Xarelto Trials for Bleeding Lawsuits Set To Begin in Feb. 2017

As a growing number of Xarelto lawsuits continue to be filed by individuals nationwide who have suffered severe and sometimes fatal bleeding complications, the federal judge presiding over the litigation has scheduled a series of four bellwether trials to go before juries in the first half of 2017. 

Since December 2014, all federal product liability lawsuits filed against Bayer and Johnson & Johnson over the bleeding side effects of Xarelto have been centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation.

The cases are consolidated for discovery and a series of early test trials to help avoid conflicting pretrial rulings and gauge how juries are likely to respond to certain evidence and testimony that is likely to be repeated throughout the cases.

According to the latest case list (PDF) released by the U.S. JPML on September 15, there are already 1,694 cases pending before Judge Fallon. However, as Xarelto injury lawyers continue to review and file complaints, it is ultimately expected that thousands of additional lawsuits will be centralized in the MDL.

As part of the coordinated handling of the litigation, Judge Fallon issued a case management order (PDF) on September 18, outlining the process for preparing a small group of cases for a series of four bellwether trials between February 2017 and May 2017.

The first two trials will be held in Judge Fallon’s court in the Eastern District of Louisiana, on February 6 and March 13, 2017. The third trial will be held in Mississippi on April 24, 2017 and the fourth trial will be held in Texas on May 30, 2017, with the specific districts to be determined at a future date.

There may be some concerns that the first trial runs into Mardi Gras festivities held in New Orleans, but that subject will be discussed at a November 2016 status conference.

Judge Fallon indicates that the specific cases that will go before juries on these dates will be selected from a pool of 40 lawsuits that will be included in an initial bellwether discovery pool, which will be selected in January 2016.

Those cases will then go through case-specific discovery, including depositions of plaintiffs, prescribing physicians, treating physicians and sales representatives of the drug maker.

Depositions are expected to be completed by July 2016, after which the court will issue a separate order regarding bellwether selection. The limited group of cases selected for the bellwether trials will then go through expert witness discovery and dispositive motions practice in the second half of 2016.

While the outcomes of these bellwether trials will not be binding on other cases in the litigation, they will be closely watched by lawyers involved in the cases and may influence eventual Xarelto settlement negotiations to resolve large numbers of claims.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011 as a superior replacement for Coumadin (warfarin), designed to reduce the risk of blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism. Since it hit the market, the drug has been aggressively marketed and 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 involving severe and uncontrollable bleeds, sometimes resulting in death.

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, plaintiffs pursuing bleeding lawsuits over Xarelto allege that the drug makers withheld information about the lack of a 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 have been 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.

It is ultimately expected that the Xarelto bleeding litigation will include many more cases than the Pradaxa litigation, as the drug has become more widely used in recent years.