OPINION OF THE COURT WYETH V. LEVINE 555 U. S. ____ (2009) SUPREME COURT OF THE UNITED STATES NO. 06-1249 WYETH, PETITIONER v. DIANA LEVINE

															on writ of certiorari to the supreme court of
vermont

															[March 4, 2009]

															   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 question we must decide is whether the
FDA’s approvals provide 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 hydrochloride, an antihistamine used to treat
nausea. The injectable form of Phenergan can be administered
intramuscularly or intravenously, and it can be administered
intravenously through either the “IV-push” method, whereby the drug
is injected directly into a patient’s vein, or the “IV-drip”
method, whereby the drug is introduced into a saline solution in a
hanging intravenous bag and slowly descends through a catheter
inserted in a patient’s vein. The drug is corrosive and causes
irreversible gangrene if it enters a patient’s artery.

															   Levine’s injury resulted from an
IV-push injection of Phenergan. On April 7, 2000, as on previous
visits to her local clinic for treatment of a migraine headache,
she received an intramuscular injection of Demerol for her headache
and Phenergan for her nausea. Because the combination did not
provide relief, she returned later that day and received a second
injection of both drugs. This time, the physician assistant
administered the drugs by the IV-push method, and Phenergan entered
Levine’s artery, either because the needle penetrated an artery
directly or because the drug escaped from the vein into surrounding
tissue (a phenomenon called “perivascular extravasation”) where it
came in contact with arterial blood. As a result, Levine developed
gangrene, and doctors amputated first her right hand and then her
entire forearm. In addition to her pain and suffering, Levine
incurred substantial medical expenses and the loss of her
livelihood as a professional musician.

															   After settling claims against the health
center and clinician, Levine brought an action for damages against
Wyeth, relying on common-law negligence and strict-liability
theories. Although Phenergan’s labeling warned of the danger of
gangrene and amputation following inadvertent intra-arterial
injection,[ Footnote 1 ] Levine
alleged that the labeling was defective 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 administration 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 conflict
pre-emption argument. With respect to the contention that there was
an “actual conflict between a specific FDA order,” id. , at
21, and Levine’s failure-to-warn action, the court reviewed the
sparse correspondence between Wyeth and the FDA about Phenergan’s
labeling and found no evidence 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 extravasation can be almost entirely eliminated
through the use of IV-drip, rather than IV-push, administration. An
IV drip is started with saline, which will not flow properly if the
catheter is not in the vein and fluid is entering an artery or
surrounding tissue. See id ., at 50–51, 60, 66–68, 75. By
contrast, even a careful and experienced clinician using the
IV-push method will occasionally expose an artery to Phenergan. See id ., at 73, 75–76. While Phenergan’s labeling warned
against intra-arterial injection and perivascular extravasation and
advised that “[w]hen administering any irritant drug intravenously
it is usually preferable to inject it through the tubing of an
intravenous infusion set that is known to be function- ing
satisfactorily,” id. , at 390, the labeling did not con-
tain a specific warning about the risks of IV-push
administration.

															   The trial record also contains correspondence
between Wyeth and the FDA discussing Phenergan’s label. The FDA
first approved injectable Phenergan in 1955. In 1973 and 1976,
Wyeth submitted supplemental new drug applications, which the
agency approved after proposing labeling changes. Wyeth submitted a
third supplemental application in 1981 in response to a new FDA
rule governing drug labels. Over the next 17 years, Wyeth and the
FDA intermittently corresponded about Phenergan’s label. The most
notable activity occurred in 1987, when the FDA suggested different
warnings about the risk of arterial exposure, and in 1988, when
Wyeth submitted revised labeling incorporating the 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 approved Wyeth’s 1981 application
in 1998, instructing that Phenergan’s final printed label “must be
identical” to the approved package insert. Id ., at
382.

															   Based on this regulatory history, the trial
judge instructed the jury that it could consider evidence of
Wyeth’s compliance with FDA requirements but that such compliance
did not establish that the warnings were adequate. He also
instructed, without objection from Wyeth, that FDA regulations
“permit a drug manufacturer to change a product label to add or
strengthen a warning about its product without prior FDA approval
so long as it later submits the revised warning for review and
approval.” Id ., at 228.

															   Answering questions on a special verdict form,
the jury found that Wyeth was negligent, that Phenergan was a
defective product as a result of inadequate warnings and
instructions, and that no intervening cause had broken the causal
connection between the product defects and the plaintiff’s injury. Id ., at 233–235. It awarded total damages of $7,400,000,
which the court reduced to account for Levine’s earlier settlement
with the health center and clinician. Id. , at 235–236.

															   On August 3, 2004, the trial court filed a
comprehensive opinion denying Wyeth’s motion for judgment as a
matter of law. After making findings of fact based on the trial
record (supplemented by one letter that Wyeth found after the
trial), the court rejected Wyeth’s pre-emption arguments. It
determined that there was no direct conflict between FDA
regulations and Levine’s state-law claims because those regulations
permit strengthened warnings without FDA approval on an interim
basis and the record contained evidence 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 question whether to warn against IV-push
administration of Phenergan. 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
requirements for Phenergan because [Wyeth] could have warned
against IV-push administration without prior FDA approval, and
because federal labeling requirements create a floor, not a
ceiling, for state regulation.” ___ Vt. ___, ___ 944 A. 2d
179, 184 (2006). In dissent, Chief Justice Reiber argued that the
jury’s verdict conflicted with federal law because it was
inconsistent with the FDA’s conclusion that intravenous
administration of Phenergan was safe and effective.

															   The importance of the pre-emption issue,
coupled with the fact that the FDA has changed its position on
state tort law and now endorses the views expressed in Chief
Justice Reiber’s dissent, persuaded us to grant Wyeth’s petition
for certiorari. 552 U. S. ___ (2008). The question presented by the
petition is whether the FDA’s drug labeling judgments “preempt
state law product liability claims premised on the theory that
different labeling judgments were necessary to make drugs
reasonably safe for use.” Pet. for Cert. i. II Wyeth makes two separate
pre-emption arguments: first, that it would have been impossible
for it to comply with the state-law duty to modify Phenergan’s
labeling without violating federal law, see Fidelity Fed. Sav.
& Loan Assn. v. De la Cuesta , 458 U. S. 141 , 153
(1982), and second, that recognition of Levine’s state tort action
creates an unacceptable “obstacle to the accomplishment and
execution of the full purposes and objectives of Congress,” Hines v. Davidowitz , 312 U. S. 52 , 67 (1941),
because it substitutes a lay jury’s decision about drug labeling
for the expert judgment of the FDA. As a preface to our evaluation
of these arguments, we identify 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 injury would not have occurred if
Phenergan’s label had included an adequate warning about the risks
of the IV-push method of administering the drug. The record
contains evidence that the physician assistant administered a
greater dose than the label prescribed, that she may have
inadvertently injected the drug into an artery rather than a vein,
and that she continued to inject the drug after Levine complained
of pain. Nevertheless, the jury rejected Wyeth’s argument that the
clinician’s conduct was an intervening cause that absolved it of
liability. See App. 234 (jury verdict), 252–254. In finding Wyeth
negligent as well as strictly liable, the jury also determined that
Levine’s injury was foreseeable. That the inadequate label was both
a but-for and proximate cause of Levine’s injury is supported by
the record and no longer challenged by Wyeth.[ Footnote 2 ]

															   The trial court proceedings further
established that the critical defect in Phenergan’s label was the
lack of an adequate warning about the risks of IV-push
administration. Levine also offered evidence that the IV-push
method should be contraindicated and that Phenergan should never be
administered intravenously, even by the IV-drip method. Perhaps 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 8, 25. But, as the Vermont
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.” ___ Vt., at ___, n. 2,
944 A. 2d, at 189, n. 2. We therefore need not decide
whether a state rule proscribing 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 cornerstones of our pre-emption jurisprudence. First, “the
purpose of Congress is the ultimate touchstone in every pre-emption
case.” Medtronic, Inc. v. Lohr , 518 U. S. 470 , 485 (1996) (internal
quotation marks omitted); see Retail Clerks v. Schermerhorn , 375 U. S. 96 , 103 (1963).
Second, “[i]n all pre-emption cases, and particularly in those in
which Congress has ‘legislated … in a field which the States have
traditionally occupied,’ … we ‘start with the assumption that the
historic police powers of the States were not to be superseded by
the Federal Act unless that was the clear and manifest purpose of
Congress.’ ” Lohr , 518 U. S., at 485 (quoting Rice v. Santa Fe Elevator Corp ., 331 U. S. 218 , 230
(1947)).[ Footnote 3 ]

															   In order to identify the “purpose of
Congress,” it is appropriate 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 misbranded
drugs, supplemented the protection for consumers already provided
by state regulation and common-law liability. 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 Act’s most substantial
innovation was its provision for premarket approval of new drugs.
It required every manufacturer 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.

