No Labeling Liability for Generic Drugmakers

(CN) - Generic drug manufacturers will not have to face claims that they failed to warn consumers about harmful side effects associated with their products, the Supreme Court ruled Thursday, finding that federal drug regulations pre-empt such actions.

Though the high court ruled in 2009 with Wyeth v. Levine that federal law does not bar patients from filing state-law tort claims against brand-name drugmakers, the court reached a different conclusion for generic drug manufacturers on Thursday.

The four dissenting justices called out the majority on this inconsistency.

"As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug," according to the dissent authored by Justice Sonia Sotomayor. T"he Court gets one thing right: This outcome 'makes little sense.'"

In support of its conclusion, the majority noted that "brand-name and generic drug manufacturers have different federal drug labeling duties."

"A brandname manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label," Justice Clarence Thomas wrote for the majority. "A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's."

Thursday's decision reverses the opinions of two federal appeals courts, which had said federal law did not pre-empt lawsuits filed two women who claimed to have developed the neurological disorder tardive dyskinesia after taking generic versions of Wyeth's name-brand digestive drug Reglan (metoclopramide).

The women, Gladys Mensing and Julie Demahy, claimed that the drugs are more dangerous than their labels indicate. The 8th and 5th Circuits, respectively, ruled that the women could sue units of Mylan, Teva Pharmaceuticals and Actavis, but affirmed dismissal of the charges against the name-brand defendants.

"It was not lawful under federal law for the Manufacturers to do what state law required of them," Thomas wrote. "And even if they had fulfilled their federal duty to ask for FDA assistance, they would not have satisfied the requirements of state law.

"If the Manufacturers had independently labels to satisfy their state-law duty, they would have violated federal law," the ruling continues. "Taking Mensing and Demahy's allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same."

Thomas and another member of the majority, Justice Anthony Kennedy, did not join in a section of the lead opinion that parses the Supremacy Clause, paying particular attention to a "non obstante provision" that says federal law is supreme "any [state law] to the Contrary notwithstanding."

Justices Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan signed Sotomayor's dissent.

"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.

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