Zofran (ondansetron), the popular anti-nausea drug that many expectant mothers use to deal with morning sickness, is the subject of a Zofran lawsuit, alleging that a mother’s use of the drug during the first trimester of pregnancy caused her child to suffer kidney problems and other birth defects.

Plaintiffs Angela and Bryan K. filed their complaint against Zofran’s manufacturer, GlaxoSmithKline, on behalf of themselves and their child, identified in paperwork only as G.K. Angela and Brian claim that GSK failed to adequately warn them of Zofran’s potential side effects when used during the first trimester.

After Angela used Zofran during her first trimester of pregnancy, G.K. was born with a missing kidney in 2007. This condition is known as a congenital unilateral renal agenesis. G.K. is also missing the connective tissues that are necessary for a kidney transplant. Doctors did not discover G.K.’s condition until 2013, when the six-year-old had an accident that damaged the one kidney he was born with.

For G.K., the danger is substantial. His only remaining kidney currently functions at 38 percent of its usual strength and capability, posing significant health problems in both the present and future.

In addition to the missing kidney, Angel and Bryan claim that G.K. was born without a fully functioning deferens. If this is true, it means that when G.K. is grown, it will be virtually impossible for him to successfully reproduce. Because he is so young, it is unclear whether he will have normal male sexual functionality.

Angela and Bryan claim that there is no family history of their son’s various conditions, and that these birth defects must be a direct result of Zofran.

Zofran Birth Defects

Zofran is widely used as a treatment for nausea, but has only been approved by the U.S. Food and Drug Administration for cancer and surgery patients. Zofran has not been FDA approved for the treatment of morning sickness in pregnant women, and can only be prescribed “off-label” to pregnant women. Despite this, the prescription of Zofran to combat morning sickness in pregnant women is common.

Angela and Bryan join a growing number of families filing lawsuits against GlaxoSmithKline for marketing Zofran to pregnant women despite allegedly knowing the risks for unborn children during the first trimester. Most of the lawsuits involve Zofran heart defects rather than kidney defects, and a number of children are born with cleft lip or cleft palate.

G.K.’s family, and other families like them whose children have been born with Zofran birth defects, accuse GSK of negligence, failure to adequately warn of the dangers of Zofran, and illegal marketing to pregnant women despite the evidence of increased risk.

If you have used Zofran as an anti-nausea drug during pregnancy, and have subsequently given birth to a child with Zofran birth defects, you may be able to file a Zofran lawsuit against GlaxoSmithKline for failing to adequately warn or inform you of the potential risks to your child.