In recent months, dozens of families across the country have sued GlaxoSmithKline (GSK) for injuries relating to the drug Zofran. What is this drug? What are the claims? This post seeks to give the reader a brief overview.
In 1991, the Food and Drug Administration (FDA) approved Zofran (ondansetron) for chemotherapy-related nausea and vomiting, as well as post-operative nausea and vomiting.
Settlement for Off-Label Marketing
In July 2012, the U.S. Department of Justice issued a press release (pdf) stating that GSK would pay a $3 billion settlement, after pleading guilty to claims that the company promoted Zofran for off-label use (i.e. a use not approved by the FDA), specifically as a treatment for pregnant women experiencing morning sickness.
“It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”
DataZofran is not approved for pregnant women. Fetal safety data is based on less than 200 births and the FDA classifies Zofran as a “Pregnancy Category B” medication, which means no one knows if it is safe. Pregnant women with questions about Zofran should talk to their doctors. Zofran has also been linked to deadly side effects for pregnant women.
According to several studies published in the last decade, Zofran passes from mother to fetus through the placenta very rapidly and in “significant amounts.” Furthermore, it remains active in the fetus much longer than in the mother.
Moreover, researchers published a study linking Zofran with a doubled risk of heart defects, leading to a 30% increased risk of birth defects overall.
In 2014, a study by researchers in Sweden found that Zofran doubled the risk of septal heart defects (i.e. “hole in the heart” defects). In addition, a 2012 study linked Zofran to a 2.4 fold increased risk of cleft palate.
On October 14, 2015 the Judicial Panel on Multidistrict Litigation transferred all pending cases to the District of Massachusetts.
If you have any questions regarding Zofran lawsuits, please call experienced product liability lawyers at Ford & Diulio PC at 714-384-5540.