Forecasting the Xarelto Bellwether Trials

New Orleans, LAThere is speculation that a bellwether Xarelto lawsuit, currently underway in the state of Louisiana, may end as the first bellwether concluded; with a verdict for the defense. However, legal commentator Tighe Wilhelmy of Velawcity notes that Louisiana’s ‘Learned Intermediary Doctrine Defense’ may not necessarily apply going forward to cases whose original jurisdictions fall outside the state of Louisiana.

Xarelto bleeding issue lawsuits are consolidated within multidistrict litigation in Louisiana. The first two bellwether trials have Louisiana as their originating jurisdictions – thus the Learned Intermediary Doctrine Defense (LIDD) can apply. However, it is understood that cases consolidated in the Xarelto MDL in Louisiana but having their origins elsewhere would not be subject to the LIDD.

The first Xarelto bleedout lawsuit was Boudreaux v. Bayer. The defense verdict was significantly influenced, according to Wilhelmy, by the testimony of expert witness Dr. Kenneth Wong, the cardiologist who treated plaintiff Joseph Boudreaux. It has been reported that Wong applied the LIDD to his testimony, which requires that a witness asserts they were aware of all risks, and the benefits outweighed the risks regarding the individual patient – or any risk not known at the time of prescription, if known, wouldn’t have changed their decision to prescribe the individual patient.

In the end, the trial jury found that defendants Janssen Pharmaceuticals Inc. (Janssen, a unit of Johnson & Johnson) and Bayer AG (Bayer) had not failed in providing the plaintiff’s cardiologist with sufficient instruction for the safe use of Xarelto for his patient.

Xarelto (rivaroxaban) is a new-age anticoagulant and one of the heirs apparent to Coumadin (warfarin), until recently the preeminent standard for blood thinners. Janssen and Bayer touted Xarelto as being easier to manage than Coumadin, with less stringent monitoring. Unlike Coumadin, however, Xarelto does not respond to an infusion of Vitamin K in the same way as warfarin does, which has the capacity to quickly reverse the anti-coagulating properties of warfarin – thereby allowing the blood to thicken and clot, helping to stem bleeding events. Xarelto was released to the market without such an antidote, heightening the risk for Xarelto bleeding complications and in some cases, Xarelto deaths.

The current Xarelto bellwether trial, which commenced May 30, is litigated under the premise that Janssen and Bayer failed to warn. However this past Thursday, June 8, the defendants urged presiding Judge Eldon Fallon to toss the plaintiff’s last remaining failure to warn claim, noting that federal regulations prohibit the manufacturer from updating or altering the product label in any way – including the addition of a diagnostic test – without the express approval of the US Food and Drug Administration (FDA).

Plaintiffs held that the Xarelto label should have directed physicians treating emergency room patients to employ a prothrombin time test, in order to determine if patients had recently taken Xarelto.

The defendants countered they would be in no position to direct a doctor to undertake such a test, as it had not been previously cleared by the FDA. “Plaintiffs’ PT-related [sic] failure-to-warn claim boils down to an assertion that defendants had a state-law duty to recommend an unapproved, ‘off-label’ use of Neoplastin in conjunction with Xarelto,” the filing by Janssen and Bayer, aimed at tossing the failure to warn claim, suggested. “But federal law governing recommendations to use a product ‘off label’ precludes state law from imposing such a duty.”

That wasn’t good enough for the plaintiffs, who suggested it would be filing a formal response expressing their disagreement with the defendant’s view.

The Xarelto side effects lawsuit is In re: Xarelto (rivaroxaban) Products Liability Litigation, Case No. 2:14-md-02592, in the US District Court for the Eastern District of Louisiana.