Mut. Pharm. Co. v. Bartlett, 12–142.

• Court: United States Supreme Court
• Writing for the Court: Justice ALITO delivered the opinion of the Court.
• Citation: 133 S.Ct. 2466,186 L.Ed.2d 607,81 USLW 4538
• Parties: MUTUAL PHARMACEUTICAL CO., INC., Petitioner v. Karen L. BARTLETT.
• Docket Number: No. 12–142.,12–142.
• Decision Date: 24 June 2013

133 S.Ct. 2466
186 L.Ed.2d 607
81 USLW 4538

MUTUAL PHARMACEUTICAL CO., INC., Petitioner
v.
Karen L. BARTLETT.

No. 12–142.

Supreme Court of the United States

Argued March 19, 2013.
Decided June 24, 2013.

[133 S.Ct. 2468]

Syllabus^*

The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce. 21 U.S.C. § 355(a). Once a drug is approved, a manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.” 21 C.F.R. § 314.70(b)(2)(i). Generic manufacturers are also prohibited from making any unilateral changes to a drug's label. See §§ 314.94(a)(8)(iii), 314.150(b)(10).

In 2004, respondent was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis. She is now severely disfigured, has physical disabilities, and is nearly blind. At the time of the prescription, sulindac's label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. Respondent sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. A jury found Mutual liable on respondent's design-defect claim and awarded her over $21 million. The First Circuit affirmed. As relevant, it found that neither the FDCA nor the FDA's regulations pre-empted respondent's design-defect claim. It distinguished PLIVA, Inc. v. Mensing, 564 U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580—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 comply with both federal and state law simply by choosing not to make the drug at all.

Held : State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA. Pp. 2472 – 2480.

(a) Under the Supremacy Clause, state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576. Even in the absence of an express pre-emption provision, a state law may be impliedly pre-empted where it is “impossible for a private party to comply

[133 S.Ct. 2469]

with both state and federal requirements.” English v. General Elec. Co., 496 U.S. 72, 79, 110 S.Ct. 2270, 110 L.Ed.2d 65. Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design. Pp. 2472 – 2477.

(1) New Hampshire's design-defect cause of action imposes affirmative duties on manufacturers, including a “duty to design [their products] reasonably safely for the uses which [they] can foresee.” Thibault v. Sears, Roebuck & Co., 118 N.H. 802, 809, 395 A.2d 843, 847. Pp. 2473 – 2474.

(2) To assess whether a product's design is “unreasonably dangerous to the user,” Vautour v. Body Masters Sports Industries, Inc., 147 N.H. 150, 153, 784 A.2d 1178, 1181, the New Hampshire Supreme Court employs a “risk-utility approach,” which asks whether the danger's magnitude outweighs the product's utility, id., at 154, 784 A.2d, at 1182. The court has repeatedly identified three factors as germane to that inquiry: “the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Ibid. Increasing a drug's “usefulness” or reducing its “risk of danger” would require redesigning the drug, since those factors are direct results of a drug's chemical design and active ingredients. Here, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac's “risk-utility” profile by strengthening its warnings. Thus, New Hampshire's law ultimately required Mutual to change sulindac's labeling. Pp. 2474 – 2477.

(3) But PLIVA makes clear that federal law prevents generic drug manufacturers from changing their labels. See 564 U.S., at ––––, 131 S.Ct. 2567. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law. Pp. 2476 – 2477.

(4) When federal law forbids an action required by state law, the state law is “without effect.” Maryland,supra, at 746, 101 S.Ct. 2114. Because it was impossible for Mutual to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce. Pp. 2476 – 2477.

(b) The First Circuit's rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by choosing to stop selling sulindac—is incompatible with this Court's pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether. Pp. 2477 – 2478.

678 F.3d 30, reversed.

ALITO, J., delivered the opinion of the Court, in which ROBERTS, C.J., and SCALIA, KENNEDY, and THOMAS, JJ., joined. BREYER, J., filed a dissenting opinion, in which KAGAN, J., joined. SOTOMAYOR, J., filed a dissenting opinion, in which GINSBURG, J., joined.

[133 S.Ct. 2470]

Jay P. Lefkowitz, New York, NY, for Petitioner.

Anthony A. Yang, for the United States as amicus curiae, supporting the Petitioner.

David C. Frederick, Washington, DC, for Respondent.

Michael W. McConnell, Michael D. Shumsky, John K. Crisham, Kirkland & Ellis LLP, Washington, DC, Jay P. Lefkowitz, P.C., Counsel of Record, Kirkland & Ellis LLP, New York, NY, for Petitioner.

Steven M. Gordon, Christine M. Craig, Shaheen & Gordon, Concord, NH, Keith M. Jensen, Jensen & Associates, PLLC, Fort Worth, TX, David C. Frederick, Counsel of Record, Brendan J. Crimmins, Joshua D. Branson, Kellogg, Huber, Hansen, Todd, Evans & Figel, P.L.L.C., Washington, DC, for Respondent.

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. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (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, 101 S.Ct. 2114, 68 L.Ed.2d 576 (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, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., drug manufacturers must gain approval from the United States Food and Drug Administration (FDA) before marketing any drug in interstate commerce. § 355(a). In the case of a new brand-name drug, FDA approval can be secured only by submitting a new-drug application (NDA). An NDA is a compilation of materials that must include “full reports of [all clinical]

[133 S.Ct. 2471]

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 C.F.R. §§ 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 C.F.R. § 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 C.F.R. § 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,...