GlaxoSmithKline is facing another Zofran birth defects lawsuit, this time from a mother in California.

Background on Zofran Lawsuit

Plaintiff Vanessa B. says she took ondansetron, a bioequivalent of Zofran, as a treatment for morning sickness. In September 2009, she gave birth to a child with a cleft palate. The child has undergone one surgery so far and will require more surgery in the future, the Zofran birth defects lawsuit claims.

Vanessa now attributes the child’s cleft palate to the Zofran she took during her pregnancy. She alleges her child has no family history of cleft palates, implicitly ruling out a genetic cause for the condition. Vanessa claims that GlaxoSmithKline hid the risk of Zofran birth defects, and that if she had known about these risks then she never would have taken Zofran.

Zofran is a nausea medication that has been on the market since 1991. The FDA has approved Zofran to treat nausea that follows surgery, chemotherapy, or radiation therapy. Zofran has not been FDA-approved for treating any other type of nausea.

Zofran Birth Defects Allegations

Vanessa’s Zofran lawsuit alleges that as early as 1998, GlaxoSmithKline has improperly promoted Zofran as a treatment for morning sickness despite a lack of FDA approval for this specific use.

She says GlaxoSmithKline marketed Zofran as a morning sickness remedy without having conducted a single study to determine the safety and efficacy of Zofran in pregnant women. In fact, claims Vanessa, GlaxoSmithKline excluded pregnant women from the trials used to earn FDA approval for Zofran.

To show that the defendant knew about the risks of Zofran birth defects, Vanessa cites studies from as far back as the 1980s. Animal studies conducted then show that Zofran could and did pass from the mother to the child through the placenta, the plaintiff states. These studies also reported evidence of “toxicity, intrauterine deaths and malformations in offspring,” she claims.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

The manufacturer began receiving reports of birth defects in human Zofran patients in 1992, according to the Zofran birth defects lawsuit. To date, the company has received 200 birth defect complaints, yet they have never revealed these reports to pregnant women or their physicians.

Vanessa’s Zofran lawsuit also mentions a 2012 settlement between GlaxoSmithKline and the U.S. Department of Justice that addresses allegations of off-label promotion of some of GSK’s drugs, one of which was Zofran.

Prosecutors had alleged that GlaxoSmithKline “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea).”

They had also alleged that the company had misrepresented the safety and efficacy of Zofran for morning sickness and that they had illegally compensated health care providers to prescribe Zofran to their patients.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Vanessa is raising claims of negligence, misrepresentation, fraud, and violation of California’s Consumer Legal Remedies Act.

This Zofran Birth Defects Lawsuit is Case No. 8:15-CV-01552, in the U.S. District Court for the Central District of California.