(Slip Opinion) OCTOBER TERM, 2012 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
MUTUAL PHARMACEUTICAL CO., INC. v. BARTLETT
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FIRST CIRCUIT
No. 12–142. Argued March 19, 2013—Decided June 24, 2013
The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before
marketing any brand-name or generic drug in interstate commerce.
21 U. S. C. §355(a). Once a drug is approved, a 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).
In 2004, respondent was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac,
for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis.
She is now severely disfigured, has physical disabilities, and is nearly
blind. At the time of the prescription, sulindac’s label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA
had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. Respondent sued Mutual
in New Hampshire state court, and Mutual removed the case to federal court. A jury found Mutual liable on respondent’s design-defect
claim and awarded her over $21 million. The First Circuit affirmed.
As relevant, it found that neither the FDCA nor the FDA’s regulations pre-empted respondent’s design-defect claim. 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 ar-2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Syllabus
guing that generic manufacturers facing design-defect claims could
comply with both federal and state law simply by choosing not to
make the drug at all.
Held: State-law design-defect claims that turn on the adequacy of a
drug’s warnings are pre-empted by federal law under PLIVA. Pp. 6–
20.
(a) Under the Supremacy Clause, state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U. S. 725,
746. Even in the absence of an express pre-emption provision, a state
law may 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. Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s
label or composition and its state-law duty to either strengthen the
warnings on sulindac’s label or change sulindac’s design. Pp. 6–13.
(1) New Hampshire’s design-defect cause of action imposes affirmative duties on manufacturers, including a “duty to design [their
products] reasonably safely for the uses which [they] can foresee.”
Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 809, 395 A. 2d 843,
847. Pp. 7–8.
(2) To assess whether a product’s design is “unreasonably dangerous to the user,” Vautour v. Body Masters Sports Industries, Inc.,
147 N. H. 150, 153, 784 A. 2d 1178, 1181, the New Hampshire Supreme Court employs a “risk-utility approach,” which asks whether
the danger’s magnitude outweighs the product’s utility, id., at 154,
784 A. 2d, at 1182. The court has repeatedly identified three factors
as germane to that 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.” Ibid. Increasing a drug’s “usefulness”
or reducing its “risk of danger” would require redesigning the drug,
since those factors are direct results of a drug’s chemical design and
active ingredients. Here, however, redesign was not possible for two
reasons. First, the FDCA requires a generic drug to have the same
active ingredients, route of administration, dosage form, strength,
and labeling as its brand-name drug equivalent. Second, because of
sulindac’s simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac’s “risk-utility” profile by
strengthening its warnings. Thus, New Hampshire’s law ultimately
required Mutual to change sulindac’s labeling. Pp. 9–13.
(3) But PLIVA makes clear that federal law prevents generic Cite as: 570 U. S. ____ (2013) 3
Syllabus
drug manufacturers from changing their labels. See 564 U. S., at
___. Accordingly, Mutual was prohibited from taking the remedial
action required to avoid liability under New Hampshire law. P. 13.
(4) When federal law forbids an action required by state law, the
state law is “without effect.” Maryland, supra, at 746. Because it
was impossible for Mutual to comply with both state and federal law,
New Hampshire’s warning-based design-defect cause of action is preempted with respect to FDA-approved drugs sold in interstate commerce. Pp. 13–14.
(b) The First Circuit’s rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by
choosing to stop selling sulindac—is incompatible with this Court’s
pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease
acting altogether. Pp. 14–16.
678 F. 3d 30, reversed.
ALITO, J., delivered the opinion of the Court, in which ROBERTS, C. J.,
and SCALIA, KENNEDY, and THOMAS, JJ., joined. BREYER, J., filed a dissenting opinion, in which KAGAN, J., joined. SOTOMAYOR, J., filed a dissenting opinion, in which GINSBURG, J., joined. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the
preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.
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 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 preempted 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, 52 Stat. 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 pre-Cite as: 570 U. S. ____ (2013) 3
Opinion of the Court
scribed, 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, 98 Stat. 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 brandname 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 4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 brandname] drug”).
