Concerns raised by plaintiffs in Zofran birth defect lawsuits echo those of parents a generation earlier, whose children were injured by the drug thalidomide.
Free Confidential Lawsuit Evaluation: If you or a loved one was born with a defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
Parents across the U.S. have filed lawsuits against GlaxoSmithKline (GSK) alleging that the anti-nausea medication Zofran (generic: ondansetron) caused birth defects in their children. The drug, which was approved by the FDA in 1991, was marketed “off-label” as a “safe” and “effective” treatment for morning sickness, a condition frequently experienced during the 1st trimester of pregnancy. However, Zofran has never been approved for this purpose, nor has GSK performed any human clinical trials showing that it was safe to be used under these conditions.
Plaintiffs have alleged that the use of Zofran during pregnancy resulted in a wide range of birth defects including cleft palate, cleft lip, respiratory distress syndrome, kidney defects, ventricular septal defect (VSD), atrial septal defect (ASD), clubfoot and more.
These defects are similar to those suffered by children exposed to thalidomide decades earlier. Like Zofran, thalidomide was hailed as a “wonder drug,” and prescribed off-label to pregnant women for morning sickness. Unfortunately, use of the drug in this capacity resulted in numerous adverse birth defects including blindness, phocomelia, and cleft palate.
Like plaintiffs in the Zofran litigation, numerous families filed lawsuits against drug companies alleging they were negligent for marketing thalidomide as a treatment for morning sickness. New complaints over the drug are still being filed today, both by parents and their now adult children whose lives were affected by the drug. New evidence has emerged indicating that Smith, Kline & French — which is now owned by GSK — may have hidden evidence of a 1956 clinical trial which found that the medicine was toxic to unborn babies.
The cases of thalidomide and Zofran are so similar that even the defendants have reacted to the charges in similar fashion. In 2013, U.S. District Judge Paul Diamond denied the defendants’ motion to dismiss in the thalidomide litigation. Last month, Judge F. Dennis Saylor denied a motion to dismiss GSK’s Zofran multidistrict litigation (MDL) in Boston.
The problems that thalidomide caused were so well known that plaintiffs in the Zofran litigation are wondering why any drugmaker would market a product that hadn’t been approved for use during pregnancy. Plaintiffs are hoping that the lawsuits they filed will raise awareness and stop doctors from prescribing the drug to expecting mothers. Hopefully, history won’t repeat itself again.
Do I Have a Zofran Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if your child was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.