Mut. Pharm. Co. v. Bartlett

* * *

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.

Dissent by:BREYER; SOTOMAYOR

Dissent

Justice Breyer, with whom Justice Kagan joins, dissenting.

It is not literally impossible here for a company like petitioner to comply with 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 512, 186 L. Ed. 2d, at 637 (quoting Crosby v. National Foreign Trade Council, 530 U. S. 363, 373, 120 S. Ct. 2288, 147 L. Ed. 2d 352 (2000)).

Normally, for the reasons I set forth in Medtronic, Inc. v. Lohr, 518 U. S. 470, 503, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (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, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (citing Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735, 739-741, 116 S. Ct. 1730, 135 L. Ed. 2d 25 (1996); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 721, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985); Lawrence County v. Lead-Deadwood School Dist. No. 40-1, 469 U. S. 256, 261-262, 105 S. Ct. 695, 83 L. Ed. 2d 635 (1985); Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-845, 104 S. Ct. 2778, 81 L. Ed. 2d 694 (1984)). See also Wyeth v. Levine, 555 U. S. 555, 576-577, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009). Cf. Skidmore v. Swift & Co., 323 U. S. 134, 140, 65 S. Ct. 161, 89 L. Ed. 124 (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 Ed. 2d 700 (opinion of Breyer, J.) (quoting Hillsborough, supra, at 718, 105 S. Ct. 2371, 85 L. Ed. 2d 714).

Here, however, I cannot give special weight to the FDA’s views. For one thing, as far as the briefing reveals, the FDA, in developing its views, has held no hearings on the matter or solicited the opinions, arguments, and views of the public in other ways. For another thing, the FDA has set forth its positions only in briefs filed in litigation, not in regulations, interpretations, or similar agency work product. See Bowen v. Georgetown Univ. Hospital, 488 U. S. 204, 212-213, 109 S. Ct. 468, 102 L. Ed. 2d 493 (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, 120 S. Ct. 1655, 146 L. Ed. 2d 621 (2000).

Finally, the FDA has set forth conflicting views on this general matter in different with PLIVA, Inc. v. Mensing, 564 U. S. 604, 613, n. 3, 615-617, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) (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, 125 S. Ct. 2688, 162 L. Ed. 2d 820 (2005) (agency views that vary over time are accorded less weight); Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29, 41-42, 103 S. Ct. 2856, 77 L. Ed. 2d 443 (1983) (same); Verizon Communications Inc. v. FCC, 535 U. S. 467, 502, n. 20, 122 S. Ct. 1646, 152 L. Ed. 2d 701 (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 also Wyeth, supra, at 578, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (“In keeping with Congress’ decision not to preempt 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, 116 S. Ct. 2240, 135 L. Ed. 2d 700. Cf. Wyeth, supra, at 574, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (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 damages payments for it there, would be so harmful that it would seriously undercut the purposes of the federal statutory scheme. Cf. post, at 515-517, 186 L. Ed. 2d, at 640-641.

Finally, similarly situated defendants in other cases remain free to argue for “obstacle pre-emption” in respect to damages 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.

Justice Sotomayor, with whom Justice Ginsburg joins, dissenting.

In PLIVA, Inc. v. Mensing, 564 U. S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (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 PLIVA to preempt New Hampshire’s law governing design-defects with respect to generic drugs.

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 493, 186 L. Ed. 2d, at 625, but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this Court. If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett’s recovery. I respectfully dissent.

I

I begin with “two cornerstones of our pre-emption jurisprudence,” Wyeth v. Levine, 555 U. S. 555, 565, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (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. that was the clear and manifest purpose of Congress.” Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230, 67 S. Ct. 1146, 91 L. Ed. 1447 (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, 129 S. Ct. 538, 172 L. Ed. 2d 398 (2008).

The Court applied both of these principles to the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq., in Levine, where we held that 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 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, 129 S. Ct. 1187, 173 L. Ed. 2d 51. Federal law in this area was initially intended to “supplemen[t] the protection for consumers already provided by state regulation and common-law enacted such provisions with respect to other products regulated by the FDA.

Congress’ preservation of a role for state law generally, and common-law remedies specifically, reflects a realistic understanding of the limitations of ex ante 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, 129 S. Ct. 1187, 173 L. Ed. 2d 51, 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, 125 S. Ct. 1788, 161 L. Ed. 2d 687 (2005).

Perhaps “[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, 123 S. Ct. 518, 154 L. Ed. 2d 466 (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, 104 S. Ct. 615, 78 L. Ed. 2d 443 (1984); see, e.g., Bates, 544 U. S., at 449, 125 S. Ct. 1788, 161 L. Ed. 2d 687; Lohr, 518 U. S., at 487, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (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, 129 S. Ct. 1187, 173 L. Ed. 2d 51, and n. 7.

