The Supreme Court of the United States recently held that state law failure-to-warn claims brought against manufacturers of generic pharmaceutical products are impliedly pre-empted by federal drug regulations. This reversed decisions from the Eighth and the Fifth Circuit Courts of Appeals. In Pilva, Inc. v. Mensing, 2011 WL 2472790, 564 U.S. ____ (2011) the plaintiffs claimed that they suffered neurological injuries as a result of taking the prescription drug Metoclopramide, which is also sold under the brand name Reglan. They alleged that the drugs warnings were inadequate to advise their physicians about the potential risk of harm. The defendants asserted that federal law pre-empted those claims and argued that federal statutes and ethics regulations required them to use the same safety and efficacy labeling as the brand-name equivalent drug, and that it thus was impossible for them to comply both with federal law and any state tort law duty to use a different label.
The Supreme Court held that because federal regulations prevent generic manufacturers from unilaterally changing their products labeling, federal law conflicts and pre-empts contrary state-law duties requiring generic manufacturers to update their warnings to account for new risk information.