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GSK Files Motion to Dismiss Zofran Birth Defect Claims

courthouseAttorneys for GlaxoSmithKline (GSK) have petitioned that Zofran lawsuits involving birth defects filed against the company be dismissed by the federal judge overseeing litigation.

The move comes relatively early in the course of a multidistrict litigation (MDL 2657) set up to process the increasing number of lawsuits filed over birth defects allegedly associated with their anti-nausea drug.

Zofran was marketed as a treatment for morning sickness but never specifically approved for this purpose; plaintiffs charge that GSK failed to warn patients about the potential dangers of taking the medication during pregnancy.

The Zofran MDL was established four months ago under the jurisdiction of U.S. District Judge Dennis Saylor of the District of Massachusetts. The U.S. Judicial Panel on Multidistrict Litigation (JPML) determined that a sufficient number of similar lawsuits had been filed to warrant the creation of the MDL in order to process the complaints more efficiently.

Lawsuits that are part of the MDL will share a discovery process, currently in its early stages. It is up to Judge Saylor to to determine whether it is too early to entertain the motion to dismiss.

Motion to dismiss filed by defendants

Lawyers for the defendant have filed the motion to dismiss based on the argument that the FDA would have rejected any change in the warning label on Zofran that would have warned of potential birth defects and that sufficient evidence exists in the public record to provide proof of this argument. The basis of their argument is that the FDA had already rejected a petition from a citizen’s watchdog group requesting stronger warning labels about the dangers to developing fetuses.

The plaintiffs have responded to the motion by pointing out that it is far too early for the judge to entertain such a motion as the discovery process for the MDL and Zofran cases is still in initial stages. To dismiss the case prior to the completion of the discovery phase, plaintiffs argue, would be entirely without precedent and inappropriate.

Zofran lawsuits say GSK failed to warn

Although Zofran litigation is still in early stages, over 200 lawsuits have already been filed alleging that GSK promoted its drug for the treatment of morning sickness despite a clear lack of research into the safety of this application for the drug. According to lawsuits filed, women thus subjected their unborn children to birth defect risks for which they received no warning. Legal experts familiar with the cases believe that hundreds more such cases will be filed against GSK.

Lawsuits cite what they claim is a growing body of scientific literature and studies which link the drug to a higher incidence birth defect risks that include cleft lip and/or palate, heart defects, and other kinds of congenital malformations. Some studies have indicated a significant rise in certain birth defects and have also presented evidence that the drug is able to cross the placental barrier to potentially have an impact on the developing fetus.

  1. PacerMonitor, In Re: Zofran (Odnasetron) Products Liability Litigation,
  2. Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,