Xarelto Risks, Science Information to be Presented to MDL Judge

As a growing number of Xarelto lawsuits continue to be filed on behalf of individuals who have suffered severe and sometimes deadly bleeding problems, the federal judge presiding over the litigation has agreed to hear presentations from both parties about the medical and scientific information that is likely to come up in the cases. 

U.S. District Judge Eldon Fallon is presiding over more than 400 complaints filed throughout the federal court system involving bleeding problems allegedly caused by side effects of Xarelto, which is a new-generation anticoagulant.

All of the complaints involve similar allegations that Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary failed to adequately warn consumers and the medical community about the bleeding risks associated with their medication, and about the lack of an effective antidote for Xarelto, which may have allowed doctors to reverse the blood thinning effects if hemorrhages develop.

Since December 2014, the cases have been centralized before Judge Fallon in the Eastern District of Louisiana as part of an MDL, or Multidistrict Litigation, to reduce duplicative discovery into common issues that impact many cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the witnesses, parties and courts.

Following a status conference earlier this month, Judge Fallon issued an order (PDF) scheduling a “Science Day” for June 11, 2015.

While specifics have not yet been provided by the Court, such presentations are often scheduled in complex pharmaceutical litigation where a large number of claims are being presented involving similar injuries associated with the same medication, allowing each side to educate the Court in a non-adversarial manner.

During the Xarelto “Science Day”, it is expected that Judge Fallon will hear information about the nature of blood thinners, the role of the drugs in preventing strokes and blood clots, data regarding the bleeding risks and information about reversal agents that may have allowed doctors to control bleeding problems experienced by patients.

Xarelto Bleeding Risks

Xarelto (rivaroxoaban) was 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.

Xarelto Litigation Status

Over the coming months, it is expected that the Xarelto litigation will continue to grow, as lawyers continue to review and file cases on behalf of individuals throughout the U.S.

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.

As part of the coordinated pretrial proceedings, 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 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.