September 18, 2015 — A growing number of lawsuits have been filed by parents of babies with cleft palate, a serious birth defect linked to the use of Zofran during pregnancy.

The federal lawsuit (PDF)Case No. 5:15-cv-00070 — was filed by a family in Mississippi on July 17 against GlaxoSmithKline (GSK).

The mother, Patricia D. Turnage, was prescribed Zofran early in her first trimester of pregnancy with “C.P.T.” When the baby was born in January 2015, he was diagnosed with cleft palate.

Turnage accuses the drug-maker of negligence for marketing Zofran to pregnant women without studying the risk of birth defects or failing to warn about the potential risk.

“C.P.T.” was diagnosed with a soft cleft palate, which means he had a gap in the soft part of the roof of his mouth. Children with this defect often must undergo surgery very early in life. They may also have problems feeding and learning to talk. Most require ongoing medical monitoring and treatment.

Turnage says her son would not have been born with birth defects if she had known about the risk:

“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.”

Zofran has been linked to cleft palate before — Birth Defects Research published a study linking it with a 2.4-fold increased risk of cleft palate, based on data from 9,000 pregnancies.


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