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Xarelto, a relatively new blood thinner, has been linked to serious and sometimes deadly incidents of uncontrollable bleeding and was sold for years without an antidote to stop its blood thinning effects.
STATUS OF XARELTO BLEEDING LAWSUITS: Product liability lawyers are reviewing whether former users who have experienced hemorrhages, gastrointestinal bleeding, strokes or wrongful death may be entitled to financial compensation through Xarelto lawsuits. The manufacturers agreed to a $775 million settlement agreement to resolve about 25,000 cases in March 2019.
Cases are being pursued for individuals throughout the United States who have suffered:
- Gastrointestinal Bleeding
- Wrongful Death
MANUFACTURERS: Johnson & Johnson and Bayer Healthcare.
OVERVIEW: Xarelto (rivaroxaban) is one of a new class of anticoagulants used to reduce the risk of blood clots and strokes, particularly among patients with atrial fibrillation or following hip or knee replacement surgery. It was developed and is distributed jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare.
Known as a “direct thrombin inhibitor,” Xarelto was designed to compete with Boehringer Ingelheim’s Pradaxa. Both drugs were released in an effort to replace the blood thinner warfarin, also known as Coumadin, which has dominated the atrial fibrillation blood thinner market for several decades.
The FDA first approved Xarelto in July 2011, to reduce the risk of blood clots, deep vein thrombosis (DVT) and pulmonary embolism following knee and hip surgery. In November 2011, it was approved as an anti-coagulant for individuals with non-valvular atrial fibrillation. In November 2012, approval was expanded to include patients with DVT and pulmonary embolism, as well as a long-term treatment to prevent recurrence.
Unlike warfarin, which has been the go-to anticoagulant treatment for decades, there was no approved reversal agent for Xarelto at the time it was introduced. As a result, doctors were left unable to control bleeding problems on Xarelto.
Since it was introduced, hundreds of adverse event reports have been submitted suggesting a link between Xarelto and bleeding injuries or death. According to allegations raised in lawsuits, the drug makers failed to adequately warn about the bleeding risk or lack of an effective Xarelto reversal agent.
A reversal agent for Xarelto was finally approved by the FDA in May 2018.
In late 2017, a Pennsylvania jury awarded a plaintiff nearly $28 million in what was considered a bellwether Xarelto trial. However, the verdict was overturned in January 2018 by a state judge who said there was insufficient evidence for the jury to have reached that verdict.
In March 2019, Bayer and Johnson & Johnson announced a settlement agreement to resolve about 25,000 bleeding injury lawsuits for an estimated $775 million.
XARELTO BLEEDING SIDE EFFECTS: Xarelto was promoted as superior to warfarin because it is easier to take and require less frequent monitoring to maintain the correct dosage.
While all anticoagulants carry a risk of bleeding, the blood thinning effects of warfarin can be reversed with a combination of vitamin K and plasma. When it was first approved, Xarelto had no such reversal agent, making it difficult for doctors to stop bleeding events before serious injury or death occur.
Some doctors have had partial success with prothrombin complex concentrates (PCCs), but the FDA has not approved an official reversal agent or strategy to stop life-threatening bleeding events. In September 2016, the FDA rejected a potential reversal agent for Xarelto and Eliquis, saying that it needed more information and data before it could grant approval. The agency finally approved the reversal agent, Andexxa, in May 2018, but then only for limited release.
In September 2013, the German newspaper Der Speigel reported that there had been nearly 1,000 adverse events involving Xarelto during the first eight months of 2013 alone, including 72 deaths.
In May 2014, the Institute for Safe Medication Practices (ISMP) reported that doctors and patients were reporting adverse events linked to the use of Xarelto in increasing numbers. ISMP reported in QuarterWatch that there were 680 Xarelto adverse events reported in the U.S. in 2013.
The number of reports linked to Xarelto surpassed those linked to Pradaxa, which had once held the dubious distinction of being the drug with the most adverse event reports.
Furthermore, some evidence suggests that blood monitoring, which the manufacturers said was not needed, could actually reduce the risk of Xarelto bleeding injuries.
A study published in October 2014 published in the Journal of Cardiology found that monitoring levels of Xarelto in the blood of patients with atrial fibrillation helped doctors determine when the drug was at peak levels and how to better control it and prevent bleeding events, similar to warfarin.
In June 2016, the Institute for Safe Medication Practices reported that Xarelto was linked to more serious injuries than any other drug monitored. The blood thinner accounted for 10,674 reports of fatal, disabling, and serious injury in 2015, according to the report.
A study published in January 2017 found that Xarelto had the “least favorable” safety profile of any of the new-generation anticoagulants, due to its rates of gastrointestinal bleeding.
A report published in July 2017 by the Institute of Safe Medication Practices linked Xarelto and similar blood thinners to at least 3,000 reports of patient deaths submitted to the FDA in 2016.
As of February 2017, there were more than 15,000 Xarelto lawsuits consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, and another 1,000 consolidated in state courts in Philadelphia.
FIND OUT IF YOU MAY QUALIFY FOR A XARELTO LAWSUIT: As a result of the drug makers’ failure to adequately warn about the risks associated with their medication, Xarelto injury lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.
Cases allege that Johnson & Johnson and Bayer withheld important safety information about the bleeding risk and the lack of an effective reversal agent. In addition, claims indicate that risk of injury outweighs any potential benefit provided by Xarelto, making the drug unreasonably dangerous and defective as it was originally formulated.
To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a lawsuit, submit information for review by an Xarelto injury lawyer.