Hundreds of Xarelto Bleeding Claims Already Pending in Federal MDL

Johnson & Johnson’s Janssen subsidiary and Bayer Healthcare face a rapidly growing number of product liability lawsuits filed on behalf of individuals nationwide who suffered severe and often fatal bleeding injuries on Xarelto.

In December 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings in the federal court system for all Xarelto bleeding claims, centralizing the cases before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of a multidistrict litigation (MDL). At that time, there were only about two dozen complaints pending.

According to the latest case list (PDF) released by the court last week, there are now 434 lawsuits pending before Judge Fallon, and the number is continuing to grow each month.

As Xarelto injury lawyers continue to review and file claims, it is ultimately expected that several thousand lawsuits will be centralized before Judge Fallon to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

A complaint (PDF) filed last week by Mary Lou Garza is one of the latest to join the litigation, containing similar allegations to those raised in many other claims. Garza indicates that her husband, Israel M. Garza, died of acute gastrointestinal bleeding in May 2013, only a few months after he began taking Xarelto.

Israel Garza was switched to the new-generation anticoagulant after previously taking Coumadin (warfarin), which has been the go-to treatment for prevention of strokes among patients with atrial fibrillation for decades. Garza had no prior history of significant bleeding events or stroke, yet he began to experience dizziness caused by gastrointestinal bleeding two days after beginning Xarelto treatment. He suffered respiratory failure and acute anemia, ultimately leading to hospitalization for several months prior to his death.

According to allegations raised in the Xarelto claim, Garza’s doctor would have never prescribed the drug had the manufacturers provided adequate warning about the bleeding risks or the lack of a safe and effective reversal agent that doctors could have used to stop or control bleeding events.

“With the knowledge of the true relationship between use of Xarelto and irreversible bleeds, rather than taking steps to pull the drug off the market, provide strong warnings, or create an antidote, Defendants promoted and continue to promote Xarelto as a safe and effective treatment for AFib,” according to the Garza complaint.

Xarelto Bleeding Risk

Xarelto (rivaroxoaban) was introduced in 2011 as a superior replacement for Coumadin (warfarin), and has been aggressively marketed for patients suffering from atrial fibrillation or for prevention of blood clots following joint replacement surgery. As a result, the drug has quickly grown to become one of the top selling medications in the United States.

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 easier to use than warfarin, 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, Garza and other plaintiffs pursuing bleeding claims against Bayer and Janssen allege that the 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 Xarelto litigation, Judge Fallon is expected to select a small group of claims to go through case-specific discovery and be prepared for a series of early trial dates.

According to minutes (PDF) from a recent status conference before Judge Fallon, the parties are expected to propose a new case management order by the end of June, which will address selection of the bellwether claims and pretrial discovery.

While the outcomes of any early trial dates will not be binding on other claims, they will heavily influence eventual Xarelto settlement negotiations to resolve the litigation.

The next status conference in the Xarelto MDL is scheduled for June 10.