Coordination of Xarelto Bleeding Lawsuits Sought Between State and Federal Courts

As a growing number of Xarelto lawsuits continue to be filed on behalf of individuals throughout the country who have suffered severe or fatal bleeding problems, the parties involved in the cases are continuing to work to coordinate the litigation between the state and federal courts.

Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary currently face more than 300 personal injury and wrongful death lawsuits over the failure to warn about the bleeding risk with Xarelto. However, it is ultimately expected that several thousand complaints will be filed nationwide over the coming months and years.

In December, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings in the federal court system, centralizing all cases before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation. The process is designed to coordinate discovery into common issues that are expected to arise through all federal cases, avoid conflicting rulings from different U.S. District Judges and to serve the convenience of the parties, witnesses and the courts.

In addition to complaints filed in the federal court system, there are several hundred more cases pending in various state courts nationwide, including about 170 pending in Pennsylvania state court, where a Xarelto mass tort was established in January.

Judge Fallon recently held an MDL status conference on April 1, during which plaintiffs’ attorneys and defense attorneys discussed the plan for moving the Xarelto litigation forward.

According to minutes (PDF) issued by the Court following the meeting, Judge Fallon indicates that the parties continue to work on coordination between the MDL and state court actions.

The next status conference before Judge Fallon is scheduled for May 13.

Xarelto Bleeding Litigation

Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the “go-to” medication for prevention of blood clots and strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding injury, Xarelto has been linked to a surprising number of problems as more and more patients are switched to the novel anticoagulant.

Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

In addition to failing to warn about the risk of bleeding and importance of blood monitoring, plaintiffs claim that drug makers withheld information about the lack of a Xarelto reversal agent, which doctors could use to stop hemorrhaging that may develop among users.

While warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto.

Similar allegations were raised in the litigation over Pradaxa, which is another new-generation anticoagulant introduced by Boehringer Ingelheim in October 2010, one year before Xarelto hit the market. More than 4,000 Pradaxa lawsuits were filed by users of that drug who suffered bleeding injuries.

Following several years of litigation, Boehringer Ingelheim ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

As part of the coordinated pretrial proceedings in the MDL, it is expected that Judge Fallon will schedule a series of early trial dates, known as “bellwether” cases. While the outcomes of these trials will not be binding on other claims, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

If the parties fail to reach Xarelto bleeding settlements following the bellwether trial process, it is possible Judge Fallon may begin remanding hundreds of individual cases back to the U.S. District Courts where they would have originally been filed for separate trial dates.