															   In 1962, Congress amended the FDCA and shifted
the burden 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(d), 104(b), 76 Stat. 781, 784. In
addition, the amendments required the manufacturer to prove the
drug’s effectiveness 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 suggested
in the proposed labeling.” §102(d), 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,
indicating 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. ___, ___
(2008) (slip op., at 8) (Ginsburg, J., dissenting); see ibid. , n. 11 (collecting state cases). And when
Congress enacted an express pre-emption provision for medical
devices in 1976, see §521, 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 manufacturer to
change its drug label based on safety information 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 required the FDA to
preapprove all changes to drug labels. See S. 1082, 110th
Cong., 1st Sess., §208, pp. 107–114 (2007) (as passed)
(proposing new §506D). Instead, it adopted a rule of construction
to make it clear that manufacturers remain 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
includes 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 approval.
§§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 manufacturer may only change its label “to reflect
newly acquired information.” 73 Fed. Reg. 49609. Resting on this
language (which Wyeth argues simply reaffirmed the interpretation
of the regulation in effect when this case was tried), Wyeth
contends that it could have changed Phenergan’s label only in
response to new information that the FDA had not considered. And it
maintains that Levine has not pointed to any such information
concerning the risks of IV-push administration. Thus, Wyeth
insists, it was impossible for it to discharge its state-law
obligation to provide a stronger warning about IV-push
administration without violating federal 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 accordance with the
amended regulation. As the FDA explained in its notice of the final
rule, “ ‘newly acquired information’ ” is not limited to
new data, but also encompasses “new analyses of previously
submitted data.” Id. , at 49604. The rule accounts for the
fact that risk information accumulates over time and that the same
data may take on a different meaning in light of subsequent
developments: “[I]f the sponsor submits adverse event information
to FDA, and then later conducts a new analysis of data showing
risks of a different type or of greater severity or frequency than
did reports previously submitted to FDA, the sponsor meets the
requirement for ‘newly acquired information.’ ” Id. ,
at 49607; see also id. , at 49606.

