By Jamie Jung -
On June 23, 2011, the US Supreme Court handed down a decision on Pliva, Inc. v. Mensing, 564 U.S. __ (2011). This case dealt with the issues of federal preemption with regard to generic drug manufacturers. The Court ruled that lawsuits by affected individuals against generic manufacturers of drugs under state laws could not be brought because those state laws were preempted by federal regulations.
Individuals who had taken a generic drug called metoclopramide, intended to treat digestive disorders, developed severe and irreversible neurological problems. The individuals brought suit under state law against the generic manufacturers of the drug, for failing to comply with state law requirements for better warnings.
The Court found that allowing the individuals to sue the generic manufacturers for failure to warn made it impossible for them to comply with both state and federal law. The FDA, the federal agency that regulates the manufacture of name-brand and generic drugs, requires that the generic drugs carry the same label as the name-brand version of that drug. State law, however, imposes a duty upon every manufacturer to adequately and safely label their products. Thus, if generic manufacturers were aware that a drug should have carried a different warning than the one provided by the name-brand drug, under state law, it was required to warn consumers. However, in doing so, the generic manufacturers would then be in violation of federal law for having a different label than the name-brand version.
The US Constitution provides in Article VI that federal law shall be “the supreme law of the land” where there is a conflict with state law. Thus, the Court found that in this case, federal law preempted the state law; the manufacturers of generic drugs cannot be sued for damages under state law for failing to warn of possible risks.
Justice Sotomayor wrote a dissenting opinion, which was joined by Justices Ginsberg, Breyer and Kagan. She wrote, “The Court today invokes the doctrine of impossibility pre-emption to hold that federal law immunizes generic drug manufacturers from all state-law failure-to-warn claims because they cannot unilaterally change their labels. I cannot agree. We have traditionally held defendants claiming impossibility to a demanding standard: Until today, the mere possibility of impossibility had not been enough to establish pre-emption.” She went on to say that “As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.”