Pharmaceutical giants Bayer and Johnson & Johnson have agreed to pay $775 million to settle thousands of product liability lawsuits filed over problems with their blood thinner medication, Xarelto, which has been linked to an increased risk of stroke, bleeding problems and death. The settlement agreement resolves nearly 25,000 Xarelto state and federal lawsuits, which allege that Bayer and J&J failed to provide adequate warnings about the potential for Xarelto to cause life-threatening bleeding episodes in users. If you or a loved one suffered a stroke, bleeding injury or another serious problem while taking Xarelto, contact our consumer advocates at Consumer Justice Foundation for help. We are dedicated to protecting the rights of consumers harmed by dangerous medications, and we can help put you in touch with an experienced Xarelto injury lawyer.

What is Xarelto?

Xarelto (rivaroxaban) belongs to a new class of anticoagulant medications introduced as alternatives to warfarin, which was the go-to blood thinner for decades. While warfarin requires regular checkups, a strict diet and frequent blood tests, Xarelto and similar drugs do not, and many patients have switched to Xarelto, Pradaxa or other new-generation oral anticoagulants for this reason. As a blood thinner, Xarelto is designed to thin the blood and prevent blood clots that can lead to stroke and other problems in patients with atrial fibrillation or those undergoing knee or hip replacement surgery. Unfortunately, the drug has also been shown to trigger massive irreversible bleeding episodes in some patients, which can lead to debilitating injury or possibly even death.

Until last year, there was no approved antidote for Xarelto, which meant doctors were unable to reverse the blood thinning effects of the medication in the event of a bleeding episode, and the risk of serious or life-threatening complications was therefore increased. The tens of thousands of product liability lawsuits included in the Xarelto litigation alleged that Bayer and J&J failed to properly warn patients and their doctors that the blood thinner could cause dangerous internal bleeding episodes, stroke and death.

Xarelto Bleeding Injuries and Deaths

This new class of blood thinners, which includes Xarelto, is intended to offer a more convenient and effective treatment option than warfarin, but the potential for patients taking Xarelto and similar drugs to suffer serious and potentially fatal bleeding events has raised serious concerns about the safety of these medications. Given the nature of the blood thinners, they all include warnings on their labels about the risk of serious or fatal bleeding, and Xarelto is no exception. The “Warnings and Precautions” section of the Xarelto drug label includes a warning that states, “Xarelto increases the risk of bleeding and can cause serious or fatal bleeding.” In 2016 alone, the FDA received more than 15,000 reports of serious injury or death associated with Xarelto, a 41% overall increase over the previous year.

Lawsuits Over Blood Thinner Side Effects

As more and more patients begin using Xarelto to reduce their risk of stroke and blood clots, the number of bleeding injuries and deaths reported in connection with the anticoagulant continues to grow, yet the FDA still has made no effort to issue a Xarelto recall. On the contrary, in October 2018, the FDA approved Xarelto for an additional indication, to reduce the risk of major cardiovascular events in patients with peripheral artery disease or chronic coronary artery disease. And Xarelto isn’t the only new-generation anticoagulant plagued by reports of bleeding problems and death. In 2014, another pharmaceutical company, Boehringer Ingelheim, agreed to pay $650 million to resolve about 4,000 product liability lawsuits over problems with its new-generation blood thinner, Pradaxa (dabigatran), which was also tied to reports of bleeding injuries and deaths in patients. In 2011, the FDA reported that the agency had received 3,781 reports of serious adverse events in Pradaxa users due to problems with excessive bleeding, including 542 patient deaths.

Bayer, J&J Do Not Admit Liability in Settlement

This Xarelto settlement agreement comes after defense verdicts were handed down in the six Xarelto lawsuits that went to trial in state and federal court, and involves lawsuits that date back to 2014, accusing Bayer and J&J of downplaying or failing to warn of the risk of Xarelto complications, including strokes, internal bleeding and deaths. Neither Bayer nor J&J admitted liability in the settlement; Janssen, the pharmaceutical division of J&J said in a statement that the company was settling simply because the litigation “demands an enormous amount of time and resources.” Bayer, in a separate statement, said, “Bayer continues to believe these claims are without merit and there is no admission of liability under the agreement. However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation.”  

While warfarin still accounts for a large part of the oral anticoagulant market, Xarelto brought in around $2.5 billion for Johnson & Johnson in both 2017 and 2018. Regarding the $775 million settlement, it will be split evenly between Bayer and J&J, with each company responsible for paying $387.5 million.