The makers of Zofran, an anti-nausea medication sometimes prescribed “off-label” to treat morning sickness, are facing a growing number of personal injury lawsuits brought by parents who claim they were not warned of serious birth defects associated with use of Zofran during pregnancy.

One of the latest of these Zofran birth defects lawsuits was filed by Arkansas parents who claim the drug caused their son to be born with a cleft lip.

The couple, Cory and Jill C. filed their Zofran birth defect lawsuit in the U.S. District Court for the Eastern District of Arkansas last month. The Zofran lawsuit is based on claims that their son was born with a partial cleft lip in 2012 as a result of his mother’s use of Zofran during pregnancy.

According to the Zofran lawsuit, the maker of Zofran, GlaxoSmithKline (GSK), failed to warn of the risk of birth defects associated with this medication. They claim that their son underwent surgery to fix a facial deformity caused by the drug when he was a mere infant and that he will have permanent facial scarring.

They also say the sedations required for medical procedures to treat his cleft lip also left him with developmental and speech delays, and that he now requires speech therapy, physical therapy and developmental therapy, as a result.

Zofran Birth Defect Studies

In the 1980s, GSK conducted animal studies that revealed evidence of toxicity, intrauterine deaths and congenital birth defects in offspring exposed to Zofran in the womb, and further indicated that ondansetron (the active ingredient contained in Zofran) passed through the placental barrier of pregnant mammals to fetuses, according to the Zofran lawsuit.

The plaintiffs claim that a later study performed on human patients confirmed that Zofran readily crosses the placental barrier and exposes fetuses to the medication. However, GSK failed to disclose this information to the public or medical communities.

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.”

Jill further alleges in the Zofran birth defects lawsuit that had she known the truth about Zofran’s unreasonable risk of harm, she never would have taken the drug and her son would not have been injured. She is seeking compensation for negligence, strict products liability, fraud, breach of express and implied warranties, and unfair or deceptive acts or practices.

Zofran  ‘Off-Label’ Marketing

The U.S. Food and Drug Administration (FDA) approved Zofran in 1991 for use in cancer patients to treat nausea and vomiting associated with certain types of surgery and chemotherapy.

Zofran is not approved for use during pregnancy as a morning sickness treatment, but is sometimes prescribed “off-label” for this purpose. While it is not illegal for doctors to prescribe drugs “off-label,” it is against federal law for drug makers to promote or endorse their products for unapproved uses.

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.

In addition to cleft lip and cleft palate, Zofran has been tied to other birth defects including heart defects, kidney defects, and foot and limb defects.