Zofran Blamed for Cleft Palate in New Montana Lawsuit

Published on April 14, 2015 by Sandy Liebhard

Zofran, an anti-nausea drug often used off-label to alleviate nausea and vomiting related to pregnancy, is the subject of yet another product liability claim over its alleged association with birth defects. This newest Zofran lawsuit claims that GlaxoSmithKline failed to warn patients about the medication’s purported link to cleft lip and palate.

The complaint, which was filed earlier this month in Montana federal court, was brought on behalf of a child who was born in 1998. Prior to her birth, the child’s mother was treated with Zofran early in her first trimester to alleviate the symptoms of morning sickness. The complaint points out that the medication was never approved by the U.S. Food & Drug Administration for this use, and alleges that Glaxo improperly marketed Zofran as a safe and effective treatment for morning sicknesses. The lawsuit further asserts that Glaxo’s “off-label” promotion of the drug for this purpose constitutes fraudulent marketing.

Zofran Cleft Palate Allegations

“Since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy. GSK has been aware that Zofran readily crosses human placental barriers during pregnancy,” the complaint states. “GSK has also been aware that the animal studies of Zofran cannot reliably support an assertion that Zofran can be used safely or effectively in pregnant women.”

In addition to detailing studies that have tied Zofran to birth defects, the lawsuit points out that Glaxo agreed to pay $3 billion to resolve criminal and civil charges relating to the marketing of several medications. Among other things, the U.S. Department of Justice (DOJ) has accused the company of illegally marketing Zofran as a treatment for morning sickness, and paying health care providers illegal kickbacks to induce them to prescribe the medication.

The complaint further notes that the plaintiff has undergone 10 surgeries to correct the cleft lip and palate she allegedly sustained due to Zofran, and will likely require further care in the future.