June 29, 2015 — A woman from Alabama who took Zofran during pregnancy and had a baby with a birth defect has filed a lawsuit against GlaxoSmithKline (GSK).
The woman, Vicki Roberts, filed the lawsuit on behalf of her daughter, named only as “T.N.” Her mother used Zofran beginning early in her first trimester and took it continuously through her second trimester to control symptoms of morning sickness.
When T.N. was just four months old, she had open heart surgery to repair the defects. When she was four years old, she had a pacemaker implanted in her body. Another pacemaker was implanted when she was 11 years old. According to the lawsuit (PDF):
“T.N. will have to have additional surgeries throughout her life to replace the pacemaker, which she cannot live without. In addition, as a result of her congenital heart defects, T.N. will never be able to participate in sports activities, and all physical activity is limited.”
The lawsuit was filed in the U.S. District Court for the Southern District of Alabama on June 23, Case No. 1:15-cv-00320.
The number of Zofran lawsuits has grown rapidly in the last year, including many filed on behalf of children with heart defects. All of the lawsuits accuse GlaxoSmithKline of illegally marketing Zofran to pregnant women without adequately testing it for safety or warning about the risk of birth defects.
A growing number of studies also support a link between Zofran and heart defects. Most recently, Reproductive Toxicology published a study linking Zofran with a doubled increased risk of “hole in the heart” defects.