A Maine plaintiff recently filed a Xarelto bleeding lawsuit against Janssen Research & Development after ingesting the anticoagulant allegedly led to excessive gastrointestinal bleeding.

Plaintiff Jeannette L., was prescribed Xarelto in June 2013. Approximately one year later, she was admitted to the hospital for severe gastrointestinal bleeding and anemia.

Jeannette claims that the use of Xarelto has permanently and severely injured her, and seeks compensation through her lawsuit.

Xarelto (rivaroxaban) is an anticoagulant produced by Bayer Healthcare and was approved by the FDA in 2011 to treat patients undergoing hip or knee replacement surgeries.

Later, Xarelto was approved to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation. In 2012, the Xarelto label was updated to include an indication for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

According to this Xarelto bleeding lawsuit, a series of clinical trials known in the medical community as the RECORD studies showed a link between Xarelto and major bleeding events.

With Xarelto, the studies indicated, there was a greater incidence of major bleeding events despite the fact that the studies’ results excluded those patients who were predisposed to have a high risk of bleeding. This Xarelto bleeding lawsuit claims that Janssen failed to report these major bleeding events as significant adverse events.

In these studies, “major bleeding” indicated bleeding that involved a critical organ, that led to reoperation, or led to fatalities.

This Xarelto bleeding lawsuit claims that Janssen failed to adequately warn the medical community, consumers, and the plaintiff of the potential major bleeding dangers of Xarelto.

Jeanette further claims that Janssen used deliberately misleading marketing tactics for Xarelto, indicating that blood monitoring is not essential with the drug, therefore inaccurately and dangerously diminishing the concern for risk of bleeding.

Unlike anticoagulants warfarin or coumadin, there is no available antidote for Xarelto to reverse dangerously excessive bleeding.

Jeannette filed this Xarelto bleeding lawsuit on multiple counts, including but not limited to negligence, breach of express and implied warranties, fraudulent misrepresentation and concealment, and negligent misrepresentation.

The Xarelto Bleeding Lawsuit is Libby v. Janssen Research & Development, et al., Case No. 2:15-cv-01760-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.

Xarelto Bleeding Lawsuits

Xarelto is currently facing hundreds of Xarelto bleeding lawsuits filed for patients who, after taking Xarelto, have experienced gastrointestinal bleeding, hemorrhaging, or other adverse events.

These Xarelto lawsuits claim that the drug makers failed to be completely transparent in the warnings for their product and the Xarelto bleeding side effects.

These cases also allege that the drug maker should be held accountable for not providing an approved antidote that could reverse the medication’s effects, given the potentially damaging Xarelto side effects many claim to have suffered.

Not all side effects of Xarelto are severe or dangerous, and not all users of Xarelto experience side effects. Those who do, however, can be subject to extremely severe and dangerous bleeding issues that cannot be controlled or reversed.

Plaintiffs claim that the drug manufacturers did not clearly portray the drug’s potentially damaging side effects on their packaging, in their advertising, or to the medical community as a whole.

Plaintiffs further allege that drug makers had a responsibility to provide blood level monitoring for users of their drug, especially after recent studies which have suggested blood level monitoring might significantly assist doctors to care for patients who use Xarelto.

Similar allegations have been brought up against Pradaxa, created by Boehringer Ingelheim Pharmaceuticals. Plaintiffs have won $650 million total in Pradaxa settlements after several years in court.

If you or someone you know has experienced Xarelto side effects such as Xarelto bleeding, you may be able to join a class action Xarelto bleeding lawsuit.