There have been thousands of Xarelto lawsuits filed so far, with the majority being handled as part of a Multidistrict Litigation (MDL) process. Settlements from litigation against a similar product, Pradaxa, resulted in payment of $650 million to over 3000 plaintiffs in the first set of cases, and a second litigation effort is in progress.


Approved for sale in the U.S. in 2011, Xarelto (Rivaroxaban) was aggressively marketed for use as a new anticoagulant. Millions of users have been prescribed this medicine to prevent blood clot formation that occurs with atrial fibrillation (irregular heartbeat) or following hip or knee replacement surgery. It also was given as a remedy to prevent new blood clots in patients suffering from deep vein thrombosis (DVT) or pulmonary embolus (PE).

  • Purpose – Xarelto (Rivaroxaban) is an anticoagulant that blocks certain clotting proteins in blood. The main reason for using this drug is to prevent blood clots from forming when there is atrial fibrillation (irregular heartbeat) in a patient. It also is prescribed to patients who have had knee or hip replacement surgery.
  • Conditions Treated: Xarelto is prescribed for conditions that involve blood clotting that needs prevention. These conditions include: clots in lungs or in a deep vein, clots that occur following knee or hip replacement surgery, clots that occur in chronic atrial fibrillation.
  • Prescription – This prescription drug is primarily used to prevent blood clots following surgery for hip or knee replacement, and in patients who experience a certain irregular heartbeat condition. It also is prescribed for patients who have blood clots due to deep vein thrombosis (DVT) or pulmonary embolus (PE).
  • Problems – There is no antidote for this drug. If it causes uncontrollable bleeding from thinning the blood, there is no remedy. This is the most dangerous potential side effect. Patients also are told there is no need to regularly monitor blood, as is required with other drugs like Warfarin. (See warfarin coumadin lawsuits & settlements). There also is a higher risk of bleeding if the patient takes Xarelto with certain other medications, including Aspirin, NSAIDs, drugs that contain heparin, Warfarin (Coumadin, Jantoven), Clopidogrel (Plavix), or other drugs prescribed to treat or prevent clot formation. In addition to interaction with other anti-coagulant and prescription medications, Xarelto may react with non-prescription medicines, vitamins or herbal supplements.

People who take Xarelto should thoroughly discuss this medicine, its usage, and potential risks with their doctor before taking it. Certain medical conditions can be negatively affected by this drug and there is a very long list of potential side effects that can occur due to taking Xarelto. In one study, 73 percent of people who took Xarelto did suffer from at least one adverse side effect.

Xarelto Timeline

Xarelto was first approved for sale and use in Canada, in 2008. By 2011, it was approved in the United States by the FDA. Since that time, over 13 million prescriptions have been written in the U.S., and according to the Xarelto website, it is the “#1 Prescribed Blood Thinner” in its class.

2011 – First approvals by FDA for sale in US.

  • July 1 – Approved for use in DVT & PE, hip & knee replacement surgery
  • November 4 – Approved for blood clot prevention and strokes due to atrial fibrillation

2012 – First reports of doctor concerns about bleeding safety, June 14th

2013 – Adverse events reported.

  • Jan 1 – FED MedWatch says 593 complaints link Xarelto to bleeding by end of 2012
  • July 1 – Bayer, Johnson & Johnson report Xarelto sales of $827 million for first half of 2013
  • September – Germany – Der Spiegel reports 968 adverse events during first 8 months of 2013, including 72 deaths
  • October 17 – Added to most dangerous drugs list; 10th reported to FDA for side effects
  • November 21 – American Heart Association suggests Xarelto causes higher risk (3x) for internal bleeding in acutely ill patients and in those with acute coronary syndrome (ACS) (4x).

2014 – Lawsuits, higher sales, recall issued, higher risks reported, and doctors get kickbacks for promoting drug.

  • January 16 – FDA votes against approval for use of Xarelto for ACS.
  • April 15 – First lawsuit filed for bleeding death of family member using Xarelto
  • June 14 – Bayer faces 10 lawsuits for internal bleeding injury or death caused by Xarelto
  • October 14 – Xarelto sales total over $1 billion for 2014
  • October 15 – FDA and J&J recall 13,500 bottles of Xarelto – concerns about microbial contamination
  • October 16 – Link between Xarelto and liver damage is found by Swiss researchers
  • December 9 – Increased risk for intestinal bleeding is higher with Xarelto than with Warfarin confirmed by U of Tel Aviv researchers
  • December 12 – Xarelto bleeding lawsuits are assigned in consolidation order from JPML to U.S. District Judge Eldon E. Fallon, Eastern District Federal Court, Louisiana

2015 – Kickbacks, second mass tort court created for new victims, more lawsuits, court date is scheduled for first Xarelto cases.

  • January 7 – Report that in last 5 months of 2013, doctors were paid almost $20 million to promote blood thinners like Xarelto
  • January 21 – Second mass tort court is created by Philadelphia judge for new group of lawsuits filed by victims suffering internal bleeding allegedly caused by Xarelto
  • August 17 – Total of 1,231 Xarelto bleeding lawsuits have now been filed in federal MDL court.
  • September 17 – First Xarelto cases are scheduled by Xarelto MDL Judge Eldon Fallon to begin February 6, 2017.

2016 – More lawsuits pending in Xarelto MDL court.

  • January 15 – 2,826 internal bleeding lawsuits reported as now filed and pending

2017 – Hearing in Xarelto MDL court is scheduled for February 6th.

