A Zofran birth defects lawsuit filed against GlaxoSmithKline by a Kentucky couple alleges the side effects of using the drug caused the death of their seven-month-old son.

Plaintiffs Heather and Timothy B. accuse manufacturer GSK of failing to warn about the risks of Zofran birth defects when the anti-nausea drug is taken during pregnancy.

In their Zofran birth defects lawsuit, Heather and Timothy accuse GSK of loss of consortium, negligence, wrongful death, design defect, failure to warn, breach of implied warranty, breach of express warranty, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, and violation of Kentucky’s Consumer Protection Act.

The Zofran Birth Defects Lawsuit is Case No. 7:15-cv-00084-ART-EBA, in the U.S. District Court for the Eastern District of Kentucky.

What is Zofran?

Zofran (ondansetron) is an anti nausea drug manufactured, marketed, and sold by GSK. Zofran was approved by the FDA in 1991 as a nausea and vomiting treatment for chemotherapy patients and for those undergoing surgery.

It is not approved as a morning sickness treatment. However, doctors are allowed to prescribe drugs like Zofran for off-label uses if they believe it would be beneficial to their patients.

Several Zofran lawsuits allege GSK illegally promoted its anti-nausea drug as a morning sickness treatment and said that Zofran is safe to use during pregnancy. Even though doctors can prescribe for off-label uses, pharmaceutical companies cannot promote a drug for uses not approved by the FDA.

Lawsuits alleging use of Zofran by pregnant mothers report the following birth defects:

• Cleft lip and cleft palate
• Heart defects
• Kidney defects
• Musculoskeletal defects
• Poor fetal growth
• Fetal death

Parents with children suffering from Zofran birth defects are pursuing lawsuits against GSK for allegedly failing to warn them of the risk of birth defects by taking Zofran during pregnancy.