Xarelto Science Day “Ground Rules” Established in MDL

With parties planning to present non-adversarial medical and research information about the potential side effects of Xarelto next week, the U.S. District Judge presiding over hundreds of lawsuits has laid out ground rules for the “science day”.

Since December 2014, all Xarelto lawsuits filed throughout the federal court system have been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of an MDL, or multidistrict litigation.

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, which has been linked to hundreds of reports involving uncontrollable hemorrhages and deaths.

As part of the coordinated pretrial proceedings, Judge Fallon has scheduled a Xarelto “science day” for June 11, at which time each side will be able to present information to the court regarding the bleeding risks associated with Xarelto and similar Factor Xa novel oral anticoagulants. The presentations are designed to be in an objective format, without advocacy.

In a pretrial order (PDF) issued on May 21, Judge Fallon outlined the procedures agreed to by the parties to educate the Court on the basic issues in the litigation and avoid duplication in presentation.

Such science days are increasingly common in complex pharmaceutical lawsuits, allowing each side to present information about the science and medical issues that are likely to come up during the Xarelto litigation.

Judge Fallon’s order notes that the presentations will not be admissible for any purpose other than educating the court. There will be lecture-style presentations by physicians and scientists, without any cross examinations.

Xarelto Bleeding Risk

Xarelto (rivaroxoaban) was introduced in 2011 as a superior replacement for Coumadin (warfarin) for reducing 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 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, 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. 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.