II
In 1978, the FDA approved a nonsteroidal antiinflammatory 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 Cite as: 570 U. S. ____ (2013) 5
Opinion of the Court
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-towarn 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 regu-6 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
lations 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 preempted 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, 142–
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”). Cite as: 570 U. S. ____ (2013) 7
Opinion of the Court
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 designdefect cause of action “is compensatory, not regulatory.”
Brief for Respondent 19. Rather, New Hampshire’s designdefect 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 manufacturer of a product has a “duty to design his product 8 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
1
We can thus save for another day the question whether a true
absolute-liability state-law system could give rise to impossibility
pre-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., 552
U. S. 312, 323–324 (2008) (“In [Medtronic, Inc. v. Lohr, 518 U. S. 470
(1996)], 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, 505 U. S. 504, 522
(1992)], common-law liability is ‘premised on the existence of a legal
duty,’ and a tort judgment therefore establishes that the defendant has Cite as: 570 U. S. ____ (2013) 9
Opinion of the Court
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 “riskutility 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 riskutility 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
——————
violated a state-law obligation”). 10 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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, mitigation, 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 administration, 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 Cite as: 570 U. S. ____ (2013) 11
Opinion of the Court
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 onemolecule 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 12 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 sulindac’s risks outweighed its benefits, then it could consider
whether the warning—regardless of its adequacy—reduced 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 in-
——————
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, both
respondent and the trial court injected the broader question of the
adequacy of sulindac’s label into the trial proceedings. Cite as: 570 U. S. ____ (2013) 13
Opinion of the Court
structed 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
——————
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 discussed 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., 14 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 143
(1963) (There would be “impossibility of dual compliance” where “federal
orders forbade the picking and marketing of any avocado testing
more 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 manufacturer 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.” 21 U. S. C. §352(j); cf. Bates v. Dow Agrosciences
LLC, 544 U. S. 431, 447 (2005) (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”). Cite as: 570 U. S. ____ (2013) 15
Opinion of the Court
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 16 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
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. Cite as: 570 U. S. ____ (2013) 17
Opinion of the Court
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 “‘impossible 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 18 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 commonlaw 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 preemption 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 Cite as: 570 U. S. ____ (2013) 19
Opinion of the Court
that the State’s design-defect claim imposed a preemptable “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 manufacturer 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 prescrip-20 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
tion 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 nonpre-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. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
BREYER, J., dissenting
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 penalty, 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 objective, in which case the relevant state law is pre-empted.
Post, at 17 (quoting Crosby v. National Foreign Trade Council, 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, 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
BREYER, J., dissenting
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, 739–741 (1996); Hillsborough County v. Automated Medical Laboratories, Inc.,
471 U. S. 707, 721 (1985); Lawrence County v. LeadDeadwood School Dist. No. 40–1, 469 U. S. 256, 261–262
(1985); Chevron U. S. A. Inc. v. Natural Resources Defense
Council, Inc., 467 U. S. 837, 842–845 (1984)). See also
Wyeth v. Levine, 555 U. S. 555, 576–577 (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 preemptive 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 Hillsborough, 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, 212–213 (1988) (“[A]gency litigating positions
that are wholly unsupported by regulations, rulings, or Cite as: 570 U. S. ____ (2013) 3
BREYER, J., dissenting
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 preemption). 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, 41–42
(1983) (same); Verizon Communications Inc. v. FCC, 535
U. S. 467, 502, 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 Med-4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
BREYER, J., dissenting
tronic, the statute before us contains no general preemption 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 convincing 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. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
SOTOMAYOR, J., dissenting
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-towarn 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 implicit 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 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 respectfully 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
——————
1
The majority’s failure to adhere to the presumption against preemption 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 Cite as: 570 U. S. ____ (2013) 3
SOTOMAYOR, J., dissenting
The Court applied both of these principles to the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52
Stat. 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, 34 Stat. 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 “danger-
——————
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., 331 U. S. 218, 230
(1947). 4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
ous 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, 76 Stat. 793. And in the years since,
with “state common-law suits ‘continu[ing] unabated despite . . . 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,
——————
2
See 21 U. S. C. §360k(a) (medical devices); §379r (labeling requirements for nonprescription drugs); §379s (labeling and packaging
requirements for cosmetics); 42 U. S. C. §300aa–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). Cite as: 570 U. S. ____ (2013) 5
SOTOMAYOR, J., dissenting
and common-law remedies specifically, reflects a realistic
understanding of the limitations of ex ante federal regulatory review in this context. On its own, even rigorous preapproval clinical testing of drugs is “generally
. . . incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in
the studies.” Kessler & Vladeck, A Critical Examination 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 opportunity to seek redress that is not available under federal law.
