Pliva, Inc. v. Mensing

131 S.Ct. 2567 (2011)

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Nature of the Case

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Facts

Metoclopramide (Reglan) is commonly used to treat digestive tract problems such as diabetic gastroparesis and gastroesophageal reflux disorder. Long-term metoclopramide use can cause tardive dyskinesia, a severe neurological disorder. Studies have shown that up to 29% of patients who take metoclopramide for several years develop this condition. Warning labels for the drug have been strengthened and clarified several times. In 2009, the FDA ordered a black box warning--its strongest--which states: “Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. . . . Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.” Mensing (Ps) were prescribed Reglan in 2001 and 2002, respectively. Both received generic metoclopramide from their pharmacists. After taking the drug as prescribed for several years, both women developed tardive dyskinesia. Ps claimed that “despite mounting evidence that long-term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label,” none of the Ds had changed their labels to adequately warn of that danger. Ds urged that federal law pre-empted the state tort claims. Federal statutes and FDA regulations required them to use the same safety and efficacy labeling as their brand-name counterparts. This means, they argued that it was impossible to simultaneously comply with both federal law and any state tort-law duty that required them to use a different label. Ds lost. The Courts of Appeals for the Fifth and Eighth Circuits rejected Ds’ arguments and held that the claims were not pre-empted. The Supreme Court granted certiorari.