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Lawsuit Questions Xarelto Safety


Xarelto boxAnother lawsuit has been transferred to the Xarelto multidistrict litigation (MDL) No. 2592, which is pending in the U.S. District Court for the Eastern District of Louisiana under Judge Fallon. The plaintiff, Cheryl Butler, claims the defendants, Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals, et al. fraudulently misrepresented the safety of the medication, Xarelto, and that the drug led to the plaintiff’s life-threatening medical problems.

As part of the MDL, the plaintiff’s Xarelto lawsuit will be subject to uniform pretrial rulings. MDLs also serve to avoid the possibility of duplicative discovery, streamlining the process for all parties. However, Ms. Butler will retain her right to an individual trial by jury. If her case is not settled while joined to the MDL, it is expected to be remanded back to her home district for trial.

Plaintiff alleges life-threatening medical problems

On February 27, 2013, the plaintiff was prescribed Xarelto (rivaroxaban) for the treatment of saddle pulmonary artery embolism and a right lower extremity deep vein thrombosis (DVT). She used the medication as directed until April 12, 2013. At that point, she was diagnosed with a severe gastrointestinal bleeding event. The plaintiff is demanding damages for life-threatening and irreversible bleeding, physical pain, mental anguish, shortened life expectancy, and diminished enjoyment of life. She claims that her Xarelto bleeding injuries are expected to be permanent. The plaintiff also demands compensatory damages for her hospitalization, medical treatment, and lost wages.

Study finds more frequent bleeding events

Xarelto was approved by the FDA in 2011 for the treatment of DVT and pulmonary embolism (PE) in patients who were undergoing joint replacement surgery. Later, FDA approval was granted for the use of Xarelto to reduce the risk of systemic embolism and stroke in patients who were diagnosed with non-valvular atrial fibrillation. Further approval for PE and DVT treatment and reduction in recurrence followed shortly.

Xarelto is an anticoagulant, or blood-thinning drug, that works by inhibiting the blood’s ability to clot. The plaintiff’s lawsuit claims that the defendants did not conduct adequate safety studies on the drug. However, studies that were conducted are known as the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism (RECORD studies). The results of the RECORD studies indicated that Xarelto was not necessarily an inferior alternative to warfarin, long considered to be the gold standard of blood-thinning therapy. However, the lawsuit goes on to note that, “the studies also showed a greater incidence with Xarelto of bleeding leading to decreased hemoglobin levels and transfusion of blood.”

Furthermore, unlike warfarin, there is no reversal agent available to treat patients who are taking Xarelto and suffer a major bleeding event. This means that doctors are essentially helpless to mitigate the effects of the drug, should a problem develop.

Lawsuit raises questions regarding defendants’ marketing

Ms. Butler’s lawsuit questions the defendants’ aggressive marketing campaign, which relied on the RECORD studies and others for the promotion of the drug. The plaintiff alleges that the marketing campaign emphasizes the potential benefits of the drug while failing to call attention to the potential for life-threatening bleeding events. The defendants’ marketing efforts highlighted what they referred to as the “Xarelto Difference,” which is the supposed superior convenience of the drug, as it does not require frequent blood monitoring, it has no known dietary requirements, and patients can take a dose once per day.

However, FDA reviewers questioned the so-called convenience of Xarelto, noting that the once-a-day dosage schedule resulted in peaks and troughs in studied blood samples, which could be avoided through twice-per-day dosing. The plaintiff claims that the defendants’ aggressive promotional materials played a significant role in her use of Xarelto.