MUTUAL PHARMACEUTICAL CO. v. BARTLETT
In December 2004, Karen Bartlett’s doctor prescribed Sulindac, a generic anti-inflammatory medication, to help treat her shoulder pain. Within months she began suffering from a severe reaction called Stevens-Johnson syndrome, which caused the skin condition toxic epidermal necrolysis. This condition deteriorated over 60 percent of her skin to the point of causing open wounds. As a result, she has suffered permanent and serious injuries, including near-blindness.
Bartlett filed a lawsuit against the Sulindac medication manufacturer, Mutual Pharmaceutical Company. Bartlett initially presented several negligence and product liability claims, but only her design defect product liability claim made it to trial. Beginning in August 2009, a jury at the Federal District Court for the District of New Hampshire heard evidence that Sulindac was unreasonably dangerous to consumers and therefore was defectively designed. Mutual countered, among several other defenses, that federal law governs generic drug manufacturers’ conduct; therefore Karen could not pursue a state design defect claim.
After 14 days of trial, the jury deliberated and sided with Bartlett, awarding over $20 million in compensatory damages. Mutual appealed the decision for several reasons, including the following: the district court misunderstood New Hampshire product liability law; and, the court improperly admitted several pieces of evidence and the jury award of damages was excessive. Mutual also reasserted its claim that federal law should prevail over a state defective design claim. Despite Mutual’s arguments, the United States Court of Appeals for the First Circuit affirmed the lower court’s decision. Mutual appealed further to the Supreme Court of the United States, which granted certiorari.
Does federal law preempt a state design defect claim against a generic drug manufacturer?
Legal provision: Federal Food, Drug, and Cosmetic Act
Yes. Justice Samuel A. Alito Jr. delivered the opinion for the 5-4 majority. The Court held that state law design-defect claims regarding the adequacy of a drug’s warnings are pre-empted by federal law which prohibits generic drug manufacturers from independently changing Food and Drug Administration (FDA) approved drug labels. New Hampshire state law obligates Mutual Pharmaceutical to place a stronger warning on the generic drug labels, a requirement that is irreconcilable with federal requirements. Therefore, the state law is pre-empted by the Supremacy Clause, which states that federal law supersedes that of the states.
Justice Sonia Sotomayor wrote a dissent in which she argued that state law should not be pre-empted without evidence that Congress acted with the intent to supersede state law, especially in fields historically dominated by states. The objective of Congress in creating the law prohibiting the alteration of labels was to prevent misbranding as a protection for the consumer; state law requiring adequate warnings on labels complements this purpose. The New Hampshire design-defect laws are an incentive to avoid strict-liability not a mandate that product labels must be altered, so they are not irreconcilable with the federal law. She also argues that design-defect claims are distinct from failure-to-warn claims. Justice Ruth Bader Ginsburg joined in the dissent. In his separate dissent, Justice Stephen G. Breyer wrote a dissent arguing that Mutual Pharmaceutical could comply with both state and federal law by not doing business in the state. However, if Mutual Pharmaceutical options are limited by the conflicting laws to paying a substantial damages remedy or leaving New Hampshire and these options are an obstacle to the goals of the federal law, then the relevant state law is pre-empted. Without any direction from the relevant federal agency, the FDA, or a general pre-emption clause in the federal statute, he concludes that the New Hampshire law is not a substantial obstacle and should not be pre-empted. Justice Elena Kagan joined in the dissent.
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
MUTUAL PHARMACEUTICAL COMPANY, INC., PETITIONER v. KAREN L. BARTLETT
on writ of certiorari to the united states court of appeals for the first circuit
[June 24, 2013]
Justice Alito delivered the opinion of the Court.
We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels. Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981) .
The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.
Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.I
Under the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52Stat. 1040, as amended, 21 U. S. C. §301 et seq., drug manufacturers must gain approval from the United States Food and Drug Administration (FDA) before marketing any drug in interstate commerce. §355(a). In the case of a new brand-name drug, FDA approval can be secured only by submitting a new-drug application (NDA). An NDA is a compilation of materials that must include “full reports of [all clinical] investigations,” §355(b)(1)(A), relevant nonclinical studies, and “any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source,” 21 CFR §§314.50(d)(2) and (5)(iv) (2012). The NDA must also include “the labeling proposed to be used for such drug,” 21 U. S. C. §355(b)(1)(F); 21 CFR §314.50(c)(2)(i), and “a discussion of why the [drug’s] benefits exceed the risks under the conditions stated in the labeling,” 21 CFR §314.50(d)(5)(viii); §314.50(c)(2)(ix). The FDA may approve an NDA only if it determines that the drug in question is “safe for use” under “the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” 21 U. S. C. §355(d). In order for the FDA to consider a drug safe, the drug’s “probable therapeutic benefits must outweigh its risk of harm.” FDA v. Brown & Williamson Tobacco Corp., 529 U. S. 120, 140 (2000) .
The process of submitting an NDA is both onerous and lengthy. See Report to Congressional Requesters, Government Accountability Office, Nov. 2006, New Drug Development, 26 Biotechnology L. Rep. 82, 94 (2007) (A typical NDA spans thousands of pages and is based on clinical trials conducted over several years). In order to provide a swifter route for approval of generic drugs, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, 98Stat. 1585, popularly known as the “Hatch-Waxman Act.” Under Hatch-Waxman, a generic drug may be approved without the same level of clinical testing required for approval of a new brand-name drug, provided the generic drug is identical to the already-approved brand-name drug in several key respects.
First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. 21 U. S. C. §§355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be “bioequivalent” to an approved brand-name drug. §355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. §355(j)(8)(B). Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” §355(j)(2)(A)(v).
Once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.” 21 CFR §314.70(b)(2)(i). Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label. See §§314.94(a)(8)(iii), 314.150(b)(10) (approval for a generic drug may be withdrawn if the generic drug’s label “is no longer consistent with that for [the brand-name] drug”).II
In 1978, the FDA approved a nonsteroidal anti-inflammatory pain reliever called “sulindac” under the brand name Clinoril. When Clinoril’s patent expired, the FDA approved several generic sulindacs, including one manufactured by Mutual Pharmaceutical. 678 F. 3d 30, 34 (CA1 2012) (case below); App. to Pet. for Cert. 144a–145a. In a very small number of patients, NSAIDs—including both sulindac and popular NSAIDs such as ibuprofen, naproxen, and Cox2-inhibitors—have the serious side effect of causing two hypersensitivity skin reactions characterized by necrosis of the skin and of the mucous membranes: toxic epidermal necrolysis, and its less severe cousin, Stevens-Johnson Syndrome. 678 F. 3d, at 34, 43–44; Dorland’s Illustrated Medical Dictionary 1872 (31st ed. 2007); Physicians’ Desk Reference 146–147, 597 (6th ed. 2013); Friedman, Orlet, Still, & Law, Toxic Epidermal Necrolysis Due to Administration of Celecobix (Celebrex), 95 Southern Medical J. 1213, 1213–1214 (2002).
In December 2004, respondent Karen L. Bartlett was prescribed Clinoril for shoulder pain. Her pharmacist dispensed a generic form of sulindac, which was manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis. The results were horrific. Sixty to sixty-five percent of the surface of respondent’s body deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind.
At the time respondent was prescribed sulindac, the drug’s label did not specifically refer to Stevens-Johnson Syndrome or toxic epidermal necrolysis, but did warn that the drug could cause “severe skin reactions” and “[f]atalities.” App. 553; 731 F. Supp. 2d 135, 142 (NH 2010) (internal quotation marks omitted). However, Stevens-Johnson Syndrome and toxic epidermal necrolysis were listed as potential adverse reactions on the drug’s package insert. 678 F. 3d, at 36, n. 1. In 2005—once respondent was already suffering from toxic epidermal necrolysis—the FDA completed a “comprehensive review of the risks and benefits, [including the risk of toxic epidermal necrolysis], of all approved NSAID products.” Decision Letter, FDA Docket No. 2005P-0072/CP1, p. 2 (June 22, 2006), online at http://www.fda.gov/ohrms/dockets/ dockets/05p0072/05p-0072-pav0001-vol1.pdf (as visited June 18, 2013, and available in Clerk of Court’s case file). As a result of that review, the FDA recommended changes to the labeling of all NSAIDs, including sulindac, to more explicitly warn against toxic epidermal necrolysis. App. 353–354, 364, 557–561, 580, and n. 8.
Respondent sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. Respondent initially asserted both failure-to-warn and design-defect claims, but the District Court dismissed her failure-to-warn claim based on her doctor’s “admi[ssion] that he had not read the box label or insert.” 678 F. 3d, at 34. After a 2-week trial on respondent’s design-defect claim, a jury found Mutual liable and awarded respondent over $21 million in damages.
The Court of Appeals affirmed. 678 F. 3d 30. As relevant, it found that neither the FDCA nor the FDA’s regulations pre-empted respondent’s design-defect claims. It distinguished PLIVA, Inc. v. Mensing, 564 U. S. ___ —in which the Court held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA’s prohibition on changes to generic drug labels—by arguing that generic manufacturers facing design-defect claims could simply “choose not to make the drug at all” and thus comply with both federal and state law. 678 F. 3d, at 37. We granted certiorari. 568 U. S. ___ (2012).III
The Supremacy Clause provides that the laws and treaties of the United States “shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U. S. Const., Art. VI, cl. 2. Accordingly, it has long been settled that state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U. S., at 746; McCulloch v. Maryland, 4 Wheat. 316, 427 (1819). See also Gade v. National Solid Wastes Management Assn., 505 U. S. 88, 108 (1992) (“[U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, however clearly within a State’s acknowledged power, which interferes with or is contrary to federal law, must yield” (internal quotation marks omitted)).
Even in the absence of an express pre-emption provision, the Court has found state law to be impliedly pre-empted where it is “impossible for a private party to comply with both state and federal requirements.” English v. General Elec. Co., 496 U. S. 72, 79 (1990) . See also Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132 –143 (1963) (“A holding of federal exclusion of state law is inescapable and requires no inquiry into congressional design where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce”).
In the instant case, it was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac’s label and its federal-law duty not to alter sulindac’s label. Accordingly, the state law is pre-empted.A
We begin by identifying petitioner’s duties under state law. As an initial matter, respondent is wrong in asserting that the purpose of New Hampshire’s designdefect cause of action “is compensatory, not regulatory.” Brief for Respondent 19. Rather, New Hampshire’s design-defect cause of action imposes affirmative duties on manufacturers.
Respondent is correct that New Hampshire has adopted the doctrine of strict liability in tort as set forth in Section 402A of the Restatement (Second) of Torts. See 2 Restatement (Second) of Torts §402A (1963 and 1964) (hereinafter Restatement 2d). See Buttrick v. Arthur Lessard & Sons, Inc., 110 N. H. 36, 37–39, 260 A. 2d 111, 112–113 (1969). Under the Restatement—and consequently, under New Hampshire tort law—“[o]ne who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused” even though he “has exercised all possible care in the preparation and sale of the product.” Restatement 2d §402A, at 347–348.
But respondent’s argument conflates what we will call a “strict-liability” regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an “absolute-liability” regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk). New Hampshire has adopted the former, not the latter. Indeed, the New Hampshire Supreme Court has consistently held that the manu-facturer of a product has a “duty to design his product reasonably safely for the uses which he can foresee.” Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 809, 395 A. 2d 843, 847 (1978). See also Reid v. Spadone Mach. Co., 119 N. H. 457, 465, 404 A. 2d 1094, 1099 (1979) (“In New Hampshire, the manufacturer is under a general duty to design his product reasonably safely for the uses which he can foresee” (internal quotation marks omitted)); Chellman v. Saab-Scania AB, 138 N. H. 73, 78, 637 A. 2d 148, 150 (1993) (“The duty to warn is part of the general duty to design, manufacture and sell products that are reasonably safe for their foreseeable uses”); cf. Simoneau v. South Bend Lathe, Inc., 130 N. H. 466, 469, 543 A. 2d 407, 409 (1988) (“We limit the application of strict tort liability in this jurisdiction by continuing to emphasize that liability without negligence is not liability without fault”); Price v. BIC Corp., 142 N. H. 386, 390, 702 A. 2d 330, 333 (1997) (cautioning “that the term ‘unreasonably dangerous’ should not be interpreted so broadly as to impose absolute liability on manufacturers or make them insurers of their products”). Accordingly, respondent is incorrect in arguing that New Hampshire’s strict-liability system “imposes no substantive duties on manufacturers.” Brief for Respondent 19. 1B
That New Hampshire tort law imposes a duty on manufacturers is clear. Determining the content of that duty requires somewhat more analysis. As discussed below in greater detail, New Hampshire requires manufacturers to ensure that the products they design, manufacture, and sell are not “unreasonably dangerous.” The New Hampshire Supreme Court has recognized that this duty can be satisfied either by changing a drug’s design or by changing its labeling. Since Mutual did not have the option of changing sulindac’s design, New Hampshire law ultimately required it to change sulindac’s labeling.
Respondent argues that, even if New Hampshire law does impose a duty on drug manufacturers, that duty does not encompass either the “duty to change sulindac’s design” or the duty “to change sulindac’s labeling.” Brief for Respondent 30 (capitalization and emphasis deleted). That argument cannot be correct. New Hampshire imposes design-defect liability only where “the design of the product created a defective condition unreasonably dangerous to the user.” Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181 (2001); Chellman, supra, at 77, 637 A. 2d, at 150. To determine whether a product is “unreasonably dangerous,” the New Hampshire Supreme Court employs a “risk-utility approach” under which “a product is defective as designed if the magnitude of the danger outweighs the utility of the product.” Vautour, supra, at 154, 784 A. 2d, at 1182 (internal quotation marks omitted). That risk-utility approach requires a “multifaceted balancing process involving evaluation of many conflicting factors.” Ibid. (internal quotation marks omitted); see also Thibault, supra, at 809, 395 A. 2d, at 847 (same).
While the set of factors to be considered is ultimately an open one, the New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: “the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Vautour, supra, at 154, 784 A. 2d, at 1182; see also Price, supra, at 389, 702 A. 2d, at 333 (same); Chellman, supra, at 77–78, 637 A. 2d, at 150 (same).
In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: A drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. See 21 CFR §201.66(b)(2) (2012) (“Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, 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 adminis-tration, dosage form, strength, and labeling as the brand-name drug on which it is based. 21 U. S. C. §§355(j)(2)(A)(ii)–(v) and (8)(B); 21 CFR §320.1(c). Consequently, the Court of Appeals was correct to recognize that “Mutual cannot legally make sulindac in another composition.” 678 F. 3d, at 37. Indeed, were Mutual to change the composition of its sulindac, the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. See 21 CFR §310.3(h) (giving examples of when the FDA considers a drug to be new, including cases involving “newness for drug use of any substance which composes such drug, in whole or in part”). Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. See 678 F. 3d, at 37 (“Mutual cannot legally make sulindac in another composition (nor it is apparent how it could alter a one-molecule drug anyway)”).
Given the impossibility of redesigning sulindac, the only way for Mutual to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen “the presence and efficacy of [sulindac’s] warning” in such a way that the warning “avoid[ed] an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Vautour, supra, at 154, 784 A. 2d, at 1182. See also Chellman, 138 N. H., at 78, 637 A. 2d, at 150 (“The duty to warn is part of the general duty to design, manufacture and sell products that are reasonably safe for their foreseeable uses. If the design of a product makes a warning necessary to avoid an unreasonable risk of harm from a foreseeable use, the lack of warning or an ineffective warning causes the product to be defective and unreasonably dangerous” (citation omitted)). Thus, New Hampshire’s design-defect cause of action imposed a duty on Mutual to strengthen sulindac’s warnings.
