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Zoll & Kranz, LLC is stepping up its investigation into congenital birth defects, including heart defects, cleft palate, and cleft lip injuries caused by Zofran. Zofran, also known generically as Ondansetron, was developed by GlaxoSmithKline (GSK) to treat nausea caused by chemotherapy.
Zofran LawsuitHowever GSK promoted Zofran off label for morning sickness. Recent studies have shown that Zofran crosses the placental barrier, and if taken during the first trimester can cause heart defects and cleft palate. It is a serotonin 5-HT3 receptor antagonist .
Researchers Anderka M, Mitchell AA, Louik C, et al. studied medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94: 22–30. That large control study by the Sloan epidemiology unit and the Centers of Disease Control and Prevention detected a 2-fold increased risk for cleft palate associated with ondansetron taken in the first trimester of pregnancy [odds ratio = 2.37 (95% CI, 1.28–4.76)].
According to the United States Department of Justice, “GSK agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.” The U.S. Department of Justice further stated that the charges included claims for promoting “Zofran for off-label, non-covered uses” and was “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”
The FDA has issued Drug Safety Communications (link to the 2012 Drug Safety Communication), for use in pregnancy, but this comes too late for many kids. If you took Zofran during your first trimester of pregnancy and your child was born with a cleft palate, cleft lip, heart defect, or similar problem, we would like to talk to you and order copies of your prescription records. Call toll free 1-888-841-9623. There is no cost and no fee unless we obtain a recovery.
Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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