Xarelto is a new-generation blood thinner that was initially approved by the U.S. Food & Drug Administration in October 2011. Xarelto is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). The drug is also to reduce the risk of recurrence of DVT or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery.
This drug has made Bayer and Johnson & Johnson a fortune. It has also left them as the defendants in 21,400 Xarelto bleeding lawsuits from patients or surviving families allege they have suffered gastrointestinal and cerebral hemorrhages, hemorrhagic strokes, and other types of bleeding issues that have caused injury or death. Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding – and there is no reversal agent available if serious bleeding occurs with Xarelto use.
Xarelto Lawsuit Allegations
Xarelto has sold like hotcakes because it is marketed to physicians and patients as a once-daily drug. This is a big deal. There is no question that Xarelto is administratively easier than other blood thinners. The dosing schedule is heralded by Bayer and J&J as superior to other blood thinners because of this ease of administration.
Generally, many plaintiffs’ lawsuits allege that Xarelto is the worst in its class of new anticoagulants with respect to bleeding risk and thromboembolic stroke prevention when compared to traditional blood thinners like warfarin. Plaintiffs also allege that the dose of Xarelto currently marketed for atrial fibrillation is too high to meet the touted “once
daily” benefit of the drug. This causes high plasma concentrations of Xarelto in everyone and in a broad spectrum of patients. This concern is more pronounced in older patients with poor renal function, exposing them to excessive bleeding risk.
But the big issue with Xarelto is that using the drug without appropriate blood monitoring, dose adjustment, and twice a day dosing — the opposite of what the marketing suggests is safe — can cause major, life-threatening bleeding events. Physicians using Xarelto have to walk much more tightrope than the drug manufacturers are suggesting. They need a table to balance the dose so that the blood is thinned enough to reduce the risk of a stroke, but not so thin that they increase the risk of a major bleeding episode.
The plaintiffs’ lawyers’ main argument is that these companies were aware of this risk and the need for blood monitoring but have failed to disclose this critical life-saving information to patients, doctors, and the FDA. No one — or very few people, anyway — are screaming for a Xarelto recall. Instead, they are saying that Bayer and J&J should have shown doctors and patients everything they knew about the risk and didn’t. These lawsuits argue the reason this was not done is that these companies put profits over the health of patients.
Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to help clotting factors when a serious bleed occurs. So Xarelto carries an increased risk of gastrointestinal bleeding. This means that in the event of hemorrhagic complications, there is no available reversal agent. When Xarelto first came out, it did not contain a warning regarding the lack of an antidote. This information was buried in the overdose section.
Big Verdict Taken Away
After some losses in federal court, a Xarelto victim won a whopping $28 million jury verdict awarded last month in Pennsylvania against Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals for failing to adequately warn about the risks of the drug. Regrettably, the verdict overturned in 2018 on a narrow issue regarding the testimony of the prescribing doctor.
The Verdict and Settlement Value of Xarelto Claims
It is hard to imagine plaintiffs or these companies trying 21,000 Xarelto lawsuits, right? Ultimately, these cases settled for $775 million. The settlements have not been fully finalized as of May 2020, and some victims have opted out of the settlement.