July 23, 2015 — A woman who took Zofran during pregnancy and had a baby with Tetralogy of Fallot, a serious heart defect, has filed a lawsuit against GlaxoSmithKline (GSK).

The lawsuit (PDF) was filed in the U.S. District Court for the Southern District of Illinois (Case No. 3:15-cv-0787) on July 21 by Jamie and Brad Bircher, parents of a minor child named in the lawsuit as “B.B.”

The boy was born in 2006 with birth defects after his mother took Zofran beginning early in her first trimester of pregnancy to alleviate symptoms of morning sickness. He was diagnosed with Tetralogy of Fallot, a syndrome involving four separate heart defects.

One of those four defects is a large ventricular septal defect, which is a hole in the wall that normally separates the two lower chambers of the heart. According to the lawsuit, there is a “serious risk that the tissue lining the ventricular septal defect will detach and block his arteries, which could be fatal without emergency surgery within the hour.”

GSK is facing at least a dozen lawsuits involving birth defects caused by Zofran, including many babies with heart defects. Last year, a study published in Reproductive Toxicology found that Zofran doubled the risk of “hole in the heart” defects, such as ventricular septal defect.

Zofran is not approved for use during pregnancy. Lawsuit accuse GSK of illegally marketing it as a safe treatment for pregnant women with morning sickness, when in fact there was no evidence of safety or effectiveness. In 2012, GSK agreed to pay a $3 billion settlement to the Justice Department for marketing Zofran “off-label” to pregnant women.

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