Filed in U.S. District Court, Texarkana District of Texas, the lawsuit alleges that a woman’s use of Zofran in her pregnancy’s first trimester caused her baby’s congenital birth defects. These include heart murmur, fluid on the brain, thickened arteries, multiple developmental delays. The plaintiff’s son, nine months old at the date of filing, faces multiple surgeries to correct the birth defects the plaintiff believes caused by Zofran.
Early Zofran Studies revealed Birth Defects
The complaint accuses GlaxoSmithKline (GSK) of illegally promoting Zofran as safe and effective to treat morning sickness, despite its never being approved (or ‘indicated’) for that purpose. The lawsuit also contends GSK’s own 1980s animal studies found Zofran easily crosses the placental barrier from mother to fetus. The studies revealed evidence of toxicity, intrauterine deaths, birth defects in babies exposed to Zofran in utero. The complaint further alleges GSK has received at least 200 reports of birth defects linked to Zofran since the drug was released in 1992. (The lawsuit is: Case No. 5:15-34.)
U.S. Gov’t: Zofran illegally promoted for Morning Sickness
While citing a case of healthcare fraud filed against GSK in 2012 by the U.S. government, the plaintiff alleges GSK unlawfully marketed Zofran as a “safe and effective” treatment for the treatment of nausea and vomiting during pregnancy. The U.S. Justice Dept. accused GSK of several crimes:
• Promoting Zofran sales and uses for conditions beyond those approved;
• Making unsubstantiated and/or false representations regarding the safety and efficacy of Zofran as a morning sickness treatment;
• Offering and paying healthcare professionals illegal compensation to ply them into promoting and prescribing Zofran.
GSK agrees to $3 Billion Fine
GSK responded to these allegations by agreeing to settle the case for an astonishing $3 billion fine, the largest ever levied against a drug maker. The company nevertheless continues to claim it never marketed Zofran for the treatment of morning sickness.
This Texas trial, another in Arkansas, and several other Zofran lawsuits will test the claims of the plaintiffs and GSK and decide these issues.