For more information or confidential assistance
Call 516.741.5600

Parents Claim Zofran Use During Pregnancy Caused Son’s Missing Kidney

pregnant woman cradling belly

In 2013, a six-year-old child from Bismarck, North Dakota was diagnosed with severe birth defects, including an absent kidney. The parents have filed a lawsuit against GlaxoSmithKline (GSK), claiming that the mother’s use of Zofran during her pregnancy led to the child’s birth defects. They filed the lawsuit on July 24, 2015 in the U.S. District Court for the District of North Dakota, Southwestern Division.

Zofran (ondansetron) is an anti-nausea drug. It has been approved by the FDA to treat nausea in patients undergoing chemotherapy and those who have undergone surgery. It has not been FDA-approved for the treatment of morning sickness in women who are pregnant; however, it is not uncommon for a doctor to prescribe a drug for off-label use. There have been some reports that claim Zofran may increase the risk of birth defects, such as kidney malformations. However, the evidence is inconclusive and some studies have been contradictory.

Parents allege birth defects attributable to Zofran

According to the Zofran lawsuit filed by the North Dakota parents, the child’s birth defects were not discovered until well after birth. The mother had been prescribed and began taking Zofran in her first trimester. She used it continuously throughout her pregnancy, taking the drug orally and receiving it intravenously. On several occasions, the mother received large dosages of Zofran intravenously at a medical center during her first and third trimesters.

Her son was born in 2007, yet it wasn’t until a household accident occurred in October 2013 that his birth defects were diagnosed. The lawsuit claims that the boy fell from a TV tray stand in the family home, at which point he was taken to the hospital. There, he was diagnosed with a grade 4 or possible grade 5 injury to his kidney. At that time, the parents were informed that the child only has one kidney, a condition known as congenital unilateral renal agenesis.

He has also been diagnosed with congenital unilateral absence of the vas deferens and the boy lacks the connective tissue that would have been required for a kidney transplant.

Kidney function down to 38 percent

The Zofran lawsuit states that because the boy’s birth defects included a missing kidney, the injury to his remaining kidney in 2013 was a particularly dire situation. The boy had to be airlifted from Bismarck, North Dakota to a hospital in Minneapolis, Minnesota, where he received specialized care during his two-week hospitalization. His remaining kidney functions at only 38 percent due to the injury, which means the boy requires ongoing and intensive care and monitoring. Should his kidney function decline to 25 percent, the boy is expected to require lifelong dialysis.

Kidney defect linked to Zofran use during pregnancy

The parents demand compensation for the boy’s past and future medical expenses, permanent injuries, physical pain, mental anguish, and diminished enjoyment of life. They claim that if the boy had not already been missing one kidney as an alleged result of the mother’s use of Zofran, the injury to his remaining kidney would not have resulted in severe disability and significant expense.