Late last year, the U.S. Judicial Panel on Multidistrict Litigation 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.
Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are exposed to at least 86 product liability lawsuits over their new-generation anticoagulant. These personal injury and wrongful death claims are pending in 24 different federal courts.
According to experts, as Xarelto injury cases mount involving patients who experienced uncontrollable bleeding, it is anticipated that eventually several thousand cases will be transferred into the MDL.
Xarelto Uncontrollable Bleeding Allegations
The complaints all share the same allegations that the drug manufacturers failed to warn about the potential side effects of Xarelto, which caused patients to develop uncontrollable bleeding that resulted in hospitalizations, the need for blood transfusions and in severe cases death.
According to the claims, 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.
MDL Centralized in Eastern District of Louisiana
The Xarelto litigation has been centralized before Judge Fallon, who oversaw the MDL proceedings for thousands of Avandia lawsuits, Chinese drywall lawsuits and several other complex product liability claims.
In complex pharmaceutical claims 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, coordinate discovery and the 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.
What is Xarelto?
Xarelto (rivaroxoaban) was developed by Bayer and Janssen Pharmaceuticals in 2011, a new generation anticoagulant touted as a superior alternative to Coumadin (warfarin).
Xarelto was the second in a new-generation of anticoagulants recently released as a superior replacement for Coumadin, which has been the “gold standard” drug for prevention of blood clots and strokes in patients with atrial fibrillation.
Pradaxa was the first in this class, released by Boehringer Ingelheim in 2010. The medication rapidly achieved blockbuster status because the doctors embraced the drug wholeheartedly. Unfortunately, Pradaxa was also most commonly associated with FDA adverse event reports.
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.
Xarelto: No Antidote
Warfarin, can be quickly reversed in the case of an emergency, with vitamin K and blood transfusions. There is no approved antidote available for patients using Xarelto, and many of the bleeding side effects have resulted in catastrophic outcomes, after doctors were unable to control the bleeds.
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.
Recent Xarelto Complaints
Recently Harriet Ibanez, filed a claim in the U.S. District Court for the Eastern District of Louisiana. According to Ibanez, she was prescribed Xarelto to prevent strokes from atrial fibrillation in October 2013, and required hospitalization for severe bleeding and blood transfusions.
Also Ann Hartman, filed a claim in the U.S. District Court for the Central District of Illinois. According to Hartman, she suffered severe rectal bleeding after being prescribed Xarelto for treatment of deep vein thrombosis (DVT) and pulmonary embolism, also requiring hospitalization and blood transfusions.