Bayer and J&J settle Xarelto lawsuits in US

Bayer and Johnson & Johnson have agreed to settle more than 25,000 US lawsuits worth more than $775 million alleging that blockbuster blood thinner Xarelto caused unstoppable and sometimes fatal bleeding, the latest in a string of similar legal agreements involving this class of drugs.

Developed in partnership with Johnson & Johnson, Xarelto is Bayer’s best-selling drug, contributing 3.6 billion euros in revenue to the German company’s pharma business in 2018.

J&J markets the drug in the US under an agreement with Bayer, where it brought in sales of $2.47 billion in 2018.

The amount will be shared equally between the two companies and as with many such agreements the companies do not admit liability, Reuters reported.

The settlement will resolve all pending US lawsuits over Xarelto, claiming it caused uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of patients.

Xarelto has been on the US market since 2011, where it was first approved to prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery.

Since then it has been approved in a number of other cardiology indications, such as stroke prevention in people with a common kind of abnormal heart rhythm, and reduction of recurrence of blood clots.

But lawsuits against Xarelto began to pile up in 2014, although the companies had so far won all six trials over Xarelto’s bleeding risk.

Xarelto and the factor Xa class of oral blood thinners including Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban) are alternatives to warfarin, which is itself associated with risks of bleeding.

Eliquis has also been subject to lawsuits, although most have been dismissed by US judges.

Boehringer Ingelheim’s rival Pradaxa (dabigatran) has also been hit with similar lawsuits, and the German pharma reached a $650 million settlement to resolve around 4,000 of those cases.

BI has produced a reversal agent to Pradaxa called Praxbind (idarucizumab), which was first approved by the FDA in 2015.