The US Supreme Court [official website] ruled [opinion, PDF] 5-4 Monday in Mutual Pharmaceutical Company, Inc. v. Bartlett [SCOTUSblog backgrounder] that generic drug design defect claims [Cornell LII backgrounder] that turn on the adequacy of a drug's warnings are preempted by federal law under PLIVA, Inc. v. Mensing [Cornell LII backgrounder; JURIST report]. Justice Samuel Alito delivered the opinion of the court, which reversed the US Court of Appeals for the First Circuit's ruling that federal law does not preempt state law design defect claims targeting generic pharmaceutical products because the conflict can be avoided if the makers of generic pharmaceuticals stop making their products. The court found that this "stop selling" rationale was inconsistent with the court's preemption jurisprudence:
Our preemption cases 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. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility preemption would be all but meaningless. The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases. In every instance in which the Court has found impossibility preemption, the "direct conflict" between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.The court asserted that adopting the First Circuit's "stop selling" rationale would mean that not only PLIVA, but also the vast majorityif not allof the cases in which the court has found impossibility preemption, were wrongly decided. Justice Stephen Breyer filed a dissenting opinion, joined by Justice Elena Kagan. Justice Sonia Sotomayor filed a separate dissent, joined by Justice Ruth Bader Ginsburg.
The court heard oral arguments [JURIST report] in the case in March. Attorneys for Mutual Pharmaceuticals argued, "[r]egardless of whether a state tort claim is captioned 'failure to warn,' 'design defect,' or something else entirely, these courts have recognized that the Constitution requires state law to yield if it would obligate a generic drug manufacturer to violate the federal sameness mandate." Conversely, attorneys for Karen Bartlett argued that impossibility does not apply, because if a jury found design defect in a generic drug, the manufacturer of that drug has the option to stop selling the drug, which makes the issue distinct for the brand-name's selling of the drug. JURIST Guest Columnist Daniel Perrone argued recently [JURIST op-ed] that the decision in PLIVA to insulate generic drug manufacturers from liability, despite their failure to adequately and safely label their products, is "an injustice that disproportionately affects those who cannot afford to purchase expensive brand-name drugs." He argued that "courts should craft an exception to the PLIVA rule that would hold generic drug manufacturers liable for their failure to adequately and safely label their products where the brand-name and generic drug manufacturers are one and the same."