GlaxoSmithKline, the manufacturer of the drug Zofran, has been listed as the defendant in another Zofran birth defect lawsuit. A family in Montana has filed a complaint alleging that Zofran, taken by the mother during her pregnancy to alleviate her pregnancy-related nausea, caused her daughter’s cleft palate and cleft lip.
The lawsuit, filed in the United States District Court of Montana Billings Division under case number 1:15-cv-00026-SPW-CSO, alleges that while the U.S. Food and Drug Administration approved Zofran for use in cancer patients receiving chemotherapy and radiation, the drug was not approved for use in pregnant women. Furthermore, GlaxoSmithKline never conducted a clinical trial on humans before actively marketing the drug to pregnant women and their doctors. The lawsuit specifically states that “GlaxoSmithKline’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.”
The mother, in this case, was given Zofran during her first trimester to treat her nausea. In 1998, she gave birth to her daughter who was diagnosed with a cleft lip and cleft palate. Per the Centers for Disease Control and Prevention , a cleft lip and cleft palate occur when the mouth and lip do not form properly during development in the womb. Children with these orofacial clefts can have problems with speech development, feeding, and routinely suffer from ear infections.
Since her birth, the Montana child has had to undergo ten surgeries in attempts to correct her cleft lip and palate. Additional allegations indicate that due to her birth defect, she is unable to enjoy a “normal life at home and at school”.
The Growing Movement Against Zofran
To date, thirty-four lawsuits against GlaxoSmithKline have been filed, all alleging that the drug Zofran caused birth defects after the pregnant mothers took it to treat nausea. The birth defects noted include cleft lip, cleft palate, tetralogy of fallot heart defect, ventricular septal defect (VSD), atrial septal defect (ASD), and renal defects.
Despite its category B label from the FDA, which indicates that there have been no studies in pregnant women to determine the safety level of the drug, GlaxoSmithKline promoted Zofran to doctors as safe to use. In 2012, GlaxoSmithKline settled a lawsuit with the Department of Justice which included allegations that it promoted “off-label” use of several medications, including Zofran.