An Alabama mother filed a Zofran lawsuit against GlaxoSmithKline, alleging that the anti-nausea drug was fraudulently marketed “off-label” to pregnant women with morning sickness, even though it was aware the drug was linked to an increased risk of heart defects and other birth defects.

Plaintiff Keyanna W. was prescribed generic Zofran to alleviate morning sickness symptoms beginning early in her first trimester of pregnancy and continued taking the drug into her third trimester, her lawsuit says. Her daughter, born in 2014, was subsequently diagnosed with multiple congenital heart defects.

According to the Zofran lawsuit, Keyanna’s medical records state there is no family history of heart defects or any indication of genetic reason for her daughter’s condition. Keyanna claims that her daughter’s birth defects were caused by prenatal exposure to Zofran.

Had she known the truth about Zofran and the risk of birth defects and harm to her child, she says she would never have taken Zofran.

Zofran During Pregnancy

Zofran is not approved for use during pregnancy but is frequently used off-label as a morning sickness treatment. The FDA classifies Zofran as a “Pregnancy Category B” medication, meaning animal studies have not found evidence of birth defect risks, but it is not clear if using the anti-nausea drug is safe.

Though medical research is still uncertain of the timing and dosage that may increase or decrease the risk of birth defects for mothers taking Zofran, studies have found there is a distinct possibility of newborns being born with three types of heart defects, including ASD (Atrial Septal Defect), VSD (Ventricular Septal Defect), and heart murmur, when a pregnant woman uses Zofran during pregnancy.

Despite its potential risks, the FDA has not stopped Zofran from being prescribed. However, doctors have the legal duty to inform all pregnant women of the risks associated with Zofran prior to prescribing it. Zofran was created to treat nausea among those with cancer, becasue surgery, chemotherapy, and radiation can often cause nausea.

Doctors are legally allowed to prescribe the medication how they wish, even for “off-label” (or non-FDA approved) uses but drug companies are not allowed to promote off-label 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.

The Zofran Heart Defects Lawsuit is Case No. 1:15-cv-00503-KD-M in the U.S. District Court for the Southern District of Alabama.