For those who have never heard of it, Xarelto is the name brand of the drug rivaroxaban, an anticoagulant blood thinner developed by Bayer HealthCare in 2008, and approved by the FDA in 2011. It is considered part of a class of “new anticoagulants,” and its development was designed to address a major clinical need in oral anticoagulant treatment.
Xarelto is generally prescribed to patients who have recently had hip or knee replacement surgery or are otherwise at risk for deep vein thrombosis, pulmonary embolism, or stroke. It is also prescribed in cases of atrial fibrillation. Xarelto is specifically intended to reduce the risk of stroke or pulmonary embolism in these situations. The risk that all these situations have in common is the formation of blood clots where none should exist. These clots then have the potential to travel the body and clog blood vessels in the heart (pulmonary embolism) or the brain (stroke). Since excessive clotting is known to occur after knee and hip replacement, blood thinners/anticoagulants have long played a role in post-surgical care.
Problems have developed around this drug, however, due to the severe side effects some patients have experienced after using it. Major negative effects have included uncontrolled bleeding, inter-cranial, abdominal, and retinal hemorrhaging, stroke, and death. The critical issue is that, unlike its predecessor, Warfarin, the anticoagulant effects cannot be stopped in an emergency, putting patients at grave risk of bleeding to death. Warafin’s anticoagulant effect can be counteracted by dosing the patient with vitamin K. There is no such “off” switch for Xarelto. There have so far been hundreds of confirmed deaths directly attributable to this unfortunate side effect, and possibly thousands more whose medical conditions were exacerbated rather than improved by treatment with Xarelto, leading to death. As doctors began prescribing the drug more frequently, the side effects began occurring in greater numbers, ultimately leading to a great many lawsuits. Currently, there are over 18,000 lawsuits that have been filed against the manufacturers of Xarelto. Of those, 40 have been selected as “bellwether” cases.
The first two of these bellwether lawsuits were tried in a Federal court in New Orleans, with the verdict being found in favor of the defendant in both cases. While this certainly represents a negative outcome for the plaintiffs in these cases, it is not at all indicative of how future cases will be decided. Bellwether cases are used to establish the legal groundwork, discovery, and other facts in situations where many lawsuits are pending before the courts. These cases, once they are all decided, will determine the potential success of both individual and class action lawsuits against the manufacturers of Xarelto, so it is wise to consider the outcome of the remaining 38 pending cases before reaching any conclusions about the efficacy of future legal actions. So far, the legal strategy employed has been the so-called intermediary doctrine defense, which is considered both weak and a last resort for defendants attorneys, as it relies on shifting responsibility from the manufacturer to the prescribing doctor. The premise, in a nutshell, being that the doctor is reasonably informed as to the risks involved and feels that the benefits of treatment outweigh those risks.
Of the next four trials to watch, three will take place in the same New Orleans District court between now and August, and a fourth will begin in November of 2017 in Philadelphia. It will take a long time for the courts, defense, and plaintiffs attorneys to establish to what degree the manufacturers are liable for the negative or harmful effects experienced by users of the drug. Although cases like this often involve reams of highly technical data, the essential points of contention are as follows:
Plaintiffs and their lawyers contend that the manufacturers of Xarelto irresponsibly, knowingly, and materially downplayed the side effects and risks of their drug in order to preserve its budding popularity and growing profits. The drug manufacturers contend that their warnings and educational materials provided to prescribing doctors are scientifically accurate and sufficient to allow for proper risk/benefit evaluation.
It remains to be seen how future juries will decide these cases, but many plaintiffs attorneys remain very optimistic about future positive results for their clients. If you, or someone you know, has suffered any ill effects after taking Xarelto, a qualified attorney can assist you in evaluating your case, and potential damages.