Xarelto Settlement to Result in $775M Payments for Bleeding Problems

Bayer and Johnson & Johnson have agreed to pay $775 million to settle more than 25,000 Xarelto lawsuits filed on behalf of individuals who have suffered serious and sometimes fatal bleeding problems after using the controversial anti-coagulant.

Each of the complaints raise similar questions of fact and law, alleging that the drug makers failed to adequately warn about the risk of internal bleeding from Xarelto, which was introduced without an effective antidote to allow doctors to reverse the blood-thinning effects of the drug when hemorrhaging occurred.

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. While a number of early test cases have resulted in conflicting results, the drug makers faced the prospect of hundreds of individual cases being remanded back to U.S. District Courts nationwide for individual trial dates if the Xarelto settlement was not reached to compensate plaintiffs.

On March 25, Bayer and Johnson & Johnson’s Janssen subsidiary issued statements announcing the settlement agreement. In a press release, Bayer claims that the agreement would settle virtually all outstanding Xarelto claims, but said the companies still believe the drug to be safe and reserve the right to withdraw from the deal if there is not an adequate level of participation.

In response to the deal, Judge Fallon issued a case management order (PDF) on Monday, staying all proceedings in the Xarelto litigation. In addition, in another order, the Court is requiring parties to begin the registration of cases and claims (PDF), including lawsuits filed in state and federal courts, as well as unfiled cases.

“In order for this Court and the cooperating state court jurisdictions with coordinated proceedings pending in Pennsylvania to cooperatively manage this litigation and to assist the Parties to effectuate the provisions of the private Final Settlement Agreement entered into between, inter alia, the MDL Plaintiffs’ Steering Committee and Defendants Janssen and Bayer, it is necessary to identify all filed and unfiled Xarelto-related claims,” the order states.

The order calls for the creation of a registration list of every claim not filed in court before March 11, due by March 28, 2019. By April 9, every case on the registration list will need to have the necessary information, such as the primary law firm and responsible attorneys, the plaintiff or claimant’s name and identifying information.

Xarelto 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 more than 25,000 lawsuits over Xarelto 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 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.

Specific details of the settlement agreement have not been released.

Bayer reported receiving $4 billion in Xarelto sales in 2018 due to its joint agreement with Johnson & Johnson’s Janssen unit, which sells the drug in the U.S. and raked in $2.47 billion in Xarelto sales last year.