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Xarelto Lawsuit

Xarelto boxXarelto was introduced by manufacturer Bayer and Johnson & Johnson’s Janssen unit in 2011, advertised as a convenient and superior alternative to warfarin. Part of a new generation of anticoagulants known as Factor Xa inhibitors, Xarelto has captured the largest share of the blood thinner market with more than one-third of all warfarin users. Over the last four years, Bayer and J&J have reaped the financial rewards of this top-selling medication, with nearly 1.5 million prescriptions doled out to American consumers.

Despite its blockbuster status and profitability, Xarelto (rivaroxaban) is the topic of dozens of lawsuits contending the drug poses unreasonable risk of severe injury and death. The direct thrombin inhibitor is FDA-approved for various uses: to reduce risk of stroke in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism, and to reduce the risk of blood clots after hip or knee replacement surgery.

At the heart of the litigation are allegations that Xarelto manufacturers failed to adequately disclose information about internal bleeding risks, as once hemorrhaging begins there is no reversal agent to quell its effects. While all blood thinners – including warfarin – pose some risk of bleeding, Xarelto is particularly dangerous, considering no antidote is available.

Xarelto injuries and lawsuits

Drug injury lawsuits filed by Xarelto patients, and in some cases their surviving family members, argue that rivaroxaban caused the following types of injuries:

  • Uncontrolled gastrointestinal bleeds
  • Brain hemorrhages
  • Hemorrhagic stroke
  • Bleeds within the eye
  • Rectal bleeding
  • Embolisms and blood clots
  • Irreversible bleeds leading to death

Plaintiffs claim that Bayer and Janssen should be held liable for “misrepresenting Xarelto as safe and efficacious for its intended use,” while actively concealing the true risks of the drug. In one recent lawsuit brought by a Tennessee family that lost their patriarch to a fatal bleed, the claimants accuse the defendants of fraud and deceit, alleging they blatantly and intentionally distributed false information.

Their claim, filed in the U.S. District Court for the Eastern District of New York last year, cites the Rocket AF clinical trial which found that “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

While Xarelto doesn’t require dietary changes or regular blood monitoring like warfarin does, thousands of adverse events and at least 65 reported deaths have raised concerns about the safety of this blood thinner. Legal action is a means for plaintiffs to hold drug makers accountable if their product is in any way defective, dangerous or sold without adequate warnings, and hopefully recoup compensation for financial losses.

Xarelto litigation centralized

When large numbers of product liability cases containing similar factual issues and allegations are filed, the courts may coordinate these actions for more efficient processing. By sharing in pretrial processes and bellwether trials, claimants with pending Xarelto lawsuits may see resolution much faster, especially if Bayer and Janssen opt to settle cases rather than proceed with individual trials.

Litigation regarding Xarelto bleeding injuries has been centralized on two fronts: as a mass tort in the Philadelphia Court of Common Pleas and as multidistrict litigation (MDL) in the Eastern District of Louisiana. The mass tort, established early in 2015 by administrative Judge Kevin Dougherty, has amassed more than 170 claims over the months, according to the Complex Litigation Center director.

The Xarelto multidistrict litigation, which coordinates all cases filed in federal courts, was also created in January 2015 and is being overseen by Judge Eldon E. Fallon. Court filings indicate that more than 300 cases have been transferred to MDL 2592, where both sides are busy preparing fact sheets, reviewing judicial orders and preparing for the next status conference.

Plaintiffs in both litigations assert that the drug makers failed to warn medical personnel in emergency rooms that Xarelto has no reversal agent to stop hemorrhagic events.

J&J and Bayer are facing additional litigation in Canada, where representative plaintiff Betty Sampson filed a class action suit asserting that Xarelto-induced bleeding almost cost her life. The claim includes other Canadians who also contend that Xarelto caused uncontrollable bleeding events and that Bayer and Janssen were negligent in their marketing efforts.

While bundled for pretrial proceedings, complaints that are coordinated under a mass tort or MDL are treated individually, with each plaintiff entitled to their own jury verdict or settlement based on the strengths and merits of their case.

Misleading advertising one of many allegations

Xarelto makers are being sued on counts of fraud, negligence, failure to warn, and breach of warranty, as plaintiffs argue that Bayer and Janssen released a dangerous anticoagulant that was aggressively promoted as better than warfarin.

Plaintiff Cheryl Butler, whose case was recently filed in the Xarelto MDL, took the blood thinner to treat a pulmonary artery embolism and deep vein thrombosis (DVT). Not long after, she suffered a life-threatening gastrointestinal bleed that doctors could barely control. Butler, like other claimants, is demanding compensation for the physical and mental pain, hospital and medical expenses, and diminished enjoyment of life she says resulted from her use of the medication.

Despite mounting numbers of complaints, Janssen maintains the importance of Xarelto in the global marketplace and stands behind the drug’s safety, adding that the benefit-risk profile of Xarelto remains “favorable and consistent with clinical trials.”


  1. JPML – Transfer Order MDL 2592 http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2592-Initial_Transfer-12-14.pdf

  2. FiercePharma, Bayer, J&J launch new stroke study to pump up payer-persuading Xarelto data http://www.fiercepharmamarketing.com/story/bayer-jj-launch-new-stroke-study-pump-payer-persuading-xarelto-data/2015-01-28

  3. Calgary Sun, Class Action Lawsuit Against Bayer Alleges Negligence Over Xarelto Anticoagulant Drug http://www.calgarysun.com/2015/02/14/calgary-class-action-lawsuit-against-bayer-alleges-negligence-over-xarelto-anticoagulant-drug

  4. Philadelphia Court of Common Please, Complex Litigation Center - Mass Tort Information http://www.courts.phila.gov/common-pleas/trial/civil/clc.asp