															   The record is limited concerning what newly
acquired information Wyeth had or should have had about the risks
of IV-push administration of Phenergan because Wyeth did not argue
before the trial court that such information was required for a CBE
labeling change. Levine did, however, present evidence of at least
20 incidents prior to her injury in which a Phenergan injection
resulted in gangrene and an amputation. See App. 74, 252.[ Footnote 4 ] After the first such
incident came to Wyeth’s attention in 1967, it notified the FDA and
worked with the agency to change Phenergan’s label. 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 warning, it would have violated federal law governing
unauthorized distribution and misbranding. Its argument that a
change in Phenergan’s labeling would have subjected it to liability
for unauthorized distribution rests on the assumption that this
labeling change would have rendered Phenergan a new drug lacking an
effective application. But strengthening the warning about IV-push
administration would not have made Phenergan a new drug. See 21 U.
S. C. §321(p)(1) (defining “new drug”); 21 CFR §310.3(h). Nor
would this warning have rendered Phenergan misbranded. The FDCA
does not provide that a drug is misbranded simply because the
manufacturer has altered an FDA-approved label; instead, the
misbranding provision focuses 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 contemplates 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 responsibility 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 manufacturer 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 provides 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)” (emphasis 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 retains
such authority in reviewing all supplemental applications. But
absent clear evidence that the FDA would not have approved a change
to Phenergan’s label, we will not conclude that it was impossible
for Wyeth to comply with both federal and state requirements. 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.[ Footnote 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 Phenergan’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 administration.
App. 249. The Vermont Supreme Court likewise concluded 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 administration. ___ Vt., at ___, 944 A. 2d, at
188–189. Moreover, Wyeth does not argue that it supplied the FDA
with an evaluation 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
adding a stronger warning about the IV-push method of intravenous
administration.[ Footnote
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 “Congress’s
purpose to entrust an expert agency to make drug labeling decisions
that strike a balance between competing objectives.” Brief for
Petitioner 46. We find no merit in this argument, which relies on
an untenable interpretation of congressional intent and an
overbroad view of an agency’s power to pre-empt state
law. Wyeth contends that the FDCA establishes both
a floor and a ceiling for drug regulation: Once the FDA has
approved 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 evidence of Congress’
purposes is to the contrary. Building on its 1906 Act, Congress
enacted the FDCA to bolster consumer protection against harmful
products. See Kordel v. United States , 335 U. S. 345 , 349
(1948); United States v. Sullivan , 332 U. S. 689 , 696
(1948). Congress did not provide a federal remedy for consumers
harmed by unsafe or ineffective drugs in the 1938 statute or in any
subsequent amendment. Evidently, it determined that widely
available state rights of action provided appropriate relief for
injured consumers.[ Footnote 7 ]
It may also have recognized that state-law remedies further
consumer protection by motivating manufacturers 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 §521, 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 ___ (slip
op., at 14) (“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 devices”).[ Footnote 8 ] Its silence on the issue, coupled
with its certain awareness of the prevalence of state tort
litigation, is powerful evidence that Congress did not intend FDA
oversight to be the exclusive means of ensuring drug safety and
effectiveness. As Justice O’Connor explained in her opinion for a
unanimous Court: “The case for federal pre-emption is particularly
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 8 (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 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 Laboratories , Inc., 471 U. S. 707 , 713 (1985). In such
cases, the Court has performed its own conflict determination,
relying on the substance of state and federal law and not on agency
proclamations of pre-emption. We are faced with no such regulation
in this case, but rather with an agency’s mere assertion that state
law is an obstacle to achieving its statutory objectives. Because
Congress has not authorized the FDA to pre-empt state law directly,
cf. 21 U. S. C. §360k (authorizing the FDA to determine the
scope of the Medical Devices Amendments’ pre-emption
clause),[ Footnote 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 history and background are complex
and extensive.” Geier , 529 U. S., at 883. Even in such
cases, however, we have not deferred to an agency’s conclusion that state law is pre-empted. Rather, we have
attended to an agency’s explanation of how state law affects the
regulatory scheme. While 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 accomplishment 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 persuasiveness. 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 proposed rulemaking in December 2000,
it explained that the rule would “not contain policies that have
federalism implications or that preempt State law.” 65 Fed. Reg.
81103; see also 71 id. , at 3969 (noting that the “proposed
rule did not propose to preempt state law”). In 2006, the agency
finalized the rule and, without offering States or other interested
parties notice or opportunity for comment, articulated a sweeping
position on the FDCA’s pre-emptive effect in the regulatory
preamble. The agency’s views on state law are inherently suspect in
light of this procedural failure. Further,
the preamble is at odds with what evidence we have of Congress’
purposes, and it reverses the FDA’s own longstanding position
without providing a reasoned explanation, including any discussion
of how state law has interfered with the FDA’s regulation of drug
labeling during decades of coexistence. The FDA’s 2006 position
plainly does not reflect the agency’s own view at all times
relevant to this litigation. Not once prior to Levine’s injury did
the FDA suggest that state tort law stood as an obstacle to its
statutory mission. To the contrary, it cast federal labeling
standards as a floor upon which States could build and repeatedly
disclaimed 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 development of
standards that would be at odds with the agency’s regulations.” 63 id. , at 66384. It further noted that, in establishing
“minimal standards” for drug labels, it did not intend “to preclude
the states from imposing additional labeling requirements.” Ibid .[ Footnote
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 regulation. The FDA has limited
resources to monitor the 11,000 drugs on the market,[ Footnote 11 ] and manufacturers have
superior access to information about their drugs, especially in the
postmarketing phase as new risks emerge. State tort suits uncover
unknown drug hazards and provide incentives for drug manufacturers
to disclose safety risks promptly. They also serve a distinct
compensatory function that may motivate injured persons to come
forward with information. Failure-to-warn actions, in particular,
lend force to the FDCA’s premise that manufacturers, not the FDA,
bear primary responsibility for their drug labeling at all times.
Thus, the FDA long maintained that state law offers an additional,
and important, layer of consumer protection that complements FDA
regulation.[ Footnote 12 ] The
agency’s 2006 preamble represents a dramatic change in
position. Largely
based on the FDA’s new position, Wyeth argues that this case
presents a conflict between state and federal law analogous to the
one at issue in Geier . There, we held that state tort
claims premised on Honda’s failure to install airbags conflicted
with a federal regulation that did not require airbags for all
cars. The Department of Transportation (DOT) had promulgated a rule
that provided car manufacturers with a range of choices among
passive restraint devices. Geier , 529 U. S., at 875.
Rejecting an “ ‘all airbag’ ” standard, the agency had
called for a gradual phase-in of a mix of passive restraints in
order to spur technological development and win consumer
acceptance. Id., at 879. Because the plaintiff’s claim was
that car manufacturers had a duty to install airbags, it presented
an obstacle to achieving “the variety and mix of devices that the
federal regulation sought.” Id. , at
881. Wyeth and
the dissent contend that the regulatory scheme in this case is
nearly identical, but, as we have described, it is quite different.
In Geier , the DOT conducted a formal rulemaking and then
adopted a plan to phase in a mix of passive restraint devices.
Examining the rule itself and the DOT’s contemporaneous record,
which revealed the factors the agency had weighed and the balance
it had struck, we determined that state tort suits presented an
obstacle to the federal scheme. After conducting our own
pre-emption analysis, we considered the agency’s explanation of how
state law interfered with its regulation, regarding it as further
support for our independent conclusion that the plaintiff’s tort
claim obstructed the federal regime. By
contrast, we have no occasion in this case to consider the
pre-emptive effect of a specific agency regulation bearing the
force of law. And the FDA’s newfound opinion, expressed in its 2006
preamble, that state law “frustrate[s] the agency’s implementation
of its statutory mandate,” 71 Fed. Reg. 3934, does not merit
deference for the reasons we have explained.[ Footnote 13 ] Indeed, the “complex and
extensive” regulatory history and background relevant to this case, Geier , 529 U. S., at 883, undercut the FDA’s recent
pronouncements of pre-emption, as they reveal the longstanding
coexistence of state and federal law and the FDA’s traditional
recognition of state-law remedies—a recognition in place each time
the agency reviewed Wyeth’s Phenergan label.[ Footnote 14 ] In short,
Wyeth has not persuaded us that failure-to-warn claims like
Levine’s obstruct the federal regulation of drug labeling. Congress
has repeatedly declined to pre-empt state law, and the FDA’s
recently adopted position that state tort suits interfere with its
statutory mandate is entitled to no weight. Although we recognize
that some state-law claims might well frustrate the achievement of
congressional objectives, this is not such a
case. V We conclude that it is not impossible for
Wyeth to comply with its state and federal law obligations and that
Levine’s common-law claims do not stand as an obstacle to the
accomplishment of Congress’ purposes in the FDCA. Accordingly, the
judgment of the Vermont Supreme Court is
affirmed. It is so
ordered. Footnote 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 perivascular extravasation or inadvertent
intra-arterial injection. Reports compatible with inadvertent
intra-arterial injection of Phenergan Injection, usually in
conjunction with other drugs intended for intravenous use, suggest
that pain, severe chemical irritation, severe spasm of distal
vessels, and resultant gangrene requiring amputation are likely
under such circumstances. Intravenous injection was intended in all
the cases reported but perivascular extravasation or arterial
placement of the needle is now suspect. There is no proven
successful management of this condition 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 provide
for evaluation of possible arterial placement or perivascular
extravasation.” App. 390. Footnote 2 The
dissent nonetheless suggests that physician malpractice was the
exclusive cause of Levine’s injury. See, e.g. , post , at 1 (opinion of Alito, J.) (“[I]t is unclear how a
‘stronger’ warning could have helped respondent”); post ,
at 16–18 (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. Footnote 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 “independent sovereigns in our federal system” leads us
to assume that “Congress does not cavalierly pre-empt state-law
causes of action.” Medtronic, Inc. v. Lohr , 518 U. S. 470 , 485 (1996). 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 21, but this Court has long held to the contrary.
See, e.g. , California v. ARC America
Corp. , 490 U. S.
93 , 101–102 (1989); Hillsborough 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 21, and n. 14, is especially curious, 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. Footnote 4 Levine
also introduced evidence that Pfizer had withdrawn Vistaril,
another antinausea drug, from intravenous use several decades
earlier because its intravenous injection had resulted in gangrene
and amputations. See App. 79. Footnote 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 App. 339–341, 311–312. When the FDA approved Wyeth’s
application, 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 administration. 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 ___ Vt. ___,
___, 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 ___ Vt., at ___, 944 A. 2d, at
189. Footnote 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
conflating warnings about IV-push administration and intra-arterial
injection, see, e.g. , post , at 9, 11–12, 15–16—to
suggest greater agency attention to the question, and it undertakes
a study of Phenergan’s labeling that is more elaborate than any FDA
order. But even the dissent’s account does not support the
conclusion that the FDA would have prohibited Wyeth from adding a
stronger warning pursuant to the CBE
regulation. Footnote 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”). Footnote 8 In 1997,
Congress pre-empted certain state requirements concerning
over-the-counter medications and cosmetics but expressly preserved
product 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”). Footnote 9 For
similar examples, see 47 U. S. C. §§253(a), (d) (2000 ed.)
(authorizing 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 requirements of
this chapter” and permitting the Secretary of the Interior to “set
forth any State law or regulation which is preempted and
superseded”); 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). Footnote 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 protection”); 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). Footnote 11 In 1955,
the same year that the agency approved Wyeth’s Phenergan
application, an FDA advisory committee issued a report finding
“conclusively” that “the budget and staff of the Food and Drug
Administration are inadequate to permit the discharge of its
existing responsibilities for the protection of the American
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 conclusions. 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%20Sci
ence%20and%20Technology.pdf (all Internet materials 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”); National Academies, Institute of Medicine, The
Future of Drug Safety: Promoting 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 postmarketing drug safety
work are especially inadequate and that resource limitations have
hobbled the agency’s ability to improve and expand this essential
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
providing management oversight of, postmarket safety issues”); see
also House Committee on Oversight and Government Reform, Majority
Staff Report, 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”). Footnote 12 See
generally Brief for Former FDA Commissioners Drs. Donald Kennedy
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). Footnote 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 id. , at
861, the Government’s explanation of federal drug regulation
departs markedly from the FDA’s understanding at all times relevant
to this case. Footnote 14 Wyeth’s
more specific contention—that this case resembles Geier because the FDA determined that no additional warning on IV-push
administration was needed, thereby setting a ceiling on Phenergan’s
label—is belied 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”). 555 U. S. ____ (2009) WYETH V. LEVINE 555 U. S. ____ (2009) SUPREME COURT OF THE UNITED STATES NO. 06-1249 WYETH, PETITIONER v. DIANA LEVINE

															on writ of certiorari to the supreme court of
vermont

															[March 4, 2009]

															   Justice Breyer, concurring.

															   I write separately to emphasize
the Court’s statement that “we have no occasion in this case to
consider the pre-emptive effect of a specific agency regulation
bearing the force of law.” Ante , at 24. State tort law
will sometimes help the Food and Drug Administration (FDA) “uncover
unknown drug hazards and [encourage] drug manufacturers to disclose
safety risks.” Ante , at 23. But it is also possible that
state tort law will sometimes interfere with the FDA’s desire to
create a drug label containing a specific set of cautions and
instructions. I also note that some have argued that state tort law
can sometimes raise prices to the point where those who are sick
are unable to obtain the drugs they need. See Lasagna, The Chilling
Effect of Product Liability on New Drug Development, in The
Liability Maze 334, 335–336 (P. Huber & R. Litan eds. 1991).
The FDA may seek to determine whether and when state tort law acts
as a help or a hindrance to achieving the safe drug-related medical
care that Congress sought. Medtronic, Inc. v. Lohr , 518
U. S. 470 , 506 (1996) (Breyer, J., concurring in part and
concurring in judgment); cf. Bates v. Dow Agrosciences
LLC , 544 U. S.
431 , 454–455 (2005) (Breyer, J., concurring). It may seek to
embody those determinations in lawful specific regulations
describing, for example, when labeling requirements serve as a
ceiling as well as a floor. And it is possible that such
determinations would have pre-emptive effect. See Lohr , supra , at 505 (opinion of Breyer, J.) (citing Hillsborough County v. Automated Medical Laboratories,
Inc. , 471 U. S.
707 (1985)). I agree with the Court, however, that such a
regulation is not at issue in this case. THOMAS, J., CONCURRING IN JUDGMENT WYETH V. LEVINE 555 U. S. ____ (2009) SUPREME COURT OF THE UNITED STATES NO. 06-1249 WYETH, PETITIONER v. DIANA LEVINE

															on writ of certiorari to the supreme court of
vermont

															[March 4, 2009]

															   Justice Thomas, concurring in the
judgment.