For these reasons, it is unsurprising that allegations that sulindac’s label was inadequate featured prominently at trial. Respondent introduced into evidence both the label for Mutual’s sulindac at the time of her injuries and the label as revised in 2005 (after respondent had suffered her injuries). App. 553–556. Her counsel’s opening statement informed the jury that “the evidence will show you that Sulindac was unreasonably dangerous and had an inadequate warning, as well. . . . You will hear much more evidence about why this label was inadequate in relation to this case.” Tr. 110–112 (Aug. 17, 2010). And, the District Court repeatedly instructed the jury that it should evaluate sulindac’s labeling in determining whether Mutual’s sulindac was unreasonably dangerous. See App. 514 (jury instruction that the jury should find “a defect in design” only if it found that “Sulindac was unreasonably dangerous and that a warning was not present and effective to avoid that unreasonable danger”); ibid. (jury instruction that no design defect exists if “a warning was present and effective to avoid that unreasonable danger”). Finally, the District Court clarified in its order and opinion denying Mutual’s motion for judgment as a matter of law that the adequacy of sulindac’s labeling had been part of what the jury was instructed to consider. 760 F. Supp. 2d 220, 231 (2011) (“if the jury found that sulin-dac’s risks outweighed its benefits, then it could consider whether the warning—regardless of its adequacy—re-duced those risks . . . to such an extent that it eliminated the unreasonable danger”). 2
Thus, in accordance with New Hampshire law, the jury was presented with evidence relevant to, and was instructed to consider, whether Mutual had fulfilled its duty to label sulindac adequately so as to render the drug not “unreasonably dangerous.” In holding Mutual liable, the jury determined that Mutual had breached that duty.C
The duty imposed by federal law is far more readily apparent. As PLIVA made clear, federal law prevents generic drug manufacturers from changing their labels. See 564 U. S., at ___ (slip op., at 10) (“Federal drug regulations, as interpreted by the FDA, prevented the Manufacturers from independently changing their generic drugs’ safety labels”). See also 21 U. S. C. §355(j)(2)(A)(v) (“[T]he labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug”); 21 CFR §§314.94(a)(8)(iii), 314.150(b)(10) (approval for a generic drug may be withdrawn if the generic drug’s label “is no longer consistent with that for [the brand-name] drug”). Thus, federal law prohibited Mutual from taking the remedial action required to avoid liability under New Hampshire law.D
When federal law forbids an action that state law requires, the state law is “without effect.” Maryland, 451 U. S., at 746. Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, 3 New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce. 4IV
The Court of Appeals reasoned that Mutual could escape the impossibility of complying with both its federaland state-law duties by “choos[ing] not to make [sulindac] at all.” 678 F. 3d, at 37. We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federaland 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 federaland state-law duties could easily have been avoided if the regulated actor had simply ceased acting.
PLIVA is an obvious example: As discussed above, the PLIVA Court held that state failure-to-warn claims were pre-empted by the FDCA because it was impossible for drug manufacturers like PLIVA to comply with both the state-law duty to label their products in a way that rendered them reasonably safe and the federal-law duty not to change their drugs’ labels. Id., at ___ (slip op., at 11). It would, of course, have been possible for drug manufacturers like PLIVA to pull their products from the market altogether. In so doing, they would have avoided liability under both state and federal law: such manufacturers would neither have labeled their products in a way that rendered them unsafe nor impermissibly changed any federally approved label.
In concluding that “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,” id., at ___ (slip op., at 12), the Court was undeterred by the prospect that PLIVA could have complied with both state and federal requirements by simply leaving the market. The Court of Appeals decision below had found that Mensing’s state-law failure-to-warn claims
escaped pre-emption based on the very same stop-selling rationale the First Circuit relied on in this case. See Mensing v. Wyeth, Inc., 588 F. 3d 603, 611 (CA8 2009) (“[G]eneric defendants were not compelled to market metoclopramide. If they realized their label was insufficient . . . they could have simply stopped selling the product”). Moreover, Mensing advanced the stop-selling rationale in its petition for rehearing, which this Court denied. PLIVA, supra; Pet. for Reh’g in No. 09–993 etc., p. 2. Nonetheless, this Court squarely determined that it had been “impossible” for PLIVA to comply with both its state and federal duties. 564 U. S., at ___ (slip op., at 12). 5
Adopting the First Circuit’s stop-selling rationale would mean that not only PLIVA, but also the vast majority—if not all—of the cases in which the Court has found impossibility pre-emption, were wrongly decided. Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in PLIVA, so it is irrelevant to our analysis here.V
The dreadful injuries from which products liabilities cases arise often engender passionate responses. Today is no exception, as Justice Sotomayor’s dissent (hereinafter the dissent) illustrates. But sympathy for respondent does not relieve us of the responsibility of following the law.
The dissent accuses us of incorrectly assuming “that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability,” post, at 1, but we make no such assumption. Rather, as discussed at length above, see supra, at 8–13, we hold that state-law design-defect claims like New Hampshire’s that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling. The dissent is quite correct that federal law establishes no safe-harbor for drug companies—but it does prevent them from taking certain remedial measures. Where state law imposes a duty to take such remedial measures, it “actual[ly] conflict[s] with federal law” by making it “ ‘impos-sible for a private party to comply with both state and federal requirements.’ ” Freightliner Corp. v. Myrick, 514 U. S. 280, 287 (1995) (quoting English, 496 U. S., at 78–79). The dissent seems to acknowledge that point when it concedes that, “if federal law requires a particular product label to include a complete list of ingredients while state law specifically forbids that labeling practice, there is little question that state law ‘must yield.’ ” Post, at 6–7 (quoting Felder v. Casey, 487 U. S. 131, 138 (1988) ). What the dissent does not see is that that is this case: Federal law requires a very specific label for sulindac, and state law forbids the use of that label.
The dissent responds that New Hampshire law “merely create[s] an incentive” to alter sulindac’s label or composition, post, at 7, but does not impose any actual “legal obligation,” post, at 13. The contours of that argument are difficult to discern. Perhaps the dissent is drawing a distinction between common-law “exposure to liability,” post, at 12, and a statutory “legal mandate,” ibid. But the distinction between common law and statutory law is irrelevant to the argument at hand: In violating a common-law duty, as surely as by violating a statutory duty, a party contravenes the law. While it is true that, in a certain sense, common-law duties give a manufacturer the choice “between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product,” post, at 16, statutory “mandate[s]” do precisely the same thing: They require a manufacturer to choose between leaving the market and accepting the consequences of its actions (in the form of a fine or other sanction). See generally Calabresi & Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 Harv. L. Rev. 1089 (1972) (discussing liability rules). And, in any event, PLIVA—which the dissent agrees involved a state-law “requirement that conflicted with federal law,” post, at 13—dealt with common-law failure-to-warn claims, see PLIVA, supra, at ___ (slip op., at 4). Because PLIVA controls the instant case, the dissent is reduced to fighting a rearguard action against its reasoning despite ostensibly swearing fealty to its holding.
To suggest that Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005) , is to the contrary is simply misleading. The dissent is correct that Bates held a Texas state-law design-defect claim not to be pre-empted. But, it did so because the design-defect claim in question was not a “requirement ‘for labeling or packaging’ ” and thus fell outside the class of claims covered by the express pre-emption provision at issue in that case. Id., at 443–444 (emphasis in original). Indeed, contrary to the impression one might draw from the dissent, post, at 12–13, the Bates Court actually blessed the lower court’s determination that the State’s design-defect claim imposed a pre-emptable “requirement”: “The Court of Appeals did, however, correctly hold that the term ‘requirements’ in §136v(b) reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties.” Bates, supra, at 443. The dissent offers no compelling reason why the “common-law duty” in this case should not similarly be viewed as a “requirement.” We agree, of course, that “determining precisely what, if any, specific requirement a state common-law claim imposes is important.” Post, at 12, n. 5. As Bates makes clear, “[t]he proper inquiry calls for an examination of the elements of the common-law duty at issue; it does not call for speculation as to whether a jury verdict will prompt the manu-facturer to take any particular action.” 544 U. S., at 445 (citation omitted). Here, as we have tried to make clear, the duty to ensure that one’s products are not “unreasonably dangerous” imposed by New Hampshire’s design-defect cause of action, Vautour, 147 N. H., at 153, 784 A. 2d, at 1181, involves a duty to make one of several changes. In cases where it is impossible—in fact or by law—to alter a product’s design (and thus to increase the product’s “usefulness” or decrease its “risk of danger”), the duty to render a product “reasonably safe” boils down to a duty to ensure “the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Id., at 154, 784 A. 2d, at 1182. The duty to redesign sulindac’s label was thus a part of the common-law duty at issue—not merely an action Mutual might have been prompted to take by the adverse jury verdict here.
Finally, the dissent laments that we have ignored “Congress’ explicit efforts to preserve state common-law liability.” Post, at 26. We have not. Suffice to say, the Court would welcome Congress’ “explicit” resolution of the difficult pre-emption questions that arise in the prescription drug context. That issue has repeatedly vexed the Court—and produced widely divergent views—in recent years. See, e.g., Wyeth v. Levine, 555 U. S. 555 (2009) ; PLIVA, 564 U. S. ___. As the dissent concedes, however, the FDCA’s treatment of prescription drugs includes neither an express pre-emption clause (as in the vaccine context, 42 U. S. C. §300aa–22(b)(1)), nor an express non-pre-emption clause (as in the over-the-counter drug context, 21 U. S. C. §§379r(e), 379s(d)). In the absence of that sort of “explicit” expression of congressional intent, we are left to divine Congress’ will from the duties the statute imposes. That federal law forbids Mutual to take actions required of it by state tort law evinces an intent to pre-empt.* * *
This case arises out of tragic circumstances. A combination of factors combined to produce the rare and devastating injuries that respondent suffered: the FDA’s decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent’s physician to prescribe sulindac despite its known risks, and Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs’ compositions or their warnings. Respondent’s situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.
It is so ordered.
1 We can thus save for another day the question whether a trueabsolute-liability state-law system could give rise to impossibilitypre-emption. As we have noted, most common-law causes of action for negligence and strict liability do not exist merely to spread risk, but rather impose affirmative duties. See Riegel v. Medtronic, Inc., 552 U. S. 312 –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 (1992)], common-law liability is ‘premised on the existence of a legal duty,’ and a tort judgment therefore establishes that the defendant has violated a state-law obligation”).
2 That Mutual’s liability turned on the adequacy of sulindac’s warnings is not unusual. Rather, New Hampshire—like a large majority of States—has adopted comment k to §402A of the Restatement (Second) of Torts, which recognizes that it is “especially common in the field of drugs” for products to be “incapable of being made safe for their intended and ordinary use.” Restatement 2d, at 353; Bellotte v. Zayre Corp.,116 N. H. 52, 54–55, 352 A. 2d 723, 725 (1976). Under comment k, “[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Restatement 2d, at 353–354. This Court has previously noted that, as of 1986, “a large number of courts” took comment k to mean that manufacturers “did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings.” Bruesewitz v. Wyeth, 562 U. S. ___, ___, n. 41 (2011) (slip op., at 10, n. 41). Mutual withdrew its comment k defense “for purposes of the trial of this matter.” Defendant’s Notice of Withdrawal of Defenses, in Case No. 08–cv–358–JL (D NH), p. 1. However, as noted above, bothrespondent and the trial court injected the broader question of the adequacy of sulindac’s label into the trial proceedings.
3 Justice Breyer argues that it is not “literally impossible” for Mutual to comply with both state and federal law because it could escape liability “either by not doing business in the relevant State or by paying the state penalty, say damages, for failing to comply with, as here, a state-law tort standard.” Post, at 1 (dissenting opinion). But, as dis-cussed below, infra, at 15–16—leaving aside the rare case in which state or federal law actually requires a product to be pulled from the market—our pre-emption cases presume that a manufacturer’s ability to stop selling does not turn impossibility into possibility. See, e.g., Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 143 (1963) (There would be “impossibility of dual compliance” where “federal orders forbade the picking and marketing of any avocado testingmore than 7% oil, while the California test excluded from the State any avocado measuring less than 8% oil content”). And, of course, PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), forecloses any argument that impossibility is defeated by the prospect that a manufacturer could “pa[y] the state penalty” for violating a state-law duty; that prospect would have defeated impossibility in PLIVA as well. See id., at ___ (slip op., at 12) (“[I]t was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same”). To hold otherwise would render impossibility pre-emption “all but meaningless.” Id., at ___ (slip op.,at 14).
4 We do not address state design-defect claims that parallel the federal misbranding statute. The misbranding statute requires a manufac-turer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 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”).
5 Respondent attempts to distinguish this case from PLIVA, arguing that “[w]here, as in PLIVA, state law imposes an affirmative duty on a manufacturer to improve the product’s label, suspending sales does not comply with the state-law duty; it merely offers an indirect means of avoiding liability for noncompliance with that duty.” Brief for Respondent 39. But that difference is purely semantic: the state-law duty in PLIVA to amend metoclopramide’s label could just as easily have been phrased as a duty not to sell the drug without adequate warnings. At least where a State imposes liability based on a balancing of a product’s harms and benefits in light of its labeling—rather than directly prohibiting the product’s sale—the mere fact that a manufacturer may avoid liability by leaving the market does not defeat a claim of impossibility.
SUPREME COURT OF THE UNITED STATES
MUTUAL PHARMACEUTICAL COMPANY, INC., PETITIONER v. KAREN L. BARTLETT
on writ of certiorari to the united states court of appeals for the first circuit
[June 24, 2013]
Justice Sotomayor, with whom Justice Ginsburg joins, dissenting.
In PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), this Court expanded the scope of impossibility pre-emption to immunize generic drug manufacturers from state-law failure-to-warn claims. Today, the Court unnecessarily and unwisely extends its holding in Mensing to pre-empt New Hampshire’s law governing design-defects with respect to generic drugs.
The Court takes this step by concluding that petitioner Mutual Pharmaceutical was held liable for a failure-to-warn claim in disguise, even though the District Court clearly rejected such a claim and instead allowed liability on a distinct theory. See infra, at 13–15. Of greater consequence, the Court appears to justify its revision of respondent Karen Bartlett’s state-law claim through an im-plicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability. Remarkably, the Court derives this proposition from a federal law that, in order to protect consumers, prohibits manufacturers from distributing new drugs in commerce without federal regulatory approval, and specifically disavows any intent to displace state law absent a direct and positive conflict.
Karen Bartlett was grievously injured by a drug that a jury found was unreasonably dangerous. The jury relied upon evidence that the drug posed a higher than normal risk of causing the serious skin reaction that produced her horrific injuries; carried other risks; and possessed no apparent offsetting benefits compared to similar pain relievers, like aspirin. See 760 F. Supp. 2d 220, 233–241, 243–244 (NH 2011). The Court laments her “tragic” situation, ante, at 20, but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this Court. If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett’s recovery. I re-spectfully dissent.I
I begin with “two cornerstones of our pre-emption jurisprudence,” Wyeth v. Levine, 555 U. S. 555, 565 (2009) , that should control this case but are conspicuously absent from the majority opinion. First, “ ‘the purpose of Congress is the ultimate touchstone’ in every pre-emption case.” Ibid. (quoting Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) ). Second, we start from the “assumption that the historic police powers of the States [are] not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress.” Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947) . “That assumption,” we have explained, “applies with particular force when,” as is the case here, “Congress has legislated in a field traditionally occupied by the States.” Altria Group, Inc. v. Good, 555 U. S. 70, 77 (2008) . 1
The Court applied both of these principles to the Fed-eral Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52Stat. 1040, as amended, 21 U. S. C. §301 et seq., in Levine, where we held that a state failure-to-warn claim against a brand-name drug manufacturer was not pre-empted by federal law. 555 U. S., at 581. Tracing the history of federal drug regulation from the 1906 Federal Food and Drugs Act, 34Stat. 768, up to the FDCA and its major amendments, the Court explained that federal drug law and state common-law liability have long been understood to operate in tandem to promote consumer safety. See Levine, 555 U. S., at 566–568, 574. That basic principle, which the majority opinion elides, is essential to understanding this case.
