Gilman Law LLP, a leading national law firm with over 40 years of experience protecting the rights of victims, is investigating allegations that Zofran can cause serious birth defects when it is prescribed during pregnancy to alleviate morning sickness. You may be eligible to file a Zofran lawsuit if you were treated with this anti-nausea medication during your first trimester of pregnancy, and your baby was born with any of the following birth defects:
- Heart defects, including septal defects (holes in the heart)
- Cleft lip and cleft palate
- Club foot
- Skull deformities (craniosynostosis)
- Musculoskeletal Defects
- Fetal growth restriction (poor growth in the womb)
- Kidney defects
To learn if you and your child might be eligible to receive compensation for Zofran birth defects, please contact Gilman Law LLP today to schedule a complimentary, no-obligation legal review of your case.
What is Zofran?
Zofran (ondansetron) is manufactured by GlaxoSmithKline, and is currently approved by the U.S. Food & Drug Administration (FDA) to treat nausea and vomiting related to chemotherapy, radiotherapy and surgery. Though the drug has never been approved to relieve nausea and vomiting related to pregnancy, Zofran lawsuit plaintiffs allege that it has long been prescribed for this use. They accuse Glaxo of wrongly promoting the drug for this off-label indication, and of misrepresenting Zofran as a safe and effective treatment for morning sickness.
In 2012, Glaxo resolved criminal and civil charges over the marketing of several drugs, including Zofran, and paid $3 billion as part of a settlement with the U.S. Department of Justice. However, this settlement provided no compensation to alleged victims of Zofran birth defects.
Zofran and Birth Defects
A number of recent studies have raised concerns that Zofran use in the first trimester of pregnancy may increase the risk that a child will be born with a serious birth defect. According to an article published in the December 2014 issue of American Journal of Obstetrics and Gynecology, an analysis of data drawn from 900,000 Dutch pregnancies found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 40 percent increased risk of major congenital malformations.”
A study published the same month in Reproductive Toxicology suggested that children born to women treated with Zofran during pregnancy were at risk for septal heart defects, including atrial septal defects and ventricular septal defects. In January 2012, research based on data from the National Birth Defects Prevention Study found that Zofran use during the first trimester was associated with a 2.37-fold increase in the incidence of oral clefts, such as cleft lip and cleft palate
Zofran Lawsuit Reviews
Alleged victims of Zofran birth defects may be entitled to significant financial compensation from GlaxoSmithKline. Zofran lawsuits are already mounting in U.S. courts, and it is important to seek legal advice now if you wish to pursue a claim on behalf of you and your child. For a no-obligation evaluation of your potential case, please fill out our free consultation form or call Gilman Law LLP direct to speak with one of our attorneys at (888) 252-0048.