Xarelto (rivaroxaban) is a blood-thinning medication that has been linked to an increased risk of severe, sometimes fatal bleeding. When Xarelto was introduced in 2011, it had no antidote and some doctors struggled to stop bleeding in patients who had injuries or needed emergency surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Xarelto induced injury cases in all 50 states. If you or somebody you know has been diagnosed with severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Xarelto (rivaroxaban) is a blood-thinning drug made by Bayer HealthCare and Janssen Pharmaceuticals that was approved by the FDA in 2011. It is used by patients who are at risk of blood clots due to atrial fibrillation (abnormal heart rhythm) or hip/knee replacement surgery.
What’s the problem?
When Xarelto hit the market in 2011, it had no reversal agent. This is a problem because doctors might be unable to reverse its effects in an emergency, which could increase the risk of uncontrollable bleeding. In comparison, warfarin can easily be reversed with a dose of Vitamin K.
Possible Antidote Discovered
It was not until January 2015 that Portola Pharmaceuticals announced a possible antidote for Xarelto had been discovered. A late-stage clinical trial of the intravenous medication, andexanet alfa, met its primary endpoint of “immediately and significantly” reversing Xarelto.
Xarelto Class Action Lawsuit
As of November 2015, over 2,200 Xarelto lawsuits were pending in Multi-District Litigation (MDL No. 2592) in the U.S. District Court for the Eastern District of Louisiana, overseen by Judge Eldon E. Fallon. These lawsuits are not part of a class action. Instead, they are individual cases that were centralized against the objections of Bayer and Janssen.
Xarelto ROCKET-AF Safety Study
ROCKET-AF was a pivotal clinical trial that compared Xarelto to wafarin. Researchers concluded that Xarelto and warfarin were equally effective and had comparable risks. A follow-up study involving nearly 30,000 patients confirmed that bleeding risks were consistent with clinical trials.
The ROCKET-AF trial concluded that Xarelto caused less bleeding in the brain and more bleeding in the stomach and intestines. In April 2015, the British Medical Journal published a study that found Xarelto could double the risk of gastrointestinal bleeding compared to warfarin.
Problems With ROCKET-AF
The safety and effectiveness of Xarelto has been questioned, after an editorial in the New England Journal of Medicine found that the use of multiple statistical analyses “muddied the waters” when it came to determining the drug’s safety.
One of the three FDA reviewers who examined the data found that the drug-makers failed to administer warfarin in an optimal way, which may have skewed the data. A defective INR-testing device used to calibrate warfarin dosage may have skewed results of the ROCKET-AF clinical trial in favor of Xarelto.
Furthermore, FDA staff recommended against approving Xarelto for use in patients with atrial fibrillation, because the results of the ROCKET study do not clearly demonstrate the safety or effectiveness of the medication compared with warfarin. The reviewers recommended that an additional study is needed to clarify potential stroke and bleeding risks.
Bleeding Risk from ROCKET-AF Study
The safety of Xarelto compared to warfarin was established in the ROCKET AF clinical trial, which involved over 7,000 people. Researchers found the following rates of internal bleeding:
- Major bleeding: Xarelto (5.6%) – Warfarin (5.4%)
- Gastrointestinal (GI) bleeding: Xarelto (3.1%) – Warfarin (2%)
- Bleeding in a critical organ: Xarelto (1.3%) – Warfarin (1.9%)
- Fatal bleeding: Xarelto (0.4%) – Warfarin (0.8%)
- Bleeding resulting in transfusion: Xarelto (2.6%) – Warfarin (2.1%)
Xarelto was also linked to cases of cerebral hemorrhage (bleeding in the brain), but the risk was found to be significantly lower than patients on warfarin.
In 2015, the size of the litigation skyrocketed from 80 cases in January to over 2,200 by December. Hundreds of lawsuits have also been centralized in a mass-tort in Pennsylvania. The judge overseeing the federal litigation has appointed 12 attorneys to leadership roles and set the first four trial dates for February 2017.
The first lawsuits involved plaintiffs who developed severe bleeding after taking Xarelto for just a few months, including several who developed bleeding in the brain or subdural hemorrhage. Many of these cases involve patients who bled to death because doctors were unable to deactivate Xarelto.
In October 2014, the FDA issued a Class II recall for about 13,500 bottles of Xarelto after receiving one customer complaint about microbial contamination in a sales sample.
Do I have a Xarelto Lawsuit?
The Schmidt Firm, PLLC is currently accepting Xarelto induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after taking Xarelto, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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