The FDCA prohibits the “introduction into interstate commerce [of ] any new drug” without prior approval from the United States Food and Drug Administration (FDA). 21 U. S. C. §355(a). Brand-name and generic drug manufacturers are required to make different showings to receive agency approval in this premarketing review process. See ante, at 2–3. But in either case, the FDA’s permission to market a drug has never been regarded as a final stamp of approval of the drug’s safety. Under the FDCA, manufacturers, who have greater “access to information about their drugs” than the FDA, Levine, 555 U. S., at 578–579, retain the ultimate responsibility for the safety of the products they sell. In addition to their ongoing obligations to monitor a drug’s risks and to report adverse drug responses to the FDA, see 21 CFR §§314.80, 314.81, 314.98 (2012), manufacturers may not sell a drug that is “deemed to be misbranded” because it is “dangerous to health” when used in the dosage or manner called for in the drug’s label. 21 U. S. C. §352(j); see §331(a); Brief for United States as Amicus Curiae 30–31 (hereinafter U. S. Brief) (indicating that the misbranding prohibition may apply to a drug that was previously approved for sale when significant new scientific evidence demonstrates that the drug is unsafe).
Beyond federal requirements, state common law plays an important “complementary” role to federal drug regulation. Levine, 555 U. S., at 578. Federal law in this area was initially intended to “supplemen[t] the protection for consumers already provided by state regulation and common-law liability.” Id., at 566. And as Congress “enlarged the FDA’s powers,” it “took care to preserve state law.” Id., at 567. In the 1962 amendments to the FDCA, which established the FDA’s premarketing review in its modern form, Congress adopted a saving clause providing that the amendments should not be construed to invalidate any provision of state law absent “a direct and positive conflict.” §202, 76Stat. 793. And in the years since, with “state common-law suits ‘continu[ing] unabated de-spite . . . FDA regulation,’ ” Levine, 555 U. S., at 567 (quoting Riegel v. Medtronic, Inc., 552 U. S. 312, 340 (2008) (Ginsburg, J., dissenting)), Congress has not enacted a pre-emption provision for prescription drugs (whether brand-name or generic) even as it enacted such provisions with respect to other products regulated by the FDA. 2
Congress’ preservation of a role for state law generally, and common-law remedies specifically, reflects a realistic understanding of the limitations of ex ante federal regu-latory review in this context. On its own, even 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 opportu-nity to seek redress that is not available under federal law. “[U]nlike most administrative and legislative regulations,” common-law claims “necessarily perform an important re-medial role in compensating accident victims.” Sprietsma v. Mercury Marine, 537 U. S. 51, 64 (2002) . While the Court has not always been consistent on this issue, it has repeatedly cautioned against reading federal statutes to “remove all means of judicial recourse for those injured” when Congress did not provide a federal remedy. Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 251 (1984) ; see e.g., Bates, 544 U. S., at 449; Lohr, 518 U. S., at 487 (plurality opinion). And in fact, the legislative history of the FDCA suggests that Congress chose not to create a federal cause of action for damages precisely because it believed that state tort law would allow injured consumers to obtain compensation. See Levine, 555 U. S., at 574–575, and n. 7.II
In light of this background, Mutual should face an uphill climb to show that federal law pre-empts a New Hampshire strict-liability claim against a generic drug manufacturer for defective design. The majority nevertheless accepts Mutual’s argument that “compliance with both federal and state [law was] a physical impossibility.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132 –143 (1963); see ante, at 7. But if state and fed-eral law are properly understood, it is clear that New Hampshire’s design-defect claim did not impose a legal obligation that Mutual had to violate federal law to satisfy.A
Impossibility pre-emption “is a demanding defense,” Le-vine, 555 U. S., at 573, that requires the defendant to show an “irreconcilable conflict” between federal and state legal obligations, Silkwood, 464 U. S., at 256. The logic underlying true impossibility pre-emption is that when state and federal law impose irreconcilable affirmative requirements, no detailed “inquiry into congressional de-sign” is necessary because the inference that Congress would have intended federal law to displace the conflicting state requirement “is inescapable.” Florida Lime, 373 U. S., at 142–143. So, for example, if federal law requires a particular product label to include a complete list of ingredients while state law specifically forbids that labeling practice, there is little question that state law “must yield.” Felder v. Casey, 487 U. S. 131, 138 (1988) .
The key inquiry for impossibility pre-emption, then, is to identify whether state and federal law impose directly conflicting affirmative legal obligations such that state law “require[s] the doing of an act which is unlawful under” federal law. California Fed. Sav. & Loan Assn. v. Guerra, 479 U. S. 272, 292 (1987) . Impossibility does not exist where the laws of one sovereign permit an activity that the laws of the other sovereign restricts or even prohibits. See Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U. S. 25, 31 (1996) ; Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, n. 21 (1984) . So, to modify the previous example, if federal law permitted (but did not require) a labeling practice that state law prohibited, there would be no irreconcilable conflict; a manufacturer could comply with the more stringent regulation. And by the same logic, impossibility does not exist where one sovereign’s laws merely create an incentive to take an action that the other sovereign has not authorized because it is possible to comply with both laws.
Of course, there are other types of pre-emption. Courts may find that state laws that incentivize what federal law discourages or forbid what federal law authorizes are pre-empted for reasons apart from impossibility: The state laws may fall within the scope of an express pre-emption provision, pose an obstacle to federal purposes and objectives, or intrude upon a field that Congress intended for federal law to occupy exclusively. See Crosby v. National Foreign Trade Council, 530 U. S. 363 –373 (2000). But absent a direct conflict between two mutually incompatible legal requirements, there is no impossibility and courts may not automatically assume that Congress intended for state law to give way. Instead, a more careful inquiry into congressional intent is called for, and that inquiry should be informed by the presumption against pre-emption.
In keeping with the strict standard for impossibility, cases that actually find pre-emption on that basis are rare. See Abrams, Plenary Power Preemption, 99 Va. L. Rev. 601, 608 (2013). Mensing is an outlier, as the Court found impossibility because a generic drug manufacturer could not strengthen its product label to come into line with a state-law duty to warn without the exercise of judgment by the FDA. See 564 U. S., at ___–___ (slip op., at 13–14). But nothing in Mensing, nor any other precedent, dictates finding impossibility pre-emption here.B
To assess whether it is physically impossible for Mutual to comply with both federal and state law, it is necessary to identify with precision the relevant legal obligations imposed under New Hampshire’s design-defect cause of action.
The majority insists that Mutual was required by New Hampshire’s design-defect law to strengthen its warning label. In taking this position, the majority effectively re-characterizes Bartlett’s design-defect claim as a de facto failure-to-warn claim. The majority then relies on that re-characterization to hold that the jury found Mutual liable for failing to fulfill its duty to label sulindac adequately, which Mensing forbids because a generic drug manufacturer cannot independently alter its safety label. Ante, at 13; see Mensing, 564 U. S., at ___ (slip op., at 10). But the majority’s assertion that Mutual was held liable in this case for violating a legal obligation to change its label is inconsistent with both New Hampshire state law and the record.
For its part, Mutual, in addition to making the argument now embraced by the majority, contends that New Hampshire’s design-defect law effectively required it to change the chemical composition of sulindac. Mutual claims that it was physically impossible to comply with that duty consistent with federal law because drug manufacturers may not change the chemical composition of their products so as to create new drugs without submitting a new drug application for FDA approval. See 21 CFR §§310.3(h), 314.70(b)(2)(i). But just as New Hampshire’s design-defect law did not impose a legal obligation for Mutual to change its label, it also did not mandate that Mutual change the drug’s design.1 a
Following blackletter products liability law under §402A of the Restatement (Second) of Torts (1963–1964) (hereinafter Second Restatement), New Hampshire recognizes strict liability for three different types of product defects: manufacturing defects, design defects, and warning defects. See Cheshire Medical Center v. W. R. Grace & Co., 49 F. 3d 26, 29 (CA1 1995). Because the District Court granted Mutual summary judgment on Bartlett’s failure-to-warn claim, only New Hampshire’s design-defect cause of action remains at issue in this case.
A product has a defective design under New Hampshire law if it “poses unreasonable dangers to consumers.” Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 807, 395 A. 2d 843, 846 (1978). To determine whether a product is unreasonably dangerous, a jury is asked to make a risk-benefit assessment by considering a nonexhaustive list of factors. See ante, at 9–10. In addition, New Hamp-shire has specifically rejected the doctrine, advocated by the Restatement (Third) of Torts: Products Liability §2(b) (1997) (hereinafter Third Restatement), that a plaintiff must present evidence of a reasonable alternative design to show that a product’s design is defective. Instead, “while proof of an alternative design is relevant in a design defect case,” it is “neither a controlling factor nor an essential element.” Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 156, 784 A. 2d 1178, 1183 (2001).
While some jurisdictions have declined to apply design-defect liability to prescription drugs, New Hampshire, in common with many other jurisdictions, does subject prescriptions drugs to this distinct form of strict products liability. See 678 F. 3d 30, 35 (CA1 2012) (citing Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 655 (CA1 1981)); see also Third Restatement §6, Comment f (collecting cases from other jurisdictions). Drug manufacturers in New Hampshire have an affirmative defense under comment k to §402A of the Second Restatement, which exempts “[u]navoidably unsafe products” from strict liability if the product is properly manufactured and labeled. As explained by the lower courts in this case, see 678 F. 3d, at 36; 731 F. Supp. 2d 135, 150–151 (NH 2010), New Hampshire takes a case-by-case approach to comment k under which a defendant seeking to invoke the defense must first show that the product is highly useful and that the dan-ger imposed by the product could not have been avoided through a feasible alternative design. See Brochu, 642 F. 2d, at 657. Comment k did not factor into the jury’s assessment of liability in this case because Mutual abandoned a comment k defense before trial. Ante, at 12, n. 2. 3b
The design-defect claim that was applied to Mutual subjects the manufacturer of an unreasonably dangerous product to liability, but it does not require that manufacturer to take any specific action that is forbidden by federal law. Specifically, and contrary to the majority, see ante, at 11, New Hampshire’s design-defect law did not require Mutual to change its warning label. A drug’s warning label is just one factor in a nonexclusive list for evaluating whether a drug is unreasonably dangerous, see Vautour, 147 N. H., at 156, 784 A. 2d, at 1183, and an adequate label is therefore neither a necessary nor a sufficient con-dition for avoiding design-defect liability. Likewise, New Hampshire law imposed no duty on Mutual to change sulindac’s chemical composition. The New Hampshire Supreme Court has held that proof of an alternative fea-sible design is not an element of a design-defect claim, see Kelleher v. Marvin Lumber & Cedar Co., 152 N. H. 813, 831, 891 A. 2d 477, 492 (2006), and as the majority recognizes, ante, at 11, sulindac was not realistically capable of being redesigned anyway because it is a single-molecule drug. 4
To be sure, New Hampshire’s design-defect claim creates an incentive for drug manufacturers to make changes to its product, including to the drug’s label, to try to avoid liability. And respondent overstates her case somewhat when she suggests that New Hampshire’s strict-liability law is purely compensatory. See Brief for Respondent 19. As is typically true of strict-liability regimes, New Hampshire’s law, which mandates compensation only for “defective” products, serves both compensatory and regulatory purposes. See Heath v. Sears, Roebuck & Co., 123 N. H. 512, 521–522, 464 A. 2d 288, 293 (1983). But exposure to liability, and the “incidental regulatory effects” that flow from that exposure, Goodyear Atomic Corp. v. Miller, 486 U. S. 174 –186 (1988), is not equivalent to a legal mandate for a regulated party to take (or refrain from taking) a specific action. This difference is a significant one: A mandate leaves no choice for a party that wishes to comply with the law, whereas an incentive may only influence a choice.
Our cases reflect this distinction. In Bates, for exam-ple, we rejected an argument that design-defect claims brought against a pesticide manufacturer were pre-empted because they would likely “induce” the manufacturer to change its product label and thus run afoul of an express pre-emption provision forbidding state labeling “requirements” that were different or in addition to federal requirements. 544 U. S., at 444–446. A requirement, we explained, “is a rule of law that must be obeyed.” Id., at 445. “[A]n event, such as a jury verdict, that merely motivates an optional decision,” does not rise to that level. Ibid. 5
So too here. The fact that imposing strict liability for injuries caused by a defective drug design might make a drug manufacturer want to change its label or design (or both) does not mean the manufacturer was actually required by state law to take either action. And absent such a legal obligation, the majority’s impossibility argument does not get off the ground, because there was no state requirement that it was physically impossible for Mutual to comply with while also following federal law. The case is therefore unlike Mensing, where it was “undisputed” that applicable state tort law “require[d] a drug manufacturer that is or should be aware of its product’s danger” to strengthen its label—a requirement that conflicted with federal law preventing the manufacturer from doing so uni-laterally, 564 U. S., at ___, ___ (slip op., at 4, 11–12). New Hampshire’s design-defect law did not require Mu-tual to do anything other than to compensate consumers who were injured by an unreasonably dangerous drug.2
Moreover, the trial record in this case confirms that, con-trary to the majority’s insistence, Mutual was not held liable for “breach[ing] [its] duty” “to label sulindac adequately.” Ante, at 13.
When Bartlett filed suit against Mutual, she raised distinct claims based on design defect and failure to warn. App. 102–108; see 659 F. Supp. 2d 279, 282 (NH 2009). Pursuing both claims was consistent with New Hampshire law’s recognition that “design defect and failure to warn claims are separate.” LeBlanc v. American Honda Motor Co., 141 N. H. 579, 586, 688 A. 2d 556, 562 (1997). After the District Court granted summary judgment to Mutual on the failure-to-warn claim, the court repeatedly explained that an alleged failure to warn by Mutual could not and did not provide the basis for Bartlett’s recovery. See 760 F. Supp. 2d, at 248–249. 6
The majority notes that the District Court admitted evidence regarding sulindac’s label. Ante, at 11–12. But the court did so because the label remained relevant for the more limited purpose of assessing, in combination with other factors, whether sulindac’s design was defective because the product was unreasonably dangerous. See 678 F. 3d, at 41. The District Court’s instructions to the jury adhered to this limited purpose. The court first told the jury to determine whether sulindac was unreasonably dangerous by weighing its danger against its utility. App. 513. The court further instructed the jury that if it determined that sulindac was unreasonably dangerous without reference to the warning label, it could then consider the presence and efficacy of the label to evaluate whether the product was unreasonably dangerous “even with its warning.” Id., 513–514. In other words, to hold Mutual liable, the jury was required to find that sulindac “was unreasonably dangerous despite its warning, not because of it.” Id., at 341. The District Court also explained to the jury that because Bartlett’s claim addressed only whether sulindac’s design was defective, Mutual’s conduct, “which included any failure to change its warning, was ‘not relevant to this case.’ ” 760 F. Supp. 2d, at 248.
