Another Lawsuit Added to Xarelto Litigation, Alleging Failure to Warn

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Bayer, Janssen Sued over Alleged Xarelto Bleeding Risks

Another lawsuit has been filed over Xarelto, an anticoagulant medication manufactured by Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. As with other injury claims in the Xarelto litigation, the lawsuit alleges that Xarelto makers knew about the risks of the blood thinner but failed to warn patients or the medical community. According to court records, the lawsuit was filed on Nov. 14 in Cook County Circuit Court. Bayer AG, Bayer Healthcare Pharmaceuticals Inc., Bayer Corporation, Bayer Healthcare LLC, Janssen Pharmaceuticals Inc., McNeil-PPC Inc., McNeil consumer Healthcare Division of McNeil-PPC Inc., McNeil Consumer & Specialty Pharmaceuticals, Johnson & Johnson, and Johnson & Johnson Services Inc were named as defendants. The lawsuit seeks compensation greater than $50,000.

Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a Xarelto lawsuit.

The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. The drug is part of a new generation of anticoagulants, along with Pradaxa and Eliquis, marketed to replace warfarin. Xarelto is used for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and reduces the risk of blood clots in knee and hip replacement surgery patients. The FDA has also approved Xarelto to prevent strokes in patients with atrial fibrillation.

DVT is when a blood clot forms in one of the deep veins, usually the legs. This clot can become life-threatening if it breaks free and becomes lodged in the lungs, leading to pulmonary embolism. Blood thinners such as warfarin and Xarelto are prescribed to prevent blood clots and related complications.

Warfarin, sold under the brand name Coumadin, has been on the market for decades. The drug, while effective, has its drawbacks. Patients taking warfarin must undergo regular blood testing to make sure the drug is present at appropriate levels; some foods and medications can also interact with warfarin. Xarelto users do not have these limitations, but personal injury lawsuits point to another issue. Plaintiffs point out that Xarelto lacks an antidote, or reversal agent, that would stop the drug’s blood thinning effects in an emergency situation. Bleeding in warfarin patients, on the other hand, can be stopped with vitamin K.

Xarelto lawsuits allege that the manufacturers knew there was no antidote to reverse the drug, but failed to warn patients or the medical community. Bayer and Janssen are accused of failing to disclose this risk while marketing Xarelto as a superior alternative to warfarin. Parker Waichman notes that these allegations are not limited to Xarelto. In fact, thousands of lawsuits were filed over Pradaxa, the first in the new line of blood thinners to be released, and a settlement was reached. Lawsuits have also been filed over Eliquis.

Xarelto Lawsuit Background

Xarelto litigation has been mounting against Janssen and Bayer. Federal lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana before U.S. District Judge Eldon Fallon. MDLs are created by the U.S. Judicial Panel on Multidistrict Litigation (JPML). The JPML establishes MDLs for large, complex litigations where many lawsuits have the same basic allegations. An MDL is a type of mass tort that consolidates these lawsuits together in one court before one judge, streamlining the litigation and making the process more efficient. Unlike in a class action, lawsuits in an MDL remain separate.

In the Xarelto MDL, lawsuits allege that the anticoagulant led to bleeding complications, such as gastrointestinal bleeding or brain hemorrhaging. Plaintiffs accuse Janssen and Bayer of failing to warn about this risk, and allege that they would have chosen differently if they knew Xarelto could lead to uncontrollable bleeding. Some lawsuits allege wrongful death.

Bellwether trials in the Xarelto litigation are scheduled to begin in March 2017. The trials were initially slated for February 2017, but have been postponed one month due to a local New Orleans event. The first Xarelto bellwether trial is now slated to begin on March 13, 2017 in the Eastern District of Louisiana and the second bellwether trial is scheduled for April 24th. The following two bellwether cases will be held in Mississippi and Texas; but the dates have not been finalized.

Bellwether cases are considered test cases for large litigations. They are the first lawsuits to go to trial, providing the parties an opportunity to try out their arguments. The goal is work towards resolution. If, for instance, jurors award large verdicts during the bellwether trials, it could facilitate settlement talks.

The most common injuries alleged in the Xarelto MDL are gastrointestinal bleeding and brain bleeding. The first two bellwether cases involve plaintiffs who took Xarelto to reduce the risk of stroke associated with non-valvular atrial fibrillation. One of the plaintiffs suffered gastrointestinal bleeding and the other suffered bleeding in the brain, allegedly due to Xarelto. The third plaintiff took Xarelto to prevent complications from deep vein thrombosis and suffered gastrointestinal bleeding. The fourth plaintiff took Xarelto for atrial fibrillation and suffered gastrointestinal bleeding.

After Pradaxa was released, manufacturer Boehringer Ingelheim faced numerous personal injury lawsuits alleging bleeding injuries. As with the Xarelto litigation, plaintiffs alleged that the drug maker failed to warn about the lack of an antidote. This has since changed, as the FDA approved a Pradaxa reversal agent in October 2015. Some 4,000 Pradaxa lawsuits were filed, including 750 cases where bleeding was fatal. On the eve of the first day of trial, Boehringer Ingelheim agreed to settle Pradaxa lawsuits for $650 million instead of seeing the cases through to trial. Plaintiffs in the Pradaxa litigation are hoping for a similar outcome.

Filing a Xarelto Lawsuit

If you or someone you know suffered uncontrollable bleeding related to the use of Xarelto, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).