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Texas Woman Seeks $10 Million in Xarelto Lawsuit

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On July 29, 2014, Texas resident Jeanne Jeffcoat filed a new Xarelto lawsuit against manufacturer Janssen Pharmaceuticals and parent company Johnson & Johnson, and Bayer Healthcare AG. The case is currently pending in the U.S. District Court for the Eastern District of New York.

According to court documents, the plaintiff used Xarelto as directed, but suffered from serious and permanent injuries as a result. She seeks $10 million in damages.

Plaintiff Suffers Xarelto Bleeding

Jeffcoat started taking Xarelto when she was about 71 years old—in March 2012. She used it for just a few months, up through July 2012. That was when she suffered life-threatening excessive bleeding, allegedly as a result of taking the anticoagulant. She states that she suffered severe and permanent injuries, pain, suffering, and emotional distress.

The FDA first approved Xarelto in 2011 for the treatment of blood clots in patients undergoing hip replacement or knee replacement surgeries. The FDA expanded the use of the drug to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation in November 2011, and again in November 2012 to reduce the recurrence of deep vein thrombosis (DVT) and pulmonary embolism.

Though Xarelto showed in initial clinical trials to reduce risk of blood clots, it was also shown to increase risk of excessive bleeding events, particularly in the gastrointestinal system. In a comparison with warfarin—the mainstay of treatments for the reduction of blood clots—Xarelto performed just as well in preventing stroke or systemic embolism in patients with non-valvular atrial fibrillation, but caused more frequent stomach bleeding that required transfusions.

Jeffcoat states in her complaint that while Xarelto manufacturers highlighted the positive results of these studies, they failed to draw similar attention to the increased risk of serious bleeding concerns. In fact, a warning letter from the FDA to J&J in June 2013 noted that a direct-to-consumer print advertisement for Xarelto “is false or misleading because it minimizes the risks associated with Xarelto in violation of the Federal Food, Drug, and Cosmetic Act….” The association requested J&J immediately stop sending out these types of advertisements.

Concerns with Xarelto

Marketing for Xarelto highlighted the fact that it came in a once-daily dose, and required no blood monitoring, as does warfarin. Such a dose, however, can cause blood levels of the drug to be inconsistent. The Institute for Safe Medication Practices (ISMP) noted in its 2012 first quarter report that even during the approval process, FDA reviewers “also questioned the convenient once-a-day dosing scheme, saying blood levels studies had shown peaks…that could be eliminated by twice-a-day dosing.”

Also of concern with Xarelto is the fact that currently, there is no readily available antidote to excessive bleeding. Should a patient taking warfarin end up in the hospital because of a hemorrhage, doctors can administer injections of vitamin K to counteract the blood thinning effect and encourage blood to clot. There is no such remedy for patients bleeding from Xarelto.

Jeffcoat brings counts of negligence, strict products liability, breach of warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, and fraud and deceit.