Inadequate Warning Claims Against Generic Drugs OK Under State Law

January 11, 2010

A federal appeals court said Friday that patients may sue generic drugmakers under state law for failing to provide adequate warnings about their drugs’ potential side effects, extending a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs.

The U.S. Fifth Circuit Court of Appeals agreed with a lower court that Actavis Inc. could face claims by a woman who said it should have alerted her to risks of metoclopramide, a drug that treats symptoms, including heartburn, nausea and vomiting. The drug’s name brand is Reglan.

U.S. Circuit Judge Patrick Higginbotham said the Fifth Circuit — covering Texas, Louisiana and Mississippi — joined one other circuit court that had considered whether patients could raise “failure-to-warn” claims under state law for generic drugs, or whether federal law could preempt claims.

He noted that the issue has divided a “rapidly growing” number of district courts. Division among federal courts can increase the odds of eventual Supreme Court review.

Generic drugs account for seven in 10 prescriptions filled in the United States, the court said.

In the case, Julie Demahy sued Actavis under Louisiana law, saying she developed a neurological disorder after the company failed to alert her to literature about the risks of using metoclopramide and failed to change the drug’s label.

Last March, a divided Supreme Court, in a case involving Wyeth’s antinausea drug Phenergan, let a patient pursue a state-law failure-to-warn claim concerning the adequacy of the drug’s label.

Saying that ruling, known as Wyeth v. Levine, “shadows” claims involving generic drugs, Higginbotham in a 39-page opinion said that “federal law provides no remedy for an injured customer” in this case.

He added that there was not enough evidence to show Congress clearly wanted to preempt state law, or let the federal Food & Drug Administration do so.

“To hold otherwise would leave us with the bizarre conclusion that Congress intended to implicitly deprive a plaintiff whose doctor prescribes a generic drug of any remedy, while under Levine, that same plaintiff would have a state-law claim had she only demanded a name brand drug instead,” the judge wrote.

A lawyer for Actavis did not immediately return a call for comment. Efforts to reach Demahy’s lawyer were unsuccessful. Actavis is based in Reykjavik, Iceland.

(Reporting by Jonathan Stempel; editing by Andre Grenon)

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