California Supreme Court Weighs Holding Brand Names Liable For Genetic Drug Problems

The California Supreme Court will consider whether brand name drug manufacturers should be held liable for failure to warn about risks associated with their medications when injuries are caused by generic equivalents, under a theory known as “innovator liability”. 

On June 8, the state’s highest court granted a review to an appeals court decision handed down in March, which found that Novartis could be held liable for injuries caused by a generic version of Brethine, an asthma drug that a mother claims caused her children to develop autism after exposure during pregnancy.

The mother used generic terbutaline while she was pregnant in 2007, for prevention of preterm labor. This was an unapproved use marketed by generic manufacturers, according to the lawsuit. As a result of side effects of terbutaline exposure before birth, the mother alleges that she gave birth to twins both diagnosed later with autism.

According to allegations presented against Novartis, which developed and sold the brand-name version known as Brethine, the drug maker knew or should have known about the pregnancy risks and provided label warnings about the impact the medication may have on fetal development before it sold the rights to the medication in 2001.

Currently, generic drug makers are required to carry the same label warnings provided with the medications they are copying, even if they are aware that the brand drug warnings fail to provide adequate information about drug risks. As a result of this inability to independently alter the warning labels, generic drug makers have successfully argued before the U.S. Supreme Court that they should not be subject to failure to warn lawsuits brought on behalf of individuals injured by medications they sold. However, this has left many individuals injured by known risks after using a generic drug with no recourse.

The U.S. Supreme Court essentially provided generic drug makers immunity in failure to warn lawsuits in a controversial 2011 ruling, known as Pliva v. Mensing.

California is one of the few states to consider allowing brand name drug companies to be held liable injuries caused by generic equivalents, due to inadequate label warnings.

The Alabama Supreme Court previously upheld such “innovator liability” in a 2014 ruling, but that decision was overridden by the state legislature last year.