Zofran Lawsuit Parties Adopt Master Form Complaints, as Birth Defect Litigation Proceeds

Zofran cleft palate birth defectMore than 260 Zofran birth defects lawsuits continue to move forward in the federal multidistrict litigation now underway in U.S. District Court, District of Massachusetts. The parties have jointly submitted proposed Master Long and Short Form Complaints.

“The use of Master Long and Short Form complaints is standard procedure in a multidistrict litigation, and will streamline the process for filing a claim in this proceeding,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP.

Zofran Birth Defects Allegations

Zofran is an anti-nausea medication that has been approved for use in post-op surgery patients or those undergoing certain cancer treatments. The lawsuits accuse GlaxoSmithKline of concealing hundreds of birth defects reports involving babies who were exposed to the drug in-utero. The complaints also claim that as early as the 1980s, Glaxo was aware of animal studies suggesting that the active ingredient in Zofran could cross the placental barrier in mammals. The placental transfer of Zofran in humans was also confirmed in a study involving 41 pregnancies, according to the lawsuits.

Zofran has never been approved to treat pregnancy-related nausea and vomiting. Yet according to an analysis recently published in the American Journal of Obstetrics and Gynecology, around 1 million expectant women are prescribed the medication or its generic equivalents every year for this purpose. Zofran lawsuits point out that in 2012, GlaxoSmithKline agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that involved a number of its medications. Among other things, the company had been accused of illegally promoting Zofran as an off-label treatment for expectant mothers suffering from pregnancy-related nausea and vomiting.


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