Plaintiffs Jamie and Brad B. of Illinois are suing GlaxoSmithKline, the makers of Zofran anti-nausea medication, over their son’s birth defects.

The couple says that Jamie took Zofran for morning sickness during her first trimester of pregnancy. She then gave birth to a son who was later diagnosed with a congenital heart condition known as Tetralogy of Fallot. She and Brad now argue that their son’s congenital heart defect was caused by the Zofran Jamie took while pregnant.

Jamie and Brad  allege that GlaxoSmithKline were aware of the risks of Zofran birth defects yet knowingly concealed that information from patients and physicians. According to the Zofran birth defects lawsuit, GlaxoSmithKline had conducted animal studies in the 1980s that revealed “toxicity, intrauterine deaths, and malformations in offspring” following ingestion of Zofran during pregnancy.

The couple also says that GlaxoSmithKline began receiving reports of possible Zofran birth defects as early as 1992. They also cited several epidemiological studies published in 2013 and 2014 demonstrating that women who took Zofran early in pregnancy were at a significantly greater risk of giving birth to a child with birth defects, particularly congenital heart defects.

Jamie says she was unaware of any risk of birth defects when she took Zofran, and if she had known the alleged risks she never would have taken Zofran during her pregnancy.

What is Tetralogy of Fallot?

Tetralogy of Fallot is a set of four different cardiovascular defects that occur together: a ventricular septal defect, thickening of the right ventricle wall, displacement of the aorta that causes redirection of blood flow within the heart, and narrowing of the valve where blood exits the heart to approach the lungs.

In the case of Jamie and Brad’s son, his Tetralogy of Fallot has already required one open heart surgery, and further need for surgery is expected. Jamie and Brad say that any type of infection could put the child at risk for serious injury.

They say that, among other possible complications, this condition threatens their son with the risk that tissue adjacent to the ventral septal defect will detach and block an artery, a condition that could be fatal if not repaired with emergency surgery within the hour.

Zofran Promoted For Off-Label Use

Zofran was originally FDA-approved for U.S. sales in 1991. It’s now approved for treatment of nausea associated with chemotherapy, radiation therapy, and recovery from surgery. However, it’s not uncommon for doctors to prescribe Zofran for “off-label” use as a treatment for morning sickness.

While doctors legally are allowed to make such off-label prescriptions, pharmaceutical companies are forbidden from promoting drugs for any use other than those approved by the FDA. Jamie and Brad allege that GlaxoSmithKline did exactly that for Zofran. The couple claims that as early as January 1998, GlaxoSmithKline unlawfully promoted Zofran as a treatment for morning sickness, even though it had never been approved for that use by the FDA.

The Zofran Birth Defects lawsuit is Case No. 3:15-cv-0797, in the U.S. District Court for the Southern District of Illinois.