In a lawsuit, filed on October 3, 2016, a mother from Oneida, New York, claims that the anti-nausea drug Zofran active ingredient caused her son to develop cleft palate and cleft lip while in the womb.
The case was filed in the U.S. District court of Massachusetts, where more than 280 other Zofran lawsuits have been consolidated, the Montgomery County (Pennsylvania) Legal Examiner reports. Pretrial proceedings are underway under the supervision of federal judge F. Dennis Saylor, IV.
Over the summer, the parties agreed to a procedure for new families to be added to the litigation. Parents of a child with birth defects attributed to the mother’s use of Zofran during pregnancy will not have to prepare a lengthy individual complaint. Instead, they can work from a master complaint that brings together the core allegations about Zofran, the Legal Examiner reports. Each family adds the details of their child’s injuries.
Zofran lawsuits allege a link between Zofran (ondansetron) and cleft palate. In 2012, researchers at Harvard and Boston University found that women who took Zofran during pregnancy to treat morning sickness were more than twice as likely to deliver children with cleft. The Zofran label, however, does not carry a warning of the possible risk for cleft palate.
Zofran lawsuits allege that drug is responsible for birth defects including heart defects, cleft lip and cleft palate, transposition of blood vessels, respiratory stress disorder, and kidney defects.
The New York mother says she was prescribed a generic version of Zofran, which she took during the first and second trimesters of pregnancy. Her child, identified as P.B. in court documents, was born with “a cleft hard palate [and] unilateral right cleft lip,” court records indicate. The child is now four years old. The mother is seeking $10 million in compensation, according to the Legal Examiner. She says she and her son have suffered “severe and permanent pain and suffering, mental anguish [and] medical expenses.”
Zofran has been widely prescribed to treat morning sickness, though ondansetron does not have Food and Drug Administration approval for this use. Ondansetron is approved to treat nausea and vomiting after chemotherapy, radiation therapy, and anesthesia. But parents who have filed Zofran lawsuits say GlaxoSmithKline quickly identified pregnant women as a potential patient population for Zofran. A doctor is permitted to prescribe a drug for any use he or she thinks will benefit the patient, but under federal law, a drug company may not promote a drug except for FDA-approved uses.
In 2012, the federal government accused GlaxoSmithKline of illegally marketing Zofran for use during pregnancy, despite never having studied the drug’s effects on fetal development. Parents claim that the company has been aware of Zofran’s birth defect risks for two decades, but failed to warn the public or the medical community.