“[U]nlike most administrative and legislative regulations,”
common-law claims “necessarily perform an important remedial 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 6 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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, 142–143 (1963); see ante, at 7. But if state and federal 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,” Levine, 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 design” 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 Cite as: 570 U. S. ____ (2013) 7
SOTOMAYOR, J., dissenting
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 preempted 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, 372–373 (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 8 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 recharacterizes Bartlett’s design-defect claim as a de facto
failure-to-warn claim. The majority then relies on that recharacterization 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 Cite as: 570 U. S. ____ (2013) 9
SOTOMAYOR, J., dissenting
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 failureto-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 riskbenefit assessment by considering a nonexhaustive list
of factors. See ante, at 9–10. In addition, New Hampshire 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 10 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 designdefect 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 danger 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
——————
3
Though the majority does not rely on comment k to find preemption, 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 adequate 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, Cite as: 570 U. S. ____ (2013) 11
SOTOMAYOR, J., dissenting
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 condition 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 feasible 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 Hamp-
——————
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. 12 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
shire’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, 185–186 (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 example, 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
——————
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., 552 U. S. 312, 323–324
(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 Cite as: 570 U. S. ____ (2013) 13
SOTOMAYOR, J., dissenting
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 unilaterally, 564 U. S., at ___, ___ (slip op., at 4, 11–12).
New Hampshire’s design-defect law did not require Mutual 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, contrary 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.
——————
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. 14 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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
——————
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-towarn instruction from the jury instructions because “[t]his is not a
failure to warn case,” and the court admonished counsel to “tread carefully” in arguing about the warning label because the label’s adequacy
was “not an issue before this jury.” Id., at 496. Cite as: 570 U. S. ____ (2013) 15
SOTOMAYOR, J., dissenting
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 designdefect 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
——————
7
To the extent the majority believes that the District Court in practice allowed the adequacy of the warning label to play a greater role
at 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 preemption 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). 16 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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
——————
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 mone-Cite as: 570 U. S. ____ (2013) 17
SOTOMAYOR, J., dissenting
From a manufacturer’s perspective, that may be an unwelcome 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 history. 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
——————
tary 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). 18 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
“dangerous to health” and thus “misbranded.” See §§331(a),
352(j); see supra, at 3–4.9
Even outside that scenario, 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
——————
9
The majority properly leaves open the question whether state design-defect claims that parallel the federal misbranding statute are preempted. 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.
10See 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). Cite as: 570 U. S. ____ (2013) 19
SOTOMAYOR, J., dissenting
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 majority 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 preemption 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 20 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 applications, 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 majority 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 considering whether that is the policy judgment that Congress
made.11
——————
11Defending 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 Cite as: 570 U. S. ____ (2013) 21
SOTOMAYOR, J., dissenting
III
While the majority never addresses obstacle preemption, 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, 98 Stat. 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 Hampshire’s design-defect claim frustrates the policy underlying 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
claim12 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 designdefect claims are pre-empted unless they parallel the
FDCA’s misbranding prohibition because the agency believes 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
——————
Failure-to-Warn Claims, 96 Geo. L. J. 461, 483–495 (2008); see also
Wyeth v. Levine, 555 U. S. 555, 578–579, and n. 11 (2009).
12The 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. 22 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 preempted,” 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 im-
——————
13I 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). Cite as: 570 U. S. ____ (2013) 23
SOTOMAYOR, J., dissenting
plies 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 liability 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
——————
14Or 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. 24 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 incentives 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.
——————
15See, e.g., 7 U. S. C. §136a (pesticides); 21 U. S. C. §348 (food additives); §360b (animal drugs); §§360c(a)(1)(C), 360e (certain medical
devices); §379e (color additives). Cite as: 570 U. S. ____ (2013) 25
SOTOMAYOR, J., dissenting
The manner in which Congress has addressed preemption 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 vaccinerelated 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 Federal 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. 26 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
* * *
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.
