July 23, 2015 — The family of a boy who was born with a heart defect known as Tetralogy of Fallot has filed a lawsuit claiming the anti-nausea drug Zofran is responsible.
The lawsuit (PDF) was filed on July 21 against the manufacturer of Zofran, GlaxoSmithKline (GSK), in the U.S. District Court for the Southern District of Illinois.
The victim, named in the lawsuit as “B.B.,” was born in 2006. His mother, Jamie Bircher, was prescribed Zofran and used it beginning early in her first trimester of pregnancy for morning sickness.
The boy was diagnosed with Tetralogy of Fallot, a syndrome involving four separate heart defects. One of those defects is a “hole in the heart,” known as ventricular septal defect. According to the complaint:
“…he lives with a much higher risk of severe injuries from infections and 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.”
This is not the first time Zofran has been linked to “hole in the heart” defects. Reproductive Toxicology recently published a study showing that Zofran doubled the risk of having a baby with a septal heart defect when it was used in the first trimester.
GSK is now facing more than a dozen lawsuits alleging that Zofran causes birth defects. The drug-maker has already paid the Justice Department a $3 billion settlement for illegally marketing several drugs, including Zofran “off-label” in pregnant women with morning sickness.