Novartis accused of promoting asthma drug for preterm labor despite brain risk

Novartis NOVN has been hit with a lawsuit by people with autism and their mothers alleging the drugmaker illegally promoted an asthma drug for treatment of preterm labor despite knowing it was ineffective and could cause abnormal fetal brain development.

The lawsuit, filed last week in Alameda County, California state court, also names the University of California, alleging that a now-deceased professor helped Novartis promote terbutaline for the dangerous off-label use.

The five plaintiffs include twins born in 1993 and a man born in 2002, along with their mothers. They accuse Novartis and the university of negligence and intentional misrepresentation and are seeking unspecified money damages.

A Novartis spokesperson said the company was reviewing the complaint. The university did not respond to a request for comment.

Novartis sold terbutaline in the United States as an asthma treatment under the brand name Brethine from 1976 to 2001. In the late 1970s, according to the lawsuit, some doctors began experimenting with using it to stop preterm labor, under the theory its muscle-relaxing properties could prevent uterine contractions.

The lawsuit alleges that in 1983, a Novartis executive sent an internal memo noting terbutaline's frequent use for preterm labor and recommending that the company either do a clinical study to determine its safety or warn against it.

Instead, the plaintiffs said, the company began actively promoting the new use, including by hiring Russell Laros, a professor at the University of California, San Francisco to author a study supporting it.

The drug became commonly used for so-called maintenance tocolysis, meaning it was administered multiple times a day for weeks to prevent preterm labor, the lawsuit said.

Beginning in 1985, according to the lawsuit, some animal studies began to show that terbutaline might affect fetal brain development. Meanwhile, other studies showed that the drug was no more effective than a placebo for maintentenance tocolysis, the plaintiffs said.

In 1993, the U.S. Food and Drug Administration invited Novartis to apply for formal approval for the drug to be used for preterm labor.

The company did not do so, and the plaintiffs say internal communications show executives decided there was no financial incentive to seek the approval because terbutaline was already the leading drug used for preterm labor, and a formal approval would expose it to lawsuits for adverse effects.

After Novartis' patent expired in 2001, the drug became available as a generic, carrying the same label as the brand name version.

In 2011, responding to a citizen petition and the animal studies, the FDA began requiring a "black box" warning, used for the most serious risks, against using terbutaline for maintenance tocolysis.

Studies published in 2011 and 2016 showed an association between terbutaline and autism, the complaint said.

The case is Del Valle et al v. Novartis Pharmaceuticals et al, Superior Court of California, County of Alameda, No. 24CV072453.

For plaintiffs: Christopher Rodriguez, Andrew Bluth and Benjamin Siminou of Singleton Schreiber