Individual Xarelto® Cases

Janssen Pharmaceuticals and Bayer Healthcare, the companies that manufacture and market Xarelto®, are accused of failing to warn doctors and patients about the inherent risks of taking the drug. The companies also face allegations that include fraud, breach of warranty, and negligent misrepresentation. If you or a loved one were prescribed Xarelto® and suffered a serious complication such as hemorrhage, stroke, deep vein thrombosis (DVT), or pulmonary embolism, please contact a product liability attorney today.

Prescribing Xarelto®

The Janssen Pharmaceuticals website boasts of 13 million Xarelto® prescription, “and growing.” Approved by the U.S. Food and Drug Administration (FDA) in July 2011, Xarelto® is prescribed to prevent blood clots that can migrate and cause stroke or pulmonary embolism (a blockage of blood vessels to the lungs). This includes patients with atrial fibrillation (rapid, irregular heartbeat) and patients who have undergone a hip or knee transplant.

Xarelto® (rivaroxaban) was heavily marketed as a more convenient alternative to Warfarin (coumadin), an anticoagulant that has been used since 1954. As explained by the promotional materials, the Xarelto® “difference” includes the elimination of the need for routine blood testing, dietary restrictions, and frequent dosage adjustments.

The most serious Xarelto® cases involve uncontrolled bleeding events and wrongful deaths, allegations detailed in thousands of lawsuits filed across the country.

Bleeding complications are a known risk associated with blood thinners, including Warfarin. Regular blood tests and dose adjustments have been used to help doctors prevent uncontrolled bleeding events. These complications can also occur in patients using Xarelto®, and with particularly devastating outcomes. Warfarin bleeding emergencies can be counteracted with high doses of Vitamin K, but Xarelto® does not have an antidote.

Xarelto® Lawsuits: Similar, Tragic Stories

From 2014 through the present stage of litigation, thousands of Xarelto® lawsuits have been filed on behalf of plaintiffs from across the country who experienced complications.

A June 2014, wrongful death case was filed in Florida by the widow of a man who was prescribed Xarelto® for atrial fibrillation. Five months later, he suffered a subdural hematoma (uncontrolled bleeding in the lining of the brain or spinal cord) and was hospitalized for several days. Doctors attempted surgery to stop the bleeding, but the treatment was unsuccessful.

Another Florida case filed in January 2015, involves the death of a man who was prescribed Xarelto® to prevent DVT. He suffered a hemorrhagic stroke after two months on the drug. The medical records from his hospitalization connected his uncontrolled bleeding with his anticoagulation medication and called the event “not survivable.”

In April 2015, a California widower filed a wrongful death case concerning the loss of his wife, who took Xarelto® for a month in 2013. She suffered internal bleeding and a hemorrhagic stroke that lead to her death a week later.

An Arizona plaintiff filed a personal injury case in February 2016. She took Xarelto® for less than two weeks, then suffered a hemorrhagic pericardial effusion (the lining around her heart filled with blood), along with other complications. She seeks compensation for serious injury and accompanying losses.

If you have been injured by a defective drug, Speak with an Attorney

Also in February 2016, a multi-party lawsuit was filed by a single law firm, including three wrongful death claims by Alabama, Colorado, and Georgia plaintiffs. Additional personal injury allegations were also brought by plaintiffs from Kentucky, Pennsylvania, and Florida. The incidents include gastrointestinal and other severe internal bleeding events.

Other Xarelto® Complications

Internal bleeding and strokes are the most common Xarelto® complications reported by doctors and patients, but other adverse events have also been noted. Patients prescribed Xarelto® after hip or knee transplant surgery are suffering DVTs and pulmonary embolisms, conditions that the medication is supposed to prevent.  

The nonprofit Institute for Safe Medication Practices (ISMP) published a report warning of 158 embolic-thrombotic events in patients taking rivaroxaban (Xarelto®) in the first quarter of 2012. The report noted that while hemorrhagic complications are a known risk associated with anticoagulants, there have been no warnings concerning the risk of blood clots.

There have also been higher than expected rates of wound complications in joint replacement patients, including serious infections. Some of these patients have had to endure additional surgery to remove their implant and later replace it, with reports of extended recovery periods and immobility. A U.K. study that was reported in 2012 noted a significantly higher risk of these complications in patients using Xarelto® when compared to another anticoagulant medication.

Consolidated Litigation

By late 2014, numerous claims had been filed related to Xarelto® complications, and in December 2014, the status of the lawsuit changed. The Judicial Panel on Multidistrict Litigation (MDL) decided to consolidate district court cases from across the country into MDL. MDLs involve multiple plaintiffs in different states with similar claims, and are very common in cases involving defective drugs.

Bayer and Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, have corporate locations in Pennsylvania. In January 2015, 75 Xarelto® cases were combined in state court. Today, more than 650 plaintiffs make up a mass tort in the Philadelphia Court of Common Pleas.

The researchers called the lack of antidotes for these drugs alarming…given the widespread use of new oral anticoagulants and the increased risk of bleeding that has now been demonstrated.

The federal MDL now has more than 2,800 cases under the direction of Judge Eldon Fallon in the Eastern District of Louisiana. The judge is currently developing a timeline for the lawsuits, which are expected to begin in 2017. MDL is an optimal way to litigate numerous cases that involve a common defendant. This method allows for efficiency in discovery and investigations, yet each plaintiff is able to pursue an individual verdict or settlement. In class action lawsuits, a small group of plaintiffs represents the larger group, and a single outcome applies to all parties involved.

As stated in many civil complaints, plaintiffs and their doctors would have chosen an alternative medication if they had been appropriately warned about the increased risks associated with Xarelto®.

This view is supported by a Netherlands medical study reported in 2013. Researchers compared patients using Warfarin with the more recent blood thinners, Pradaxa® and Xarelto®, and found an increased risk of internal bleeding with the newer drugs. The researchers called the lack of antidotes for these drugs “alarming…given the widespread use of new oral anticoagulants and the increased risk of bleeding that has now been demonstrated.”

About 4,000 state and federal lawsuits were filed against the makers of Pradaxa for bleeding and other claims. In May 2014, the company agreed to a $650 million settlement to end all cases.  

Seeking Legal Help

If you or a loved one suffered a serious injury after taking Xarelto®, you may be entitled to a settlement or award. The marketers and manufacturers of the drug have made a staggering amount of money selling the medication. Anyone who has endured complications because of their negligence deserves compensation for medical costs, wage losses, and pain and suffering.

You can find out your legal options by talking to a qualified product liability attorney. It is important to act quickly, because the statute of limitations laws can limit filing deadlines. Please contact our pharmaceutical team today and schedule a complimentary consultation.