II

In light of this background, Mutual should face an uphill climb to show that federal law pre-empts a New Hampshire strict-liability claim against a generic drug manufacturer for defective design. The majority nevertheless accepts Mutual’s argument that “compliance with both federal and state [law was] a physical impossibility.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 142-143, 83 S. Ct. 1210, 10 L. Ed. 2d 248 (1963); see ante, at 480, 186 L. Ed. 2d, at 618. But if state and federal law are properly understood, it is clear that New Hampshire’s design-defect claim did not impose a legal obligation that Mutual had to violate federal law to satisfy.

A

Impossibility pre-emption “is a demanding defense,” Levine, 555 U. S., at 573, 129 S. Ct. 1187, 173 L. Ed. 2d 51, that requires the defendant to show an “irreconcilable conflict” between federal and state legal obligations, Silkwood, 464 U. S., at 256, 104 S. Ct. 615, 78 L. Ed. 2d 443. The logic underlying true impossibility pre-emption is that when state and federal law impose irreconcilable affirmative requirements, is little question that state law “'must yield.'” Felder v. Casey, 487 U. S. 131, 138, 108 S. Ct. 2302, 101 L. Ed. 2d 123 (1988).

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, 372-373, 120 S. Ct. 2288, 147 L. Ed. 2d 352 (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 pre-emption, 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 618-624, 131 S. Ct. 2567, 180 L. Ed. 2d 580. 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 recharacterization to hold that the jury found Mutual liable for failing to fulfill its duty to label sulindac adequately, which PLIVA forbids because a generic drug manufacturer cannot independently alter its safety label. Ante, at 486, 186 L. Ed. 2d, at 621; see PLIVA, 564 U. S., at 617, 131 S. Ct. 2567, 180 L. Ed. 2d 580. But the majority’s assertion that Mutual 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.

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 483, 186 L. Ed. 2d, at 619-620. In addition, New Hampshire has specifically rejected the doctrine, advocated by the Restatement (Third) of Torts: Products Liability §2(b) (1997) (hereinafter Third Restatement), that a plaintiff must present evidence of a reasonable alternative design to show that a product’s design is defective. Instead, “while proof of an alternative design is relevant in a design defect case,” it is “neither a controlling factor nor an 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 danger imposed by the product could not have been avoided through a feasible alternative design. See Brochu, 642 F. 2d, at 657. Comment k did not factor into the jury’s assessment of liability in this case because Mutual abandoned a comment k defense before trial. Ante, at 485-486, n. 2, 186 L. Ed. 2d, at 621.

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 484, 186 L. Ed. 2d, at 620, New Hampshire’s design-defect law did not require Mutual to change its warning label. A drug’s warning label is just one factor in a nonexclusive list for evaluating whether a drug is unreasonably dangerous, see Vautour, 147 N. H., at 156, 784 A. 2d, at 1183, and an adequate label is therefore neither a necessary nor a sufficient condition for avoiding design-defect liability. Likewise, New Hampshire law imposed no duty on Mutual to change sulindac’s chemical composition. The New Hampshire Supreme Court has held that proof of an alternative feasible design is not an element of a design-defect claim, see Kelleher v. Marvin Lumber & Cedar Co., 152 N. H. 813, 831, 891 A. 2d 477, 492 (2006), and as the majority recognizes, ante, at 484, 186 L. Ed. 2d, at 620, sulindac was not realistically capable of being redesigned anyway because it is a single-molecule drug.

To be sure, New Hampshire’s design-defect claim creates an incentive for a drug manufacturer to make changes to its 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, 108 S. Ct. 1704, 100 L. Ed. 2d 158 (1988), is not equivalent to a legal mandate for a regulated party to take (or refrain from taking) a specific action. This difference is a significant one: A mandate leaves no choice for a party that wishes to comply with the law, whereas an incentive may only influence a choice.

Our cases reflect this distinction. In Bates, for example, we rejected an argument that design-defect claims brought against a pesticide manufacturer were pre-empted because they would likely “induce” the manufacturer to change its product label and thus run afoul of an express we explained, “is a rule of law that must be obeyed.” Id., at 445, 125 S. Ct. 1788, 161 L. Ed. 2d 687. “[A]n event, such as a jury verdict, that merely motivates an optional decision” does not rise to that level. Ibid.

it was physically impossible for Mutual to comply with while also following federal law. The case is therefore unlike PLIVA, where it was “undisputed” that applicable state tort law “require[d] a drug manufacturer that is or should be aware of its product’s danger” to strengthen its label — a requirement that conflicted with federal law preventing the manufacturer from doing so unilaterally, 564 U. S., at 611, 614, 131 S. Ct. 2567, 180 L. Ed. 2d 580. New Hampshire’s design-defect law did not require Mutual to do anything other than to compensate consumers who were injured by an unreasonably dangerous drug.