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
MUTUAL PHARMACEUTICAL CO., INC. v. BARTLETT
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FIRST CIRCUIT
No. 12–142. Argued March 19, 2013—Decided June 24, 2013
The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before
marketing any brand-name or generic drug in interstate commerce.
21 U. S. C. §355(a). Once a drug is approved, a 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).
In 2004, respondent was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac,
for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis.
She is now severely disfigured, has physical disabilities, and is nearly
blind. At the time of the prescription, sulindac’s label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA
had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. Respondent sued Mutual
in New Hampshire state court, and Mutual removed the case to federal court. A jury found Mutual liable on respondent’s design-defect
claim and awarded her over $21 million. The First Circuit affirmed.
As relevant, it found that neither the FDCA nor the FDA’s regulations pre-empted respondent’s design-defect claim. 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 ar-2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Syllabus
guing that generic manufacturers facing design-defect claims could
comply with both federal and state law simply by choosing not to
make the drug at all.
Held: State-law design-defect claims that turn on the adequacy of a
drug’s warnings are pre-empted by federal law under PLIVA. Pp. 6–
20.
(a) Under the Supremacy Clause, state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U. S. 725,
746. Even in the absence of an express pre-emption provision, a state
law may 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. Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s
label or composition and its state-law duty to either strengthen the
warnings on sulindac’s label or change sulindac’s design. Pp. 6–13.
(1) New Hampshire’s design-defect cause of action imposes affirmative duties on manufacturers, including a “duty to design [their
products] reasonably safely for the uses which [they] can foresee.”
Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 809, 395 A. 2d 843,
847. Pp. 7–8.
(2) To assess whether a product’s design is “unreasonably dangerous to the user,” Vautour v. Body Masters Sports Industries, Inc.,
147 N. H. 150, 153, 784 A. 2d 1178, 1181, the New Hampshire Supreme Court employs a “risk-utility approach,” which asks whether
the danger’s magnitude outweighs the product’s utility, id., at 154,
784 A. 2d, at 1182. The court has repeatedly identified three factors
as germane to that 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.” Ibid. Increasing a drug’s “usefulness”
or reducing its “risk of danger” would require redesigning the drug,
since those factors are direct results of a drug’s chemical design and
active ingredients. Here, however, redesign was not possible for two
reasons. First, the FDCA requires a generic drug to have the same
active ingredients, route of administration, dosage form, strength,
and labeling as its brand-name drug equivalent. Second, because of
sulindac’s simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac’s “risk-utility” profile by
strengthening its warnings. Thus, New Hampshire’s law ultimately
required Mutual to change sulindac’s labeling. Pp. 9–13.
(3) But PLIVA makes clear that federal law prevents generic Cite as: 570 U. S. ____ (2013) 3
Syllabus
drug manufacturers from changing their labels. See 564 U. S., at
___. Accordingly, Mutual was prohibited from taking the remedial
action required to avoid liability under New Hampshire law. P. 13.
(4) When federal law forbids an action required by state law, the
state law is “without effect.” Maryland, supra, at 746. Because it
was impossible for Mutual to comply with both state and federal law,
New Hampshire’s warning-based design-defect cause of action is preempted with respect to FDA-approved drugs sold in interstate commerce. Pp. 13–14.
(b) The First Circuit’s rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by
choosing to stop selling sulindac—is incompatible with this Court’s
pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease
acting altogether. Pp. 14–16.
678 F. 3d 30, reversed.
ALITO, J., delivered the opinion of the Court, in which ROBERTS, C. J.,
and SCALIA, KENNEDY, and THOMAS, JJ., joined. BREYER, J., filed a dissenting opinion, in which KAGAN, J., joined. SOTOMAYOR, J., filed a dissenting opinion, in which GINSBURG, J., joined. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the
preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.
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 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 preempted 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, 52 Stat. 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 pre-Cite as: 570 U. S. ____ (2013) 3
Opinion of the Court
scribed, 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, 98 Stat. 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 brandname 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 4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 brandname] drug”).
II
In 1978, the FDA approved a nonsteroidal antiinflammatory 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 Cite as: 570 U. S. ____ (2013) 5
Opinion of the Court
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-towarn 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 regu-6 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
lations 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 preempted 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, 142–
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”). Cite as: 570 U. S. ____ (2013) 7
Opinion of the Court
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 designdefect cause of action “is compensatory, not regulatory.”
