia 346 (1966)
(“The risk of producing gangrene of the forearm by accidental injection of
sodium thiopentone into an artery at the elbow has been recognised for
many years” (cited in App. 314, no. 10)); see also Hager & Wilson, 94 Ar
chives of Surgery, at 88 (emphasizing that one of the best ways to prevent
inadvertent intra-arterial injections is to be aware of “aberrant or super
ficial arteries at the antecubital, forearm, wrist, and hand level”); Mosta
favi & Samimi, supra (warning against antecubital injections).
11 See App. 311 (requiring Phenergan’s label to warn that practitioners
should “ ‘[b]eware of the close proximity of arteries and veins at commonly
used injection sites and consider the possibility of aberrant arteries’ ”).
12 “Aspiration” refers to drawing a small amount of blood back into the
needle to determine whether the needle is in an artery or a vein. Ordi
narily, arterial blood is brighter than venous blood—but contact with Phen
ergan causes discoloration, which makes aspiration an unreliable method
of protecting against intra-arterial injection. See id., at 282. Therefore,
the label warned that when using IV push, a medical professional should

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618 WYETH v. LEVINE
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label also cautioned against the use of “syringes with rigid
plungers,” App. 390, which are used only to administer the
drug via IV push. As respondent’s medical expert testified
at trial, “by talking plungers and rigid needles, that’s the
way you do it, to push it with the plunger.” Id., at 53 (testi
mony of Dr. John Matthew). Moreover, Phenergan’s 2000
label devoted almost a full page to discussing the “Tubex
system,” see id., at 391, which, as noted above, is used only
to administer the drug via IV push.
While Phenergan’s label very clearly authorized the use of
IV push, it also made clear that IV push is the delivery
method of last resort. The label specified that “[t]he pre
ferred parenteral route of administration is by deep intra
muscular injection.” Id., at 390. If an intramuscular injec
tion is ineffective, then “it is usually preferable to inject
[Phenergan] through the tubing of an intravenous infusion
set that is known to be functioning satisfactorily.” Ibid.
See also id., at 50–51 (testimony of respondent’s medical ex
pert, Dr. John Matthew) (conceding that the best way to de
termine that an IV set is functioning satisfactorily is to use
IV drip). Finally, if for whatever reason a medical profes
sional chooses to use IV push, he or she is on notice that
“INADVERTENT INTRA-ARTERIAL INJECTION CAN
RESULT IN GANGRENE OF THE A FFECTED EX-
TREMITY.” Id., at 391; see also id., at 390 (“Under no
circumstances should Phenergan Injection be given by
intra-arterial injection due to the likelihood of severe
arteriospasm and the possibility of resultant gangrene”).
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
beware that “[a]spiration of dark blood does not preclude intra-arterial
needle placement, because blood is discolored upon contact with Phener
gan Injection.” Id., at 390.

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treme care should be exercised to avoid perivascular
extravasation or inadvertent intra-arterial injection.
Reports compatible with inadvertent intra-arterial in
jection 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 amputa
tion are likely under such circumstances.” Ibid.
Thus, it is demonstrably untrue that, as of 2000, Phener
gan’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 exten
sive 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 con
clusion that IV push has certain benefits. At trial, her med
ical 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 “retch
ing” and “vomiting,” and when “every possible” alternative
treatment had “failed.” App. 40 (testimony of Dr. John Mat
thew); 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

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620 WYETH v. LEVINE
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CAN RESULT IN GANGRENE OF THE AFFECTED EX-
TREMITY,” id., at 391, and when the FDA required Wyeth
to warn that “[u]nder no circumstances should Phenergan In
jection be given by intra-arterial injection,” id., at 390, the
agency could reasonably assume that medical professionals
would take care not to inject Phenergan intra-arterially.
See also 71 Fed. Reg. 3934 (noting that a drug’s warning
label “communicates to health care practitioners the agency’s
formal, authoritative conclusions regarding the conditions
under which the product can be used safely and effectively”).
Unfortunately, the physician’s assistant who treated respond
ent in this case disregarded Phenergan’s label and pushed
the drug into the single spot on her arm that is most likely
to cause an inadvertent intra-arterial injection.
As noted above, when the FDA approved Phenergan’s
label, it was textbook medical knowledge that the “antecubi
tal 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 rec
ommended” 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 physi
cian’s assistant pushed a double dose of the drug into an ante
cubital artery over the course of “[p]robably about three to
four minutes,” id., at 111; id., at 105, notwithstanding re
13 In addition, respondent’s own medical expert testified at trial that it is
a principle of “basic anatomy” that the antecubital fossa contains aberrant
arteries. See 2 Tr. 34–35 (Mar. 9, 2004) (testimony of Dr. Daniel O’Brien);
see also ibid. (noting that Gray’s Anatomy, which is “the Bible of anatomy,”
also warns of arteries in the antecubital space).

