In a lawsuit brought against Novartis AG, the California Supreme Court ruled Dec. 21 that the maker of the branded medicines bears the responsibility of providing adequate warning labels for its product, Brethine, as well as its generic equivalent, terbutaline.
According to Reuters, the lawsuit claimed that two twin children were diagnosed with developmental delays and autism after their mother took a prescribed generic version of Brethine to suppress premature labor during pregnancy in 2007.
Federal law requires generic medicine makers to use warning labels of their branded versions, voiding generic manufacturers from being sued for inadequate label warnings, according to a 2011 ruling by the U.S. Supreme Court. The suit was thus brought up against Novartis, who manufactured Brethine until December 2001 when it sold the rights to aaiPharma Inc.
The plaintiffs claim that Novartis knew or should have known Brethine's risk to fetal brain development if used by pregnant women since the label used by the generic manufacturers and aaiPharma was the same that Novartis had used.
Novartis asserted that its duty to warn customers did not include patients who were prescribed the generic version of Brethine and for those who were prescribed the drug after the company divested it. The court disagreed with Novartis' argument, ruling that the company could still be sued after it sold the medicine because of its failure to update the warning label.