Brief for Respondent 19. Rather, New Hampshire’s designdefect 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 manufacturer of a product has a “duty to design his product 8 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
1
We can thus save for another day the question whether a true
absolute-liability state-law system could give rise to impossibility
pre-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., 552
U. S. 312, 323–324 (2008) (“In [Medtronic, Inc. v. Lohr, 518 U. S. 470
(1996)], 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, 505 U. S. 504, 522
(1992)], common-law liability is ‘premised on the existence of a legal
duty,’ and a tort judgment therefore establishes that the defendant has Cite as: 570 U. S. ____ (2013) 9
Opinion of the Court
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 “riskutility 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 riskutility 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
——————
violated a state-law obligation”). 10 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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, mitigation, 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 administration, 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 Cite as: 570 U. S. ____ (2013) 11
Opinion of the Court
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 onemolecule 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 12 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 sulindac’s risks outweighed its benefits, then it could consider
whether the warning—regardless of its adequacy—reduced 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 in-
——————
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, both
respondent and the trial court injected the broader question of the
adequacy of sulindac’s label into the trial proceedings. Cite as: 570 U. S. ____ (2013) 13
Opinion of the Court
structed 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
——————
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 discussed 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., 14 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 143
(1963) (There would be “impossibility of dual compliance” where “federal
orders forbade the picking and marketing of any avocado testing
more 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 manufacturer 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.” 21 U. S. C. §352(j); cf. Bates v. Dow Agrosciences
LLC, 544 U. S. 431, 447 (2005) (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”). Cite as: 570 U. S. ____ (2013) 15
Opinion of the Court
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 16 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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
——————
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. Cite as: 570 U. S. ____ (2013) 17
Opinion of the Court
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 “‘impossible 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 18 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
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 commonlaw 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 preemption 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 Cite as: 570 U. S. ____ (2013) 19
Opinion of the Court
that the State’s design-defect claim imposed a preemptable “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 manufacturer 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 prescrip-20 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
Opinion of the Court
tion 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 nonpre-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. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
BREYER, J., dissenting
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 penalty, 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 objective, in which case the relevant state law is pre-empted.
Post, at 17 (quoting Crosby v. National Foreign Trade Council, 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, 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
BREYER, J., dissenting
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, 739–741 (1996); Hillsborough County v. Automated Medical Laboratories, Inc.,
471 U. S. 707, 721 (1985); Lawrence County v. LeadDeadwood School Dist. No. 40–1, 469 U. S. 256, 261–262
(1985); Chevron U. S. A. Inc. v. Natural Resources Defense
Council, Inc., 467 U. S. 837, 842–845 (1984)). See also
Wyeth v. Levine, 555 U. S. 555, 576–577 (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 preemptive 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 Hillsborough, 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, 212–213 (1988) (“[A]gency litigating positions
that are wholly unsupported by regulations, rulings, or Cite as: 570 U. S. ____ (2013) 3
BREYER, J., dissenting
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 preemption). 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, 41–42
(1983) (same); Verizon Communications Inc. v. FCC, 535
U. S. 467, 502, 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 Med-4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
BREYER, J., dissenting
tronic, the statute before us contains no general preemption 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 convincing 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. _________________
_________________
Cite as: 570 U. S. ____ (2013) 1
SOTOMAYOR, J., dissenting
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-towarn 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 implicit 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 2 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 respectfully 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
——————
1
The majority’s failure to adhere to the presumption against preemption 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 Cite as: 570 U. S. ____ (2013) 3
SOTOMAYOR, J., dissenting
The Court applied both of these principles to the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52
Stat. 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, 34 Stat. 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 “danger-
——————
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., 331 U. S. 218, 230
(1947). 4 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
ous 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, 76 Stat. 793. And in the years since,
with “state common-law suits ‘continu[ing] unabated despite . . . 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,
——————
2
See 21 U. S. C. §360k(a) (medical devices); §379r (labeling requirements for nonprescription drugs); §379s (labeling and packaging
requirements for cosmetics); 42 U. S. C. §300aa–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). Cite as: 570 U. S. ____ (2013) 5
SOTOMAYOR, J., dissenting
and common-law remedies specifically, reflects a realistic
understanding of the limitations of ex ante federal regulatory review in this context. On its own, even rigorous preapproval clinical testing of drugs is “generally
. . . incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in
the studies.” Kessler & Vladeck, A Critical Examination 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 opportunity to seek redress that is not available under federal law.
