Judge Denies GlaxoSmithKline Motion to Dismiss Lawsuits

New York, NYA judge has reportedly denied GlaxoSmithKline’s motion to dismiss Zofran lawsuits, which alleged the morning sickness drug caused birth defects in infants exposed to the medication prior to birth. Plaintiffs in the Zofran side effects lawsuits argued it’s too early to dismiss the lawsuits because no discovery has happened yet, and because animal studies suggest a link between Zofran and birth defects.

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.)

The families further argued that animal studies suggest a link between Zofran and potential birth defects, and they believe GlaxoSmithKline has that evidence. In 2012, GlaxoSmithKline settled allegations from the US Department of Justice that the drugmaker had illegally promoted multiple drugs - including Zofran - for off-label use. Although prescribing medication off label is not illegal, promoting it for such uses is.

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.