Zofran Pregnancy Side Effects Led to Atrial Septal Defect for Baby, Lawsuit Alleges

An infant girl’s family is pursuing a lawsuit against GlaxoSmithKline, alleging that the side effects of Zofran used during the mother’s pregnancy to treat nausea caused the development of a congenital heart defect, known as . 

The complaint (PDF) was filed by Tara McClellan and Jose Jimenez on March 10, in the U.S. District Court for the District of Massachusetts, claiming that GlaxoSmithKline failed to warn consumers and or her doctor of the risk of atrial septal defects from Zofran use while pregnant.

McClellan indicates that she was prescribed Zofran to alleviate symptoms of morning sickness during her pregnancy. Although the family has no history of heart defects, she indicates that her daughter, identified only by the initials “T.J.” in the lawsuit, was diagnosed with a moderate-sized atrial septal defect following birth in 2014. This congenital defect involves a hole in the wall that separates the two top chambers, allowing oxygenated blood to leak into the oxygen poor parts of the heart and forcing the heart and lungs to work harder.

“As a result of her condition, T. J. will require life-long monitoring as she will always be at risk for potentially serious and/or life-threatening conditions,” the lawsuit indicates. “Had Plaintiff known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she would never have ingested the Zofran or generic ondansetron and T.J. would have never been injured as described herein.”

The case joins a growing number of Zofran birth defect lawsuits filed by families throughout the U.S., each involving similar claims that children have suffered severe injuries and malformations following exposure to the drug.

Zofran Birth Defect Risks

Zofran (ondansetron) is a popular anti-nausea and vomiting medication that was introduced by GlaxoSmithKline in 1991. Although it has been widely marketed for use among pregnant women, the medication is only approved for treatment of nausea associated with chemotherapy or surgery.

In July 2012, GlaxoSmithKline agreed to pay the federal government $3 billion to resolve criminal and civil claims stemmig from the alleged illegal off-label marketing of a number of drugs, including use of Zofran among pregnant women. While approved medications can be prescribed “off-label” for any reason a doctor sees fit, drug makers are prohibited from promoting such uses until they have conducted adequate studies to establish it is safe and effective.

The Zofran birth defect litigation has rapidly emerged over the past two years, as more and more families learned about the link between the anti-nausea drug to their children’s congenital malformations, including heart problems, cleft lip, cleft palate and other congenital malformations.

McClellan and Jimenez’s complaint will be transferred into a federal multidistrict litigation (MDL) established for all Zofran cases filed throughout the federal court system, which are currently centralized before U.S. District Judge Dennis Saylor in the District of Massachusetts.

There are currently at least 200 complaints pending before Judge Saylor. However, as Zofran birth defect lawyers continue to review and file cases, it is ultimately expected that more than 1,000 cases may be included in the litigation.

As part of the coordinated proceedings, it is expected that a small group of cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

If GlaxoSmithKline fails to reach Zofran settlements to resolve birth defect cases following these early “bellwether” trials, each of the individual lawsuits included in the MDL may end up being remanded back to U.S. District Courts nationwide for separate trial dates.