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Michael Monheit
Michael Monheit
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Illinois Woman Says Zofran Caused “Life-Threatening” Birth Defects


Zofran is a potent anti-nausea medication manufactured by GlaxoSmithKline. And while Zofran’s active ingredient, ondansetron, has never been approved for use during pregnancy, doctors frequently prescribe the drug “off-label” as a treatment for morning sickness. But hundreds of families say that Zofran causes major birth defects.

Zofran Led To Termination Of Pregnancy, Plaintiff Claims

In a new Zofran lawsuit (.PDF), a woman from Illinois says that her Zofran prescription led to tragic consequences. In court documents obtained by attorneys at Monheit Law, the woman claims that she was forced to terminate a 2014 pregnancy due to “severe physical malformations” allegedly induced by her unborn child’s exposure to Zofran.

The woman’s lawsuit was filed in the US District Court of Massachusetts on July 25, 2016. Logged under the case number 1:16-cv-11536-FDS, her complaint joins more than 250 similar lawsuits that have been consolidated in the Boston federal court.

Plaintiff became pregnant in 2014, according to court documents, and was soon prescribed Zofran to “alleviate the symptoms of morning sickness.” But in July of that year, a diagnostic test revealed that her unborn child had developed congenital malformations, including “severe and life-threatening abdominal defects.” The malformations, Plaintiff contends, “were the direct and proximate result of prenatal exposure to Zofran.” In August, Plaintiff terminated her pregnancy.

GlaxoSmithKline Promoted Zofran For Morning Sickness, Parents Allege

Echoing families from across the country, the woman accuses GlaxoSmithKline of promoting Zofran – in violation of federal law – as a morning sickness drug. She is not alone in her damning allegation. In fact, the US Federal Government has made the same assertion.

In a case that ultimately led to the largest settlement for alleged health care fraud in US history, the Department of Justice accused GlaxoSmithKline of marketing Zofran directly to obstetricians and gynecologists. According to federal prosecutors, GlaxoSmithKline attempted to corner the market for morning sickness treatments by promoting its nausea drug illegally.

GlaxoSmithKline continues to deny these allegations, but Plaintiffs are insistent. As the Illinois woman writes in her complaint, “had she not been misled by GSK’s promotion of the drug’s purported safety benefits for sue during pregnancy, on which she reasonably relied, Plaintiff would not have taken branded or generic Zofran during pregnancy and [her] baby would have been born a healthy child.”

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