Xarelto, or rivaroxban, is an anticoagulant, or blood thinner, developed by Bayer and Janssen Pharmaceuticals, Johnson & Johnson’s unit based on New Jersey, prescribed to prevent blood clot formation. Prevention of blood clot formations helps reduce any risk of strokes and heart attacks in patients who suffer from blood vessel or heart disease. Xarelto was designed to avoid the risks that results from taking other drugs such as Warfarin. Xarelto is specifically used to treat deep vein thrombosis, blood clot formation in the lungs after surgery. The drug is also prescribed to treat people with the heart rhythm disorder, atrial fibrillation to prevent strokes and embolisms. Patients who suffer from any liver or kidney problems, are pregnant or breastfeeding, are strongly advised against taking Xarelto.
USAGE OF XARELTO
Before Xarelto, patients were prescribed Warfarin, another anticoagulant, since 1954. Xarelto was first approved by the FDA in November 2011 for patients who underwent hip and knee replacement surgery. Warfarin is not the simplest drug to prescribe, like Xarelto, as the dosage varies by patient and their age, medications and diet. Patients prescribed Warfarin must have monthly blood tests to check their Vitamin K levels, as an increase of Vitamin K could have adverse effects while taking Warfarin.
Once Xarelto was approved and companies spent millions to market the drug, Xarelto quickly became one of the most popular anticoagulants, as the drug did not require constant surveillance of the patient. Even though the annual cost of Xarelto, approximately $3,000, was substantially greater than the annual cost to take Warfarin, approximately $200, patients felt Warfarin was too much of a burden to take. After a study of 14,000 patients and when contrasted with other anticoagulants such as Pradaxa and Elqiuis, Xarelto was the modern drug that closely resembled Warfarin. However, a study published by the New England Journal of Medicine revealed Warfarin was the more effective drug when compared to Xarelto.
SIDE EFFECTS OF XARELTO
Although Xarelto has shown positive results in some patients, such results are overshadowed by the large amount of patients with strong side effects from the drug. Based on doctors’ orders, once a patient has taken Xarelto, the patient must continue as any sudden stop will increase the likelihood of hemorrhaging, or uncontrolled bleeding, and strokes. Xarelto has led to multiple fatalities due to the inability to stop any uncontrolled bleeding. Patients who are taking Xarelto are strongly advised to notify their physician before they proceed with any epidural or spine procedures, as the risk for bleeding near the spine increases. If uncontrolled bleeding occurs around the brain, kidney, lungs or any other major organ, blood flow and functionality of the organ is disrupted. As Xarelto was designed to prevent blood clots and does not have an antidote, the uncontrolled bleeding will only stop once the drug has left the patient’s system. However, flushing out the drug through dialysis is not an option.
LAWSUITS FILED against XARELTO
The first case against the drug’s developers was filed in state court in mid-2014. The plaintiff suffered extreme internal bleeding and claims Xarelto was the causing factor. The amount of lawsuits against Bayer and Johnson & Johnson have increased in the past few months. Nearly two dozen cases have been filed in federal courts. The amount of lawsuits due to the drug is expected to reach several thousand within the year. With thousands of lawsuits come large amounts of discovery to be completed by the companies. A majority of the lawsuits allege the drug does not allow the blood to clot properly, leading to uncontrollable bleeding from minor cuts. Plaintiffs allege the defendants failed to warn prescribing physicians and the patients, based on the warning label, that an antidote to stop the uncontrolled bleeding was non-existent, unlike Warfarin which has an antidote. Plaintiffs further allege the companies failed to execute a complete study, warn of the varied degrees of anticoagulation in each patient and failed to research Xarelto’s safety. Most plaintiffs believe the companies willfully endangered the patients as they withheld information in regard to the risks of life-threatening bleeding.
