This week, Bayer and Johnson & Johnson paid $775 million to resolve the remaining lawsuits concerning the anticoagulant Xarelto (rivaroxaban). The two companies had previously won some of the cases. Under the settlement agreement, Bayer and Johnson & Johnson admit no liability.
Lawsuits filed against Xarelto primarily allege that the two companies failed to warn patients and physicians about the increased risk of fatal internal bleeding associated with its use. In December 2017, a judge ordered the two companies to pay $28 million to Lynn Hartman and her husband. Ms. Hartman had been taking the drug to treat atrial fibrillation. Approximately one year after starting the medication, she began experiencing severe internal bleeding. She recovered after discontinuing the drug. Lawsuits similar to Ms. Hartman’s remain pending trial. However, the verdict was overturned in 2018. Nevertheless, approximately 25,000 lawsuits have been filed against the two companies regarding Xarelto.
In December 2018, the FDA approved Xarelto to reduce the risk of major cardiovascular events, such as cardiovascular death, myocardial infarction, and stroke, in patients with chronic coronary artery disease or peripheral artery disease. Currently, Xarelto has been approved for seven indications, including the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) in adults. According to Reuters, Xarelto generated more than $4 billion in revenue for Bayer and $2.47 billion for Johnson & Johnson in 2018. Bayer and Johnson & Johnson each bear half of the costs associated with the U.S. sales of Xarelto.
In a latest statement released on Monday (March 25), although Bayer agreed to resolve the current litigation, the company believes that the claims against Xarelto brought by the court lack legal basis. Bayer stated that treating compensation as a "favorable solution" would allow the company to "avoid distractions and significant costs associated with continuing the lawsuit."
Johnson & Johnson also stated that the allegations regarding Xarelto are baseless. The pharmaceutical giant noted that although both companies have won their appeals in court, the thousands of lawsuits require “significant time and resources.” In a brief statement, Johnson & Johnson said it hopes to devote its time to improving lives and discovering new treatments.
Last week, Janssen, a subsidiary of Johnson & Johnson, announced that Xarelto outperformed warfarin in a study on non-valvular atrial fibrillation (NVAF). Janssen stated that patients treated with Xarelto had significantly lower rates of stroke, severe stroke, and stroke-related death compared to those taking warfarin. The study results showed that Xarelto reduced all strokes by 18% compared to the anticoagulant warfarin. The data also indicated that Xarelto lowered the risk of severe stroke by 47%, moderate stroke by 5%, and minor stroke by 18%. Furthermore, across the entire study population, Janssen reported that Xarelto significantly reduced the risk of death within 30 days post-stroke by 59% and the risk of stroke-related death at any time by 22%.
In a Phase III trial published in December 2018, Xarelto failed to demonstrate statistical significance in the management and prevention of venous thromboembolism (VTE; blood clots) in high-risk cancer patients. Johnson & Johnson noted that, although the trial did not meet its primary endpoint, treatment with Xarelto resulted in a clinically meaningful and nominally significant 60% reduction in VTE events compared with placebo while patients were on therapy.
In addition to resolving litigation related to Xarelto, Bayer faces more than 10,000 lawsuits concerning its agricultural herbicide Roundup (whose active ingredient is glyphosate), primarily involving allegations linking glyphosate to cancer. In August, after a jury determined that Roundup had caused a user to develop non-Hodgkin lymphoma, it awarded $289 million in damages to the plaintiff. The judge later reduced the award to $78 million, and Bayer has filed an appeal.
