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Justice Sonia Sotomayor - Mutual Pharmaceuticals v. Bartlett, Sotomayor's Dissent lyrics

No. 12–142

[June 24, 2013]

JUSTICE SOTOMAYOR, with whom JUSTICE GINSBURG joins, dissenting.

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

The Court takes this step by concluding that petitionerMutual Pharmaceutical was held liable for a failure-towarn claim in disguise, even though the District Courtclearly rejected such a claim and instead allowed liability on a distinct theory. See infra, at 13–15. Of greater consequence, the Court appears to justify its revision of respondent Karen Bartlett's state-law claim through an implicit and undefended assumption that federal law givespharmaceutical 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 manufacturersfrom distributing new drugs in commerce without federalregulatory 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 reliedupon evidence that the drug posed a higher than normal risk of causing the serious skin reaction that produced her horrific injuries; carried other risks; and possessed no apparent offsetting benefits compared to similar pain relievers, like aspirin. See 760 F. Supp. 2d 220, 233–241, 243–244 (NH 2011). The Court laments her “tragic” situation, ante, at 20, but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this Court. If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett's recovery. I respectfully dissent.

I begin with “two cornerstones of our pre-emption jurisprudence,” Wyeth v. Levine, 555 U. S. 555, 565 (2009), thatshould control this case but are conspicuously absent fromthe majority opinion. First, “‘the purpose of Congress isthe 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 thehistoric 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,” wehave explained, “applies with particular force when,” as is the case here, “Congress has legislated in a field traditionally occupied by the States.” Altria Group, Inc. v. Good,
555 U. S. 70, 77 (2008).1


1 The majority's failure to adhere to the presumption against preemption is well illustrated by the fact that the majority calls on Congress to provide greater clarity with regard to the “difficult pre-emption questions that arise in the prescription drug context.” Ante, at 19–20. Certainly, clear direction from Congress on pre-emption questions is useful. But the whole point of the presumption against pre-emption isthat congressional ambiguity should cut in favor of preserving state autonomy. See Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947).

The Court applied both of these principles to the Federal 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 byfederal law. 555 U. S., at 581. Tracing the history of federal drug regulation from the 1906 Federal Food and Drugs Act, 34 Stat. 768, up to the FDCA and its major amendments, the Court explained that federal drug law and state common-law liability have long been understood to operate in tandem to promote consumer safety. See Levine, 555 U. S., at 566–568, 574. That basic principle,which the majority opinion elides, is essential to understanding this case.

The FDCA prohibits the “introduction into interstate commerce [of] any new drug” without prior approval fromthe United States Food and Drug Administration (FDA).21 U. S. C. §355(a). Brand-name and generic drug manufacturers are required to make different showings to receive agency approval in this premarketing review process.See ante, at 2–3. But in either case, the FDA's per- mission to market a drug has never been regarded as afinal 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 reportadverse drug responses to the FDA, see 21 CFR §§314.80,314.81, 314.98 (2012), manufacturers may not sell a drugthat 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 playsan 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 “enlargedthe 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 thatthe amendments should not be construed to invalidate any provision of state law absent “a direct and positiveconflict.” §202, 76 Stat. 793. And in the years since,with “state common-law suits ‘continu[ing] unabated despite . . . FDA regulation,'” Levine, 555 U. S., at 567 (quoting Riegel v. Medtronic, Inc., 552 U. S. 312, 340 (2008) (GINSBURG, J., dissenting)), Congress has not enacted a pre-emption provision for prescription drugs(whether brand-name or generic) even as it enacted suchprovisions with respect to other products regulated by the FDA.2


2See 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 thatthe express pre-emption provisions in these statutes do not affect state product liability law. See 21 U. S. C. §§379r(e), 379s(d).


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 regulatory review in this context. On its own, even rigorous preapproval clinical testing of drugs is “generally . . . incapable of detecting adverse effects that oc-cur infrequently, have long latency periods, or affect subpopulations not included or adequately represented inthe 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) (discussinglimitations “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 dangerousdrugs. See Levine, 555 U. S., at 578–579, and n. 11; Brief for Former FDA Commissioner Donald Kennedy et al. as Amici Curiae 6–7, 12–20. Tort suits can help fill the gaps in federal regulation by “serv[ing] as a catalyst” to identify previously unknown drug dangers. Bates v. Dow Agrosciences LLC, 544 U. S. 431, 451 (2005).

