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Zofran Blamed for Birth Defects in Two New Lawsuits





Mothers, Cheri Flynn and Tomisha LeClair, were unaware there was a risk of birth defects when they took Zofran, an anti-emetic, for morning sickness during their pregnancies. The physicians prescribing Zofran were also unaware of these risks. However, pharmaceutical company GlaxoSmithKline, the manufacturers of Zofran, knew about the potential chance of birth defects, and illegally marketed and promoted the drug to physicians as safe for use in pregnant women.

Zofran (Ondansetron) is not approved by the Food and Drug Administration (FDA) as a treatment for morning sickness, or nausea and vomiting of pregnancy (NVP). According to FDA regulations, doctors may prescribe drugs for off-label use, but drug manufacturers may not promote such uses. Off-label use is using drugs for unapproved indications. In this case, Zofran is approved for treatment of nausea and vomiting related to chemotherapy, radiation, and surgery but not nausea and vomiting of pregnancy. Therefore, doctors may legally prescribe Zofran “off-label” to pregnant women but GlaxoSmithKline cannot legally promote those uses.

Ms. Flynn and Ms. LeClair filed product liability lawsuits against GlaxoSmithKline in February 2015. They both claim Zofran (Ondansetron) use during their respective pregnancies caused severe birth defects in their children. The respective lawsuits assert GlaxoSmithKline failed to warn consumers and medical professionals of the link between Zofran (Ondansetron) and an elevated risk of congenital heart defects, cleft lip and cleft palate. Ms. Flynn took Zofran during two of her pregnancies. Her complaint alleges taking Zofran during her pregnancies caused congenital heart defects in her children who were born in 2004 and 2006; Ms. LeClair claims her daughter suffers from heart malformations and a permanent developmental delay secondary to  Zofran (Ondansetron) use during her pregnancy. In addition, the lawsuits contend GlaxoSmithKline knew about the potential risks associated with Zofran (ondansetron) since initially manufacturing the drug in the 1980s.

This is not GlaxoSmithKline’s first time falsely misleading the public. In 2012, the United States government actually sued GlaxoSmithKline for promoting and marketing Zofran for off-label uses to doctors.  The lawsuit explicitly stated, “GSK knowingly: (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea); (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”  GSK plead guilty and eventually paid a $3 Billion fine in order to resolve fraud allegations and failure to report safety data. The failure to report safety data refers to the fact that Zofran has never been adequately tested and determined safe for use in pregnant women.

If you took Zofran (Ondansetron) in your first trimester of pregnancy, and your child was born with birth defects, call us for a free case consultation or fill out our confidential online form. We focus on your case, so you can focus on yourself.


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