Monheit Law Reports: Two Zofran Lawsuits Filed After Researchers Link Anti-Nausea Drug To Cleft Palate

June 24, 2015 – – In two recent lawsuits, parents claim that GlaxoSmithKline’s anti-nausea drug Zofran causes orofacial clefts, like cleft lip and palate. According to attorneys at Monheit Law, a firm currently investigating potential Zofran birth defect claims, families allege that GlaxoSmithKline unlawfully promoted Zofran as a morning sickness treatment, while concealing evidence that the drug could potentially increase birth defect risks. The claims come on the heels of multiple large studies linking prenatal Zofran exposure to increased rates of birth defects, including orofacial clefts.

Registered under case number 1:15-cv-00026-SPW-CSO, the first complaint was filed on April 3, 2015 in the US District Court for the District of Montana, Billings Division. Along with her husband, a mother claims that she was prescribed Zofran “early in her first trimester” to control the symptoms of morning sickness. Her daughter, born in 1998, “was diagnosed with […] cleft lip and palate at birth.” In her first sixteen years of life, plaintiff’s child has “been forced to undergo ten surgeries,” the parents write. “Had [she] known the truth about Zofran’s unreasonable risk of harm[,] she would never have taken Zofran, and her child would never have been injured,” plaintiff claims.

The second complaint was brought on May 21, 2015. Filed in the US District Court for the Eastern District of Arkansas, Western Division, the lawsuit is registered under case number 4:15-cv-00284-BRW. Plaintiff claims that she was prescribed Zofran during the September of 2011. She delivered her son, who was born with a “partial cleft lip,” on June 1, 2012. At only three months old, the child “underwent corrective surgery […] to repair his lip,” plaintiff says, and now lives with a “permanent scar […] that is often red and inflamed.” Their son has also experienced developmental delays, due to the sedations required during his corrective procedure. Plaintiffs say that their child has visited multiple treatment specialists, and “it took him longer to speak and walk than the average infant.”

A copy of these Zofran birth defect complaints can be found at ZofranLegal.com.

In both lawsuits, plaintiffs note that Zofran has never been approved for use during pregnancy. Zofran is only approved to treat severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia. But according to many medical experts, a lack of FDA approval has not stopped physicians from prescribing the drug to alleviate morning sickness. Recent estimates have found that as many as 1 million Zofran prescriptions are written for pregnant women every year.

In 2012, the US Department of Justice proposed its own explanation for Zofran’s rapid rise in “off label” popularity. After eight years of investigation, the federal government charged GlaxoSmithKline for marketing a number of drugs, including Zofran, for unapproved uses. In court documents, the government accused GlaxoSmithKline of making unsubstantiated and / or false statements about Zofran’s safety during pregnancy, in violation of federal law. While the company ultimately settled the government’s allegations, it continues to deny promoting Zofran for off label use.

But plaintiffs in recent lawsuits are insistent, even saying that GlaxoSmithKline “continues to negligently and misleadingly market […] Zofran to consumers.” They blame this alleged “off label” promotion for placing a drug with potentially disastrous effects for unborn children into the hands of pregnant women across the country. Many of these lawsuits claim damages on behalf of children born with congenital heart defects, which have been linked to Zofran by no less than three major epidemiological studies. But the first study to investigate Zofran’s potential effects on fetal development, conducted by researchers at Harvard and Boston Universities, found a 2.37 times increase in the rate of cleft palate.

Plaintiffs now claim that GlaxoSmithKline failed to adequately respond to these study results. Rather than warning the public and medical community of Zofran’s potential association to major birth defects, parents say the company has actively concealed vital safety information from patients.

If these allegations are true, any mother who was prescribed Zofran as a morning sickness treatment and delivered a child with major birth defects may be able to file a lawsuit against GlaxoSmithKline. Monheit Law has joined forces with an alliance of distinguished plaintiffs’ attorneys to investigate potential claims. For more information and a free case evaluation, call 1-877-620-8411.

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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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