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Xarelto Bleeding LawsuitDrug Can Lead to Uncontrollable Bleeding

Xarelto Bleeding Lawsuit

Xarelto is a prescription anticoagulant used to prevent blood clots in individuals who suffer from atrial fibrillation or are susceptible to deep vein thrombosis (DVT) or pulmonary embolism (PE). However, the drug can lead to uncontrollable bleeding, which can lead to a blood transfusion, hospitalization, or even death. Lawsuits filed allege the manufacturer failed to warn individuals of the bleeding risks involved.

Litigation Updates

Litigation Continues, Cases for Trial Planned

March 2018 – Litigation continues. The federal judge in charge of the MDL has initiated a plan to select 1200 cases for trial work-up. The first 600 of those will be announced this spring.

$28.7M Verdict Overturned

January 9, 2018 – A Pennsylvania state court judge overturned the verdict that awarded $28.7 million to a plaintiff.

Plaintiff Awarded $28.7M

December 5, 2017 – A  Pennsylvania jury awarded $28.7 million to a plaintiff who claimed that Xarelto manufacturers failed to warn consumers of the adverse health risks associated with the blood thinner. The verdict consisted of $1.78 million in compensatory damages and $26 million in punitive damages.

Xarelto Video Update - Attorney Steven Davis

 

Jury Once Again Ruled in Favor of Manufacturer

August 18, 2017 – In the third bellwether trial, a jury once again ruled in favor of Xarelto's manufacturers.

Jury Ruled in Favor of Manufacturer

June 12, 2017 – A New Orleans jury ruled in favor of Xarelto manufacturers in the second bellwether trial in the multidistrict litigation.

Jury Ruled in Favor of Defendant

May 3, 2017 – In the first of four bellwether trials, a jury in the Eastern District of Louisiana ruled in favor of the defense, rejecting the plaintiff's claim that the defendants had failed to notify the plaintiff's doctor of the risks associated with Xarelto.

Black Box Warning Added to Label

August 2013 – A black box warning, the strongest warning required by the FDA, was added to Xarelto packaging. The warning cautioned particular individuals against taking the medication if undergoing certain procedures or taking certain medications in conjunction with Xarelto.

FDA Warning Letter Sent to Companies

June 6, 2013 – The FDA sent a warning letter to Johnson & Johnson and its partner, Bayer Pharmaceuticals, after determining the companies failed to adequately warn individuals of the potentially serious side effects associated with Xarelto.

The FDA took issue with certain marketing material. One print advertisement called into question was an advertisement published on WebMD which the FDA said failed to properly draw attention to the drug's side effects while claiming the efficacy of Xarelto "appeared to be disassociated with the risks."

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Xarelto Approved for Additional Usage

May 2012 – Xarelto was approved for extended use, including the treatment of deep vein thrombosis and pulmonary embolism by the FDA.

Xarelto Approved by FDA

November 2011 – The U.S. Food & Drug Administration (FDA) approved Xarelto to reduce the risk of stroke and systemic embolism in people with non-valvular atrial fibrillation.

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What is Xarelto?

Xarelto (Rivaroxaban) was developed by Bayer Pharmaceuticals and is now marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit. Gaining FDA approval in 2011, Xarelto is prescribed to block clotting of the blood, specifically, a particular type of blood clot called deep vein thrombosis (DVT). It is also used in individuals with atrial fibrillation to decrease the risk of stroke caused by a blood clot.

Patients prescribed Xarelto or other new oral anticoagulants need to understand that taking these drugs comes with some risk.

In instances of an emergency situation, traumatic accident, or cerebral hemorrhage, bleeding can be difficult to stop in patients taking Xarelto.  As of January 2018, an antidote has still not been released to prevent the severe, uncontrollable bleeding from occurring. The uncontrollable severe bleeding events, including gastrointestinal bleeds, could lead to blood transfusions, hospitalization, or even death. However, there is a drug, AndexXa, currently undergoing an approval process by the FDA that would cease potentially fatal Xarelto bleeding side effects. More information on the approval process should be released in May 2018.