															   I agree with the Court that the
fact that the Food and Drug Administration (FDA) approved the label
for petitioner Wyeth’s drug Phenergan does not pre-empt the
state-law judgment before the Court. That judgment was based on a
jury finding that the label did not adequately warn of the risk
involved in administering Phenergan through the IV-push injection
method. Under federal law, without prior approval from the FDA,
Wyeth could have “add[ed] or strengthen[ed]” information on its
label about “a contraindication, warning, precaution, or adverse
reaction,” 21 CFR §314.70(c)(6)(iii)(A) (2008), or “about dosage
and administration that is intended to increase the safe use of the
drug product,” §314.70(c)(6)(iii)(C), in order to “reflect newly
acquired information,” including “new analyses of previously
submitted data,” about the dangers of IV-push administration of
Phenergan, 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 approved by the FDA. In addition,
federal law does not give drug manufacturers an unconditional right
to market their federally approved drug at all times with the
precise label initially approved by the FDA. The Vermont court’s
judgment in this case, therefore, did not directly conflict with
federal law and is not pre-empted.

															   I write separately, however, because I cannot
join the majority’s implicit endorsement of far-reaching implied
pre-emption doctrines. In particular, I have become increasingly
skeptical of this Court’s “purposes and objectives” pre-emption
jurisprudence. Under this approach, the Court routinely invalidates
state laws based on perceived conflicts with broad federal policy
objectives, legislative history, or generalized notions of
congressional purposes that are not embodied within the text of
federal law. Because implied pre-emption doctrines that wander far
from the statutory text are inconsistent with the Constitution, I
concur only in the judgment.

															I

															A

															   In order “to ensure the
protection of our fundamental liberties,” Atascadero State
Hospital v. Scanlon , 473 U. S. 234 , 242
(1985) (internal quotation marks omitted), the “Constitution
establishes a system of dual sovereignty between the States and the
Federal Government.” Gregory v. Ashcroft , 501 U. S. 452 ,
457 (1991). The Framers adopted this “ ‘constitutionally
mandated balance of power,’ ” Atascadero State
Hospital , supra , at 242, to “reduce the risk of
tyranny and abuse from either front,” because a “federalist
structure of joint sovereigns preserves to the people numerous
advantages,” such as “a decentralized government that will be more
sensitive to the diverse needs of a heterogeneous society” and
“increase[d] opportunity for citizen involvement in democratic
processes,” Gregory , supra , at 458 . Furthermore, as the Framers observed, the “compound republic of
America” provides “a double security … to the rights of the people”
because “the power surrendered by the people is first divided
between two distinct governments, and then the portion allotted to
each subdivided among distinct and separate departments.” The
Federalist No. 51, p. 266 (M. Beloff ed., 2d ed. 1987).

															   Under this federalist system,
“the States possess sovereignty concurrent with that of the Federal
Government, subject only to limitations imposed by the Supremacy
Clause.” Tafflin v. Levitt , 493 U. S. 455 , 458
(1990). In this way, the Supremacy Clause gives the Federal
Government “a decided advantage in [a] delicate balance” between
federal and state sovereigns. Gregory , 501 U. S., at 460.
“As long as it is acting within the powers granted it under the
Constitution, Congress may impose its will on the States.” Ibid. That is an “extraordinary power in a federalist
system.” Ibid. Nonetheless, the States retain
substantial sovereign authority. U. S. Const., Amdt. 10 (“The
powers not delegated to the United States by the Constitution, nor
prohibited by it to the States, are reserved to the States
respectively, or to the people”); see also Alden v. Maine , 527
U. S. 706 , 713 (1999); Printz v. United
States , 521 U.
S. 898 , 918–922 (1997); New York v. United
States , 505 U.
S. 144 , 155–156 (1992); Gregory , supra , at
457–459; Tafflin , supra , at 458. In accordance
with the text and structure of the Constitution, “[t]he powers
delegated by the proposed constitution to the federal government,
are few and defined” and “[t]hose which are to remain in the state
governments, are numerous and indefinite.” The Federalist No. 45,
at 237–238. Indeed, in protecting our constitutional government,
“the preservation of the States, and the maintenance of their
governments, are as much within the design and care of the
Constitution as the preservation of the Union and the maintenance
of the National government.” Texas v. White , 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 Treaties
made, or which shall be made, under the Authority of the United
States, shall be the supreme Law of the Land; and the Judges in
every State shall be bound thereby, any Thing in the Constitution
or Laws of any state to the Contrary notwithstanding.” Art. VI,
cl. 2.

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

															   Federal laws “made in Pursuance” of the
Constitution must comply with two key structural limitations in the
Constitution that ensure that the Federal Government does not amass
too much power at the expense of the States. The first structural
limitation, which the parties have not raised in this case, is “the
Constitution’s conferral upon Congress of not all governmental
powers, but only discrete, enumerated ones.” Printz , supra , at 919; see also United States v. Morrison , 529 U. S. 598 , 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”).[ Footnote 1 ]

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

															B

															   In light of these constitutional
principles, I have become “increasing[ly] reluctan[t] to expand
federal statutes beyond their terms through doctrines of implied
pre-emption.” Bates v. Dow Agrosciences LLC , 544 U. S. 431 ,
459 (2005) (Thomas, J., concurring in judgment in part and
dissenting in part). My review of this Court’s broad implied
pre-emption precedents, particularly its “purposes and objectives”
pre-emption jurisprudence, has increased my concerns that implied
pre-emption doctrines have not always been constitutionally
applied. Under the vague and “potentially boundless” doctrine of
“purposes and objectives” pre-emption, Geier v. American Honda Motor Co. , 529 U. S. 861 , 907 (2000) (Stevens,
J., dissenting), for example, the Court has pre-empted state law
based on its interpretation of broad federal policy objectives,
legislative history, or generalized notions of congressional
purposes that are not contained within the text of federal law.
See, e.g. , Pharmaceutical Research and Mfrs. of
America v. Walsh , 538 U. S. 644 , 678
(2003) (Thomas, J., concurring in judgment) (referring to the
“concomitant danger of invoking obstacle pre-emption based on the
arbitrary selection of one purpose to the exclusion of others”); Crosby v. National Foreign Trade Council , 530 U. S. 363 ,
388–391 (2000) (Scalia, J., concurring in judgment) (criticizing
the majority’s reliance on legislative history to discern statutory
intent when that intent was “perfectly obvious on the face of th[e]
statute”); Geier , supra , at 874–883 (relying on
regulatory history, agency comments, and the Government’s
litigating position to determine that federal law pre-empted state
law).

															   Congressional and agency musings,
however, do not satisfy the Art. I, §7 requirements for
enactment of federal law and, therefore, do not pre-empt state law
under the Supremacy Clause. When analyzing the pre-emptive effect
of federal statutes or regulations validly promulgated thereunder,
“[e]vidence of pre-emptive purpose [must be] sought in the text and
structure of the [provision] at issue” to comply with the
Constitution. CSX Transp., Inc. v. Easterwood , 507 U. S. 658 ,
664 (1993); see also New York v. FERC , 535 U. S. 1 , 18 (2002)
(“[A] federal agency may pre-empt state law only when and if it is
acting within the scope of its congressional delegated authority …
[for] an agency literally has no power to act, let alone pre-empt
the validly enacted legislation of a sovereign State, unless and
until Congress confers power upon it” (internal quotation marks
omitted; second alteration in original)); Camps
Newfound/Owatonna, Inc. v. Town of Harrison , 520 U. S. 564 , 617 (1997) (Thomas, J.,
dissenting) (noting that “treating unenacted congressional intent
as if it were law would be constitutionally dubious”). Pre-emption
analysis should not be “a freewheeling judicial inquiry into
whether a state statute is in tension with federal objectives, but
an inquiry into whether the ordinary meanings of state and federal
law conflict.” Bates , supra , at 459
(Thomas, J., concurring in judgment in part and dissenting in
part) (internal quotation marks and citation omitted); see also Geier , supra , at 911 (Stevens., J., dissenting)
(“[P]re-emption analysis is, or at least should be, a matter of
precise statutory [or regulatory] construction rather than an
exercise in free-form judicial policymaking” (internal quotation
marks omitted)). Pre-emption must turn on whether state law
conflicts with the text of the relevant federal statute or with the
federal regulations authorized by that text. See Foster v. Love , 522 U.
S. 67 , 71 (1997) (finding that conflict pre-emption question
“turn[ed] entirely on the meaning of the state and federal
statutes” at issue before the Court); see also New York v. FERC, supra , at 19.

