Zofran Lawsuit Defendant Thwarted in Dismissal Attempt

Published on January 27, 2016 by Sandy Liebhard

GlaxoSmithKline has been unsuccessful in an attempt to dismiss hundreds of Zofran lawsuits filed on behalf of children who allegedly suffered birth defects related to their mother’s use of the medication in early pregnancy. In an Order issued in the U.S. District Court, District of Massachusetts, the judge characterized Glaxo’s push for dismissal as premature, and said that plaintiffs should first have a chance to develop facts.

Glaxo had asserted in a motion filed last month that plaintiffs’ failure-to-warn claims were preempted by federal law. Among other things, the pharmaceutical giant maintained that “clear evidence” in the public record indicates that the U.S. Food & Drug Administration (FDA) would have rejected any Zofran label modifications intended to provide warnings regarding a potential association with birth defects. However, plaintiffs countered that they have reason to believe that Glaxo possesses evidence about the link between Zofran and alleged birth defects, including animal studies the company conducted in Japan. One of those studies purportedly revealed a heart defect cited in many of the Zofran cases.

In an Order issued on January 22^nd, U.S. District Judge F. Dennis Saylor IV stated that he was loath to dismiss the cases so early in the litigation.

“The Court is reluctant to issue a ruling on a motion to dismiss without giving the plaintiffs some opportunity to develop the facts, whatever the facts may be,” the Order stated. “Accordingly, GSK’s motion to dismiss plaintiffs’ state law failure-to-warn claims appear to be premature at best, and will be denied without prejudice to its renewal at a later date.”

The Zofran Litigation

At least 211 Zofran lawsuits have been filed in the District of Massachusetts that accuse Glaxo of concealing the alleged link between Zofran and birth defects. The litigation was created last October to allow all such federally-filed cases to undergo coordinated pretrial proceedings. While Zofran has never been approved to treat morning sickness in pregnant woman, it has, in fact, been prescribed to millions of women for this purpose. Some legal experts believe that the litigation involving the drug could ultimately grow to include hundreds of filings.