Legal Insights, a quarterly publication produced by the Issue Management Group of Chartis Insurance, published an article in the Fall 2011 edition written by Austin partner Leslie Benitez titled “U.S. Supreme Court Holds State Law Failure-to-Warn Claims Impliedly Preempted.”
The article provides an in-depth analysis of Pilva v. Mensing, the recent Supreme Court ruling which held that state law failure-to-warn claims against generic drug manufacturers are impliedly preempted by federal regulations because federal regulations prevent generic manufacturers from unilaterally changing their products’ labeling. Federal law conflicts with and preempts contrary state law duties requiring generic manufacturers to update risk warnings on labels. As the court explained, “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.” The Mensing decision reversed previous decisions made by the Eighth and Fifth Circuit Courts of Appeals.
Claiming that they had suffered neurological injuries from taking the generic prescription drug metoclopramide (also sold under the brand name Reglan), the Plaintiffs in Mensing sued the generic manufacturers alleging warning labels for the generic drug failed to provide their physicians with adequate information about the potential health risks associated with the drug. The generic manufacturers argued that federal statutes and FDA regulations required them to use the same safety and efficacy labeling as the brand-name equivalent drug, Reglan, and that it was impossible for them to comply with both federal labeling laws and state tort laws that require different labels.
As the Court further explained, the 1984 Drug Price Competition and Patent Term Restoration Act, also referred to as the Hatch-Waxman Amendments, permits manufacturers to gain approval from the FDA for generic drugs by showing equivalence to an already-approved reference listed drug without the need for duplicating clinical trials already performed on the brand-name product. That law also provides that generic drug labeling must be “the same” as the brand name drug. The Supreme Court ultimately agreed that the federal regulatory scheme barred the plaintiff’s tort claims and ruled in favor of the generic manufacturers. The Mensing decision is notable for its impact on the viability of tort claims against generic drug manufacturers and for its interpretation of implied preemption principles.
Please click here to read the full article.