Facts of the Case
Five years after the Food and Drug Administration (FDA) first approved metoclopramide, a drug commonly used to treat digestive tract problems, under the brand name Reglan, generic manufacturers such as petitioners also began producing the drug. Because of accumulating evidence that long-term metoclopramide use can cause tardive dyskinesia, a severe neurological disorder, warning labels for the drug have been strengthened and clarified several times, most recently in 2009. Respondents were prescribed Reglan in 2001 and 2002, but both received the generic drug from their pharmacists. After taking the drug as prescribed for several years, both developed tardive dyskinesia. In separate state-court tort actions, they sued petitioners, the generic drug manufacturers that produced the metoclopramide they took (Manufacturers). Each respondent alleged, inter alia, that long-term metoclopramide use caused her disorder and that the Manufacturers were liable under state tort law for failing to provide adequate warning labels. In both suits, the Manufacturers urged that federal statutes and FDA regulations pre-empted the state tort claims by requiring the same safety and efficacy labeling for generic metoclopramide as was mandated at the time for Reglan. The Fifth and Eighth Circuits rejected these arguments, holding that respondents’ claims were not pre-empted.
Can generic drug makers be sued for not warning about potentially dangerous side effects on their drug labels even when they follow federal rules that only require their labels to match those of their brand-name equivalents?
No. The Supreme Court reversed the lower court order in an opinion by Justice Clarence Thomas. Justice Kennedy joined the opinion in part. We defer to the FDA’s interpretation of its CBE and generic labeling regulations, Justice Thomas wrote. Meanwhile, Justice Sonia Sotomayor dissented, joined by Justices Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan. 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, Sotomayor wrote.
- Citation: 564 US _ (2011)
- Granted: Dec 10, 2010
- Argued: Mar 30, 2011
- Decided Jun 23, 2011