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On November 2, 2012, the FDA approved the use of Xarelto (rivaroxaban) for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism, and to help patients reduce the risk of recurrence of these conditions.

Illinois plaintiff Mary Lemp took the medication to prevent these sorts of blood clots, and later claims she suffered from a life-threatening injury. She and her husband, Charles Lemp, recently filed a new lawsuit against manufacturers Janssen Pharmaceuticals and Bayer AG in an attempt to recover damages.

Plaintiff Suffers Uterine Bleeding

According to her complaint, Lemp started taking Xarelto in November 2013. She claims to have followed the dosing instructions. Only a few weeks later, however, she allegedly suffered life-threatening uterine bleeding. She had to be hospitalized and received multiple blood transfusions to save her life.

Lemp asserts that the manufacturers did not provide adequate warnings as to the risks of the drug. Had she known about the potential for such injuries, she states that she would never have agreed to take the medication.

Lemp Involved in Motion to Consolidate Xarelto Lawsuits

Lemp is one of the plaintiffs who recently filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal Xarelto lawsuits into one court for pre-trial proceedings. Centralization would eliminate conflicting rulings, reduce duplicative discovery, and provide for the convenience of all parties, she and the other plaintiffs asserted.

Lemp’s case is currently pending in the U.S. District Court for the Southern District of Illinois, which she and the other plaintiffs have suggested as the best location for the Xarelto MDL.

Defendants Failed to Warn About Serious Xarelto Side Effects

The initial clinical trials used to gain FDA approval for Xarelto for the treatment of DVT and pulmonary embolism showed that the drug was superior to a placebo in preventing dangerous blood clots. The studies also showed that Xarelto increased risk of adverse events, however, including those that caused patients to stop taking the medication, or that resulted in prolonged hospitalization.

Lemp and other plaintiffs in Xarelto lawsuits claim that the defendants failed to highlight these risks in their promotional materials. The advertising was quick to promote the positive results of studies, but did not adequately warn patients about the possible serious side effects.

No Antidote to Xarelto Bleeding

Xarelto manufacturers also claimed that Xarelto was superior to warfarin, the leading anticoagulant for the past several decades. Warfarin requires regular blood monitoring and dietary changes, whereas Xarelto comes in a convenient once-daily dose and does not require any lifestyle changes.

Plaintiffs seeking damages for their injuries, however, note that the manufacturers failed to mention that Xarelto has no antidote. In the event of life-threatening bleeding, doctors have no way to stop the blood-thinning effects, making excessive bleeding extremely dangerous. Patients taking warfarin, on the other hand, should they experience excessive bleeding, can have that bleeding stopped with injections of vitamin K.

Lemp brings counts of negligence and fraud and seeks in excess of $75,000 in damages.

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