Marc J. Bern & Partners and its professional team are reviewing potential lawsuits for Xarelto users who have experienced severe internal bleeding while taking Xarelto. Xarelto is a new blood thinner that has been associated with reports of serious and life-threatening problems, including death. Research has linked side effects of Xarelto to an increased risk of certain health problems about which the manufacturer and marketers failed to adequately warn.
Compensation may be available through a Xarelto lawsuit for individuals who have experienced:
- Internal bleeding
- Brain hemorrhage
- Kidney bleeding
To review a potential Xarelto case on behalf of yourself, a friend or family member, request a free consultation and claim evaluation.
XARELTO PROBLEMS AND THE DRUG COMPANIES’ FAILURE TO WARN
Xarelto (rivaroxaban) was introduced in 2011 as a “new generation” anticoagulant (commonly referred to as a “blood thinner”) and is manufactured by Bayer and marketed by a Johnson & Johnson subsidiary, Janssen Pharmaceuticals. Xarelto is widely prescribed to prevent blood clots, including strokes, in patients suffering from atrial fibrillation, or irregular heartbeat; treat and prevent recurrence of deep vein thrombosis (“DVT”), which is a blood clot that forms within deep veins in the body – usually in the legs; treat and prevent recurrence of a pulmonary embolism, which is a blood clot in an artery in the lungs; and prevent DVTs in patients who have recently undergone a knee or hip replacement surgery. It generally is prescribed as an alternative to warfarin (or Coumadin). Bayer and Johnson & Johnson have made billions of dollars from Xarelto sales since introducing it into the market.
Many critics have questioned the clinical trial used to gain FDA approval for Xarelto. Xarelto was approved based on a clinical trial study known as Rocket AF, which compared the outcomes of Xarelto use with warfarin use. Indeed, the FDA itself criticized Rocket AF in 2011 for various reasons. In 2016, the FDA launched an investigation of the Rocket AF clinical trial after it came to light that a faulty device, “INRatio,” which the FDA later recalled in 2014, was used to administer the dose of warfarin to patients in the Rocket AF study. This faulty device often resulted in patients receiving too high of a dose of warfarin, increasing the patient’s risk of bleeding. Johnson & Johnson knew of this faulty device’s malfunctions during the Rocket AF study but failed to notify the FDA and other safety boards prior to Xarelto’s FDA approval. In October 2016, despite many concerns and alarming findings, the FDA concluded that the effects of the unintentional increased warfarin dosage on clinical outcomes were likely modest. The FDA concluded that no label change as a result of the use of the faulty device in the study were warranted and issued a short statement accordingly.
The most dangerous side effect for people who take Xarelto is uncontrollable internal bleeding: internal bleeding events linked to Xarelto use include fatal brain bleeds and stomach bleeds. While all blood thinners carry a risk of internal bleeding, Xarelto appears to carry a greater risk than was indicated on the warning label or communicated to prescribers. Xarelto was introduced as a blood thinner that was superior to warfarin because, unlike warfarin, it does not require its users to undergo blood testing or restrict their diet. However, while warfarin users who experience abnormal bleeding can counteract those side effects with Vitamin K, no antidote to Xarelto currently exists, which may pose a more serious risk of users of the medication. Xarelto’s manufacturers have not released information for doctors on how to treat bleeding complications, making it difficult for doctors to save patients suffering from them.
ALLEGATIONS RAISED IN XARELTO LAWSUITS
Thousands of claimants who have suffered severe bleeding as a result of taking the anticoagulant medication have filed suit against the makers and marketers of Xarelto, alleging that they were not warned sufficiently about the medication’s risks. Because there is no antidote, former Xarelto users claim that bleeding events associated with Xarelto use are much more serious and dangerous. These claimants argue that if doctors and patients had known the risks – including the fact that internal bleeding caused or exacerbated by Xarelto could not be stopped or reversed – the patient would have used warfarin or a different anticoagulant medication, where internal bleeding can be treated with dosages of Vitamin K.
Individuals throughout the United States who experienced internal bleeding problems may be eligible to pursue a Xarelto lawsuit as a result of Bayer and Johnson & Johnson’s failure to warn about the risk of serious and potentially life-threatening side effects of Xarelto.
XARELTO MASS TORT/CLASS ACTION LAWYERS
Marc J. Bern & Partners and its professional team are reviewing potential Xarelto class action lawsuits and individual injury lawsuits for individuals throughout the United States. To have a case evaluated by one of our Xarelto lawyers, request a free consultations and case evaluation.
All Xarelto cases are investigated under a contingency fee agreement, which means that there are never any out-of-pocket expenses to hire our law firm and we are paid no attorney fees until a recovery is obtained for a Xarelto injury.