Zofran (ondansetron) is an anti-nausea medication that is approved to treat nausea and vomiting caused by surgery, chemotherapy, and radiation. However, it is sometimes prescribed off-label to treat morning sickness in pregnant women. Zofran use during pregnancy has been linked to birth defects including cleft palate, cleft lip, and congenital heart defects.
Off-Label Marketing and Kickbacks
On July 2, 2012, the Justice Department announced that GlaxoSmithKline LLC (GSK) agreed to plead guilty and pay $3 billion in, what was at the time, the largest health care fraud settlement in U.S. history. Part of that $3 billion went to resolve GSK’s liability for off-label marketing of Zofran to treat morning sickness in pregnant women and paying kickbacks to health care professionals to promote and prescribe the drug off label.
Several studies have found an increased risk of birth defects associated with Zofran use in pregnancy, including a two-fold increase in risk of cleft palate and a two-fold increased risk in heart defect.
A study, published in February, 2013, which looked at data from a Danish registry, found no link between Zofran and an increased risk of birth defects. However, In August, 2013, another group of researchers looked at a larger set of data from the same registry and found that Zofran was associated with a 30% increased risk in birth defects overall and a doubled risk of heart defects.
If you believe that your child has been harmed Zofran, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find a lawyer near you.