September 18, 2015 — Another mom has filed a lawsuit claiming her son’s cleft palate was caused by exposure to Zofran in the womb.
The lawsuit (PDF) was filed in federal court in Mississippi on July 17 (Case No. 5:15-cv-00070). Plaintiffs Stephen and Patricia Turnage accuse GlaxoSmithKline (GSK) of marketing Zofran to pregnant women without testing it for that purpose.
Zofran is an anti-nausea drug approved for chemotherapy patients — not morning sickness. Partly due to illegal marketing by GSK, Zofran has become a popular “off-label” (unapproved) drug for pregnant women.
Turnage was prescribed Zofran early during her first trimester of pregnancy. When her son, “C.P.T.,” was born in July 2015, he was diagnosed with a soft cleft palate — a gap in the soft part of the roof of his mouth.
Turnage says she was never warned about the risk of birth defects. According to the complaint:
“She did not become aware of the dangerousness of Zofran and the fraud of defendant GSK until April 2015. … Had [Turnage] known of the increased risk of birth defects, C.P.T. would not have been born with congenital malformations.”
Cleft palate is not life-threatening, but it can interfere with feeding during infancy. Babies with cleft palate often have problems with speech and language, hearing, and may also have dental defects. They may need surgery or ongoing medical care.
In 2012, the journal Birth Defects Research published a study linking Zofran with a 2.4-fold increased risk of cleft palate. Conclusions were based on data from 9,000 pregnant women who participated in the National Birth Defects Prevention Study.