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															SUPREME COURT OF THE UNITED STATES

															_________________

															No. 12–142

															_________________

															MUTUAL PHARMACEUTICAL COMPANY, INC.,
PETITIONER v. KAREN L. BARTLETT

															on writ of certiorari to the united states
court of appeals for the first circuit

															[June 24, 2013]

															     Justice Alito
delivered the opinion of the Court.

															     We must decide whether
federal law pre-empts the New Hampshire design-defect claim under
which respondent Karen Bartlett recovered damages from petitioner
Mutual Pharmaceutical, the manufacturer of sulindac, a generic
nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law
imposes a duty on manufacturers to ensure that the drugs they
market are not unreasonably unsafe, and a drug’s safety is
evaluated by reference to both its chemical properties and the
adequacy of its warnings. Because Mutual was unable to change
sulindac’s composition as a matter of both federal law and
basic chemistry, New Hampshire’s design-defect cause of
action effectively required Mutual to change sulindac’s
labeling to provide stronger warnings. But, as this Court
recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564
U. S. ___ (2011), federal law prohibits generic drug
manufacturers from independently changing their drugs’
labels. Accordingly, state law imposed a duty on Mutual not to
comply with federal law. Under the Supremacy Clause, state laws
that require a private party to violate federal law are pre-empted
and, thus, are “without effect.” Maryland v. Louisiana,
451 U. S. 725, 746 (1981) .

															     The Court of
Appeals’ solution—that Mutual should simply have pulled
sulindac from the market in order to comply with both state and
federal law—is no solution. Rather, adopting the Court of
Appeals’ stop-selling rationale would render impossibility
pre-emption a dead letter and work a revolution in this
Court’s pre-emption case law.

															     Accordingly, we hold
that state-law design-defect claims that turn on the adequacy of a
drug’s warnings are pre-empted by federal law under PLIVA. We
thus reverse the decision of the Court of Appeals below.

															I

															     Under the Federal
Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52Stat. 1040, as
amended, 21 U. S. C. §301 et seq., drug
manufacturers must gain approval from the United States Food
and Drug Administration (FDA) before marketing any drug in
interstate commerce. §355(a). In the case of a new brand-name
drug, FDA approval can be secured only by submitting a new-drug
application (NDA). An NDA is a compilation of materials that must
include “full reports of [all clinical]
investigations,” §355(b)(1)(A), relevant nonclinical
studies, and “any other data or information relevant to an
evaluation of the safety and effectiveness of the drug product
obtained or otherwise received by the applicant from any
source,” 21 CFR §§314.50(d)(2) and (5)(iv) (2012).
The NDA must also include “the labeling proposed to be used
for such drug,” 21 U. S. C. §355(b)(1)(F); 21
CFR §314.50(c)(2)(i), and “a discussion of why the
[drug’s] benefits exceed the risks under the conditions
stated in the labeling,” 21 CFR §314.50(d)(5)(viii);
§314.50(c)(2)(ix). The FDA may approve an NDA only if it
determines that the drug in question is “safe for use”
under “the conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof.” 21
U. S. C. §355(d). In order for the FDA to consider a
drug safe, the drug’s “probable therapeutic benefits
must outweigh its risk of harm.” FDA v. Brown &
Williamson Tobacco Corp., 529 U. S. 120, 140 (2000) .

															     The process of
submitting an NDA is both onerous and lengthy. See Report to
Congressional Requesters, Government Accountability Office, Nov.
2006, New Drug Development, 26 Biotechnology L. Rep. 82, 94
(2007) (A typical NDA spans thousands of pages and is based on
clinical trials conducted over several years). In order to provide
a swifter route for approval of generic drugs, Congress passed the
Drug Price Competition and Patent Term Restoration Act of 1984,
98Stat. 1585, popularly known as the “Hatch-Waxman
Act.” Under Hatch-Waxman, a generic drug may be approved
without the same level of clinical testing required for approval of
a new brand-name drug, provided the generic drug is identical to
the already-approved brand-name drug in several key respects.

															     First, the proposed
generic drug must be chemically equivalent to the approved
brand-name drug: it must have the same “active
ingredient” or “active ingredients,” “route
of administration,” “dosage form,” and
“strength” as its brand-name counterpart. 21
U. S. C. §§355(j)(2)(A)(ii) and (iii). Second,
a proposed generic must be “bioequivalent” to an
approved brand-name drug. §355(j)(2)(A)(iv). That is, it must
have the same “rate and extent of absorption” as the
brand-name drug. §355(j)(8)(B). Third, the generic drug
manufacturer must show that “the labeling proposed for the
new drug is the same as the labeling approved for the [approved
brand-name] drug.” §355(j)(2)(A)(v).

															     Once a
drug—whether generic or brand-name—is approved, the
manufacturer is prohibited from making any major changes to the
“qualitative or quantitative formulation of the drug product,
including active ingredients, or in the specifications provided in
the approved application.” 21 CFR §314.70(b)(2)(i).
Generic manufacturers are also prohibited from making any
unilateral changes to a drug’s label. See
§§314.94(a)(8)(iii), 314.150(b)(10) (approval for a
generic drug may be withdrawn if the generic drug’s label
“is no longer consistent with that for [the brand-name]
drug”).

															II

															     In 1978, the FDA
approved a nonsteroidal anti-inflammatory pain reliever called
“sulindac” under the brand name Clinoril. When
Clinoril’s patent expired, the FDA approved several generic
sulindacs, including one manufactured by Mutual Pharmaceutical. 678
F. 3d 30, 34 (CA1 2012) (case below); App. to Pet. for Cert.
144a–145a. In a very small number of patients,
NSAIDs—including both sulindac and popular NSAIDs such as
ibuprofen, naproxen, and Cox2-inhibitors—have the serious
side effect of causing two hypersensitivity skin reactions
characterized by necrosis of the skin and of the mucous membranes:
toxic epidermal necrolysis, and its less severe cousin,
Stevens-Johnson Syndrome. 678 F. 3d, at 34, 43–44;
Dorland’s Illustrated Medical Dictionary 1872 (31st ed.
2007); Physicians’ Desk Reference 146–147, 597 (6th ed.
2013); Friedman, Orlet, Still, & Law, Toxic Epidermal
Necrolysis Due to Administration of Celecobix (Celebrex), 95
Southern Medical J. 1213, 1213–1214 (2002).

															     In December 2004,
respondent Karen L. Bartlett was prescribed Clinoril for shoulder
pain. Her pharmacist dispensed a generic form of sulindac, which
was manufactured by petitioner Mutual Pharmaceutical. Respondent
soon developed an acute case of toxic epidermal necrolysis. The
results were horrific. Sixty to sixty-five percent of the surface
of respondent’s body deteriorated, was burned off, or turned
into an open wound. She spent months in a medically induced coma,
underwent 12 eye surgeries, and was tube-fed for a year. She is now
severely disfigured, has a number of physical disabilities, and is
nearly blind.

															     At the time respondent
was prescribed sulindac, the drug’s label did not
specifically refer to Stevens-Johnson Syndrome or toxic epidermal
necrolysis, but did warn that the drug could cause “severe
skin reactions” and “[f]atalities.” App. 553; 731
F. Supp. 2d 135, 142 (NH 2010) (internal quotation marks omitted).
However, Stevens-Johnson Syndrome and toxic epidermal necrolysis
were listed as potential adverse reactions on the drug’s
package insert. 678 F. 3d, at 36, n. 1. In
2005—once respondent was already suffering from toxic
epidermal necrolysis—the FDA completed a “comprehensive
review of the risks and benefits, [including the risk of toxic
epidermal necrolysis], of all approved NSAID products.”
Decision Letter, FDA Docket No. 2005P-0072/CP1, p. 2 (June 22,
2006), online at http://www.fda.gov/ohrms/dockets/
dockets/05p0072/05p-0072-pav0001-vol1.pdf (as visited June 18,
2013, and available in Clerk of Court’s case file). As a
result of that review, the FDA recommended changes to the labeling
of all NSAIDs, including sulindac, to more explicitly warn against
toxic epidermal necrolysis. App. 353–354, 364, 557–561,
580, and n. 8.

															     Respondent sued Mutual
in New Hampshire state court, and Mutual removed the case to
federal court. Respondent initially asserted both failure-to-warn
and design-defect claims, but the District Court dismissed her
failure-to-warn claim based on her doctor’s
“admi[ssion] that he had not read the box label or
insert.” 678 F. 3d, at 34. After a 2-week trial on
respondent’s design-defect claim, a jury found Mutual liable
and awarded respondent over $21 million in damages.

															     The Court of Appeals
affirmed. 678 F. 3d 30. As relevant, it found that neither the
FDCA nor the FDA’s regulations pre-empted respondent’s
design-defect claims. It distinguished PLIVA, Inc. v. Mensing, 564
U. S. ___ —in which the Court held that failure-to-warn
claims against generic manufacturers are pre-empted by the
FDCA’s prohibition on changes to generic drug labels—by
arguing that generic manufacturers facing design-defect claims
could simply “choose not to make the drug at all” and
thus comply with both federal and state law. 678 F. 3d, at 37.
We granted certiorari. 568 U. S. ___ (2012).

															III

															     The Supremacy Clause
provides that the laws and treaties of the United States
“shall be the supreme Law of the Land . . . any
Thing in the Constitution or Laws of any State to the Contrary
notwithstanding.” U. S. Const., Art. VI,
cl. 2. Accordingly, it has long been settled that state laws
that conflict with federal law are “without effect.”
Maryland v. Louisiana, 451 U. S., at 746; McCulloch v.
Maryland, 4 Wheat. 316, 427 (1819). See also Gade v. National Solid
Wastes Management Assn., 505 U. S. 88, 108 (1992)
(“[U]nder the Supremacy Clause, from which our pre-emption
doctrine is derived, any state law, however clearly within a
State’s acknowledged power, which interferes with or is
contrary to federal law, must yield” (internal quotation
marks omitted)).

															     Even in the absence of
an express pre-emption provision, the Court has found state law to
be impliedly pre-empted where it is “impossible for a private
party to comply with both state and federal requirements.”
English v. General Elec. Co., 496 U. S. 72, 79 (1990) . See
also Florida Lime & Avocado Growers, Inc. v. Paul, 373
U. S. 132 –143 (1963) (“A holding of federal
exclusion of state law is inescapable and requires no inquiry into
congressional design where compliance with both federal and state
regulations is a physical impossibility for one engaged in
interstate commerce”).

															     In the instant case, it
was impossible for Mutual to comply with both its state-law duty to
strengthen the warnings on sulindac’s label and its
federal-law duty not to alter sulindac’s label. Accordingly,
the state law is pre-empted.

															A

															     We begin by
identifying petitioner’s duties under state law. As an
initial matter, respondent is wrong in asserting that the purpose
of New Hampshire’s design- defect cause of action “is
compensatory, not regulatory.” Brief for Respondent 19.
Rather, New Hampshire’s design-defect cause of action imposes
affirmative duties on manufacturers.