Perhaps most significant, state common law provides injured consumers like Karen Bartlett with an opportunity to seek redress that is not available under federal law. “[U]nlike most administrative and legislative regulations,” common-law claims “necessarily perform an important remedial role in compensating accident victims.” Sprietsma v. Mercury Marine, 537 U. S. 51, 64 (2002). While the Court has not always been consistent on this issue, it has repeatedly cautioned against reading federal statutes to “remove all means of judicial recourse for those injured”when Congress did not provide a federal remedy. Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 251 (1984); see 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 toobtain compensation. See Levine, 555 U. S., at 574–575, and n. 7.


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 withboth federal and state [law was] a physical impossibility.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 142–143 (1963); see ante, at 7. But if state and federal law are properly understood, it is clear that New Hampshire's design-defect claim did not impose a legalobligation that Mutual had to violate federal law to satisfy.


Impossibility pre-emption “is a demanding defense,” Levine, 555 U. S., at 573, that requires the defendant to show an “irreconcilable conflict” between federal and state legal obligations, Silkwood, 464 U. S., at 256. The logic underlying true impossibility pre-emption is that when state and federal law impose irreconcilable affirmativerequirements, no detailed “inquiry into congressional design” is necessary because the inference that Congresswould have intended federal law to displace the conflictingstate requirement “is inescapable.” Florida Lime, 373
U. S., at 142–143. So, for example, if federal law requiresa particular product label to include a complete list ofingredients 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 thatthe laws of the other sovereign restricts or even prohibits. See Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, n. 21 (1984). So, to modify the previous example, if federal law permitted (but did not require)a labeling practice that state law prohibited, there would be no irreconcilable conflict; a manufacturer could com- ply with the more stringent regulation. And by the samelogic, impossibility does not exist where one sovereign'slaws merely create an incentive to take an action that theother sovereign has not authorized because it is possible to comply with both laws.

Of course, there are other types of pre-emption. Courts may find that state laws that incentivize what federal law discourages or forbid what federal law authorizes are preempted for reasons apart from impossibility: The state laws may fall within the scope of an express pre-emption provision, pose an obstacle to federal purposes and objectives, or intrude upon a field that Congress intended for federal law to occupy exclusively. See Crosby v. National Foreign Trade Council, 530 U. S. 363, 372–373 (2000). But absent a direct conflict between two mutually incompatible legal requirements, there is no impossibility and courts may not automatically assume that Congress intended for state law to give way. Instead, a more careful inquiry into congressional intent is called for, and that inquiry should be informed by the presumption against

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 judgmentby the FDA. See 564 U. S., at ___–___ (slip op., at 13–14). But nothing in Mensing, nor any other precedent, dictatesfinding impossibility pre-emption here.


To assess whether it is physically impossible for Mutualto comply with both federal and state law, it is necessaryto identify with precision the relevant legal obligationsimposed 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 warninglabel. In taking this position, the majority effectively recharacterizes Bartlett's design-defect claim as a de facto failure-to-warn claim.

The majority then relies on that recharacterization to hold that the jury found Mutual liablefor 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 thiscase for violating a legal obligation to change its label isinconsistent 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 tochange 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.



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

A product has a defective design under New Hampshirelaw 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 isunreasonably dangerous, a jury is asked to make a riskbenefit assessment by considering a nonexhaustive list of factors. See ante, at 9–10. In addition, New Hampshire has specifically rejected the doctrine, advocated bythe Restatement (Third) of Torts: Products Liability §2(b) (1997) (hereinafter Third Restatement), that a plaintiffmust present evidence of a reasonable alternative designto 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 designdefect liability to prescription drugs, New Hampshire, incommon with many other jurisdictions, does subject prescriptions drugs to this distinct form of strict productsliability. See 678 F. 3d 30, 35 (CA1 2012) (citing Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 655 (CA11981)); see also Third Restatement §6, Comment f (collecting cases from other jurisdictions). Drug manufacturers inNew Hampshire have an affirmative defense under comment k to §402A of the Second Restatement, which exempts “[u]navoidably unsafe products” from strict liabilityif 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 firstshow that the product is highly useful and that the danger imposed by the product could not have been avoidedthrough a feasible alternative design. See Brochu, 642
F. 2d, at 657. Comment k did not factor into the jury'sassessment of liability in this case because Mutual abandoned a comment k defense before trial. Ante, at 12, n. 2.3


3 Though the majority does not rely on comment k to find preemption, it misleadingly implies that New Hampshire, like “a large majority of States,” has applied comment k categorically to prescriptiondrugs to exempt manufacturers from “ ‘strict liability for side effects ofproperly manufactured prescription drugs that [are] accompanied by adequate warnings.' ” Ante, at 12, n. 2 (quoting Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___, n. 41 (2011) (slip op., at 10, n. 41). That is in- correct. The majority also neglects to mention that while some courtshave 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 liabilityunder 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, ProductsLiability §8.07[5], pp. 8–287 to 8–293 (2012).