Xarelto Side Effects

Side effects are a concern for people using Xarelto, an anticoagulant medicine. The most common and dangerous side effect of Xarelto is considered to be uncontrollable bleeding complications. This medication is a strong blood thinner, designed to prevent blood clots that result from a variety of medical conditions. Some side effects may not require medical attention, or they may go away as the body gets used to Xarelto. There may be an increased risk for bleeding when Xarelto is used by certain patient groups, including those with uncontrolled and severe arterial hypertension or those using other treatments that affect hemostasis.

Common Systemic Side Effects

Use of Xarelto can result in a variety of problems with the internal systems of the body. The following are the most common systemic side effects that users of this drug have experienced.

  • Hematologic – Bleeding is the most common effect
  • Gastrointestinal – The entire digestive system, including constipation, diarrhea, vomiting, bleeding, pain, and hemorrhages
  • Nervous system – dizziness, headache, cerebral hemorrhage, intracranial bleeding
  • Cardiovascular – deep vein thrombosis, hypertension, tachycardia, stroke (during transition from Rivaroxaban (active ingredient in Xarelto) to Warfarin in some patients
  • Hepatic – increased transaminases, liver problems
  • Renal – impairment, potential for renal failure,
  • Hypersensitivity – anaphylactic shock or reaction, hypersensitivity
  • Dermatologic – blister, hemorrhages, contusion, rash, wound secretion, itching, cutaneous and subcutaneous bleeding
  • Genitourinary – urinary retention, hemorrhage in urogenital tract or vagina
  • Metabolic – hyperglycemia, increased LDH, amylase and lipase
  • Musculoskeletal – arthralgia, back pain, muscle cramping or spasm, osteoarthritis, extremity pain
  • Ocular – hemorrhage in the eye, conjunctival hemorrhage
  • Psychiatric – Anxiety, sleep disorders
  • Respiratory – sinusitis, shortness of breath, oropharyngeal pain, nosebleed, hemotypsis
  • Other – Fatigue, decreased energy and general strength

Many common side effects have been reported by users of Xarelto. One website,, reports that over 50 different problems, ranked common to rare, are potential side effects that can occur when using Xarelto (generic name: Rivaroxaban).

Typical side effects related to use of Xarelto include:

  • Bleeding – in gums, bloody stools, coughing up blood, increase in menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, vomiting of bloody material
  • Pain – back pain, headache, dizziness, leg weakness, difficulty breathing or swallowing, paralysis
  • Bowel or Bladder dysfunction – red or black stools, red or dark brown urine
  • Skin disorders – numbness, burning, itching, tingling feelings

Side effects that are less common or rare are many, and the list includes: fainting, wound secretion, arm/leg pain, and burning or difficult urination. More rare problems involve the systemic problems mentioned above. Symptoms include: blurred vision, chills, blisters, fast or irregular heartbeat, hives, loss of appetite, puffiness in the facial area and eyes, yellow eyes or skin, and muscle spasms.

Xarelto Lawsuit & Settlement

People who have used Xarelto and experienced side effects, disability or lost a loved one to death from using this drug can file a lawsuit to obtain compensation for their financial losses and emotional injuries. In some cases, this is the only way to make the drug companies accountable for allowing the manufacture and sale of dangerous drugs that cause harm to users.

Plaintiffs who have already filed Xarelto lawsuits are accusing the makers of this drug with negligence and failure to warn users of potential dangers. In addition to this issue, it has been disclosed that doctors were paid $20 million to promote the use of dangerous blood thinning drugs like Xarelto. The primary defendants in the initial group of Xarelto lawsuits are Bayer and Janssen Pharmaceuticals.

Lawsuit claims presented in the Xarelto case are similar to claims made in other personal injury lawsuits. Reasons for filing a Xarelto lawsuit include recovery of fair compensation for financial hardships caused by medical treatment, long-term care and lost wages. The injured parties may also seek compensation for non-economic claims like pain and suffering, and for their mental and emotional stress. Compensation to relatives who care for loved ones suffering from side effects or damage due to use of this drug include non-economic damage claims for their emotional distress, as well as economic damage claims to recover expenses they paid out for care of their loved one. When there is a death from use of Xarelto, survivors seek compensation for funeral and burial expenses.

Xarelto Lawyer/Attorney

If you have been harmed by taking Xarelto or you helped a loved one who was harmed by or died from taking Xarelto, it is important to seek legal assistance from a legal professional who has handled many Xarelto cases. An experienced Xarelto Lawyer/Attorney will have current knowledge of the status of existing lawsuits against the makers of this drug. They also will understand the tort system that allowed a judge to put the first group of lawsuits into a multi-district litigation status.

Multi-District Litigation (MDL) is a method for handling multiple claims against a defendant, bringing lawsuits from across the country into one courtroom. New claims may be added to this group, put into a new group or handled separately, depending on the circumstances of the legal issues. Your attorney knows how to manage your case to bring about the best possible results for you. You can start with a free consultation, so there is no reason to not consult right away with an experienced Xarelto Lawyer/Attorney. Since there may also be a statute of limitations that could affect your eligibility to file claims, contact your chosen attorney immediately.

Negligence is a key point to prove in these types of lawsuits. It has already been established that the manufacturers of Xarelto were negligent by not informing users of the bleeding dangers and other side effects that occur due to use of this drug. Adding to the dangers of use is the fact that Xarelto does not have an antidote, so bleeding can become uncontrolled and even fatal in some cases. If you or a loved one has been harmed or died due to use of Xarelto, you deserve fair compensation. Bring your concerns to our experienced Xarelto Lawyer/Attorney for resolution of your claims and the best possible outcome. Call us today!