In December 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) granted consolidated pretrial proceedings for all federal Xarelto cases filed against Bayer and Johnson & Johnson’s Janssen subsidiary over the new-generation blood thinner.
Bayer and Johnson & Johnson is now exposed to at least 220 bleeding cases in the federal multi-district litigation (MDL), with more on the way.
According to experts the total tally may be in the several thousands before the litigation is over.
The plaintiffs blame the manufacturers for severe, and often fatal, bleeding injuries were caused by Xarelto side effects.
Xarelto Lack of Adequate Warnings
Plaintiffs allege that the drug manufacturers neglected to adequately warn about the risks associated with the new-generation anticoagulant and the lack of an effective antidote for Xarelto, in the event of uncontrollable bleeding.
Xarelto Uncontrollable Bleeding Risks
Xarelto (rivaroxoaban) is a new-generation anticoagulant approved in 2011 as a replacement for Coumadin (warfarin). Coumadin, has been the “gold standard” medication for prevention of blood clots and strokes in patients with atrial fibrillation, a common heart rhythm for the past 60 years.
All blood thinners carry a risk of bleeding, BUT Xarelto has been linked to a severe injuries as more patients are transferred over to the new blood thinner.
Xarelto has been touted as a safer alternative to Coumadin, with the drug makers promoting that it is easier to use, since it does not require regular blood tests to measure its effectiveness.
According to several recent studies there are concerns about those claims, with researchers noting that Xarelto blood tests may help doctors identify patients at the greatest risk of bleeding.
Additionally, plaintiffs blame the drug makers for withholding critical information about the lack of a Xarelto reversal agent, which doctors could use to stop hemorrhaging.
Coumadin’s blood thinning effects can be quickly reversed in an emergency, there is no similar antidote for Xarelto.
Xarelto Federal MDL Lawsuits
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.
As part of the coordinated pretrial proceedings, it is common in complex pharmaceutical and medical device mass tort litigation, that a small group of cases will be selected as “bellwether” cases.
These lawsuits will be prepared for early trial dates to help the parties determine how juries may respond to certain evidence and similar testimony that is likely to be repeated throughout the litigation.
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.