On November 12, 2015, a Louisiana resident filed a new Xarelto lawsuit in the Eastern District of Louisiana, the current location of the consolidated Xarelto MultiDistrict Litigation (“MDL”).
The plaintiff blames Xarelto for her grandmother’s death, and seeks in excess of $75,000 in damages from Xarelto manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson (J&J), Bayer Healthcare, and related entities.
Plaintiff Blames Xarelto for Her Grandmother’s Death
According to her complaint, the plaintiff’s grandmother started taking Xarelto around September 2014 for treatment of her deep vein thrombosis (DVT). The FDA approved Xarelto for this use in 2012. DVT is a condition in which the patient is at risk for a blood clot developing in the deep veins of the legs. The clot can cause inflammation and discomfort, and may travel from the legs back to the lungs, where it can cause a pulmonary embolism (PE), a dangerous clot in the lung.
According to the complaint, the plaintiff’s grandmother took the medication as directed by her doctor. Just a couple months after starting it on November 12, 20145, she ended up in the hospital with an intracranial bleed. This means that she had bleeding around or within the brain, which can be a life-threatening situation, and can also be qualified as a stroke.
Doctors were unable to stop the bleeding and the plaintiff’s grandmother died two days later, on November 14, 2014. The plaintiff alleges that it was Xarelto that caused the uncontrollable bleeding and death.
FDA Reviewers Question Once-a-Day Dosing
The plaintiff notes that Xarelto was granted FDA approval for the treatment of DVT based on clinical trials that tested the drug against a placebo. Xarelto was found to be an option for the treatment of the condition, but also presented an increased risk of bleeding events.
The defendants promoted Xarelto as a way to reduce the risk of clots and PE in patients with DVT, but failed to provide adequate warnings about the risks of internal bleeding, particularly gastrointestinal bleeding that required transfusion. They also positioned Xarelto as a better alternative to warfarin, the leading antiocoagulant for decades, because it didn’t require dietary adjustments or blood monitoring.
The Institute for Safe Medicine Practices (ISMP) noted in their QuarterWatch publication, however, that even during the approval process, some FDA reviewers questioned the convenient once-a-day dosing system, since studies showed peaks and troughs in the drug’s activity that could be eliminated with twice-a-day dosing.
The plaintiff also notes in her complaint that Xarelto has no readily available antidote, which makes the risk of internal bleeding even more dangerous. Whereas patients taking warfarin can be treated with vitamin K injections to start blood clotting again, patients taking Xarelto just have to “wait it out” until the drug clears from the system.
Xarelto the Subject of Over 2,000 Medwatch Reports
The plaintiff also asserts the defendants overstated the benefits of Xarelto in their promotional materials—materials that both her grandmother and her grandmother’s doctor became aware of prior to the date her grandmother starting the drug. These materials suggested that Xarelto was just as effective as warfarin yet was more convenient, without emphasizing that there was no reversal agent to stop or control bleeding in patients.
Notably, by the end of the 2012 fiscal year, the FDA Medwatch program had received over 2,000 reports of adverse events associated with Xarelto. Of those, 151 resulted in death.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.
Death due to PE in the setting of a DVT is the indication for anticoagulation. She needed anticoagulation. There is no way to know how the grandmother was taking the Xarelto (did she take too much?) nor how compliant she would have been on Coumadin. If anticoagulation with Coumadin was inadequate or overdone she might have had a PE or a bleeding event. The risk was present no matter what type anticoagulation was used. The fact that there is no reversal agent for Xarelto is well known, was known by the prescribing physician and was probably mentioned to the patient at the time it was prescribed. That risk was also available in the package insert.
Intracranial bleeding, GI bleeding, bleeding as a result of trauma or surgery are all dangerous events while anticoagulated on Xarelto or Coumadin, even with the possibility of reversing the effect. Nothing new here. I don't think this complaint should get any traction. It was a known risk of a needed therapy. The option of Coumadin had its issues as well.
Xarelto warnings for any type of extensive bleeding are new.Xarelto Safety Communications
January – March 2014 — Warning Updates
In 2014, the FDA required the makers of Xarelto to add new language to the anticoagulant’s warnings and precautions, including at least one update to the “black box” warning, the FDA’s strongest and most urgent type of warning. The additional verbiage notifies patients and caregivers about certain risks and potentially dangerous side effects of Xarelto, including the following:
Uncertainty about the best timing for the application of Xarelto in relation to neuraxial procedures (regional anaesthetic techniques)
A warning about the risks of using Xarelto with a epidural anesthesia and spinal puncture
Results from a study of Xarelto on renal functionality
Lack of an antidote to treat excessive bleeding due to the blood-thinning effects of Xarelto
Caution against using Xarelto with combined P-gp and strong CYP3A4 inhibitors, such as ritonavir, itraconazole, ketoconazole, conivaptan, lopinavir/ritonavir, and indinavir
Incomplete data with respect to Xarelto’s effects on who have heart valves
Thrombotic events upon early discontinuation of the anticoagulant
This lawsuit is justified.
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