September 21, 2015 — Bayer and Janssen Pharmaceuticals are facing about 1,700 lawsuits involving uncontrollable bleeding from the blood-thinner Xarelto.
The Judicial Panel on Multidistrict Litigation (JPML) released statistics (PDF) on September 15, reporting that 1,694 cases were pending in the Eastern District of Louisiana (MDL No. 2592) under Judge Eldon E. Fallon.
Judge Fallon has set “bellwether” trial dates starting as early as August 2016. Two trials will occur in Louisiana, followed by Texas and Mississippi. The outcome of each trial is not binding on other cases in the litigation, but will help resolve cases involving similar injuries.
All of the lawsuits accuse Janssen Pharmaceuticals and Bayer of downplaying the risk of uncontrollable bleeding and cherry-picking good data from studies to market Xarelto.
The problem is that when Xarelto was introduced in 2011, it had no reversal agent. In an emergency, doctors might struggle to reverse its blood-thinning effects. Dozens of deaths and thousands of adverse events have been reported in the last three years.
Xarelto was designed to replace warfarin (Coumadin), a blood-thinner that has been on the market since the 1950s. The big difference is that warfarin can be reversed with a dose of Vitamin K, but not even dialysis can remove Xarelto from a patient’s bloodstream.