Kentucky woman files Xarelto lawsuit after being hospitalized with severe gastrointestinal bleeding

by Charles Miller

Rivaroxaban is an oral anticoagulant manufactured by Bayer. The drug is marketed as Xarelto in the United States by Janssen Pharmaceutica. There is currently no specific way to reverse the anticoagulant effect of rivaroxaban in the event of a major bleeding event.

Xarelto can be used to prevent strokes in those with atrial fibrillation due to causes other than heart valve disease, and at least one additional risk factor for stroke (congestive heart failure, hypertension, age, diabetes, and prior stroke). Rivaroxaban can also be used to prevent the formation of blood clots in the veins (deep venous thrombosis) in adults who have had an operation to replace a hip or knee and following an acute deep venous thrombosis in adults.

Xarelto increases the risk of bleeding and can cause serious, potentially fatal bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding including aspirin and other anti-platelet agents (clopidogrel), other anticoagulants (warfarin and other new anticoagulants), heparin and LWMH, thrombolytic agents, SSRIs and SNRIs (both antidepressants), and NSAIDs (anti-inflammatory). Concommitant use of strong CYP3A4- and P-gp-inhibitors also increases the bleeding risk.

In 2013, the German newspaper Der Speigel wrote that 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths.

Kentucky resident Virginia Stuntebeck, has recently filed a product liability lawsuit against Johnson & Johnson and Bayer, claiming that she nearly bled to death from the side effects of Xarelto, a newer type of anticoagulant. Stuntebeck alleges she used Xarelto in July 2012 to treat atrial fibrillation. In February 2013, she was hospitalized for several days with severe internal and gastrointestinal bleeding. The lawsuit claims that Johnson & Johnson and Bayer sold an unreasonably dangerous and defective drug, failing to warn consumers and the doctors about the risk of bleeding events that might be “irreversible.”

Unlike warfarin, Xarelto does not have an FDA-approved reversal agent to quickly stop the drug’s blood thinning effects. According to experts, doctors have been using emergency treatments to stop Xarelto’s bleeding side effects in an attempt to prevent serious injuries and deaths.

Doctors use vitamin K and plasma to reverse any bleeding problems with warfarin. Unfortunately, no antidote is available for the direct thrombin inhibitors such as Xarelto. As a result, it can sometimes be impossible to prevent serious injury or death if patients suffer bleeding problems after taking Xarelto.

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Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us for a free consultation to find out more about your legal options.