Washington, DCPlaintiffs having filed a Xarelto lawsuit on behalf of themselves or family members whose health may have been compromised by the blockbuster drug, may have been handed a new angle against an anticoagulant that in five years has risen to the top of the blood thinner mountain in spite of criticisms, including lack of an antidote.
It has now been revealed that a device used in clinical trials gauging the effectiveness of Xarelto (rivaroxaban) when compared with Coumadin (warfarin) may have given an unfair advantage to Xarelto. It should be noted that both the European Medicines Agency and the Duke Clinical Research Institute have concluded through their own analyses that the potentially faulty device did not, after all, affect the outcome of the clinical trials.
But questions remain.
According to the New York Times (02/22/16), the device in question is the INRatio, a medical device reportedly used to assist trial doctors in determining whether trial participants were being given the correct amounts of warfarin. Getting that right was not only integral to the trial - and to the participant - but also remains as the bane of doctors and patients who have longed complained about the tight monitoring of blood, diet and other medications required to ensure optimum levels of warfarin were maintained.
Part of the basket of claims made when Xarelto hit the market was that rivaroxaban did not require the degree of monitoring necessary with the older-generation Coumadin (warfarin). To that end, to fairly gauge the effectiveness of Xarelto v. Coumadin, warfarin levels had to be spot-on.
Doubts began to surface in earnest when the INRatio device was recalled in 2014 over suspicion that the INRatio was understating a patient’s bleeding risk, and how that may compare with a potential Xarelto Bleeding Issue.
And yet, it appears there were questions even before the recall. It has been reported that doctors involved in those first clinical trials were questioning the accuracy of the INRatio device. The New York Times reported that a legal motion filed late last month revealed there were so many complaints about the device that study proponents were motivated to investigate.
And even before that - in 2005 and 2006 - the US Food and Drug Administration (FDA) appears to have had the INRatio device on its radar, sending warning letters to the manufacturer at the time, HemoSense, over concerns of “clinically significant” values that appeared to be erroneous. The FDA was concerned at the time that HemoSense was not undertaking due diligence with regard to investigating the complaints.
At some later time, Alere Inc. acquired HemoSense. In 2014, Alere recalled the suspect INRatio.
Plaintiffs litigating against Johnson & Johnson over Xarelto due to an Xarelto Bleedout or some other serious adverse reaction - including Xarelto Death - have taken J&J to task for bringing Xarelto to market without an obvious antidote akin to warfarin, whose blood-thinning properties can usually be reversed in short order with an infusion of vitamin K. Not only did Xarelto appear without a ready reversing agent, plaintiffs in Xarelto Bleeding complications lawsuits allege the manufacturer was irresponsible in bringing Xarelto to market - and to market supremacy - while claiming the degree of extensive monitoring that is the bastion of warfarin was not needed for Xarelto.
Plaintiffs claim that Xarelto indeed does require close and tight monitoring, especially in the absence of an antidote. To suggest otherwise would only add to the danger inherent with Xarelto Side Effects, or so plaintiffs have alleged.
There is another curious sidebar to these most recent revelations. According to the New York Times, the doctor who led the so-called Rocket AF clinical trial was Dr. Robert M. Califf, who was serving as the director of the Duke Clinical Research Institute. Duke was responsible for conducting the clinical trial that led to the approval of Xarelto, and Califf served as co-chairman of the study.
Having left Duke some time ago, Califf is now a deputy commissioner with the FDA and is the President’s nominee for FDA Commissioner. Late last month, the US Senate confirmed Dr. Califf’s nomination. The New York Times reports Dr. Califf has no role whatsoever in the FDA probe into the Rocket AF trial.
Plaintiffs having suffered Xarelto Bleeding complications and other Xarelto Side Effects might also be interested in knowing that the FDA’s own medical reviewers, in 2011, recommended against approval of Xarelto. The concern at the time - noted by others - remained that patients receiving warfarin during the Rocket AF clinical trial were being inadequately managed.
An outside advisory committee voted to supersede the concerns of the FDA medical reviewers, and gave Xarelto the green light.
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