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In Moving Forward, a Look Back at Xarelto

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New Orleans, LAWith the first Xarelto Death and Xarelto Bleeding Issue lawsuits expected to begin about a year from now, in August 2016, it’s instructive to take a look back and see from whence we came.

Xarelto is one of the so-called “new age” blood thinners designed to knock warfarin (Coumadin) from its perch with a promise of reduced monitoring heretofore necessary in order to avoid bleeding events (all anticoagulants carry risk for bleeding events). Pradaxa was first out of the gate, with Xarelto having come to the party about a year later, in November 2011.

By 2013, according to Bloomberg (12/4/14), Xarelto had racked up more than $2 billion in sales for its principals: Bayer AG, which produces the drug, and Johnson & Johnson (J&J), which owns the US rights to Xarelto. A year later, the lawsuits started coming - allegations that Xarelto was approved for market without an accompanying reversing agent in the event of a Xarelto Bleedout.

The thinning properties of warfarin can be reversed with an infusion of vitamin K, which can help to stem a potentially dangerous hemorrhage. While doctors have reportedly found various workarounds to help minimize a Xarelto Bleedout, a reversing agent of similar effectiveness to that of vitamin K and warfarin remains in the development stages.

Plaintiffs allege they were unaware that a significant bleeding event could not be stopped as effectively as a similar event involving warfarin, and that Bayer and J&J were negligent in bringing Xarelto to market without a dedicated way to control unexpected Xarelto Bleeding complications.

And what began as a trickle of lawsuits in 2014 has grown by mid-2015 to about 2,000 in number.

In early December, there were attempts to have Xarelto lawsuits consolidated before US District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings. Herndon had presided over the $650 million settlement involving Xarelto competitor Pradaxa. The blood thinner manufactured by Boehringer Ingelheim Gmbh was linked by researchers, according to Bloomberg, to more than 500 deaths.

“If you have a judge already familiar with these blood-thinner suits, the cause of efficiency would be better served by sending the cases to him,” said Carl Tobias, a professor of product-liability law at the University of Richmond in Virginia, in comments published in Bloomberg last year.

In the end, pretrial proceedings for the Xarelto MDL went to US District Judge Eldon Fallon in New Orleans. Fallon had overseen the consolidation of lawsuits in the Vioxx portfolio that resulted in a settlement of $4.85 billion in 2007, and was touted as a worthy backup choice to Herndon.

As lawsuits continue to mount, Kristina Chang, a spokeswoman for J&J, said in comments published by Bloomberg in December of last year that “the benefit-risk profile of Xarelto remains favorable and consistent with the clinical trials.

“All anticoagulants carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks,” she noted in an e-mail to Bloomberg.

J&J and Bayer had wanted the cases to go to New Jersey, but their petition was not granted.

The case is In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, US District Court for the Eastern District of Louisiana.


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