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The Timeline of the Xarelto® Lawsuit


Complications from the anticoagulant drug Xarelto® have triggered thousands of lawsuits against the manufacturer Janssen Pharmaceuticals, and Bayer Healthcare, the corporation marketing the drug. Plaintiffs accuse the defendants of failing to warn the public about risks that have caused serious adverse events, including many deaths. The timeline of the Xarelto® lawsuit begins with the initial claims filed in early 2014 and extends through the current status of being consolidated into federal multidistrict litigation (MDL).

Xarelto pills
The FDA began receiving adverse event reports almost immediately after Xarelto® was available on the market.

MDL is considered to be an efficient way to handle litigation involving multiple plaintiffs from numerous states against a common defendant. MDL can expedite aspects of the case, but still allows plaintiffs to retain their own attorneys and obtain individual verdicts and settlements. If you or a loved one suffered a complication from Xarelto®, you may be entitled to significant compensation for your injuries. Please contact our qualified team of pharmaceutical attorneys to schedule a complimentary consultation and case review.  

About Xarelto®

Anticoagulants are used to prevent dangerous blood clots, including deep vein thrombosis (DVT), which can migrate through the circulatory system and have devastating consequences. Xarelto® belongs to a class of drugs called new oral anticoagulants (NOACs), which are thought to offer an improved experience for patients who are required to take blood thinners.

A British study noted a significantly higher risk of complications and repeat surgeries for patients using Xarelto® compared to another therapy.

For over 50 years, Warfarin has been the standard prescription anticoagulant, but Xarelto® has been marketed as a convenient alternative that does not require continual blood monitoring and dietary restrictions. Xarelto® quickly became a top-selling medication in 2012, but problems soon emerged.

Timeline of the Xarelto® Lawsuit

The timeline provides an overview of events associated with Xarelto® litigation, including published reports, discovery, and significant case filings.

July 2011 - Xarelto® was approved by the U.S. Food and Drug Administration (FDA) and introduced to the United States market.

February 2012 - A British study was reported that compared complications in patients undergoing hip and knee replacement surgeries who were taking different anticoagulant medications. The conclusions noted a significantly higher risk of complications and repeat surgeries for patients using Xarelto® compared to another therapy.      

October 2012 - The nonprofit Institute for Safe Medication Practices (ISMP) issued a published warning after tracking FDA reports of adverse events in the first quarter of 2012. They counted 356 reports of serious or fatal injuries with a suspected connection to rivaroxaban (the generic form of Xarelto®). These included 158 embolic-thrombotic events (strokes caused by blood clots) and 121 cases of hemorrhage. The report noted strokes were occurring in younger patients (median age 66) who were taking the drug following surgery.

January 2013 - A subsequent ISMP report identified anticoagulants as among the riskiest of all outpatient drugs, noting continued deaths involving Xarelto® as well as Pradaxa® (dabigatran) and Warfarin.

June 2013 - The FDA sent a letter to Johnson & Johnson, the parent company of Janssen Pharmaceuticals, concerning a misleading Xarelto® advertisement in an issue of WebMD Magazine. The FDA criticized the company for minimizing the drug’s risks and making a misleading claim of “no dosage adjustments”, which is in violation of law. The letter stated, “This overall presentation misleadingly minimizes the risks associated with Xarelto® because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims.”  

July 2013 - A medical study from the Netherlands that compared patients using Warfarin with Pradaxa® and Xarelto® users was published. Researchers found a statistically significant increased risk of internal bleeding among patients taking the newer drugs, and the lack of an antidote for such events was called “alarming.”

January 2014 - The FDA announced changes for Xarelto® packaging, with added warnings about the increased risk of bleeding and blood loss.

February 2014 – The first Xarelto® lawsuits were filed, including a Kentucky woman who was prescribed Xarelto® to treat her atrial fibrillation, and was subsequently hospitalized with severe gastrointestinal bleeding.

