June 29, 2015 — GlaxoSmithKline (GSK) has been hit with a lawsuit from a mom in Alabama who claims the anti-nausea drug Zofran caused her daughter to be born with life-threatening “hole in the heart” defects.
The lawsuit was filed by Vicki Roberts, who used Zofran beginning early in her first trimester for the prevention of nausea and vomiting associated with morning sickness. She used Zofran continuously until her second trimester of pregnancy.
Unfortunately, her daughter “T.N.” was born in 2001 with a severe heart defect known as atrial septal defect. When T.N. was just four months old, she had to undergo open heart surgery to close the hole in her heart. At four years of age, she was implanted with a pacemaker, and again when she was eleven.
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 on June 23 in federal court in Alabama, Case No. 1:15-cv-00320.
GlaxoSmithKline is accused of illegally marketing Zofran as an “off-label” (unapproved) drug for pregnant women with morning sickness, without testing it for safety or warning about potential risks to a baby.
Last year, Reproductive Toxicology published a study linking Zofran with a doubled increased risk of atrial septal defects. Other studies have also found higher rates of heart defects and other birth defects associated with with the use of Zofran during pregnancy.