A federal court has denied GlaxoSmithKline’s bid to dismiss hundreds of Zofran lawsuits involving the drug’s alleged association with birth defects. According to an Order issued in the U.S. District Court, District of Massachusetts on January 22nd, the Court found that GlaxoSmithKline’s Motion to Dismiss was premature at this early stage in the litigation.

The District of Massachusetts serves as the venue for a federal multidistrict litigation that includes more than 200 product liability lawsuits involving Glaxo’s anti-nausea medication. All of the complaints were filed on behalf of children who allegedly sustained serious birth defects, including heart malformations and oral clefts, due to their mother’s use of Zofran in the first trimester of pregnancy. Glaxo is accused of concealing these alleged risks and of improperly marketing the drug as an off-label treatment for pregnancy-related nausea and vomiting.

Glaxo Cites Preemption in Dismissal Bid

On December 11th, Glaxo filed a Motion to Dismiss with the Court arguing that the Zofran lawsuits were pre-empted by federal law. In doing so the company asserted that “clear evidence” indicates that the U.S. Food & Drug Administration (FDA) would have rejected the birth defects warnings plaintiffs claim should have been included on the Zofran label. Among other things, the Motion pointed out that the agency had turned down a citizen petition that sought to have Zofran placed in a different pregnancy category that is reserved for medications that might place an unborn fetus at risk.

In a response filed with the Court on January 5th, plaintiffs countered that they believe evidence exists that connects Zofran to the development of birth defects, but given that discovery has yet to get underway, there is as of yet no way to assess these purported risks. That evidence allegedly includes animal studies conducted by the pharmaceutical company in Japan, one of which revealed the same cardiac birth defect alleged by many of the complaints.

In the end the, the plaintiffs viewpoint prevailed, with the Court finding that Glaxo’s Motion to Dismiss was not yet ripe. Among other things, the Court held that plaintiffs are entitled to an opportunity to develop the record as to how the FDA would have responded to a proposed warning had Glaxo submitted one.

“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,” the judge said. “That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it.”

Was Your Child Harmed by Zofran? Contact Our Firm About a Lawsuit.

If your child was born with a serious birth defect following pre-natal Zofran exposure, please contact Bernstein Liebhard LLP to learn more about filing your own lawsuit. Free case evaluations can be arranged by call 877-779-1414.

Published January 26, 2016 by