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13 Plaintiffs File Joint Xarelto Internal Bleeding Lawsuit

Xarelto packagingThirteen plaintiffs have filed a joint Xarelto internal bleeding lawsuit over injuries allegedly sustained in connection to the popular new blood thinner. Injuries include severe gastrointestinal bleeding and brain hemorrhage, and ultimately resulted in the death of three plaintiffs (represented by their next of kin). The lawsuit was filed on August 6 in the US District Court, Eastern District of Louisiana, where a major litigation process devoted to Xarelto cases was established late last year.

Judge Eldon Fallon presides over the multidistrict litigation (MDL No. 2592, In re Xarelto (Rivaroxaban) Products Liab. Litig., 2014 WL 7004048) in Louisiana created to process the growing number of complaints filed over Xarelto, one of the so-called “next generation” of blood thinners that was supposedly safer and more user friendly than warfarin (or Coumadin), which had been on the market for decades. However, the lack of a reversal agent for the new wave of blood thinners has posed significant risks for patients who experience bleeding events as doctors have limited means to bring any internal hemorrhaging under control.

Plaintiffs in Xarelto lawsuit make numerous allegations

Plaintiffs who have brought the Xarelto lawsuit against defendants Bayer and Janssen Pharmaceuticals, manufacturers of the anticoagulant medication, have made numerous allegations concerning the drug. Among their claims are that the manufacturers failed to adequately research the safety of the drug, failed to warn about its true risk, failed to disclose the need for dose adjustments and blood monitoring, failed to inform potential patients about the lack of a reversal agent, and failed to include adequate warning labels.

Xarelto was introduced into the US on July 1, 2011, the second of the so-called New Oral Anticoagulants (“NOACs”). The first such drug was Pradaxa, marketed by Boehringer Ingelheim in 2010. The drugs were marketed as safer than older blood thinners and much more convenient, requiring less frequent testing and monitoring.

However, the complaint states that Xarelto was “overmarketed” and that the “Xarelto Difference” advertising segments amounted to “nothing more than a marketing campaign based on flawed science,” given that regular monitoring is needed to maintain a safety level comparable to the other generation of anticoagulants and that a lack of reversal agent dramatically increases safety risks should internal bleeding occur. In contrast, vitamin K infusions can often halt bleeding for a patient taking warfarin.

Xarelto plaintiffs would not have used drug had they been warned

All of the plaintiffs suffered serious internal bleeding episodes after taking Xarelto, which doctors found difficult to control. In some cases, patients died: for instance, James W. Burnett, Sr. used Xarelto from February 28, 2013 to August 8 or 9, 2014. He experienced severe internal bleeding, including a brain hemorrhage, on August 10, 2014 and on died on April 5, 2015 due to injuries. He was a resident of DeSoto County, Mississippi, and is represented by his surviving spouse, Margaret Burnett.

The complaint charges that the plaintiffs would not have used the drug if they had been given accurate information about its risks. The joint complaint adds to a growing number of similar lawsuits over alleged Xarelto side effects filed across the country.

Lawsuits about the first new generation blood thinner, Pradaxa, also included similar allegations. Boehringer Ingelheim has agreed to a $650 million settlement deal to wrap up the more than 4000 lawsuits filed over Pradaxa.

  1. LAED Courts, MDL-2592 Xarelto Products Liability Litigation

  2. British Medical Journal, Dabigatran: how the drug company withheld important analyses

  3. Reuters, Insight: Top heart doctors fret over new blood thinners

  4. Huffington Post, Pradaxa And Xarelto: Top Heart Doctors Concerned Over New Blood Thinners