Terbutaline Lawsuit: The Case Against Drug Manufacturer Novartis


In December 2017, TBM, a law firm out of San Diego, won a ruling by the California Supreme Court that a brand-name drug manufacturer (in this case, Novartis) can be held responsible for injuries suffered by those who took a generic version of the same drug. The ruling is a major victory for victims of dangerous pharmaceutical drugs and became the only standing state supreme court decision to rule in favor of plaintiffs on that issue.

What did Novartis do wrong?

The litigation is against Novartis, a major pharmaceutical manufacturer, for Brethine (generic name terbutaline), an asthma drug that was prescribed off-label to pregnant women in order to keep them from going into premature labor. TBM alleged that Novartis not only knew the drug was popular with OB/GYNs for preventing premature labor, but also that it caused fetal brain damage when administered to pregnant women. Despite that knowledge, Novartis chose not to update the drug’s warning label with that information. Instead, the company sold the product line to another manufacturer who, predictably, also failed to update the drug’s label. The necessary warning did not appear on the drug’s label until a decade later, after the FDA stepped in to mandate stronger warnings against the use of Brethine (terbutaline) with pregnant women.

Why was the ruling so monumental?

At least 80% of the prescription drugs taken in the United States are generic drugs. And yet, the U.S. Supreme Court previously held that makers of generic drugs cannot be sued for inadequate warning labels, citing the fact that federal law requires their warning labels to be identical to those used by the makers of the corresponding brand-name drug.

Victims of inadequately labeled generic drugs responded to that decision by suing brand-name manufacturers instead. They argued that if the brand-name manufacturers were responsible for the content of all warning labels associated with that drug – whether brand-name or generic – then the brand-name manufacturers should be held liable for injuries caused by deficient warning labels. That argument had, unfortunately for consumers, not fared well in the nation’s courts and had been rejected in at least 90 published decisions throughout the United States.

But a California Supreme Court broke with those decisions and ruled in favor of TBM’s clients, holding that brand-name manufacturers who knew or should have known about undisclosed warnings on a drug’s label can be sued even by someone who took a generic form of that drug.

Who is most directly impacted by this important decision?

While TBM’s victory at the California Supreme Court is a big win for all victims of dangerous pharmaceutical drugs, the decision will have the biggest impact on children in California who were injured by in utero exposure to Brethine (terbutaline), which was frequently prescribed to pregnant women between 2002-2011. While any child who was exposed to the drug may have been injured as a result, the damaging effects of Brethine (terbutaline) are most obvious in fraternal twins, where the odds of both twins developing autism or brain damage in the absence of a harmful chemical like Brethine (terbutaline) are astronomically low.

Fresh off their victory at the California Supreme Court, TBM is now reviewing cases of fraternal twins who (1) suffer from any type of cognitive or social delay and/or autism diagnosis and (2) whose mothers took the drug in California in the past 15 years while pregnant.

If you feel that your children may have been affected by this drug, please visit for more information.

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