This case is one of many consolidated in a multi-district litigation proceeding arising out of claims that the use of the drug Zofran by pregnant women caused birth defects. Plaintiffs alleged that their use of Zofran during pregnancy caused congenital heart defects in their children.
Background on the Zofran lawsuit
Defendant GlaxoSmithKline manufactures the drug ondansetron under the brand name Zofran. Zofran was first approved in 1991 to prevent post operative nausea and vomiting related to anesthesia. At that time, it was also alleged that GSK had promoted it as an “off-label” pregnancy medication for nausea and vomiting [morning sickness] related to pregnancy.
Plaintiffs in this multidistrict litigation allege that Zofran was in fact unsafe for use in pregnant women, and that in utero exposure to Zofran caused birth defects in children born to mothers who took the drug. All four plaintiffs bring eight counts against defendant GSK arising out of congenital heart defects suffered by their children and allegedly caused by the plaintiffs’ use of name-brand Zofran during pregnancy.