Pharma Can Be Sued Over Generic Drug Warnings

The California Supreme Court ruled that Novartis can be held responsible for injuries caused by versions of its drugs made by generic manufacturers. This type of liability has been a contentious issue ever since the U.S. Supreme Court ruled in 2011 that generic drug makers cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the branded drug’s labeling.

The California lawsuit was brought by the children of a woman who took a generic version of an asthma medication called Brethine, a drug that Novartis marketed until 2001 and then sold to AAI Pharma six years later. In the lawsuit, the plaintiffs claimed the drug, which was prescribed to the woman in 2007 to stop premature labor, caused her children to suffer brain injuries. The plaintiffs accused Novartis of failing to adequately warn about these risks.

Novartis argued it did not have a responsibility for the warning label that was on generic versions of drugs it did not make and no longer sold brand-name versions of.

“It is at least plausible that a successor manufacturer may choose to undertake only a cursory investigation of the medical literature, on the assumption that the prior manufacturer must have done a more thorough inquiry during the period that it was responsible for maintaining the warning label,” Associate Justice Mariano-Florentino Cuellar wrote in the majority opinion.

A similar case is pending in West Virginia. Elsewhere, lower courts have sometimes ruled in favor of consumers, but those decisions typically do not have pending implications beyond those cases.

Source: STAT News, December 22, 2017.