April 22, 2015 — A mother from Texarkana, Texas has filed a federal lawsuit alleging that the anti-nausea drug Zofran caused her child to be born with a number of birth defects.
The child, identified only as “B.C.W.,” was born in 2014 with congenital heart defects, brain defects, and a number of other congenital abnormalities that will require multiple corrective surgeries and extensive medical treatment.
The Zofran Lawsuit (PDF) was filed by Julia Shonkwiler, who used Zofran early during the first trimester of her pregnancy with B.C.W. She says she never would have used Zofran if she had known about its risks to a developing baby.
The case is now pending in the U.S. District Court for the Eastern District of Texas against the manufacturer of Zofran, GlaxoSmithKline (GSK).
GSK has already resolved a federal litigation in which the Justice Department accused the drug-maker of illegally marketing Zofran “off-label” to pregnant women. Now, many of those women who used Zofran during pregnancy and had a baby with a birth defect are coming forward to seek justice.
The lawsuit cites three studies linking Zofran with an increased risk of heart defects. One study, published in October 2014 by Danielsson, et al., found that babies exposed to Zofran were twice as likely to be born with a “hole in the heart” and 62% more likely to have a cardiovascular defect compared to babies who were not exposed to Zofran.
Another study, published by Dr. Jon T. Andersen in 2013, found that Zofran doubled the risk of having a baby with a heart defect, leading to a 30% increased risk of major birth defects overall. Conclusions were based on data from nearly 900,000 pregnancies in Denmark from 1997-2010.
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