Drugmakers liable for harm caused by bad warning labels
Consumer advocates scored a major victory over drug companies Thursday when the California Supreme Court said pharmaceutical manufacturers are responsible for harm caused by defective warnings in labels on generic versions of their products.
Federal law allows only a brand-name manufacturer, and not the companies that sell the identical drugs as generics, to write the labels that warn of potential side effects, the court said. As a consequence, the justices said, customers who relied on faulty labels when they took generic drugs should be allowed to sue the manufacturer.
That portion of the ruling was unanimous. The justices also ruled 4-3 that a drug’s original manufacturer, who later sells the brand-name rights to another company, remains responsible for illnesses caused by defects in its original warning label that harm users of generic drugs.
Most commonly used pharmaceuticals are sold generically, usually at lower prices than brandname makers charge. Companies obtain the right to sell drugs as generic from the government once the manufacturer’s patent expires.
The original brandname manufacturer has a legal duty “to warn of the risks about which it knew or reasonably should have known,” a duty that also applies to generic sales of the identical product, Justice Mariano Florentino Cuéllar said in the ruling. That duty does not end when the manufacturer sells the rights to the product, he said, since “economic interests and simple inertia” may discourage the new owner from changing a defective label.
Dissenting from that part of the ruling, Justice Carol Corrigan said the original manufacturer has no control over the new owner’s actions and should not be held responsible for its failure to update a warning label.
The case comes from San Diego County, where a family sued the pharmaceutical giant Novartis for birth defects in their twins.
The children’s mother was prescribed terbutaline, a generic form of the brand-name drug Brethine, to prevent premature labor during her pregnancy in 2007. Her children were not born prematurely but were diagnosed with autism at age 5.
Brethine, a muscle relaxant, was developed as an asthma drug but has been commonly used to prevent premature labor, based on a 1976 study. But the court said later studies have questioned its effectiveness and indicated possible interference with fetal brain development.
Such possible harms were not mentioned on the label issued by Novartis, which manufactured Brethine until 2001 and then sold the rights to a company called aaiPharma. That company did not change the label, and Leslie Brueckner, a lawyer for the family, described it as a “fly-bynight” operation that had disappeared by the time the suit was filed.
Brueckner, with a nonprofit called Public Justice, said the ruling has potential nationwide importance.
“Over 90 percent of all prescription drugs sold in this country are generic,” she said. Federal law bars customers from suing generic drug companies over warning labels, Brueckner said, and courts elsewhere have ruled that commercial manufacturers can’t be sued for harm caused by generic drugs they didn’t sell.
The California court recognized that manufacturers like Novartis “write the labels, and it’s the labels that cause the injury,” Brueckner said. She said the ruling also “stops companies like Novartis from tossing the hot potato of an inadequately labeled drug to another company.”
Novartis said it disagreed with the court’s decision “to hold the company potentially responsible for injury allegedly caused by the use of another manufacturer’s product after Novartis had sold the brand name product to a subsequent manufacturer.” The company said it would continue to defend itself against the family’s “unfounded claims” in further proceedings in the lawsuit.
The case is T.H. vs. Novartis, S233898.