Xarelto Lawsuits Filed by 1,200 People Over Cerebral, Gastrointestinal Other Bleeding

While Bayer Healthcare reports that Xarelto sales rose over the last quarter, the drug maker confirms that it already faces about 1,200 Xarelto lawsuits filed on behalf of patients who have suffered cerebral hemorrhaging, gastrointestinal bleeding or other adverse events after using the controversial anticoagulants. 

In a second quarter investor report released this week, Bayer warned investors about the growing number of product liability, indicating that it anticipates additional claims will continue to be filed in the future. The drug maker also disclosed that it faces at least six Xarelto class action lawsuits in Canada.

All of the cases involve similar allegations that the drug makers failed to provide adequate warnings about the potential Xarelto bleeding side effects, as well as the lack of an approved antidote that would allow doctors to reverse the blood thinning effects of the medication.

Despite the mounting litigation and health concerns, Xarelto sales rose 43% over the last quarter, generating a total of $600 million in revenue for Bayer.

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.

In the federal court system, the Xarelto bleeding litigation is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated discovery and a series of representative “bellwether” trials.

Judge Fallon has indicated that the first Xarelto trials may begin by August 2016, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

While the outcomes of these trials are not binding on other cases, they are designed to to help facilitate potential Xarelto settlements that may resolve the litigation without the need for hundreds of individual cases to go before juries nationwide.