															     Respondent is correct
that New Hampshire has adopted the doctrine of strict liability in
tort as set forth in Section 402A of the Restatement (Second) of
Torts. See 2 Restatement (Second) of Torts §402A (1963 and
1964) (hereinafter Restatement 2d). See Buttrick v. Arthur Lessard
& Sons, Inc., 110 N. H. 36, 37–39, 260 A. 2d 111,
112–113 (1969). Under the Restatement—and consequently,
under New Hampshire tort law—“[o]ne who sells any
product in a defective condition unreasonably dangerous to the user
or consumer or to his property is subject to liability for physical
harm thereby caused” even though he “has exercised all
possible care in the preparation and sale of the product.”
Restatement 2d §402A, at 347–348.

															     But respondent’s
argument conflates what we will call a
“strict-liability” regime (in which liability does not
depend on negligence, but still signals the breach of a duty) with
what we will call an “absolute-liability” regime (in
which liability does not reflect the breach of any duties at all,
but merely serves to spread risk). New Hampshire has adopted the
former, not the latter. Indeed, the New Hampshire Supreme Court has
consistently held that the manu-facturer of a product has a
“duty to design his product reasonably safely for the uses
which he can foresee.” Thibault v. Sears, Roebuck & Co.,
118 N. H. 802, 809, 395 A. 2d 843, 847 (1978). See also Reid
v. Spadone Mach. Co., 119 N. H. 457, 465, 404 A. 2d 1094, 1099
(1979) (“In New Hampshire, the manufacturer is under a
general duty to design his product reasonably safely for the uses
which he can foresee” (internal quotation marks omitted));
Chellman v. Saab-Scania AB, 138 N. H. 73, 78, 637 A. 2d 148,
150 (1993) (“The duty to warn is part of the general duty to
design, manufacture and sell products that are reasonably safe for
their foreseeable uses”); cf. Simoneau v. South Bend Lathe,
Inc., 130 N. H. 466, 469, 543 A. 2d 407, 409 (1988) (“We
limit the application of strict tort liability in this jurisdiction
by continuing to emphasize that liability without negligence is not
liability without fault”); Price v. BIC Corp., 142 N. H.
386, 390, 702 A. 2d 330, 333 (1997) (cautioning “that
the term ‘unreasonably dangerous’ should not be
interpreted so broadly as to impose absolute liability on
manufacturers or make them insurers of their products”).
Accordingly, respondent is incorrect in arguing that New
Hampshire’s strict-liability system “imposes no
substantive duties on manufacturers.” Brief for Respondent
19. [ 1 ]

															B

															     That New Hampshire
tort law imposes a duty on manufacturers is clear. Determining the
content of that duty requires somewhat more analysis. As discussed
below in greater detail, New Hampshire requires manufacturers to
ensure that the products they design, manufacture, and sell are not
“unreasonably dangerous.” The New Hampshire Supreme
Court has recognized that this duty can be satisfied either by
changing a drug’s design or by changing its labeling. Since
Mutual did not have the option of changing sulindac’s design,
New Hampshire law ultimately required it to change sulindac’s
labeling.

															     Respondent argues that,
even if New Hampshire law does impose a duty on drug manufacturers,
that duty does not encompass either the “duty to change
sulindac’s design” or the duty “to change
sulindac’s labeling.” Brief for Respondent 30
(capitalization and emphasis deleted). That argument cannot be
correct. New Hampshire imposes design-defect liability only where
“the design of the product created a defective condition
unreasonably dangerous to the user.” Vautour v. Body Masters
Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178,
1181 (2001); Chellman, supra, at 77, 637 A. 2d, at 150. To
determine whether a product is “unreasonably
dangerous,” the New Hampshire Supreme Court employs a
“risk-utility approach” under which “a product is
defective as designed if the magnitude of the danger outweighs the
utility of the product.” Vautour, supra, at 154, 784
A. 2d, at 1182 (internal quotation marks omitted). That
risk-utility approach requires a “multifaceted balancing
process involving evaluation of many conflicting factors.”
Ibid. (internal quotation marks omitted); see also Thibault, supra,
at 809, 395 A. 2d, at 847 (same).

															     While the set of
factors to be considered is ultimately an open one, the New
Hampshire Supreme Court has repeatedly identified three factors as
germane to the risk-utility inquiry: “the usefulness and
desirability of the product to the public as a whole, whether the
risk of danger could have been reduced without significantly
affecting either the product’s effectiveness or manufacturing
cost, and the presence and efficacy of a warning to avoid an
unreasonable risk of harm from hidden dangers or from foreseeable
uses.” Vautour, supra, at 154, 784 A. 2d, at 1182; see
also Price, supra, at 389, 702 A. 2d, at 333 (same); Chellman,
supra, at 77–78, 637 A. 2d, at 150 (same).

															     In the drug context,
either increasing the “usefulness” of a product or
reducing its “risk of danger” would require redesigning
the drug: A drug’s usefulness and its risk of danger are both
direct results of its chemical design and, most saliently, its
active ingredients. See 21 CFR §201.66(b)(2) (2012)
(“Active ingredient means any component that is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitiga- tion, treatment, or prevention of disease,
or to affect the structure of any function of the body of
humans” (italics deleted)).

															     In the present case,
however, redesign was not possible for two reasons. First, the FDCA
requires a generic drug to have the same active ingredients, route
of adminis-tration, dosage form, strength, and labeling as the
brand-name drug on which it is based. 21 U. S. C.
§§355(j)(2)(A)(ii)–(v) and (8)(B); 21 CFR
§320.1(c). Consequently, the Court of Appeals was correct to
recognize that “Mutual cannot legally make sulindac in
another composition.” 678 F. 3d, at 37. Indeed, were
Mutual to change the composition of its sulindac, the altered
chemical would be a new drug that would require its own NDA to be
marketed in interstate commerce. See 21 CFR §310.3(h) (giving
examples of when the FDA considers a drug to be new, including
cases involving “newness for drug use of any substance which
composes such drug, in whole or in part”). Second, because of
sulindac’s simple composition, the drug is chemically
incapable of being redesigned. See 678 F. 3d, at 37
(“Mutual cannot legally make sulindac in another composition
(nor it is apparent how it could alter a one-molecule drug
anyway)”).

															     Given the impossibility
of redesigning sulindac, the only way for Mutual to ameliorate the
drug’s “risk-utility” profile—and thus to
escape liability—was to strengthen “the presence and
efficacy of [sulindac’s] warning” in such a way that
the warning “avoid[ed] an unreasonable risk of harm from
hidden dangers or from foreseeable uses.” Vautour, supra, at
154, 784 A. 2d, at 1182. See also Chellman, 138 N. H., at
78, 637 A. 2d, at 150 (“The duty to warn is part of the
general duty to design, manufacture and sell products that are
reasonably safe for their foreseeable uses. If the design of a
product makes a warning necessary to avoid an unreasonable risk of
harm from a foreseeable use, the lack of warning or an ineffective
warning causes the product to be defective and unreasonably
dangerous” (citation omitted)). Thus, New Hampshire’s
design-defect cause of action imposed a duty on Mutual to
strengthen sulindac’s warnings.

															     For these reasons, it
is unsurprising that allegations that sulindac’s label was
inadequate featured prominently at trial. Respondent introduced
into evidence both the label for Mutual’s sulindac at the
time of her injuries and the label as revised in 2005 (after
respondent had suffered her injuries). App. 553–556. Her
counsel’s opening statement informed the jury that “the
evidence will show you that Sulindac was unreasonably dangerous and
had an inadequate warning, as well. . . . You will hear
much more evidence about why this label was inadequate in relation
to this case.” Tr. 110–112 (Aug. 17, 2010). And, the
District Court repeatedly instructed the jury that it should
evaluate sulindac’s labeling in determining whether
Mutual’s sulindac was unreasonably dangerous. See App. 514
(jury instruction that the jury should find “a defect in
design” only if it found that “Sulindac was
unreasonably dangerous and that a warning was not present and
effective to avoid that unreasonable danger”); ibid. (jury
instruction that no design defect exists if “a warning was
present and effective to avoid that unreasonable danger”).
Finally, the District Court clarified in its order and opinion
denying Mutual’s motion for judgment as a matter of law that
the adequacy of sulindac’s labeling had been part of what the
jury was instructed to consider. 760 F. Supp. 2d 220, 231
(2011) (“if the jury found that sulin-dac’s risks
outweighed its benefits, then it could consider whether the
warning—regardless of its adequacy—re-duced those risks
. . . to such an extent that it eliminated the
unreasonable danger”). [ 2 ]

															     Thus, in accordance
with New Hampshire law, the jury was presented with evidence
relevant to, and was instructed to consider, whether Mutual had
fulfilled its duty to label sulindac adequately so as to render the
drug not “unreasonably dangerous.” In holding Mutual
liable, the jury determined that Mutual had breached that duty.

															C

															     The duty imposed by
federal law is far more readily apparent. As PLIVA made clear,
federal law prevents generic drug manufacturers from changing their
labels. See 564 U. S., at ___ (slip op., at 10)
(“Federal drug regulations, as interpreted by the FDA,
prevented the Manufacturers from independently changing their
generic drugs’ safety labels”). See also 21
U. S. C. §355(j)(2)(A)(v) (“[T]he labeling
proposed for the new drug is the same as the labeling approved for
the [approved brand-name] drug”); 21 CFR
§§314.94(a)(8)(iii), 314.150(b)(10) (approval for a
generic drug may be withdrawn if the generic drug’s label
“is no longer consistent with that for [the brand-name]
drug”). Thus, federal law prohibited Mutual from taking the
remedial action required to avoid liability under New Hampshire
law.

															D

															     When federal law
forbids an action that state law requires, the state law is
“without effect.” Maryland, 451 U. S., at 746.
Because it is impossible for Mutual and other similarly situated
manufacturers to comply with both state and federal law, [ 3 ] New Hampshire’s warning-based
design-defect cause of action is pre-empted with respect to
FDA-approved drugs sold in interstate commerce. [ 4 ]

															IV

															     The Court of Appeals
reasoned that Mutual could escape the impossibility of complying
with both its federal- and state-law duties by “choos[ing]
not to make [sulindac] at all.” 678 F. 3d, at 37. We
reject this “stop-selling” rationale as incompatible
with our pre-emption jurisprudence. Our pre-emption cases presume
that an actor seeking to satisfy both his federal- and state-law
obligations is not required to cease acting altogether in order to
avoid liability. Indeed, if the option of ceasing to act defeated a
claim of impossibility, impossibility pre-emption would be
“all but meaningless.” 564 U. S., at ___ (slip
op., at 14).

															     The incoherence of the
stop-selling theory becomes plain when viewed through the lens of
our previous cases. In every instance in which the Court has found
impossibility pre-emption, the “direct conflict”
between federal- and state-law duties could easily have been
avoided if the regulated actor had simply ceased acting.

