The parents of a child born with a severe congenital birth defect have filed a Zofran lawsuit against GlaxoSmithKline (GSK), alleging that side effects of the anti-nausea drug used during pregnancy caused their son to be born without a kidney.

The Zofran birth defects lawsuit was filed on July 27 by North Dakota residents Angela and Bryan K., both individually and on behalf of their minor son who was born in 2007 and is identified in the claim as “G.K.”

According to the Zofran lawsuit, Angela was prescribed and began taking Zofran during her first trimester of pregnancy, and continued to take it continuously during her pregnancy to alleviate and prevent symptoms of morning sickness, both intravenously and in pill form.

Angela’s son was diagnosed with several kidney defects, including being born with one kidney, malformation of the vas deferens, kidney damage and absence of connective kidney tissue, which prevents kidney transplants.

The Zofran lawsuit goes on to claim that in October 2013, G.K. was in an accident that damaged the one remaining kidney to the extent that it operates at only 38 percent. As a result, doctors have ruled out any sporting activities; additionally, due to his vas deferens defect, he may not be able to have children in the future.

Like other lawsuits filed across the country, this Zofran lawsuit alleges that the mother’s use of the morning sickness treatment during pregnancy caused the birth defect. Angela and Bryan also allege that had their child been born with two kidneys, his current health situation would be much less debilitating and significantly less grave.

The Zofran lawsuit claims that GSK aggressively marketed Zofran off-label nationwide as a morning sickness “wonder drug” for pregnant women, despite “having never once undertaken a single study establishing that this powerful drug was safe or effective for pregnant mothers and their growing children in utero ” and that GSK “knew that Zofran was unsafe for ingestion by expectant mothers.”

Angela and Bryan are bringing claims for compensatory and punitive damages, as well as equitable relief for themselves and G.K. They also hope to ensure that similarly situated mothers-to-be are fully informed about the risks of Zofran.

Studies Suggest Risk of Zofran Birth Defects

Zofran (ondansetron) is an anti-nausea drug approved by the FDA for chemotherapy patients who experience nausea and vomiting as a result of their cancer treatments. However, the drug is also commonly prescribed off-label to women who suffer from morning sickness during pregnancy.

Recent medical studies and post-market reports have raised the suggestion of a possible link between Zofran and birth defects including:

• Atrial septal defect
• Ventricular septal defect
• Cleft palate and lip
• Fetal growth restriction in the womb
• Jaundice
• Kidney defects
• Heart murmur
• Fetal death

A study that included all women giving birth in Denmark between 1997 and 2010 (903,207 births) found the risk for major congenital heart defects doubled with use of Zofran to treat nausea and vomiting during the first trimester. In 2006, a Hong Kong-based study showed Zofran readily crosses the human placenta during the first trimester of pregnancy, and was detected in every sample of fetal tissue collected from forty-one patients.

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.”

Zofran Birth Defect Lawsuits

Growing numbers of women are pursuing Zofran lawsuits after learning that their child’s birth defect may have been caused by the morning sickness drug.

Mothers and families are not the only ones filing Zofran lawsuits. In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

If you took Zofran for morning sickness during pregnancy and your baby was born with birth defects, you may be eligible to file a Zofran Birth Defects lawsuit.

Angela and Bryan’s Zofran Birth Defect Lawsuit is Case No: 1:15-cv-00102-CSM, in the U.S. District Court for the District of North Dakota, Southwestern Division.