February 23, 2015 — GlaxoSmithKline (GSK) has been hit with another lawsuit alleging that Zofran, a popular morning sickness drug, causes birth defects.
The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania on February 12.
The plaintiff, Cheri Flynn, is a mother from Minnesota who had two children with heart defects after using Zofran during the first trimester of pregnancy to treat morning sickness.
One child, “B.F.,” was born in 2004 with a “hole in the heart” defect. The condition prevented her from thriving physically and developmentally. In 2011, she was forced to undergo surgery to repair the hole.
The other child, “T.F.,” was born in 2006 with a congenital heart defect. As a result, she was unable to breathe and required 24-hour monitoring with an electronic alarm if her oxygen levels were too low. The condition stifled her growth and development, causing her to fall below the 5th percentile for other children her age.
According to the lawsuit (PDF):
“Until recently, Ms. Flynn did not suspect Zofran as the cause of B.F.’s condition, having never been informed until recently that the safety of Zofran treatment in pregnant women has not been established and that Zofran was never FDA-approved to treat morning sickness.”
The lawsuit accuses GSK of failing to warn that Zofran is unsafe for pregnant women. As early as the 1980s, GSK knew that Zofran could pass through the placenta. The company has allegedly received more than 200 reports of birth defects to date.
In addition, scientists have conducted several large-scale epidemiological studies that have estimated Zofran increases the risk of birth defects by 20-30%. Other studies have found that Zofran doubles the risk of heart defects, including atrial septal defect (“hole in the heart”) and cleft palate.