The parents of a child born with a cleft palate birth defect have filed a Zofran lawsuit against GlaxoSmithKline (GSK), alleging that side effects of the anti-nausea drug used during pregnancy caused their unborn baby to suffer a congenital malformation.

The Zofran birth defects lawsuit was filed on April 4 by Montana residents Leslie and Pam M., both individually and on behalf of their daughter who was born in 1988 and is identified in the claim as “M.M.”

According to the Zofran lawsuit, allegations were first raised by the U.S. Department of Justice that GlaxoSmithKline marketed Zofran ‘off label’ as a safe and effective treatment for morning sickness.

The Zofran lawsuit contends that GSK alleged fraudulent marketing of Zofran continued in spite of the fact that GSK “had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero ” and that GSK “knew that Zofran was unsafe for ingestion by expectant mothers.”

The Zofran lawsuit mentions studies performed in the 1980s on pregnant animals, and claims that these tests “revealed evidence of toxicity, intrauterine deaths and malformations in offspring.” The plaintiffs allege that “GSK did not disclose this information to pregnant women or their physicians.”

As a result of her birth defect, the plaintiffs claim their daughter has “been forced to undergo ten surgeries within her first sixteen years of life and more are planned and likely.”

The Zofran lawsuit states that the cleft palate birth defect “impairs her development and enjoyment of a normal life at home and at school.”

Studies Suggest Possible Risk of Zofran Birth Defects

Zofran (ondansetron) is an anti-nausea medication approved by the FDA as a treatment for nausea and vomiting among cancer patients undergoing chemotherapy. However, the drug is also commonly prescribed off-label to pregnant women suffering from morning sickness.

While taking Zofran during pregnancy is considered to be safe by many, a growing number of studies have highlighted the potential link between Zofran use among pregnant women and an increased risk of serious birth defects in babies, including a cleft palate.

One of these Zofran birth defects studies published in 2012 in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology warns that women taking Zofran while pregnant may be 2.37 times more likely to give birth to a child with a cleft palate birth defect.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defects Lawsuits

As restitution, Leslie and Pam M. bring claims for “compensatory and punitive damages, as well as equitable relief in an effort to ensure that similarly situated mothers-to-be are fully informed about the risks, benefits and alternatives attending drugs marketed for use in pregnant women.”

If you believe you or a loved one has been adversely affected by Zofran side effects, such as a birth defect like a cleft palate, you may be eligible to file a Zofran Birth Defects lawsuit.

The Zofran Cleft Palate Lawsuit is Case No: 1:15-cv-00026-SPW-CSO filed in the U.S. District Court of Montana.