The distinction drawn by the District Court between permissible and impermissible uses of evidence regarding sulindac’s label is faithful to New Hampshire law. That law recognizes that the effectiveness of a warning label is just one relevant factor in determining whether a product’s design is unreasonably dangerous, and that design-defect and failure-to-warn claims are “separate.” LeBlanc, 141 N. H., at 586, 688 A. 2d, at 562. 7 In short, as the District Court made clear, Mutual was not held liable for “failing to change” its warning. 760 F. Supp., at 248–249.C
Given the distinction that New Hampshire draws between failure-to-warn claims and design-defect claims, as well as the clear and repeated statements by the trial judge that Mutual’s liability was not predicated on breaching a duty to label sulindac adequately, on what basis does the majority reach a contrary conclusion? Though the majority insists otherwise, ante, at 17, it appears to rely principally on an implicit assumption about rights conferred by federal premarket approval under the FDCA. After correctly observing that changing sulindac’s chemical composition would create a new drug that would have to go through its own approval process, the majority reasons that Mutual must have been under a state-law duty to change its label because it had no other option to avoid liability while continuing to sell its product. Ante, at 10–11. But that conclusion is based on a false premise.
A manufacturer of a drug that is unreasonably dangerous under New Hampshire law has multiple options: It can change the drug’s design or label in an effort to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business. If federal law or the drug’s chemical properties take the redesign option off the table, then that does not mean the manufacturer suddenly has a legal obligation under state law to improve the drug’s label. Indeed, such a view of state law makes very little sense here because even if Mutual had strengthened its label to fully account for sulindac’s risks, the company might still have faced liability for having a defective design. See Thibault, 118 N. H., at 808, 395 A. 2d, at 847 (explaining that strict liability “may attach even though . . . there was an adequate warning”). When a manufacturer cannot change the label or when doing so would not make the drug safe, the manufacturer may still choose between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product. 8
From a manufacturer’s perspective, that may be an un-welcome choice. But it is a choice that a sovereign State may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation. That is, a State may impose such a choice unless the FDCA gives manufacturers an absolute right to sell their products free from common-law liability, or state law otherwise “stands as an obstacle to the accomplishment” of federal objectives. Crosby, 530 U. S., at 373 (internal quotation marks omitted). Because the majority does not rely on obstacle pre-emption, it must believe that a manufacturer that received FDA premarket approval has a right not only to keep its drug on the market unless and until the FDA revokes approval, but also to be free from state-law liability that makes doing so more expensive. That proposition is fundamentally inconsistent with the FDCA’s text, structure, saving clause, and his-tory. See supra, at 3–6; Levine, 555 U. S., at 583 (Thomas, J., concurring in judgment).
It is simply incorrect to say that federal law presupposes that drug manufacturers have a right to continue to sell a drug free from liability once it has been approved. Nothing in the language of the FDCA, which is framed as a prohibition on distribution without FDA approval, see 21 U. S. C. §355(a), suggests such a right. Federal law itself bars the sale of previously approved drugs if new information comes to light demonstrating that the drug is “dangerous to health” and thus “misbranded.” See §§331(a), 352(j); see supra, at 3–4. 9 Even outside that scenario, manufacturers regularly take drugs off the market when evidence emerges about a drug’s risks, particularly when safer drugs that provide the same therapeutic benefits are available. 10 According to the FDA, while it has formal authority to withdraw approval for a drug based on new adverse information, see §355(e), it is far more common for a manufacturer to stop selling its product voluntarily after the FDA advises the manufacturer that the drug is unsafe and that its risk-benefit profile cannot be adequately addressed through labeling changes or other measures. See U. S. Brief 5.
New Hampshire’s design-defect cause of action thus does no more than provide an impetus for an action that is permitted and sometimes encouraged or even required by federal law.D
The majority derides any suggestion that Mutual’s ability to “stop selling” sulindac is relevant to the validity of its impossibility pre-emption defense. Ante, at 2, 14–16. But the majority’s argument is built on the mistaken premise that Mutual is legally obligated by New Hampshire’s design-defect law to modify its label in a way that federal law forbids. It is not. See supra, at 11–13. For that reason, rejecting impossibility pre-emption here would not render the doctrine “a dead letter” or “ ‘all but meaningless.’ ” Ante, at 2, 15 (quoting Mensing, 564 U. S., at ___ (slip op., at 14)). On the other hand, it is the majority that “work[s] a revolution in this Court’s [impossibility] pre-emption case law,” ante, at 2, by inferring a state-law requirement from the steps a manufacturer might wish to take to avoid or mitigate its exposure to liability.
Not all products can be made safe for sale with an improved warning or a tweak in design. New Hampshire, through its design-defect law, has made a judgment that some drugs that were initially approved for distribution turn out to be inherently and unreasonably dangerous and should therefore not be sold unless the manufacturer is willing to compensate injured consumers. Congressional intent to pre-empt such a cause of action cannot be gleaned from the existence of federal specifications that apply to the product if it is sold. Instead, whether New Hampshire’s design-defect cause-of-action is pre-empted depends on assessing whether it poses an obstacle to a federal policy to approve sulindac for use. Yet the major-ity skips that analysis and instead finds impossibility where it does not exist by relying on a question-begging assumption that Congress intended for Mutual to have a way to continue selling sulindac without incurring common-law liability. See ante, at 9–11.
The distinction between impossibility and obstacle pre-emption is an important one. While obstacle pre-emption can be abused when courts apply an overly broad conception of the relevant federal purpose to find pre-emption, see Levine, 555 U. S., at 601–602 (Thomas, J., concurring in judgment), it is a useful framework for a case like this one because it would at least lead the Court to ask the right questions.
For example, properly evaluating the asserted conflict here through the lens of obstacle pre-emption would allow the Court to consider evidence about whether Congress intended the FDA to make an optimal safety determination and set a maximum safety standard (in which case state tort law would undermine the purpose) rather than a minimal safety threshold (in which case state tort law could supplement it). See, e.g., Williamson v. Mazda Motor of America, Inc., 562 U. S. ___, ___ (2011) (slip op., at 11). By contrast, the majority’s overbroad impossibility framework takes no account of how federal drug safety review actually works. Though the majority gestures to the rigorous nature of the FDA’s review of new drug ap-plications, ante, at 2–3, nothing in the majority’s reasoning turns on how the FDA’s premarketing review operates or on the agency’s capacity to engage in postmarketing review.
In taking the approach it does, the majority replaces careful assessment of regulatory structure with an ipse dixit that pharmaceutical companies must have a way to “escape liability,” ante, at 11, while continuing to sell a drug that received FDA approval. As a result, the major-ity effectively makes a highly contested policy judgment about the relationship between FDA review and state tort law—treating the FDA as the sole guardian of drug safety—without defending its judgment and without con-sidering whether that is the policy judgment that Congress made. 11III
While the majority never addresses obstacle pre-emption, Mutual did argue in the alternative that Bartlett’s design-defect cause of action is pre-empted because it conflicts with the purposes and objectives of the FDCA, as supplemented by the Hatch-Waxman Act, 98Stat. 1585. Though it presents a closer question than the impossibility argument on which the majority relies, I would reject Mutual’s obstacle pre-emption defense as well.
Mutual’s most substantial contention is that New Hamp-shire’s design-defect claim frustrates the policy under-lying the FDCA’s broader scheme of vesting authority in the FDA as an expert agency to determine which drug designs should enter and remain in interstate commerce. The FDA, through an amicus brief filed by the United States, generally supports this argument. The FDA states that the question whether a design-defect claim 12 is pre-empted is “difficult and close,” and it recognizes that “[s]everal factors do weigh in favor of finding no preemption,” including the absence of textual support in the FDCA for the idea that an approved drug must be made available in any particular State. See U. S. Brief 12, 21–22. But the FDA ultimately contends that design-defect claims are pre-empted unless they parallel the FDCA’s misbranding prohibition because the agency be-lieves that permitting juries to balance the health risks and benefits of an FDA-approved drug would undermine the FDA’s drug-safety determinations and could reduce access to drugs that the FDA has determined are safe and effective.
Our cases have “given ‘some weight’ to an agency’s views about the impact of tort law on federal objectives when ‘the subject matter is technica[l] and the relevant history and background are complex and extensive.’ ” Levine, 555 U. S., at 576 (quoting Geier v. American Honda Motor Co., 529 U. S. 861, 883 (2000) ). But courts do not “defe[r] to an agency’s conclusion that state law is pre-empted,” 555 U. S., at 576, and the tension that the FDA identifies in an effort to justify complete pre-emption of design-defect claims for prescription drugs does not satisfy the “ high threshold [that] must be met if a state law is to be pre-empted for conflicting with the purposes of a federal Act,” Chamber of Commerce of United States of America, v. Whiting, 563 U. S. ___, ___ (2011) (slip op., at 22) (internal quotation marks omitted); see Silkwood, 464 U. S., at 256. Given the FDCA’s core purpose of protecting consumers, our recognition in Levine that state tort law generally complements the statute’s safety goals, the practical limits on the FDA’s ability to monitor and promptly address concerns about drug safety once a drug is in the market, see supra, at 5, 20–21, n. 11, and the absence of any federal remedy for injured consumers, I would reject this broad obstacle pre-emption argument as well. 13IV
The most troubling aspect of the majority’s decision to once again expand the scope of this Court’s traditionally narrow impossibility pre-emption doctrine is what it implies about the relationship between federal premarket review and state common-law remedies more generally. Central to the majority’s holding is an assumption that manufacturers must have a way to avoid state-law lia-bility while keeping particular products in commerce. See ante, at 9–11, 14–15. This assumption, it seems, will always create an automatic conflict between a federal premarket review requirement and state-law design-defect liability because premarket review, by definition, prevents manufacturers from unilaterally changing their products’ designs. 14 That is true, for example, of the designs (i.e., the chemical composition) of brand-name drugs under the FDCA no less than it is for generic drugs. See ante, at 3–4.
If the creation of such an automatic conflict is the ultimate end-point of the majority’s continued expansion of impossibility pre-emption, then the result is frankly astonishing. Congress adopted the FDCA’s premarketing approval requirement in 1938 and then strengthened it in 1962 in response to serious public-health episodes involving unsafe drugs. See Future of Drug Safety 152. Yet by the majority’s lights, the very act of creating that requirement in order to “safeguard the consumer,” United States v. Sullivan, 332 U. S. 689, 696 (1948) , also created by operation of law a shield for drug manufacturers to avoid paying common-law damages under state laws that are also designed to protect consumers. That is so notwithstanding Congress’ effort to disclaim any intent to pre-empt all state law. See supra, at 4. The majority’s reasoning thus “has the ‘perverse effect’ of granting broad immunity ‘to an entire industry that, in the judgment of Congress, needed more stringent regulation.’ ” Riegel, 552 U. S., at 338 (Ginsburg, J., dissenting) (quoting Lohr, 518 U. S., at 487 (plurality opinion)).
This expanded notion of impossibility pre-emption threatens to disturb a considerable amount of state law. The FDCA’s premarket approval process for prescription drugs has provided a model for the regulation of many other products. 15 In some statutes, Congress has paired premarket regulatory review with express pre-emption provisions that limit the application of state common-law remedies, including, in some instances, claims for defective product design. See, e.g., Riegel, 552 U. S., at 323–325; see supra, at 4, and n. 2. In other instances, such as with prescription drugs, it has not. Under the majority’s approach, it appears that design-defect claims are categorically displaced either way, and Congress’ efforts to set the boundaries of pre-emption more precisely were largely academic. This could have serious consequences for product safety. State design-defect laws play an important role not only in discovering risks, but also in providing in-centives for manufacturers to remove dangerous products from the market promptly. See Levine, 555 U. S., at 578–579; Bates, 544 U. S., at 451; see also Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability? 109 Yale L. J. 1087, 1130 (2000) (“The tort system can encourage FDA regulatory vigor and competence”). If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.
The manner in which Congress has addressed pre-emption with respect to vaccines is particularly instructive. “[V]accines have been subject to the same federal premarket approval process as prescription drugs,” and prior to Congress’ intervention, “compensation for vaccine-related injuries ha[d] been left largely to the States.” Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___ (2011) (slip op., at 1). In 1986, in response to a rise in tort suits that produced instability in the vaccine market, Congress enacted the National Childhood Vaccine Injury Act (Vaccine Act), 42 U. S. C. §300aa–22(b)(1). The Act established a no-fault compensation program funded through an excise tax on vaccines to compensate individuals injured or killed by vaccine side effects. “The quid pro quo for this” system, the Court stated in Bruesewitz, “was the provision of significant tort-liability protections for vaccine manufacturers.” 562 U. S., at ___ (slip op., at 4).
While Members of this Court disagreed on the scope of the tort protections the Vaccine Act was intended to offer, the Act’s history demonstrates that Congress is perfectly capable of responding when it believes state tort law may compromise significant federal objectives under a scheme of premarket regulatory review for products it wants to make available. And it illustrates that “an important reason to require that preemption decisions be made by Congress,” rather than by courts on the basis of an expanded implied pre-emption doctrine, is Congress’ ability to tie its pre-emption decisions “to some alternative means for securing compensation.” Metzger, Federalism and Fed-eral Agency Reform, 111 Colum. L. Rev. 1, 33 (2011). By instead reaching out to find pre-emption in a context where Congress never intended it, the majority leaves consumers like Karen Bartlett to bear enormous losses on their own.* * *
The Court recognizes that “[t]his case arises out of tragic circumstances.” Ante, at 20. And I do not doubt that Members of the majority personally feel sympathy for Karen Bartlett. But the Court’s solemn affirmation that it merely discharges its duty to “follo[w] the law,” ante, at 17, and gives effect to Congress’ policy judgment, rather than its own, is hard to accept. By once again expanding the scope of impossibility pre-emption, the Court turns Congress’ intent on its head and arrives at a holding that is irreconcilable with our precedents. As a result, the Court has left a seriously injured consumer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.
I respectfully dissent.
1 The majority’s failure to adhere to the presumption against pre-emption is well illustrated by the fact that the majority calls on Congress to provide greater clarity with regard to the “difficult pre-emption questions that arise in the prescription drug context.” Ante, at 19–20. Certainly, clear direction from Congress on pre-emption questions is useful. But the whole point of the presumption against pre-emption is that congressional ambiguity should cut in favor of preserving state autonomy. See Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947) .
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).
3 Though the majority does not rely on comment k to find pre-emption, it misleadingly implies that New Hampshire, like “a large majority of States,” has applied comment k categorically to prescription drugs to exempt manufacturers from “ ‘strict liability for side effects of properly manufactured prescription drugs that [are] accompanied by ade-quate warnings.’ ” Ante, at 12, n. 2 (quoting Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___, n. 41 (2011) (slip op., at 10, n. 41). That is in-correct. The majority also neglects to mention that while some courts have applied comment k categorically to prescription drug designs, “[m]ost courts have stated that there is no justification for giving all prescription drug manufacturers blanket immunity from strict liability under comment k.” 2 American Law of Products Liability 3d §17.45,p. 108 (2010). Like New Hampshire courts, these courts apply comment k on a case-by-case basis. See 1 L. Frumer & M. Friedman, Products Liability §8.07, pp. 8–287 to 8–293 (2012).
4 Because of this feature of New Hampshire law, it is unnecessary to consider whether the pre-emption analysis would differ in a jurisdiction that required proof of a feasible alternative design as an element of liability.
