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Failure to recommend appropriate blood monitoring or warn about the potential side effects of Xarelto allegedly caused a New York woman to suffer a severe upper gastrointestinal bleed and anemia, according to allegations raised in a recent lawsuit filed against Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary.
The complaint (PDF) was filed by Frances Pizzani in the U.S. District Court for the Eastern District of Louisiana on April 7, joining more than 15,000 similar complaints filed throughout the federal court system, which are all consolidated before U.S. District Judge Eldon Fallon in New Orleans as part of an MDL, or multidistrict litigation.
Xarelto (rivaroxoaban) is part of a new generation of blood thinners introduced in 2011 as an alternative to Coumadin (warfarin), which has been the go-to anticoagulation treatment for decades. However, while the blood thinning effects of warfarin can be quickly reversed with a known antidote, there was no approved reversal agent for Xarelto or other members of this new class of anticoagulants when they were introduced. This has left doctors unable to control or stop bleeds or hemorrhages that occurred among users.
Pizzani indicates that she took Xarelto from April 2013 to March 2015, and suffered bleeding and anemia injuries in July 2013, which the lawsuit says is a direct result of the Xarelto side effects.
The case raises allegations nearly identical to those presented in other Xarelto lawsuits, indicating that the drug makers withheld warnings about the bleeding risk from consumers or the medical community, including information about the lack of a reversal agent for the new-generation anticoagulant and the importance of monitoring during treatment.
Xarelto was promoted as easier to use than warfarin, with the drug makers claiming that patients do not require the same close blood monitoring to maintain the appropriate dose. However, the complaint indicates that the manufacturers oversold the safety of Xarelto to maximize profits, placing patients at risk due to the inadequate warnings and instructions.
“The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” the lawsuit states. “Physicians using Xarelto have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event. The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”
Xarelto Bleeding Lawsuits
Since the drug was introduced, there have been a large number of reports involving severe and sometimes fatal bleeding problems with Xarelto, as well as the other members of this new class, including Pradaxa and Eliquis.
As part of the coordinated MDL proceedings before Judge Fallon, Pizzani’s case will likely be stayed while discovery into common issues that impact all claims continue, and a small group of individual cases go to trial this year, which are designed to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout large numbers of cases.
The first Xarelto bellwether trial is set to begin later this month, with a second case set to start on May 30. Each of those first two cases will go before juries in New Orleans, with additional bellwether cases set to begin in Mississippi in June 2017 and Texas in July 2017.
Although the outcomes of these early trial dates will not be binding on other claims, they may help facilitate Xarelto settlement negotiations necessary to avoid the need for thousands of separate trials to be scheduled in courts nationwide.
Following several years of litigation over Pradaxa, which was the first member of this class introduced about one year before Xarelto hit the market, the manufacturer of that competing drug agreed to pay $650 million in Pradaxa settlements, resolving more than 4,000 cases. However, as users continue to experience bleeding problems, new Pradaxa lawsuits continue to be filed.
In recent months, there have also been an increasing number of Eliquis lawsuits filed over this newer member of the class, once again raising similar allegations that the drug maker failed to warn about the bleeding risk. Last week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments over whether to consolidate and centralize the federal Eliquis bleeding cases before one judge as part of a separate MDL.