The first Xarelto bellwether trial was originally expected to commence next month before US District Judge Eldon Fallon in US District Court of Eastern District of Louisiana. This would have been an important step since bleeding cases tied to this blood-thinner are around 14,000. However, both parties agreed to reschedule this monumental avenue of justice due to New Orleans playing host to the NBA All-Star Game. The date changed since the Xarelto bellwether trial and the All-Star Game coincided in the same week in March.
First Xarelto Bellwether Trial Case
Now rescheduled for March 13, the first trial concerns Joesph Boudreaux. According to court documents, Boudreaux began taking Xarelto for the treatment of atrial fibrillation in January 2014. Within a month, doctors hospitalized him because of a Xarelto bleeding issue. He needed multiple blood transfusions to survive.
Boudreaux feels manufacturers Janssen Pharmaceuticals and Bayer misrepresented the safety of Xarelto not just to him but also to the public, the medical community, and the FDA. His case references issues surrounding the results of the ROCKET AF clinical trial.
In the trial, researchers used Alere’s INRatio measuring device. The safety and efficacy of Xarelto have come into question after the recall of the device last July. Allegations suggest the INRatio readings may have resulted in patients in the warfarin control group receiving too much warfarin, which in turn may have cast Xarelto in a more favorable light. The FDA said any potential variations in the INRatio readings were insufficient to skew the trial results in Xarelto’s favor.
Less Monitoring Brings More Danger
Xarelto was an instant success since it is a blood thinner bringing a less-involved regimen of monitoring. All blood thinners run the risk of bleeding events. This is why doctors order the strict monitoring of diet and other blood factors to maintain anti-coagulants at optimum levels. This will help mitigate stroke risk and the formation of blood clots. Xarelto brought an easier way with once-a-day dosing. Unfortunately, the ease came with serious bleeding complications that did not have an antidote.
With warfarin, doctors could administer an infusion of Vitamin K to reverse bleeding complications. There is no antidote with Xarelto. Xarelto lawsuit plaintiffs allege that manufacturers were irresponsible to claim Xarelto required less monitoring than warfarin. Since there is not a reversing agent, manufacturers should have told patients to be more vigilant and to be monitored closely by their doctors.
At The Michael Brady Lynch Firm, we take these bleeding side effects very seriously, and we fight to make sure that pharmaceutical companies understand the seriousness as well. If Xarelto caused your or a loved one’s bleeding event, contact us at 877-513-9517. Let us fight for you.
Related Links
- Xarelto May Cause Dementia in AFib Patients
- Xarelto Purposely Pushed to Market Regardless of Dangers
- Corporate Greed and the Saga of Xarelto and Pradaxa