2

Moreover, the trial record in this case confirms that, contrary to the majority’s insistence, Mutual was not held liable for “breach[ing] [its] duty” “to label sulindac adequately.” Ante, at 486, 186 L. Ed. 2d, at 621.

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, 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.

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. 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 490, 186 L. Ed. 2d, at 623, 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 duty to change its label because it had no other option to avoid liability while continuing to sell its product. Ante, at 483-484, 186 L. Ed. 2d, at 619-620. 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.

quotation marks omitted). Because the majority does not rely on obstacle pre-emption, it must believe that a manufacturer that received FDA premarket approval has a right not only to keep its drug on the market unless and until the FDA revokes approval, but also to be free from state-law liability that makes doing so more expensive. That proposition is fundamentally inconsistent with the FDCA’s text, structure, saving clause, and history. See supra, at 498-501, 186 L. Ed. 2d, at 629-631; Levine, 555 U. S., at 583, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (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 when safer drugs that provide the same therapeutic benefits are available. 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 475, 488, 186 L. Ed. 2d, at 615, 622-623. 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 506-508, 186 L. Ed. 2d, at 634-637. For that reason, rejecting impossibility pre-emption here would not render the doctrine “a dead letter” or “‘all but meaningless.’” Ante, at 475, 488, 186 L. Ed. 2d, at 615, 622 (quoting PLIVA, 564 U. S., at 621, 131 S. Ct. 2567, 180 L. Ed. 2d 580). On the other hand, it is the majority that “work[s] a revolution 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 depends on assessing whether it poses an obstacle to a federal policy to approve sulindac for use. Yet the majority skips that analysis and instead finds impossibility where it does not exist by relying on a question-begging assumption that Congress intended for Mutual to have a way to continue selling sulindac without incurring common-law liability. See ante, at 483-484, 186 L. Ed. 2d, at 619-620.

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, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (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. 323, 335, 562 U.S. 323, 131 S. Ct. 1131, 179 L. Ed. 2d 75 (2011). By contrast, the majority’s 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 484, 186 L. Ed. 2d, at 620, while continuing to sell a drug that received FDA approval. As a result, the majority effectively makes a highly contested policy judgment about the relationship between FDA review and state tort law—treating the FDA as the sole guardian of drug safety—without defending its judgment and without considering whether that is the policy judgment that Congress made.

III

While the majority never addresses obstacle pre-emption, Mutual did argue in the alternative as supplemented by the Hatch-Waxman Act, 98 Stat. 1585. Though it presents a closer question than the impossibility argument on which the majority relies, I would reject Mutual’s obstacle pre-emption defense as well.

Mutual’s most substantial contention is that New Hampshire’s design-defect claim frustrates the policy underlying the agency believes that permitting juries to balance the health risks and benefits of an FDA-approved drug would undermine the FDA’s drug-safety determinations and could reduce 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, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (quoting Geier v. American Honda Motor Co., 529 U. S. 861, 883, 120 S. Ct. 1913, 146 L. Ed. 2d 914 (2000)). But courts do not “defe[r] to an agency’s conclusion that state law is pre-empted,” 555 U. S., at 576, 129 S. Ct. 1187, 173 L. Ed. 2d 51, 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 (2011) (pluraity opinion) (internal quotation marks omitted); see Silkwood, 464 U. S., at 256, 104 S. Ct. 615, 78 L. Ed. 2d 443. 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 500, 515-516, n. 11, 186 L. Ed. 2d, at 630, 639-640, and the absence of any federal remedy for injured consumers, I would reject this broad obstacle pre-emption argument as well.

IV

The most troubling aspect of the majority’s decision to once again expand designs. 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 477, 186 L. Ed. 2d, at 615-616.

If the creation of such an automatic conflict is the ultimate end-point of the majority’s continued expansion of impossibility 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, 68 S. Ct. 331, 92 L. Ed. 297 (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 499-500, 186 L. Ed. 2d, at 630. 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, 128 S. Ct. 999, 169 L. Ed. 2d 892 (Ginsburg, J., dissenting) (quoting Lohr, 518 U. S., at 487, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (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. In some statutes, Congress has paired premarket regulatory review with 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’ manufacturers.” 562 U. S., at 229, 131 S. Ct. 1068, 1074, 179 L. Ed. 2d 1, 8.

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 pre-emption decisions be made by Congress,” rather than by courts on the basis of an expanded implied pre-emption doctrine, is Congress’ ability to tie its pre-emption decisions “to some alternative means for securing compensation.” Metzger, Federalism and Federal Agency Reform, 111 Colum. L. Rev. 1, 33 (2011). By instead reaching out to find pre-emption in a context where Congress never intended it, the majority leaves consumers like Karen Bartlett to bear enormous losses on their own.

* * *

The Court recognizes that “[t]his case arises out of tragic circumstances.” Ante, at 493, 186 L. Ed. 2d, at 625. 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 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.