Last-Minute Maneuvering Underway Prior to Next Round of Xarelto Lawsuits

Philadelphia, PAWith three new bellwether Xarelto bleeding issue trials set to begin next month in Philadelphia, defendants Bayer Healthcare Pharmaceuticals and Janssen Pharmaceuticals Inc. are pushing back against attempts by plaintiffs to amend the master complaint in the Xarelto mass tort. In spite of the fact defendants won the first three bellwether trials - and stood by while a multi-million dollar award to a plaintiff this past December was voided in post-trial motions - Bayer and Janssen nonetheless feel that an amended master complaint so close to trial would significantly prejudice them in their attempts to present a coherent defense.

The Philadelphia mass tort was put together three years ago, in January 2015 in an effort to consolidate a case load that has since grown to about 1,700 Xarelto lawsuits from plaintiffs citing Xarelto bleedout and various other Xarelto bleeding complications. A second amended master complaint was filed in July, 2016. Now, on the eve of three trial dates commencing next month plaintiffs are asking for the opportunity to further refine their pleadings through the submission and filing of a third amended complaint.

Plaintiffs, according to court documents, stress it is not their intent to add any additional causes of action, but rather seek an opportunity to "reorganize the allegations and provide more details about the actions and inactions that form the bases of already-existing causes of action."

Defendants reject plaintiff's desire to update master complaint in mass tort

But Janssen and Bayer say, not so fast: "Plaintiffs should be required to complete this bellwether stage of the litigation under their existing pleadings," the defendants argued in briefs presented on March 5. "To allow otherwise, on the very eve of trial, would inject significant prejudice into the administration of these cases."

Having lost the first three bellwether trials in rulings favoring the defendants - and having their only mass tort win overturned in post-trial motions - plaintiffs are looking to further tighten, and refine their case.

Xarelto is one of a handful of new-age anticoagulants brought to market in an effort to succeed Coumadin (warfarin) as the go-to blood thinner of choice for patients in need of anticoagulants. While Coumadin has proven effective for several decades, warfarin requires an involved regimen of blood monitoring and dietary restrictions in order to remain safe and effective. Consumers and care-givers alike have been clamoring for an easier way to achieve optimum anticoagulation without all the fuss.

Plaintiffs have said, 'where's the antidote?'

Xarelto - and Pradaxa before it - promised just that. However, one important benefit unique to warfarin was not immediately present in Xarelto when it was brought to market amidst much fanfare: a reversing agent that would rapidly negate the thinning properties of warfarin should a serious bleeding issue occur.

An infusion of Vitamin K does not carry the same effect in Xarelto as it does with Coumadin, and at the time the drug was brought to market there was no alternative then available, or immediately on the horizon. Plaintiffs claim the absence of an antidote negates the advantages of Xarelto when compared against Coumadin, and poses a greater threat of Xarelto bleeding complications that can't be reversed, or minimized.

That makes Xarelto more dangerous, plaintiffs claim. Plaintiffs also assert they were not told about the lack of a reversing agent, and that any claims associated with a reduced need for monitoring is foolhardy given the lack of an antidote.

Plaintiff Lynn Hartman, who saw her $27.8 million verdict tossed in December, is fighting back through the issuance on February 19 of a statement citing purported errors on the part of the trial judge. Hartman claims that Judge Michael Erdos ignored evidence that additional warnings by Bayer and Janssen would not have changed her physician's opinion, or decision to prescribe Xarelto to Hartman.

Janssen and Bayer used that as the basis for their post-trial motions to have the case dismissed, given that additional warnings would not have changed the prescribing physician's mind.

Plaintiffs says she would not have taken Xarelto had she known the risks

Legal counsel for Hartman, in turn, noted that Hartman may not have consented to taking Xarelto had she been aware - or made aware - of warnings pertaining to the risk for Xarelto side effects that could lead to Xarelto death in extreme cases.

"The evidence before the jury, when viewed in the light most favorable to plaintiff, establishes that plaintiff's prescribing physician would not have prescribed to plaintiff, and plaintiff would not have ingested, [Xarelto]…had the defendants adequately warned plaintiff's prescribing physician of the actual risks," the filing said.

The Xarelto lawsuit is Hartman v. Janssen Pharmaceuticals Inc. et al., Case No. 160603416, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.

The Xarelto mass tort is In Re: Xarelto Litigation, Case No. 150102349, in the Court of Common Pleas of Philadelphia County. Bayer Healthcare Pharmaceuticals is a unit of Bayer AG, while Janssen Pharmaceuticals Inc. is a subsidiary of Johnson & Johnson.