Drug Company Liable In Warning-Label Case

Pharmaceutical companies may be liable for harm their drugs cause if the warning labels are defective, even if the labels are on the generic versions of their medications, the California Supreme Court held Thursday.

The unanimous ruling marks a major victory for consumer advocates.

Federal law explicitly limits responsibility to provide an adequate warning label to the brand-name manufacturer for both generic and brand-name drugs. Accordingly, the consumers who say they were injured by relying on an inadequate label on a generic should have the right to sue the maker of the brand-name version of the drug.

The case stems from a lawsuit against Novartis Pharmaceuticals Corp. over prescription use of terbutaline, a generic form of Novartis’ Brethine. The drug is an asthma drug that is also prescribed in an “off label” use to suppress premature labor during pregnancy. In this case, two children were born at full term after their mother took the drug but later had developmental delays and autism.

The lawsuit alleged the terbutaline label should have included a warning about these risks, which had been discovered in studies of the drug on rats and in humans, according to the court.

In a more controversial section of the decision, the court held by 4-3 vote that the drug’s original manufacturer remains responsible for illnesses caused by the drug even if the brand-name rights are sold to another company.

Novartis stopped making Brethine and sold all its rights in 2001, six years after the plaintiffs’ injuries. The court found that Norvartis still had a legal duty to disclose its risks in the drug’s warning label.

Case: T.H. v. Novartis Pharmaceuticals, No. S233898




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