Zofran heart defect cases continue to mount U.S. courts, as more families seek restitution for congenital abnormalities allegedly caused by the anti-nausea medication. One of the most recent lawsuits was filed by a Kansas woman whose son was born with an atrial septal defect after she was prescribed Zofran to alleviate nausea and vomiting throughout her pregnancy.
An atrial septal defect, also known as a hole in the heart, occurs when a hole develops in the wall that separates the top two chambers of the heart (the atria). Depending on its severity, an atrial septal defect may be life-threatening, and require that an infant undergo open heart surgery to repair the malformation.
According to the Zofran lawsuit currently pending in the U.S. District Court, District of Kansas, the child’s mother began taking the anti-nausea medication in the first trimester of pregnancy to alleviate morning sickness, and continued using the medication through the third trimester. Her son was born on November 12, 2013, with an atrial septal defect that the complaint claims was the result of his exposure to Zofran in-utero. Among other things, the plaintiff asserts that there is no known genetic cause for her son’s condition, and alleges that there is no history of birth defects in their family.
Like other Zofran birth defects cases currently pending in U.S. courts, this complaint accuses GlaxoSmithKline of concealing evidence linking the drug to fetal harm, and of failing to warn patients and doctors of its risks. The company is also accused of wrongly marketing Zofran as a safe and effective treatment for pregnancy-related nausea and vomiting, even though the drug has never been approved by the U.S. Food & Drug Administration for this indication. The complaint charges that this aggressive and fraudulent marketing campaign has made Zofran the single most popular drug for the treatment of morning sickness.
The Zofran heart defect complaint also cites numerous studies that suggest exposure to the medication in the womb can increase the likelihood that a child will be born with birth defects. In addition, the plaintiff claims that Glaxo has received more than 200 reports of birth defects in children who were exposed to Zofran during pregnancy. “The most commonly reported birth defects arising from Zofran use during pregnancy and reported to GSK were congenital heart defects, though multiple other defects such as orofacial defects, intrauterine death, stillbirth and severe malformations in newborns were frequently reported,” the complaint states.
The Kansas Zofran case is just one of dozens of birth defect claims involving the drug that have been filed in U.S. courts this year. In July, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a centralized proceeding for all federally-filed Zofran birth defect claims in the U.S. District Court, District of Massachusetts. As of November 16th, more than 100 cases were pending in that litigation.
Bernstein Liebhard LLP has been retained by a number of Zofran lawsuit plaintiffs who blame the drug for their child’s birth defects. If you would like to pursue a similar case, please call to schedule a free, no-obligation case review with a member of our legal team today.