A lawsuit recently filed in Montana federal court alleges that Zofran caused cleft palate in a young girl who was exposed to the anti-nausea drug during her mother’s pregnancy. According to the complaint, which was filed by the child’s mother on April 3rd, the girl has undergone 10 surgeries since her birth in 1998 to correct the problem.
Cleft palate occurs when a baby is born with a gap or split in the roof of the mouth. The birth defect forms in the first trimester of pregnancy, sometimes between the sixth and twelfth week of fetal development, when the roof of the mouth fails to close. The first trimester is also when Zofran is usually prescribed to alleviate pregnancy-related nausea and vomiting.
The Montana Zofran lawsuit accuses GlaxoSmithKline of marketing the medication “off label” as a safe and effective treatment for the nausea and vomiting experienced by many pregnant woman, even though the company had never once undertaken a single study to investigate the effects of Zofran on a developing fetus. The lawsuit also claims that Glaxo obtained data in the 1980s that indicted the drug’s active ingredient crossed the placental barrier in pregnant mammals, and that it has been receiving reports of Zofran-related birth defects since 1992.
Because the medication lacks appropriate warnings, the lawsuit asserts that the girl’s parents did not become aware that Zofran may cause cleft palate until 2015. Had her mother known that Zofran could harm her unborn baby, she would never have used the medication.
This lawsuit is one of at least five legal actions over alleged Zofran birth defects that have been filed in U.S. courts in recent months. Two pending in federal courts in Pennsylvania and Massachusetts allege that the medication caused congenital heart defects, as does another case that was filed in California state court. Another Zofran lawsuit pending in Alabama federal court claims that prenatal exposure to the drug caused a chromosomal abnormality that was responsible for numerous birth defects suffered by another child.
Zofran has never been approved to treat nausea and vomiting related to pregnancy, and the drug’s labeling notes that it has not been well studied in pregnant woman. However, in 2012 GlaxoSmithKline paid $3 billion to resolve illegal drug marketing charges with the U.S. Department of Justice, including accusations that the company had promoted Zofran as a treatment for morning sickness.
Children born with cleft lip or palate, congenital heart abnormalities and other birth defects that could be related to prenatal Zofran exposure may be entitled to compensation from GlaxoSmithKline. To learn more about filing a Zofran lawsuit on behalf of your child, please contact Bernstein Liebhard LLP by calling (888) 881-3077.