Bleeding is one of the most common side effects of Xarelto, but it does not have a reversal agent to stop bleeding in an emergency. About 17,000 lawsuits have been filed by people who were seriously injured by uncontrollable bleeding.
Do I have a Xarelto lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping people who have been injured or wronged. If you or a loved one was injured by uncontrollable bleeding, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: 1st Xarelto Trials Start April 2017
The first Xarelto jury trial involving uncontrollable bleeding is set to begin on April 24, 2017 in Louisiana. It will be followed by a second trial on May 30, unless lawyers negotiate a settlement agreement sometime this month. Around 17,000 lawsuits have been filed in state and federal courts nationwide.
What is Xarelto?
Xarelto (rivaroxaban) is a blood-thinning drug that was approved for the prevention of stroke in July 2011. It changes blood chemistry to prevent the formation of blood clots in patients who are recovering from hip or knee surgery. In November 2011, approval extended to patients with atrial fibrillation, a type of irregular heartbeat that can cause blood clots and stroke.
What is the Problem?
Unlike warfarin, which can be reversed with a dose of Vitamin K, Xarelto hit the market in 2011 with no antidote. The problem is that in an emergency bleeding situation, or if a patient needs unexpected surgery, doctors must de-activate any blood-thinning medication a patient is taking. If they cannot de-activate Xarelto, the patient is at risk of bleeding to death. Xarelto has also been linked to higher rates of bleeding than Pradaxa.
Does Xarelto Have a Reversal Agent?
Portola Pharmaceuticals developed a reversal agent for Xarelto and Eliquis called andexanet alfa or AndexXa. It worked in Phase III clinical trials after it “immediately and significantly” reversed Xarelto. Even so, in August 2016, the FDA delayed approving it due to manufacturing concerns.
Clinical Trial Relied on Defective Device
Concerns have been raised about the integrity of data from the ROCKET-AF clinical trial, which compared Xarelto to warfarin, after investigators found that the study relied on defective device to calibrate warfarin usage. The device was recalled because it could give erroneously low readings, which could cause patients to overdose on warfarin and experience bleeding. Critics say this may have skewed the study in favor of Xarelto.
Xarelto “ROCKET” Safety Study
The maker of Xarelto, Bayer, conducted a major safety study that compared Xarelto to a traditional anti-clotting medication, warfarin. The ROCKET-AF study involved more than 14,000 patients and it concluded that Xarelto was no better or worse than warfarin. Bleeding was the most common side effect of Xarelto, with less bleeding in the brain, but more gastrointestinal bleeding than warfarin. In April 2015, another study confirmed that Xarelto doubled the risk of gastrointestinal bleeding.
Percentage of Xarelto Patients Who Experience Bleeding
The safety of Xarelto compared to warfarin was established in the ROCKET AF clinical trial, which involved over 14,000 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.
The post-marketing data suggests that the real-world risk of bleeding is consistent with ROCKET-AF. However, other studies have questioned the safety of once-daily dosing, especially in people with risk-factors for bleeding. Other studies suggest that combining common painkillers with Xarelto could increase bleeding risks for people with atrial fibrillation.
The number of Xarelto lawsuits has grown significantly in recent years. Here are a few examples of Xarelto lawsuits:
- Lawsuit filed by the family of a woman who died of uncontrollable bleeding and other side effects after taking Xarelto.
- Lawsuit filed on behalf of a 92 year-old man who bled to death in 2013.
- Lawsuit filed in federal court in New York by a woman from Texas who developed severe bleeding after taking Xarelto for just five months.
- Lawsuit filed on behalf of a man from Vermont who died of uncontrollable bleeding in his brain after taking Xarelto.
- Lawsuit filed on behalf of a man who took Xarelto for atrial fibrillation and died six month later from uncontrollable bleeding in the brain (subdural hemorrhage).
Xarelto Doubles Bleeding Risk in Acutely Ill Patients
The results of a study in April 2011 found that people with acute illnesses who took Xarelto for 35 days had more than twice the risk of bleeding compared with traditional treatment with Lovenox. The chance of bleeding was 4.1% of patients taking Xarelto, compared with 1.7% of patients taking Lovenox.
Xarelto Class Action Lawsuit
Many people have already filed Xarelto lawsuits against Janssen and Bayer. However, these are not part of a Xarelto class action lawsuit. Instead, they are individual lawsuits filed by people who have hired an attorney to represent their individual legal interests. In December 2014, about 80 Xarelto lawsuits were centralized at the federal level in a Multi-District Litigation (MDL) in Louisiana. One month later, a mass-tort was created to centralize Xarelto lawsuits in Philadelphia.
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. Xarelto has not been recalled due to safety concerns about bleeding side effects.
Do I have a Xarelto Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Xarelto lawsuit review.