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May 2014 - Pradaxa® manufacturer Boehringer Ingelheim agreed to pay $650 million to settle 4,000 state and federal lawsuits related to the drug’s complications, including hemorrhage and stroke.

October 2014 - The ISMP issued another report that revealed widespread Xarelto® prescriptions and increased bleeding events. The article cited 2,081 reports of adverse incidents in 2012, including 151 deaths, ranking the drug 10th among pharmaceuticals with complications reported to the FDA. The report warned, “More and better information for clinicians is needed about how to manage hemorrhages that occur either as a side effect or as a result of accident or trauma.”  

December 2014 - The U.S. Judicial Panel on Multidistrict Litigation consolidated nearly two dozen Xarelto® lawsuits into MDL. All existing federal lawsuits were transferred to the Eastern District of Louisiana under the supervision of Judge Eldon Fallon.

January 2015 - All state lawsuits filed in Pennsylvania, where Janssen and Bayer have business locations, were transferred into a new mass tort in the Philadelphia County Court of Common Pleas. At that time, there were 73 separate Xarelto® cases.

February 2015 - A new study was published reporting an assessment of 27,467 patients who took Xarelto® from January 2013 to March 2014. It noted that 478 of the patients suffered a major bleeding event, most commonly gastrointestinal or intracranial, and 14 patients died from the condition.

September 2015 - The ISMP issued their Annual Report, stating “As previously noted in this publication, bringing a new generation of oral anticoagulants to market-based on ease of use rather than improved safety was a major wrong turn.” Referring to raised questions about unmonitored dosing regimens, the authors stated that rivaroxaban’s once-a-day dosing “results in higher maximum concentrations and higher bleeding risk on one hand, and an extended period each day when concentrations may be suboptimal for preventing stroke.”  

October 2015 - The FDA’s Postmarket Drug Safety Evaluation Summaries report was posted. Regarding Xarelto®, it said the agency is “continuing to evaluate thrombocytopenia and thromboembolic events to determine if regulatory action is required.”  This same month, the FDA posted a Medication Guide for Xarelto® patients warning that the drug “can cause bleeding, which can be serious, and rarely may lead to death.” It also warned that halting the drug increases the risk of a blood clot or a stroke.

December 2015 - A report posted on the FDA website connected rivaroxaban with increased cancer rates, particularly colon cancer. Dr. Thomas Marciniak stated that the evidence supports a conclusion that excess bleeding from higher anticoagulant dosing increases the risk of solid cancers.

While effective for many patients, it is clear that Xarelto® has also caused a great deal of unnecessary pain.

February 2016 - Several new Xarelto® lawsuits were filed, bringing the number to well over 3,000. One Arizona woman claimed that she took Xarelto® for less than two weeks, then suffered a serious bleeding event, hemorrhagic pericardial effusion, which affects the tissue surrounding the heart. A Florida woman filed a wrongful death lawsuit after her husband suffered an uncontrollable bleeding event and died from a subdural hemorrhage.

February 2016 - Judge Fallon selected the first bellwether cases in the Xarelto® MDL, with trials expected to begin February 2017. Bellwethers are the primary cases that go to trial in an MDL, and often set precedents for future settlements and awards.

Compensation for Victims

Janssen Pharmaceutical’s website counts 13 million Xarelto® prescription, “and growing.” Sales of this drug reached $2 billion for the fiscal year of 2013, and it is considered the leading anticoagulant in terms of global sales. While effective for many patients, it is clear that Xarelto® has also caused a great deal of unnecessary pain.

Patients and physicians were not adequately warned about the risks of bleeding events associated with Xarelto®. If they had been, an alternate treatment method would have been preferred.

Plaintiff lawsuits seek compensation for medical expenses, lost wages, and the suffering experienced by patients and bereaved families. If you have been the victim of a Xarelto® complication, please contact an experienced product liability lawyer today to schedule your free consultation.

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