A family hit by tragedy is suing pharmaceutical giant GlaxoSmithKline (GSK), alleging that the company knew that a generic version of its drug Zofran (ondansetron) caused fetal birth defects, but failed to warn patients.

Trish and Bryce Belanger have filed suit in Louisiana, claiming their two children developed birth defects after Trish used ondansetron to help treat her morning sickness.

Mother Used Zofran to Help Morning Sickness

GSK obtained a patent for ondansetron in 1988 and was approved by the US Food and Drug Administration (FDA) for sale in the US as Zofran in 1991. Generic versions of ondansetron were approved in December 2006. The Belanger’s children were born in 2009 and 2010.

Ondansetron was originally approved to ease nausea for chemotherapy patients. Its use then spread to help patients with other nausea-inducing conditions like radiation therapy, post-surgical nausea, and gastroenteritis.

“Off-Label” Use of Zofran Didn’t Have Adequate Warnings

Using ondansetron to treat morning sickness is considered an “off-label” use of the drug. An off-label prescription occurs when a doctor prescribes an FDA-approved drug to treat a disease or symptom for which the drug hasn’t been approved.

GSK Made Billions on the Nausea Drug

Before its patent expired, Zofran was a high-earning drug for GSK. In 2006, it was the 20th highest-selling drug in the US. Zofran made GSK $1.3 billion in only the first three quarters of 2006. Generics pharma companies Teva Pharmaceuticals USA and SICOR Pharmaceuticals picked up the rights to sell the unbranded generic version, ondansetron, at the end of 2006.

Parents’ Heartbreak Over Zofran Birth Defects

The Belangers claim that GSK knew the risks to pregnant women but continued to market the drug with inadequate warning labels.

Other parents across the country have also filed suit against GSK. In Alabama alone, 151 new cases were added to a lawsuit against GSK, including couples like Jon and Clara Rickman. Their son was born with heart defects they attribute to ondansetron, forcing the infant to endure open heart surgery at only four days old.

Studies on Zofran Birth Defects Mixed

One study on fetal safety with ondansetron looked at fewer than 200 births, finding no risks. However, other studies show increased risks for cleft palate, QT prolongation, and torsade de pointes. The US National Institutes of Health advise: “Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy.”

 

If you think Zofran or other pharmaceutical use may have caused a birth defect in one of your family members, you may be entitled to compensation. Talk to our legal team.