Zofran, an anti-emetic, was first used by the medical community in the early 1990’s to treat nausea and vomiting in patients undergoing chemotherapy treatments or patients that experienced nausea after having been administered anesthesia. The U.S. Food and Drug Administration had approved Zofran for these two uses, however, it did not approve Zofran to treat morning sickness in pregnant women.
GlaxoSmithKline, the makers of Zofran, proceeded to market the drug “off-label” to doctors as a treatment for morning sickness despite the lack of approval from the FDA. GSK has not performed any studies or clinical trials in humans to show that Zofran was safe to use while pregnant. Since it first began its marketing campaign to OB/GYN’s GSK has received over 200 reports of birth defects in children born to women who took Zofran during their pregnancy. Those birth defects include atrial septal defect (ASD), ventricular septal defect (VSD), cleft lip, cleft palate, and kidney defects.
The Alabama Lawsuit
The most recent Zofran lawsuit, filed in the United States District Court Northern District of Alabama Southern Division under case number 2:15-cv-01233-JEO, alleges that an Alabama child was born in 2014 with congenital heart and kidney defects because his mother was prescribed Zofran during her first trimester.
The child, a son, was found to have Hypoplastic Left Heart Syndrome while still in the womb. The child was also diagnosed with a kidney defect after his birth, although the lawsuit does not provide the specific name of this defect. According to the infant’s doctor, there is no known genetic cause for either defect and there is no known family history of either condition. As a result of his life-threading heart defect, the child has had to suffer through several surgeries. His first was an open heart procedure when he was just three days old. Then, at six months of age, he had an open heart transplant which resulted in the need for extended hospitalization and medical care.
The lawsuit alleges that these birth defects are the direct result of the mother ingesting Zofran during her first trimester. The complaint states that “Had the plaintiff known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she would never have ingested Zofran and/or its generic bioequivalent.”
This latest lawsuit is just one of many, all alleging Zofran caused birth defects.