June 17, 2015 — A lawsuit has been filed by the parents of an infant who died of heart defects after her mother took the anti-nausea drug Zofran.
The lawsuit (PDF) was filed on behalf of Molly Regan, a baby girl who was exposed to Zofran in the womb. Her mother, Valerie Regan, used Zofran for the “off-label” treatment of morning sickness and had an otherwise unremarkable pregnancy.
Nine days before giving birth, her baby’s heart-rate slowed dramatically. Her baby was born in March 2006 with a right ventricular heart defect, but only survived for three days before she “crashed,” according to the lawsuit.
The lawsuit (Case No. 3:15-cv-1166) was filed in the U.S. District Court for the Northern District of Ohio against GlaxoSmithKline (GSK). The drug-maker is accused of negligence for marketing Zofran to pregnant women without warning them about the possible risk of birth defects:
“GlaxoSmithKline actively concealed information and actively misled the Regans, their physician, the medical community in general, the public at large, and federal regulators regarding Zofran’s propensity to cause birth defects and its appropriateness for use by pregnant mothers.”
Three years ago, GSK and the Justice Department settled allegations of illegally marketing Zofran to pregnant women. Since then, several studies have found evidence that Zofran increases the risk of having a baby with a heart defect. One study published last year in Reproductive Toxicology found that Zofran doubled the risk of having a baby with a “hole in the heart” defect.