On June 24, 2013, the Supreme Court of the United States decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, holding that state-law design-defect claims against generic-drug manufacturers that turn on the adequacy of a drug's warnings are preempted by federal law under PLIVA, Inc. v. Mensing.
A drug must be approved by the Food and Drug Administration (FDA) before it can be marketed in interstate commerce. To receive approval for a new brand-name drug, a drug manufacturer must submit a new-drug application (NDA) to the FDA through what the Supreme Court characterized as an "onerous and lengthy" process. In contrast, the Hatch-Waxman Act allows the FDA to approve generic versions of brand-name drugs without the same level of clinical testing required for approval of a new brand-name drug, but only if the generic drug is equivalent to the brand-name drug in several respects and the label for the generic drug is "the same as the labeling approved for the [brand-name] drug." 21 U.S.C. § 355(j)(2)(A)(v). Once the FDA approves a generic drug for marketing, the manufacturer may not make any major changes to the formulation of the drug or to the drug's label, and a generic manufacturer cannot make any unilateral changes to the drug's label. The federal framework reflects "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' composition or their warnings."
Karen Bartlett began taking the generic version of the pain reliever sulindac. She developed a severe case of toxic epidermal necrolysis, which left her severely disfigured and nearly blind. When her doctor prescribed the drug, its warnings did not specifically refer to toxic epidermal necrolysis and only generally to "severe skin reactions" and "[f]atalities," while listing toxic epidermal necrolysis as a potential adverse reaction. After Bartlett was already suffering from toxic epidermal necrolysis, the FDA recommended that all approved non-steroidal anti-inflammatory drugs (NSAIDs) specifically warn against toxic epidermal necrolysis.
Bartlett sued the manufacturer of the generic drug, Mutual Pharmaceutical, on a design-defect claim. Mutual asserted that the Federal Food, Drug, and Cosmetic Act as well as FDA regulations pre-empted Bartlett's design-defect claim. The District Court disagreed. (The District Court dismissed Bartlett's separate failure-to-warn claim based on her doctor's admission that he had not read the box label or the package insert.) The jury awarded Bartlett $21 million. The First Circuit affirmed the judgment, agreeing with the District Court that federal law did not preempt the design-defect claim. The First Circuit distinguished PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S. Ct. 2567 (2011) which held that failure-to-warn claims against generic manufacturers are pre-empted by federal law's prohibition on changes to generic drug labels. The First Circuit reasoned that generic manufacturers facing design-defect claims could comply with both federal and state law by simply choosing not to make the drug at all. Persons injured by generic drugs have made similar arguments elsewhere in an attempt to distinguish PLIVA's failure-to-warn preemption ruling from design-defect claims, including in a June 14, 2013, decision of the Eighth Circuit, Bell v. Pfizer, Inc., No. 12-1674.
The Supreme Court reversed the First Circuit and rejected the lower court's attempt to distinguish PLIVA. The Court explained that under New Hampshire law of strict products liability, a drug manufacturer must ensure that its products are not "unreasonably dangerous," and that the manufacturer could satisfy that duty either by changing a drug's design or changing its labeling. However, federal law prohibited Mutual from changing the drug's design, so New Hampshire law effectively required Mutual to change the drug's labeling. Because PLIVA "made clear" that federal law prevents generic-drug manufacturers from changing the labels on their drugs, federal law prohibited Mutual from taking the remedial action that New Hampshire law required it to take to avoid liability. Federal law therefore pre-empted both state law duties.
The Court rejected the First Circuit's approach that Mutual could comply with both federal and state law by simply choosing to stop making the drug, stating: "Our pre-emption cases [including PLIVA itself] presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability." The Court expressly "save[d] for another day" whether federal law would pre-empt a state-law "absolute liability" approach "in which liability does not reflect the breach of any duties at all, but merely serves to spread risk."
Justice Alito delivered the opinion of the Court, in which Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas joined. Justice Breyer filed a dissenting opinion, in which Justice Kagan joined. Justice Sotomayor filed a dissenting opinion, in which Justice Ginsburg joined.