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Plaintiffs Claim Xarelto Should be Monitored, MDL Moving Forward

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Washington, DCAmongst the questions of fact common to all lawsuits consolidated in the Xarelto multidistrict litigation portfolio is the alleged need for blood monitoring. The latter claim may pale in comparison to other allegations stemming from Xarelto Death and Xarelto Bleedout, but blood monitoring remains a pivotal issue.

And here’s why: Xarelto was sold to the consumer and the healthcare community as a product that did not need the kind of stringent, ongoing blood monitoring inherent with the use of Coumadin (warfarin), the anticoagulant Xarelto and another in its class was meant to replace. Both doctor and patient alike had been calling for years for a product that did not require the same degree of strict, ongoing oversight required for Coumadin, the de facto blood thinner that’s been the go-to product for more than a half century.

The fact that Xarelto was marketed without the capacity to reverse its thinning properties in the event of an Xarelto Bleeding Issue - something which Coumadin always had - has prompted advocates, plaintiffs and their legal counsel to question the wisdom and safety of eschewing the need for blood monitoring given the absence of a reversing agent.

The anticoagulant properties of Coumadin can be quickly reversed with an infusion of vitamin K, which allows for the blood to clot and stem a serious hemorrhage. Plaintiffs and their lawyers note that sudden bleeds and hemorrhages were also possible with Coumadin - hence the need to carefully monitor diet and blood properties on an ongoing basis to help mitigate a potentially life-threatening hemorrhage.

However, Coumadin always had the vitamin K fix in its tool kit. Consumers assumed Xarelto benefited from the same protections and therefore question why Xarelto was brought to market without them, together with a claim that blood monitoring wasn’t necessary - at least to the degree that Coumadin required. Plaintiffs suggest that may have been an unwise and dangerous claim to make on the part of the manufacturer.

The Xarelto Bleeding Complications MDL is benefiting from new forms, identified as “Joint Complaint” and “Short Form Complaint” that will provide guidance and help expedite the process of injecting any new Xarelto lawsuit into the pipeline, according to court documents recently filed in US District Court in the Eastern District of Louisiana. Along with questions surrounding the wisdom not to require strict blood monitoring given the lack of an available antidote is the adequacy of the warning label with respect to the blood monitoring, as well as the results of certain clinical studies and Xarelto Bleeding Complications including severe internal bleeding and hemorrhagic stroke.

Defendants include Johnson & Johnson, Janssen Research & Development, and Bayer Healthcare Pharmaceuticals. The MDL is In Re Xarelto Products Liability Litigation, MDL No. 2592, US District Court, Eastern District of Louisiana.


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