April 8, 2015 — GlaxoSmithKline (GSK) has been hit with a lawsuit on behalf of a child who was born with cleft lip and cleft palate after her mother used Zofran during pregnancy.
The lawsuit was filed in the U.S. District Court for the District of Montana by Leslie “Casey” and Pam Marlenee on behalf of their daughter, named in the complaint as “M.M.”
Mrs. Marlenee used Zofran early in her first trimester of pregnancy to alleviate symptoms of morning sickness. The child was born in 1998 with cleft lip and cleft palate. According to the lawsuit:
“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.”
The lawsuit accuses GSK of negligence for failing to warn about the risk of birth defects from Zofran. Mrs. Marlenee says she never would have taken Zofran if she hd known about its dangers or the fraudulent nature of GSK’s marketing.
In 2012, GSK agreed to a settlement with the Justice Department after marketing Zofran “off-label” to pregnant women with morning sickness. Doctors are allowed tp prescribe medications for whatever purpose they see fit, but federal law prohibits “off-label” marketing by pharmaceutical companies.
Zofran is not approved or recommended for use during pregnancy. In January 2012, a study published in Birth Defects Research found a 2.4-fold increased risk of cleft palate associated with the use of Zofran in the first trimester.