Zofran Birth Defect Lawsuit

Stuart Talley of Kershaw, Cook & Talley created this video to provide additional information regarding the Zofran lawsuit. Zofran is a drug approved by the Food and Drug Administration (FDA) in 1991. It was initially approved for use in cancer patients suffering from nausea and vomiting secondary to chemotherapy and radiation therapy. It is now approved for nausea and vomiting from surgery and anesthesia. There are allegations despite this limited approval GlaxoSmithKline (GSK), the manufacturer of Zofran, was promoting Zofran for unapproved uses. Specifically, there are allegations Zofran was promoted for use in pregnant women experiencing morning sickness, or nausea and vomiting of pregnancy.

Many pregnant women are widely prescribed this drug. There are allegations and several complaints stating the reason for this is that the manufacturer was improperly promoting and marketing off-label uses for Zofran to the physicians. The United States government sued GlaxoSmithKline for these practices in United States of America v. GlaxoSmithKline LLC. GlaxoSmithKline plead guilty and paid a $3 Billion fine to resolve fraud allegations and failure to report safety data.

The reason for current litigation against Zofran involve studies indicating the use of Zofran in pregnancy, specifically the first trimester, increase the risk of birth defects. Birth defects potentially linked to Zofran include oral clefts (i.e. cleft lip and palate) and congenital heart abnormalities (e.g. atrial septal defect and ventricular septal defects). There are some studies illustrating no association between Zofran and birth defects. Our firm is further investigating this case. Our attorneys are contacted by women who took Zofran in their first trimester of pregnancy, and have a child with birth defects.


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