Last month, Heidi Turner reported that as of June 15 of this year there were 5,853 lawsuits housed in Multidistrict Litigation in US District Court for the Eastern District of Louisiana.
Two months later, we can tell you that the number of Xarelto Bleeding Issue lawsuits had climbed to 6,660 by the third week in July.
The Xarelto story is akin to manufacturing a firearm without a ‘safety’ to prevent it from firing - and once the trigger is pulled, there’s no turning back.
Most are familiar with Coumadin - generic name warfarin - which for decades has been used as a blood thinner for those patients at a high risk for stroke and other cardiovascular issues. For Coumadin to remain effective, and to minimize risk, a regimen of strict monitoring was needed to ward against hemorrhages, or sudden and uncontrolled bleeding. Patients, in concert with their health care providers, would have to undergo frequent monitoring of diet, blood and other factors to keep dosages of warfarin in proper balance.
It has been, for some 50 years, a fine dance which done properly can yield excellent results. If not done properly, however, a sudden hemorrhage can occur that puts the patient in certain jeopardy: thinned blot doesn’t clot, or at the very least takes too long to do so.
Thus, hemorrhages happen with Coumadin too - as is the case with a Xarelto Bleedout. However, one thing unique about Coumadin was the ‘safety’ available to doctors and health care providers in the event of a sudden bleed: the infusion of Vitamin K, which has the capability to reverse the blood thinning properties of warfarin, allowing the blood to clot in a more normal fashion.
Like the ‘safety’ on a firearm that can prevent it from accidentally going off in an uncontrolled fashion, a sudden bleeding event with a warfarin patient can be minimized with Vitamin K, which in this context serves as an antidote. It’s a tool doctors can use to help quell an otherwise uncontrollable bleeding event, thereby allowing the patient to survive.
And yet, patients and their health care providers have been clamoring endlessly for an equally effective blood thinner that doesn’t require the kind of rigorous monitoring that remains the bastion of warfarin.
There had to be an easier way.
That ‘easier way’ finally arrived with the introduction of Pradaxa, soon followed by Xarelto. The latter was hailed as an absolute breakthrough in blood thinning, with the capacity to thin blood safely and effectively for the indicated patients, while dispensing with the rigorous monitoring previously required with warfarin.
Xarelto was given the stamp of approval by the US Food and Drug Administration (FDA) and quickly brought to market. It was initially heralded as the elusive Holy Grail of blood thinners that patients, and their caregivers had long sought.
And then, trouble: a Xarelto Bleeding Issue. Hemorrhages can happen in spite of careful adherence to factors designed to minimize risk of Xarelto Bleeding complications. Well, no problem, we’ll just quickly infuse the patient with Vitamin K, and…
Not this time.
Vitamin K does not reverse the thinning properties of Xarelto as it does with warfarin.
Okay, then what does?
Nothing - or so plaintiffs in many a Xarelto lawsuit have alleged. There is no de facto antidote for Xarelto. It was brought to market without one. Were a Xarelto Bleedout to occur, a doctor has far fewer options to deal with such an event.
Research has reportedly been ongoing to find an antidote similar to that of warfarin. In the meantime, patients prescribed Xarelto as a blood thinner without the need for stringent monitoring are, in effect navigating a minefield blindfolded, without an escape route.
An attorney conversant with the issue noted that Xarelto can be both safe, and dangerous within a very close range. Periodic monitoring of a patient’s blood would allow for a regular assessment of where things are within the context of risk for a serious Xarelto Bleedout. But then, Xarelto does not require regular monitoring. In the absence of periodic monitoring, one cannot know whether they are in the safe zone, or within imminent danger.
And if Xarelto Bleeding complications occur, there is no standard way to stop it in the same fashion as with warfarin. For many, it has led to Xarelto Death.
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Plaintiffs allege that Xarelto should not have been brought to market without an antidote in place, and that the manufacturers of Xarelto were negligent to suggest monitoring was not necessary. In fact, say plaintiffs, given the lack of a standard antidote for Xarelto to reverse a Xarelto Bleedout, periodic monitoring is vital.
Plaintiffs - presumably approaching 7,000 in number - also assert that Xarelto was brought to market without any mention of the lack of an antidote.