															     PLIVA is an obvious
example: As discussed above, the PLIVA Court held that state
failure-to-warn claims were pre-empted by the FDCA because it was
impossible for drug manufacturers like PLIVA to comply with both
the state-law duty to label their products in a way that rendered
them reasonably safe and the federal-law duty not to change their
drugs’ labels. Id., at ___ (slip op., at 11). It would, of
course, have been possible for drug manufacturers like PLIVA to
pull their products from the market altogether. In so doing, they
would have avoided liability under both state and federal law: such
manufacturers would neither have labeled their products in a way
that rendered them unsafe nor impermissibly changed any federally
approved label.

															     In concluding that
“it was impossible for the Manufacturers to comply with both
their state-law duty to change the label and their federal law duty
to keep the label the same,” id., at ___ (slip op., at 12),
the Court was undeterred by the prospect that PLIVA could have
complied with both state and federal requirements by simply leaving
the market. The Court of Appeals decision below had found that
Mensing’s state-law failure-to-warn claims

															escaped pre-emption based on the very same
stop-selling rationale the First Circuit relied on in this case.
See Mensing v. Wyeth, Inc., 588 F. 3d 603, 611 (CA8 2009)
(“[G]eneric defendants were not compelled to market
metoclopramide. If they realized their label was insufficient
. . . they could have simply stopped selling the
product”). Moreover, Mensing advanced the stop-selling
rationale in its petition for rehearing, which this Court denied.
PLIVA, supra; Pet. for Reh’g in No. 09–993 etc.,
p. 2. Nonetheless, this Court squarely determined that it had
been “impossible” for PLIVA to comply with both its
state and federal duties. 564 U. S., at ___ (slip op., at 12).
[ 5 ]

															     Adopting the First
Circuit’s stop-selling rationale would mean that not only
PLIVA, but also the vast majority—if not all—of the
cases in which the Court has found impossibility pre-emption, were
wrongly decided.      Just as the prospect that
a regulated actor could avoid liability under both state and
federal law by simply leaving the market did not undermine the
impossibility analysis in PLIVA, so it is irrelevant to our
analysis here.

															V

															     The dreadful injuries
from which products liabilities cases arise often engender
passionate responses. Today is no exception, as Justice
Sotomayor’s dissent (hereinafter the dissent) illustrates.
But sympathy for respondent does not relieve us of the
responsibility of following the law.

															     The dissent accuses us
of incorrectly assuming “that federal law gives
pharmaceutical companies a right to sell a federally approved drug
free from common-law liability,” post, at 1, but we make no
such assumption. Rather, as discussed at length above, see supra,
at 8–13, we hold that state-law design-defect claims like New
Hampshire’s that place a duty on manufacturers to render a
drug safer by either altering its composition or altering its
labeling are in conflict with federal laws that prohibit
manufacturers from unilaterally altering drug composition or
labeling. The dissent is quite correct that federal law establishes
no safe-harbor for drug companies—but it does prevent them
from taking certain remedial measures. Where state law imposes a
duty to take such remedial measures, it “actual[ly]
conflict[s] with federal law” by making it
“ ‘impos-sible for a private party to comply with
both state and federal requirements.’ ”
Freightliner Corp. v. Myrick, 514 U. S. 280, 287 (1995)
(quoting English, 496 U. S., at 78–79). The dissent
seems to acknowledge that point when it concedes that, “if
federal law requires a particular product label to include a
complete list of ingredients while state law specifically forbids
that labeling practice, there is little question that state law
‘must yield.’ ” Post, at 6–7 (quoting
Felder v. Casey, 487 U. S. 131, 138 (1988) ). What the dissent
does not see is that that is this case: Federal law requires a very
specific label for sulindac, and state law forbids the use of that
label.

															     The dissent responds
that New Hampshire law “merely create[s] an incentive”
to alter sulindac’s label or composition, post, at 7, but
does not impose any actual “legal obligation,” post, at
13. The contours of that argument are difficult to discern.
     Perhaps the dissent is drawing a
distinction between common-law “exposure to liability,”
post, at 12, and a statutory “legal mandate,” ibid. But
the distinction between common law and statutory law is irrelevant
to the argument at hand: In violating a common-law duty, as surely
as by violating a statutory duty, a party contravenes the law.
While it is true that, in a certain sense, common-law duties give a
manufacturer the choice “between exiting the market or
continuing to sell while knowing it may have to pay compensation to
consumers injured by its product,” post, at 16, statutory
“mandate[s]” do precisely the same thing: They require
a manufacturer to choose between leaving the market and accepting
the consequences of its actions (in the form of a fine or other
sanction). See generally Calabresi & Melamed, Property Rules,
Liability Rules, and Inalienability: One View of the Cathedral, 85
Harv. L. Rev. 1089 (1972) (discussing liability rules). And,
in any event, PLIVA—which the dissent agrees involved a
state-law “requirement that conflicted with federal
law,” post, at 13—dealt with common-law failure-to-warn
claims, see PLIVA, supra, at ___ (slip op., at 4). Because PLIVA
controls the instant case, the dissent is reduced to fighting a
rearguard action against its reasoning despite ostensibly swearing
fealty to its holding.

															     To suggest that Bates
v. Dow Agrosciences LLC, 544 U. S. 431 (2005) , is to the
contrary is simply misleading. The dissent is correct that Bates
held a Texas state-law design-defect claim not to be pre-empted.
But, it did so because the design-defect claim in question was not
a “requirement ‘for labeling or
packaging’ ” and thus fell outside the class of
claims covered by the express pre-emption provision at issue in
that case. Id., at 443–444 (emphasis in original). Indeed,
contrary to the impression one might draw from the dissent, post,
at 12–13, the Bates Court actually blessed the lower
court’s determination that the State’s design-defect
claim imposed a pre-emptable “requirement”: “The
Court of Appeals did, however, correctly hold that the term
‘requirements’ in §136v(b) reaches beyond positive
enactments, such as statutes and regulations, to embrace common-law
duties.” Bates, supra, at 443. The dissent offers no
compelling reason why the “common-law duty” in this
case should not similarly be viewed as a “requirement.”
We agree, of course, that “determining precisely what, if
any, specific requirement a state common-law claim imposes is
important.” Post, at 12, n. 5. As Bates makes clear,
“[t]he proper inquiry calls for an examination of the
elements of the common-law duty at issue; it does not call for
speculation as to whether a jury verdict will prompt the
manu-facturer to take any particular action.” 544 U. S.,
at 445 (citation omitted). Here, as we have tried to make clear,
the duty to ensure that one’s products are not
“unreasonably dangerous” imposed by New
Hampshire’s design-defect cause of action, Vautour, 147 N.
H., at 153, 784 A. 2d, at 1181, involves a duty to make one of
several changes. In cases where it is impossible—in fact or
by law—to alter a product’s design (and thus to
increase the product’s “usefulness” or decrease
its “risk of danger”), the duty to render a product
“reasonably safe” boils down to a duty to ensure
“the presence and efficacy of a warning to avoid an
unreasonable risk of harm from hidden dangers or from foreseeable
uses.” Id., at 154, 784 A. 2d, at 1182. The duty to
redesign sulindac’s label was thus a part of the common-law
duty at issue—not merely an action Mutual might have been
prompted to take by the adverse jury verdict here.

															     Finally, the dissent
laments that we have ignored “Congress’ explicit
efforts to preserve state common-law liability.” Post, at 26.
We have not. Suffice to say, the Court would welcome
Congress’ “explicit” resolution of the difficult
pre-emption questions that arise in the prescription drug context.
That issue has repeatedly vexed the Court—and produced widely
divergent views—in recent years. See, e.g., Wyeth v. Levine,
555 U. S. 555 (2009) ; PLIVA, 564 U. S. ___. As the
dissent concedes, however, the FDCA’s treatment of
prescription drugs includes neither an express pre-emption clause
(as in the vaccine context, 42 U. S. C.
§300aa–22(b)(1)), nor an express non-pre-emption clause
(as in the over-the-counter drug context, 21 U. S. C.
§§379r(e), 379s(d)). In the absence of that sort of
“explicit” expression of congressional intent, we are
left to divine Congress’ will from the duties the statute
imposes. That federal law forbids Mutual to take actions required
of it by state tort law evinces an intent to pre-empt.

															*  *  *

															     This case arises out
of tragic circumstances. A combination of factors combined to
produce the rare and devastating injuries that respondent suffered:
the FDA’s decision to approve the sale of sulindac and the
warnings that accompanied the drug at the time it was prescribed,
the decision by respondent’s physician to prescribe sulindac
despite its known risks, and Congress’ decision to regulate
the manufacture and sale of generic drugs in a way that reduces
their cost to patients but leaves generic drug manufacturers
incapable of modifying either the drugs’ compositions or
their warnings. Respondent’s situation is tragic and evokes
deep sympathy, but a straightforward application of pre-emption law
requires that the judgment below be reversed.

