GlaxoSmithKline is facing a growing number of personal injury lawsuits brought by parents who claim they were not warned of the possibility of serious birth defects associated with the use of the anti-nausea medication Zofran, during pregnancy.

A recent Zofran birth defect lawsuit was filed by California parents who claim the drug caused their daughter to be born with serious heart defects.

The couple, Katherine and Matthew M. filed their Zofran birth defect lawsuit in the U.S. District Court for the Northern District of California. The Zofran lawsuit is based on claims that their daughter was born with severe heart defects, specifically an atrial septal defect in 2007 as a result of her mother’s use of Zofran during pregnancy.

According to the lawsuit, the maker of Zofran, GlaxoSmithKline (GSK), failed to warn of the risk of birth defects associated with this anti-nausea medication.

They claim their daughter underwent a cardiac catheterization and placement of a septal occluder at age 4 and will require continuous medical monitoring and treatment due to her exposure to Zofran.

The couple also claims they were unaware of the dangerous risks associated with Zofran and accuse GSK of fraudulent marketing and for illegally promoting Zofran off-label as a morning sickness treatment when it was never approved for that use.

Studies Link Zofran To Birth Defects

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.

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.”

Katherine and Matthew further allege in the Zofran birth defect lawsuit that had they known about the risk, Katherine would not have taken the drug and their daughter would not have suffered heart defects.

Zofran Never Approved for Morning Sickness

The 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 heart defects, Zofran has been tied to other birth defects including cleft lip and palate, club foot, and kidney defects.

The Zofran Birth Defect Lawsuit is Case No. 3:15-cv-04474-LB in the U.S. District Court for the Northern District of California.