Marketed and often prescribed off-label to expecting mothers as a morning sickness medication, anti-nausea drug Zofran has been the target of hundreds of birth defect lawsuits across the country.
While the FDA initially approved Zofran for consumers in 1991, it never approved use of the drug during pregnancy. However, plaintiffs allege that drug maker GlaxoSmithKline knew about the potential risk of birth defects from animal testing and should have disclosed this information to the FDA so that they could warn consumers about Zofran’s potential risks.
In 2015, a special multidistrict litigation venue was created for victims of the defective drug seeking legal remedy and compensation for the pain and suffering that off-label use of the drug caused their families.
Drug manufacturer GlaxoSmithKline recently requested a motion to dismiss the lawsuits, citing the case of Wyeth v. Levine that went before the Supreme Court. United States District Judge F. Dennis Saylor IV, who is overseeing the Zofran MDL, denied the motion, saying he was “loath to dismiss” the complaints before giving plaintiffs the opportunity to develop their case.
“If — as plaintiffs allege — GSK was in exclusive possession of information not previously submitted to the FDA indicating the need for a new or strengthened warning, that information would presumably be included in a [change being effected] request,” he said. “That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it.”