															It is so ordered. Notes 1 We can thus save for
another day the question whether a trueabsolute-liability state-law
system could give rise to impossibilitypre-emption. As we have
noted, most common-law causes of action for negligence and strict
liability do not exist merely to spread risk, but rather impose
affirmative duties. See Riegel v. Medtronic, Inc., –324
(2008) (“In [Medtronic, Inc. v. Lohr, ], five Justices
concluded that common-law causes of action for negligence and
strict liability do impose ‘requirement[s]’ and would
be pre-empted by federal requirements specific to a medical device.
. . . We adhere to that view”); id., at 324 (“Absent
other indication, reference to a State’s
‘requirements’ includes its common-law duties. As the
plurality opinion said in Cipollone [v. Liggett Group, (1992)],
common-law liability is ‘premised on the existence of a legal
duty,’ and a tort judgment therefore establishes that the
defendant has violated a state-law obligation”). 2 That Mutual’s
liability turned on the adequacy of sulindac’s warnings is
not unusual. Rather, New Hampshire—like a large majority of
States—has adopted comment k to §402A of the Restatement
(Second) of Torts, which recognizes that it is “especially
common in the field of drugs” for products to be
“incapable of being made safe for their intended and ordinary
use.” Restatement 2d, at 353; Bellotte v. Zayre Corp.,116 N.
H. 52, 54–55, 352 A. 2d 723, 725 (1976). Under comment k,
“[s]uch a product, properly prepared, and accompanied by
proper directions and warning, is not defective, nor is it
unreasonably dangerous.” Restatement 2d, at 353–354.
This Court has previously noted that, as of 1986, “a large
number of courts” took comment k to mean that manufacturers
“did not face strict liability for side effects of properly
manufactured prescription drugs that were accompanied by adequate
warnings.” Bruesewitz v. Wyeth, 562 U. S. ___, ___, n.
41 (2011) (slip op., at 10, n. 41). Mutual withdrew its comment k
defense “for purposes of the trial of this matter.”
Defendant’s Notice of Withdrawal of Defenses, in Case No.
08–cv–358–JL (D NH), p. 1. However, as noted
above, bothrespondent and the trial court injected the broader
question of the adequacy of sulindac’s label into the trial
proceedings. 3 Justice Breyer argues
that it is not “literally impossible” for Mutual to
comply with both state and federal law because it could escape
liability “either by not doing business in the relevant State
or by paying the state penalty, say damages, for failing to comply
with, as here, a state-law tort standard.” Post, at 1
(dissenting opinion). But, as dis-cussed below, infra, at
15–16—leaving aside the rare case in which state or
federal law actually requires a product to be pulled from the
market—our pre-emption cases presume that a
manufacturer’s ability to stop selling does not turn
impossibility into possibility. See, e.g., Florida Lime &
Avocado Growers, Inc. v. Paul, (There would be “impossibility
of dual compliance” where “federal orders forbade the
picking and marketing of any avocado testingmore than 7% oil, while
the California test excluded from the State any avocado measuring
less than 8% oil content”). And, of course, PLIVA, Inc. v.
Mensing, 564 U. S. ___ (2011), forecloses any argument that
impossibility is defeated by the prospect that a manufacturer could
“pa[y] the state penalty” for violating a state-law
duty; that prospect would have defeated impossibility in PLIVA as
well. See id., at ___ (slip op., at 12) (“[I]t was impossible
for the Manufacturers to comply with both their state-law duty to
change the label and their federal law duty to keep the label the
same”). To hold otherwise would render impossibility
pre-emption “all but meaningless.” Id., at ___ (slip
op.,at 14). 4 We do not address state
design-defect claims that parallel the federal misbranding statute.
The misbranding statute requires a manufac-turer to pull even an
FDA-approved drug from the market when it is “dangerous to
health” even if “used in the dosage or manner, or with
the frequency or duration prescribed, recommended, or suggested in
the labeling thereof.” ; cf. Bates v. Dow Agrosciences LLC,
(state-law pesticide labeling requirement not pre-empted under
express pre-emption provision, provided it was “equivalent
to, and fully consistent with, [federal] misbranding
provisions”). The parties and the Government appear to agree
that a drug is misbranded under federal law only when liability is
based on new and scientifically significant information that was
not before the FDA. Because the jury was not asked to find whether
new evidence concerning sulindac that had not been made available
to the FDA rendered sulindac so dangerous as to be misbranded under
the federal misbranding statute, the misbranding provision is not
applicable here. Cf. 760 F. Supp. 2d 220, 233 (NH 2011) (most
of respondent’s experts’ testimony was “drawn
directly from the medical literature or published FDA
analyses”). 5 Respondent attempts to
distinguish this case from PLIVA, arguing that “[w]here, as
in PLIVA, state law imposes an affirmative duty on a manufacturer
to improve the product’s label, suspending sales does not
comply with the state-law duty; it merely offers an indirect means
of avoiding liability for noncompliance with that duty.”
Brief for Respondent 39. But that difference is purely semantic:
the state-law duty in PLIVA to amend metoclopramide’s label
could just as easily have been phrased as a duty not to sell the
drug without adequate warnings. At least where a State imposes
liability based on a balancing of a product’s harms and
benefits in light of its labeling—rather than directly
prohibiting the product’s sale—the mere fact that a
manufacturer may avoid liability by leaving the market does not
defeat a claim of impossibility. SUPREME COURT OF THE UNITED STATES

															_________________

															No. 12–142

															_________________

															MUTUAL PHARMACEUTICAL COMPANY, INC.,
PETITIONER v. KAREN L. BARTLETT

															on writ of certiorari to the united states
court of appeals for the first circuit

															[June 24, 2013]

															     Justice Breyer, with
whom Justice Kagan joins, dissenting.

															     It is not literally
impossible here for a company like petitioner to comply with
conflicting state and federal law. A company can comply with both
either by not doing busi- ness in the relevant State or by paying
the state pen- alty, say damages, for failing to comply with, as
here, a state-law tort standard. See post, at 16–18
(Sotomayor, J., dissenting). But conflicting state law that
requires a company to withdraw from the State or pay a sizable
damages remedy in order to avoid the conflict between state and
federal law may nonetheless “ ‘stan[d] as an
obstacle to the accomplishment’ of” the federal
law’s ob- jective, in which case the relevant state law is
pre-empted. Post, at 17 (quoting Crosby v. National Foreign Trade
Coun-cil, 530 U. S. 363, 373 (2000) ).

															     Normally, for the
reasons I set forth in Medtronic, Inc. v. Lohr, 518 U. S. 470,
503 (1996) (opinion concurring in part and concurring in judgment),
in deciding whether there is such a conflict I would pay particular
attention to the views of the relevant agency, here the Food and
Drug Administration (FDA). Where the statute contains no clear
pre-emption command, courts may infer that the administrative
agency has a degree of leeway to determine the extent to which
governing statutes, rules, regulations, or other administrative
actions have pre-emptive effect. See id., at 505–506 (citing
Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735
–741 (1996); Hillsborough County v. Automated Medical
Laboratories, Inc., 471 U. S. 707, 721 (1985) ; Lawrence
County v. Lead-Deadwood School Dist. No. 40–1, 469 U. S.
256 –262 (1985); Chevron U. S. A. Inc. v. Natural
Resources Defense Council, Inc., 467 U. S. 837 –845
(1984)). See also Wyeth v. Levine, 555 U. S. 555 –577
(2009). Cf. Skidmore v. Swift & Co., 323 U. S. 134, 140
(1944) . The FDA is responsible for administering the relevant
federal statutes. And the question of pre-emption may call for
considerable drug-related expertise. Indeed, one might infer that,
the more medically valuable the drug, the less likely Congress
intended to permit a State to drive it from the marketplace.

															     At the same time, the
agency can develop an informed position on the pre-emption question
by providing interested parties with an opportunity to present
their views. It can translate its understandings into particular
pre-emptive intentions accompanying its various rules and
regulations. And “[i]t can communicate those intentions
 . . . through statements in
‘regulations, preambles, interpretive statements, and
responses to comments.’ ” Medtronic, supra, at 506
(opinion of Breyer, J.). (quoting Hillsbor-ough, supra, at
718).

															     Here, however, I cannot
give special weight to the FDA’s views. For one thing, as far
as the briefing reveals, the FDA, in developing its views, has held
no hearings on the matter or solicited the opinions, arguments, and
views of the public in other ways. For another thing, the FDA has
set forth its positions only in briefs filed in litigation, not in
regulations, interpretations, or similar agency work product. See
Bowen v. Georgetown Univ. Hospital, 488 U. S. 204 –213
(1988) (“[A]gency litigating positions that are wholly
unsupported by regulations, rulings, or administrative
practice” are entitled to less than ordinary weight). Cf.
Christensen v. Harris County, 529 U. S. 576, 587 (2000) .

															     Finally, the FDA has
set forth conflicting views on this general matter in different
briefs filed at different times. Compare Wyeth, supra, at 577, 579,
580, n. 13 (noting that the FDA had previously found no
pre-emption, that the United States now argued for pre-emption, and
that this new position was not entitled to deference), with PLIVA,
Inc. v. Mensing, 564 U. S. ___, ___, n. 3, ___ (2011)
(slip op., at 6–7, n. 3, 8–11) (declining to defer
to the United States’ argument against pre-emption and,
instead, finding pre-emption), and with Brief for United States as
Amicus Curiae 12–13 (now arguing, again, for pre-emption).
See National Cable & Telecommunications Assn. v. Brand X
Internet Services, 545 U. S. 967, 981 (2005) (agency views
that vary over time are accorded less weight); Motor Vehicle Mfrs.
Assn. of United States, Inc. v. State Farm Mut. Automobile Ins.
Co., 463 U. S. 29 –42 (1983) (same); Verizon
Communications Inc. v. FCC, 535 U. S. 467 , n. 20 (2002)
(same).

															     Without giving the
agency’s views special weight, I would conclude that it is
not impossible for petitioner to comply with both state and federal
regulatory schemes and that the federal regulatory scheme does not
pre-empt state common law (read as potentially requiring petitioner
to pay damages or leave the market). As two former FDA
Commissioners tell us, the FDA has long believed that state tort
litigation can “supplemen[t] the agency’s regulatory
and enforcement activities.” Brief for Donald Ken- nedy
et al. as Amici Curiae 5. See also Wyeth, supra, at 578
(“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”).

															     Moreover, unlike the
federal statute at issue in Medtronic, the statute before us
contains no general pre-emption clause. See 518 U. S., at
481–482. Cf. Wyeth, supra, at 574 (presence of pre-emption
clause could show that “Congress thought state-law suits
posed an obstacle to its objectives”). Furthermore, I have
found no con- vincing reason to believe that removing this
particular drug from New Hampshire’s market, or requiring
damage payments for it there, would be so harmful that it would
seriously undercut the purposes of the federal statutory scheme.
Cf. post, at 21–22.

															     Finally, similarly
situated defendants in other cases remain free to argue for
“obstacle pre-emption” in respect to damage payments or
market withdrawal, and demonstrate the impossibility-of-compliance
type of conflict that, in their particular cases, might create true
incompatibility between state and federal regulatory schemes.

															     For these reasons, I
respectfully dissent. SUPREME COURT OF THE UNITED STATES

															_________________

															No. 12–142

															_________________

															MUTUAL PHARMACEUTICAL COMPANY, INC.,
PETITIONER v. KAREN L. BARTLETT

															on writ of certiorari to the united states
court of appeals for the first circuit

															[June 24, 2013]

															     Justice Sotomayor,
with whom Justice Ginsburg joins, dissenting.

															     In PLIVA, Inc. v.
Mensing, 564 U. S. ___ (2011), this Court expanded the scope
of impossibility pre-emption to immunize generic drug manufacturers
from state-law failure-to-warn claims. Today, the Court
unnecessarily and unwisely extends its holding in Mensing to
pre-empt New Hampshire’s law governing design-defects with
respect to generic drugs.

															     The Court takes this
step by concluding that petitioner Mutual Pharmaceutical was held
liable for a failure-to-warn claim in disguise, even though the
District Court clearly rejected such a claim and instead allowed
liability on a distinct theory. See infra, at 13–15. Of
greater consequence, the Court appears to justify its revision of
respondent Karen Bartlett’s state-law claim through an
im-plicit and undefended assumption that federal law gives
pharmaceutical companies a right to sell a federally approved drug
free from common-law liability. Remarkably, the Court derives this
proposition from a federal law that, in order to protect consumers,
prohibits manufacturers from distributing new drugs in commerce
without federal regulatory approval, and specifically disavows any
intent to displace state law absent a direct and positive
conflict.

