An Illinois woman has joined hundreds of other plaintiffs who are pursuing Zofran lawsuits over the anti-nausea medication’s alleged association with birth defects. According to her July 25th filing in the U.S. District Court, District of Massachusetts, the woman was forced to terminate a recent pregnancy due to “severe physical malformations” that she claims were caused by Zofran.
The Plaintiff became pregnant in 2014, and was prescribed Zofran by her physicians to alleviate symptoms of morning sickness. In July of that year, diagnostic testing revealed that her child was suffering from severe malformations, including “severe and life-threatening abdominal defects.” Her pregnancy was terminated in August 2014.
Her lawsuit claims that these birth defects were the “direct and proximate” result of her exposure to Zofran, and accuses GlaxoSmithKline of failing to provide doctors and patients with adequate warnings regarding the drug’s potential to harm a developing fetus.
“Had Plaintiff and/or her healthcare providers known of the increased risk of birth defects associated with Zofran, she would not have taken branded or generic Zofran during pregnancy, and her pregnancy would have progressed to term with a healthy child,” the complaint asserts.
While Zofran is approved to relieve nausea and vomiting related to surgery or certain cancer treatments, it has never been approved to treat morning sickness or any form of pregnancy-related nausea and vomiting. Yet data suggests that as many as 1 million women annually in the U.S. are prescribed the drug or a generic equivalent for this off-label indication. Zofran lawsuit plaintiffs assert that this practice is the result of an aggressive and improper campaign by Glaxo to market the drug for this unapproved purpose.
“GSK’s concealment and omissions of material facts concerning, among other things, the safety and efficacy of Zofran for pregnancy-related nausea was made purposefully, willfully, wantonly, and/or recklessly, to mislead physicians, hospitals and healthcare providers, and expectant mothers including Plaintiff, into reliance, continued use of branded or generic Zofran, and to cause them to promote, purchase, prescribe, and/or dispense Zofran,” this recent lawsuit charges.
Among other things, the complaint points out that in 2012, GlaxoSmithKline agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that involved a number of its medications. Among other things, the company had been accused of promoting Zofran as an off-label treatment for expectant mothers who experience nausea and vomiting.
The U.S. District Court, District of Massachusetts is home to a multidistrict litigation that includes at least 289 similar Zofran birth defects cases. Plaintiffs fault Glaxo for allegedly marketing Zofran for use in pregnant women, despite never having tested the drug to ensure it was safe for expectant mothers or their babies. They also cite a number of recent studies which suggest that pre-natal Zofran exposure can harm a developing fetus. These include a Dutch study involving 900,000 pregnancies found a doubled risk of heart defects and a 30% increased risk of birth defects overall. In another study published in 2012, Zofran was linked to a 2.4-fold increased risk of cleft palate.