Families File Lawsuits After Studies Link Zofran To Birth Defect Risks

June 02, 2015 – – Zofran, a medication manufactured by GlaxoSmithKline, is approved for the treatment of severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia. But immediately after the drug’s initial approval in 1991, physicians quickly found another use for the potent anti-nausea medication: the treatment of morning sickness during the first trimester of pregnancy.

Zofran has never been approved for use during pregnancy. In fact, GlaxoSmithKline has never studied the drug’s effects on pregnant women or their unborn babies.

Despite this critical lack of understanding, estimates now place the number of prescriptions for Zofran’s unapproved use during pregnancy around 1 million every year. Medical experts have proposed several theories to explain Zofran’s widespread adoption as an “off label” treatment during pregnancy, including a thirty year drought in which America had no FDA-approved treatment for morning sickness. But in 2012, the federal government brought another possibility to light. In a landmark case of alleged health care fraud, the US Department of Justice charged GlaxoSmithKline with actively promoting Zofran as a “safe and effective” drug for pregnant women to take. Federal law prohibits pharmaceutical companies from promoting their products for unapproved uses, but according to federal prosecutors, the company prepared marketing materials for obstetricians and gynecologists that presented Zofran as a safe, effective treatment for morning sickness. Although the company ultimately settled the government’s case for $3 billion, GlaxoSmithKline continues to deny all allegations that it promoted Zofran unlawfully.

Spurred by Zofran’s rapid rise in off label prescription, teams of researchers from across the globe set out to investigate the drug’s potential effects on developing babies in utero. Their studies reviewed hundreds of thousands of live births, in search of differences between pregnancies exposed to Zofran’s active ingredient and those unexposed. Several teams have now published their reports, with troubling findings. Researchers at Harvard linked Zofran to a 2.37 times increase in the risk of cleft palate. Scientists in Denmark and Sweden have found significantly increased risks of congenital heart defects in at least two separate studies. A team in Australia tentatively linked Zofran to a class of rare kidney malformations.

As evidence of Zofran’s potential to adversely affect fetal development grows, American families have begun to file personal injury lawsuits against GlaxoSmithKline. These parents repeat the allegations made by the federal government in 2012, saying that the company unlawfully promoted Zofran for use during pregnancy. But their new allegations go further.

In at least seven separate legal claims, families from across the nation allege that over the course of two decades, GlaxoSmithKline has received mounting evidence of Zofran’s association to major birth defects. But rather than alert the public and medical community, and attempt to discourage the drug’s use during pregnancy, plaintiffs say that GlaxoSmithKline actively concealed the results of preclinical trials and birth defect reports from the FDA. All the while, the company continued to promote Zofran as an “off label” treatment during pregnancy, plaintiffs allege.

If these allegations are true, any woman who was prescribed Zofran during the first trimester and then delivered a child with birth defects may be eligible to file an individual legal claim. Families interested in learning about their own case eligibility can find more information on ZofranLegal.com. The website, an informational resource that provides detailed reviews of scientific findings and current Zofran birth defect lawsuit filings, is sponsored by a national alliance of plaintiffs’ attorneys. Led by Michael Monheit, Esq., managing partner at Pennsylvania’s Monheit Law, the team of attorneys is dedicated to protecting the rights of birth defect survivors and families. They are currently offering free consultations to any individual who believes they may have been harmed by prenatal exposure to Zofran.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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