New Orleans, LAIt was barely two months ago that consolidated lawsuits in the Xarelto Lawsuit multidistrict litigation numbered about 4,500. Today, there are in excess of 5,381 pending in US District Court for the Eastern District of Louisiana. Pundits from the outset held that Xarelto, akin to Pradaxa, would result in heavy litigation due to the way in which it was brought to market, the requirement for less monitoring, and the Achilles’ heel that is any lack of an antidote.
Those gazes into the litigation crystal ball appear to have come to pass…
Coumadin (warfarin), the once de facto heritage blood thinner that also doubles as rat poison, has nonetheless remained effective as a viable anticoagulant for patients with atrial fibrillation or those at risk for stroke. Constant monitoring of diet and blood is required to maintain what is normally a delicate dance between effective blood thinning and sudden bleeds - but an infusion of vitamin K quickly reverses the thinning properties of warfarin, providing for the patient a reasonable chance to survive.
Still, doctors and their patients have been clamoring for a magic bullet that would provide all the benefits of warfarin without the need for constant monitoring.
Enter Xarelto, heralded as the savior from constant monitoring people were looking for - especially important to a health care system under constant strain from increased demand and dwindling resources.
There has always been a risk for uncontrolled bleeding with Coumadin. However, an emphasis on blood and diet monitoring (for example, how much asparagus a patient consumes) has been effective in associating a reasonably safe profile with warfarin.
The manufacturers of Xarelto brought Rivaroxaban (Xarelto) to market with much fanfare over a reduced need for monitoring. However, like warfarin, there is also a Xarelto Bleedout risk for Rivaroxaban. Attorneys conversant with the Xarelto file note that Rivaroxaban possesses a low therapeutic index, which lands Xarelto in both a safe and dangerous zone within a relatively close margin.
And then there is the lack of an antidote - a driver for most of the Xarelto Bleeding Issue lawsuits. Unlike warfarin, which can be reversed with an infusion of vitamin K, no such reversing agent was available when Xarelto entered the market. An antidote is reportedly being researched and is under development, but its eventual arrival will come too late for the thousands of plaintiffs who allege grievous Xarelto Bleeding complications and even Xarelto Death due to a hemorrhage that can’t be as easily brought under control.
One plaintiff, Ruth McGowan (Ruth E. McGowan v. Janssen Research & Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc., Bayer Healthcare Pharmaceuticals Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG and Bayer AG, Case No. 2:2014cv02867, December 30, 2014, Louisiana Eastern District Court), filed a Xarelto lawsuit in 2014 on behalf of her deceased father. Thomas Dunkley had been prescribed Xarelto for only a month due to stroke risk, when he suffered a serious Xarelto Bleeding Issue in his brain and died.
Nancy Packard (Packard v. Janssen Research & Development LLC et al, Case No. 0:2014cv61448, June 23, 2014, Florida Southern District Court, Fort Lauderdale Office, Broward County) is another plaintiff suing the manufacturers of Xarelto after her husband suffered a Xarelto Bleedout in his brain. Doctors breached the man’s skull in an effort to relieve the building pressure, but the attempt was not successful in saving his life. He had been taking Xarelto for six months for atrial fibrillation when he died.
Plaintiffs are alleging that defendants were not only negligent in bringing Xarelto to market without an available antidote, but also in not adequately advising patients and their health care providers with regard to the lack of a reversing agent that had so long been a part of the warfarin equation. Plaintiffs also assert that defendants were negligent in suggesting that less monitoring was required when, given the lack of an antidote and the risk for a Xarelto Bleedout, monitoring is in effect even more integral.
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