A woman from Alabama is suing GlaxoSmithKline on behalf of herself and her son, alleging her child suffers from birth defects caused by the company’s drug Zofran.

The woman says she took Zofran during her pregnancy as a treatment for morning sickness starting in January 2006. Later that August, she gave birth to a son with serious birth defects.

According to her Zofran birth defect lawsuit, the most immediately apparent defects were a deformed palate and supernumerary digits. Nine months later, her baby began having seizures and doctors later diagnosed him with a seizure disorder. Testing revealed the son has a chromosomal defect that neither of his parents have, according to the Zofran lawsuit.

Since then, the boy has developed glaucoma, and at the age of 8 is still nonverbal and shows slow reaction time. Doctors expect he will live with these problems for the rest of his life. According to the Zofran birth defects lawsuit, the child’s mother now attributes these birth defects to the Zofran she took early in her pregnancy.

Zofran History

Zofran has been on the market since 1998, when the FDA first approved it as a treatment for nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. Although the FDA has never approved Zofran to treat nausea and vomiting related to pregnancy morning sickness, many doctors have prescribed Zofran for this off-label use, expecting it to ease some of the effects of early pregnancy.

Results of Zofran birth defects studies have been mixed, but some research has found that Zofran may increase the risk of certain birth defects.

A study published in Clinical Pharmacokinetics in 2006 revealed that Zofran, studied under its generic name ondansetron, can and does cross the placenta and reaches the embryo when taken in the first trimester of pregnancy.

In 2012, a birth defects study of every woman who gave birth in Denmark between 1997 and 2010 found an increase in “the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of ondansetron in the first trimester of pregnancy.”

An analysis of Swedish childbirth and prescription registries in 2014 revealed a statistically significant increase in the risk of heart birth defects, particularly cardiac septum defect.

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.”

Zofran Investigation and Settlement

In 2001, two whistle-blowers notified GlaxoSmithKline that their employees were marketing certain drugs illegally. Federal prosecutors in Colorado began investigating GlaxoSmithKline in 2004 for improper marketing practices.

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.