The Judicial Panel on Multidistrict Litigation decided to consolidate the Xarelto lawsuits for multidistrict litigation. The decision came after plaintiffs filed a motion for their lawsuits to be consolidated for pretrial proceedings. Multidistrict litigation, or MDL, is a legal procedure in federal courts created to speed up the process for complicated cases. MDL is generally requested in civil case petitions in various districts that all share similar questions of fact. Once granted, MDL is designed to help the court efficiently handle cases with large number of plaintiffs with similar issues in various federal courts. All cases are transferred from their original court to a second court known as the transferee, where discovery and other pretrial proceedings occur. If the cases do not settle or are not dismissed in the transferee court, the cases are sent back, or remanded, to their original court to prepare for trial. This year, the focus for the Xarelto MDL will be determining how to organize the lawsuits and review any of the companies’ internal documents that mention Xarelto through preliminary discovery. These initial steps are crucial as it will determine if the companies will have to pay large sums of compensation for separate cases if the cases will have to proceed to trial. The companies’ determination to settle usually depends on what a jury would most likely award in each case. Juries factor in the nature of the plaintiff’s injury, the extremity of the damage that has occurred and how much the injury has impacted the plaintiff. Other factors for the juries include the amount of pain and suffering, past and future medical expenses, lost wages and the duration the injury has occurred.
Although most corporations prefer MDL due to its efficiency, Xarelto’s developers unsuccessfully tried to fight the decision. Xarelto argued each plaintiff’s individual facts such as their medical history and alleged injuries was a greater factor than common facts, and if the lawsuits are granted MDL, an influx of copycat complaints will flood the courts. The panel granted the plaintiff’s motion for MDL as the plaintiffs all raised similar issues of fact in regard to the warning label and the severe risk of hemorrhaging, which are not negated by the individualized facts. The panel decided to consolidate all lawsuits to the Eastern District of Louisiana, describing their choice as “a geographically central forum for this nationwide litigation.”
Judge Eldon E. Fallon, the judge for the Louisiana federal court, has presided over MDL cases in the past. In 2011, Judge Fallon presided over MDL cases that involved Chinese Drywall installed in multiple properties and involved over 10,000 homeowners. The drywall was said to not only corrode the copper piping and electrical wiring in the homes, but also emit an unsettled smell which adversely affected the homeowners’ sinuses, breathing and vision. The cases settled for over $1 billion.
Pradaxa, another anticoagulant, faced similar lawsuits that were consolidated to MDL. Pradaxa was approved in October 2010 by the FDA, and like Xarelto, Pradaxa does not have an antidote for uncontrolled bleeding. Lawsuits over the drug were first petitioned in March 2012 against BoehringerIngelheim International GmbH, the developers of Pradaxa. In 2011 alone, 542 deaths due to Pradaxawere reported to the FDA. In Mid-2014, the company agreed to a $650 million settlement in hopes to resolve the 4,000 lawsuits filed. As part of their settlement statement, the company brought notice to the FDA’s positive reaffirmation of Pradaxa’s benefit-risk profile.
Despite the amount of lawsuits against Bayer and Janssen Pharmaceuticals, the number of sales for the drug has risen and is expected to continue rising. First year sales for the drug reached over $670 million in the United State and Europe. Analysts expect annual sales to reach $3.68 billion by 2018.
FURTHER XARELTO APPROVAL FROM FDA
Recently, Bayer and Janssen Pharmceuticals announced their plans for further Xarelto approval from the FDA as the companies would like the drug to be prescribed to patients who suffer from strokes. Previously, the companies tried to receive the FDA’s approval to expand the drug’s treatment for patients with acute coronary syndrome, the blockage of blood supply to the heart. Despite its prior approval to treat atrial fibrillation, deep vein thrombosis and pulmonary embolisms, the FDA unanimously rejected the company’s request as they cited insufficient clinical data to approve the drug. The FDA’s rejection prevented the companies from reaching 1.2 million Americans who suffer from ACS.
The companies believe, as with all newly developed treatment, it is ultimately up to the doctor to understand the drug they are prescribing and to determine the best way to administer the drug, using their “common medical-sense judgment.” Despite their arguments, complaints filed still address the companies’ failure to warn of the increased risk for the severe hemorrhaging.
FREE CASE REVIEW
Generally, when injuries result from medication or a recall occurs, patients should file a lawsuit so their rights are heard. If you or a loved one has suffered any injuries from Xarelto, you may have a claim against Bayer and Janssen Pharmaceuticals. MAS Law Firm urges you to contact our office as we offer a free consultation to evaluate your case. Our experienced litigation attorneys have the knowledge, experience, and dedication to analyze the details of the injuries and complications caused by Xarelto. Contact us by calling 1-866-789-1664, emailing firstname.lastname@example.org, or filling out the form on top of this page. Our legal team is looking forward to working on your case.