Second Bellwether Xarelto Lawsuit Goes to Defendant, All Eyes on Third


The second bellwether Xarelto lawsuit in multidistrict litigation over allegations of Xarelto bleedout in association with the new age blood thinner has gone, like the first, to the defendant. While this may prove disappointing to litigants alleging the anticoagulant is unsafe, there are still two more bellwether trials to roll out later this year, with some 15,000 cases in the federal multidistrict litigation pipeline housed in New Orleans. Additional cases are percolating at the state level in Philadelphia.

Meanwhile, years after Xarelto was introduced to the market amidst much fanfare, word is finally settling into the public consciousness with regard to the lack of an antidote inherent with Xarelto bleeding complications. A Buffalo, New York medical doctor who also hosts a radio show and pens an advice column in the press noted, in a show about anticoagulants, both the advantages and the shortcomings of Xarelto and other blood thinners in the Novel Oral Anticoagulant class (NOAC).

Xarelto, said Dr. Zorba Paster on WBFO 88.7 FM and in comments published in The Buffalo News (06/24/17), remains much easier to use than warfarin, the previous standby that’s tricky to regulate but has afforded effective anticoagulation for some 50 years, provided stringent monitoring is undertaken.

Easier, but with a caveat: there’s no surefire way to reverse a Xarelto bleeding issue were one to occur. Unlike the anticoagulant properties of warfarin, which can be reversed with an infusion of Vitamin K, Xarelto was brought to market with no such antidote in place.

That seemed to catch consumers by surprise. Warfarin has been around for so long, with a reversing agent so ingrained in patient awareness, it was assumed by many this fantastic, new Xarelto would be similarly equipped.

That was not the case. Now, many a Xarelto lawsuit asserts that manufacturers of Xarelto – Bayer AG and Janssen Pharmaceuticals – were negligent in suggesting that less-stringent monitoring of the latest-generation blood thinner was required when – given the lack of an effective reversing agent – more intense monitoring was appropriate. Suggesting anything less would be unthinkable.

There is little doubt that warfarin (brand name Coumadin) is finicky.

And yet, “warfarin is the old standby,” said Dr. Paster in The Buffalo News, and on WBFO. “Although it’s cheaper, it can be difficult to regulate. You need periodic blood tests, monthly for most people but more often for others. There are lots of interactions with food such as spinach and Brussels sprouts. Even green tea and alcohol can alter its effect. It’s a finicky drug to regulate.

“In our group, we have nurse specialist whose sole job it is to call patients about their blood test results and tell them whether or not to take more warfarin, less warfarin or just stay on the same dose.

“Close monitoring is critical.”

Paster noted that in contrast, NOAC drugs such as Xarelto are easier to regulate, but cost much more than Coumadin. Thus, for many patients cost may be a factor, with patients gladly undertaking headache-worthy monitoring in exchange for saving the drain on their pocketbook.

“But there is one more reason to consider warfarin,” Dr. Paster opined. “You can reverse the thinning effect with a simple injection or an IV infusion. If you’re in a car accident and bleeding or you need emergency surgery this can be a huge deal. You can’t do that with NOACs. These two factors – cost and reversing effect – should figure into your decision of which drug to use should your doctor recommend it.”

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That message is finally getting out now, in tandem with research and testing aimed at establishing an antidote for Xarelto bleeding complications that would prove at least as effective as the response Vitamin K has to warfarin. However, that information wasn’t necessarily front and center when Xarelto was introduced to the masses, with the promise of a blood thinner that was easier to regulate than warfarin resonating with a healthy number of atrial fibrillation patients, and those at high risk for stroke.

With the bellwether scorecard of 2-0 in favor of the defendant, all eyes will be on the third Xarelto bellwether lawsuit due to roll out next month in federal court in New Orleans. The first state-based trial housed at Philadelphia is due to begin in November. Pundits will be looking to see if the trend of wins for the defendant is maintained, or if the tide turns in favor of the plaintiff.