A new lawsuit filed in Illinois alleges that the birth defect discovered in a young boy was secondary to the use of Zofran by his mother during her pregnancy.
Aug 28, 2015 /prREACH/ -- Zofran, an anti-nausea medication, has been approved by the U.S. Food and Drug Administration for use in patients with nausea relating to chemotherapy or radiation since 1991. However, the FDA never approved the drug for use in pregnant women, and in fact labeled it a Category B drug, which means that there have not been enough human studies to show that the drug was safe for use in pregnant patients.
Despite the lack of approval, GlaxoSmithKline, the manufacturer of Zofran, proceeded to market the drug “off-label” to pregnant women and their doctors, as a treatment for morning sickness. By 2000, GSK had been informed of 32 cases of birth defects in mothers who had taken Zofran during their pregnancy. Despite these adverse events, no warning was issued to the medical community or the public.
In 2012, GSK settled a lawsuit brought against them by the U.S. Department of Justice, which alleged that GSK had promoted the “off-label” use of several drugs, including Zofran. In the settlement, GSK agreed to pay three billion dollars to the federal government.
On August 13th, 2015, a new lawsuit was filed under case number 3:15-cv-00902 in United States District Court of the Southern District of Illinois. The lawsuit alleges that because a mother was prescribed Zofran during both her first and second trimester, her son, who was born in 2009, developed a cardiac birth defect. The child was diagnosed with a ventricular septal defect shortly after birth. As a result, the lawsuit alleges 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 lawsuit further alleges that there is no known genetic cause of the ventricular septal defect, pointing out that the mother has two other children who are perfectly healthy. During those two pregnancies, she did not take Zofran or it’s generic version, Ondansetron. The mother stated in the complaint that, had she “known about the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she never would have taken Zofran, and her child never would have been injured.”
To date, thirty-four total lawsuits have been filed against GSK alleging that Zofran caused birth defects. The birth defects detailed in the lawsuits include atrial septal defects, ventricular septal defects, heart murmurs, cleft palates, cleft lips, and renal defects. In several cases, the birth defect has proved fatal to the child.