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621 Cite as: 555 U. S. 555 (2009)
Alito, J., dissenting
spondent’s complaints of a “ ‘burn[ing]’ ” sensation that she
subsequently described as “ ‘one of the most extreme pains
that I’ve ever felt,’ ” id., at 110, 180–181. And when asked
why she ignored Phenergan’s label and failed to stop pushing
the drug after respondent complained of burning pains, the
physician’s assistant explained that it would have been “just
crazy” to “worr[y] about an [intra-arterial] injection” under
the circumstances, id., at 111.
The FDA, however, did not think that the risks associated
with IV push—especially in the antecubital space—were
“just crazy.” That is why Phenergan’s label so clearly warns
against them.
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 re
quires turning yesterday’s dissent into today’s majority
opinion.
First, the Court denies the existence of a federal-state con
flict 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 con
cludes 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 dis
sent’s assertions to the contrary), the degree of a State’s in
trusion 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 re
cently as last Term, we held that the Supremacy Clause pre

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622 WYETH v. LEVINE
Alito, J., dissenting
empts a “[s]tate tort law that requires a manufacturer’s cath
eters to be safer, but hence less effective, than the model the
FDA has approved . . . .” Riegel, 552 U. S., at 325. It did
not matter there that the State stopped short of altogether
prohibiting the use of FDA-approved catheters—just as it
does not matter here that Vermont stopped short of alto
gether prohibiting an FDA-approved method for administer
ing Phenergan. See also Lohr, 518 U. S., at 504 (Breyer,
J., concurring in part and concurring in judgment) (noting it
would be an “anomalous result” if pre-emption applied differ
ently to a state tort suit premised on the inadequacy of the
FDA’s safety regulations and a state law that specifically
prohibited an FDA-approved design).
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 rule
making, 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 wel
comes 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 ap
propriate here than in Geier because the FDA (unlike the
DOT) declared its pre-emptive intent in the Federal Regis

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623 Cite as: 555 U. S. 555 (2009)
Alito, J., dissenting
ter. See 71 Fed. Reg. 3933–3936. Yet the majority dis
misses the FDA’s published preamble as “inherently sus
pect,” ante, at 577, and an afterthought that is entitled to
“no weight,” ante, at 581. Cf. Lohr, supra, at 506 (opinion
of Breyer, J.) (emphasizing that the FDA has a “special un
derstanding of the likely impact of both state and federal
requirements, as well as an understanding of whether (or
the extent to which) state requirements may interfere with
federal objectives,” and that “[t]he FDA can translate these
understandings into particularized pre-emptive intentions
. . . through statements in ‘regulations, preambles, interpre
tive statements, and responses to comments’ ”).
Third, the Court distinguishes Geier because the DOT’s
regulation “bear[s] the force of law,” whereas the FDA’s pre
amble 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 21 U. S. C. § 355. It is well within the FDA’s discretion
to make its labeling decisions through administrative adjudi
cations rather than through less formal and less flexible rule
making proceedings, see SEC v. Chenery Corp., 332 U. S. 194
(1947), and we have never previously held that our pre
emption analysis turns on the agency’s choice of the latter
over the former. Moreover, it cannot be said that Geier’s
outcome hinged on the agency’s choice to promulgate a rule.
See ante, at 576, 580–581. The Geier Court relied—again
over the dissenters’ protestations—on materials other than
the Secretary’s regulation to explain the conflict between
state and federal law. Compare 529 U. S., at 881, with
id., at 899–900 (Stevens, J., dissenting), and ante, at 582
(Breyer, J., concurring).
Fourth, the Court sandwiches its discussion of Geier be
tween 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

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624 WYETH v. LEVINE
Alito, J., dissenting
senters in that case) that the “presumption against pre
emption” is relevant to the conflict pre-emption analysis.
See 529 U. S., at 906–907 (Stevens, J., dissenting) (“[T]he
Court simply ignores the presumption [against pre
emption]”). Rather than invoking such a “presumption,”
the Court emphasized that it was applying “ordinary,” “long
standing,” and “experience-proved principles of conflict pre
emption.” Id., at 874. Under these principles, the sole
question is whether there is an “actual conflict” between
state and federal law; if so, then pre-emption follows auto
matically by operation of the Supremacy Clause. Id., at
871–872. See also Buckman, 531 U. S., at 347–348 (“[P]eti
tioner’s dealings with the FDA were prompted by [federal
law], and the very subject matter of petitioner’s statements
[to the FDA] were dictated by [federal law]. Accordingly—
and in contrast to situations implicating ‘federalism concerns
and the historic primacy of state regulation of matters of
health and safety’—no presumption against pre-emption ob
tains in this case” (citation omitted)).14
14 Thus, it is not true that “this Court has long” applied a presumption
against pre-emption in conflict pre-emption cases. Ante, at 566, n. 3 (ma
jority opinion). As long ago as Gibbons v. Ogden, 9 Wheat. 1, 210 (1824),
the Court inquired whether a state law “interfer[ed] with,” was “contrary
to,” or “c[a]me into collision with” federal law—and it did so without ever
invoking a “presumption.” See also Davis, Unmasking the Presumption
in Favor of Preemption, 53 S. C. L. Rev. 967, 974 (2002) (noting that many
of the Court’s early pre-emption cases “resulted in almost automatic pre
emption of concurrent state regulation”). In subsequent years the Court
has sometimes acknowledged a limited “presumption against pre
emption,” but it nonetheless remained an open question—before today—
whether that presumption applied in conflict pre-emption cases. See
Crosby v. National Foreign Trade Council, 530 U. S. 363, 374, n. 8 (2000)
(“We leave for another day a consideration in this context of a presumption
against preemption”). Moreover, this Court has never held that the “pre
sumption” applies in an area—such as drug labeling—that has long been
“reserved for federal regulation.” United States v. Locke, 529 U. S. 89,
111 (2000). See also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U. S.
341, 347–348 (2001).

