J&J, Bayer to Pay $775 Million to Settle Xarelto Lawsuits

Xarelto box sitting on pharmacy counter

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Despite having won some legal appeals regarding the blood thinner medication Xarelto, Bayer and Johnson & Johnson have agreed to pay $755 million to settle all remaining lawsuits against the two companies.

Germany-based Bayer and J&J, which markets Xarelto in the United States, will each shoulder half of the financial burden of the settlement, Reuters reported. Under the settlement agreement, Bayer and J&J did not admit any liability. There are approximately 25,000 lawsuits that have been filed against the two companies over Xarelto (rivaroxaban). Xarelto generated more than $4 billion for Bayer and $2.47 billion for J&J last year, Reuters said.

In a statement released Monday, Bayer said that despite agreeing to settle the lawsuits, the company believes the claims made in court about Xarelto are without merit. Bayer said the “favorable settlement” allows the company to “avoid the distraction and significant cost of continued litigation.”

Xarelto has been approved for seven indications, including the treatment of pulmonary embolisms in adults and the treatment of deep vein thrombosis in adults.

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Lawsuits filed against the two companies over Xarelto claim the companies failed to warn patients and physicians of increased risks of fatal internal bleeding when using the drug. In December 2017, a judge ordered the two companies to pay $28 million to Lynn Hartman and her husband. Lynn Hartman had been taking the drug to treat atrial fibrillation. About a year after being on the medication, she began to experience significant internal bleeding. Once she was taken off the medication, she recovered. Lawsuits similar to the one won by the Hartman family are still awaiting a trial. That award was overturned in 2018.

Johnson & Johnson also called the allegations made about Xarelto without merit. The life sciences giant said that although the companies have won appeals in court, the thousands of lawsuits require “an enormous amount of time and resources.” J&J said in a brief statement that it wants to spend its time improving lives and finding new cures.

Last week, Janssen, J&J’s subsidiary, announced that Xarelto bested warfarin in a nonvalvular atrial fibrillation (NVAF) study. Janssen said patients who took Xarelto experienced significantly fewer strokes, significantly fewer severe strokes and fewer stroke-related deaths compared to those taking warfarin. The study results showed that Xarelto reduced overall strokes by 18 percent compared to the blood thinner warfarin. Data also showed that Xarelto reduced the risk of severe stroke by 47 percent, moderate stroke by 5 percent and minor stroke by 18 percent. Also, across the entire study population, Xarelto significantly reduced the risk of post-stroke mortality at 30 days by 59 percent and at any time by 22 percent, Janssen said.

In December the U.S. Food and Drug Administration approved Xarelto to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease.

Also in December, Xarelto failed to demonstrate a statistical significance in the management and prevention of venous thromboembolism (blood clots) in high-risk cancer patients during a late-stage trial. Janssen noted that although the trial failed to hit its endpoints, the use of Xarelto resulted in a clinically meaningful and nominally significant 60 percent reduction of VTE events compared to placebo while patients were receiving treatment.

While Bayer settled the Xarelto lawsuits, the company is still facing more than 10,000 lawsuits regarding its weed killer Roundup and alleged links to cancer associated with glyphosate, the active ingredient in the product. In August, a jury awarded a plaintiff $289 million after determining Roundup caused his non-Hodgkin’s lymphoma. That award was cut by a judge to $78 million and Bayer has appealed the charges.

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