April 24, 2015 — GlaxoSmithKline (GSK) has been hit with a federal lawsuit in Massachusetts by a woman who took Zofran and was forced to terminate her pregnancy after her baby developed severe, life-threatening abdominal birth defects.
The lawsuit (PDF) was filed on April 17 in the U.S. District Court for Massachusetts by Kim Duong.
Beginning in May 2013, Duong allegedly used Zofran during the first trimester of pregnancy to alleviate symptoms of morning sickness. In October 2013, diagnostic tests showed that her developing baby had severe birth defects, including abdominal malformation.
According to the complaint:
“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 accuses GSK of negligence for failing to adequately warn about the risk of birth defects from Zofran. Had she known, Duong says she never would have used Zofran during pregnancy and her baby would have been healthy.
This is at least the second Zofran lawsuit filed in Massachusetts. Earlier this year, another lawsuit was filed on behalf of a girl who was born with life-threatening congenital heart defects, including a “hole in the heart,” and several other major birth defects.
There are now at least a half-dozen birth defect lawsuits pending against GSK by women like Duong. All of the lawsuits accuse GSK of improperly promoting Zofran “off-label” for pregnant women with morning sickness, despite a lack of studies indicating this use is safe.
In fact, a growing number of studies have found evidence linking Zofran and birth defects. One recent study involving nearly 900,000 pregnancies in Denmark found a 30% increased rate of major birth defects among babies who were exposed to Zofran during the first trimester.