															II

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

															A

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

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

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

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

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

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

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

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

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

															B

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

															1

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

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

															   Justice Stone, in dissent, questioned the
majority’s decision to read an exclusive registration system for
aliens into a statute that did not specifically provide such
exclusivity. See id. , at 75. He noted his concern that
state power would be improperly diminished through a pre-emption
doctrine driven by the Court’s “own conceptions of a policy which
Congress ha[d] not expressed and which is not plainly to be
inferred from the legislation which it ha[d] enacted.” Ibid. In his view, nothing that Congress enacted had
“denie[d] the states the practicable means of identifying their
alien residents and of recording their whereabouts.” Id. ,
at 78. Yet, the Hines majority employed pre-emption to
override numerous state alien-registration laws even though enacted
federal law “at no point conflict[ed] with the state legislation
and [was] harmonious with it.” Id. , at 79.[ Footnote 4 ]

															2

															   The consequences of this Court’s
broad approach to “purposes and objectives” pre-emption are
exemplified in this Court’s decision in Geier , which both
the majority and the dissent incorporate into their analysis today.
See ante , at 23–24, and nn. 13–14; post , at 6–9
(opinion of Alito, J.). In Geier , pursuant to the National
Traffic and Motor Vehicle Safety Act of 1966 (Safety Act), 80 Stat.
718, 15 U. S. C. §1381 et seq. (1988 ed.), the
Department of Transportation (DOT) had promulgated a Federal Motor
Vehicle Safety Standard that “required auto manufacturers to equip
some but not all of their 1987 vehicles with passive restraints.”
529 U. S., at 864–865. The case required this Court to decide
whether the Safety Act pre-empted a state common-law tort action in
which the plaintiff claimed that an auto manufacturer, though in
compliance with the federal standard, should nonetheless have
equipped a 1987 automobile with airbags. Id. , at 865. The
Court first concluded that the Safety Act’s express pre-emption
provision and its saving clause, read together, did not expressly
pre-empt state common-law claims. See id. , at
867–868.[ Footnote 5 ] The Court
then proceeded to consider whether the state action was nonetheless
pre-empted as an “obstacle” to the purposes of the federal law. The
Court held that the state tort claim was pre-empted, relying in
large part on comments that DOT made when promulgating its
regulation, statements that the Government made in its brief to the
Court, and regulatory history that related to the federal
regulation of passive restraints. See id. , at 874–886.

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

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

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

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

															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
Cosmetic Act to enact an express pre-emption provision that
addresses approval of a drug label by the FDA. Ante , at
18. That “silence on the issue, coupled with [Congress’] certain
awareness of the prevalence of state tort litigation,” the majority
reasons, is evidence that Congress did not intend for federal
approval of drug labels to pre-empt state tort judgments. Ibid.; see also ante , at 17–18 (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 inferences that the Court may draw
from congressional silence about the motivations or policies
underlying Congress’ failure to act. See Brown v. Gardner , 513 U. S. 115 , 121
(1994) (“[C]ongressional silence lacks persuasive significance”
(internal 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 presumably 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 congressional 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 18. That is the required conclusion, but only because it is
compelled by the text of the relevant statutory and regulatory
provisions, not judicial suppositions about Congress’ unstated
goals. The fact that the Court reaches the proper conclusion does
not justify its speculation about the reasons for congressional
inaction. In this case, the Court has relied on the perceived
congressional policies underlying inaction to find that state law
is not pre-empted. But once the Court shows a willingness
to guess at the intent underlying congressional inaction, the Court
could just as easily rely on its own perceptions regarding
congressional inaction to give unduly broad pre-emptive effect to
federal law. See, e.g. , American Ins. Assn. v. Garamendi , 539 U. S. 396 , 401,
405–408, 429 (2003) (finding that Congress’ failure to pass
legislation indicating that it disagreed with the President’s
executive agreement supported, at least in part, the Court’s
determination that the agreement pre-empted state law). Either
approach is illegitimate. Under the Supremacy Clause, state law is
pre-empted only by federal law “made in Pursuance” of the
Constitution, Art. VI, cl. 2—not by extratextual
considerations 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 … are not
helpful”); TVA v. Hill , 437 U. S. 153 , 194
(1978) (“Our individual appraisal of the wisdom or unwisdom of a
particular 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, extratextual,
and broad evaluations of the “purposes and objectives” embodied
within federal law. This, in turn, leads to decisions giving
improperly broad pre-emptive effect to judicially manufactured
policies, rather than to the statutory text enacted by Congress
pursuant to the Constitution and the agency actions authorized
thereby. Because such a sweeping approach to pre-emption leads to
the illegitimate—and thus, unconstitutional—invalidation of state
laws, I can no longer assent to a doctrine that pre-empts state
laws merely because they “stan[d] as an obstacle to the
accomplishment and execution of the full purposes and objectives”
of federal law, Hines , 312 U. S., at 67, as perceived by
this Court. I therefore respectfully concur only in the
judgment. Footnote 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 example, 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 Antonio
Metropolitan Transit Authority , 469 U. S. 528 , 583–584
(1985) (O’Connor, 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”). Footnote 2 The majority’s pre-emption analysis relies in
part on a presumption against pre-emption. Ante , at 8, and
n. 3 (opinion of Stevens, J.). Because it is evident from the
text of the relevant federal statutes and regulations 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 , 555 U. S. ___, ___ (2008) (Thomas, J.,
dissenting) (rejecting the use of a presumption against pre-emption
in express pre-emption cases). Footnote 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 identification
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 failure to show it upon proper demand,
the punishment is a fine … or imprisonment … .” Hines , 312 U. S., at 59–60 (footnote omitted).

															   The Court explained that the federal Alien
Registration Act required:

															   “a single registration of aliens 14 years of
age and over; detailed information specified by the Act, plus ‘such
additional matters as may be prescribed by the Commissioner, with
the approval of the Attorney General’; finger-printing of all
registrants; and secrecy of the federal files … . No
requirement that aliens carry a registration card to be exhibited
to police or others is embodied in the law, and only the wilful
failure to register is made a criminal offense … .” Id. , at 60–61. Footnote 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 Congress’ unstated intentions. Id. , at 78–79. See
also Camps Newfound/Owatonna, Inc. v. Town of
Harrison , 520 U. S. 564 , 616–617 (1997) (Thomas,
J., dissenting) (noting that “field pre-emption is itself suspect,
at least as applied in the absence of a congressional command that
a particular field be pre-empted”). Footnote 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 subchapter does not exempt any person
from any liability under common law.” §1397(k). The majority and
dissent in Geier 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 Geier , 529 U. S., at 867–868; id. , at 895–898 (Stevens, J., dissenting). Footnote 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 purpose of the Safety Act, as stated by Congress, was generally
“ ‘to reduce traffic accidents and deaths and injuries to
persons resulting from traffic accidents.’ ” Id. , at
888–889 (opinion of Stevens, J.) (quoting 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)
(1988 ed.)). 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 judgment finding that a manufacturer acted
negligently when it failed to include an airbag in a particular
car. See id. , at 903–904. ALITO, J., DISSENTING WYETH V. LEVINE 555 U. S. ____ (2009) SUPREME COURT OF THE UNITED STATES NO. 06-1249 WYETH, PETITIONER v. DIANA LEVINE

															on writ of certiorari to the supreme court of
vermont

															[March 4, 2009]

															   Justice Alito, with whom The
Chief Justice and Justice Scalia join, dissenting.

															   This case illustrates that tragic
facts make bad law. The Court holds that a state tort jury, rather
than the Food and Drug Administration (FDA), is ultimately
responsible for regulating warning labels for prescription drugs.
That result cannot be reconciled with Geier v. American Honda Motor Co. , 529 U. S. 861 (2000), or general
principles of conflict pre-emption. I respectfully dissent.

