Recently, in the Pennsylvania State Court a new Xarelto Lawsuit has been filed against the medication’s manufacturers Janssen Pharmaceuticals. More than 1,700 federal Xarelto litigations have been filed in the last few years accusing the pharmaceutical of negligence in properly warning their patients about the life-threatening dangers of the blood-thinning drug. Xarelto was, in fact, associated with uncontrollable bleeding events that can even cause a patient’s death as no antidote is available to reverse the drug’s effects. The number of Xarelto litigations was so high that they were consolidated in the Multi District Litigation number 2592 in the US District Court for the Eastern District of Louisiana presided by the United States District Court Judge Eldon Fallon.
What’s new about this particular Xarelto lawsuit, however, is that a new argument has come up against the Novel Oral Anticoagulant (NOAC) drug. The plaintiff alleges that the once-daily dosage of Xarelto could not be sufficient to protect the patient for an entire 24-hours period as it should. All the other lawsuits so far accused Xarelto of being way too effective, to the point of being dangerous or even lethal. This one is the first litigation that accuses Xarelto of being ineffective, however.
One of the main selling points of Xarelto was its once-daily dosage that allowed the patient to take a single pill every day, without much fuss about continuous blood monitoring and dietary restrictions. A famous advertisement even featured the comedian Kevin Nealon throwing a punchline about choosing between spending their afternoons in a Golf clinic instead of in a blood clinic. All other anticoagulant medications available such as warfarin instead, usually require proper blood monitoring to adjust the dosage, which is usually distributed in several dosing through the day.
The plaintiff that on October 8th, 2015 filed this new Xarelto lawsuit, was a patient who was prescribed the medication to prevent the risk of stroke because of his atrial fibrillation. The patient, however, suffered a stroke after only four days of taking Xarelto, so it was argued that the drug did not protect him as it was supposed to. After taking the medication, however, the plaintiff started suffering from several Xarelto side effects, so in the lawsuit he even alleged that the NOAC itself could be the cause of his stroke.
In 2011, the United States Food and Drug Administration (FDA) granted approval for Xarelto for the prevention of strokes in patients with atrial fibrillation, and to reduce the risk of blood clots formation in individuals who undertook knee and hip surgeries. The medication should prevent a dangerous blood clot from blocking a major vessel, causing a life-threatening pulmonary embolism or a deep vein thrombosis. Recent findings, however, showed that Xarelto could be considered a very dangerous medication, and many argued if this drug could do more harm than good.
- “Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience.” Prescrire Int. 2013 Jun;22(139):155-9.
- Institute for Safe Medication Practices (ISMP) “QuarterWatch Monitoring FDA MedWatch Reports – Anticoagulants the Leading Reported Drug Risk in 2011 – May 31, 2012 – New Data from 2011 Quarters 3 – 4” http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf (Accessed June 2015)
- FDA U.S. Food and Drug Administration Website: “MEDICATION GUIDE XARELTO® (zah-REL-toe) (rivaroxaban) tablets” Reference ID: 3688029 http://www.fda.gov/downloads/drugs/drugsafety/ucm280333.pdf (Accessed June 2015):
- Institute for Safe Medication Practices (ISMP) “ISMP List of High-Alert Medications in Acute Care Settings” https://www.ismp.org/tools/highalertmedications.pdf (Accessed June 2015)