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High Court Rules Generic Drug Companies Not Liable Under State Law

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In a 5-4 vote, the U.S. Supreme Court overturned a U.S. appeals court decision which allowed generic drug companies to be sued under state law over allegations that they failed to provide adequate label warnings.

The justices were presented with the interesting issue of whether makers of generic drugs, whose products must mimic the warning labels of the corresponding brand-name drugs and who cannot alter those labels, should also be sued under state law for failing to warn users about the risks posed by their products,” reported the New York Times.

Justice Clarence Thomas agreed with the majority, concluding that “federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus pre-empt state claims.”

A similar issue was decided in Wyeth v. Levine, when the Court addressed whether federal law pre-empts state law in personal injury claims against drug manufacturers. The high court held that federal law did not preempt the plaintiff’s state claim; thus, allowing makers of brand-name drugs to be sued under state law for failing to adequately warn consumers.

In the present case, the companies relied on the fact that federal law requires generic drugs to have the same labels as their brand-name equivalent. They argued federal law barred such lawsuits since the U.S. Food and Drug Administration (FDA) approved the drugs; therefore, making it illegal for the companies to alter drug labels.

Unlike generic drug companies, brand-name drug makers are permitted to sometimes change the labels on their products without FDA permission, says the Times.

The high court recognized this issue and agreed the generic drug makers “had no choice but to use the same drug labels as the brand manufacturer,” reported Reuters.

The lawsuit was brought by women who took the generic equivalent of Reglan. The plaintiffs claimed defendants, Teva Pharmaceutical, UDL Laboratories and Actavis Inc., failed to warn consumers of increased risks of developing a neurological movement disorder, reported Reuters.

When the plaintiffs started taking the drug, the FDA approved label said that ‘“therapy longer than 12 weeks has not been evaluated and cannot be recommended;’” however, in 2004, it was changed to say therapy should not exceed 12 weeks. In 2009, the FDA ordered that a specific warning about the movement disorder be added to Reglan and its generic brand equivalent, metoclopramide.

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