															     Karen Bartlett was
grievously injured by a drug that a jury found was unreasonably
dangerous. The jury relied upon evidence that the drug posed a
higher than normal risk of causing the serious skin reaction that
produced her horrific injuries; carried other risks; and possessed
no apparent offsetting benefits compared to similar pain relievers,
like aspirin. See 760 F. Supp. 2d 220, 233–241,
243–244 (NH 2011). The Court laments her “tragic”
situation, ante, at 20, but responsibility for the fact that Karen
Bartlett has been deprived of a remedy for her injuries rests with
this Court. If our established pre-emption principles were properly
applied in this case, and if New Hampshire law were correctly
construed, then federal law would pose no barrier to Karen
Bartlett’s recovery. I re-spectfully dissent.

															I

															     I begin with
“two cornerstones of our pre-emption jurisprudence,”
Wyeth v. Levine, 555 U. S. 555, 565 (2009) , that should
control this case but are conspicuously absent from the majority
opinion. First, “ ‘the purpose of Congress is the
ultimate touchstone’ in every pre-emption case.” Ibid.
(quoting Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) ).
Second, we start from the “assumption that the historic
police powers of the States [are] not to be superseded by [a]
Federal Act unless that was the clear and manifest purpose of
Congress.” Rice v. Santa Fe Elevator Corp., 331 U. S.
218, 230 (1947) . “That assumption,” we have explained,
“applies with particular force when,” as is the case
here, “Congress has legislated in a field traditionally
occupied by the States.” Altria Group, Inc. v. Good, 555
U. S. 70, 77 (2008) . [ 1 ]

															     The Court applied both
of these principles to the Fed-eral Food, Drug, and Cosmetic Act
(FDCA), ch. 675, 52Stat. 1040, as amended, 21 U. S. C.
§301 et seq., in Levine, where we held that a state
failure-to-warn claim against a brand-name drug manufacturer was
not pre-empted by federal law. 555 U. S., at 581. Tracing the
history of federal drug regulation from the 1906 Federal Food and
Drugs Act, 34Stat. 768, up to the FDCA and its major amendments,
the Court explained that federal drug law and state common-law
liability have long been understood to operate in tandem to promote
consumer safety. See Levine, 555 U. S., at 566–568, 574.
That basic principle, which the majority opinion elides, is
essential to understanding this case.

															     The FDCA prohibits the
“introduction into interstate commerce [of ] any new
drug” without prior approval from the United States Food and
Drug Administration (FDA). 21 U. S. C. §355(a).
Brand-name and generic drug manufacturers are required to make
different showings to receive agency approval in this premarketing
review process. See ante, at 2–3. But in either case, the
FDA’s per- mission to market a drug has never been regarded
as a final stamp of approval of the drug’s safety. Under the
FDCA, manufacturers, who have greater “access to information
about their drugs” than the FDA, Levine, 555 U. S., at
578–579, retain the ultimate responsibility for the safety of
the products they sell. In addition to their ongoing obligations to
monitor a drug’s risks and to report adverse drug responses
to the FDA, see 21 CFR §§314.80, 314.81, 314.98 (2012),
manufacturers may not sell a drug that is “deemed to be
misbranded” because it is “dangerous to health”
when used in the dosage or manner called for in the drug’s
label. 21 U. S. C. §352(j); see §331(a); Brief
for United States as Amicus Curiae 30–31 (hereinafter
U. S. Brief) (indicating that the misbranding prohibition may
apply to a drug that was previously approved for sale when
significant new scientific evidence demonstrates that the drug is
unsafe).

															     Beyond federal
requirements, state common law plays an important
“complementary” role to federal drug regulation.
Levine, 555 U. S., at 578. Federal law in this area was
initially intended to “supplemen[t] the protection for
consumers already provided by state regulation and common-law
liability.” Id., at 566. And as Congress “enlarged the
FDA’s powers,” it “took care to preserve state
law.” Id., at 567. In the 1962 amendments to the FDCA, which
established the FDA’s premarketing review in its modern form,
Congress adopted a saving clause providing that the amendments
should not be construed to invalidate any provision of state law
absent “a direct and positive conflict.” §202,
76Stat. 793. And in the years since, with “state common-law
suits ‘continu[ing] unabated de-spite . . . FDA
regulation,’ ” Levine, 555 U. S., at 567
(quoting Riegel v. Medtronic, Inc., 552 U. S. 312, 340 (2008)
(Ginsburg, J., dissenting)), Congress has not enacted a pre-emption
provision for prescription drugs (whether brand-name or generic)
even as it enacted such provisions with respect to other products
regulated by the FDA. [ 2 ]

															     Congress’
preservation of a role for state law generally, and common-law
remedies specifically, reflects a realistic understanding of the
limitations of ex ante federal regu-latory review in this context.
On its own, even rig- orous preapproval clinical testing of drugs
is “generally . . . incapable of detecting adverse
effects that oc- cur infrequently, have long latency periods, or
affect subpopulations not included or adequately represented in the
studies.” Kessler & Vladeck, A Critical Examina- tion of
the FDA’s Efforts to Preempt Failure-to-Warn Claims, 96 Geo.
L. J. 461, 471 (2008); see National Academies, Institute of
Medicine, The Future of Drug Safety: Promoting and Protecting the
Health of the Public 37–38 (2007) (hereinafter Future of Drug
Safety) (discussing limitations “inherent” to a system
of premarket clinical trials). Moreover, the FDA, which is tasked
with monitoring thousands of drugs on the market and considering
new drug applications, faces significant resource constraints that
limit its ability to protect the public from dangerous drugs. See
Levine, 555 U. S., at 578–579, and n. 11; Brief for
Former FDA Commissioner Donald Kennedy et al. as Amici Curiae
6–7, 12–20. Tort suits can help fill the gaps in
federal regulation by “serv[ing] as a catalyst” to
identify previously unknown drug dangers. Bates v. Dow Agrosciences
LLC, 544 U. S. 431, 451 (2005) .

															     Perhaps most
significant, state common law provides injured consumers like Karen
Bartlett with an opportu-nity to seek redress that is not available
under federal law. “[U]nlike most administrative and
legislative regulations,” common-law claims
“necessarily perform an important re-medial role in
compensating accident victims.” Sprietsma v. Mercury Marine,
537 U. S. 51, 64 (2002) . While the Court has not always been
consistent on this issue, it has repeatedly cautioned against
reading federal statutes to “remove all means of judicial
recourse for those injured” when Congress did not provide a
federal remedy. Silkwood v. Kerr-McGee Corp., 464 U. S. 238,
251 (1984) ; see e.g., Bates, 544 U. S., at 449; Lohr, 518
U. S., at 487 (plurality opinion). And in fact, the
legislative history of the FDCA suggests that Congress chose not to
create a federal cause of action for damages precisely because it
believed that state tort law would allow injured consumers to
obtain compensation. See Levine, 555 U. S., at 574–575,
and n. 7.

															II

															     In light of this
background, Mutual should face an uphill climb to show that federal
law pre-empts a New Hampshire strict-liability claim against a
generic drug manufacturer for defective design. The majority
nevertheless accepts Mutual’s argument that “compliance
with both federal and state [law was] a physical
impossibility.” Florida Lime & Avocado Growers, Inc. v.
Paul, 373 U. S. 132 –143 (1963); see ante, at 7. But if
state and fed-eral law are properly understood, it is clear that
New Hampshire’s design-defect claim did not impose a legal
obligation that Mutual had to violate federal law to satisfy.

															A

															     Impossibility
pre-emption “is a demanding defense,” Le-vine, 555
U. S., at 573, that requires the defendant to show an
“irreconcilable conflict” between federal and state
legal obligations, Silkwood, 464 U. S., at 256. The logic
underlying true impossibility pre-emption is that when state and
federal law impose irreconcilable affirmative requirements, no
detailed “inquiry into congressional de-sign” is
necessary because the inference that Congress would have intended
federal law to displace the conflicting state requirement “is
inescapable.” Florida Lime, 373 U. S., at 142–143.
So, for example, if federal law requires a particular product label
to include a complete list of ingredients while state law
specifically forbids that labeling practice, there is little
question that state law “must yield.” Felder v. Casey,
487 U. S. 131, 138 (1988) .

															     The key inquiry for
impossibility pre-emption, then, is to identify whether state and
federal law impose directly conflicting affirmative legal
obligations such that state law “require[s] the doing of an
act which is unlawful under” federal law. California Fed.
Sav. & Loan Assn. v. Guerra, 479 U. S. 272, 292 (1987) .
Impossibility does not exist where the laws of one sovereign permit
an activity that the laws of the other sovereign restricts or even
prohibits. See Barnett Bank of Marion Cty., N. A. v. Nelson,
517 U. S. 25, 31 (1996) ; Michigan Canners & Freezers
Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467
U. S. 461, 478, n. 21 (1984) . So, to modify the previous
example, if federal law permitted (but did not require) a labeling
practice that state law prohibited, there would be no
irreconcilable conflict; a manufacturer could com- ply with the
more stringent regulation. And by the same logic, impossibility
does not exist where one sovereign’s laws merely create an
incentive to take an action that the other sovereign has not
authorized because it is possible to comply with both laws.

															     Of course, there are
other types of pre-emption. Courts may find that state laws that
incentivize what federal law discourages or forbid what federal law
authorizes are pre-empted for reasons apart from impossibility: The
state laws may fall within the scope of an express pre-emption
provision, pose an obstacle to federal purposes and objectives, or
intrude upon a field that Congress intended for federal law to
occupy exclusively. See Crosby v. National Foreign Trade Council,
530 U. S. 363 –373 (2000). But absent a direct conflict
between two mutually incompatible legal requirements, there is no
impossibility and courts may not automatically assume that Congress
intended for state law to give way. Instead, a more careful inquiry
into congressional intent is called for, and that inquiry should be
informed by the presumption against pre-emption.

															     In keeping with the
strict standard for impossibility, cases that actually find
pre-emption on that basis are rare. See Abrams, Plenary Power
Preemption, 99 Va. L. Rev. 601, 608 (2013). Mensing is an
outlier, as the Court found impossibility because a generic drug
manufacturer could not strengthen its product label to come into
line with a state-law duty to warn without the exercise of judgment
by the FDA. See 564 U. S., at ___–___ (slip op., at
13–14). But nothing in Mensing, nor any other precedent,
dictates finding impossibility pre-emption here.

															B

															     To assess whether it
is physically impossible for Mutual to comply with both federal and
state law, it is necessary to identify with precision the relevant
legal obligations imposed under New Hampshire’s design-defect
cause of action.

															     The majority insists
that Mutual was required by New Hampshire’s design-defect law
to strengthen its warning label. In taking this position, the
majority effectively re-characterizes Bartlett’s
design-defect claim as a de facto failure-to-warn claim. The
majority then relies on that re-characterization to hold that the
jury found Mutual liable for failing to fulfill its duty to label
sulindac adequately, which Mensing forbids because a generic drug
manufacturer cannot independently alter its safety label. Ante, at
13; see Mensing, 564 U. S., at ___ (slip op., at 10). But the
majority’s assertion that Mutual was held liable in this case
for violating a legal obligation to change its label is
inconsistent with both New Hampshire state law and the record.