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625 Cite as: 555 U. S. 555 (2009)
Alito, J., dissenting
Finally, the Geier Court went out of its way to emphasize
(yet again over the dissenters’ objections) that it placed
“some weight” on the DOT’s amicus brief, which explained
the agency’s regulatory objectives and the effects of state
tort suits on the federal regulatory regime. 529 U. S., at
883; cf. id., at 910–911 (Stevens, J., dissenting) (criticiz
ing the majority for “uph[olding] a regulatory claim of
frustration-of-purposes implied conflict pre-emption based
on nothing more than an ex post administrative litigating
position and inferences from regulatory history and final
commentary”). See also Lohr, 518 U. S., at 496 (recognizing
that the FDA is “uniquely qualified” to explain whether state
law conflicts with the FDA’s objectives). Yet today, the
FDA’s explanation of the conflict between state tort suits
and the federal labeling regime, set forth in the agency’s
amicus brief, is not even mentioned in the Court’s opinion.
Instead of relying on the FDA’s explanation of its own regu
latory purposes, the Court relies on a decade-old and now
repudiated statement, which the majority finds preferable.
See ante, at 578, 580, n. 13. Cf. Riegel, 552 U. S., at 327
(noting that “the agency’s earlier position (which the dissent
describes at some length and finds preferable) is . . . compro
mised, indeed deprived of all claim to deference, by the fact
that it is no longer the agency’s position” (citation omitted));
Altria Group, Inc. v. Good, ante, at 89 (rejecting petitioners’
reliance on the pre-emptive effect of the agency’s “longstand
ing policy” because it is inconsistent with the agency’s cur
rent one). And Justice Breyer suggests that state tort
suits may “help the [FDA],” ante, at 581–582 (concurring
opinion), notwithstanding the FDA’s insistence that state
tort suits will “disrupt the agency’s balancing of health risks
and benefits,” Brief for United States as Amicus Curiae 9.
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.

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C
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 prod
uct’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, pa
tients 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 rul
ing, however, parochialism may prevail.
The problem is well illustrated by the labels borne by “ves
icant” 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
15 Vesicants may cause “blistering, severe tissue injury, or tissue necro
sis” upon extravasation—even if the drug is not injected into an artery.
See, e. g., Schulmeister, Administering Vesicants, 9 Clinical J. of Oncology
Nursing 469, 469–470 (2005). See also ante, at 561 (majority opinion) (not
ing that Phenergan is labeled as an “ ‘irritant’ ”); cf. Brief for Anju Budh
wani et al. as Amici Curiae 15 (suggesting Phenergan should be consid
ered a “vesicant”).

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627 Cite as: 555 U. S. 555 (2009)
Alito, J., dissenting
tim of such a tragedy, a jury’s cost-benefit analysis in a par
ticular case may well differ from the FDA’s.
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 ophthal
mologic 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, fol
lowed by 2% sodium thiosulfate solution. Medical at
tention 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.” (Empha
sis added.) Similarly, the FDA-approved labels for other
powerful chemotherapeutic vesicants—including Dactino
mycin, Oxaliplatin, Vinblastine, and Vincristine—specifically
allow IV push, notwithstanding their devastating effects
when extravasated.
16 FDA, Oncology Tools Product Label Details, online at http://www.
accessdata.fda.gov/scripts/cder/onctools/ labels.cfm?GN=meclorethamine,
%20nitrogen%20mustard (as visited Mar. 2, 2009, and available in Clerk of
Court’s case file).
17 Ibid.

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628 WYETH v. LEVINE
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The fact that the labels for such drugs allow IV push is
striking—both because vesicants are much more dangerous
than Phenergan, and also because they are so frequently ex
travasated, see Boyle & Engelking, Vesicant Extravasation:
Myths and Realities, 22 Oncology Nursing Forum 57, 58
(1995) (arguing that the rate of extravasation is “consider
ably higher” than 6.4% of all vesicant administrations). Re
gardless of the FDA’s reasons for not contraindicating IV
push for these drugs, it is odd (to say the least) that a jury
in Vermont can now order for Phenergan what the FDA has
chosen not to order for mustard gas.18
* * *
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.
18 The same is true of the FDA’s regulation of hydroxyzine. See n. 9,
supra.

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629 Cite as: 555 U. S. 555 (2009)
Appendix to opinion of Alito, J.
APPENDIX
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).

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Reporter’s Note
The next page is purposely numbered 801. The numbers between 629
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tions available upon publication of the preliminary prints of the United
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