GlaxoSmithKline has asked a federal court to dismiss fraud claims put forth in hundreds of Zofran birth defects lawsuits now pending in a multidistrict litigation underway in the U.S. District Court, District of Massachusetts. According to, the company asserts that the suits fail to sufficiently outline the details of the alleged misconduct.

Glaxo is currently named a defendant in more than 300 Zofran lawsuits filed by families who allege that their child was born with serious birth defects due to prenatal exposure to the drug. Among other things, plaintiffs claim that the company engaged in an improper marketing scheme to encourage doctors to prescribed Zofran to expectant mothers suffering from pregnancy-related nausea and vomiting. The U.S. Food & Drug Administration has never approved the medication for that purpose.

“The drug maker asked to dismiss claims of negligent misrepresentation, fraudulent misrepresentation and concealment and violation of state consumer protection laws, arguing that the plaintiffs didn’t specify who made or received the false representations, when and where they were made and what those misrepresentations were,” Law360 stated in its October 14th report.

Zofran Litigation

Zofran is only approved by the FDA to treat nausea related to surgery and certain cancer treatments. While doctors are permitted to prescribe medications for any purpose they deem appropriate, drug makers are legally prohibited in most instances from marketing their products for off-label uses. Zofran lawsuits point out that Glaxo agreed to a $3 billion settlement with the U.S. Department of Justice in 2012 which, among other things, resolved claims that it had illegally promoted Zofran as a safe and effective treatment for pregnant women suffering from morning sickness.

The lawsuits also cite a number of studies published in recent years that suggest pre-natal Zofran exposure increases an infants risk for  cleft palate, cleft lip, heart defects and other congenital abnormalities. Plaintiffs further assert that Glaxo has  has received more than 200 complaints of birth defects associated with Zofran but failed to appropriately update the product’s warning label.

Zofran Lawsuit Reviews

Bernstein Liebhard LLP offers free legal reviews to families whose children may have been harmed by Zofran. If you would like to learn more about filing a Zofran lawsuit, please call (877) 779-1414 to schedule your review.

Published October 19, 2016 by