															     For its part, Mutual,
in addition to making the argument now embraced by the majority,
contends that New Hampshire’s design-defect law effectively
required it to change the chemical composition of sulindac. Mutual
claims that it was physically impossible to comply with that duty
consistent with federal law because drug manufacturers may not
change the chemical composition of their products so as to create
new drugs without submitting a new drug application for FDA
approval. See 21 CFR §§310.3(h), 314.70(b)(2)(i). But
just as New Hampshire’s design-defect law did not impose a
legal obligation for Mutual to change its label, it also did not
mandate that Mutual change the drug’s design.

															1

															a

															     Following blackletter
products liability law under §402A of the Restatement (Second)
of Torts (1963–1964) (hereinafter Second Restatement), New
Hampshire recognizes strict liability for three different types of
product defects: manufacturing defects, design defects, and warning
defects. See Cheshire Medical Center v. W. R. Grace & Co.,
49 F. 3d 26, 29 (CA1 1995). Because the District Court granted
Mutual summary judgment on Bartlett’s failure-to-warn claim,
only New Hampshire’s design-defect cause of action remains at
issue in this case.

															     A product has a
defective design under New Hampshire law if it “poses
unreasonable dangers to consumers.” Thibault v. Sears,
Roebuck & Co., 118 N. H. 802, 807, 395 A. 2d 843, 846
(1978). To determine whether a product is unreasonably dangerous, a
jury is asked to make a risk-benefit assessment by considering a
nonexhaustive list of factors. See ante, at 9–10. In
addition, New Hamp-shire has specifically rejected the doctrine,
advocated by the Restatement (Third) of Torts: Products Liability
§2(b) (1997) (hereinafter Third Restatement), that a plaintiff
must present evidence of a reasonable alternative design to show
that a product’s design is defective. Instead, “while
proof of an alternative design is relevant in a design defect
case,” it is “neither a controlling factor nor an
essential element.” Vautour v. Body Masters Sports
Industries, Inc., 147 N. H. 150, 156, 784 A. 2d 1178,
1183 (2001).

															     While some
jurisdictions have declined to apply design-defect liability to
prescription drugs, New Hampshire, in common with many other
jurisdictions, does subject prescriptions drugs to this distinct
form of strict products liability. See 678 F. 3d 30, 35 (CA1
2012) (citing Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d
652, 655 (CA1 1981)); see also Third Restatement §6, Comment f
(collecting cases from other jurisdictions). Drug manufacturers in
New Hampshire have an affirmative defense under comment k to
§402A of the Second Restatement, which exempts
“[u]navoidably unsafe products” from strict liability
if the product is properly manufactured and labeled. As explained
by the lower courts in this case, see 678 F. 3d, at 36; 731
F. Supp. 2d 135, 150–151 (NH 2010), New Hampshire takes
a case-by-case approach to comment k under which a defendant
seeking to invoke the defense must first show that the product is
highly useful and that the dan-ger imposed by the product could not
have been avoided through a feasible alternative design. See
Brochu, 642 F. 2d, at 657. Comment k did not factor into the
jury’s assessment of liability in this case because Mutual
abandoned a comment k defense before trial. Ante, at 12, n. 2.
[ 3 ]

															b

															     The design-defect
claim that was applied to Mutual subjects the manufacturer of an
unreasonably dangerous product to liability, but it does not
require that manufacturer to take any specific action that is
forbidden by federal law. Specifically, and contrary to the
majority, see ante, at 11, New Hampshire’s design-defect law
did not require Mutual to change its warning label. A drug’s
warning label is just one factor in a nonexclusive list for
evaluating whether a drug is unreasonably dangerous, see Vautour,
147 N. H., at 156, 784 A. 2d, at 1183, and an adequate
label is therefore neither a necessary nor a sufficient con-dition
for avoiding design-defect liability. Likewise, New Hampshire law
imposed no duty on Mutual to change sulindac’s chemical
composition. The New Hampshire Supreme Court has held that proof of
an alternative fea-sible design is not an element of a
design-defect claim, see Kelleher v. Marvin Lumber & Cedar Co.,
152 N. H. 813, 831, 891 A. 2d 477, 492 (2006), and as the
majority recognizes, ante, at 11, sulindac was not realistically
capable of being redesigned anyway because it is a single-molecule
drug. [ 4 ]

															     To be sure, New
Hampshire’s design-defect claim creates an incentive for drug
manufacturers to make changes to its product, including to the
drug’s label, to try to avoid liability. And respondent
overstates her case somewhat when she suggests that New
Hampshire’s strict-liability law is purely compensatory. See
Brief for Respondent 19. As is typically true of strict-liability
regimes, New Hampshire’s law, which mandates compensation
only for “defective” products, serves both compensatory
and regulatory purposes. See Heath v. Sears, Roebuck & Co., 123
N. H. 512, 521–522, 464 A. 2d 288, 293 (1983). But
exposure to liability, and the “incidental regulatory
effects” that flow from that exposure, Goodyear Atomic Corp.
v. Miller, 486 U. S. 174 –186 (1988), is not equivalent
to a legal mandate for a regulated party to take (or refrain from
taking) a specific action. This difference is a significant one: A
mandate leaves no choice for a party that wishes to comply with the
law, whereas an incentive may only influence a choice.

															     Our cases reflect this
distinction. In Bates, for exam-ple, we rejected an argument that
design-defect claims brought against a pesticide manufacturer were
pre-empted because they would likely “induce” the
manufacturer to change its product label and thus run afoul of an
express pre-emption provision forbidding state labeling
“requirements” that were different or in addition to
federal requirements. 544 U. S., at 444–446. A
requirement, we explained, “is a rule of law that must be
obeyed.” Id., at 445. “[A]n event, such as a jury
verdict, that merely motivates an optional decision,” does
not rise to that level. Ibid. [ 5 ]

															     So too here. The fact
that imposing strict liability for injuries caused by a defective
drug design might make a drug manufacturer want to change its label
or design (or both) does not mean the manufacturer was actually
required by state law to take either action. And absent such a
legal obligation, the majority’s impossibility argument does
not get off the ground, because there was no state requirement that
it was physically impossible for Mutual to comply with while also
following federal law. The case is therefore unlike Mensing, where
it was “undisputed” that applicable state tort law
“require[d] a drug manufacturer that is or should be aware of
its product’s danger” to strengthen its label—a
requirement that conflicted with federal law preventing the
manufacturer from doing so uni-laterally, 564 U. S., at ___,
___ (slip op., at 4, 11–12). New Hampshire’s
design-defect law did not require Mu-tual to do anything other than
to compensate consumers who were injured by an unreasonably
dangerous drug.

															2

															     Moreover, the trial
record in this case confirms that, con-trary to the
majority’s insistence, Mutual was not held liable for
“breach[ing] [its] duty” “to label sulindac
adequately.” Ante, at 13.

															     When Bartlett filed
suit against Mutual, she raised distinct claims based on design
defect and failure to warn. App. 102–108; see 659
F. Supp. 2d 279, 282 (NH 2009). Pursuing both claims was
consistent with New Hampshire law’s recognition that
“design defect and failure to warn claims are
separate.” LeBlanc v. American Honda Motor Co., 141
N. H. 579, 586, 688 A. 2d 556, 562 (1997). After the
District Court granted summary judgment to Mutual on the
failure-to-warn claim, the court repeatedly explained that an
alleged failure to warn by Mutual could not and did not provide the
basis for Bartlett’s recovery. See 760 F. Supp. 2d, at
248–249. [ 6 ]

															     The majority notes that
the District Court admitted evidence regarding sulindac’s
label. Ante, at 11–12. But the court did so because the label
remained relevant for the more limited purpose of assessing, in
combination with other factors, whether sulindac’s design was
defective because the product was unreasonably dangerous. See 678
F. 3d, at 41. The District Court’s instructions to the
jury adhered to this limited purpose. The court first told the jury
to determine whether sulindac was unreasonably dangerous by
weighing its danger against its utility. App. 513. The court
further instructed the jury that if it determined that sulindac was
unreasonably dangerous without reference to the warning label, it
could then consider the presence and efficacy of the label to
evaluate whether the product was unreasonably dangerous “even
with its warning.” Id., 513–514. In other words, to
hold Mutual liable, the jury was required to find that sulindac
“was unreasonably dangerous despite its warning, not because
of it.” Id., at 341. The District Court also explained to the
jury that because Bartlett’s claim addressed only whether
sulindac’s design was defective, Mutual’s conduct,
“which included any failure to change its warning, was
‘not relevant to this case.’ ” 760
F. Supp. 2d, at 248.

															     The distinction drawn
by the District Court between permissible and impermissible uses of
evidence regarding sulindac’s label is faithful to New
Hampshire law. That law recognizes that the effectiveness of a
warning label is just one relevant factor in determining whether a
product’s design is unreasonably dangerous, and that
design-defect and failure-to-warn claims are
“separate.” LeBlanc, 141 N. H., at 586, 688
A. 2d, at 562. [ 7 ] In
short, as the District Court made clear, Mutual was not held liable
for “failing to change” its warning. 760 F. Supp.,
at 248–249.

															C

															     Given the distinction
that New Hampshire draws between failure-to-warn claims and
design-defect claims, as well as the clear and repeated statements
by the trial judge that Mutual’s liability was not predicated
on breaching a duty to label sulindac adequately, on what basis
does the majority reach a contrary conclusion? Though the majority
insists otherwise, ante, at 17, it appears to rely principally on
an implicit assumption about rights conferred by federal premarket
approval under the FDCA. After correctly observing that changing
sulindac’s chemical composition would create a new drug that
would have to go through its own approval process, the majority
reasons that Mutual must have been under a state-law duty to change
its label because it had no other option to avoid liability while
continuing to sell its product. Ante, at 10–11. But that
conclusion is based on a false premise.

															     A manufacturer of a
drug that is unreasonably dangerous under New Hampshire law has
multiple options: It can change the drug’s design or label in
an effort to alter its risk-benefit profile, remove the drug from
the market, or pay compensation as a cost of doing business. If
federal law or the drug’s chemical properties take the
redesign option off the table, then that does not mean the
manufacturer suddenly has a legal obligation under state law to
improve the drug’s label. Indeed, such a view of state law
makes very little sense here because even if Mutual had
strengthened its label to fully account for sulindac’s risks,
the company might still have faced liability for having a defective
design. See Thibault, 118 N. H., at 808, 395 A. 2d, at
847 (explaining that strict liability “may attach even though
. . . there was an adequate warning”). When a
manufacturer cannot change the label or when doing so would not
make the drug safe, the manufacturer may still choose between
exiting the market or continuing to sell while knowing it may have
to pay compensation to consumers injured by its product. [ 8 ]

															     From a
manufacturer’s perspective, that may be an un-welcome choice.
But it is a choice that a sovereign State may impose to protect its
citizens from dangerous drugs or at least ensure that seriously
injured consumers receive compensation. That is, a State may impose
such a choice unless the FDCA gives manufacturers an absolute right
to sell their products free from common-law liability, or state law
otherwise “stands as an obstacle to the accomplishment”
of federal objectives. Crosby, 530 U. S., at 373 (internal
quotation marks omitted). Because the majority does not rely on
obstacle pre-emption, it must believe that a manufacturer that
received FDA premarket approval has a right not only to keep its
drug on the market unless and until the FDA revokes approval, but
also to be free from state-law liability that makes doing so more
expensive. That proposition is fundamentally inconsistent with the
FDCA’s text, structure, saving clause, and his-tory. See
supra, at 3–6; Levine, 555 U. S., at 583 (Thomas, J.,
concurring in judgment).

