Xarelto Bleeding Claims Filed on Behalf of Nearly 200 People in One Day

As lawyers involved in the federal Xarelto lawsuits plan to meet today with the judge presiding over the litigation for a status conference, new bleeding claims continue to pour in, with cases filed on behalf of nearly 200 different people so far this week under bundled complaints now allowed by the Court.

On Monday, four separate lawsuits were filed in the U.S. District Court for the Eastern District of Louisiana, which involved Xarelto bleeding claims for 198 different individuals who allegedly suffered severe or fatal complications after using the new-generation anticoagulant.

Since December 2014, all product liability lawsuits filed against Bayer and Johnson & Johnson over bleeding side effects of Xarelto have been centralized in the federal court system 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.

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With the recent approval of new filing procedures, the number of claims has begun to grow rapidly. Among the four bundled complaints filed on August 3, injuries involving as few as 11 and as many as 89 different claimants were combined in each filing. The injuries included gastrointestinal bleeding, hematuria, subdural hematoma, cerebral hemorrhaging and various other bleeding complications, including several wrongful death claims.

As part of the coordinated pretrial proceedings in the federal multidistrict litigation (MDL), Judge Fallon has indicated that a small group of “bellwether” claims 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 that may avoid the need for each case to go before a jury.

Lawyers involved in the Xarelto claims are scheduled to meet with Judge Fallon today, at which time the status of discovery and other progress in the litigation will be reviewed, according to a joint report (PDF) filed last week.

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 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.

Judge Fallon has indicated that the first Xarelto trials may begin by August 2016. If the parties fail to reach a settlement or other resolution for the bleeding claims following the bellwether trials, hundreds of individual cases may be remanded back to U.S. District Courts throughout the country for individual trial dates in the future.

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