U.S. District Judge F. Dennis Saylor denied GlaxoSmithKline PLC’s request to dismiss hundreds of birth defect lawsuits filed by women, who used Zofran as an anti-nausea medication during their pregnancy.
The federal judge stated that the question of fact about whether GSK fully revealed the material data about Zofran to the FDA, and the agency would have rejected a request for a stricter warning label, was yet to be resolved by the jury. GSK claimed that the FDA conducted an extensive review of Zofran and a warning label for the alleged birth defects was not backed up by science. The company argued that the claims filed by the women were barred under federal preemption. In his decision, Judge Saylor told it was unclear if GSK had complied with the FDA's letter of regulations and whether GSK had presented expert backing for its argument about the data's authenticity.
There are more than 200 complaints against the company that its drug Zofran, approved to treat nausea during chemotherapy procedures, was illegally promoted to treat morning sickness in pregnant women. Zofran multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) was formed in October 2015 in the District of Massachusetts for consolidated pretrial proceedings.