Zofran Lawsuit Information
Zofran (ondansetron) has been associated with serious birth defects when women use the drug during pregnancy. Evidence suggests the manufacturer promoted the medication for treatment of morning sickness without FDA approval, without conducting clinical trials, and despite troubling safety concerns.
If birth defects have affected your family, you may have grounds to file a Zofran lawsuit. An experienced pharmaceutical lawyer in our office can evaluate your claim at no cost and help you understand your legal options.
Call (866) 808-2424 or send a message using our brief online form for a confidential case review.
Birth Defects From Zofran
In 1991 the FDA approved Zofran for the limited purpose of preventing nausea and vomiting in patients following surgery, chemotherapy, or radiation therapy. Since 1998, however, the manufacturer is believed to have widely promoted the drug to Ob-Gyns for use by pregnant women. Medical studies now link this “off label” use of Zofran to the following congenital heart defects in newborns:
- Heart murmer
- Atrial septal defect
- Ventricular septal defect
Other malformations under investigation include:
- Cleft lip
- Cleft palate
- Neural tube defects
- Kidney defects
- Craniosynostosis (head shape abnormality)
- Gastroschisis (hole in the abdominal wall)
Our attorneys believe expectant mothers would refuse prenatal exposure to Zofran if properly warned about the risks to unborn children.
Failure to Warn Mothers
Zofran lawsuits allege the manufacturer was aware that high concentrations of the drug could transfer through the placental barrier to the fetus during pregnancy. Lawsuits further allege that post-marketing reports to the company demonstrated a prevalence of birth defects in newborns. Instead of warning consumers, however, the manufacturer allegedly continued its off label marketing of Zofran as a safe and effective treatment for common morning sickness.
Get an Evaluation of Your Zofran Lawsuit
Despite widespread use of the medication, a Zofran class action lawsuit has not been established in the United States. Instead, cases are filed individually in the appropriate state or federal court and litigated according to the specific facts of each case. This means you will need your own attorney to represent you in an individual Zofran lawsuit.
Our firm has over 25 years’ experience in complex drug and medical device litigation and we represent clients on a no-fee, contingency basis. Contact us now to learn more about the Zofran litigation and how our firm can help.