In an unusual move, lawyers for defendants GlaxoSmithKline (GSK) recently filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) in Washington D.C., whereby they moved for consolidation of all federally filed lawsuits involving allegations that Zofan (Ondansetron) caused certain child birth defects. In a mass tort, usually most defendants fight or oppose consolidation in favor of individually dealing and coordinating with the litigation.
To date there have been 15 Zofran lawsuits in total filed all containing similar allegations against GSK.
A Background On The Zofran Lawsuits
Zofran was first approved by the Food and Drug Administration (FDA) as a anti emetic for combating extreme nausea faced by those on radiation or cancer therapy treatments. This approval came in 1991. Shortly after approval, the drug was marketed by GSK “off-label” to the pregnant moms market. 75% of all pregnant women in the US, suffer from morning sickness. Some suffer from a recognized condition known as Hyperemesis Gravidarum, which is an extreme form of morning sickness that causes severe dehydration and often requires hospitalization so that IV fluids can return the hydration levels. Zofran became the “g0-to” prescription by the medical community to deal with PRN (pregnancy related nausea) and hyperemesis gravidarum.
There have been several studies published by the medical community analyzing the effects of Ondansetron on fetal development. Some of the studies have returned very concerning, statistically significant risk data. These studies have suggested that conditions such as those mentioned below have more than a 2X increased risk of occurrence where the mother took Zofran for morning during the first trimester of pregnancy:
- Atrial Septal Defect
- Atrio Ventricular Septal Defect
- Ventricular Septal Defect; and
- Cleft Palate
In light of the science, and large number of adverse events reported to the FDA, and allegedly to GSK as early as the mid 1990’s, lawsuits are being filed by parents of children who were born with child birth defects where Zofran was taken during the first trimester. All complaints allege that GSK knew about the risks but chose to not warn women or the medical community about those risks.
The Motion To Form A Zofran MDL
The latest filing by GSK to consolidate cases requested two specific judges to preside over discovery and pretrial motions in Philadelphia, PA. To date, there have been no cases filed in Philadelphia or the Commonwealth of Pennsylvania, however GSK argue that it would be a convenient venue for them given their large presence in Philadelphia with over 1,000 staff working there.
We await the response to the consolidation motion from Plaintiffs and a decision from the JPML when it hears arguments in October. The Legal Herald will as always be here to keep you up to date.