To date, thirty-four lawsuits have been filed against GlaxoSmithKline, the manufacturer of Zofran, all alleging that the use of the drug during pregnancy resulted in defects in unborn children. One of the most recent lawsuits, filed in he United States District Court of the Southern District of Illinois under case number 3:15-cv-00902, alleges that the child in question suffers from a diminished quality of life due to his birth defect.
The mother, in this case, was prescribed Zofran during both the first and second trimester of her pregnancy to treat morning sickness. Her child, a son, was born in 2009. Not long after his birth, doctors diagnosed him with a ventricular septal defect (VSD). A VSD is an opening the cardiac wall which separates the two lower chambers of the heart. Per the American Heart Association, while children with a small opening may not notice clinical signs and symptoms, children with a large opening can suffer from complications. These complications can include difficulty breathing, high blood pressure in the lungs, difficulty feeding in infants, and delayed growth.
Much like the complications description from the AHA, the lawsuit states that the child’s quality of life has been diminished because he has “experienced severe development delay, cannot run or play hard with other children, and has exhibited emotional challenges due to his injury that was caused by his mother’s ingestion of Zofran.” The mother is noted to have two other children who were born without birth defects – during each of those pregnancies the mother did not take Zofran.
Zofran and “Off-Label” Use
Approved by the FDA to treat nausea in patients being treated for cancer with chemotherapy and radiation, Zofran was never approved for use in pregnant women, in part because GSK never performed clinical trials in pregnant human patients. Nonetheless, GSK advertised the drug to the medical community, as well as the public, as safe to use for the treatment of morning sickness.
In recent years, the U.S. Department of Justice filed a lawsuit against GSK. This lawsuit alleged that GSK promoted the “off-label” use of several medications, including Zofran. In 2012, GSK opted to settle for a total of three billion dollars.