															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
administer Phenergan. Ante , at 8. But that ignores the
antecedent question of who—the FDA or a jury in Vermont—has the
authority and responsibility for determining the “adequacy” of
Phenergan’s warnings. Moreover, it is unclear how a “stronger”
warning could have helped respondent, see ante , at 16;
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.[ Footnote 1 ]

															   More to the point, the question
presented by this case is not a “narrow” one, and it does not
concern whether Phenergan’s label should bear a “stronger” warning.
Rather, the real issue is whether a state tort jury can countermand
the FDA’s considered judgment that Phenergan’s FDA-mandated warning
label renders its intravenous (IV) use “safe.” Indeed, respondent’s
amended complaint alleged that Phenergan is “not reasonably safe
for intravenous administration,” App. 15, ¶6; respondent’s attorney
told the jury that Phenergan’s label should say, “ ‘Do not use
this drug intravenously,’ ” id. , at 32; respondent’s
expert told the jury, “I think the drug should be labeled ‘Not for
IV use,’ ” id. , at 59; and during his closing
argument, respondent’s attorney told the jury, “Thank God we don’t
rely on the FDA to … make the safe[ty] decision. You will make the
decision. … The FDA doesn’t make the decision, you do,” id. , at 211–212.[ Footnote
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
general and its use to administer Phenergan in particular. Whether
wisely or not, the FDA has concluded—over the course of extensive,
54-year-long regulatory proceedings—that the drug is “safe” and
“effective” when used in accordance with its FDA-mandated labeling.
The unfortunate fact that respondent’s healthcare providers ignored
Phenergan’s labeling may make this an ideal medical-malpractice
case.[ Footnote 3 ] But turning a
common-law tort suit into a “frontal assault” on the FDA’s
regulatory regime for drug labeling upsets the well-settled meaning
of the Supremacy Clause and our conflict pre-emption jurisprudence.
Brief for United States as Amicus Curiae 21.

															II

															A

															   To the extent that “[t]he purpose
of Congress is the ultimate touchstone in every pre-emption case,” Medtronic, Inc. v. Lohr , 518 U. S. 470 , 485
(1996) (internal quotation marks omitted), Congress made its
“purpose” plain in authorizing the FDA—not state tort juries—to
determine when and under what circumstances a drug is “safe.”
“[T]he process for approving new drugs is at least as rigorous as
the premarket approval process for medical devices,” Riegel v. Medtronic, Inc. , 552 U. S. ___, ___
(2008) (slip op., at 11) (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 ___ (slip op., at 11) (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 reports 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 evidence 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 misleading in any particular.” 21 U. S. C.
§355(d).

															   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 affect
the FDA’s previous conclusions about the safety, effectiveness, or
labeling of the drug, 21 U. S. C. §355(k). If the FDA finds
that the drug is not “safe” when used in accordance with its
labeling, the agency “shall” withdraw its approval 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 duration 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 product can be used safely
and effectively.” 71 Fed. Reg. 3934 (2006). The FDA has underscored
the importance it places on drug labels by promulgating
comprehensive regulations—spanning an entire part of the Code of
Federal Regulations, see 21 CFR pt. 201, with seven subparts and 70
separate sections—that set forth drug manufacturers’ labeling
obligations. 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.

															B

															1

															   Where the FDA determines, in
accordance with its statutory mandate, that a drug is on balance
“safe,” our conflict pre-emption cases prohibit any State from
countermanding that determination. See, e.g. , Buckman
Co. v. Plaintiffs’ Legal Comm. , 531 U. S. 341 , 348 (2001) (after the
FDA has struck “a somewhat delicate balance of statutory
objectives” and determined that petitioner submitted a valid
application to manufacture a medical device, a State may not use
common law to negate it); International Paper Co. v. Ouellette , 479 U. S. 481 , 494
(1987) (after the EPA has struck “the balance of public and private
interests so carefully addressed by” the federal permitting regime
for water pollution, a State may not use nuisance law to “upse[t]”
it); Chicago & North Western Transp. Co. v. Kalo
Brick & Tile Co. , 450 U. S. 311 , 321
(1981) (after the Interstate Commerce Commission has struck a
“balance” between competing interests in permitting the abandonment
of a railroad line, a State may not use statutory or common law to
negate it).

															   Thus, as the Court itself
recognizes, it is irrelevant in conflict pre-emption cases whether
Congress “enacted an express pre-emption provision at some point
during the FDCA’s 70-year history.” Ante , at 18; 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 question 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 effort to regulate the safety and efficacy of
Phenergan pre-empts respondent’s tort suit. Indeed, that result
follows directly from our conclusion in Geier . Geier arose under the
National Traffic and Motor Safety Vehicle Act of 1966, which
directs the Secretary of the Department 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 performance,” §1391(2). Acting pursuant to that statutory
mandate, the Secretary of Transportation promulgated Federal Motor
Vehicle Safety Standard 208, which required car manufacturers 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 passive 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
suffered serious injuries. She then sued Honda under state tort
law, alleging that her car was negligently and defectively designed
because it lacked a driver’s-side airbag. She argued that Congress
had empowered the Secretary to set only “minimum standard[s]” for
vehicle safety. 15 U. S. C. §1391(2). She also emphasized that
the National Traffic and Motor Safety Vehicle Act contains a saving
clause, which provides that “[c]ompliance with any Federal motor
vehicle safety standard issued under this subchapter does not
exempt any person from any liability under common law.”
§1397(k).

															   Notwithstanding the statute’s saving clause,
and notwithstanding 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 relied
heavily on the view of the Secretary of Transportation—expressed in
an amicus brief—that Standard 208 “ ‘embodies the
Secretary’s policy judgment that safety would best be promoted if
manufacturers installed alternative protection systems in
their fleets rather than one particular system in every
car.’ ” 529 U. S., at 881 (quoting Brief for United States as Amicus Curiae , O. T. 1999, No. 98–1811, p. 25).
Because the Secretary determined that a menu of alternative
technologies was “safe,” the doctrine of conflict pre-emption
barred Geier’s efforts to deem some of those federally approved
alternatives “unsafe” under state tort law.

															   The same rationale applies here. Through
Phenergan’s label, the FDA offered medical professionals a menu of
federally approved, “safe” and “effective” alternatives—including
IV push—for administering the drug. Through a state tort suit,
respondent attempted to deem IV push “unsafe” and “ineffective.” To
be sure, federal law does not prohibit Wyeth from contraindicating
IV push, just as federal law did not prohibit Honda from installing
airbags in all its cars. But just as we held that States may not
compel the latter, so, too, are States precluded from compelling
the former. See also Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta , 458 U. S. 141 , 155
(1982) (“The conflict does not evaporate because the [agency’s]
regulation simply permits, but does not compel,” the action
forbidden by state law). If anything, a finding of pre-emption is
even more appropriate here because the FDCA—unlike the National
Traffic and Motor Safety Vehicle Act—contains no evidence that
Congress intended the FDA to set only “minimum standards,” and the
FDCA does not contain a saving clause.[ Footnote 4 ] See also ante , at 18 (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 specific costs and benefits associated with
IV push. Second, as a legal matter, Geier does not stand
for the legal propositions espoused by the dissenters (and
specifically rejected by the majority) in that case. Third, drug
labeling by jury verdict undermines both our broader pre-emption
jurisprudence and the broader workability of the federal
drug-labeling regime.

															A

															   Phenergan’s warning label has
been subject to the FDA’s strict regulatory oversight since the
1950’s. For at least the last 34 years, the FDA has focused
specifically on whether IV-push administration of Phenergan is
“safe” and “effective” when performed in accordance with
Phenergan’s label. The agency’s ultimate decision—to retain IV push
as one means for administering Phenergan, albeit subject to
stringent 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 specifically
considered and reconsidered the strength of Phenergan’s
IV-push-related warnings in light of new scientific and medical
data. The majority’s factual assertions to the contrary 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 (Plaintiff’s Trial Exh. 17,
Internal Correspondence from W. E. Langeland to File (Sept. 5,
1975) (hereinafter 1975 Memo)). “Tubex” is a syringe system used
exclusively for IV push. See App. 43. An FDA official explained
that the agency’s concerns arose from medical-malpractice lawsuits
involving IV push of the drug, see 1975 Memo 586, and that the FDA
was aware of “5 cases involving amputation where the drug had been
administered by Tubex together with several additional cases
involving necrosis,” id. , at 586–587. Rather than
contraindicating Phenergan for IV push, however, the agency and
Wyeth agreed “that there was a need for better instruction
regarding the problems of intraarterial injection.” Id. ,
at 587.

															   The next year, the FDA convened
an advisory committee to study, among other things, the risks
associated with the Tubex system and IV push. App. 294. At the
conclusion of its study, the committee recommended an additional
IV-push-specific warning for Phenergan’s label, see ibid. ,
but did not recommend eliminating IV push from the drug label
altogether. In response to the committee’s recommendations, the FDA
instructed Wyeth to make several changes to strengthen Phenergan’s
label, including the addition of upper case 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 placement.’ ” Id. , at 311–312.

															The first of the two quoted sentences refers
specifically to IV push; as respondent’s medical expert testified
at trial, the label’s recommended rate of administration (not to
exceed 25 mg per minute) refers to “IV push, as opposed to say
being in a bag and dripped over a couple of hours.” Id. ,
at 52. The second of the two quoted sentences refers to IV drip.
See id. , at 15–16 (emphasizing that a “running IV” is the
same thing as “IV drip”).