															     It is simply incorrect
to say that federal law presupposes that drug manufacturers have a
right to continue to sell a drug free from liability once it has
been approved. Nothing in the language of the FDCA, which is framed
as a prohibition on distribution without FDA approval, see 21
U. S. C. §355(a), suggests such a right. Federal law
itself bars the sale of previously approved drugs if new
information comes to light demonstrating that the drug is
“dangerous to health” and thus
“misbranded.” See §§331(a), 352(j); see
supra, at 3–4. [ 9 ] Even
outside that sce- nario, manufacturers regularly take drugs off the
market when evidence emerges about a drug’s risks, particu-
larly when safer drugs that provide the same therapeutic benefits
are available. [ 10 ]
According to the FDA, while it has formal authority to withdraw
approval for a drug based on new adverse information, see
§355(e), it is far more common for a manufacturer to stop
selling its product voluntarily after the FDA advises the
manufacturer that the drug is unsafe and that its risk-benefit
profile cannot be adequately addressed through labeling changes or
other measures. See U. S. Brief 5.

															     New Hampshire’s
design-defect cause of action thus does no more than provide an
impetus for an action that is permitted and sometimes encouraged or
even required by federal law.

															D

															     The majority derides
any suggestion that Mutual’s ability to “stop
selling” sulindac is relevant to the validity of its
impossibility pre-emption defense. Ante, at 2, 14–16. But the
majority’s argument is built on the mistaken premise that
Mutual is legally obligated by New Hampshire’s design-defect
law to modify its label in a way that federal law forbids. It is
not. See supra, at 11–13. For that reason, rejecting
impossibility pre-emption here would not render the doctrine
“a dead letter” or “ ‘all but
meaningless.’ ” Ante, at 2, 15 (quoting Mensing,
564 U. S., at ___ (slip op., at 14)). On the other hand, it is
the major- ity that “work[s] a revolution in this
Court’s [impossibility] pre-emption case law,” ante, at
2, by inferring a state-law requirement from the steps a
manufacturer might wish to take to avoid or mitigate its exposure
to liability.

															     Not all products can be
made safe for sale with an improved warning or a tweak in design.
New Hampshire, through its design-defect law, has made a judgment
that some drugs that were initially approved for distribution turn
out to be inherently and unreasonably dangerous and should
therefore not be sold unless the manufacturer is willing to
compensate injured consumers. Congressional intent to pre-empt such
a cause of action cannot be gleaned from the existence of federal
specifications that apply to the product if it is sold. Instead,
whether New Hampshire’s design-defect cause-of-action is
pre-empted depends on assessing whether it poses an obstacle to a
federal policy to approve sulindac for use. Yet the major-ity skips
that analysis and instead finds impossibility where it does not
exist by relying on a question-begging assumption that Congress
intended for Mutual to have a way to continue selling sulindac
without incurring common-law liability. See ante, at
9–11.

															     The distinction between
impossibility and obstacle pre-emption is an important one. While
obstacle pre-emption can be abused when courts apply an overly
broad conception of the relevant federal purpose to find
pre-emption, see Levine, 555 U. S., at 601–602 (Thomas,
J., concurring in judgment), it is a useful framework for a case
like this one because it would at least lead the Court to ask the
right questions.

															     For example, properly
evaluating the asserted conflict here through the lens of obstacle
pre-emption would allow the Court to consider evidence about
whether Congress intended the FDA to make an optimal safety
determination and set a maximum safety standard (in which case
state tort law would undermine the purpose) rather than a minimal
safety threshold (in which case state tort law could supplement
it). See, e.g., Williamson v. Mazda Motor of America, Inc., 562
U. S. ___, ___ (2011) (slip op., at 11). By contrast, the
majority’s overbroad impossibility framework takes no account
of how federal drug safety review actually works. Though the
majority gestures to the rigorous nature of the FDA’s review
of new drug ap-plications, ante, at 2–3, nothing in the
majority’s reasoning turns on how the FDA’s
premarketing review operates or on the agency’s capacity to
engage in postmarketing review.

															     In taking the approach
it does, the majority replaces careful assessment of regulatory
structure with an ipse dixit that pharmaceutical companies must
have a way to “escape liability,” ante, at 11, while
continuing to sell a drug that received FDA approval. As a result,
the major-ity effectively makes a highly contested policy judgment
about the relationship between FDA review and state tort
law—treating the FDA as the sole guardian of drug
safety—without defending its judgment and without
con-sidering whether that is the policy judgment that Congress
made. [ 11 ]

															III

															     While the majority
never addresses obstacle pre-emption, Mutual did argue in the
alternative that Bartlett’s design-defect cause of action is
pre-empted because it conflicts with the purposes and objectives of
the FDCA, as supplemented by the Hatch-Waxman Act, 98Stat. 1585.
Though it presents a closer question than the impossibility
argument on which the majority relies, I would reject
Mutual’s obstacle pre-emption defense as well.

															     Mutual’s most
substantial contention is that New Hamp-shire’s design-defect
claim frustrates the policy under-lying the FDCA’s broader
scheme of vesting authority in the FDA as an expert agency to
determine which drug designs should enter and remain in interstate
commerce. The FDA, through an amicus brief filed by the United
States, generally supports this argument. The FDA states that the
question whether a design-defect claim [ 12 ] is pre-empted is “difficult and
close,” and it recognizes that “[s]everal factors do
weigh in favor of finding no preemption,” including the
absence of textual support in the FDCA for the idea that an
approved drug must be made available in any particular State. See
U. S. Brief 12, 21–22. But the FDA ultimately contends
that design-defect claims are pre-empted unless they parallel the
FDCA’s misbranding prohibition because the agency be-lieves
that permitting juries to balance the health risks and benefits of
an FDA-approved drug would undermine the FDA’s drug-safety
determinations and could reduce access to drugs that the FDA has
determined are safe and effective.

															     Our cases 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.’ ” Levine,
555 U. S., at 576 (quoting Geier v. American Honda Motor Co.,
529 U. S. 861, 883 (2000) ). But courts do not “defe[r]
to an agency’s conclusion that state law is
pre-empted,” 555 U. S., at 576, and the tension that the
FDA identifies in an effort to justify complete pre-emption of
design-defect claims for prescription drugs does not satisfy the
“ high threshold [that] must be met if a state law is to
be pre-empted for conflicting with the purposes of a federal
Act,” Chamber of Commerce of United States of America, v.
Whiting, 563 U. S. ___, ___ (2011) (slip op., at 22) (internal
quotation marks omitted); see Silkwood, 464 U. S., at 256.
Given the FDCA’s core purpose of protecting consumers, our
recognition in Levine that state tort law generally complements the
statute’s safety goals, the practical limits on the
FDA’s ability to monitor and promptly address concerns about
drug safety once a drug is in the market, see supra, at 5,
20–21, n. 11, and the absence of any federal remedy for
injured consumers, I would reject this broad obstacle pre-emption
argument as well. [ 13 ]

															IV

															     The most troubling
aspect of the majority’s decision to once again expand the
scope of this Court’s traditionally narrow impossibility
pre-emption doctrine is what it implies about the relationship
between federal premarket review and state common-law remedies more
generally. Central to the majority’s holding is an assumption
that manufacturers must have a way to avoid state-law lia-bility
while keeping particular products in commerce. See ante, at
9–11, 14–15. This assumption, it seems, will always
create an automatic conflict between a federal premarket review
requirement and state-law design-defect liability because premarket
review, by definition, prevents manufacturers from unilaterally
changing their products’ designs. [ 14 ] That is true, for example, of the designs (i.e.,
the chemical composition) of brand-name drugs under the FDCA no
less than it is for generic drugs. See ante, at 3–4.

															     If the creation of such
an automatic conflict is the ultimate end-point of the
majority’s continued expansion of impossibility pre-emption,
then the result is frankly astonishing. Congress adopted the
FDCA’s premarketing approval requirement in 1938 and then
strengthened it in 1962 in response to serious public-health
episodes involving unsafe drugs. See Future of Drug Safety 152. Yet
by the majority’s lights, the very act of creating that
requirement in order to “safeguard the consumer,”
United States v. Sullivan, 332 U. S. 689, 696 (1948) , also
created by operation of law a shield for drug manufacturers to
avoid paying common-law damages under state laws that are also
designed to protect consumers. That is so notwithstanding
Congress’ effort to disclaim any intent to pre-empt all state
law. See supra, at 4. The majority’s reasoning thus
“has the ‘perverse effect’ of granting broad
immunity ‘to an entire industry that, in the judgment of
Congress, needed more stringent regulation.’ ”
Riegel, 552 U. S., at 338 (Ginsburg, J., dissenting) (quoting
Lohr, 518 U. S., at 487 (plurality opinion)).

															     This expanded notion of
impossibility pre-emption threatens to disturb a considerable
amount of state law. The FDCA’s premarket approval process
for prescription drugs has provided a model for the regulation of
many other products. [ 15 ]
In some statutes, Congress has paired premarket regulatory review
with express pre-emption provisions that limit the application of
state common-law remedies, including, in some instances, claims for
defective product design. See, e.g., Riegel, 552 U. S., at
323–325; see supra, at 4, and n. 2. In other instances,
such as with prescription drugs, it has not. Under the
majority’s approach, it appears that design-defect claims are
categorically displaced either way, and Congress’ efforts to
set the boundaries of pre-emption more precisely were largely
academic. This could have serious consequences for product safety.
State design-defect laws play an important role not only in
discovering risks, but also in providing in-centives for
manufacturers to remove dangerous products from the market
promptly. See Levine, 555 U. S., at 578–579; Bates, 544
U. S., at 451; see also Conk, Is There a Design Defect in the
Restatement (Third) of Torts: Products Liability? 109 Yale
L. J. 1087, 1130 (2000) (“The tort system can encourage
FDA regulatory vigor and competence”). If manufacturers of
products that require preapproval are given de facto immunity
from design-defect liability, then the public will have to rely
exclusively on imperfect federal agencies with limited resources
and sometimes limited legal authority to recall approved products.
And consumers injured by those products will have no recourse.