5 The majority suggests my account of Bates is “simply misleading,” ante, at 18, but it simply misses the point. I recognize that, under the Court’s precedents, common-law duties may qualify as “requirements,” at least as that term has been used in express pre-emption provisions in federal law. See Riegel v. Medtronic, Inc., 552 U. S. 312 –324 (2008). But determining precisely what, if any, specific requirement a state common-law claim imposes is important. In Bates, the lower court had accepted the same basic argument that the majority advances here: that the plaintiffs’ design-defect claim that a pesticide was “unreasonably dangerous” was “merely a disguised claim for failure to warn” because success on the claim that the pesticide was dangerous to crops in soil above a certain pH level would “necessarily induce” a manufacturer to change its product’s label to avoid liability. Dow Agrosciences LLC v. Bates, 332 F. 3d 323, 332–333 (CA5 2003). This Court explicitly rejected the notion that because design-defect liability might lead a manufacturer to make a label change, it meant that the State’s design-defect claim imposed a requirement for labeling or packaging. See 544 U. S., at 445–446. The majority contends that this case is different because the duty to redesign sulindac’s label was an element of New Hampshire’s design-defect law. Ante, at 19. But it is not. See supra, at 11. Rather, altering a product label is merely one step a manufacturer might take to prevent its product from being considered unreasonably dangerous, and it is a step that New Hampshire law recognizes may be insufficient. See infra, at 16.
6 For example, in a ruling on proposed jury instructions, the District Court made clear that “Bartlett cannot be allowed to circumvent this court’s summary judgment ruling by using Sulindac’s warning to establish that the drug is unreasonably dangerous (i.e., arguing that Sulindac is unreasonably dangerous because of its warning), where this court has already ruled that any inadequacy in the warning did not cause Bartlett’s injuries.” App. 343. Doing so, the court explained “would effectively turn this case back into a failure-to-warn case, rendering the summary judgment ruling meaningless.” Ibid. The District Court later told counsel that it had removed a failure-to-warn instruction from the jury instructions because “[t]his is not a failure to warn case,” and the court admonished counsel to “tread care-fully” in arguing about the warning label because the label’s adequacy was “not an issue before this jury.” Id., at 496.
7 To the extent the majority believes that the District Court in practice allowed the adequacy of the warning label to play a greater roleat trial than it should have, see ante, at 11–12, that is irrelevant to the question before the Court. Statements by counsel, even if improper, do not change the state law cause of action that we evaluate for pre-emption purposes. And the Court of Appeals specifically concluded that the District Court’s jury instructions were appropriate and that “[i]f Mutual wanted a further caution in the instructions” concerning its warning label, then Mutual “should have sought it.” 678 F. 3d 30, 41–42 (CA1 2012).
8 The majority’s suggestion that a manufacturer’s option of continuing to sell while paying compensation is akin to violating a statutory mandate and then suffering the consequence (such as paying a fine) is flawed. See ante, at 18. In that scenario, the manufacturer would have violated the law, and the fact that the law is enforced through monetary sanctions (rather than through an injunction or imprisonment) would not change that. Here, no matter how many times the majority insists otherwise, ibid., a manufacturer who sells a drug whose design is found unreasonably dangerous based on a balance of factors has not violated a state law requiring it to change its label. In both cases, the manufacturer may owe money. But only in the former will it have failed to follow the law. Cf. National Federation of Independent Business v. Sebelius, 567 U. S. __, __ (2012) (slip op., at 32) (recognizing that a condition that triggers a tax is not necessarily a “legal command” to take a certain action).
9 The majority properly leaves open the question whether state design-defect claims that parallel the federal misbranding statute are pre-empted. See ante, at 14, n. 4. The majority fails to appreciate, however, that this statute undermines its impossibility argument (as compared to an argument based on obstacle pre-emption) because it shows that there is no federal right or obligation to continue to sell a drug like sulindac that was previously approved. In fact, the statute demonstrates that sometimes a drug manufacturer like Mutual may have a federal duty not to sell its drug.
10 See Government Accountability Office, Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process 10 (GAO–06–402, 2006) (noting that 10 drugs were voluntarily withdrawn for safety reasons between 2000 and 2006); Wysowski & Swartz, Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969–2002, 165 Archives Internal Med. 1363 (2005) (noting that more than 75 drugs and drug products were withdrawn from the market for safety reasons between 1969 and 2002).
11 Defending a policy judgment that treats the FDA as the exclusive guarantor of drug safety would be no easy task in light of evidence that resource constraints and gaps in legal authority, among other factors, limit the agency’s ability to safeguard public health. See Kessler & Vladeck, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 483–495 (2008); see also Wyeth v. Levine, 555 U. S. 555 –579, and n. 11 (2009).
12 The FDA purports to address what it calls a “pure” design-defect claim, and it references the Third Restatement §6 by way of illustration. The FDA’s separate discussion of a “pure” design-defect claim is based on the premise that New Hampshire’s design-defect claim turns on the adequacy of a drug’s warning. See U. S. Brief 20. But that is incorrect. See supra, at 11.
13 I note that we are not confronted with a case in which the FDA promulgated “lawful specific regulations describing” whether and under what circumstances state design-defect liability interferes with “the safe drug-related medical care” sought through the FDCA. Levine, 555 U. S., at 582 (Breyer, J., concurring). See also ante, at 2–3 (Breyer, J., dissenting).
14 Or at least it creates an automatic conflict with the caveat that design-defect claims that parallel a federal duty for manufacturers to withdraw a product might not be pre-empted. See ante, at 13–14, n. 3.
15 See, e.g., 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).
SUPREME COURT OF THE UNITED STATES
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 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. 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 Coun-cil, 530 U. S. 363, 373 (2000) ).
Normally, for the reasons I set forth in Medtronic, Inc. v. Lohr, 518 U. S. 470, 503 (1996) (opinion concurring in part and concurring in judgment), in deciding whether there is such a conflict I would pay particular attention to the views of the relevant agency, here the Food and Drug Administration (FDA). Where the statute contains no clear pre-emption command, courts may infer that the administrative agency has a degree of leeway to determine the extent to which governing statutes, rules, regulations, or other administrative actions have pre-emptive effect. See id., at 505–506 (citing Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735 –741 (1996); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 721 (1985) ; Lawrence County v. Lead-Deadwood School Dist. No. 40–1, 469 U. S. 256 –262 (1985); Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 –845 (1984)). See also Wyeth v. Levine, 555 U. S. 555 –577 (2009). Cf. Skidmore v. Swift & Co., 323 U. S. 134, 140 (1944) . The FDA is responsible for administering the relevant federal statutes. And the question of pre-emption may call for considerable drug-related expertise. Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.
At the same time, the agency can develop an informed position on the pre-emption question by providing interested parties with an opportunity to present their views. It can translate its understandings into particular pre-emptive intentions accompanying its various rules and regulations. And “[i]t can communicate those intentions . . . through statements in ‘regulations, preambles, interpretive statements, and responses to comments.’ ” Medtronic, supra, at 506 (opinion of Breyer, J.). (quoting Hillsbor-ough, supra, at 718).
Here, however, I cannot give special weight to the FDA’s views. For one thing, as far as the briefing reveals, the FDA, in developing its views, has held no hearings on the matter or solicited the opinions, arguments, and views of the public in other ways. For another thing, the FDA has set forth its positions only in briefs filed in litigation, not in regulations, interpretations, or similar agency work product. See Bowen v. Georgetown Univ. Hospital, 488 U. S. 204 –213 (1988) (“[A]gency litigating positions that are wholly unsupported by regulations, rulings, or administrative practice” are entitled to less than ordinary weight). Cf. Christensen v. Harris County, 529 U. S. 576, 587 (2000) .
Finally, the FDA has set forth conflicting views on this general matter in different briefs filed at different times. Compare Wyeth, supra, at 577, 579, 580, n. 13 (noting that the FDA had previously found no pre-emption, that the United States now argued for pre-emption, and that this new position was not entitled to deference), with PLIVA, Inc. v. Mensing, 564 U. S. ___, ___, n. 3, ___ (2011) (slip op., at 6–7, n. 3, 8–11) (declining to defer to the United States’ argument against pre-emption and, instead, finding pre-emption), and with Brief for United States as Amicus Curiae 12–13 (now arguing, again, for pre-emption). See National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967, 981 (2005) (agency views that vary over time are accorded less weight); Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29 –42 (1983) (same); Verizon Communications Inc. v. FCC, 535 U. S. 467 , n. 20 (2002) (same).
Without giving the agency’s views special weight, I would conclude that it is not impossible for petitioner to comply with both state and federal regulatory schemes and that the federal regulatory scheme does not pre-empt state common law (read as potentially requiring petitioner to pay damages or leave the market). As two former FDA Commissioners tell us, the FDA has long believed that state tort litigation can “supplemen[t] the agency’s regulatory and enforcement activities.” Brief for Donald Kennedy et al. as Amici Curiae 5. See also Wyeth, supra, at 578 (“In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation”).
Moreover, unlike the federal statute at issue in Medtronic, the statute before us contains no general pre-emption clause. See 518 U. S., at 481–482. Cf. Wyeth, supra, at 574 (presence of pre-emption clause could show that “Congress thought state-law suits posed an obstacle to its objectives”). Furthermore, I have found no 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.
ORAL ARGUMENT OF JAY P. LEFKOWITZ ON BEHALF OF THE PETITIONER
Chief Justice John G. Roberts: We will hear argument next in Case 12-142, Mutual Pharmaceutical Company v. Bartlett.
Jay P. Lefkowitz: Mr. Chief Justice, and may it please the Court:
This is a classic case of impossibility preemption.
Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version, but a New Hampshire jury imposed liability because sulindac didn't have a different safety profile, meaning a different ingredient or a different warning.
And as Mensing recognized, that's an impossibility conflict.
And there is no principle basis for treating design defect claims any differently from failure to warn claims.
Justice Elena Kagan: Mr. Lefkowitz, could I understand something just about the scope of your argument?
It -- it seems to me that in this case we are not really dealing with generics; we are also dealing with brand-named drugs.
And I guess the -- the thought there would be, in -- with -- with -- in this respect, as to design, as compared to warnings, but as to design, they're really all in the same boat.
In other words, you know, they have a design; that it is only that design that's approved.
If they change their design there's no authority to continue marketing it.
They have to go back to square one.
And that's just as true of brand names as it is of generics.
So am I right about that?
That -- that if we're just looking at a pure design defect claim, putting the warning card aside, where you are in a different position from the brand-name drugs, but as to design, don't the brand-name and the generics go hand in hand?
Jay P. Lefkowitz: Justice Kagan, it's -- it's certainly the position that the government takes in its brief.
I'm sure Plaintiff's lawyers would find arguments to differ.
But the important thing is that it's really a distinction without a difference in real life, because in light of this Court's decision in the Wyeth case, what happens across the board is that design defect claims are brought either as they are in nearly every State where there is a warning component, or--
Justice Elena Kagan: I want you to put that aside for me for just a second, and I understand that's a very significant thing in your argument to put aside.
But let's just assume that there was a design defect claim that didn't have to do with warnings, where you are in a different position.
Let's just assume on a pure design defect claim, am I right that generics and brand-name manufacturers are in the same position with respect to those claims?
Jay P. Lefkowitz: --If you are hypothecating -- hypothesizing a pure design defect regime, we're not--
Justice Elena Kagan: Just about how you make the drug?
Jay P. Lefkowitz: --Correct.
That is certainly the argument the government makes.
I'm not sure whether or not the Court would find any type of distinction as the Court did in Wyeth, but that is certainly an appropriate interpretation of what the government is saying--
Justice Elena Kagan: Not what the government, I mean, I myself, I just can't figure out what distinction there would be.
Jay P. Lefkowitz: --Your Honor--
Justice Elena Kagan: So I'm asking you.
Jay P. Lefkowitz: --As a legal matter, I'm not sure reading the FDCA there is a matter.
My point is simply that in the real world, the cases are going to be brought as failure to warn claims, or as design defect claims with warnings component.
Justice Elena Kagan: But, you -- but again, and I know that this is a big part of your argument, but to the extent that a warning was not involved in the claim, and it was just about the design of a drug, I guess I'm asking you, is there any possible way to distinguish between generics and brand-name manufacturers?
Jay P. Lefkowitz: I'm not sure, Your Honor, that there is a way to distinguish.
If you were dealing in a regime in a State statute or a State tort regime where the only issue was design, unlike in the New Hampshire design defect, where as we know from PA 18 where the First Circuit made clear that it in fact was the lack of an adequate warning that in fact made the drug more dangerous under the design defect case, the Supreme Court's case Vautour, which is the leading New Hampshire case.
And in fact the jury instruction in this case was a binary choice.
It specifically said, if you find that the drug is unreasonably dangerous, then you have to take a look at was the warning sufficient or not.
We have a case here that is directly controlled by Mensing, because the warning was critical to the design defect case.
We also have a case here that even if it were just purely a design defect case, at least with respect to a generic drug company, the Federal sameness mandate, the same Federal sameness mandate that applied in Mensing to warnings, applies in design defect cases.
And therefore it is a classic impossibility case, just as the Court found in Mensing.
Justice Sonia Sotomayor: So tell me, is -- is it now your position, and it seems to be, that any time the FDA approves a product that there can never be a tort liability claim because the FDA's approval is now the ceiling of what you can do?
Jay P. Lefkowitz: Absolutely not, Justice Sotomayor.
Justice Sonia Sotomayor: They approve nonprescription drugs.
They approve a lot of things.
Jay P. Lefkowitz: Absolutely.
And Justice Sotomayor, as this Court made clear in Mensing -- in Wyeth -- and as Justice Thomas made clear in his concurring opinion in that case, just because a drug is granted an approval by the FDA does not mean that it's entitled to have the same label for all time.
The distinction, though, that the Court articulated was that in Wyeth a brand company has the authority, and indeed as this Court found, the obligation to update its warnings.
Justice Sonia Sotomayor: But that's not true with respect to the active ingredients.
An active ingredient requires a new FDA approval process.
Jay P. Lefkowitz: --But -- but we were talking in that case about the warning.
Justice Sonia Sotomayor: But -- but we came back to the same point, which is -- and we are sort of dancing around the argument -- which is what happens with a truly dangerous drug, and we can posit one, that has nothing to do with a warning of whether it's adequate or not, but a drug that on its face no reasonable practitioner -- I'm going to the restatement third formulation -- no reasonable practitioner, knowing all the benefits and risks, would ever prescribe this drug.
Because your adversary basically took that position at trial.
Jay P. Lefkowitz: Well--
Justice Sonia Sotomayor: It doesn't matter -- there were other, safer, one-molecule drugs; no one should have prescribed this, no matter what the label.
Jay P. Lefkowitz: --Actually, Justice Sotomayor, that is not the position my adversary took at trial.
My adversary specifically put on a case about the warnings and said, the fact that SJS/TEN was warned about in the adverse reaction section and cross-referenced within the warning section was not sufficient.
If it had been in the warning section like the FDA later said it should be, that would have made the difference.
Justice Sonia Sotomayor: We can argue.
But let's go to the point I raised, which is, I think what you are arguing now is that no truly bad drug, that shouldn't be on the market, would there ever be a tort claim that anybody could bring--
Jay P. Lefkowitz: Absolutely not--
Justice Sonia Sotomayor: --because the FDA approved it.
Jay P. Lefkowitz: --Absolutely not.
That's not our argument at all.
Our argument, first of all, is a very narrow argument--
Justice Sonia Sotomayor: So what tort claim could they bring?
Jay P. Lefkowitz: --Well, they could bring--
Justice Sonia Sotomayor: Both, again, the brand could manufacture and the generic.
Jay P. Lefkowitz: --Right now if the Plaintiff -- the Respondent here had taken the brand-name drug Clinoril instead of the generic sulindac, in the New Hampshire law, as it exists and as it existed at the time of the lawsuit, she would have had both a design defect claim and a failure to warn claim.
Justice Sonia Sotomayor: How?
The FDA approved the design.