															   In its 1987 labeling order, the FDA cited
voluminous materials to “suppor[t]” its new and stronger warnings
related to IV push and the preferability of IV drip.[ Footnote 5 ] Id. , at 313. One of
those articles specifically discussed the relative advantages and
disadvantages of IV drip compared to IV push, as well as the costs
and benefits of administering Phenergan via IV push.[ Footnote 6 ] The FDA also cited published
case reports from the 1960’s of gangrene caused by the
intra-arterial injection of Phenergan,[ Footnote 7 ] and the FDA instructed Wyeth to amend
Phenergan’s label in accordance with the latest medical
research.[ Footnote 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.[ Footnote 9 ]

															   In “support” of its labeling order, the FDA
also cited numerous articles that singled out the inner crook of
the elbow—known as the “antecubital fossa” in the medical
community—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
misdirected injections.” Stone & Donnelly, The Accidental
Intra-arterial Injection of Thiopental, 22 Anesthesiology 995, 996
(1961) (footnote omitted; cited in App. 315, no. 20).[ Footnote 10 ]

															Based on this and other research, the FDA ordered
Wyeth to include a specific warning related to the use of the
antecubital space for IV push.[ Footnote 11 ]

															2

															   When respondent was injured in
2000, Phenergan’s label specifically addressed IV push in several
passages (sometimes in lieu of and sometimes in addition to those
discussed above). For example, the label warned of the risks of
intra-arterial injection associated with “aspiration,” which is a
technique used only in conjunction with IV push.[ Footnote 12 ] The 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 (testimony 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 preferred parenteral route of administration is by deep
intramuscular injection.” Id. , at 390. If an intramuscular
injection 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 expert,
Dr. John Matthew) (conceding that the best way to determine that an
IV set is functioning satisfactorily is to use IV drip). Finally,
if for whatever reason a medical professional chooses to use IV
push, he or she is on notice that “ INADVERTENT
INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED
EXTREMITY.” 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, extreme care should be exercised to avoid perivascular
extravasation or inadvertent intra-arterial injection. Reports
compatible with inadvertent intra-arterial injection of Phenergan
Injection, usually in conjunction with other drugs intended for
intravenous use, suggest that pain, severe chemical irritation,
severe spasm of distal vessels, and resultant gangrene requiring
amputation are likely under such circumstances.” Ibid. Thus, it is
demonstrably untrue that, as of 2000, Phenergan’s “labeling did not
contain a specific warning about the risks of IV-push
administration.” Ante , at 4. And whatever else might be said
about the extensive medical authorities and case reports that the
FDA cited in “support” of its approval of IV-push administration of
Phenergan, it cannot be said that the FDA “paid no more than
passing attention to” IV push, ante , at 6; nor can it be
said that the FDA failed to weigh its costs and benefits, Brief for
Respondent 50. 3 For her part,
respondent does not dispute the FDA’s conclusion that IV push has
certain benefits. At trial, her medical practitioners testified
that they used IV push in order to help her “in a swift and timely
way” when she showed up at the hospital for the second time in one
day complaining of “intractable” migraines, “terrible pain,”
inability to “bear light or sound,” sleeplessness, hours-long
spasms of “retching” and “vomiting,” and when “every possible”
alternative treatment had “failed.” App. 40 (testimony of Dr. John
Matthew); id. , at 103, 106, 109 (testimony of physician’s
assistant Jessica Fisch). Rather than disputing
the benefits of IV push, respondent complains that the FDA and
Wyeth underestimated its costs (and hence did not provide
sufficient warnings regarding its risks). But when the FDA mandated
that Phenergan’s label read, “ INADVERTENT
INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED
EXTREMITY,” id. , at 391, and when the FDA required Wyeth
to warn that “[u]nder no circumstances should Phenergan Injection
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 respondent 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 “antecubital fossa” creates a high risk of
inadvertent intra-arterial injection, given the close proximity of
veins and arteries. See supra , at 13–14; see also The
Lippincott Manual of Nursing Practice 99 (7th ed. 2001) (noting, in
a red-text “NURSING ALERT,” that the antecubital fossa is “not
recommended” for administering dangerous drugs, “due to the
potential for extravasation”).[ Footnote 13 ] According to the physician’s assistant who
injured respondent, however, “[i]t never crossed my mind” that an
antecubital injection of Phenergan could hit an artery. App. 110;
see also ibid. (“[It] just wasn’t something that I was
aware of at the time”). Oblivious to the risks emphasized in
Phenergan’s warnings, the physician’s assistant pushed a double
dose of the drug into an antecubital artery over the course of
“[p]robably about three to four minutes,” id. , at 111; id. , at 105, notwithstanding respondent’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 requires turning yesterday’s
dissent into today’s majority opinion. First,
the Court denies the existence of a federal-state conflict in this
case because Vermont merely countermanded the FDA’s determination
that IV push is “safe” when performed in accordance with
Phenergan’s warning label; the Court concludes that there is no
conflict because Vermont did not “mandate a particular” label as a
“replacement” for the one that the jury nullified, and because the
State stopped short of altogether “contraindicating IV-push
administration.” Ante , at 8. But as we emphasized in Geier (over the dissent’s assertions to the contrary), the
degree of a State’s intrusion upon federal law is irrelevant—the
Supremacy Clause applies with equal force to a state tort law that
merely countermands a federal safety determination and to a state
law that altogether prohibits car manufacturers from selling cars
without airbags. Compare 529 U. S., at 881–882, with id. ,
at 902 (Stevens, J., dissenting). Indeed, as recently as last Term,
we held that the Supremacy Clause pre-empts a “[s]tate tort law
that requires a manufacturer’s catheters to be safer, but hence
less effective, than the model the FDA has approved … .” Riegel , 552 U. S., at ___ (slip op., at 11). 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 altogether prohibiting an
FDA-approved method for administering 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 differently 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 21; see also ante , at 24. But the Geier Court
specifically rejected the argument (again made by the dissenters in
that case) that conflict pre-emption is appropriate only where the
agency expresses its pre-emptive intent through notice-and-comment
rulemaking. Compare 529 U. S., at 885 (“To insist on a specific
expression of agency intent to pre-empt, made after
notice-and-comment rulemaking, would be in certain cases to
tolerate conflicts that an agency, and therefore Congress, is most
unlikely to have intended. The dissent, as we have said, apparently
welcomes that result … . We do not”), with id. , at
908–910 (Stevens, J., dissenting) (emphasizing that “we generally
expect an administrative regulation to declare any intention to
pre-empt state law with some specificity,” and that “[t]his
expectation … serves to ensure that States will be able
to have a dialog with agencies regarding pre-emption decisions ex ante through the normal notice-and-comment procedures
of the Administrative Procedure Act” (internal quotation marks
omitted)). Indeed, pre-emption is arguably more appropriate here
than in Geier because the FDA (unlike the DOT) declared
its pre-emptive intent in the Federal Register. See 71 Fed. Reg.
3933–3936. Yet the majority dismisses the FDA’s published preamble
as “inherently suspect,” ante , at 21, and an afterthought
that is entitled to “no weight,” ante , at 25. Compare Lohr , supra , at 506 (opinion of Breyer, J.)
(emphasizing that the FDA has a “special understanding 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, pre-
ambles, interpretive 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 preamble does not. Ante , at 24; see also ante , at 19. 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 adjudications rather than
through less-formal and less-flexible rulemaking 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 19,
24. 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 1–2 (Breyer, J.,
concurring). Fourth,
the Court sandwiches its discussion of Geier between the
“presumption against pre-emption,” ante , at 18, and heavy
emphasis on “the longstanding coexistence of state and federal law
and the FDA’s traditional recognition of state-law remedies,” ante , at 24. But the Geier Court specifically
rejected the argument (again made by the dissenters 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,”
“longstanding,” 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
automatically by operation of the Supremacy Clause. Id. ,
at 871–872. See also Buckman , 531 U. S., at 347–348
(“[P]etitioner’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 obtains in this case”
(citation omitted)).[ Footnote
14 ] 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; compare id. ,
at 910–911 (Stevens, J., dissenting) (criticizing 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
regulatory purposes, the Court relies on a decade-old and
now-repudiated statement, which the majority finds preferable. See ante , at 21–22, 24, n. 13. Cf. Riegel , 552
U. S., at ___ (slip op., at 13) (noting that “the agency’s earlier
position (which the dissent describes at some length and finds
preferable) is … compromised, 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 ,
