The mother who filed a new Zofran lawsuit says her child was born with Zofran birth defects after she took the drug to treat her morning sickness.

Plaintiff Stacy T. is suing on her own behalf and on behalf of her child D.L., who’s still a minor child. Stacy says in her Zofran birth defects lawsuit she started taking Zofran early in her first trimester and kept taking it until February 2007, about five months before D.L. was born.

Even while still in utero, D.L. was diagnosed with a cleft lip and a cleft palate, the Zofran lawsuit says. She claims he has needed speech, occupational and physical therapy to deal with the alleged Zofran birth defects.

Despite multiple surgeries, the Zofran lawsuit says, D.L. continues to exhibit physical malformations. Stacy further alleges he has suffered dental problems and developmental delays that interfere with speaking and eating.

Zofran Birth Defects

Zofran is a drug used to prevent nausea and vomiting. It’s also known by its generic name ondansetron. It works by blocking the action of the neurotransmitter serotonin, which can cause nausea and vomiting.

Since first being approved for sale in 1991, Zofran is now approved as a treatment only for symptoms associated with surgery, chemotherapy and radiation therapy. Doctors may occasionally prescribe Zofran for motion sickness, but the FDA has never evaluated the drug for safety and effectiveness in that context.

While it’s not improper for a doctor to prescribe a drug for such an “off-label” use, pharmaceutical companies are forbidden from promoting a drug for any use other than those for which the FDA has approved the drug.

But that’s exactly what Stacy says Zofran’s manufacturer GlaxoSmithKline did. Starting in January 1998,  the Zofran lawsuit says, GSK marketed Zofran as a “wonder drug” for women needing to treat nausea and vomiting associated with pregnancy.

Yet not only had the FDA not approved Zofran for that use, the Zofran lawsuit says, but GSK had not even done any clinical studies of its own to determine Zofran’s safety and effectiveness for that use. Stacy accuses GSK of purposely avoiding such studies out of fear their results might reduce sales of Zofran.

Thanks to that allegedly illicit marketing campaign by GSK, Zofran became the most frequently prescribed drug for morning sickness in the early 2000s, the Zofran birth defects lawsuit says.

Even though GSK did not actively conduct its own studies, Stacy believes the scientific evidence of Zofran birth defects was sufficient to put GSK on notice that they were a problem.

The Zofran lawsuit cites animal studies from the 1980s that revealed intrauterine toxicity and deaths. Starting in the early 1990s, she says, GSK started receiving dozens of reports of congenital anomalies associated with Zofran.

Stacy argues that Zofran manufacturer GlaxoSmithKline failed to properly warn her and her physician about the risks associated with taking Zofran for morning sickness. She says that if she had been properly informed, she would not have taken Zofran and her son would not have been born with birth defects.

The Zofran Lawsuit is filed under Case No. 1:15-CV-759 in the U.S. District Court for the Southern District of Ohio.