Jay P. Lefkowitz: Because the design defect claim--
Justice Sonia Sotomayor: And they couldn't change it without FDA approval.
Jay P. Lefkowitz: --But they could change the warning, and that's the essential component, as the First Circuit made clear.
At PA 18 what the First Circuit said was the label was relevant to the design defect claim.
The lack of a clearer warning made the product itself more dangerous under the risk/benefit tests prescribed by Bextra.
That's the design defect standard.
So had the Respondent taken the brand-name drug, she would have had a cause of action, even under the articulation of the sameness standard under Hatch-Waxman that we are articulating here.
Chief Justice John G. Roberts: One of our cases--
Justice Ruth Bader Ginsburg: And she didn't take -- she didn't take the -- the brand-name drug because the pharmacist gave her the generic, but she didn't know brand, generic; isn't that correct?
Jay P. Lefkowitz: That's correct, Justice Ginsburg, and that's exactly the same issue that we had in the Mensing case a couple years ago.
Obviously we understand that not all consumers get to select on their own; their doctors select or maybe their State Medicaid laws make this choice, or the pharmacy; but the standards -- again, conflict preemption comes when the State is imposing a requirement or an obligation or enforcing a standard that you simply can't comply with under Federal law without violating Federal law.
Justice Samuel Alito: Suppose that New Hampshire had a real strict liability regime, so that you -- you sell a drug, and whether it's unreasonably dangerous or not it causes an injury, you pay, to spread the costs.
Would there be a problem with that?
Jay P. Lefkowitz: Justice Alito, I think if we had what would really be an absolute liability scheme, I think is really what you are suggesting, something similar to the kind of vaccine compensation program that we heard about this morning, that would not raise impossibility preemption problems at all.
It might or might not raise obstacle issues; it would depend perhaps on the scope of the program, whether it was singling out certain types of drugs, how expensive it was; but that would be a very different situation.
Justice Sonia Sotomayor: Isn't there a First Circuit--
Justice Samuel Alito: Mr. Frederick argues that that -- that's the thrust of the -- of the New Hampshire law.
Why is he wrong on that?
Jay P. Lefkowitz: Well, he's wrong because -- Price v. Dick -- the New Hampshire Supreme Court case, says very clearly:
"We do not have an absolute liability system. "
"We do not make manufacturers insurers of their product. "
And in fact, Mr. Frederick on page 21 of his brief articulates the standards for liability in this very case where he said, it has to be found unreasonably dangerous.
And we know from Judge Boudin's statement that I just read that that -- that condition of unreasonable dangerousness is premised in large part on the question of the warning; and it makes sense, because drugs are unavoidably dangerous.
If you have--
Justice Samuel Alito: Can I just ask this one more follow-up?
Jay P. Lefkowitz: --Sure.
Justice Samuel Alito: Why -- why would -- why is a generic manufacturer in a worse position under the absolute liability scheme than it would be under the New Hampshire scheme?
Jay P. Lefkowitz: Well--
Justice Samuel Alito: Because under the absolute scheme they might say, if that's the cost, we are not going to sell this drug at all?
Is that the reason?
Jay P. Lefkowitz: --No, it's -- it's not a question of -- of policy choices, it's a question of operation of law.
The issue here -- States are free to do lots of different things; they only are not free to do things when they conflict directly with Federal obligations.
Basically the Supremacy Clause sets up a rule of priority.
And you have that rule of priority come into play when you have a State requirement and you have a Federal requirement.
Here the vaccine program does not hinge on a question of whether or not the generic company violated a safety standard, whether the State is saying, your drug is too dangerous either because of the warning or because of the design.
It is simply saying, we are going to charge manufacturers $1 dollar per prescription or--
Justice Ruth Bader Ginsburg: Mr. -- Mr. Lefkowitz, then what you are saying is that the FDA's approval is not only what everyone agrees it is, a floor to enable you to market, but it is also a ceiling; that is you meet the FDA objective -- FDA approval and that gives you a right to market, not simply an access to the market, but it -- it operates as a ceiling?
Jay P. Lefkowitz: --With respect to the question, Justice Ginsburg, as the Mensing Court made clear, when this very issue came up with respect to warnings which are commanded as a sameness requirement by Federal law in exactly the same way as the molecule, the design, the Federal regime does operate as a floor and as a ceiling.
And when Federal law authorizes you to market a drug in interstate commerce by granting you the ANDA, that comes with it enormous protections.
In fact, Congress has established--
Justice Ruth Bader Ginsburg: Is there something in the -- in the Act that says that the States have no role with respect to the safety and efficacy of the drug -- the drug; it's only the FDA approval, that's it?
Jay P. Lefkowitz: --There is no express preemption clause here.
However, as we know from Mensing where the Court articulated it in footnote 5 and as we know from Geier where the Court went and said ordinary conflict principles apply.
In fact, even when we have an express preemption clause and we have a savings clause, that they don't apply, we have to use ordinary operations of conflict--
Justice Elena Kagan: But, Mr. Lefkowitz, I think in describing the FDCA just now, you used the word “ authorizes ”, and typically, when we think about impossibility, it's not enough that a State law penalizes what Federal law authorizes.
What we -- something is impossible when a State law penalizes what Federal law requires or maybe -- or, where State law penalizes what Federal law gives you a right to do.
But it's not enough for impossibility that State law penalizes what Federal law permits.
And it seems as though what we have in the FDCA is a statute that authorizes, that says, you can sell this.
But it doesn't say you must sell it, and it doesn't give you a right to sell it.
Jay P. Lefkowitz: --Your Honor, Justice Kagan, I'd like to give you two answers to that.
The first as to the impossibility, for over 50 -- 50 years exactly now, this Court has been articulating as the paradigmatic example of impossibility preemption.
The example from Florida Lime and Avocado Growers where the Federal government said you can't sell an avocado with less than 7 percent and you can't sell -- and the State said you can't sell the avocado with more than 8 percent oil.
Now, clearly, there is no Federal obligation to sell avocados.
I would submit that Congress is not agnostic about the sale drugs, but the key is that the quintessential example of impossibility has nothing to do with a Federal right at all.
It is simply conflicting standards.
Justice Elena Kagan: Well, that is your best case, but, you know, there are quite a number of cases where we've really held when a Federal law permits something, typically, a State can do more if it wants to.
Jay P. Lefkowitz: Justice Kagan, the very same issue came out in Mensing as well.
After all, PLIVA was not obligated in any way to sell metoclopramide in Mensing.
But, of course, this Court found that that was a case of impossibility conflict.
And moreover, Congress has -- as I said, is not agnostic here.
Congress had established a regime where in order to take a drug off the market, Congress had said the FDA has to provide the company with all sorts of due process protection, direct appeal to the Federal court, and in fact, Congress, in 1997, specified that any people at the FDA involved in the drug approval process at all, withdrawing drugs or approving drugs, has to have special technical, scientific expertise, very different from what we have in lay jurors.
But simply stated, Your Honor, from a impossibility perspective, this is not only the Florida Lime example, this is the Mensing case as well.
Now, you know, the -- the Respondent doesn't really take issue with either the sameness requirement of design or the sameness requirement of warning.
The Respondent recognizes that our hands are tied.
The Respondent also doesn't really try to do much with salvaging the First Circuit's dodge on supremacy by saying we could stay out of the market.
Instead, what the Respondent does is he tries to carve out a distinction between strict liability and negligence claims.
And all I will say before reserving my time is there's simply no basis in the law.
This Court made clear in Riegel and in Cipollone and in several other cases that with respect to preemption, the same rules apply, strict liability or negligence imposed requirements by this case.
Chief Justice John G. Roberts: --Thank you, counsel.
ORAL ARGUMENT OF ANTHONY A. YANG, FOR UNITED STATES, AS AMICUS CURIAE, SUPPORTING THE PETITIONER
Anthony A. Yang: Mr. Chief Justice, and may it please the Court:
New Hampshire law applies a hybrid design-defect standard that imposes liability for harm caused by a product if the product, in light of the manufacturer's warnings, is unreasonably dangerous.
Now, that standard falls within the traditional way that this Court has looked at impossibility preemption in Mensing.
It's also implicit in Levine, because the analysis of the courts -- the analysis in Levine reflects an implicit judgment that the manufacturer could simply stop selling the product.
You know, if that were enough to avoid a Federal impossibility preemption, there'd be no reason to do the--
Chief Justice John G. Roberts: Well, but it's a little different.
Our cases are focused on the concern that the State is going to impose on the manufacturer a different duty than the Federal government.
That's not what's going on in a strict liability regime.
They're saying, we're not saying you should have a different structure, we're not saying anything about warning; we're saying if you do this, you're going to have to pay for the damage.
It's not -- it's not a different duty.
And I think that's what's underlying the argument that, well, you can just stop selling, because you don't have to adjust how you're going to make the drug.
You understand that it's going to be the same as the Federal drug, but our system is, you pay for the damage.
Anthony A. Yang: --There are two, I think, arguments embedded within that.
There is a question of whether State tort law, whether by negligence or strict liability, imposes a duty that might conflict with the Federal obligation.
And the second argument, I think, which is distinct, is that if you could simply stop selling, that would be a way of -- of cancelling impossibility preemption if there were in fact a conflict between the two standards.
Justice Anthony Kennedy: How would you define the duty that New Hampshire imposed here according to the First Circuit and according to the Respondent?
Anthony A. Yang: The duty is that one cannot market an unreasonably dangerous drug in light of the warnings -- that's unreasonably dangerous in light of the warnings.
And what that means is that a manufacturer will have to pay money in the liability suit if he doesn't meet that standard.
And as this Court recognized in Riegel and in earlier -- in Cipollone, that this type of tort obligation, when you contingent -- make an obligation to pay tort liability based on meeting a standard under State law, that is a duty that could conflict with a Federal duty.
And the Federal duty--
Chief Justice John G. Roberts: But is that meeting a standard under State law that your friend's argument says, that's not what we're talking about here.
The standard is the same.
It's just a question under strict liability that if you follow the same Federal standard and market this in our State, you're going to pay the compensation for the reason of, you know, spreading the costs.
We don't want you to do something different.
We just want to say that you want to do the same thing as the Federal government, and then you're going to have to pay.
It's different than the -- at least that's how I understand their argument, which is that it's different where the situation says, yes, you can market it and avoid payment, but only if you do it our way.
That's a different duty for the manufacturer.
Anthony A. Yang: --Well, with respect to the question of stop selling, which I think is what your question goes to, that you can always escape liability if you simply stop selling and don't have the market.
It's not clear to me, first, that Respondent is in fact adopting the Government's position, because in our view, the obligation to change the labeling to make it safer and therefore escape liability under design-defect law in New Hampshire falls within the Court's decision in PLIVA v. Mensing.
The only distinguishing factor we think that is material here would be whether the ability to stop selling mean that there's really not a conflicting obligation.
And as that would have been true in Mensing, it would have been true also in Levine, and would not have necessitated any impossibility analysis.
And I think this, as my brother was just explaining, traces back to Florida Lime and Avocado Growers.
The court framed the impossibility preemption inquiry there -- and I think this is important -- at the top of page 143.
It says, the question is whether compliance with Federal and State regulation is a physical impossibility for one engaged in interstate commerce.
That was the -- the formulation.
So the idea is if you are an avocado grower in Florida and the Federal government said you have to pick your avocados before they're at 7 percent oil and then California says, you can't sell in our State unless it's 8 percent oil, it's impossible to be a person engaged in interstate commerce there unless you violate one of those obligations.
And when you have to violate one of those obligations, it's the State law that -- that falls.
And I think, Justice Kagan, you were explaining--
Justice Elena Kagan: I mean, that suggests that there is an obligation of the Federal government.
If there is one, yes, there's a conflict and yes, there's an impossibility defense.
But if there's no obligation, if all there is, is permission from the Federal government, where do you get the impossibility from?
Anthony A. Yang: --Let me draw a distinction if -- that I think might help.
When the Federal Government were to say -- let's go -- stay with avocados -- that avocados must have at least 7 percent oil.
And the State says, you know what, we think it actually means 8 percent oil.
It's not impossible to comply there.
But what we have here is a comprehensive regulatory scheme, where an expert agency with the relevant information makes an expert judgment based on sound scientific evidence that this drug is, in fact, safe and effective and--
Justice Elena Kagan: Well, I take that point, Mr. Yang.
I take that point, Mr. Yang, but I think then you're -- you're saying something quite deep about the FDCA, which is that the FDCA should not be thought of as merely authorizing drug sales.
You're saying essentially that when the -- when the FDA does what it does, it's saying not just -- you know, you can do this if you want to, but you can do this and we really think this drug ought to be marketed.
So that when States take action against that, you know, it's -- it's a conflict.
Anthony A. Yang: --Our -- our position is--
Justice Elena Kagan: And that's--
Anthony A. Yang: --a little narrower.
Justice Elena Kagan: --and that's something I don't think we've really ever said.
Anthony A. Yang: I don't think the Court has addressed this question expressly.
That is -- that's true.
But I think our position is a little -- little tighter than that.
Which is, when the State is imposing an obligation, they do it based on a safety standard -- that is in fact second-guessing the FDA -- that is preemptive.
Not simply because the FDA has set the standard, but the FDCA also has within it the judgment that safety is best effectuated not only by having the FDA set the standard, but by forbidding any manufacturer from deviating from that once it's been approved by the FDA.
When we're talking about a drug's formulation, the manufacturer cannot change it.
And that's what brings this within the ambit of PLIVA v. Mensing.
And it also, I think, reflects why the Florida Lime example is -- is relevant, because when--
Justice Sonia Sotomayor: So without the preemption clause, actually, with an express saving clause, you're arguing essentially complete field preemption.
You're basically saying the minute that the FDA gives you permission to sell, it's a right to sell.
And -- and it can't be altered by any State police power.
Anthony A. Yang: --No, we're -- we're actually not saying that.
Justice Sonia Sotomayor: Well, I don't see how you're not saying that.
Anthony A. Yang: Well, no, with respect to the design-defect claims that -- and failure to warn, with respect to generics -- remember, this is exactly what the Court said in Mensing -- we're saying the result in Mensing controls here.
Now, if we go to the pure design-defect claim -- and a pure claim, in our view, is one in which carves out the failure to warn issue, and it hypothesizes a reasonable physician that knows all the -- the health benefits and risks--
Justice Sonia Sotomayor: But that's your -- you're telling me that's exactly what the FDA is saying.
You're saying there is no such thing.
Anthony A. Yang: --No, but we -- in that--
Justice Sonia Sotomayor: And there's no strict liability that a State could impose.
Anthony A. Yang: --If I might just finish.
Justice Antonin Scalia: I would like to hear your answer.
Anthony A. Yang: Yes.
When that pure design-defect standard has been satisfied, it means that no physician would prescribe the drug for any person, which means that drug, regardless of how you might improve the warnings -- it just doesn't matter, because they know all -- all the adverse and positive benefits of the drug.
It should not be marketed because it should never be prescribed.
And when it should not be marketed and it complies with the Federal Government's misbranding standard, about dangerous to health when used as instructed, and it honors the FDA's rule by requiring new and scientifically significant information that was not previously before the FDA, that would not be preemptive.
That is not this case.
And so what we are trying to do is preserve the FDA's role here, not have juries second-guess on a case-by-case and State-by-State basis imposing different safety obligations on manufacturers -- when Congress has established a regime for FDA to control this.
Now, we're not saying the FDA's decision is forever binding.
If there is new and scientifically significant evidence that hasn't been considered by the FDA -- and this is analogous to what the Court already did in Wyeth v. Levine -- because there, in the impossibility preemption, the Court looked to whether or not there would be newly acquired information that would allow a manufacturer to go within the changes being effected regulation in order to change the labeling.
