- For the first time, Bayer is dealing with lawsuits related to its anticoagulant Xarelto (rivoroxaban).
- Xarelto grossed $1.3 billion last year and has been well-received by the clinical community.
- Xarelto competes with Boehringer Ingelheim’s Pradaxa (dabigatran), which has already faced lawsuits.
The introduction of Xarelto and Pradaxa several years ago were supposed to be the start of something new—the next generation of anticoagulants to provide an alternative to warfarin, which had been the standard of care for half a century. Warfarin requires constant monitoring and adjustment to achieve the right amount of blood thinning.
In contrast, the new oral anticoagulants (NOAC) were designed to be easier to use, with better control. However, in the last two years there have been allegations of numerous serious side effects associated with Pradaxa, including internal bleeds, stroke, heart attack, blood clots and even death. Lawyer Levin Papantonio has reached a $650 million settlement with Boehringer Ingelheim on behalf of patients harmed by Pradaxa. The main claim is that BI did not provide sufficient information to patients and did not sufficiently take into consideration that patient response to anticoagulation is highly individual.
Until now, Xarelto has not been the subject of litigation, but that has changed. The first few suits have been filed and Papantonio is conducting a full investigation. On the positive side, Bayer has patient data, including safety data, on more than 75,000 patients.