- Bayer and its partner Johnson & Johnson have agreed to pay $775 million to settle thousands of lawsuits centered on their blood thinner, Xarelto.
- The lawsuits, of which there are roughly 25,000 in the U.S., claim Bayer and J&J either downplayed or didn't properly inform doctors and patients of the risks associated with Xarelto. Patients experienced bleeding injuries, stroke and even death after taking the drug, according to many of the cases.
- The drugmakers aren't admitting liability in their settlement. Though six Xarelto lawsuits have gone in their favor, Bayer and J&J explained they're looking for an end to the ongoing litigation that has taken time and resources away from their employees. The companies maintain the right to withdraw from their settlement if not enough eligible claimants participate in it. If the settlement does happen, J&J and Bayer agreed to split the payment equally.
Xarelto (rivaroxaban) is part of a recent wave of new blood-thinners meant to offer a more effective treatment option than warfarin, a commonly used mainstay. While warfarin still holds onto a good chunk of the oral anticoagulant market, novel therapies have made significant inroads in the last few years.
J&J, for instance, recorded around $2.5 billion in Xarelto sales in both 2017 and 2018. Bristol-Myers Squibb and Pfizer's Eliquis (apixaban) and Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate) have also achieved blockbuster status. Last year, Bristol-Myers recorded $6.4 billion in Eliquis revenue.
Given the nature of these therapies, the labels for Xarelto, Pradaxa and Eliquis all warn about the risk of serious or fatal bleeding. That risk appears to be a cornerstone of the lawsuits facing J&J and Bayer.
The companies maintain Xarelto is safe and effective, and that the claims against them are without merit. In a statement, J&J's subsidiary Janssen said Xarelto's label has "always appropriately informed physicians of the information that they need to make treatment decisions with their patients."
J&J and Bayer expect their proposed settlement will resolve essentially all the U.S. federal and state litigation regarding their handling of Xarelto.
"This is a fair and just resolution for thousands of consumers who have substantial claims," said Andy Birchfield, co-lead counsel of the Plaintiffs' Steering Committee for the federal multidistrict litigation, in a statement from the Beasley Allen law firm.
"It may have taken more than four years and six separate trials but litigation like this is an important way for consumers to have a voice in matters of drug safety," said Brian Barr, also a co-lead counsel of the Plaintiffs' Steering Committee for multidistrict litigation, in that statement.
J&J has argued that the litigation paints a misleading view of Xarelto, and could deter patients who would benefit from receiving the drug.
"We have all seen these lawyer ads on TV — ads related to Xarelto have been aired millions of times," J&J said in a statement. "The ads frequently contain unsubstantiated, incomplete and misleading claims about the medicine. The concerns these ads cause can create barriers to the critical doctor-patient relationship and complicate decisions about treatment options."
The settlement pertains to lawsuits that are part of the multidistrict litigation, according to Beasley Allen, as well as some recently filed claims that meet specific requirements. The law firm said claimants would receive "substantially reduced" payments if their first Xarelto prescriptions were in or after December 2015, and/or if their first alleged Xarelto injuries occurred in or after March 2016.
Patients hospitalized for two consecutive days or less are subject to a cap in their payment, according to Beasley Allen.