So what we're doing is just like what the Court required to be done in Wyeth, that in that context, if you meet the Federal misbranding standard, and you avoid the problem of PLIVA -- because you don't have--
Justice Sonia Sotomayor: This applies to everything that requires FDA approval, or is this a prescription drug-only rule?
Anthony A. Yang: --May I answer?
Chief Justice John G. Roberts: Briefly.
Anthony A. Yang: With respect to failure to warn, you can -- prescription drugs can be sued, generics cannot.
With respect to pure design-defect claims, our view applies to both.
Chief Justice John G. Roberts: Thank you, counsel.
ORAL ARGUMENT OF DAVID C. FREDERICK ON BEHALF OF THE RESPONDENT
David C. Frederick: Thank you, Mr. Chief Justice, and may it please the Court:
I'd like to start with the questions that you and Justice Alito posed about State law, because it's important to understand, before you have impossibility conflict preemption, to understand what the State duty is here.
I think it was conceded that it would not be impossible to have an absolute liability regime.
So the question here is: Because New Hampshire actually makes it somewhat easier for manufacturers to evade liability, that that somehow creates a different kind of preemption problem.
We would submit that it doesn't.
What the State law is seeking to do here, Mr. Chief Justice, is to impose liability where there is proof of an unreasonably dangerous product.
That unreasonable danger entails evidence of a risk/benefit analysis that looks at the overall risks to the population against the overall benefits that are provided for the drug.
Justice Antonin Scalia: The jury decides all of this, right?
David C. Frederick: That's correct.
Justice Antonin Scalia: That's wonderful.
Twelve -- twelve tried men and few -- and true decide for the whole State what the -- what the cost/benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives.
And the jury's going to decide that?
David C. Frederick: Yes, it is.
And notably, the FDCA doesn't preclude that.
Wyeth v. Levine affirms that principle.
And what's important here is that under State law, there's not a duty to change the design or to change the label.
It is, Justice -- Mr. Chief Justice, exactly as you postulated, that if there is an unreasonably dangerous drug, that the people that are harmed egregiously, like Karen Bartlett, will have an opportunity to compensate them--
Chief Justice John G. Roberts: I'm not so sure -- I'm not so sure it works that way, because of the jury point.
They didn't say that yes, you can market this drug, it benefits, you know, 99.9 percent of the people, but there is that 0.1 percent, and you're going to have to compensate that person.
They said the risks outweigh the benefits, period.
So you should not market this at all.
And it does seem inconsistent with the -- the Federal regime.
David C. Frederick: --Well, of course, Mr. Chief Justice, Mutual put in their defense in this case -- they rested after the plaintiffs put in their case.
So it's not to say that in another case, they wouldn't have an opportunity to prove that there is some benefit of their drug.
Chief Justice John G. Roberts: Well, what do you in that case?
You've got one jury saying the risks outweigh the benefits; can't do it.
And then you're saying well, later, there might be another jury saying yes, you can.
David C. Frederick: Well, there's no claim preclusion effect of a jury verdict, and that is why there is no offensive collateral estoppel that would be applied, Mutual can adopt a different trial strategy.
It is often the case, Mr. Chief Justice, that in these kinds of cases, the defense applies different tactics to how they defend this case.
In this particular case, they chose to waive their comment k affirmative defense.
They chose not to put in any affirmative evidence itself.
They chose after the trial in their Rule 50 motion for judgment as a matter of law not to challenge the warning instructions that were given to the jury -- as Judge Boudin noted and as the district court noted -- they had waived their preemption warning argument.
And so what they seek to do here after not being able to show -- which they cannot show under New Hampshire Supreme Court precedent -- Vautour and Kelleher -- cases that we cited in our brief, that New Hampshire imposes any duty to change any conduct by the manufacturer whatsoever.
Justice Elena Kagan: Mr. Frederick, it -- it does seem to me, and I understand that there's a waiver argument floating around here, but it does seem to me that this case was litigated such that the adequacy of the warning is really all over this case.
There was expert testimony about the adequacy of the warning, there were jury instructions about the adequacy of the warning.
In the closing statements that the lawyer gave, it was -- there was a lot of talk about -- that the FDA's decision to change the label, to show that the label was ineffective before.
So there is just all over this stuff about adequacy of the warning, which does suggest that this is sort of within the four corners of Mensing.
David C. Frederick: Let me address that, because I think that's the hardest part of this case to understand, and why this is different from Mensing.
In a strict liability case in New Hampshire, the warning is not relevant as a -- as an element of the claim.
What the jury is required as an element of the claim is to prove unreasonable dangerousness.
And District Judge La Plant, who presided over this very complex and difficult trial with a lot of skill, understood the difference between the concept of adequacy of a warning which describes the risks and efficacy of the warning which limits or minimizes the risks.
And all over the pretrial instructions, he made very clear to the counsel, you are not to argue about adequacy of the warning, because that goes to the comment k defense that they waived on the eve of trial.
Instead, once the jury finds that the drug is unreasonably dangerous, it may use the warning as a way to limit or minimize the risk.
In other words, the warning could only benefit Mutual, because liability was going to be found in spite of the warning and not because of the warning.
Justice Stephen G. Breyer: I see that.
But I don't understand why that matters.
That is, the -- I mean, I was thinking just what you said.
I was thinking well, I -- I dissented in the other case, but I lost, okay?
So I lost, I lost.
The -- the -- the point is that -- that you have a drug, and you say to the jury, well, if there were no warning here at all, then it would be unreasonably dangerous.
I think, yes, that probably applies to chemotherapy, it probably applies to Parkinson's, it probably applies to all kind -- but you see, says the defense, there is a warning here and it says how to use it.
And as you say, that would be not -- it would be despite or whatever it is, despite, not because.
But it seems to me in terms of -- it comes for the same thing, lots of drugs would be dangerous, too dangerous, unreasonably so without a warning.
Chemotherapy is what I'm thinking of.
But properly labeled they're not, and so that seems to be your case.
David C. Frederick: It is not.
Justice Stephen G. Breyer: Because -- why?
David C. Frederick: No, absolutely not.
The evidence here was clear.
No warning would have made any difference to lessening the risk.
And that is because, and this is on--
Justice Stephen G. Breyer: In other words, in this case, they have to find that -- that no warning -- there is no such warning that could make a difference, that's what they're asked to find?
David C. Frederick: --All that they -- in terms of minimizing the risk.
Justice Breyer, here--
Justice Elena Kagan: Well, how can that be, Mr. Frederick, because the plaintiff really spent a large portion of their case trying to show this, that the warning was inadequate.
So the plaintiff must have thought that there was a possibility that if the warning was adequate, the jury would find one thing, but if the warning was not adequate, liability would follow.
David C. Frederick: --The case as it was litigated up until the day before the trial was with a comment k defense, which allows as an affirmative defense the defendant to say if the drug is unavoidably unsafe and it has an adequate warning, i.e., it adequately describes what the risks are, complete immunity from suit.
They abandoned that comment k defense on the eve of trial.
And so as the judge understood and instructed the jury, the only role that the warning actually played was whether it could lessen the risk to patients who took the drug, i.e., in the risk/benefit analysis, it's somewhat less risky in weighing it against the benefits.
Justice Ruth Bader Ginsburg: The failure -- the failure to warn defense was -- the -- the judge struck that out.
So there was no failure to warn defense in the case.
David C. Frederick: That's correct, that's correct.
And as the Le Blanc case held in the New Hampshire Supreme Court, the New Hampshire law treats failure to warn cases as distinct from design-defect cases.
Here, no words would have made any difference because the scientific--
Justice Stephen G. Breyer: Where is that?
That's -- I do see that distinction.
If, what you're -- but look, the complaint's filled with words about adequate warning, no adequate warning, no adequate warning, da, da, da.
David C. Frederick: --Yes.
Justice Stephen G. Breyer: Okay.
Now what you're saying is, is really what the jury found, nothing to do with adequate.
There is no warning in the world that anybody could have invented that would have made a difference.
I'll have to think about that one.
But in the meantime, where is it that that's what they said?
David C. Frederick: Where is it in the record?
Justice Stephen G. Breyer: Yes.
How do I discover that you're right about this?
Because everything in the -- in the complaint that I've read so far seems to talk about the adequacy of warnings, not that there is no warning in the universe could possibly have made a difference.
David C. Frederick: Well, I would direct you to two--
Justice Stephen G. Breyer: How do I discover that?
David C. Frederick: --two pieces.
The JMOL order that the judge issued, which is in the petition appendix, goes through this very clearly.
And Judge Le Plant understood how the different roles of warning apply, and he instructed the jury, and this is in the pre-formal colloquy that he's giving to the jury orally, you can find this at 496 of the Joint Appendix where he says,
"Adequacy is not an issue for -- the adequacy of the warning is not an issue for you to decide. "
He then goes further to explain that
"You will only consider the warning after you have considered the unreasonable danger. "
--that's at 513 to 514, and then on page 516 of the Joint Appendix, he says,
"You only consider the warning to minimize the risk. "
i.e., to benefit Mutual in the assessment of whether or not in a risk/benefit analysis this drug has greater risks than--
Justice Stephen G. Breyer: The second point is a different point.
The second point is, look, I have chemotherapy, it saves 100 and it kills 10.
If you have no label at all, a jury might find it was unreasonably dangerous, but once you put in the label explaining the whole thing, it doesn't.
It isn't unreasonably dangerous because of the situation, and they could perhaps wouldn't find it.
Now, you can call that diminishing or you could call it adequacy.
Call it what you want, but that seems to me to come to the same thing and is different from saying, no label in the universe would say it.
David C. Frederick: --Justice Breyer, a chemotherapy drug has got a huge benefit.
It potentially saves you from cancer.
A nonsteroidal antiinflammatory drug, of which there were 16 other types, is not at all analogous to a chemotherapy drug.
Justice Stephen G. Breyer: We're talking about what juries could find and that's what -- and I don't know about Parkinson's -- I don't know what these drugs are.
That's why I said let the FDA say it.
David C. Frederick: But that's why when the jury gets evidence that aspirin and acetaminophen, Tylenol produce the same kind of pain relief, but they do not produce the kind of SJS/10 that Ms. Bartlett -- that caused 60 percent of her body to burn.
I mean, that gives you a very clear contrast.
Justice Samuel Alito: If that's correct, and maybe it is, doesn't that mean the drug should never have been approved?
David C. Frederick: No, because the evidence at the time of approval had not yet been ascertained.
What was clear from the unpublished pharmacia report that went into evidence in this case was that between the time of 1980 and 1997, the adjusted reporting rate of these adverse incidents went very high, and it was of a rate that was comparable to Bextra, which went on the market several years after that study ended, in which the FDA, in looking at a comparable adjusted adverse reporting rate, concluded should be taken off the market.
Justice Samuel Alito: But isn't it true that when the -- the FDA reviewed this whole class of drugs, they decided to pull Bextra but not this drug?
David C. Frederick: That is true, but what the FDA did not take into account, and this is what the district judge instructed the jury on September 22nd, 2010, I think it's page 108 in the charging colloquy, is the evidence in this case was that the FDA did not have that evidence.
So what the Solicitor General seeks to argue here is evidence that was not in the record and in which Mutual's own expert who created this evidence testified in deposition he didn't give it to the FDA.
And then Mutual never put him on the stand to be cross examined.
And so now what we have is a trial record that shows this evidence was not given to the FDA at all.
Justice Samuel Alito: The -- the SG says that the FDA did have this right, did have it and did consider it, and that's incorrect?
David C. Frederick: That is incorrect.
That the FDA, if it considered it, there is no record of it doing so because in the response to the 2005 citizen petition and in a later memorandum, it never mentions sulindac.
So if you are to take any kind of regulatory preemption here, it surely has to be on the basis of a considered action that the FDA takes after notice and comment rulemaking.
That was the kind of standard that was advocated in the concurring opinion in Wyeth v. Levine, that is absent here.
And, in fact, this case has even a weaker case for that kind of considered and rejected than in Levine itself where there was evidence that Phenergan had caused some arterial exposure.
Justice Anthony Kennedy: Do you want me to write down in this case, from my understanding, that under New Hampshire law, strict liability is determined quite without reference to the adequacy of warning?
David C. Frederick: You can do that.
Yes, Justice Kennedy, you can do that.
It is a factor for the jury to consider.
It is not an element of the claim.
And what PLIVA makes clear--
Justice Anthony Kennedy: Now wait.
What's -- what's a factor?
The warning is or is not a factor?
David C. Frederick: --The warning can be a factor.
Justice Anthony Kennedy: Well, that's -- that's not the thrust of your argument.
And I think it was a factor here for some of the reasons Justice Kagan has suggested.
David C. Frederick: --And Justice Kennedy--
Justice Anthony Kennedy: I mean, which does -- was the warning relevant or not relevant to the determination of strict liability?
David C. Frederick: --Yes, it was relevant as in this case.
But, Justice Kennedy, if you were to take the position that mere evidence that is a factor for the jury to consider, even though there is no need to change any legal duty, you would be adopting field preemption under this statute, because the whole thrust of PLIVA--
Justice Anthony Kennedy: I'm talking about the definition of the duty.
Was it permissible for the jury to define the duty here and the breach of the duty in part by -- by reference to the adequacy of the warning?
And I -- I now understand your answer to be yes.
David C. Frederick: --No.
And let's be clear on our nomenclature here.
A duty is a legal requirement imposed under State common law, a duty to use due care, a duty to change the label, which is what was conceded in PLIVA and Mensing.
Here New Hampshire law does not require a duty to change the label or to change the design.
All it does, Justice Kennedy, is to say, if the jury finds that the risks outweigh the benefits, it may consider whether the warning would have lessened the risk.
Chief Justice John G. Roberts: So you are saying there is a huge difference between saying you didn't put the warning in, so you are liable for $9 million, and saying, you are liable for $15 million, but if you put the warning in, you are only liable for 9 million?
David C. Frederick: Well, when there is a comment k defense, Mr. Chief Justice, you may be off completely.
And that's why the role of comment k is so critical in these strict liability claims.
Chief Justice John G. Roberts: But -- but just to get back to my -- to my question.
You say there is a difference between saying, you have to put on warning and you are going to be liable if you don't, and saying, you are liable no matter no matter what, because it's strict liability, but if you put on a warning it's reduced.
If you are a drug manufacturer, you are supposed to see a difference in those two situations?
David C. Frederick: --There is a difference, and the difference is this: Assume in the Diana Levine case there had been a strict liability claim that went all the way through.
The question under a strict liability law would be would a -- would -- did the warning lessen the risk that she would have had gangrene and amputation of her arm?
The adequacy of the warning under a strict liability law simply goes to did the manufacturer adequately describe the risks that the patient might incur.
In the Levine case it very well might have been that the warning adequately describes that there's a possibility of gangrene, but it didn't do enough to lessen the risk that she would sustain.
And because there was a way to change the label to lessen that risk, she got a judgment for a failure to warn.
Because the manufacturer's conduct was such that it could have improved the label.
Here we acknowledge and the evidence shows there is no way to change the label here.
Some -- some -- some number of people, maybe some in this room, might take sulindac and get SJS/TEN.
We don't know who they are, and we can't write words that would tell anyone in this room, you have a lesser chance of getting that horrible disease.
Justice Stephen G. Breyer: Well, but then if you apply this -- what is deeply bothering me in all these cases, and it's why I came up with and said, the FDA has to tell us, you know.
Because just what you said before; what you say applies to sulindac also applies to 12 people who will tell the Mary Hitchcock Hospital up in Dartmouth that they can't use a certain kind of chemotherapy.
