Xarelto is one of two latter-day anticoagulants designed as an alternative to the decades-old warfarin (Coumadin). The latter requires constant blood and diet monitoring, but the blood-thinning properties of warfarin can be quickly reversed with the application of vitamin K - a handy weapon in the medical tool belt that can help stem a hemorrhage and give the patient a chance to survive.
Xarelto was introduced to the market a few years ago amidst claims that such stringent monitoring was not needed, allowing for less ongoing medical intervention and heightened convenience. Unlike warfarin, however, there was no means of reversing the blood-thinning properties of Xarelto in the event of a serious Xarelto Bleedout.
“The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” the plaintiffs said. “Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects.”
The lawsuit notes that Xarelto is primarily prescribed for nonvalvular atrial fibrillation, deep vein thrombosis or pulmonary embolism - but is also employed in the treatment protocols of patients in receipt of hip and knee replacements. Thus, Xarelto cuts a wide swath and at one point, according to the Xarelto Bleeding Complications lawsuit, it was the most widely advertised drug in medical journals routinely used by doctors to keep abreast of the latest medical and pharmaceutical advancements.
However, plaintiffs accuse J&J and Bayer of cherry-picking the more positive aspects of studies for marketing purposes, while concealing the possibility of Xarelto death through a bleeding issue that could not be controlled by way of a reversing agent.
Two of the plaintiffs in the latest Xarelto lawsuit represent the estates of patients who died of severe bleeding. Plaintiffs note the existence of thousands of “adverse events” linked to the use of Xarelto in both the US and Germany, not to mention reports of dozens of deaths in both countries. Even then, according to the complaint, neither J&J nor Bayer undertook any additional investigative studies into Xarelto, or provide additional and more adequate warnings.
When the US Food and Drug Administration (FDA) approved Xarelto (Rivaroxaban), the agency did so based on data it viewed as sufficient to regard Xarelto as having an appropriate risk/benefit profile for the intended community of patients.
The Xarelto lawsuit claims that studies referenced in marketing materials to doctors were not only unreliable and poorly managed, but were also encumbered by instances of falsification, discarded medical records and improper dosing, or so it is alleged.
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“Defendants’ fraudulent representations and concealment evidence flagrant, willful, and depraved indifference to health, safety, and welfare,” the plaintiffs said, accusing the companies of acting with “callous indifference.”
Xarelto lawsuits alleging Xarelto Bleeding complications and Xarelto death have been consolidated in multidistrict litigation in Louisiana. This latest lawsuit was filed September 10 in the Eastern District of Louisiana.
The case is Adams et al v. Janssen Research & Development LLC f/k/a Johnson and Johnson Pharmaceutical Research and Development LLC et al, Case No. 2:15-cv-04273 in the US District Court for the Eastern District of Louisiana.