On June 24, 2013, in a landmark decision, the U.S. Supreme Court reversed a First Circuit Court of Appeal’s ruling under federal preemption principles that allowed a user of a generic drug to bring a state law claim for design defect against a generic drug manufacturer. Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____(2013).

Karen Bartlett was prescribed Clinoril, the brand-name version of the nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain in 2004. Her pharmacist dispensed a generic form of sulindac manufactured by Mutual Pharmaceutical. Ms. Bartlett soon developed an acute case of toxic epidermal necrolysis. As a result, 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. Ms. Bartlett sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. A jury found Mutual liable on Bartlett’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. ___ (2011) -- 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.

Mutual petitioned the U.S. Supreme Court to reverse the First Circuit’s controversial holding and answer the question as to whether federal law preempts the New Hampshire design defect claim under which Ms. Bartlett recovered damages from a generic drug manufacturer like Mutual. The high court granted certiorari and held in a 5-4 decision that the appeals court was wrong to uphold a $21 million award to plaintiff Karen Bartlett. The majority opinion was written by Justice Samuel Alito, which was joined by Chief Justice John Roberts and Justices Antonin Scalia, Clarence Thomas and Anthony Kennedy.

The majority rejected the First Circuit’s solution that Mutual should have simply pulled sulindac from the market in order to comply with both state and federal law. “Adopting the Court of Appeal’s stop selling rationale would render impossibility of preemption a dead letter and work a revolution in this Court’s preemption case law.” The Court determined that the duty imposed by New Hampshire product liability design defect law required Mutual to either change the design of sulindac to reduce the risk of danger or to strengthen the warnings labels. According to the Court, redesign was not possible for two reasons: “First, the Federal Food, Drug, and Cosmetic Act (FDCA) requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based. 21 U. S. C. §§355(j)(2)(A)(ii)–(v) and (8)(B); 21 CFR §320.1(c). Consequently, the Court of Appeals was correct to recognize that “Mutual cannot legally make sulindac in another composition.” 678 F. 3d, at 37. Indeed, were Mutual to change the composition of its sulindac, the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. See 21 CFR §310.3(h) (giving examples of when the FDA considers a drug to be new, including cases involving “newness for drug use of any substance which composes such drug, in whole or in part”). Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. See 678 F. 3d, at 37 (“Mutual cannot legally make sulindac in another composition (nor it is apparent how it could alter a one molecule drug anyway)”).”

As for Mutual strengthening its warning labels, the Court noted: “Given the impossibility of redesigning sulindac, the only way for Mutual to ameliorate the drug’s ‘risk-utility’ profile—and thus to escape liability—was to strengthen the presence and efficacy of [sulindac’s] warning” in such a way that the warning “avoid[ed] an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Vautour, supra, at 154, 784 A. 2d, at 1182. See also Chellman, 138 N. H., at 78, 637 A. 2d, at 150 (“The duty to warn is part of the general duty to design, manufacture and sell products that are reasonably safe for their foreseeable uses. If the design of a product makes a warning necessary to avoid an unreasonable risk of harm from a foreseeable use, the lack of warning or an ineffective warning causes the product to be defective and unreasonably dangerous” (citation omitted)). Thus, New Hampshire’s design-defect cause of action imposed a duty on Mutual to strengthen sulindac’s warnings.

Ultimately, the Court found that Bartlett’s design defect claims were in reality an imposition of a duty on Mutual to change the sunlindac labeling which were preempted by federal law: “The duty imposed by federal law is far more readily apparent. As PLIVA made clear, federal law prevents generic drug manufacturers from changing their labels. See 564 U. S., at ___ (slip op., at 10) (“Federal drug regulations, as interpreted by the FDA, prevented the Manufacturers from independently changing their generic drugs’ safety labels”). See also 21 U. S. C. §355(j)(2)(A)(v) (“[T]he labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug”); 21 CFR §§314.94(a)(8)(iii), 314.150(b)(10) (approval for a generic drug may be withdrawn if the generic drug’s label “is no longer consistent with that for [the brand-name] drug”). Thus, federal law prohibited Mutual from taking the remedial action required to avoid liability under New Hampshire law.” It was therefore” impossible”, the Court noted, for Mutual and any other similarly situated manufacturers to comply with both state and federal law.

Click here to read the entire 53 page opinion.