Xarelto Bleeding Cases to be Selected for Discovery, Early Trial Dates

As a growing number of Xarelto bleeding lawsuits continue to be filed by individuals nationwide, the U.S. District Judge presiding over the federal litigation has ordered the parties to identify between 40 and 60 plaintiffs to go through case-specific discovery and possible early test trials. 

There are currently more than 400 product liability lawsuits filed against Bayer and Johnson & Johnson’s Janssen unit in the federal court system, which all involve similar allegations that the drug makers failed to adequately warn about the potential side effects of Xarelto, which have been linked to cases of uncontrollable bleeding and death.

Since December 2014, the federal Xarelto bleeding cases have been centralized for discovery and pretrial proceedings before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of a multidistrict litigation (MDL). The consolidated proceedings are designed 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.

In a case management order (PDF) issued May 4, Judge Fallon instructed both parties to meet and confer before June 15, to propose a process for identifying between 40 and 60 cases to be part of a “bellwether” pool. These cases will go through additional discovery specific to the circumstances surrounding the claim and be prepared for early trial dates designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Judge Fallon also issued a pre-trial order (PDF) on the same day, ordering that a Plaintiff Fact Sheet be submitted in each case within the next sixty days, including an authorization for the release of medical records, so that the drug makers will be provided with certain information about each case.

A separate order (PDF) requires that a Defendant Fact Sheet be completed for each Plaintiff Fact Sheet received, providing information on sales representatives and contact with physicians involved in the case, as well as other information.

Over the coming months, as Xarelto lawyers continue to review and file bleeding cases on behalf of individuals who have suffered an injury or wrongful death, it is ultimately expected that thousands of cases will be filed in the MDL.

To minimize expenses to all parties, Judge Fallon issued another pretrial order (PDF) this week, allowing up to 100 plaintiffs’ complaints to be bundled into a single filing for one filing fee.

Xarelto Bleeding Risk

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.

If the parties fail to reach settlements for the Xarelto bleeding cases 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.