Xarelto Lawsuit Lawyer – Settlement, Recall & 2018 Updates
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The Xarelto lawsuits claim that Xarelto can cause irreversible internal bleeding, and that a substitute medication was just as effective at reducing blood clots but without the life-threatening danger of excessive blood loss.

The lawsuits also claim the manufacturers of Xarelto failed to provide physicians with clear guidance in regard to whether a patient was qualified to take Xarelto and whether the patient should stop taking it if occasional screening showed potential problems.

As of July 2018, more than 22,000 lawsuits are filed in federal court alleging Xarelto injuries.

 

Why Are Xarelto Lawsuits Being Filed

Many thousands of lawsuits are pending against Janssen Pharmaceutical (the manufacturer of Xarelto), Johnson & Johnson (the parent company of Janssen), and Bayer Healthcare (the marketer of the drug) by individuals who claim to have suffered injuries as a result of taking Xarelto.

The Key Legal Issue

Xarelto can cause uncontrollable bleeding. Before starting Xarelto, patients should be tested to determine whether Xarelto is the right anti-coagulant for them. Patients also should be retested on a regular basis to make sure Xarelto continues to be a proper drug.

Plaintiff lawyers argue Janssen and Bayer marketed Xarelto as a "one size fits all" type pill. Yet, this is not true. Patients need regular coagulation monitoring of their prothrombin time (PT) & international normalized ratio (INR) to determine if they are susceptible to a severe bleed, and to determine whether they are no longer good candidates for Xarelto.

Plaintiff lawyers claim the following:

  1. Xarelto is defective and unreasonably dangerous.
  2. Janssen was negligent in the manufacturing of the drug.
  3. Janssen and Bayer failed to properly test the medication, and failed to warn of the potential for uncontrolled bleeding.
  4. Janssen and Bayer concealed evidence of the dangers from the government and the public, and misrepresented the safety of the drug in its marketing material.
  5. Janssen and Bayer falsely promoted Xarelto as not needing monitoring to determine a patient's suitability for the drug.

 

Xarelto Injuries & Side Effects

The most serious potential injury caused by Xarelto is internal bleeding. Currently, there is no known potential cure to reverse the type of blood loss caused by Xarelto, other than possibly emergency dialysis. Individuals with severe pulmonary arterial hypertension are at greater risk for experiencing a Xarelto related bleed.

The Main Concern

While a warfarin overdose can be treated with Vitamin K and other substances, doctors can only wait for Xarelto to be flushed out from the patient’s body when extensive blood loss begins. Not even dialysis may be sufficient, and even a simple gastrointestinal bleed can become a fatal hemorrhage.

Other potential injuries caused by Xarelto include infection associated with hip or knee replacement surgery; decreased hemoglobin (a substance that carries oxygen in red blood cells); hematoma (a mass in the blood); peripheral edema (swelling of the lower limbs); and dyspnea (difficulty breathing).

If you are currently taking Xarelto, it is important to do your best to avoid activities that could result in you getting cut or bruised. If you do sustain these types of injuries (and especially if you experience swelling, bruising, bleeding, vision changes, confusion, weakness, dizziness or a migraine headache), immediately inform your healthcare provider.

Make sure to tell all doctors of your use of Xarelto, especially before undergoing any medical/dental procedures and surgeries, or if you have an artificial heart valve, uncontrolled high blood pressure, abnormal kidney function, ulcers, take medication associated with bleeding (e.g. aspirin), or abuse alcohol.

If you are, or become, pregnant make sure your obstetrician-gynecologist is clearly aware of this information, and especially before receiving an epidural.

Do not stop taking Xarelto, or reduce your dosage, without first consulting with your treating physician.

 

Compensation in a Xarelto Lawsuit

If you have suffered a severe bleed while prescribed Xarelto, you might be entitled to the following types of damages:

  1. Past and future medical expenses related to a Xarelto complication, including hospitalization, surgery, rehabilitation and follow-up care.
  2. Past and future pain and suffering arising from your injuries.
  3. Past and future wage loss, if any.
  4. Punitive damages, if appropriate.

As of July 2018, more than 22,000 lawsuits were pending in federal court against the manufacturers of Xarelto by individuals who claim to have experienced various injuries. The cases are being heard by Judge Eldon E. Fallon with the Eastern District of Louisiana.

 

Xarelto Lawsuit Settlement Amounts

xarelto settlements

As of this time, there have been no large mass tort settlements involving Xarelto and the link to uncontrolled blood loss. However, in December 2017, a Philadelphia jury in one of the first bellwether trials awarded plaintiff Lynn Hartman $27.8 million for injuries she sustained as a result of taking Xarelto.

The verdict consisted of $1.78 million in compensatory damages, and $26 million in punitive damages. Our law firm served as one of the lead trial law firms on the case. On the other hand, five others trials involving Xarelto have resulted in jury verdicts in favor of Johnson & Johnson.

 

Attorney Mike Papantonio Discusses the Xarelto Lawsuits

 
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Xarelto Recall Information

As of this time, there has not been a recall of Xarelto related to internal bleeding. However, the FDA has issued several warnings regarding the dangers of the drug.

In June 2013, the FDA sent a warning letter to Johnson & Johnson after it was determined that the company's subsidiary Janssen Pharmaceuticals, and its development partner Bayer AG, failed to properly warn patients and doctors in marketing material of the serious side effects linked to Xarelto (rivaroxaban). The letter stated that Johnson & Johnson's print ad for Xarelto was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.”

