Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are exposed to at least 50 product liability lawsuits over their new-generation anticoagulant Xarelto.

Johnson & Johnson and Bayer introduced Xarelto three years ago, claiming it could change the quality of people’s lives who need to take anticoagulants (blood thinning medication) daily. Now there are already so many Xarelto lawsuits filed alleging the drug caused severe complications that an MDL has been created.

The Xarelto lawsuits allege that the drug manufacturers failed to warn about the potential Xarelto side effects, which caused patients to develop uncontrollable gastrointestinal bleeding that resulted in hospitalizations, the need for blood transfusions and in severe cases death.

According to the Xarelto lawsuits, severe injuries and deaths were avoidable if the pharmaceutical companies had not provided misleading information about the blood monitoring, and if stronger warnings had been provided about the lack of a Xarelto reversal agent or antidote.

These personal injury and wrongful death claims are now consolidated into a Xarelto MDL in the Eastern District of Louisiana.

Xarelto Bleeding Lawsuits

The U.S. Judicial Panel on Multidistrict Litigation recently announced consolidation and centralization of all nationwide Xarelto lawsuits filed in federal courts before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana. Judge Fallon oversaw the MDL proceedings for thousands of Avandia lawsuits and several other complex product liability claims.

In complex pharmaceutical lawsuits, coordinated pretrial proceedings are established where a large number of lawsuits are filed over personal injuries. The MDL has an important role in streamlining the litigation process, as all plaintiffs and defendants are under one roof. Coordinated discovery and bellwether trials can be set to determine the strength of the claims.

If the parties fail to negotiate a settlement or resolve the litigation following pretrial proceedings, Judge Fallon may remand cases back to the U.S. Districts where they were originally filed for separate trial dates in the future.

The Problem With Xarelto

Unlike Warfarin or Coumadin, alternative blood thinners that required constant blood monitoring, Xarelto was touted as a revolutionary product that was the only once-a-day prescription blood thinner for atrial fibrillation patients that was not caused by a heart valve problem that did not burden the patient with constant monitoring.

Xarelto drug makers claim that it is easier to use, since it does not require regular blood monitoring. Some medical experts, however, suggest that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

Coumadin has been the go-to blood thinner for the prevention of strokes among patients with atrial fibrillation for the past 60 years. While all blood thinners have side effects and increased risk of bleeding problems, Xarelto has been associated with an increasing number of adverse event reports involving uncontrollable bleeding injuries.

Warfarin bleeds can be quickly reversed in the case of an emergency with vitamin K and blood transfusions. However, there is no approved bleeding antidote available for patients using Xarelto, and many of the bleeding side effects have resulted in catastrophic outcomes after doctors were unable to control Xarelto bleeds.