Zofran (ondansetron)

Zofran (ondansetron), a medication prescribed for the treatment of nausea and vomiting, has been prescribed to thousands of women during their pregnancies even though it has not been approved for this use. Studies are now showing that taking Zofran while pregnant may increase the risk for serious birth defects, including heart defects, skull malformations, cleft lip, cleft palate and club foot. But, what is more concerning is that drug maker GlaxoSmithKline may have been illegally marketing the medication to pregnant women, despite a knowledge of the potential risks.

At The Law Office of Melinda J. Helbock, A.P.C., we find this troubling and are investigating potential Zofran lawsuits on behalf of women who took the medication while pregnant and who gave birth to babies with various birth defects. If you or a loved one was prescribed Zofran during your pregnancy and your baby is suffering from one or more health complications, contact us today for more information and to find out if you have the right to sue for damages.

Did GlaxoSmithKline Withhold Information about Zofran Birth Defects?

According to court documents, Glaxo was aware that Zofran presented “unreasonable risk of harm” to developing babies back in 1992 when it learned that the medication passes through the placenta. Despite its knowledge of the potential dangers, Glaxo continued to market the drug to pregnant women, essentially knowingly putting them at risk.

Because of this, Zofran lawsuits have been filed against Glaxo, alleging that the company:

  • Failed to make sure Zofran was safe for use before offering it to the public
  • Failed to determine all safety risks before putting it on the market
  • Failed to warn the public about dangerous side effects and risks
  • Wrongfully advertised the drug for the treatment of morning sickness even though it was never approved by the FDA for this use
  • Misrepresented results from animal studies which showed use of the drug caused abnormal bone growth and signs of toxicity
  • Failed to properly evaluate all the data and safety information on the effects of Zofran on pregnant women and developing babies
  • Produced a defective drug and failed to warn consumers of the risks
  • Misrepresented the safety of Zofran and fraudulently claimed that it was safe for pregnant women

Who Qualifies for a Birth Defect Lawsuit?

Mothers of babies born with congenital defects and who took Zofran during their pregnancies should speak with an attorney about their right to file a lawsuit. The first Zofran birth defect lawsuits were filed in early 2015 and many more are expected to follow. Some of the birth defects named in the lawsuits include:

  • Heart defects
  • Cleft lip and/or cleft palate
  • Club foot
  • Craniosynostosis (skull defects)

At The Law Office of Melinda J. Helbock, A.P.C., we believe that drug manufacturers have a responsibility to protect the safety of consumers by properly testing their drugs for all risks and properly warning the public of any potential side effects. We are available to investigate claims on behalf of parents and babies who may have suffered as a result of Glaxo’s actions. To learn more and to find out if you qualify to file a lawsuit, please contact us today.