“[U]nlike most administrative and legislative regulations,”
common-law claims “necessarily perform an important remedial 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 6 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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, 142–143 (1963); see ante, at 7. But if state and federal 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,” Levine, 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 design” 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 Cite as: 570 U. S. ____ (2013) 7
SOTOMAYOR, J., dissenting
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 preempted 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, 372–373 (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 8 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 recharacterizes Bartlett’s design-defect claim as a de facto
failure-to-warn claim. The majority then relies on that recharacterization 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 Cite as: 570 U. S. ____ (2013) 9
SOTOMAYOR, J., dissenting
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 failureto-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 riskbenefit assessment by considering a nonexhaustive list
of factors. See ante, at 9–10. In addition, New Hampshire 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 10 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 designdefect 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 danger 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
——————
3
Though the majority does not rely on comment k to find preemption, 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 adequate 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, Cite as: 570 U. S. ____ (2013) 11
SOTOMAYOR, J., dissenting
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 condition 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 feasible 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 Hamp-
——————
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. 12 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
shire’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, 185–186 (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 example, 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
——————
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., 552 U. S. 312, 323–324
(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 Cite as: 570 U. S. ____ (2013) 13
SOTOMAYOR, J., dissenting
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 unilaterally, 564 U. S., at ___, ___ (slip op., at 4, 11–12).
New Hampshire’s design-defect law did not require Mutual 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, contrary 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.
——————
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. 14 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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
——————
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-towarn instruction from the jury instructions because “[t]his is not a
failure to warn case,” and the court admonished counsel to “tread carefully” in arguing about the warning label because the label’s adequacy
was “not an issue before this jury.” Id., at 496. Cite as: 570 U. S. ____ (2013) 15
SOTOMAYOR, J., dissenting
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 designdefect 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
——————
7
To the extent the majority believes that the District Court in practice allowed the adequacy of the warning label to play a greater role
at 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 preemption 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). 16 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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
——————
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 mone-Cite as: 570 U. S. ____ (2013) 17
SOTOMAYOR, J., dissenting
From a manufacturer’s perspective, that may be an unwelcome 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 history. 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
——————
tary 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). 18 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
“dangerous to health” and thus “misbranded.” See §§331(a),
352(j); see supra, at 3–4.9
Even outside that scenario, 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
——————
9
The majority properly leaves open the question whether state design-defect claims that parallel the federal misbranding statute are preempted. 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.
10See 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). Cite as: 570 U. S. ____ (2013) 19
SOTOMAYOR, J., dissenting
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 majority 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 preemption 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 20 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 applications, 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 majority 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 considering whether that is the policy judgment that Congress
made.11
——————
11Defending 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 Cite as: 570 U. S. ____ (2013) 21
SOTOMAYOR, J., dissenting
III
While the majority never addresses obstacle preemption, 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, 98 Stat. 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 Hampshire’s design-defect claim frustrates the policy underlying 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
claim12 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 designdefect claims are pre-empted unless they parallel the
FDCA’s misbranding prohibition because the agency believes 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
——————
Failure-to-Warn Claims, 96 Geo. L. J. 461, 483–495 (2008); see also
Wyeth v. Levine, 555 U. S. 555, 578–579, and n. 11 (2009).
12The 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. 22 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 preempted,” 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 im-
——————
13I 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). Cite as: 570 U. S. ____ (2013) 23
SOTOMAYOR, J., dissenting
plies 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 liability 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
——————
14Or 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. 24 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
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 incentives 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.
——————
15See, e.g., 7 U. S. C. §136a (pesticides); 21 U. S. C. §348 (food additives); §360b (animal drugs); §§360c(a)(1)(C), 360e (certain medical
devices); §379e (color additives). Cite as: 570 U. S. ____ (2013) 25
SOTOMAYOR, J., dissenting
The manner in which Congress has addressed preemption 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 vaccinerelated 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 Federal 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. 26 MUTUAL PHARMACEUTICAL CO. v. BARTLETT
SOTOMAYOR, J., dissenting
* * *
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.
