April 8, 2015 — The parents of a girl who was born with a cleft lip and cleft palate after being exposed to Zofran in the womb has filed a lawsuit against GlaxoSmithKline (GSK) for failing to warn about the risk.
The lawsuit was filed in federal court in Montana by Leslie “Casey” and Pam Marlenee, on behalf of their minor child “M.M.”
The girl was born in 1998 with birth defects after Mrs. Marlenee used Zofran early during her first trimester of pregnancy for the treatment of morning sickness. According to the complaint:
“M.M. has had to undergo ten surgeries to try and correct her cleft lip and palate. This birth defect impairs her development and enjoyment of a normal life at home and at school.”
Mrs. Marlenee says she never would have used Zofran had she known about the risk of birth defects and fraudulent marketing by GSK. In 2012, the Justice Department accused GSK of improperly marketing Zofran “off-label” to pregnant women with morning sickness, in violation of federal law.
There is growing evidence linking Zofran and cleft palate. A study published in January 2012 by Birth Defects Research found that Zofran increased the risk of cleft palate by 2.4-times when it was used during the first trimester.
Zofran (ondansetron) is an anti-nausea drug that is only approved for chemotherapy patients suffering from nausea. It is not approved or recommended during pregnancy. The FDA classifies it as a “Pregnancy Category B” drug, which means its safety to a developing baby is unknown.