Plaintiff attorneys say three recently decided Xarelto bellwether trials may have ended differently if jurors would have access to a new report published September 14 in the Journal of Thrombosis and Haemostatis.
In August, a jury in the Southern District of Mississippi found Bayer and its subsidiary Janssen Pharmaceuticals not liable for the internal bleeding and anemia suffered by a 69-year-old Xarelto patient in Mississippi. During the trial, jurors were told that “no practical and effective lab test exists to protect patients taking Xarelto from excessive bleeding and sometimes death,” but the recently published study found the Prothrombin time or “PT” test has been shown to be sensitive to rivaroxaban (Xarelto). The attorneys maintain that knowledge of this research may have led to a different result in court.
What is Xarelto?
Xarelto is an anticoagulant (blood thinner) prescribed to patients suffering from atrial fibrillation (irregular heart beat) who are at increased risk of a blood clot in the heart, which can potentially travel to the brain and cause a stroke.
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 those who take the drug, and many of the side effects have been particularly severe because the bleeding cannot be successfully controlled.
Black Box Warnings
Since U.S. Food and Drug Administration (FDA) approval in 2011, Xarelto has been given two black box warnings from the FDA:
- In August 2013, Xarelto received a black box warning stating 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.
Xarelto use has been linked to at least 370 deaths, according to a Chicago Tribune report.