A Minnesota mother is suing the maker of the anti-nausea drug, Zofran, alleging the company knew about Zofran and pregnancy risks to unborn fetuses but failed to adequately warn expectant mothers who were given the drug to treat nausea associated with pregnancy.

Plaintiff Sheri F., according to filed court documents, alleges Zofran’s manufacturer GlaxoKlineSmith (GSK) not only marketed Zofran “off-label” as a safe and effective treatment for morning sickness during pregnancy, it did so without even having tested the drug for its potential risks to pregnant mothers and their unborn babies.

It is not illegal for doctors to prescribe drugs off-label, but it is illegal for drug manufacturers to market their drugs for unapproved uses. Sheri’s Zofran lawsuit alleges GSK chose not to conduct studies because it would have hurt profits. As a result, Sheri claims, women took Zofran during pregnancy because they thought it was safe, but allegedly is was not. GSK allegedly knew Zofran was unsafe because of animal studies that showed evidence of intrauterine deaths and malformations in the offspring, proof that Zofran could cross the placental barrier and affect fetuses, according to the Zofran lawsuit.

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.”

Sheri alleges in the Zofran birth defects lawsuit that two of her children were born with birth defects after being exposed to Zofran. Her first child, born in 2004, had a congenital heart defect, has undergone surgery to repair the hole and has not thrived physically or developmentally since. Sheri’s second child was born in 2006 also with a congenital heart defect and required 24-hour monitoring of her oxygen levels. Sheri argues that if she had known about the risks of Zofran she would not have taken Zofran during pregnancy.

What is Zofran?

Zofran is a member of a class of medications known as 5-HT3 receptor antagonists. They work by reducing the effects of serotonin, a substance in the body. Serotonin is known to cause nausea and ultimately vomiting; Zofran basically interrupts the messages sent from the brain to the rest of the body that it should feel nauseous and get ready to vomit. Therefore, since many women get morning sickness during pregnancy, Zofran was prescribed.

Zofran has been on the market for more than 20 years. It was originally approved in the United States by the FDA in 1992, mainly used by cancer victims. Yet, GSK recently found a new market for this drug – women who were pregnant and suffering from morning sickness – and saw a potential new revenue stream that could generate millions of dollars for the company.

Zofran Birth Defects

Though it is uncertain of the timing and dosage use for mothers taking Zofran, one thing is clear. There is a distinct possibility of newborns being born with cleft palate and cleft lip and three types of heart defects including:

• ASD – (Atrial Septal Defect)
• VSD – (Ventricular Septal Defect)
• Heart Murmur

Zofran Lawsuits

Zofran is not approved for use in pregnant women, and Zofran lawsuits accuse GlaxoSmithKline of marketing the drug to expectant mothers, as well as paying doctors to prescribe it. The drug brought in millions of dollars for GSK, and roughly 1 million women take the medication or its generic counterpart each year.

Sheri is seeking general, compensatory, and punitive damages for GSK’s alleged off-label promotion of Zofran to treat morning sickness without properly testing the drug. She has demanded a jury trial for this case.

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