On January 22, a Massachusetts federal judge agreed with plaintiffs and rejected GlaxoSmithKline’s motion to dismiss. Judge F. Dennis Saylor IV said he couldn’t dismiss the lawsuits without giving the families a chance to examine the facts. GlaxoSmithKline’s motion to dismiss was based on federal preemption law, with Glaxo reportedly arguing that past decisions by the FDA regarding Zofran indicated it would reject a stronger label for the drug.
Lawsuits filed against GlaxoSmithKline allege women were given Zofran off label for morning sickness and were not warned about the risk of birth defects they argue are linked to use of the drug. Because the drug was prescribed off label to treat morning sickness - which is not against any rules - the families argue the FDA may not have seen evidence about the risks of using Zofran while pregnant.
“Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects,” families wrote in response to GlaxoSmithKline’s motion to dismiss (as found in court documents). “What Plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence. Furthermore, there is no evidence that anyone at the FDA ever considered these animal studies in conjunction with the Woodcock letter.” (The Woodcock letter is an October 2015 letter from Janet Woodcock of the FDA in response to a citizen’s petition regarding Zofran.)
READ MORE ZOFRAN BIRTH DEFECT LEGAL NEWS
According to court documents, there are 211 lawsuits consolidated for pretrial proceedings in MDL 2657. A class-action lawsuit has also been filed in Canada alleging babies were born with birth defects - including cleft lip and cleft palate - after being exposed to Zofran prior to birth.
The lawsuit is In Re. Zofran (Ondansetron) Products Liability Litigation, case number 1:15-md-02657, in the US District Court for the District of Massachusetts.