According to the Institute for Safe Medicine Practices (ISMP), a watchdog group, anticoagulant drugs are a “high-risk treatment” and cause bleeding in approximately 15% of patients with atrial fibrillation. Many physicians are wary of the newer anticoagulants since there is limited data on how to manage bleeding in patients taking them.

The pharmaceutical companies that produced Xarelto are now under fire for not only causing side effects in individuals but for failing to provide adequate warnings of the risks.

 

Injuries We’re Pursuing in a Xarelto Bleeding Lawsuit

TorHoerman Law is currently pursuing cases for those, who while taking Xarelto,

  • Experienced a bleeding event that required blood transfusions;
  • Experienced a bleeding event that required hospitalization, serious injury, and/or death.

 

Xarelto Bleeding Lawsuit

More than 20,000 plaintiffs allege that Xarelto, an anticoagulant, caused them to suffer from uncontrollable bleeding and that the manufacturers of the drug failed to provide adequate warnings of the deadly side effects that could occur. The Xarelto lawsuits have been consolidated into a multidistrict litigation in Louisiana.

Similar lawsuits involved Boehringer Ingelheim’s blood thinner Pradaxa. Tor Hoerman was a co-lead attorney in the Pradaxa litigation that resulted in the settlement of $650 million to individuals injured as a result of their Pradaxa use.

Lawyers speaking to people injured by Xarelto believe that Bayer Pharmaceuticals and Johnson & Johnson’s Janssen Pharmaceuticals may also find themselves defending Xarelto as Boehringer Ingelheim Pharmaceuticals Inc. did in the case of Pradaxa. Xarelto is now the top prescribed anticoagulant in the U.S and has shown similar serious injuries as in the case of Pradaxa.

If you or a loved one believe Xarelto may be to blame for serious injuries that resulted when uncontrollable or internal bleeding occurred, TorHoerman Law would like to discuss your options regarding a Xarelto bleeding lawsuit.

+ - References

Cheung, Ka-Shing, and Wai K Leung. “Gastrointestinal Bleeding in Patients on Novel Oral Anticoagulants: Risk, Prevention and Management.” World Journal of Gastroenterology, U.S. National Library of Medicine National Institutes of Health, 21 Mar. 2017, www.ncbi.nlm.nih.gov/pmc/articles/PMC5360636/.

Depp, Aurora. “FDA Delays AndexXa Antidote for Xarelto Bleeding · MedTruth.” MedTruth, 24 Jan. 2018, medtruth.com/fda-andexxa-antidote-xarelto-bleeding/.

“FDA Warnings & Safety Communications for Xarelto Users.” Recall Center, RecallCenter, www.recallcenter.com/xarelto/fda-news/.

Raymond, Nate, and Tina Bellon. “Bayer, J&J Win Reversal of $28 Million Verdict in Xarelto Lawsuit.” Reuters, Reuters, 2018, www.reuters.com/article/us-bayer-xarelto/bayer-jj-win-reversal-of-28-million-verdict-in-xarelto-lawsuit-idUSKBN1EZ08M.

Thomas J Moore, Michael R Cohen, Curt D Furberg. “Perspective on Drug Hypersensitivity.”QuarterWatch: Monitoring FDA MedWatch Reports, www.ismp.org/quarterwatch/pdfs/2013Q1.pdf.

“United States District Court.” MDL - 2592 Xarelto Products Liability Litigation | Eastern District of Louisiana | United States District Court, United States District Court - Eastern District of Louisana, 27 Feb. 2018, www.laed.uscourts.gov/xarelto.

“Xarelto Uses, Dosage, Side Effects & Warnings.” Drugs.com, Drugs.com, www.drugs.com/xarelto.html.

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