A California couple filed a Zofran birth defects lawsuit against GlaxoSmithKline (GSK), alleging the drug maker off-label marketed its anti-nausea drug Zofran (ondansetron) as a pregnancy morning sickness relief even it knew Zofran was unsafe for use by pregnant women and could cause serious birth defects.

Plaintiffs Margaret and Nathaniel G. claim that Margaret was prescribed and began taking Zofran early in her first trimester of pregnancy to alleviate severe morning sickness. Their son, born in 2008, was born with heart defects and experienced heart failure when he was less than four months old and underwent open heart surgery when he was just 16 weeks old.

According to the Zofran lawsuit, Margaret contends that had she known the truth about Zofran’s unreasonable risk of harm allegedly concealed by GSK, she never would have taken Zofran and her son never would have been injured.

Margaret and Nathaniel claim that their son’s birth defects were directly caused by prenatal exposure to Zofran. They are seeking compensatory and punitive damages, and equitable relief from the injuries to their son.

Zofran Use In Pregnancy

Zofran is not approved for use during pregnancy but is frequently used off-label as a treatment for morning sickness.  The FDA classifies the drug as a “Pregnancy Category B” medication, which means while animal studies have not found evidence of a risk, there is no certainty as to the safety of Zofran in pregnancy for humans.

Yet despite its potential risks, the FDA has not pulled Zofran from the market and while doctors have the legal duty to inform all pregnant women of the risks associated with the anti-nausea drug prior to prescribing it, many do not.

This may stem from the fact that Zofran isn’t created specifically for nausea and vomiting. Its main function is to treat those with cancer, as surgery, chemotherapy, and radiation can cause nausea. However, doctors are still legally allowed to prescribe the medication how they wish.

The most common types of Zofran birth defects include musculoskeletal anomalies, mouth deformities, such as cleft lip and palate, and heart defects

Zofran Birth Defects Lawsuits

Although some pregnant women have found that Zofran serves as welcome remedy for morning sickness symptoms, many have filed birth defect lawsuits against GlaxoSmithKline.  These lawsuits allege the drug manufacturer promoted Zofran use in pregnancy to capitalize on the vast market created by women suffering from morning sickness during pregnancy.

The Zofran Birth Defects Lawsuit is Case No. 4:15-cv-03130-DMR, in the U.S. District Court for the Northern District of California.