Posted July 24th, 2011 in Top Stories
PLIVA V. MENSING–Supreme Court Determines Failure to Warn Claims Against Generic Pharmaceutical Manufacturers are Preempted Under Federal Law
On June 23, 2011, the United States Supreme Court issued its decision in Pliva, Inc. v. Mensing, No. 09-993, 564 U.S. ___ (2011), which effectively eliminates claims against generic pharmaceutical manufacturers for failing to provide adequate warnings required by state law. In Mensing, the plaintiffs alleged that the manufacturers of generic metoclopramide, a drug used to treat digestive tract problems, were liable under Minnesota and Louisiana law for failing to provide an adequate warning regarding the risk of tardive dyskinesia associated with long-term metoclopramide use. Tardive dyskinesia is a serious and often irreversible movement disorder.
The generic metoclopramide manufacturers, in turn, argued that they could not be held liable under state failure to warn claims as federal law precludes them from instituting label changes that differ from the labels of their name-brand counterparts. In a 5-4 decision with the majority opinion written by Justice Thomas, the Supreme Court sided with the generic pharmaceutical manufacturers. The Court held that it is impossible for generic drug manufacturers to comply with both federal labeling requirements and state law duties to warn, as generic drug manufacturers are required by federal law to keep their labels the same as the name brand drugs they copy.
The Court held that generic pharmaceutical manufacturers are prohibited from using the “Changes Being Effected” (CBE) process to unilaterally strengthen their labels with new safety information, and that generic manufacturers are prohibited from using so-called “Dear Doctor” letters to warn physicians of risks that are not contained in the FDA-approved labeling of the name-brand drug. The Court acknowledged the argument that, upon learning of potential safety problems, generic drug manufacturers have a duty to ask the FDA “to work toward strengthening the label that applies to both the generic and brand name equivalent drug.” However, the Court determined that even if generic manufacturers had a such a duty under federal law, which the Court did not decide, satisfying that duty would not, in turn, satisfy the manufacturers’ duty to warn under state law. The Court explained that it is possible that if the generic drug manufacturers asked the FDA for help, the FDA may have decided there was enough information to support a label change. In the event the FDA negotiated with the brand-name manufacturer to institute a label change, then a change potentially made to both the name brand and generic labeling is not a basis for avoiding impossibility preemption. “If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force.” The Court concluded that “the pre-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties. When the ‘ordinary meaning’ of federal law blocks a private party from independently accomplishing what state law requires, that party has established pre-emption.”
The Mensing decision is a significant win for generic drug manufacturers, as it effectively eliminates all state law claims that such manufacturers failed to provide adequate warnings. The U.S. market for generic pharmaceuticals has grown tremendously since 1984 when requirements for bringing generic drugs to market were relaxed. As Justice Sotomayor wrote in her dissenting opinion, approximately 75 percent of all prescriptions in this country are filled with generic drugs.
Given the widespread use of generic drugs, the Mensing decision is likely to draw criticism from consumer groups. There is some tension between Mensing and Supreme Court’s 2009 decision in Wyeth v. Levine, in which the Court rejected a name-brand pharmaceutical manufacturer’s claim that it could not comply with both federal labeling requirements and its duty to warn under state law. The difference between whether a consumer does or does not have a viable claim may well depend on whether the pharmacist chose to fill his or her prescription with a generic versus a name-brand drug.
Contact: Tracy Van Steenburgh