On June 24, 2013, the Supreme Court ruled 5-4 in Mutual Pharmaceutical Co. v. Bartlett, --- S.Ct. ---, 2013 WL 3155230, that, under PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), a plaintiff’s state-law design-defect claim against generic drug manufacturers was preempted by federal law.

The case involved a US$21 million jury verdict for Karen Bartlett, who developed a rare skin condition after taking generic sulindac, a nonsteroidal anti-inflammatory drug (NSAID) manufactured by Mutual. Bartlett had sued Mutual in New Hampshire state court, and the case was tried solely on a design defect theory. The defendant had argued that the claim was preempted under Mensing, but the First Circuit disagreed and affirmed the trial court ruling.

The Supreme Court reversed. It explained that, under New Hampshire law, the duty to sell a product that is not unreasonably dangerous can be satisfied either by changing the product’s design or by strengthening its warnings. But Mutual could not change its drug’s design “as a matter of federal law and basic chemistry.” Therefore its only recourse was to strengthen the warning. As the Court had held in Mensing, it was impossible for the generic company to comply with both its state-law duty to strengthen the warning label and its federal-law duty not to alter it. The claim was thus preempted.

The majority opinion also specifically rejected the First Circuit’s reasoning that Mutual could comply with both its federal and state law duties if it simply stopped selling sulindac. The Court reasoned that such logic would apply in every instance where it has previously found impossibility preemption and would render the doctrine a dead letter.

At a minimum, Bartlett further shields generic drug manufacturers from state tort liability and puts an end to the “stop-selling” rationale as a potential loophole for avoiding preemption. Bartlett’s impact on state design-defect claims against branded pharmaceutical companies will be a significant issue for the courts to take up in the wake of the opinion.