The lawsuit involving Xarelto states the manufacturer failed to warn patients and physicians of the increased risks of fatal internal bleeding when using the medication.
Why are Xarelto Lawsuits Being Filed
Numerous claims have been filed against Janssen Pharmaceutical (the manufacturer of Xarelto) and Bayer Healthcare (the marketer of the drug) by people who have suffered severe bleeding as a result of taking the anticoagulant medication.
Attorneys argue that if doctors and patients had known the risks, the patient would have used warfarin, a different anticoagulant medication, where internal bleeding can be treated with dosages of Vitamin K.
What are the Specific Allegations in the Xarelto Litigation
Lawyers in the Xarelto cases argue the following:
- Xarelto is defective and unreasonably dangerous.
- Janssen Pharmaceutical was negligent in the manufacturing of Xarelto.
- Janssen Pharmaceutical and Bayer Healthcare failed to properly test Xarelto, and failed to warn doctors and patients of the potential for incurable severe bleeding.
- Janssen Pharmaceutical and Bayer Healthcare concealed evidence of the dangers of Xarelto from the government and the public, and misrepresented the safety of the drug in its marketing material.
What is the Purpose of Xarelto
Xarelto is an anticoagulant (blood thinner) manufactured by Janssen Pharmaceutical that has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (irregular heartbeat); deep vein thrombosis (blood clots deep within the body); pulmonary embolism (blood clots in the lungs); stroke; and patients who have recently undergone a knee or hip replacement surgery.
It generally is prescribed as an alternative to warfarin (Coumadin), a blood thinner that began to be used in 1954.
Xarelto Injuries & Side Effects
The most serious potential side effect caused by Xarelto is severe internal bleeding that can result in death. Currently, there is no known cure to reverse the type of internal bleeding caused by Xarelto.
While a warfarin overdose can be treated by administering Vitamin K and other substances to stop the bleeding, doctors can only wait for Xarelto to be flushed out from the patient’s body when an uncontrolled bleeding accident occur. Not even dialysis is sufficient, and even a simple gastrointestinal bleeding can quickly evolve into a fatal internal hemorrhage.
Other potential injuries caused by Xarelto include infection associated with hip or knee replacement surgery; decreased hemoglobin (a substance that carries oxygen in red blood cells); bleeding in the brain; hematoma (a mass in the blood); peripheral edema (swelling of the lower limbs); and dyspnea (difficulty breathing).
If you are currently taking Xarelto, it is important to do your best to avoid activities that could result in you getting cut, bruised, or suffering external or internal bleeding. If you do sustain these types of injuries (and especially if you experience swelling, bruising, bleeding, vision changes, confusion, weakness, dizziness or severe headaches), it's important to immediately contact and inform your doctor.
Additionally, make sure to inform all your doctors and dentists of your use of Xarelto, and especially before having any medical/dental procedures or surgeries, or if you have uncontrolled high blood pressure, abnormal kidney function, take medication associated with bleeding (e.g. aspirin), or abuse alcohol.
Also, if you are, or become, pregnant make sure your doctor is clearly told.
Xarelto Lawsuit NewsFDA Ignores Faulty Data in Approving Xarelto:
For some time, there have been serious questions about the ROCKET-AF trial, the clinical study of the anti-coagulant medication Xarelto (rivaroxaban), prescribed for patients at risk for stroke. The study compared the performance of Xarelto to that of warfarin, the standard treatment for nearly seven decades. Specifically, the medical community has been raising serious concerns about the objectivity and accuracy of the results. To read more, click Drug Safety NewsDocument Claims Drug Makers Deceived a Top Medical Journal:
It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals? Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe. To read more, click New York Times
European and U.S. drug regulators are looking into whether a defective blood clotting test device affected a trial involving Bayer's top-selling anti-clotting drug Xarelto, hitting the German drugmaker's shares. The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the elderly. "Due to the defect it is now thought that the INR (international normalised ratio) device may have impacted the clotting results in some patients in the warfarin group," the European Medicines Agency (EMA) said, adding it would publish results of its investigation when complete. To read more, click ReutersData on trial of anticoagulant is to be reanalyzed after discovery that investigators used faulty device:
Data from the key phase III trial that allowed the oral anticoagulant rivaroxaban on to the market for the prevention of ischemic stroke in non-valvular atrial fibrillation is being reanalyzed because of the use of a faulty device. The European Medicines Agency has also told The BMJ that it has launched an investigation into the trial. To read more, click British Medical JournalNew anticoagulant drugs provide stroke prevention with dose of danger:
Xarelto is one of four anticoagulants approved since 2010 that make up a class of lucrative new drugs marketed as more convenient than warfarin. While warfarin has a blood thinning action that can be halted in a bleeding emergency, none of the newer drugs has an approved antidote. When Glatz developed gastrointestinal bleeding, a few months after she started taking Xarelto, doctors could not make it stop. She died March 23, 2012, at a Kenosha hospital. To read more, click Journal SentinelDamning Evidence Revealed in Xarelto Lawsuit: Were Bayer and Janssen Corrupt, or Lazy?:
In early January of 2012, William Packard’s physician prescribed a new anti-coagulant for the treatment of his atrial fibrillation (AT), a condition characterized by irregular heartbeat and palpitations. Patients suffering from AT run an increased risk for heart failure as well as stroke. Mr. Packard’s doctor thought the new medication would be more effective than the old treatment, because there were fewer interactions and the patient wouldn’t have to undergo nearly as much monitoring. To read more, click The Ring of Fire Network
For additional news stories, click Levin Law Xarelto News
Xarelto Lawsuit Videos
FDA and Scientific Studies Regarding Xarelto
Perspective on Drug HypersensitivitySince 2012 QuarterWatch has reported prominent signals for the bleeding risks of three anticoagulant drugs, dabigatran (PRADAXA), rivaroxaban (XARELTO), and warfarin (COUMADIN). The concerns arose in a setting of a race to market replacements for warfarin, a generic drug first approved in 1956. Both dabigatran and rivaroxaban were marketed as providing the same or slightly better results than warfarin in preventing strokes and other blood clot-related events, but were easier to use because weekly or monthly blood level tests were not required or available. Dabigatran was first to win approval in October 2010 for use in non-valvular atrial fibrillation, followed by rivaroxaban for this population, in November 2011. In December 2012, the FDA approved an additional contender, apixaban (ELIQUIS), but no data are yet available for review. To read more, click Institute for Safe Medication Practices
Rivaroxaban (XARELTO) Safety ProfileIn the first quarter of 2012 we identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug. The report total more than doubled from the previous quarter total of 128 cases. The unexpected result was that unlike other anticoagulants (warfarin, dabigatran, and enoxaparin) the primary reported event was not the well-understood risk of hemorrhage. Instead, the largest identifiable category was serious blood-clot-related injury—most frequently pulmonary embolism—the very events rivaroxaban is intended to prevent. To read more, click Institute for Safe Medication Practices
Xarelto Recall Information
As of this time, there has not been a recall of Xarelto related to internal bleeding. However, the investigation into this drug, from a legal standpoint, is still at its early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that will lead to a recall.
Xarelto Settlement Information
As of this time, there have been no large group settlements involving Xarelto and the link to severe internal bleeding. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.