The design-defect claim that was applied to Mutualsubjects 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 federallaw. Specifically, and contrary to the majority, see ante, at 11, New Hampshire's design-defect law did not require Mutual to change its warning label. A drug's warning label is just one factor in a nonexclusive list for evaluating whether a drug is unreasonably dangerous, see Vautour, 147 N. H., at 156, 784 A. 2d, at 1183, and an adequate label is therefore neither a necessary nor a sufficient condition for avoiding design-defect liability. Likewise, New Hampshire law imposed no duty on Mutual to change sulindac's chemical composition. The New HampshireSupreme Court has held that proof of an alternative feasible design is not an element of a design-defect claim, see Kelleher v. Marvin Lumber & Cedar Co., 152 N. H. 813, 831, 891 A. 2d 477, 492 (2006), and as the majority recognizes, ante, at 11, sulindac was not realistically capable ofbeing 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 changesto its product, including to the drug's label, to try to avoidliability. And respondent overstates her case somewhatwhen 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, 185–186 (1988), is not equivalent to a legal mandate for a regulated party to take (or refrain from taking) a specific action. This difference is a significant one: A mandate leaves no choice for a party that wishes to comply with the law, whereas an incentive may only influence a choice.


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 ofliability.


Our cases reflect this distinction. In Bates, for example, we rejected an argument that design-defect claims brought against a pesticide manufacturer were pre-emptedbecause they would likely “induce” the manufacturer tochange 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, weexplained, “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.

5 The majority suggests my account of Bates is “simply misleading,” ante, at 18, but it simply misses the point. I recognize that, under the Court's precedents, common-law duties may qualify as “requirements,”at least as that term has been used in express pre-emption provisions in federal law. See Riegel v. Medtronic, Inc., 552 U. S. 312, 323–324 (2008). But determining precisely what, if any, specific requirement astate common-law claim imposes is important. In Bates, the lower court had accepted the same basic argument that the majority advanceshere: that the plaintiffs' design-defect claim that a pesticide was “unreasonably dangerous” was “merely a disguised claim for failure towarn” 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 liabilitymight lead a manufacturer to make a label change, it meant that theState's design-defect claim imposed a requirement for labeling or packaging. See 544 U. S., at 445–446. The majority contends that thiscase 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 onestep a manufacturer might take to prevent its product from beingconsidered unreasonably dangerous, and it is a step that New Hampshire law recognizes may be insufficient. See infra, at 16.

[Lyrics from: https:/]

So too here. The fact that imposing strict liability for injuries caused by a defective drug design might make adrug 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 staterequirement that it was physically impossible for Mutualto 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 withfederal law preventing the manufacturer from doing so unilaterally, 564 U. S., at ___, ___ (slip op., at 4, 11–12). New Hampshire's design-defect law did not require Mutual to do anything other than to compensate consumerswho were injured by an unreasonably dangerous drug.


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

When Bartlett filed suit against Mutual, she raiseddistinct 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 warnclaims 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 Mutualon the failure-to-warn claim, the court repeatedly explained that an alleged failure to warn by Mutual couldnot 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 admittedevidence 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 defectivebecause 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 unreasonablydangerous 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 theproduct 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'sdesign was defective, Mutual's conduct, “which includedany failure to change its warning, was ‘not relevant to thiscase.'” 760 F. Supp. 2d, at 248.

6 For example, in a ruling on proposed jury instructions, the DistrictCourt 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 thiscourt has already ruled that any inadequacy in the warning did notcause Bartlett's injuries.” App. 343. Doing so, the court explained “would effectively turn this case back into a failure-to-warn case, rendering the summary judgment ruling meaningless.” Ibid.

The District Court later told counsel that it had removed a failure-towarn instruction from the jury instructions because “[t]his is not a failure to warn case,” and the court admonished counsel to “tread carefully” in arguing about the warning label because the label's adequacywas “not an issue before this jury.” Id., at 496.


