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On April 24, 2015, a woman from Randolph, Massachusetts filed one of the most recent lawsuits to claim that Zofran, an anti-nausea drug manufactured by GlaxoSmithKline, causes severe birth defects. In her complaint, she alleges that prenatal exposure to Zofran led to the development of “severe and life-threatening abdominal defects” in her unborn child. As a result of these critical abnormalities, plaintiff says that she was forced to terminate her pregnancy.

Her complaint was filed in the US District Court for the District of Massachusetts, Eastern Division under case number 1:15-11627. A copy of the court documents can be read at

Severe Abdominal Defects Caused By Zofran Forced Termination Of Pregnancy, Plaintiff Alleges

In filing her complaint, this new plaintiff adds yet another voice to the growing Zofran litigation. At least ten plaintiffs now allege that GlaxoSmithKline has been concealing evidence of its potent anti-nausea drug’s potential to increase birth defect risks for more than two decades.

Plaintiff claims that she was prescribed the drug as an “off label” morning sickness treatment, early in a pregnancy that began in May of 2013. She notes that Zofran has never been approved for any use during pregnancy. Six months later, a routine diagnostic examination revealed that her unborn child “had developed severe physical malformations, including […] life-threatening abdominal defects.” Plaintiff writes that she was forced to “terminate her pregnancy on or about October 16, 2013.”

Plaintiff Claims GlaxoSmithKline Unlawfully Promoted Zofran As Morning Sickness Treatment

Zofran was first approved in 1991, but only as a treatment for nausea and vomiting in chemotherapy patients. As plaintiff writes, GlaxoSmithKline had never even studied Zofran’s potential effects on fetal development in controlled clinical trials. But this lack of approval did not stop the company from exploiting another, lucrative market: pregnant women suffering from morning sickness, plaintiff claims. She says that immediately after the drug’s initial approval, GlaxoSmithKline “launched a marketing scheme to promote Zofran to obstetric[ians] and gynecolog[ists] as a safe treatment alternative for morning sickness.”

Her allegations echo charges first leveled in 2012 by the US Federal Government. The US Department of Justice claimed GlaxoSmithKline had promoted Zofran as a “safe and effective” morning sickness treatment, without FDA approval and thus in violation of federal law. The case would eventually result in the largest settlement for alleged health care fraud in US history.

Company Concealed Evidence Of Zofran’s Risk From Patients & Doctors, Plaintiff Says

But plaintiffs in Zofran birth defect lawsuits have gone even further. Families and survivors claim that GlaxoSmithKline hid early pre-approval evidence of Zofran’s possible risks from the US Food & Drug Administration. In recent years, they say that GlaxoSmithKline has failed to adequately respond to a series of studies that have found an association between prenatal exposure to Zofran and an increased risk of congenital heart defects and cleft palate.

In addition, claimaints have alleged that GlaxoSmithKline began receiving reports of birth defects, fetal abnormalities with suspected ties to Zofran exposure, as early as 1992. They say that the company has received more than 200 such reports to date, and accuse GSK of failing to “disclose[…] these reports to pregnant women or their physicians.”

The plaintiff in case 1:15-11627 claims that if she had been informed of Zofran’s association to major birth defects, she would not have taken the drug during pregnancy and her pregnancy “would have progressed to term with a healthy child.”

More Families May Be Eligible To File Zofran Birth Defect Claims

Monheit Law has assembled a national coalition of plaintiffs’ attorneys to investigate the claims of parents who believe that prenatal exposure to Zofran may have caused their children to develop major birth defects in utero. Any woman who was prescribed Zofran as an “off label” morning sickness treatment and delivered a child with congenital abnormalities may be able to file a lawsuit against GlaxoSmithKline.

Led by Michael Monheit, Esq., the attorneys of are currently providing free consultations and Zofran case eligibility evaluations. To learn more about legal options, call 1-877-620-8411.

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