Bayer announced Monday that along with partner Johnson & Johnson, the companies have reached a deal in principle to pay $775 million to settle "virtually all" of the roughly 25 000 pending US lawsuits alleging the anticoagulant Xarelto (rivaroxaban) causes uncontrollable and irreversible bleeding leading to severe injuries and even death. Neither Bayer nor Johnson & Johnson admitted liability under the agreement, which will be shared equally between the two firms. 

The German company stated it "continues to believe these claims are without merit," adding that Xarelto's safety profile "remains positive and unchanged as confirmed time and again by regulatory agencies worldwide." According to Bayer, although the drugmakers have prevailed in all six Xarelto cases that went to trial, the settlement will allow it "to avoid the distraction and significant cost of continued litigation." Bayer indicated that its share of the settlement amount will be partially offset by product liability insurance. 

Xarelto generated 993 million euros ($1.1 billion) in the fourth quarter of 2018 for Bayer and contributed 3.6 billion euros ($4.1 billion) in revenue to its pharmaceutical business last year. Johnson & Johnson reported Xarelto sales of $608 million in the fourth quarter, and just under $2.5 billion for 2018. 

Xarelto was approved in the US, where it is sold by Johnson & Johnson, in 2011 for the treatment of deep vein thrombosis in patients undergoing knee or hip replacement surgery. The label has since been expanded to include a number of other indications, including more recently to reduce the risk of major cardiovascular events in patients with chronic coronary or peripheral artery disease. 

Meanwhile, Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran) also became the subject of thousands of lawsuits claiming the company had understated its bleeding risk. In 2014, the drugmaker reached a $650-million settlement to resolve more than 4000 of those cases.

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