Although Johnson & Johnson and Bayer AG won the first battle when a jury found that the companies aren’t responsible for an Xarelto user’s internal bleeding, the war is far from over.
The ruling was the first of more than 18,000 lawsuits that have been brought against J&J and Bayer over side effects associated with the anticoagulant drug Xarelto. The companies face three more separate Xarelto trials in the next three months.
What is Xarelto?
Xarelto is a blood thinner that is prescribed to patients suffering from atrial fibrillation (irregular heart beat) who are at increased risk of formed a blood clot in the heart traveling to the brain and causing a stroke. Xarelto works by thinning the blood and lowering the chance of clots forming.
But since approval in 2011, Xarelto has receive two black box warnings from the FDA:
- In August 2013, Xarelto received a black box warning indicating that the premature discontinuation of Xarelto increases the risk of thrombotic events and spinal/epidural hematoma in patients.
- In March 2014, Xarelto received another black box warning stating that the optimal timing between the administration of Xarelto and neuraxial procedures in each individual patient is not known.
Although all blood thinners increase the risk of bleeding problems, Xarelto has been linked to an increased number of uncontrollable bleed injuries, mostly because there is no approved antidote available for patients who use the medication, and many of the side effects have been severe because the bleeding cannot be effectively controlled.
Xarelto plaintiffs allege that they were not aware that the medication entered the market without an effective antidote and maintain that it was irresponsible of Xarelto manufacturers Janssen Pharmaceuticals and Bayer to claim that less monitoring was needed with Xarelto when, because of the absence of an antidote, more monitoring would actually be more appropriate.