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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200

Zofran Lawsuits – Birth Defects

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Zofran is the marketed name of Ondansetron, an anti-nausea medication that is sometimes prescribed to women in the first trimester of their pregnancy to treat morning sickness.  The manufacturer is alleged to have encouraged doctors to prescribe this powerful medication to pregnant women although it was never approved for that use by the FDA. Zofran has been associated with serious birth defects including heart defects, cleft palate and cleft lip.

Three years ago, a study found a two-fold increase in the risk of cleft palate defects in children of women who took Zofran while pregnant.  Another study in 2014 found the drug causes a 30 percent overall increased risk of congenital malformations.  Women who took Zofran while they were pregnant have been filing lawsuits against GlaxoSmithKline.  The lawsuits allege that the manufacturer was aware that high concentrations of the drug could transfer through the placental barrier to the fetus during pregnancy.  Further alleged is the fact that post-marketing reports to the company demonstrated a prevalence of birth defects in newborns.  However, the manufacturer continued its off label marketing of Zofran as a safe and effective treatment for common morning sickness.

Recently the lawsuits of families claiming the anti-nausea drug caused birth defects in their children were consolidated to a single court in the District of Massachusetts.  The U.S. Judicial Panel on Multidistrict Litigation found sufficient evidence that the cases involved similar facts and a similar defendant – drug maker GlaxoSmithKline.  The cases were consolidated in a process called multidistrict litigation (MDL) in order to increase efficiency and decrease costs. MDL’s are different from class-action lawsuits in that each plaintiff still files an individual lawsuit.  The consolidation of Zofran lawsuits to a single court is a big win for plaintiffs.

The lawyers at DJD are presently involved in the Zofran litigation.  If you have questions, feel free to call us at 866-327-2952.