The Zofran cases in the multidistrict litigation (MDL) consolidated in the U.S. District Court for the District of Massachusetts are now estimated at 160, and more are expected. Zofran MDL Plaintiffs allege that the anti-nausea medication, manufactured by GlaxoSmithKline, has caused caused serious birth defects.
Zofran was approved by the U.S. Food and Drug Administration specifically to treat individuals suffering from nausea and vomiting after undergoing chemotherapy, radiation, or anesthesia. After FDA approval, however, GSK began to market the drug “off label” to OB/Gyns and the general public as a morning sickness treatment even though Zofran was never approved by the FDA to treat pregnant women or tested for safety for expectant mothers.
Many women who used Zofran to combat nausea during the first trimester of their pregnancy are now alleging that Zofran caused birth defects and an increasing number of studies support the connection. Plaintiffs in the Zofran MDL are claiming that Zofran caused birth defects such as cleft lip and palate, clubfoot, kidney defects, atrial septal defect and ventricular septal defect, transposition of the greater vessels, tetralogy of fallot and respiratory disorders.