April 24, 2015 — A woman who used Zofran and terminated her pregnancy due to life-threatening birth defects has filed a federal lawsuit against GlaxoSmithKline (GSK).
The lawsuit (PDF) was filed by Kim Duong in the U.S. District Court for Massachusetts on April 17.
Duong became pregnant in May 2013. To alleviate and prevent symptoms of morning sickness, she was prescribed and started using Zofran.
In October 2013, diagnostic tests found that her unborn baby had developed physical malformations, including severe and life-threatening birth defects. According to the lawsuit:
“These fetal defects were the direct and proximate result of the Plaintiff’s exposure to Zofran. On or about October 16, 2013, as a result of these fetal birth defects, the Plaintiff terminated her pregnancy.”
Duong says she was not aware of the risk of birth defects associated with Zofran due to fraudulent marketing by GSK. Had she known about the risk, she said she never would have taken Zofran and she would have had a healthy child.
Earlier this year, another mother from Massachusetts filed a similar lawsuit. The child in the lawsuit was born with numerous birth defects, including a “hole in the heart” and other congenital heart defects.
GSK is accused of negligence for failing to adequately study the safety risks of Zofran during pregnancy, while simultaneously promoting it for pregnant women. In 2012, GSK and the Justice Department settled allegations involving illegal marketing of Zofran, including providing kickbacks to convince doctors to prescribe it for morning sickness.
Several recent studies have linked Zofran with an increased risk of birth defects. One study involving nearly 900,000 pregnancies in Denmark found a 30% increased risk of major birth defects, including a doubled increased risk of heart defects.