An Alabama mother and father have filed a Zofran lawsuit against GlaxoSmithKline alleging the company’s anti-nausea medication caused their son’s congenital heart defect. The claims claims the mother used Zoran during her pregnancy to help with morning sickness. When the couple’s child was born in 2013, he was diagnosed with atrial septal defect, a severe birth complication that has required multiple surgeries.
Zofran, an antiemetic used to treat nausea and vomiting in patients who have undergone certain surgeries or therapies, is not approved by the U.S. Food and Drug Administration (FDA) for treatment of morning sickness. Nonetheless, doctors often prescribe the drug off-label to pregnant women experiencing nausea and vomiting. Unfortunately, Zofran has been linked in studies from as early as 2006 to an increased risk of birth defects in children whose mothers took the drug during pregnancy.
As in other Zofran lawsuits, the Alabama plaintiffs argue that GlaxoSmithKline knowingly promoted Zofran for the off-label use of treating morning sickness. Furthermore, the Zofran lawsuit argues GlaxoSmithKline was aware of the birth defect risk associated with Zofran, having received more than 200 adverse event reports starting as early as 1992. Yet, the company has failed to update the warning label on Zofran to reflect this birth defect risk.
Over 100 Zofran birth defect lawsuits have already been centralized in a multidistrict litigation established earlier this year. If you or a loved one gave birth to a child with a congenital defect, you may be eligible to join the growing Zofran multidistrict litigation. Contact Lopez McHugh today to discuss your possible case free of charge with a pharmaceutical lawyer.