564 U.S. 604 (2011)
In 1980, the Food and Drug Administration first approved metoclopramide tablets under the brand name Reglan to treat digestive tract conditions such as diabetic gastroparesis and gastroesophageal reflux disorder.1 Five years later, generic manufacturers including petitioners PLIVA, Inc., Actavis Elizabeth, LLC, and Actavis, Inc. began producing the generic version of the drug.2 Respondents Gladys Mensing and Julie Demahy were prescribed Reglan in 2001 and 2002 respectively but received generic metoclopramide from their pharmacists.3
Evidence accumulated that long-term metoclopramide use can cause tardive dyskinesia, a severe neurological disorder, with studies showing up to 29 percent of patients who take the drug for several years developing the condition.4 Warning labels for the drug were strengthened and clarified several times.5 In 1985, the label was modified to warn that tardive dyskinesia may develop and that therapy longer than 12 weeks had not been evaluated.6 In 2004, the brand-name Reglan manufacturer requested and the FDA approved a label change to add that therapy should not exceed 12 weeks in duration.7 In 2009, the FDA ordered a black box warning stating that treatment with metoclopramide can cause tardive dyskinesia and should be avoided for longer than 12 weeks in all but rare cases.8
After taking the generic drug as prescribed for several years, both Mensing and Demahy developed tardive dyskinesia.9 In separate state-court tort actions in Minnesota and Louisiana, they sued the generic drug manufacturers that produced the metoclopramide they took, alleging that long-term use caused their disorder and that the manufacturers were liable under state tort law for failing to provide adequate warning labels despite mounting evidence of the risk.10
The manufacturers urged that federal statutes and FDA regulations preempted the state tort claims by requiring the same safety and efficacy labeling for generic metoclopramide as was mandated for Reglan.11 The district courts dismissed the claims, but the Courts of Appeals for the Fifth and Eighth Circuits reversed, holding that the claims were not preempted.12 The Supreme Court granted certiorari, consolidated the cases, and now reverse each.13
Whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims?14
Under the Supremacy Clause, U.S. Const., Art. VI, cl. 2, state law is preempted when it is impossible for a private party to comply with both state and federal requirements.15 Impossibility exists where federal law imposes a duty of sameness on generic drug labels that prevents manufacturers from independently altering those labels to satisfy a state-law duty to provide adequate warnings.16
Yes. State tort law in Minnesota and Louisiana imposed a duty on the Manufacturers to provide adequate warnings once they knew or should have known of the high risk of tardive dyskinesia from long-term metoclopramide use. This duty required a stronger label than the one actually used.17 Federal regulations, however, required generic labels to remain identical to the brand-name Reglan label at all times and barred unilateral changes through the CBE process or Dear Doctor letters.18
Because the Manufacturers could not independently do under federal law what state law required, compliance with both was impossible.19
Federal law preempts the state-law failure-to-warn claims against the generic drug manufacturers, and the judgments of the Fifth and Eighth Circuits are reversed.20
Related opinions on this issue
Justice Sotomayor dissented on the ground that the majority invented a new and unduly expansive test for impossibility preemption.21 She maintained that the FDA permits and may require generic manufacturers to propose label changes when they identify safety risks.22 The Manufacturers had not shown it was impossible to invoke that mechanism in time to prevent the injuries.23 In her view, the proper standard requires defendants to demonstrate that the FDA would have rejected any proposed change, a burden the Manufacturers failed to carry.24
She further argued that the presumption against preemption in traditional state health-and-safety regulation should have applied with full force.25 The decision creates an arbitrary distinction between brand-name and generic consumers.26 It undermines the Hatch-Waxman goal of treating generic and brand-name drugs as equivalent.27