Xarelto Makers Face New Wrongful Death Lawsuit Alleging Uncontrollable Bleeding
Another wrongful death lawsuit has been filed over Xarelto, an anticoagulant drug manufactured by Bayer and Johnson & Johnson’s Janssen unit. The plaintiff alleges that the blood thinner caused uncontrollable, fatal bleeding in his wife. Like other Xarelto lawsuits, the plaintiff alleges that drug makers failed to warn patients and the medical community about the lack of an antidote to reverse the drug’s effects. This presents a risk of uncontrollable bleeding in patients, the lawsuit states.
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.
According to court records, a Wisconsin man is suing Xarelto makers on behalf of his wife, who died after taking the drug. The lawsuit alleges that her death was caused by Xarelto adverse events and that manufacturers failed to warn of the risks. The complaint states that drug makers are liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, advertising, distribution, labeling, and/or sale of the pharmaceutical drug Xarelto.”
The lawsuit alleges that Xarelto did not contain proper warnings on its label. Drug makers are accused of concealing safety information and misrepresenting the safety of the drug, according to the complaint.
Among other things, the lawsuit alleges that Xarelto makers engaged in aggressive marketing while failing to fully disclose the risks.
The case adds to the growing number of Xarelto lawsuits alleging uncontrollable bleeding. Court records indicate that a federal multidistrict litigation (MDL) containing Xarelto lawsuits has reached over 13,000 cases. Xarelto cases are consolidated in the Eastern District of Louisiana. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML); they centralized similar lawsuits to one court before one judge. Consolidating cases in this manner makes litigation proceed faster and more efficiently because it eliminates duplicate pretrial proceedings such as the discovery phase and expert testimony.
The MDL was created in December 2014.
Plaintiffs in the litigation also raise questions about the ROCKET AF study used to approve Xarelto, alleging that the data did not appropriately compare the risk of warfarin compared to Xarelto.
Xarelto Uncontrollable Bleeding Lawsuits
Lawsuits filed over Xarelto allege that the anticoagulant caused uncontrollable bleeding, such as gastrointestinal hemorrhaging or brain hemorrhaging. Excessive bleeding is a potential risk for any type of blood thinner. However, plaintiffs point out that with Xarelto, there is no antidote, or “reversal agent” to combat the drug’s blood thinning effects. This means that doctors have few options when treating a Xarelto patient who is bleeding uncontrollably.
Plaintiffs note that Xarelto is part of a new generation of blood thinners, along with Pradaxa and Eliquis. These medications emerged to compete with warfarin, a decades-old anticoagulant that requires blood monitoring and dietary restrictions. Xarelto users do not face these limitations. However, plaintiffs point out that warfarin has a reversal agent to stop the bleeding. Lawsuits allege that Xarelto makers promoted the benefits of the drug while failing to warn about the lack of an antidote.
Similar lawsuits have been filed over Pradaxa and Eliquis. The U.S. Food and Drug Administration (FDA) has since approved a Pradaxa reversal agent.
Pradaxa bleeding injury lawsuits were settled for $650 million on the eve of trial.
In 2014, the Xarelto label was updated to warn about the lack of a reversal agent. The Warnings and Precautions section was revised to state, “Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement,” under Risk of Bleeding.
The FDA approved Xarelto in July 2011. The drug is used to treat patients with blood clots or blood clot-related conditions, including deep vein thrombosis and atrial fibrillation. Xarelto is also used to prevent blood clots in patients undergoing a knee or hip replacement surgery.
Deep vein thrombosis is a condition where a blood clot forms in one of the deep veins. Typically, this occurs in the legs. This condition can lead to pulmonary embolism, a life-threatening condition where a piece of the clot breaks off and gets trapped in the lungs. Atrial fibrillation is an abnormal heart rhythm that increases the risk of a blood clot. By nature, anticoagulants impair the blood’s ability to clot. This is necessary to prevent serious, potentially fatal complications in some patients. However, there are also situations where doctors may need to counteract the drug’s blood thinning effects, such as during an uncontrollable brain or GI bleed.
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).