You see, you could in certain horrible cases find a very sympathetic plaintiff who really did suffer terribly.
And -- and -- and you are getting 12 people rather than the FDA.
So my solution to it, which you know, because you read Medtronics, may not work; but it's the best I can think of.
Now, what -- what -- you can tell me if you want, no, there is some totally different thing.
But what you are saying at the moment, what I do in my mind is I say, beware; because it's also true potentially of some of these life-saving drugs and that's what's worrying me.
David C. Frederick: Let's be clear, Justice Breyer.
There is a difference between the application of impossibility preemption, which I don't think anybody here can argue with a straight face that simply paying a judgment in strict liability is impossible in light of the Federal regime, an obstacle preemption.
Now, it may well be that there could be cases out there like your life-saving type drug, which by the way has a special regulation under a special statute to ensure that that is on the market, and some other drug where the risk/benefit equation is -- is such.
But surely in our system we have to trust district judges to be able to grant or deny judgments as a matter of law, where they conclude that the evidence would not be sufficient to show that the risk outweighed the benefit.
And here, the judge made very clear that because Mutual had not put in any evidence of the benefit of its drug at all and arguably couldn't have done so because this drug is like aspirin -- except that it causes these horrific injuries -- it's reasonable to suppose that a jury which can decide misbranding actions under the FDCA, and that has been acknowledged by the majority in Wyeth v. Levine, can make the very same risk/benefit safety determination that Justice Thomas in his concurring opinion said also is -- enabled the States to make.
The States are not precluded under the FDCA from making that kind of judgment.
So in the hard case, Justice Breyer, there is a mechanism for preemption.
The FDA has to act.
It has to act pursuant to notice and comment rulemaking.
It has to identify which drugs it thinks would not be subject to these kinds of strict liability claims.
But it hasn't done that here.
All it's done is to say, we happen to have some evidence in our files, ergo preemption.
Well, preemption doesn't work like that under the Supremacy Clause.
Justice Sonia Sotomayor: Just -- just to -- because my memory is failing me, is this drug still on the market?
David C. Frederick: Yes.
Justice Sonia Sotomayor: All right.
And is it on the market with a different label?
David C. Frederick: It is.
The label changed after Karen Bartlett sustained the injuries that she did in this case.
In fact, that was one of the arguments that -- that at the time, this was before PLIVA, okay?
So there was a lot of failure to warn being argued, because the regime, as the case came into trial was under Wyeth v. Levine, it was not under the PLIVA v. Mensing case.
So Justice Kagan, that's why it's perfectly reasonable for the trial lawyers here to think that the warning is an appropriate thing because this Court's case that had just been decided made that perfectly clear.
But what was interesting here was that Judge Laplante made a very clear distinction between the role that the warning would play, appropriately so, under a strict liability regime.
Now, I would like to note that the avocado case is one that did not entail the State banning avocado sales.
Judge Boudin is absolutely right when he says that there is nothing under the FDCA to preclude the State from making a reasonable safety determination that might lead to the withdrawal of the drug.
Now, admittedly, that is a rare circumstance.
And that is not what New Hampshire is doing here, and in his post-trial orders Judge Laplante made clear that is not what New Hampshire is imposing here.
All New Hampshire is imposing here is a duty to pay compensation if your unreasonably dangerous product harms a patient.
Justice Samuel Alito: This argument about stopping the sale of the drug completely seems to me to eliminate the impossibility -- impossibility preemption, doesn't it?
David C. Frederick: No, because the -- the duty here, if there is any duty to stop selling under New Hampshire law, it can be complied with by not selling the drug.
There's nothing in Federal law that requires or mandates the sale of these drugs.
Justice Samuel Alito: But that's true -- isn't that true often in -- in these impossibility cases?
Let me say Congress passes a law that says everywhere in the United States you must drive on the right side of the road, and New Hampshire is quirky, they say, in New Hampshire you have to drive on the left side of the road.
That would seem to me to be a very clear impossibility case, wouldn't it?
David C. Frederick: Yes.
Justice Samuel Alito: But you could comply with both rules by not driving.
David C. Frederick: It would be very dangerous.
Justice Samuel Alito: Not to drive at all?
David C. Frederick: Well, it would be dangerous to try comply with both at the same time.
But certainly if--
Justice Samuel Alito: You decide -- if you decide to drive--
David C. Frederick: --Yeah.
If the difference -- right.
But the difference, Justice Alito, is what is the content of the substantive duty.
If the content of the substantive duty is you -- the State says to do one thing and the Feds say do the opposite, that's impossibility conflict.
Justice Antonin Scalia: The Feds didn't say to do the opposite.
They said -- they didn't say you have to drive in New Hampshire.
They say, you must drive on the right if you drive.
They don't require you to drive in New Hampshire.
David C. Frederick: Right.
But our position, Justice Scalia, is if you that follow PLIVA to what it says in its logical extension, you look at the -- you look at the content of the duty there, the content of the duty was to change the label.
What the majority opinion says is that Minnesota and Louisiana law said you must change the label and the Federal government says, you cannot change the label.
Chief Justice John G. Roberts: Well, just -- I'm sorry to interrupt you.
But your friend on the other side, of course, says PLIVA involves strict liability as well.
So it did not say you must change the label.
David C. Frederick: --Actually we dispute what they say, and we've got an -- an excursus about Mensing in our brief, and what is clear is that as the case came to this Court, the only duty that was being litigated was the duty concerning the warning label.
There was not a strict liability claim in the sense of a design defect.
Mind you, there are strict liability claims in -- in failure to warn as well.
That is essentially what comment k gets at.
This case however, was tried as a design case only, and the State law duty made very clear there was no duty to change the design of the drug.
And so therefore, under Mensing, there can't be impossibility because State law is not telling you--
Justice Stephen G. Breyer: But even the compensation, suppose you had strict liability that Florida Avocado Growers could -- what they have to do, all they have to do since they can just be fined and the money would go to pay the consumers of California who have the unfortunate mixup sometimes of eating Florida avocados.
I mean, that would raise at least serious problems of -- commerce clause problems and preemption and so forth.
David C. Frederick: --Justice Breyer, that's not an impossibility hypothetical.
That's an obstacle hypothetical.
And in Wyeth, I think six justices said there is no obstacle under the FDCA of having State law remedies to compensate injured patients.
So, you know, the reason why it's important to keep these concepts of preemption distinct is that they ask you to grant cert on whether or not it is impossible to comply in light of PLIVA, which was an impossibility preemption case.
That was not an obstacle preemption case.
Now, having, you know, I think gotten a deeper view of what State law requires, they're seeking to shift the case into an obstacle case, and virtually all of the Federal government's arguments here are obstacle-type arguments.
It is because the FDA is so expert that it has this information in its files and that that should therefore negate and displace and nullify State law, which is a rather sweeping proposition.
Justice Sonia Sotomayor: Is your point in this case that obstacle preemption has been waived?
David C. Frederick: Granted--
Justice Sonia Sotomayor: Or were you granted cert just on impossibility?
David C. Frederick: --Yes, yes.
Our position, and we -- we -- we made this clear that all they were asking in the cert petition was for an impossibility look at PLIVA.
The obstacle argument has been waived in our view of the way this Court ordinarily takes certiorari cases and then decides them.
So -- and on the impossibility point, I think that our position is clear.
Now, Justice Kagan, the very first question out of the box was does this rule that they're advocating apply to brand name drugs and the answer unfortunately is yes.
Because the premise of their argument is that simply because the FDA approved the drug and there would need to be some State law claim that would give rise to some alteration, that that necessarily would mean that it would be impossible to comply with.
And so that applies to brand name drugs as well as generic drugs.
We don't see a principal difference, unfortunately, to distinguish them.
There may be some difference in certain State laws.
I don't want to speak for all 50 States, but the basic gist of their argument is FDA approval over olives.
Justice Elena Kagan: There is no such thing then as a brand name manufacturer can change some design features of the drug, you know, without FDA approval or without going back to square one of the FDA, there's nothing like that?
David C. Frederick: No, the FDA requires a -- a new drug or an abbreviated drug application -- I get the terms of them sometimes confused -- but if there was to be a tweak to the design, they'd need to go to the FDA to get approval for that.
I want to make one other point, which is that strict liability applies to distributors as well as to manufacturers.
And so here it seems obvious that a distributor can't change the design and it cannot change the label.
But under normal principles of strict liability, the idea is that if you are a seller of the product in your normal course and it is a dangerous product that causes somebody to be injured, you can be held liable in strict liability.
That principle is very well settled.
And so it would seem odd to suppose that the distributor who has no power to make any change in conduct that would make the product any safer also gets to be immunized from suit.
I have no further points unless the Court has further questions.
Justice Ruth Bader Ginsburg: How do you respond to the argument, Mutual's argument that they have -- in 2005, they made -- this drug produced $7 million.
The jury verdict was 21 million.
They said that 3 years of their earnings wiped out.
David C. Frederick: Justice Ginsburg, I've never been in a case in my time arguing before this Court where somebody in a reply brief at the merits put in evidence that they did not put in at trial and they sought to persuade you that that was somehow relevant.
Number 2, the issue here concerns sulindac manufactured by all the different manufacturers of sulindac, not just Mutual.
Number 3, we never have seen that information.
It was never served on us.
We have no way to test it.
I have no idea whether it is accurate or not.
Number 4, if they are only making $7 million, they ought to withdraw from the market, because their -- their product causes such horrific injuries it ought not to be sold.
Chief Justice John G. Roberts: Thank you, counsel.
Mr. Lefkowitz, you have three minutes remaining.
REBUTTAL ARGUMENT OF JAY P. LEFKOWITZ ON BEHALF OF THE PETITIONER
Jay P. Lefkowitz: Thank you.
I'd like to just make three brief points.
It is rather incredible to hear counsel talk about how the warnings were not the issue in this case.
From the opening statement of plaintiff's counsel, I'm quoting now,
"The evidence will show you that sulindac was unreasonably dangerous and had an inadequate warning as well. "
"One of the easiest ways to show you this will be to show you that they got a new and better warning about six months after respondent took the drug. "
"The label got better. "
"And at CA App. 2761, we have the FDA letter explaining exactly why, in the FDA's view, the new warning was going to make the drug safer. "
"What it said-- "
Justice Ruth Bader Ginsburg: Did you get to the jury's -- to the instructions to the jury?
Jay P. Lefkowitz: --Absolutely not.
It was a proper instruction under New Hampshire law.
It was an instruction that--
Justice Ruth Bader Ginsburg: So that's what the jury was supposed to apply, not what counsel said.
Jay P. Lefkowitz: --The jury applied the instruction that the court gave it, which was to decide whether or not the jury was good enough -- the warning was good enough or not.
And, in fact, as the First Circuit made very, very clear at PA 18A, it said, the label was relevant to the design defect.
The lack of a clearer warning made the product itself more dangerous under the risk/benefit analysis of New Hampshire law.
Justice Ruth Bader Ginsburg: But you just said there was nothing wrong with the jury instructions, at least you didn't object.
Jay P. Lefkowitz: Your Honor, let me be clear.
We objected at the very beginning of this case, we said this is all preempted.
There is no ability to change the warnings.
The warnings are acceptable as a matter of Federal law.
And this Court, every Justice on the Court agreed in Mensing that we couldn't change the warning.
Once the Court rejected that, it was a fair statement of New Hampshire law.
Justice Ruth Bader Ginsburg: How -- how did the Court reject it?
They threw out the failure to warn claim.
Jay P. Lefkowitz: The trial judge rejected our summary judgment motion on preemption.
We raised these issues.
Justice Stephen G. Breyer: It says on page 5496, adequacy of the warning, I guess, the judge says, is not an issue before this jury.
And that was the point.
Jay P. Lefkowitz: Well, he said that, but then he went and he instructed the jury and, again, as the First Circuit made clear, it was in fact -- the dangerousness was because of the arguable inadequacies of the warning, which the plaintiff said we could have changed, we should have changed.
I want to just finish with two brief points, if I may.
On impossibility, look, this impossibility doctrine under preemption is premised on the fact that parties will engage in conduct.
As Justice Breyer made clear in his opinion in the Geier case, he said, under ordinary obstacle principles, a State might be able to make you liable for using the Federally required windshield retention requirements.
Obviously, there is no Federal requirement to sell cars.
It conditions that if you sell the car, you have a requirement.
If you sell a drug, a generic drug, you have a particular requirement.
The distinction between strict liability and negligence, Cipollone, Riegel, make absolutely clear there is no basis whatsoever for a distinction under law.
Chief Justice John G. Roberts: Thank you, counsel.
The case is submitted.
Chief Justice John G. Roberts: Justice Alito also has our opinion this morning in case 12-142, Mutual Pharmaceutical Company versus Bartlett.
Justice Samuel Alito: In this case, we must determine whether New Hampshire's design-defect tort law cause of action was preempted by federal law.
Responding Karen Bartlett was prescribed Clinoril, the brand name version of the pain reliever sulindac for shoulder pain.
Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical.
The results were disastrous.
Respondent experienced a rare hypersensitivity reaction to sulindac and suffered severe and permanent injuries.
She sued Mutual Pharmaceutical and a federal jury ultimately retuned a large verdict against Mutual Pharmaceutical based on a New Hampshire design-defect tort law cause of action.
The First Circuit affirmed.
The Supremacy Clause of the Constitution provides that the laws and treaties of the United States are the supreme Law of the Land and we have long held that state laws that conflict with federal law are preempted.
That is without a fact.
One way that state laws can conflict with federal law is by requiring a private party to take an action that federal law prohibits.
In such cases, there is what has been termed impossibility pre-emption.
Here, state law imposes just such a duty. New Hampshire's design-defect cause of action requires a manufacturer to ensure that its products are not unreasonably dangerous to consumers.
It may fulfill that duty in any or all of three ways by increasing the products' usefulness, by decreasing its risk of danger, or by strengthening the products' warnings.
Here, the first two avenues were close to Mutual by both federal law and basic chemistry.
Changing sulindac's usefulness or risk of danger would have required Mutual to change sulindac's chemical composition, but federal law prohibits manufacturers from making such changes.
The Federal Food and Drug Act fast tracks generic drugs to market on the assurance that their chemical composition is identical to that of their brand-name counterparts and federal law prohibits manufacturers from deviating from that approved design.
Moreover, because sulindac is a one-molecule drug redesign, it was chemically impossible.
Thus, New Hampshire law ultimately required Mutual to strengthen its label.
Unsurprisingly, allegations that sulindac's labeling was inadequate featured prominently at trial.
But as we recognized two terms ago in PLIVA, Inc. versus Mensing, federal law prohibits generic drug manufacturers from changing the labels that the FDA has approved for their drugs.
Accordingly, because it required Mutual to take actions that federal law prohibited New Hampshire's warning-based design-defect cause of action is pre-empted.
The First Circuit solution that Mutual could have complied with both state and federal law by simply pulling sulindac from the market is no real solution.
Our impossibility pre-emption cases have presumed that an actor seeking to satisfy conflicting state and federal law obligations is not required to cease acting altogether in order to avoid liability, at least where neither state law nor federal law imposes such an obligation.
Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless in every case including PLIVA in which we have found impossibility pre-emption would have been wrongly decided.
This case arises out of tragic circumstances and we reach our conclusion only reluctantly, but the application of long standing pre-emption principles compels our result.
The judgment of the First Circuit is reversed.
Justice Breyer has filed a dissenting opinion in which Justice Kagan has joined.
Justice Sotomayor has also filed a dissenting opinion in which Justice Ginsburg has joined.