Details: Mutual Pharmaceutical Co. v. Bartlett
on Jun 24, 2013 at 12:03 pm
The federal government and the states share responsibility for regulating the drug industry. But when their regulations conflict, federal law prevails. In prior decisions, the Court has recognized that it may sometimes be impossible for a drug company to comply with FDA design and labeling requirements, on the one hand, and state laws on the other – typically because state law authorizes liability for drugs that meet FDA standards. The conflict is especially acute for generic versions of name-brand drugs. Federal law requires that generic drugs be chemically equivalent to their name-brand counterparts, and it also provides that generic drug labels must be consistent with their name-brand counterparts. It thus does not permit generic manufacturers to unilaterally make any significant alterations to either the chemical composition or the labeling of their drugs. In PLIVA, Inc. v. Mensing, the Court thus held that federal generic drug law preempts state failure-to-warn claims. Today, the Court applied PLIVA to hold that federal law also preempts certain state design defect claims.
Both the majority and the dissents acknowledge that the facts underlying this case are tragic. Karen Bartlett suffered horrific injuries as a side effect of the generic drug sulindac, a non-steroidal anti-inflammatory drug. She sued the drug manufacturer under New Hampshire law, alleging strict product liability. The jury found that sulindac was unreasonably dangerous, and awarded Bartlett $21 million in damages. The manufacturer challenged the award, arguing that it was impossible for it to simultaneously avoid liability under New Hampshire law and comply with the FDA’s design and labeling requirements. The U.S. Court of Appeals for the First Circuit rejected that argument, holding that the manufacturer could comply with both sets of law by simply not selling sulindac in New Hampshire, or by paying the small number of patients who suffer the adverse side effects.
The Supreme Court reversed. In a five-to-four decision by Justice Alito, the Court held that in effect, avoiding liability under New Hampshire law would require the manufacturer to either alter the composition of the drug or alter its label (both of which federal law prohibits). The Court rejected the lower court’s “stop-selling” rationale as “incompatible with our pre-emption jurisprudence,” and specifically with the decision in PLIVA, which found preemption even though the manufacturer there could also have stopped selling the relevant drug. The decision drew two dissenting opinions, which argued that the stop-selling theory is valid, and also that Congress would have wanted to preserve a role for state law in drug regulation. Justice Sotomayor’s dissent concludes that “the Court has left a seriously injured customer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”