Xarelto Bleedout Lawsuits Seek MDL Status, Hearing Slated for December

New York, NYAny good plumber will tell you that before you start working on the kitchen taps, you shut off either the secondary water supply or the main valve. That’s because if the spigot or pipe you are working on experiences a breach, there is no other way to turn off the flow. This, in generalized terms, is the basis for the typical Xarelto Lawsuit: once a Xarelto Bleeding Issue starts, it’s extremely challenging to get it to stop.

At the moment, various Xarelto Bleeedout plaintiffs and their legal teams are campaigning to have their lawsuits consolidated. To that end, arguments supporting consolidation in multidistrict litigation are scheduled to be heard December 4. According to court documents, In Re: Xarelto Products Liability Litigation (Case No. 2592) has been proposed for MDL status by six plaintiffs who have also lobbied to have at least 21 other Xarelto Bleedout lawsuits consolidated within MDL status for the Southern District of Illinois.

The defendant, Janssen Research & Development LLC, is on the record as opposing the consolidation based on its assertion that there is insufficient commonality in the cases to group them as such.

However, plaintiffs disagree based upon claims and queries as to the accuracy of the product label, the adequacy of testing and a determination of breach of warranty. As well, there is the question of whether or not Xarelto is as safe and effective as the manufacturer claims.

It’s an interesting - and for some families heartbreaking - debate.

Xarelto, like Pradaxa, was developed as a modern successor to the decades-old warfarin, marketed under the brand name Coumadin. The elder statesmen of anticoagulants, which has been the gold standard for 50 years or longer, has proven effective as a blood thinner for patients with atrial fibrillation and those at risk for stroke. Warfarin is also blessed with an effective antidote in the event of an unexpected bleeding event, where the blood is too thin to clot. By way of immediate intervention with vitamin K, most bleeding events can be reversed.

The frustration with warfarin has been the constant need for rigorous monitoring, in order to maintain its proper functionality. Such monitoring has proven to be labor-intensive for both doctor and patient, and an easier alternative has been sought for some time.

That alternative arrived in the form of Xarelto and before it, Pradaxa. Both require less monitoring, and both have been deemed safe and effective by the US Food and Drug Administration (FDA) insomuch as the benefits for the intended patient outweigh the risks.

Where is the “off switch?”

The problem, say critics, is that unlike warfarin and its vitamin K antidote, there is no handy tool to deploy in the event of an unexpected Xarelto bleedout. Vitamin K is not an option. The key, therefore, is to try and prevent a bleeding event from beginning, as once Xarelto Bleeding complications start, there is virtually no way to stop it.

Manufacturers are reportedly in the throes of developing an antidote that works in the same way as vitamin K does with warfarin. Thus far, nothing has been forthcoming - and even the attempt doesn’t help the California plaintiff who filed her Xarelto lawsuit at the end of August (Case1:14-cv-05133-FB-RML, US District Court, Eastern District of New York).

The plaintiff holds that after being put on Xarelto by her doctor, she experienced a sudden and uncontrollable Xarelto Bleedout in August 2012. Her lawsuit claims the event, which she thankfully survived, nonetheless caused her permanent pain, injuries and suffering, together with the need for ongoing medical care she will require for the rest of her life.

It could have been worse. The plaintiff’s Xarelto Bleeding Issue could have resulted in Xarelto death. According to various reports, the FDA’s adverse events reporting system had received no fewer than 2,081 reports of Xarelto bleeding complications by the end of the 2012 fiscal year. Xarelto had only been on the market for about a year, by then.

Amongst those reports of Xarelto side effects were 151 reports of Xarelto death. In contrast, there were 56 deaths associated with the use of warfarin during that time.

Given the advancing age of baby boomers, the legal community is watching this portfolio carefully and the Hearing Session of December 4 in particular.