Immediate Appeal in Xarelto Lawsuits Sought Over Federal Pre-Emption

The U.S. District Judge presiding over more than 20,000 Xarelto lawsuits pending in the federal court system will hear oral arguments today over whether to allow Bayer and Johnson & Johnson to pursue an immediately appeal, which argues the claims should be pre-empted by federal law. 

Each of the product liability lawsuits raise similar questions of fact and law, alleging that the drug makers failed to adequately warn about the risk of internal bleeding from Xarelto. Since December 2014, the litigation has been centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated discovery and a series of early “bellwether” trials.

Judge Fallon has denied prior motions for summary judgment filed by the drug makers on the issue of federal pre-emption. However, Bayer and Johnson & Johnson now seek an interlocutory appeal of the issue, which would ask the U.S. Court of Appeals for the Fifth Circuit to reconsider the defense, arguing that it may dispose of many, or all, of the claims in the litigation, without the need for more thousands of individual trials.

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Xarleto Litigation

Xarelto (rivaroxoaban) was introduced in 2011, as the second member of a new class of drugs known as novel oral anticoagulants. The drugs were were marketed as easier to use than warfarin, which had been the go-to anti-clotting treatment for decades. However, as an alarming number of adverse event reports involving severe and often fatal bleeding problems began to emerge, a mounting number of lawsuits began to be filed against the drugs manufacturers.

Each of the 20,000 lawsuits over Xarelty raise similar claims involving uncontrollable gastrointestinal bleeding, brain bleeds or other injuries that occurred after doctors were unable to stop hemorrhaging among users. Plaintiffs claim that the drug makers provided false and misleading information for consumers and the medical community, failing to adequately warn about the risks associated with their medication.

Most of the cases pending nationwide are in the federal court system, where the Xarelto litigation has been centralized before Judge Fallon as part of an MDL, or multidistrict litigation. At least three “bellwether” cases have already been set for trial, each of which resulted in defense verdicts in favor o the drug makers, and the parties are now preparing a group of 1,200 additional Xarleto cases for trial.

In the request for an immediate appeal, Bayer and Johnson & Johnson argue that this issue should be resolved before additional trial dates are scheduled.

“The Court knows firsthand the enormous time and effort required to prepare and try each of these cases,” according to the motion (PDF) filed by the drug makers on June 4. “That burden falls not only on the parties, but also on the judicial system itself. And that burden will increase exponentially when the approximately 1,200 cases selected for pretrial workup… are remanded to federal judges throughout the country without appellate guidance on preemption.”

In a response (PDF) filed on June 14, plaintiffs argued that the federal preemption issue has already been settled by the court using well-defined existing law, and that granting the interlocutory appeal would unnecessarily delay the litigation.

“Your Honor concluded that federal regulatory law did not foreclose either the pre-market design-defect claims or the pre-approval and post-approval failure-to-warn claims asserted by Plaintiffs in these cases,” the response notes. “More importantly for present purposes, the Court reached its conclusions based on an analysis well-settled in the jurisprudence, as to which no substantial difference of opinion exists.”

According to a joint report (PDF) submitted by the parties on Monday, oral arguments on the motion to certify the interlocutory appeal will be heard following a status conference today.


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