															     The manner in which
Congress has addressed pre-emption with respect to vaccines is
particularly instructive. “[V]accines have been subject to
the same federal premarket approval process as prescription
drugs,” and prior to Congress’ intervention,
“compensation for vaccine-related injuries ha[d] been left
largely to the States.” Bruesewitz v. Wyeth LLC, 562
U. S. ___, ___ (2011) (slip op., at 1). In 1986, in response
to a rise in tort suits that produced instability in the vaccine
market, Congress enacted the National Childhood Vaccine Injury Act
(Vaccine Act), 42 U. S. C. §300aa–22(b)(1).
The Act established a no-fault compensation program funded through
an excise tax on vaccines to compensate individuals injured or
killed by vaccine side effects. “The quid pro quo for
this” system, the Court stated in Bruesewitz, “was the
provision of significant tort-liability protections for vaccine
manufacturers.” 562 U. S., at ___ (slip op., at 4).

															     While Members of this
Court disagreed on the scope of the tort protections the Vaccine
Act was intended to offer, the Act’s history demonstrates
that Congress is perfectly capable of responding when it believes
state tort law may compromise significant federal objectives under
a scheme of premarket regulatory review for products it wants to
make available. And it illustrates that “an important reason
to require that preemption decisions be made by Congress,”
rather than by courts on the basis of an expanded implied
pre-emption doctrine, is Congress’ ability to tie its
pre-emption decisions “to some alternative means for securing
compensation.” Metzger, Federalism and Fed-eral Agency
Reform, 111 Colum. L. Rev. 1, 33 (2011). By instead reaching
out to find pre-emption in a context where Congress never intended
it, the majority leaves consumers like Karen Bartlett to bear
enormous losses on their own.

															*  *  *

															     The Court recognizes
that “[t]his case arises out of tragic circumstances.”
Ante, at 20. And I do not doubt that Members of the majority
personally feel sympathy for Karen Bartlett. But the Court’s
solemn affirmation that it merely discharges its duty to
“follo[w] the law,” ante, at 17, and gives effect to
Congress’ policy judgment, rather than its own, is hard to
accept. By once again expanding the scope of impossibility
pre-emption, the Court turns Congress’ intent on its head and
arrives at a holding that is irreconcilable with our precedents. As
a result, the Court has left a seriously injured consumer without
any remedy despite Congress’ explicit efforts to preserve
state common-law liability.

															     I respectfully
dissent. Notes 1 The majority’s
failure to adhere to the presumption against pre-emption is well
illustrated by the fact that the majority calls on Congress to
provide greater clarity with regard to the “difficult
pre-emption questions that arise in the prescription drug
context.” Ante, at 19–20. Certainly, clear direction
from Congress on pre-emption questions is useful. But the whole
point of the presumption against pre-emption is that congressional
ambiguity should cut in favor of preserving state autonomy. See
Rice v. Santa Fe Elevator Corp., . 2 See (medical devices);
§379r (labeling requirements for nonprescription drugs);
§379s (labeling and packaging requirements for cosmetics);
–22(b)(1) (vaccines). Instructively, Congress included a
saving clause in the statutes addressing nonprescription drugs and
cosmetics, which makes clear that the express pre-emption
provisions in these statutes do not affect state product liability
law. See 21 U. S. C. §§379r(e),
379s(d). 3 Though the majority does
not rely on comment k to find pre-emption, it misleadingly implies
that New Hampshire, like “a large majority of States,”
has applied comment k categorically to prescription drugs to exempt
manufacturers from “ ‘strict liability for side
effects of properly manufactured prescription drugs that [are]
accompanied by ade-quate warnings.’ ” Ante, at 12,
n. 2 (quoting Bruesewitz v. Wyeth LLC, 562 U. S. ___,
___, n. 41 (2011) (slip op., at 10, n. 41). That is in-correct. The
majority also neglects to mention that while some courts have
applied comment k categorically to prescription drug designs,
“[m]ost courts have stated that there is no justification for
giving all prescription drug manufacturers blanket immunity from
strict liability under comment k.” 2 American Law of Products
Liability 3d §17.45,p. 108 (2010). Like New Hampshire courts,
these courts apply comment k on a case-by-case basis. See 1 L.
Frumer & M. Friedman, Products Liability §8.07[5], pp.
8–287 to 8–293 (2012). 4 Because of this feature
of New Hampshire law, it is unnecessary to consider whether the
pre-emption analysis would differ in a jurisdiction that required
proof of a feasible alternative design as an element of
liability. 5 The majority suggests my
account of Bates is “simply misleading,” ante, at 18,
but it simply misses the point. I recognize that, under the
Court’s precedents, common-law duties may qualify as
“requirements,” at least as that term has been used in
express pre-emption provisions in federal law. See Riegel v.
Medtronic, Inc., –324 (2008). But determining precisely what,
if any, specific requirement a state common-law claim imposes is
important. In Bates, the lower court had accepted the same basic
argument that the majority advances here: that the
plaintiffs’ design-defect claim that a pesticide was
“unreasonably dangerous” was “merely a disguised
claim for failure to warn” because success on the claim that
the pesticide was dangerous to crops in soil above a certain pH
level would “necessarily induce” a manufacturer to
change its product’s label to avoid liability. Dow
Agrosciences LLC v. Bates, 332 F. 3d 323, 332–333 (CA5
2003). This Court explicitly rejected the notion that because
design-defect liability might lead a manufacturer to make a label
change, it meant that the State’s design-defect claim imposed
a requirement for labeling or packaging. See 544 U. S., at
445–446. The majority contends that this case is different
because the duty to redesign sulindac’s label was an element
of New Hampshire’s design-defect law. Ante, at 19. But it is
not. See supra, at 11. Rather, altering a product label is merely
one step a manufacturer might take to prevent its product from
being considered unreasonably dangerous, and it is a step that New
Hampshire law recognizes may be insufficient. See infra, at
16. 6 For example, in a ruling
on proposed jury instructions, the District Court made clear that
“Bartlett cannot be allowed to circumvent this court’s
summary judgment ruling by using Sulindac’s warning to
establish that the drug is unreasonably dangerous (i.e., arguing
that Sulindac is unreasonably dangerous because of its warning),
where this court has already ruled that any inadequacy in the
warning did not cause Bartlett’s injuries.” App. 343.
Doing so, the court explained “would effectively turn this
case back into a failure-to-warn case, rendering the summary
judgment ruling meaningless.” Ibid. The District Court later
told counsel that it had removed a failure-to-warn instruction from
the jury instructions because “[t]his is not a failure to
warn case,” and the court admonished counsel to “tread
care-fully” in arguing about the warning label because the
label’s adequacy was “not an issue before this
jury.” Id., at 496. 7 To the extent the
majority believes that the District Court in practice allowed the
adequacy of the warning label to play a greater roleat trial than
it should have, see ante, at 11–12, that is irrelevant to the
question before the Court. Statements by counsel, even if improper,
do not change the state law cause of action that we evaluate for
pre-emption purposes. And the Court of Appeals specifically
concluded that the District Court’s jury instructions were
appropriate and that “[i]f Mutual wanted a further caution in
the instructions” concerning its warning label, then Mutual
“should have sought it.” 678 F. 3d 30, 41–42
(CA1 2012). 8 The majority’s
suggestion that a manufacturer’s option of continuing to sell
while paying compensation is akin to violating a statutory mandate
and then suffering the consequence (such as paying a fine) is
flawed. See ante, at 18. In that scenario, the manufacturer would
have violated the law, and the fact that the law is enforced
through monetary sanctions (rather than through an injunction or
imprisonment) would not change that. Here, no matter how many times
the majority insists otherwise, ibid., a manufacturer who sells a
drug whose design is found unreasonably dangerous based on a
balance of factors has not violated a state law requiring it to
change its label. In both cases, the manufacturer may owe money.
But only in the former will it have failed to follow the law. Cf.
National Federation of Independent Business v. Sebelius, 567
U. S. __, __ (2012) (slip op., at 32) (recognizing that a
condition that triggers a tax is not necessarily a “legal
command” to take a certain action). 9 The majority properly
leaves open the question whether state design-defect claims that
parallel the federal misbranding statute are pre-empted. See ante,
at 14, n. 4. The majority fails to appreciate, however, that
this statute undermines its impossibility argument (as compared to
an argument based on obstacle pre-emption) because it shows that
there is no federal right or obligation to continue to sell a drug
like sulindac that was previously approved. In fact, the statute
demonstrates that sometimes a drug manufacturer like Mutual may
have a federal duty not to sell its drug. 10 See
Government Accountability Office, Drug Safety: Improvement Needed
in FDA’s Postmarket Decision-making and Oversight Process 10
(GAO–06–402, 2006) (noting that 10 drugs were
voluntarily withdrawn for safety reasons between 2000 and 2006);
Wysowski & Swartz, Adverse Drug Event Surveillance and Drug
Withdrawals in the United States, 1969–2002, 165 Archives
Internal Med. 1363 (2005) (noting that more than 75 drugs and drug
products were withdrawn from the market for safety reasons between
1969 and 2002). 11 Defending a policy judgment that
treats the FDA as the exclusive guarantor of drug safety would be
no easy task in light of evidence that resource constraints and
gaps in legal authority, among other factors, limit the
agency’s ability to safeguard public health. See Kessler
& Vladeck, A Critical Examination of the FDA’s Efforts to
Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461,
483–495 (2008); see also Wyeth v. Levine, –579, and n.
11 (2009). 12 The
FDA purports to address what it calls a “pure”
design-defect claim, and it references the Third Restatement
§6 by way of illustration. The FDA’s separate discussion
of a “pure” design-defect claim is based on the premise
that New Hampshire’s design-defect claim turns on the
adequacy of a drug’s warning. See U. S. Brief 20. But
that is incorrect. See supra, at 11. 13 I
note that we are not confronted with a case in which the FDA
promulgated “lawful specific regulations describing”
whether and under what circumstances state design-defect liability
interferes with “the safe drug-related medical care”
sought through the FDCA. Levine, 555 U. S., at 582 (Breyer,
J., concurring). See also ante, at 2–3 (Breyer, J.,
dissenting). 14 Or at
least it creates an automatic conflict with the caveat that
design-defect claims that parallel a federal duty for manufacturers
to withdraw a product might not be pre-empted. See ante, at
13–14, n. 3. 15 See,
e.g., (pesticides); (food additives); §360b (animal drugs);
§§360c(a)(1)(C), 360e (certain medical devices);
§379e (color additives).

Summary: The Supreme Court ruled that federal law preempts state design-defect claims that impose a duty on drug manufacturers to change their labels, as this conflicts with federal law prohibiting generic drug manufacturers from independently altering drug labels. The Court rejected the argument that manufacturers should resolve this conflict by pulling their products from the market, as this would undermine impossibility preemption and revolutionize preemption case law.