Xarelto Litigation Update: 5 Key Points
Thornton Law Firm is no longer accepting new Xarelto cases.
Posted on Jan 22, 2015
The blood thinner Xarelto can lead to life-threatening uncontrollable internal bleeding. Currently, there is no reversal agent (antidote) to stop bleeding caused by Xarelto, and as a result many patients have suffered serious injuries. Below are the most recent updates in the ongoing Xarelto litigation against the manufacturer, Bayer HealthCare AG, and U.S. distributor Janssen Pharmaceuticals Inc., a division of Johnson & Johnson:
1. 86 new Xarelto cases have been filed on the docket of the recently approved Xarelto federal MultiDistrict Litigation in the Eastern District of Louisiana. An initial pretrial conference is scheduled for January 29, 2015 before the Honorable Judge Eldon E. Fallon, who has been appointed to oversee the coordinated litigation. The first case management order issued by Judge Fallon also requires the parties to preserve all evidence that may be relevant to the litigation.
2. A recent analysis of Physician Payment Sunshine Act data (a healthcare reform bill requiring payments to doctors by pharmaceutical and medical device manufacturers be made public) by the media organization Pro Publica shows that Bayer and Johnson & Johnson have spent $6.93 million dollars in payments to doctors for “speaker programs” in which the doctors are paid for “meals, promotional speeches, consulting gigs and educational gifts”. The blood thinner Xarelto was the 6th-most promoted pharmaceutical product of 2013.
3. Janssen has released preliminary results of a 5-year study of Xarelto showing that over the initial 15-months of the study, Xarelto had the same rates of bleeding and complications as were shown during the clinical trials that lead the FDA to approve Xarelto. The study, which surveyed health records, showed a 2.86 per 100 person-year incidence of major bleeding. Of course, as there is still no antidote or reversal agent, this number of major bleeding incidents is still a potentially deadly side effect.
3. Janssen has released preliminary results of what will be a 5-year study of Xarelto, showing that over the first 15 months of the study, Xarelto had the same rates of bleeding and complications as were shown during the clinical trials that lead the FDA to approve Xarelto. The study, which surveyed health records, showed a 2.86 per 100 person-year incidence of major bleeding. Of course, as there is still no antidote or reversal agent, this number of major bleeding incidents is still a potentially deadly side effect.
4. The manufacturers and distributors of Xarelto continue to resist the FDA’s recommendation that the label and advertisements be changed to recommend blood monitoring while taking Xarelto. Instead, advertising suggests that one of the major advantages of Xarelto over the traditional blood thinners like warfarin (Coumadin) is that the patient doesn’t have to undergo regular blood tests,
5. However, the latest scientific evidence makes it clear that regular blood monitoring can identify patients at risk for severe uncontrollable bleeding. A Japanese study just published in the peer-reviewed Journal of Cardiology followed 136 patients prescribed Xarelto to treat non-valvular atrial fibrillation. A review of the study results indicates that blood monitoring did in fact reveal that certain patients’ coagulation status showed them to be at risk for severe bleeding events.
If you or a loved one has taken Xarelto and suffered a severe bleeding complication, contact one of our Massachusetts Xarelto attorneys today by calling 888-341-1405 or by telling us your story here. Thornton Law Firm is filing claims on behalf of patients who have suffered severe bleeding, uncontrolled bleeding, decreased hemoglobin levels requiring blood transfusions, strokes, or even death. The consultation is free and confidential. Like all legal claims, your Xarelto claim will be subject to short, strictly enforced legal time limits, so do not delay seeking legal advice.