Dan Harkins Jul. 20, 2015, 12:36pm


A mother whose child was born with physical defects is suing the company that makes Zofran, alleging it advertised for nausea when it has only been approved for cancer cases.

Alexis Alexander and her unnamed child filed a lawsuit June 6 in U.S. District Court of the Eastern District of Louisiana against GlaxoSmithKline.

According to the complaint, Alexander was dosed with the drug Zofran, which made by the defendant, while pregnant. The suit says the drug is only supposed to be given to people with the most severe nausea, such as those undergoing radiation or chemotherapy treatments. Although the Food and Drug Administration only approved the drug in 1991 for these most severe cases, the lawsuit states, doctors regularly use it "off-label" to treat "morning sickness." Still, as early as 1992, the company started receiving "mounting evidence of reports of birth defects associated with Zofran," the suit states.

In 2012, the company settled with the FDA and pleaded to criminal charges for its off-label promotion of the drug, the lawsuit states, as well as settling about $1 billion worth of civil lawsuits. The suit says Anderson's child was born in 2006 with several congenital defects to his heart and lungs after his mother had begun taking the drug early in her first trimester and continued to take it well into her final trimester.

Alexander seeks unspecified damages above the court's $75,000 jurisdictional limit, a full refund on Zofran purchases, consequential and compensatory damages, attorney fees and court costs. She is represented by attorneys Leonard A. Davis, James C. Klick and Danielle T. Hufft of Herman Herman & Katz in New Orleans, as well as attorneys Jay W. Eisenhofer and Caitlin M. Moyna of Grant and Eisenhofer in New York, and M. Elizabeth Graham and Thomas V. Ayala in Wilmington, Del.

U.S. Court District of the Eastern District of Louisiana case number 2:15-cv-02323-ILRL-MBN.

More News