Split Supreme Court Says Generic Drug Warning Claims Are Preempted

WASHINGTON, D.C. - (Mealey's) State tort law failure-to-warn claims involving the generic drug metoclopramide are preempted by federal law, the U.S. Supreme Court said June 23 in a 5-4 ruling (Pliva, Inc., et al. v. Gladys Mensing, No. 09-993, Actavis Elizabeth LLC v. Gladys Mensing, No. 09-1039, Actavis, Inc. v. Julie Demahy, No. 09-1501, U.S. Sup.).


Generic drug makers Pliva Inc., Actavis Elizabeth LLC and Actavis Inc. appealed rulings by the Fifth and Eighth Circuit U.S. Courts of Appeals that the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act do not prevent the manufacturers from adding new warnings to labels of generic drugs.  Gladys Mensing and Julie Demahy each claim that they developed tardive dyskinesia, a permanent movement disorder similar to Parkinson's disease, after taking the generic drug metoclopramide (brand name Reglan) for long-term treatment of gastroesophageal reflux disease. 

Writing for the majority, Justice Clarence Thomas said the court must defer to the Food and Drug Administration's opinion that generic metoclopramide makers cannot use the changes being effected (CBE) process to add stronger tardive dyskinesia warnings to the drug label or send out "dear doctor" letters about the risk. 

The majority said it would have been impossible for the manufacturers to both ask the FDA for assistance in changing the metoclopramide label and comply with state tort law requirements.  It said federal law bars them from changing their labels while state law would require them to do so. 

The majority cited the supremacy clause of the U.S. Constitution in affirming federal preemption. 

Justice Thomas said the majority's decision does not conflict with the court's ruling on preemption of state law failure-to-warn claims involving prescription drugs in Wyeth v. Diana Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774).  "We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated," he wrote, adding that the FDA can change its regulations and Congress can change the law. 

Chief Justice G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. joined in the entire majority opinion.  Justices Thomas and Anthony M. Kennedy did not join in Part III-B-2 relating to supremacy clause contingency. 

Justice Sonia Sotomayor dissented and was joined by Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan.  Justice Sotomayor said the majority "invents new principles of pre-emption law out of thin air to justify its dilution of the impossibility standard" and effectively rewrites Levine.   

Justice Sotomayor said the majority's decision affects 75 percent of all prescription drugs, which are generic, and leads to many "absurd consequences" not intended by Congress.  She noted that consumers are protected only if they get brand-name drugs - providing the brand-name drugs are still made and health insurance will pay for them. 

Generic drug makers, Justice Sotomayor said, "will remain unincentivized to uncover safety risks." 

[Editor's Note:  Full coverage will be in the July 7 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-110707-008Z.  For all of your legal news needs, please visit] 

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