Zofran Birth Defect Attorneys

Our Zofran birth defect attorneys are working with families from all over the United States to pursue just compensation after their babies were born with serious birth defects linked to use of Zofran during pregnancy. Zofran (ondansetron) is a medication approved to treat nausea in cancer and post-surgical patients, and it is sometimes prescribed "off-label" as a treatment for morning sickness or nausea during pregnancy. Unfortunately, many mothers were not aware that Zofran is associated with multiple potentially fatal birth defects.

A Brief History of Zofran Birth Defects Research

Zofran has never been approved for use in pregnant women, though it has been prescribed to treat morning sickness to thousands of expectant mothers. In truth, the FDA includes Zofran in Pregnancy Category B because there is inadequate research to determine the effect of Zofran on human fetuses.

Studies have linked Zofran to birth defects and fetal harm since as far back in 2006, when researchers in Hong Kong found high concentrations of the drug in tissues from aborted fetuses. In 2011, researchers examined data from the National Birth Defects Prevention Study and concluded that women who use Zofran during pregnancy are up to two times more likely to have a baby with cleft lip or cleft palate birth defects. The following year, Reproductive Toxicity published a study where researchers found that the risk of a serious heart defect doubles when women use Zofran for morning sickness. A Danish study came to the same conclusion about Zofran and heart defects in 2013. In 2014, researchers published a study in Clinical Pharmacology and Therapeutics in which they found that Zofran can cross the placenta quickly and remain in a developing baby's body for a longer period of time than expected.

In all, Zofran during pregnancy has been linked to the following severe congenital birth defects:

• Heart defects
• Oral cleft defects
• Kidney defects
• Skeletal defects
• Club foot
• Webbed feet
• Restricted fetal growth

Makers of Zofran Fined for Illegal Marketing and Healthcare Fraud

In 2012, GlaxoSmithKline was brought under investigation by the U.S. Department of Justice when it was suspected that they had engaged in illegal marketing of Zofran and multiple other drugs. Zofran is not approved for use as a morning sickness treatment, though it is still legal for doctors to prescribe it "off-label" for this use. However, it is not legal to promote or advertise a drug for "off-label" uses, and the DoJ alleged that GlaxoSmithKline had illegally marketed several drugs including Zofran for use during pregnancy. In the end, GSK settled at $3 billion for the alleged actions while maintaining that they had committed no wrongdoing. The Department of Justice called this "the largest healthcare fraud settlement in U.S. history."

Zofran Lawsuit Consultations

If your child was born with heart defects, oral cleft, or another serious birth defect after his or her mother used Zofran to treat morning sickness, you could be owed compensation. A number of families have filed Zofran birth defect lawsuits based on claims that they were not warned of the high risk of birth defects associated with this allegedly dangerous drug. For more information on Zofran lawsuits and a free case evaluation, please contact our personal injury lawyers today.