GlaxoSmithKline the pharmaceutical manufacturers of Zofran recently filed a motion to consolidate all Zofran birth defect lawsuits before a single judge into a multi-district litigation.

Treating individual lawsuits as a multidistrict litigation brings all the individual lawsuits under a single judge allowing the pretrial discovery process to be streamlined and prevent inconsistent pretrial rulings from occurring.

The motion was filed on July 6 and GlaxoSmithKline is requesting that the Zofran birth defect lawsuits be consolidated in the U.S. District Court for the Eastern District of Pennsylvania.

Zofran, generically known as ondansetron, is a popular anti-nausea medication on the market. The medication was approved by the Food and Drug Administration in 1991.

Zofran was approved to treat vomiting and nausea in patients who recently underwent surgery or who are undergoing chemotherapy.

However, Zofran is not FDA approved to treat morning sickness in pregnant women, but at times doctors have prescribed the medication for this off-label use.

An off-label use means any use not approved FDA. While doctors are allowed to prescribe medications for off-label uses, it is illegal for drug manufacturers to market and publicize drugs for off-label uses.

Unfortunately for many pregnant women, studies suggest that using Zofran while pregnant, especially during the first trimester, can lead to a heightened risk of birth defects.

Zofran birth defects include cleft lip and cleft palate, heart defects, kidney defects, musculoskeletal defects, poor fetal growth, and fetal death.

This classification was based on information provided from fewer than 200 births, over the years several other Zofran studies have been performed and some of them suggest that Zofran can be harmful to a developing fetus.

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.”

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.

Overview of Zofran Lawsuits

Several Zofran birth defect lawsuits have been filed against GlaxoSmithKline. The lawsuits generally allege that the pharmaceutical company violated consumer protection laws and failed to warn the medical community and general public about serious risks associated with taking the medication.

Awards and settlements from these Zofran lawsuits will help victims pay for past and future medical bills and will serve as a small step towards compensating them for the pain and suffering they have been forced to endure due to taking the medication.