Zofran lawsuit defendant, GlaxoSmithKline, is trying to convince a federal judge to dismiss fraud claims in hundreds of cases involving the drug’s alleged association with serious birth defects. However, plaintiffs reject assertions that their master pleading  lacks adequate  details regarding  false representation allegedly made by the company.

Zofran is an antiemetic indicated to treat nausea and vomiting experienced by post-op surgery patients, or those undergoing certain cancer treatments. However, roughly 1 million expectant mothers in the U.S. are prescribed the drug every year to combat nausea and vomiting related to pregnancy, even though Zofran has never been approved by the U.S. Food & Drug Administration (FDA) for this purpose. . Recently, a growing body of research has suggested that a baby may be more likely to develop serious birth defects, including oral clefts and heart defects, when Zofran is taken in the first trimester of pregnancy.

Zofran Fraud Allegations

Court records indicate that t least 360 Zofran lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, District of Massachusetts. All of the claims were filed on behalf of children who were allegedly born with serious congenital abnormalities due to their mothers’ use of the drug during pregnancy. The master complaint covering all of the pending lawsuits claims that Glaxo committed fraud in marketing and labeling Zofran.

Glaxo is now trying to have the fraud claims dismissed. During Oral Arguments before the Court last month, the company’s attorney pointed out that the master complaint doesn’t cite any specific instances where a Glaxo sales rep promoted Zofran for off-label use in pregnancy, nor does it include claims that a doctor prescribed the drug to an expectant mother per the advice of a Glaxo rep. According to Law360.com, the attorney also faulted the complaint for not specifying what studies were overlooked in labeling the drug.

An attorney for the plaintiff fired back, arguing that the fraud claims were adequately pled, and asserting that the specific misrepresentations to doctors will be an “individualized determination” that can’t be spelled out with in a master complaint.

“It was a complex scheme,” the attorney argued. “But there was one core promotional theme: Zofran is safe and effective for pregnancy-related nausea.

Contact an Attorney Today

Bernstein Liebhard LLP continues to offer free legal reviews to individuals who may be interested in filing a Zofran lawsuit for birth defects. To learn more, please call 877-779-1414.

Published February 9, 2017 by