New Orleans, LA Xarelto Class Action Claim Lawyers

Xarelto pillsHerman Herman & Katz attorneys are investigating claims on behalf of those who took the drug Xarelto (rivaroxaban) as a blood thinning medication.

What is Xarelto?

Xarelto (rivaroxaban) is in a class of blood thinning drugs known as new oral anticoagulants. It inhibits a protein involved in the coagulation process called Factor Xa, which interrupts the blood-clotting process and prevents thrombin, another protein, from forming.

Xarelto is primarily used to prevent strokes and systemic embolism in patients with nonvalvular atrial fibrillation. Xarelto is the second most prescribed drug for this purpose, behind only Coumadin (warfarin). Atrial fibrillation is a cardiac arrhythmia that causes the heart to pump inefficiently, often resulting in the pooling of blood in the chambers of the heart, potentially causing strokes and systemic embolism. Xarelto does not directly treat atrial fibrillation, but instead acts directly on the blood by preventing it from clotting.

What is the risk involved in taking Xarelto?

Xarelto was first approved by the FDA in July 2011 for preventing deep vein thrombosis, which can lead to pulmonary embolism, in adults undergoing knee and hip replacement surgery. In November 2011, the FDA expanded the approved uses of Xarelto to include stroke prophylaxis in patients with nonvalvular atrial fibrillation. Xarelto is also indicated for the treatment of deep vein thrombosis and/or pulmonary embolism, and the reduction of deep vein thrombosis and/or pulmonary embolism.

Before its approval by the FDA, a clinical trial of more than 14,000 patients found that Xarelto was “non-inferior” to warfarin as to safety and efficacy. However, industry-wide opposition identified problems with the trial, specifically that the warfarin comparison protocol was flawed and the once-a-day dosage of Xarelto was not better than the twice-a-day alternative. That Xarelto is thus “non-inferior” to warfarin is questionable, as the design of the study was questionable at best. In fact, the FDA clinical reviewers recommended voting against approving Xarelto, a sentiment mirrored by numerous other medical professionals and public interest organizations. Despite the recommendation against approval, the FDA approved Xarelto, noting the decision was made difficult by the concerns raised in this clinical trial.

Marketed as a replacement for warfarin, Xarelto differs from warfarin in that patients are not subject to routine blood testing or dose adjustment, and no antidote exists for uncontrolled bleeding. The “inconveniences” of blood testing or other procedures are required for other medications to ensure safe and effective use. Omitting these requirements from the use of Xarelto leads to heightened risk of harmful side effects. In fact, Xarelto has one of the highest rates of reported serious and fatal adverse events associated with its use. By the end of 2012, Xarelto ranked 10th overall for the number of direct reports of adverse events to the FDA, which included 2,081 serious adverse events, including 151 fatalities. Patients taking Xarelto have suffered uncontrolled bleeding, strokes, bleeding ulcers, and other harmful side effects that may have resulted from exposure to Xarelto.

The British Medical Journal recently revealed that the makers of Pradaxa, another blood thinner, found that major bleeding events could be significantly reduced by dosages based on single blood test results instead of based on patient characteristics. Xarelto labeling currently recommends basing dosages on patient characteristics. The FDA’s 2011 review of Xarelto agreed that patients could benefit from blood-test-based dosing methods, even though the more frequent monitoring may be more convenient for patients.

Why should Xarelto developers, manufacturers, distributers, and promoters be held liable?

The Defendant companies questionably tested Xarelto to guarantee approval by the FDA, and have since led an aggressive and misleading marketing campaign of the “Xarelto Difference” in comparison to warfarin. An explosion in Xarelto sales (almost $1.5 billion in 2012) was followed by an unsurprising explosion in the number of reported adverse events in patients taking Xarelto. The Defendant companies ignored the wisdom of the responses to their 2011 clinical study, and continue to fail in informing their patients of the need for routine blood testing to ensure safe and effective use of Xarelto. The basis for the concerns of medical professionals and the FDA – the lack of routine blood monitoring – has been touted by the Defendants as an advantage to patients. The failure to properly inform and protect patients and physicians causes increased risk of major, life-threatening bleeding events. The Defendants knew or should have known of the dangers that would result from their aggressive, profit-driven marketing strategy. However, the Defendants chose not to inform patients, physicians, or the medical community of the implications of their substandard recommendations for use of Xarelto.

Multi-district litigation

MDL proceedings are separate federal legal procedures designed to streamline the litigation process in cases involving common questions of fact, and may involve thousands of plaintiffs in many different states. Individual cases in an MDL are sent from one federal court to another federal court for all pretrial proceedings and discovery.

Approximately 187 cases have been transferred or are in the process of being transferred from federal district courts across the country to a Multi-district litigation (“MDL”) court in the Eastern District of Louisiana. The MDL proceedings will centralize the litigation of claims arising from the development, manufacture, regulatory approval, labeling, marketing, and use of Xarelto. Judge Eldon E. Fallon has been selected to manage the litigation, and will preside of common issues including allegations of injuries resulting from the use of Xarelto and the failure to adequately warn of the risks associated with Xarelto. Leonard A. Davis, Partner at Herman Herman & Katz, and Gerald E. Meunier have been appointed as Co-Plaintiffs’ Liaison Counsel, to communicate and coordinate between the Court and the Plaintiffs in this MDL proceeding.

If you or someone you know have been injured from the drug Xarelto, learn about your legal rights from an experienced Louisiana class action lawyer by calling 1-844-943-7626 or by filling out our free, no obligation case review form. All consultations are free and completely confidential.