June 16, 2015 — GlaxoSmithKline (GSK) has been hit with a lawsuit by two women who were prescribed Zofran for the “off-label” treatment of morning sickness and had babies with life-threatening heart defects.
The lawsuit (PDF) was filed in the U.S. District Court for the Western District of Louisiana (Case No. 6:15-cv-01815) on June 8.
One mother, Stacy Coughlin, says she started using Zofran in January 2010 to prevent nausea and vomiting in her first trimester of pregnancy. Six months later, she gave birth to a baby girl who was born with “hole in the heart” defects and needed surgery.
Her heart defects included ventricular septal defect (VSD), atrial septal defect (ASD), and intermittent tachypnea, which is a sign of congestive heart failure.
Another mother named in the lawsuit, Ashley Swann, had a baby in August 2005 after taking Zofran for six months. Her baby was born with a serious heart rhythm disorder known as ventricular arrhythmia, which nearly caused her death soon after birth. She required routine medical treatment and testing during her first five years of life.
The women accuse GSK of negligence for failing to adequately warn about the risk of birth defects. The drug-maker is also accused of negligence for marketing Zofran to pregnant women without testing it for that purpose.
A number of recent studies support the link between Zofran and heart defects, including one published last year in Reproductive Toxicology that found a doubled rate of heart defects among babies exposed to Zofran in the first trimester.
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