Xarelto Bellwether Trials Expected to Begin in August 2016 For Bleeding Lawsuits

The U.S. District Judge presiding over all federal Xarelto bleeding lawsuits has indicated a series of bellwether trials in the federal multidistrict litigation (MDL) may begin by August 2016.

For the past six months, all product liability complaints filed throughout the federal court system involving bleeding problems with Xarelto have been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

There are currently at least 552 bleeding lawsuits pending in the Xarelto MDL, which all involve similar allegations that the drug makers failed to provide adequate warnings about the potential side effects of Xarelto.

As a growing number of complaints continue to be filed, Judge Fallon has indicated that a small group of “bellwether” cases will be selected for early trial dates. While the outcomes of these trials are not binding on other cases, they are designed to to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation and may facilitate eventual Xarelto settlements.

According to a Minute Entry (PDF) issued following a status conference on June 22, Judge Fallon has proposed that 40 plaintiffs be selected for a “pool” of bellwether cases, which will go through case-specific discovery in preparation for a series of trials that are expected to begin late next year.

The potential discovery and trial schedule discussed by Judge Fallon calls for the first Xarelto trial to begin on August 1, 2016, followed by a second trial on August 22, 2016, a third trial on September 12, 2016, and the fourth trial on October 17, 2016. The Court has suggested that the first two trials would take place in the Eastern District of Louisiana, the third trial would take place in the Southern District of Texas, and the fourth trial would take place in the Southern District of Mississippi.

The conference came following a Xarelto “Science Day” held by Judge Fallon earlier this month, which allowed both sides to present information to the Court in a non-adversarial manner about the medical and scientific issues that will come up throughout the bleeding lawsuits.

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 claims 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.