The distinction drawn by the District Court betweenpermissible and impermissible uses of evidence regarding sulindac's label is faithful to New Hampshire law. That law recognizes that the effectiveness of a warning label is just one relevant factor in determining whether a product's design is unreasonably dangerous, and that designdefect and failure-to-warn claims are “separate.” LeBlanc, 141 N. H., at 586, 688 A. 2d, at 562.7 In short, as the District Court made clear, Mutual was not held liable for “failing to change” its warning. 760 F. Supp., at 248–249.

7To the extent the majority believes that the District Court in practice allowed the adequacy of the warning label to play a greater role at trial than it should have, see ante, at 11–12, that is irrelevant to the question before the Court. Statements by counsel, even if improper, donot change the state law cause of action that we evaluate for preemption purposes. And the Court of Appeals specifically concluded that the District Court's jury instructions were appropriate and that “[i]f Mutual wanted a further caution in the instructions” concerning itswarning label, then Mutual “should have sought it.” 678 F. 3d 30, 41– 42 (CA1 2012).


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 haveto 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 alterits 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 attacheven though . . . there was an adequate warning”). When a manufacturer cannot change the label or when doing sowould not make the drug safe, the manufacturer may still choose between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product.8


8 The majority's suggestion that a manufacturer's option of continuing to sell while paying compensation is akin to violating a statutorymandate and then suffering the consequence (such as paying a fine) isflawed. 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 designis 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 thata condition that triggers a tax is not necessarily a “legal command” to take a certain action).


From a manufacturer's perspective, that may be an unwelcome choice. But it is a choice that a sovereignState may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumersreceive compensation. That is, a State may impose such achoice 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 mustbelieve 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 tobe free from state-law liability that makes doing so more expensive. That proposition is fundamentally inconsistentwith the FDCA's text, structure, saving clause, and history. See supra, at 3–6; Levine, 555 U. S., at 583 (THOMAS, J., concurring in judgment).

It is simply incorrect to say that federal law presupposesthat 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, particu- larly when safer drugs that provide the same therapeutic benefits are available.10 According to the FDA, whileit has formal authority to withdraw approval for a drug based on new adverse information, see §355(e), it is farmore 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 changesor 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 ispermitted and sometimes encouraged or even required by federal law.

9 The majority properly leaves open the question whether state design-defect claims that parallel the federal misbranding statute are preempted. See ante, at 14, n. 4. The majority fails to appreciate, however, that this statute undermines its impossibility argument (as comparedto an argument based on obstacle pre-emption) because it shows thatthere 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 afederal duty not to sell its drug.

10 See Government Accountability Office, Drug Safety: ImprovementNeeded 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 UnitedStates, 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).



The majority derides any suggestion that Mutual'sability 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 mistakenpremise that Mutual is legally obligated by New Hampshire's design-defect law to modify its label in a way thatfederal law forbids. It is not. See supra, at 11–13. For that reason, rejecting impossibility pre-emption here would not render the doctrine “a dead letter” or “ ‘all but meaningless.'” Ante, at 2, 15 (quoting Mensing, 564 U. S., at ___ (slip op., at 14)). On the other hand, it is the major- ity that “work[s] a revolution in this Court's [impossibility] pre-emption case law,” ante, at 2, by inferring a state-law requirement from the steps a manufacturer might wish totake 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 thatapply 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 afederal policy to approve sulindac for use. Yet the majority skips that analysis and instead finds impossibility where it does not exist by relying on a question-begging assumption that Congress intended for Mutual to have away to continue selling sulindac without incurring common-law liability. See ante, at 9–11.

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

For example, properly evaluating the asserted conflicthere through the lens of obstacle pre-emption would allow the Court to consider evidence about whether Congressintended 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 thana 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 tothe rigorous nature of the FDA's review of new drug applications, ante, at 2–3, nothing in the majority's reasoning turns on how the FDA's premarketing review operates or on the agency's capacity to engage in postmarketingreview.
In taking the approach it does, the majority replaces careful assessment of regulatory structure with an ipse dixit that pharmaceutical companies must have a way to“escape liability,” ante, at 11, while continuing to sell a drug that received FDA approval. As a result, the majority effectively makes a highly contested policy judgmentabout the relationship between FDA review and state tort law—treating the FDA as the sole guardian of drug safety—without defending its judgment and without considering whether that is the policy judgment that Congressmade.11


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, 578–579, and n. 11 (2009). 12The FDA purports to address what it calls a “pure” design-defect claim, and it references the Third Restatement §6 by way of illustration. The FDA's separate discussion of a “pure” design-defect claim isbased 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.


