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California Says Drugmakers Can Be Held Liable for Mislabeling Generics

— December 29, 2017

California Says Drugmakers Can Be Held Liable for Mislabeling Generics

The California Supreme Court recently ruled that brand-name drug manufacturers could held liable for mislabeling generics, and can be sued in the state for failing to warn users about the risks of taking generic versions of their medications.  Plaintiffs’ attorney Leslie Brueckner said, “This is just a huge victory for public health and safety, and this victory will be felt nationwide.”  She added, “The decision is hugely significant because it opens the courthouse doors to millions of generic drug victims who are injured by unsafe drugs.”

The state’s Supreme Court’s decision followed a lawsuit centered on two twin children diagnosed with developmental delays and autism after their mother took a generic version of Brethine while pregnant in order to suppress premature labor.  The father of the children sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while the woman was consuming the drug.

Image Courtesy of Mark Terry,

Under a U.S. Supreme Court ruling in 2011, generic drug companies cannot be sued for mislabeling and failing to provide adequate label warnings about potential side effects.  This is because federal law requires them to use the brand-name versions’ labels.  Therefore, the father chose to go after Novartis.

“Under current federal law, generic manufacturers are entirely immune from suit for injuries caused by their inadequate labels, because the brand-name manufacturers control the label,” Brueckner said. “Despite this fact, most courts have refused to allow generic consumers to sue brand-name manufactured for injuries caused by mislabeled drugs, leaving them totally unprotected.  Today’s decision rectifies that gross unfairness and gives consumers of generic drugs the right to seek justice for their injuries.  It will also protect public health and safety, by giving brand-name manufacturers a strong incentive to update their labels when new risks emerge after their drugs go generic.”

Novartis argued its duty to warn consumers has to do with its brand-name drugs and it was not responsible for any mislabeling of generics.  The company appealed and had the support of the U.S. Chamber of Commerce.  However, in the recent decision, Justice Mariano-Florentino Cuéllar nominated to his position by Governor Jerry Brown, wrote that brand-name manufacturers are the only entities who can issue an adequate warning label.

“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brand-name manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Cuéllar wrote.  “In such circumstances, 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.”

The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale.  In a dissenting opinion, Associate Justice Carol Corrigan, appointed by Arnold Schwarzenegger, contended, “When a drug manufacturer acquires a new product line, it assumes the responsibility to update the warning label if and when reasonable evidence demonstrates a link to a serious health hazard.  Predecessor manufacturers have a right to presume successors will perform their duty and follow the law.”

Novartis indicated it vehemently disagrees with the court’s decision.  The company said in a statement it is reviewing the opinion and “will continue to defend against the plaintiffs’ unfounded claims.”


California Court Exposes Drug Makers to Additional Liability

Brand-Name Drugmakers Liable for Poor Labels on Generics in California


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