A Zofran birth defect lawsuit was filed against GlaxoSmithKline (GSK), the manufacturers of the popular anti-nausea drug. Zofran often has been prescribed off label to treat morning sickness in pregnant women. However, many children have been born with Zofran birth defects as a result of this off label use.

Plaintiff Cheri F. filed the Zofran lawsuit on behalf of herself and her two children. One child was born in 2004 with a congenital heart defect after Cheri used Zofran while pregnant. This Zofran birth defect “prevented [the child] from thriving physically and developmentally … [her] growth metrics were below the fifth percentile compared with other children her age,” said the Zofran lawsuit.

The second child was born in 2006 and also had a congenital heart defect, a potential Zofran side effect. This child “was unable to breathe adequately and required 24-hour monitoring with an electric alarm,” said the Zofran lawsuit.

Cheri claimed that had she been aware that this nausea medication was not approved for morning sickness treatment she never would have taken Zofran.

Zofran for Morning Sickness

Zofran was approved in 1992 to help cancer patients with the nausea that follows chemotherapy or radiation treatments. All four indication and usage options on the Zofran label are focused on cancer treatments only. In spite of only being approved for this use, GSK allegedly promoted Zofran for use in pregnant women as well as a “safe and effective treatment” for morning sickness, according to the Zofran lawsuit.

“GSK did this despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child,” stated the Zofran lawsuit.

Many women, including Cheri, were prescribed and used Zofran while pregnant even though there are anti-nausea medications that have been adequately tested and approved by the FDA for use in pregnant women. Animal studies examining Zofran side effects found signs of birth defects.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Using Zofran for morning sickness has not been FDA approved and can lead to life-altering Zofran birth defects such as:

• Cleft lip and cleft palate (2.4-fold increased risk)
• Heart defects (doubled risk)
• Kidney defects
• Musculoskeletal defects
• Poor fetal growth
• Fetal death

Zofran Lawsuits

As a result of alleged off-label promotion, many children have been born with Zofran birth defects.  
GSK has been faced with lawsuits accusing them of off-label promotion in the past. The drug manufacturer has paid large settlements to individuals who have suffered because they concealed safety information about their drugs.

The Zofran Lawsuit is Case No. 2:15-cv-00709, in the U.S. District Court for the Eastern District of Pennsylvania.