Zofran is a drug that was approved by the FDA for use by patients who suffer from extreme nausea after a surgical operation, or after cancer treatment such as radiation therapy or chemotherapy. However, GSK, the manufacturer, actively advertised the drug to the medical community and pregnant women as a solution for morning sickness during pregnancy.
Now, several studies have suggested a potential link between Zofran and severe childbirth defects. Specifically, there have been many reports of defects such as cleft lip, cleft palate, atrial septal defect, ventricular septal defect, hole in the heart, kidney malformations, clubbed foot, and many more. The studies suggest that these defects were caused by the mother taking Zofran (Ondansetron) during the first trimester of pregnancy for morning sickness.
Studies have shown that the first trimester is when crucial tissues of the mouth and heart are fused. Any drugs that penetrate the placental barrier, such as Zofran, can then cause malformations.
Lawsuits are being filed across the country by parents of children who suffered birth defects alleging that Zofran was the cause, and had they known about the risks of taking Zofran they would not have taken the drug, and their child would not have been born with a birth defect.
The manufacturer of Zofran denies that Zofran caused the birth defects, and denies that they illegally marketed the drug off-label to mothers and the medical community. However, GSK has settled a lawsuit with the government where there were allegations that GSK illegally promoted the drug off-label, and allegations that they gave kickbacks to doctors to prescribe Zofran, among other drugs, to patients.
Several lawsuits have been filed across the country to date and several thousand more are expected to be filed in the coming year.
If you or a loved one delivered a baby with a birth defect, and you believe Zofran may have been the cause, then please do not hesitate to contact us. We are here 24/7 to listen and advise you of your legal options.