A mother in California has filed a Zofran lawsuit alleging her child is the victim of a heart defect brought on by the anti-nausea medication, which she was prescribed during her first trimester of pregnancy. According to a complaint filed in Alameda Superior Court on March 6th, the baby was born in 2010 with a type of cardiac arrhythmia called supraventricular tachycardia, or SVT.
Court documents indicate that the complaint is one of at least three Zofran birth defect claims filed in U.S. courts over the past month, all of which involve cardiac malformations. The first was filed on February 12th in the U.S. District Court, Eastern District of Pennsylvania, by a woman who alleges her use to the medication during both of her pregnancies in 2004 and 2006 caused two of her children to be born with serious heart abnormalities. A second complaint was filed in the U.S. District Court, District of Massachusetts, on February 16th that seeks compensation for a child who was allegedly born with several congenital heart abnormalities, including atrial septal defect, right ventricular hypertension and aortic arch hypoplasia, due to the mother’s use of Zofran during the first trimester of pregnancy.
All of these lawsuits share a number of common factual allegations. For one thing, they all point out that Zofran was never approved to treat pregnancy-related nausea and vomiting, and accuse GlaxoSmithKline of illegally promoting its use for this purpose. While doctors are legally permitted to use prescription mediations in any way they see fit, pharmaceutical companies are forbidden from marketing their products for unapproved (off-label) indications.
The Zofran lawsuits also claim that Glaxo knew in the 1980s of animal studies that indicated the drug could cross the placental barrier in pregnant mammals. Plaintiffs also claim that between 1992 and 2000, the company received around 200 reports of Zofran birth defects in children born to women who were prescribed the medication during their pregnancy, but failed to inform regulators or the medical community of these cases. They also cite studies which investigated the possible association between ondansetron and birth defects, including research from 2013 that drew data from more than 900,000 pregnancies included in a Danish health registry. That research suggested the drug could increase the risk for birth defects, including heart malformations.