Potentially Fatal Xarelto® Complications

Xarelto® and Warfarin

Xarelto®, the brand name for rivaroxaban, was approved by the U.S. Food and Drug Administration (FDA) in 2011. It was introduced as a competitor to Warfarin, and touted as a superior product that did not require routine blood testing appointments. In use since 1954, Warfarin uses patient blood tests as a preventative measure to avoid dangerous bleeding events.

DVTs are dangerous because they can migrate throughout the body, causing a potentially fatal pulmonary embolism.

If internal bleeding does occur on Warfarin, high doses of Vitamin K are an effective emergency treatment. However, there is no antidote for internal bleeding caused by Xarelto®, a primary complication that has proved fatal for many patients.

Complications Triggering Xarelto® Lawsuits

Thousands of Xarelto® lawsuits against Janssen and Bayer allege breach of warranty and failure to warn physicians and patients about dangerous complications. These lawsuits claim personal injury and wrongful death damages, primarily from internal bleeding and strokes, but also from blood clotting events and infections. There have been hundreds of deaths and thousands of reports of bleeding emergencies attributed to Xarelto®.

Bleeding Events

There are several causes of bleeding emergencies, including severe bodily trauma from the impact of a car collision or other type of accident. Internal injuries to blood vessels or organs can cause hemorrhaging inside the body. Normally, traumatic internal bleeding can be controlled in a hospital setting with surgery or other treatment. Anticoagulants can cause extensive, uncontrolled bleeding in patients, making an unplanned, emergency surgery extremely dangerous.

Internal bleeding can also happen spontaneously, such as a ruptured aneurysm that can cause bleeding in the brain. Inflammation and bleeding may occur in the gastrointestinal tract or liver, especially in patients with a history of anti-inflammatory medication or alcohol use. In patients taking blood thinners, spontaneous bleeding can be deadly.

This situation is illustrated by a case filed in November 2015, in Louisiana. A patient taking Xarelto® for two months developed bleeding in the brain which could not be controlled or repaired by doctors. The claim was filed by a family member after the patient’s injuries proved fatal.

Blood Clots

Xarelto® has been prescribed to prevent deep vein thrombosis (DVT), pulmonary embolism, and stroke for at-risk patients, but many cases of adverse events have been reported. Soon after the drug was introduced to the market, the Institute for Safe Medication Practices (ISMP) reported unexpectedly large numbers of thromboembolic (migrating blood clot) events in rivaroxaban patients.  

DVTs are blood clots that form deep inside the body, often in the legs. They are dangerous because they can migrate throughout the body, causing a potentially fatal pulmonary embolism (blocked blood flow to the lungs). Some people are prone to DVT because of medical conditions, and others may be at risk because of an extended period of immobility after surgery. Xarelto® is often prescribed to patients following surgery, particularly joint transplant patients.

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Xarelto® is also commonly prescribed for patients with atrial fibrillation (irregular, often rapid heartbeat). These patients are at a higher risk of blood clots forming in the heart and migrating throughout the body, causing even more severe conditions.

Patient Deaths

Because of the serious nature of Xarelto® complications, a number of the reported cases have described fatal incidents. Doctors have been unable to help many patients who were taking the medication prior to an internal bleeding emergency. Hemorrhagic strokes have also caused many deaths in patients.

A case illustrating this was filed in Florida in January 2015. The plaintiff’s husband had been taking Xarelto® for two months when he collapsed while doing yard work. Emergency room doctors diagnosed a focal hemorrhage/hemorrhagic stroke, and the patient died in the intensive care unit a day later. His medical records indicated the intracranial hemorrhage was associated with the use of an anticoagulant, and stated, “this is not a survivable event.”

Post-Surgery Infections

An increased risk of wound complications has been seen in patients prescribed Xarelto® after undergoing hip or knee replacement surgery. Excessive post-surgery bleeding can delay wound healing and lead to serious infection. A 2012 British medical study reported by the American Academy of Orthopaedic Surgeons, compared patients using Xarelto® and another anticoagulant medication and noted a significantly increased risk of complications in Xarelto® patients, often requiring a “return to surgery.”

The lawsuits seek to hold the companies liable for manufacturing and design defects, failure to warn, breach of warranty, negligent misrepresentation, fraud, and violation of consumer protection laws.

Reports of Xarelto® wound complications involve serious conditions, including deep infections that are difficult to treat. Some patients must have their implant removed and replaced with a temporary spacer implant infused with antibiotics. This can mean months of immobility and treatment in hospitals and skilled nursing facilities.

The Xarelto® Lawsuit

Xarelto® complications have led to more than 3,400 lawsuits filed against Bayer and Janssen Pharmaceutical, a Johnson & Johnson subsidiary. The lawsuits seek to hold the companies liable for manufacturing and design defects, failure to warn, breach of warranty, negligent misrepresentation, fraud, and violation of consumer protection laws.

Plaintiffs are claiming damages that include medical expenses, lost wages, pain and suffering, and more. In wrongful death cases, family members have extensive emotional and financial damages as well.

In December 2014, numerous individual cases were consolidated into multidistrict litigation (MDL) in the U.S. Eastern District Court in Louisiana. Soon after, a mass tort was created in the Philadelphia Court of Common Pleas. The Pennsylvania lawsuit now includes over 650 state cases, and the MDL has over 2,800 cases.

Judge Eldon Fallon is overseeing the Louisiana MDL, and status reports show he is beginning to schedule the first cases for trial. MDL is considered to be an optimal way to handle lawsuits involving multiple parties with similar claims, which is common in product liability cases. MDL allows for efficient handling of discovery matters, yet enables plaintiffs to pursue individual verdicts and settlements with their respective attorneys.

If You Were Harmed by Xarelto®

It is estimated that one million Xarelto® prescriptions were written by the end of 2013, when the drug was the widely advertised in professional healthcare journals. Today, Janssen Pharmaceuticals claims more than 13 million U.S. prescriptions, and calls Xarelto® “the number one prescribed blood thinner in its class.”

Xarelto® cases continue to be filed and transferred to the MDL from all 50 states. Many more plaintiffs are expected to come forward and seek compensation for injuries and wrongful deaths. If you have been adversely affected by Xarelto®, it’s important to seek help as soon as possible. Statute of limitations laws apply, and these case filing deadlines can vary from state to state. Learn about your legal options by discussing your case with a knowledgeable pharmaceutical attorney. To schedule a free consultation, please contact our legal team today.