GlaxoSmithKline (GSK) is facing yet another Zofran birth defect lawsuit that claims their anti-nausea drug Zofran features inadequate warnings for the birth defects that allegedly followed using Zofran during pregnancy.

Plaintiff Kim D., a Massachusetts resident, filed the Zofran lawsuit following her experience with adverse Zofran side effects, which allegedly includes giving birth to an infant with Zofran birth defects.

Overview

Zofran is an anti-nausea medication that is prescribed to treat only the most severe cases of nausea. Patients using Zofran are often undergoing cancer treatments (radiation or chemotherapy) and need a strong anti-nausea drug to ease their vomiting symptoms. However, many women are also prescribed Zofran to treat severe morning sickness, unaware of the Zofran birth defect risks associated with the drug.

According to Zofran birth defect lawsuits, GSK allegedly “marketed Zofran ‘off label’ as a safe and effective treatment for a very common side effect of a normal pregnancy” even though the company allegedly had “knowledge that such representations were utterly unsupported and unproven.” It is important to note that any drugs that a pregnant woman takes has the ability to cross the placenta and thus affect the fetus, much like researchers suspect Zofran did in many Zofran birth defects cases. 

GSK’s alleged actions could have put countless women at risk of giving birth to a child with Zofran birth defects. The anti-nausea treatment has been on the market since 1991, yet GSK has issued no warning about these alleged Zofran side effects.

Zofran Birth Defect Case

Kim reportedly used Zofran as her anti-nausea medication during her 2013 pregnancy. Kim’s “unborn child was diagnosed with severe and life-threatening fetal defects, including a severe abdominal malformation,” says the Zofran birth defect lawsuit. These birth defects allegedly led to a termination of pregnancy.

The plaintiff alleges in the birth defect lawsuit that Zofran caused her to experience “severe and ongoing pain, distress, suffering, and expense.” Kim further claims that had she been aware of potential Zofran side effects, she never would have taken the anti-nausea drug in the first place. The Zofran birth defect lawsuit goes on to allege that the plaintiff could not have suspected the dangers associated with taking the GSK anti-nausea medication during pregnancy.

Zofran has been regularly marketed off-label to women as an option for treating morning sickness even though no proper studies were performed to determine how Zofran would affect the fetus or infant. 

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Zofran birth defects may include:

• Cleft lip and cleft palate (2.4-fold increased risk)
• Heart defects (doubled risk)
• Kidney defects
• Musculoskeletal defects
• Poor fetal growth
• Fetal death (Note: the baby’s death must have been related to a birth defect to be eligible for a lawsuit claim)

Counts in this Zofran birth defect lawsuit include negligence, product liability, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, breach of warranty, and others.

This Zofran Birth Defect Lawsuit is Case No. 1:15-cv-11627, in the U.S. District Court for the District of Massachusetts, Eastern Division.