Zofran Manufacturer Seeks Dismissal of Birth Defects Failure-to-Warn Claims

Published on January 15, 2016 by Sandy Liebhard

GlaxoSmithKline, the manufacturer of Zofran, is seeking the dismissal of state failure-to-warn claims included in more than 200 birth defects lawsuits now consolidated in the U.S. District Court, District of Massachusetts. However, plaintiffs argue that such a move would be premature, as discovery has only just begun to get underway in the proceeding.

Glaxo filed its Omnibus Motion to Dismiss back on December 11^th, which argued that all of the Zofran lawsuits included in the federal multidistrict litigation are preempted by federal law. The company asserts that there there exists sufficient evidence in the public record to establish that the U.S. Food & Drug Administration (FDA) would have disallowed any warning label update pertaining to the drug’s alleged association with birth defects, and points out that the regulatory agency had rejected a citizen petition that sought to have Zofran placed in a different pregnancy category. Such a label modification that would have indicated that the drug could place an unborn fetus at risk.

Zofran Plaintiffs Respond

In a response filed on January 5^th, plaintiffs asked the Court to reject Glaxo’s motion, asserting , among other things, that animal studies support their failure to warn claims. They further assert that at least one of these studies pointed to a potential for the types of Zofran-related cardiac defects alleged in many of the lawsuits.

“Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects,” the response stated. “What plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence.”

Plaintiffs also assert that it is far too early for the Court to even consider dismissal of their state-failure-to warn claims.

“Defendant GlaxoSmithKline, LLC’s (“GSK’s”) request to dismiss all cases at the initial pleading stage is unripe, unprecedented and violates established federal law, they argue. “GSK has not cited a single case in which a court has addressed the so-called “clear evidence” preemption exception at the pleading stage, and Plaintiffs’ research has disclosed no case in which a court upheld a clear evidence affirmative defense prior to any discovery. Indeed, every case cited by GSK addressing the issue did so based on a summary judgment or trial record.”

Zofran Allegations

At least 211 Zofran lawsuits are currently pending in the consolidated proceeding now underway in the District of Massachusetts. All of the cases were filed on behalf of children who allegedly suffered heart malformations, cleft lip, cleft palate and other serious birth defects due to their mother’s use of the anti-nausea medication during the first trimester of pregnancy. Plaintiffs further claim that Glaxo improperly marketed Zofran to treat morning sickness, even though the FDA had never approved the drug for this indication.

Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to the families of children who may have been harmed by Zofran. To learn more about filing a Zofran lawsuit, please call (888) 994-5118.