Bayer, J&J settle thousands of US Xarelto lawsuits for $775 million

Bayer, J&J settle thousands of US Xarelto lawsuits for $775 million

Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 US lawsuits alleging that their blockbuster blood thinner Xarelto (rivaroxaban) caused unstoppable and in some cases fatal bleeding for a total of $775 million, court documents on Monday showed.

The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement.

The settlement will resolve all pending US lawsuits over rivaroxaban, which plaintiffs claimed caused uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of patients. Plaintiffs accused the drugmakers of having failed to warn about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.

Bayer in a statement on Monday said it continues to believe the claims are without merit. “However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,” the company said. Lawsuits over rivaroxaban began piling up in 2014, and the companies had so far won all six trials over rivaroxaban’s alleged bleeding risk.

J&J in a statement said it continued to believe in the safety of rivaroxaban but that the settlement was the right thing to do for patients and their doctors.

Rivaroxaban is Bayer’s best-selling drug. It contributed 3.6 billion euros ($4.07 billion) in revenue to the German group’s pharmaceutical business last year. Bayer said its share of the settlement amount will be partially offset by product liability insurance.

Bayer jointly developed rivaroxaban with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States. J&J reported 2018 rivaroxaban sales of $2.47 billion.

The US Food and Drug Administration approved rivaroxaban in 2011. It is prescribed for people with atrial fibrillation, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolism. The companies in the past have said rivaroxaban’s warning label provides “complete, accurate, and science-based information on the medicine’s benefits and risks.”

The majority of the claims were consolidated in New Orleans federal court, where three cases were selected as so-called bellwether trials, aimed to help determine the range of damages and define settlement options. The companies won those three trials throughout 2017. J&J and Bayer were also cleared of liability in three other state court trials in 2018.

Rivaroxaban is among a class of oral blood thinners, including Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), that are alternatives to decades-old warfarin. Most of the lawsuits over apixaban have been dismissed by US judges.

A similar drug, Boehringer Ingelheim’s Pradaxa (dabigatran), also became the subject of thousands of lawsuits claiming the company understated its bleeding risk. Boehringer in 2014 reached a $650 million settlement to resolve more than 4,000 of those cases.

Why did these companies agree to make these settlements ??.. because in MY PROFESSIONAL OPINION – they are dangerous…  A number of years ago, Barb had A-Fib and her then cardiologist wanted to discharge her from the hospital on one of these “new oral anticoagulants” that – at the time – had no way to reverse of a pt started bleeding… I reluctant to allow her to be discharged on the one that could at least be reversed with dialysis  – on top of that  – the particular med he wanted her on has a LEVEL ONE DRUG INTERACTION with one or more of her other meds – LEVEL ONE is DO NOT GO THERE.

Once I got her into the PCP… I got her switched to Warfarin… our PCP really kinda of defended using these new meds but he caved to my persistence. Thru a medical procedure, Barb was able to get her A-Fib correct and no longer on Warfarin…

A few years later, I showed up with some clots and had to go on a blood thinner and our PCP – either remembered me be “hard-headed” about using Warfarin  – or he had seen the problems with these new blood thinners and never discussed me being on anything but Warfarin.  A Warfarin bleed can be quickly reversed with Vit K and while there is a new reversal agent for these blood thinners… the studies I have seen suggests that it works so slow that 17% of the pt will still BLEED OUT !

I can do home testing with a meter and with Medicare and a Supplement… the cost is paid 100% and it takes maybe a total of 5 minutes to do the test



2 Responses

  1. It is unbelievable. How dare the companies playing with people’s health. I suffered a severe ulcer in my leg, that cost me and my insurance company lot a money because I used Xarelto as blood thinner. It tookek more than 3 months to heal, at the point doctors used an artificial skin piece to close the ulcer. The lawyers I called because of the ads on Xarelto issues, saying there was not a case. But the curious thing that on TV everybody can watch sports and business professionals performing the act that the Xarelto help them to get a “better life”. Astonish, right? Wondering, and respectfully, how much money those people get for the ads on TV?

  2. While $775 million sounds like a LOT of money, in reality it isn’t. When numbers get this large, people have no concept to compare to. You have to do the math to show how FRIVOLOUS this amount really is. Between Bayer AG and Johnson & Johnson, their combined earnings recently total over $120 billion. Do the math: $120,000,000,000 divided by 365 days per year = $328,767,123 per day. That’s $328 MILLION per day, EVERYDAY, not just business days. So divide that out of their settlement amount of $775 million, and you see that it only takes them 2.36 days to make that amount of money; that’s only 56.6 HOURS. When the average citizen gets fined or penalized, it ususally represents a BIG proportion of their income. This $775 million out of $120 billion represents LESS THAN 1% of their revenue! WOW! THAT WILL REALLY TEACH THEM A LESSON! While they are laughing their way to the bank.

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