555 U. S. ___, ___ (2008) (slip op., at 16–17) (rejecting
petitioners’ reliance on the pre-emptive effect of the agency’s
“longstanding policy” because it is inconsistent with the agency’s
current one). And Justice Breyer suggests that state tort suits may
“help the [FDA],” ante , at 1 (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. 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 product’s design or warning label that arguably
contributed to a particular plaintiff’s injury, not on the overall
benefits of that design or label; “the patients who reaped those
benefits are not represented in court.” 552 U. S., at ___ (slip
op., at 12). Indeed, patients like respondent are the only ones
whom tort juries ever see, and for a patient like respondent—who
has already suffered a tragic accident—Phenergan’s risks are no
longer a matter of probabilities and
potentialities. In contrast, the FDA has the benefit of the
long view. Its drug-approval determinations consider the interests
of all potential users of a drug, including “those who would suffer
without new medical [products]” if juries in all 50 States were
free to contradict the FDA’s expert determinations. Id. ,
at ___ (slip op., at 13). And the FDA conveys its warnings with one
voice, rather than whipsawing the medical community with 50 (or
more) potentially conflicting ones. After today’s ruling, however,
parochialism may prevail. The
problem is well illustrated by the labels borne by “vesicant”
drugs, many of which are used for chemotherapy. As a class,
vesicants are much more dangerous than drugs like
Phenergan,[ Footnote 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 lifesaving benefits of these drugs offer
hollow solace to the victim of such a tragedy, a jury’s
cost-benefit analysis in a particular 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.”[ Footnote 16 ] Indeed, the drug is so highly
toxic: “Should accidental eye contact occur, copious irrigation for at
least 15 minutes with water, normal saline or a balanced salt
ophthalmic irrigating solution should be instituted immediately,
followed by prompt ophthalmologic consultation. Should accidental
skin contact occur, the affected part must be irrigated immediately
with copious amounts of water, for at least 15 minutes while
removing contaminated clothing and shoes, followed by 2% sodium
thiosulfate solution. Medical attention should be sought
immediately. Contaminated clothing should be destroyed.”[ Footnote
17 ] Yet
when it comes to administering this highly toxic drug, the label
provides that “the drug may be injected directly into any
suitable vein , [but] it is injected preferably into the rubber
or plastic tubing of a flowing intravenous infusion set. This
reduces the possibility of severe local reactions due to
extravasation or high concentration of the drug.” (Emphasis added.)
Similarly, the FDA-approved labels for other powerful
chemotherapeutic vesicants—including Dactinomycin, Oxaliplatin,
Vinblastine, and Vincristine—specifically allow IV push,
notwithstanding their devastating effects when
extravasated. 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
extravasated, see Boyle & Engelking, Vesicant Extravasation:
Myths and Realities, 22 Oncology Nursing Forum 57, 58 (1995)
(arguing that the rate of extravasation is “considerably higher”
than 6.4% of all vesicant administrations). Regardless 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.[ Footnote
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 17–18. 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. Appendix TO OPINION OF ALITO,
J. 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). Footnote
1 Indeed, respondent conceded below that Wyeth did propose an adequate warning of Phenergan’s risks. See Plaintiff
Diana Levine’s Memorandum in Opposition to Wyeth’s Motion for
Summary Judgment in Levine v. American Home Products
Corp. (now Wyeth), No. 670–12–01 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 the labeling instruction, if followed, would
have prevented the inadvertent administration of Phenergan into an
artery …”). The FDA rejected Wyeth’s proposal. See App.
359. Footnote
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 benefits of intravenous administration and
the potential for injury to patients.” Id. , at 220. See
also ___ Vt. ___, ___, 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”). Footnote
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 “responsibility” for her injury and expressed his
“profoun[d] regre[t]” and “remors[e]” for his actions. 1 Tr.
178–179 (Mar. 8, 2004) (testimony of Dr. John Matthew); see also
App. 102–103 (testimony of physician’s assistant Jessica Fisch)
(noting that her “sense of grief” was so “great” that she “would
have gladly cut off [her own] arm” and given it to respondent).
Thereafter, both the physician and the physician’s assistant agreed
to testify on respondent’s behalf in her suit against
Wyeth. Footnote
4 To
be sure, Congress recognized the principles of conflict pre-emption
in the FDCA. See Drug Amendments of 1962, §202, 76 Stat. 793
(“Nothing in the amendments made by this Act to the Federal Food,
Drug, and Cosmetic Act shall be construed as invalidating any
provision of State law … unless there is a direct and positive
conflict between such amendments and such provision of State law”).
But a provision that simply recognizes the background principles of
conflict pre-emption is not a traditional “saving clause,” and even
if it were, it would not displace our conflict-pre-emption
analysis. See Geier v. American Honda Motor Co. , 529 U. S. 861 , 869 (2000) (“[T]he
saving clause … does not bar the ordinary working of
conflict pre-emption principles”); id. , at 873–874 (“The
Court has … refused to read general ‘saving’ provisions to tolerate
actual conflict both in cases involving impossibility and in ‘frustration-of-purpose’ cases” (emphasis deleted and citation
omitted)). Footnote
5 The
FDA cited numerous articles that generally discuss the costs and
benefits associated with IV push. See, e.g. , Nahrwold
& Phelps, Inadvertent Intra-Arterial Injection of
Mephenteramine, 70 Rocky Mountain Medical J. 38 (Sept. 1973) (cited
in App. 314, no. 14); Albo, Cheung, Ruth, Snyder, &
Beemtsma, Effect of Intra-Arterial Injections of Barbituates, 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 Anesthesiology 51 (1985) (cited in App. 314,
no. 9); Correspondence Regarding Thiopental and Thiamylal (3
letters), 59 Anesthesiology 153 (1983) (cited in App. 314,
no. 11); Miller, Arthur, & Stratigos, Intra-arterial
Injection of a Barbituate, 23 Anesthesia Progress 25 (1976) (cited
in App. 315,
no. 19). Footnote
6 See
Webb & Lampert, Accidental Arterial Injections, 101 Am. J.
Obstetrics & Gynecology 365 (1968) (cited in App. 313,
no. 5). Footnote
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) (noting “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 Injection of Promethazine HCl During General
Anesthesia, 35 Anesthesiology 645 (1971) (reporting a case of
gangrene, which required partial amputation of three fingers, after
Phenergan was inadvertently pushed into an artery in the
“antecubital” area); Promethazine, p. 7, in Clinical
Pharmacology (Gold Standard Multimedia Inc. CD–ROM, version 1.16
(1998) (noting that “[i]nadvertent intra-arterial injection [of
Phenergan] can result in arteriospasm … and development of
gangrene”)). Footnote
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’ ”). Footnote
9 See
Enloe 427 (discussing hydroxyzine—an antihistamine with chemical
properties similar to those of Phenergan—and suggesting its
“temporary” 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 Barbituates
and Tranquilizing Drugs, 92 Radiology 700 (1969) (same) (cited in
App. 314, no. 13). With full knowledge of those risks, 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 injection,” including the
use of “an obviously well-functioning venoclysis”), with App. 312
(FDA’s 1987 changes to Phenergan’s label). In contrast, at some
time around 1970, the FDA prohibited all intravenous use of
hydroxyzine. 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)
(“[Hydroxyzine’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 usually not the practitioner with
the intravenous technique
problems”). Footnote
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, 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 Anaesthesia 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 Anesthesia 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 Archives of Surgery, at 88
(emphasizing that one of the best ways to prevent inadvertent
intra-arterial injections is to be aware of “aberrant or
superficial arteries at the antecubital, forearm, wrist, and hand
level”); Mostafavi & Samimi, supra (warning against
antecubital
injections). Footnote
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’ ”). Footnote
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. Ordinarily, arterial blood is brighter than
venous blood—but contact with Phenergan 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
beware that “[a]spiration of dark blood does not preclude
intra-arterial needle placement, because blood is discolored upon
contact with Phenergan Injection.” Id. , at
390. Footnote
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). Footnote
14 Thus, it is not true that “this Court has long” applied a
presumption against pre-emption in conflict pre-emption cases. Ante , at 9, n. 3 (majority 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 preemption 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 “presumption” 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). Footnote
15 Vesicants may cause “blistering, severe tissue injury, or
tissue necrosis” 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 4 (majority opinion)
(noting that Phenergan is labeled as an “irritant”); cf. Brief for
Anju Budhwani et al. as Amici Curiae 15 (suggesting
Phenergan should be considered a
“vesicant”). Footnote
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). Footnote
17 Ibid. Footnote
18 The same is true of FDA’s regulation of hydroxyzine.
See n. 9,
supra .