Mutual Pharmaceutical Co. v. Bartlett
570 U.S. ___ (2013)

Annotate this Case
Justia Opinion Summary
The Food, Drug, and Cosmetic Act requires Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce, 21 U.S.C. 355(a). The manufacturer of an approved drug is prohibited from making any major change to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application." Generic manufacturers are also prohibited from making any unilateral change to a drug’s label. In 2004, a patient was prescribed Clinoril, a brand-name nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by Mutual. The patient developed an acute case of toxic epidermal necrolysis and is 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, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. A jury found Mutual liable on a design-defect claim and awarded the patient more than $21 million. The First Circuit affirmed. The Supreme Court reversed. State-law design-defect claims based on the adequacy of a drug’s warnings are preempted by federal law under a 2011 Supreme Court decision, PLIVA, Inc. v. Mensing. 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 the label or change sulindac’s design. Redesign was not possible because 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 and, due to sulindac’s simple composition, the drug is chemically incapable of being redesigned. Mutual could only ameliorate sulindac’s "risk-utility" profile, therefore, by strengthening its warnings, an action forbidden by federal law.

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321 .

SUPREME COURT OF THE UNITED STATES

Syllabus

MUTUAL PHARMACEUTICAL CO., INC. v. BARTLETT

certiorari to the united states court of appeals for the first circuit

No. 12–142. Argued March 19, 2013—Decided June 24, 2013

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

          In 2004, respondent was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis. She is now severely disfigured, has physical disabilities, and is nearly blind. At the time of the prescription, sulindac’s label did not specifically refer to toxic epidermal necrolysis. By 2005, however, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. Respondent sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. A jury found Mutual liable on respondent’s design-defect claim and awarded her over $21 million. The First Circuit affirmed. As relevant, it found that neither the FDCA nor the FDA’s regulations pre-empted respondent’s design-defect claim. It distinguished PLIVA, Inc. v. Mensing, 564 U. S. ___—in which the Court held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA’s prohibition on changes to generic drug labels—by 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. 6–20.

     (a) Under the Supremacy Clause, state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U. S. 725 . Even in the absence of an express pre-emption provision, a state law may be impliedly pre-empted where it is “impossible for a private party to comply with both state and federal requirements.” English v. General Elec. Co., 496 U. S. 72 . Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on sulindac’s label or change sulindac’s design. Pp. 6–13.

          (1) New Hampshire’s design-defect cause of action imposes affirmative duties on manufacturers, including a “duty to design [their products] reasonably safely for the uses which [they] can foresee.” Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 809, 395 A. 2d 843, 847. Pp. 7–8.

          (2) To assess whether a product’s design is “unreasonably dangerous to the user,” Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181, the New Hampshire Supreme Court employs a “risk-utility approach,” which asks whether the danger’s magnitude outweighs the product’s utility, id., at 154, 784 A. 2d, at 1182. The court has repeatedly identified three factors as germane to that inquiry: “the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Ibid. Increasing a drug’s “usefulness” or reducing its “risk of danger” would require redesigning the drug, since those factors are direct results of a drug’s chemical design and active ingredients. Here, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac’s “risk-utility” profile by strengthening its warnings. Thus, New Hampshire’s law ultimately required Mutual to change sulindac’s labeling. Pp. 9–13.

          (3) But PLIVA makes clear that federal law prevents generic drug manufacturers from changing their labels. See 564 U. S., at ___. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law. P. 13.

          (4) When federal law forbids an action required by state law, the state law is “without effect.” Maryland, supra, at 746. Because it was impossible for Mutual to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce. Pp. 13–14.

     (b) The First Circuit’s rationale—that Mutual could escape the impossibility of complying with both its federal- and state-law duties by choosing to stop selling sulindac—is incompatible with this Court’s pre-emption cases, which have presumed that an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether. Pp. 14–16.

678 F. 3d 30, reversed.

     Alito, J., delivered the opinion of the Court, in which Roberts, C. J., and Scalia, Kennedy, and Thomas, JJ., joined. Breyer, J., filed a dissenting opinion, in which Kagan, J., joined. Sotomayor, J., filed a dissenting opinion, in which Ginsburg, J., joined.

Official Supreme Court case law is only found in the print version of the United States Reports. Justia case law is provided for general informational purposes only, and may not reflect current legal developments, verdicts or settlements. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or information linked to from this site. Please check official sources.