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

Mutual's most substantial contention is that New Hampshire's design-defect claim frustrates the policy underlying the FDCA's broader scheme of vesting authority in the FDA as an expert agency to determine whichdrug designs should enter and remain in interstate commerce. The FDA, through an amicus brief filed by theUnited States, generally supports this argument. The FDA states that the question whether a design-defect claim12 is pre-empted is “difficult and close,” and it recognizes that “[s]everal factors do weigh in favor of finding no preemption,” including the absence of textual support in the FDCA for the idea that an approved drug must bemade available in any particular State. See U. S. Brief 12, 21–22. But the FDA ultimately contends that designdefect claims are pre-empted unless they parallel theFDCA's misbranding prohibition because the agency believes that permitting juries to balance the health risksand benefits of an FDA-approved drug would underminethe 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'sviews about the impact of tort law on federal objectives when ‘the subject matter is technica[l] and the relevant history and background are complex and extensive.'” Levine, 555 U. S., at 576 (quoting Geier v. American Honda Motor Co., 529 U. S. 861, 883 (2000)). But courts do not “defe[r] to an agency's conclusion that state law is preempted,” 555 U. S., at 576, and the tension that the FDA identifies in an effort to justify complete pre-emption of design-defect claims for prescription drugs does not satisfy the “high threshold [that] must be met if a state law is to be pre-empted for conflicting with the purposes of a federal Act,” Chamber of Commerce of United States of America,
v. Whiting, 563 U. S. ___, ___ (2011) (slip op., at 22) (internal quotation marks omitted); see Silkwood, 464 U. S., at
256. Given the FDCA's core purpose of protecting consumers, our recognition in Levine that state tort law generally complements the statute's safety goals, the practicallimits on the FDA's ability to monitor and promptly address concerns about drug safety once a drug is in themarket, see supra, at 5, 20–21, n. 11, and the absence of any federal remedy for injured consumers, I would reject this broad obstacle pre-emption argument as well.13


13 I note that we are not confronted with a case in which the FDA promulgated “lawful specific regulations describing” whether and underwhat circumstances state design-defect liability interferes with “thesafe 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).


The most troubling aspect of the majority's decision to once again expand the scope of this Court's traditionallynarrow impossibility pre-emption doctrine is what it implies about the relationship between federal premarketreview and state common-law remedies more generally.Central to the majority's holding is an assumption thatmanufacturers must have a way to avoid state-law liability while keeping particular products in commerce. See ante, at 9–11, 14–15. This assumption, it seems, will always create an automatic conflict between a federal premarket review requirement and state-law design-defect liability because premarket review, by definition, preventsmanufacturers from unilaterally changing their products' designs.14 That is true, for example, of the designs (i.e., the chemical composition) of brand-name drugs underthe 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 in1962 in response to serious public-health episodes involving unsafe drugs. See Future of Drug Safety 152. Yet bythe 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'sreasoning thus “has the ‘perverse effect' of granting broad immunity ‘to an entire industry that, in the judgment ofCongress, needed more stringent regulation.' ” Riegel, 552 U. S., at 338 (GINSBURG, J., dissenting) (quoting Lohr, 518 U. S., at 487 (plurality opinion)).


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.

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 pairedpremarket regulatory review with express pre-emption provisions that limit the application of state common-lawremedies, 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 theboundaries of pre-emption more precisely were largely academic. This could have serious consequences for product safety. State design-defect laws play an important role not only in discovering risks, but also in providing incentives for manufacturers to remove dangerous productsfrom 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 andsometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.

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 medicaldevices); §379e (color additives).


The manner in which Congress has addressed preemption with respect to vaccines is particularly instructive. “[V]accines have been subject to the same federal premarket approval process as prescription drugs,” and prior to Congress' intervention, “compensation for vaccinerelated injuries ha[d] been left largely to the States.” Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___ (2011) (slip op., at 1). In 1986, in response to a rise in tort suits thatproduced 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 perfectlycapable of responding when it believes state tort law may compromise significant federal objectives under a scheme of premarket regulatory review for products it wants tomake available. And it illustrates that “an importantreason to require that preemption decisions be made by Congress,” rather than by courts on the basis of an expanded implied pre-emption doctrine, is Congress' ability to tie its pre-emption decisions “to some alternative means for securing compensation.” Metzger, Federalism and Federal Agency Reform, 111 Colum. L. Rev. 1, 33 (2011).By instead reaching out to find pre-emption in a contextwhere 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, ratherthan 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 thatis irreconcilable with our precedents. As a result, the Court has left a seriously injured consumer without anyremedy despite Congress' explicit efforts to preserve state common-law liability. I respectfully dissent.

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