In August 2013, the FDA mandated that Xarelto packaging contain a black box warning stating that patients who stopped taking Xarelto prematurely could have an elevated risk for deep vein thrombosis, embolism, and spinal hematoma.

In 2014, the manufacturer of Xarelto was required to provide additional information on interactions with anesthesia and various other medications, including CYP3A4 inhibitors as well as the herbal supplement St. John's Wort. Warnings regarding the effects on renal function, and the lack of an antidote were also mandated later that year.

 

What is the Purpose of Xarelto

Xarelto is an anticoagulant (blood thinner) first approved by the FDA in 2011. Since that time, it has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (irregular heartbeat); deep vein thrombosis (blood clots deep within the body); pulmonary embolism (blood clots in the lungs); stroke; and patients who have recently undergone a knee or hip replacement surgery.

Xarelto generally is prescribed as an alternative to warfarin (Coumadin), a blood thinner that began to be used in 1954. The primary benefit of Xarelto over warfarin is the manufacturer claims the drug requires little patient monitoring, blood tests, and the dosage level is standard for virtually all users. Whether this statement is true is being addressed in pending litigation.

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Xarelto is a Factor Xa (10-A) Inhibitor, which is a biochemical substance produced in the liver that plays an important role in blood clotting. It operates by disabling the production of Factor Xa, which is dependent upon Vitamin K.

Xarelto is specifically prescribed for patients who:

  1. suffer from non-valvular atrial fibrillation (irregular heartbeat) and are at risk for systemic embolism and stroke
  2. have undergone joint surgery in order to prevent deep vein thrombosis (DVT) that may cause pulmonary embolism
  3. are at risk for stroke due to acute coronary syndrome (a set of conditions that can result in a sudden reduction of blood supply to the heart)

 

Xarelto Lawsuit News

Judge orders 1,200 Xarelto liability cases to be prepped for trials

Johnson & Johnson and Bayer have already prevailed in several lawsuits claiming their anticoagulant Xarelto caused severe injuries, and now a judge has ordered 1,200 more cases to be prepared for trials in courts around the country. Reported in FiercePharma- Judge Orders Trials

Jury orders Bayer, J&J to pay $28 million in Xarelto lawsuit

A Philadelphia state court jury on Tuesday ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers’ failure to warn of internal bleeding risks from their blood thinner Xarelto. Reported in Reuters - Philadelphia Xarelto Jury Verdict

Bayer, J&J win reversal of $28 million verdict in Xarelto lawsuit

A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG and Johnson & Johnson of failing to warn of internal bleeding risks of their drug Xarelto, the companies said. The next trial is May 30. Reported in Reuters - Reversal of Jury Verdict

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Document Claims Drug Makers Deceived a Top Medical Journal

It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals? Reported in New York Times - Xarelto Faulty Data

Report: More than 15,000 Adverse Events Linked to Xarelto in 2016

As the number of lawsuits against the blood thinner Xarelto continues to climb, so do reports of injuries and deaths caused by the controversial anticoagulant, according to a recent study by the Institute for Safe Medication Practices. According to ISMP, the U.S. Food and Drug Administration received 15,043 reports of serious injury or death linked to Xarelto last year — a 41 percent increase over the previous year. Reported in Market Insider - Xarelto Adverse Events

Bayer, J&J win first trial over Xarelto bleeding risks

A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the first trial to flow out of thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drugmakers said on Wednesday. . . . The lawsuit is one of an estimated 18,000 lawsuits in federal and state courts related to Xarelto. The verdict came in the first of four test trials, or bellwethers, scheduled in the federal litigation. The next trial is May 30. Reported in Reuters - Xarelto Trial

Data on trial of anticoagulant is to be reanalyzed after discovery that investigators used faulty device

The ROCKET-AF trial compared Xarelto with warfarin in more than 14 000 people. The trial used the INRatio device, made by Alere, to determine whether, and by how much, patients’ doses of warfarin should be adjusted to keep the drug in the right therapeutic range. Too much warfarin and patients are at an increased risk of bleeding; too little and they are at risk of clots. Reported in British Medical Journal - Xarelto Data on Trial

 

FDA and Scientific Studies Regarding Xarelto

Xarelto Medication Guide

Xarelto can cause bleeding, which can be serious, and might lead to death. This is because Xarelto is a blood thinner medicine that reduces blood clotting. Reported in FDA - Xarelto Guide

Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation

In this trial comparing a once-daily, fixed dose of rivaroxaban with adjusted-dose warfarin in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke, rivaroxaban was noninferior to warfarin in the prevention of subsequent stroke or systemic embolism. There were no significant differences in rates of major and clinically relevant nonmajor bleeding between the two study groups, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. Reported in New England Journal of Medicine - Xarelto vs Warfarin

Xarelto Full-Prescribing Information

Xarelto increases the risk of bleeding and can cause serious or fatal hemorrhaging. In deciding whether to prescribe Xarelto, the risk of thrombotic events should be weighed against the risk of bleeding. A specific antidote is not available. Reported in FDA - Xarelto Information

Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study

We cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban (Xarelto) compared with warfarin. Reported in British Medical Journal - Xarelto vs Warfarin

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Rivaroxaban (XARELTO) Safety Profile

In the first quarter of 2012, QuarterWatch identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban [Xarelto] was the primary suspect drug. The total more than doubled from the previous quarter of 128 cases. Reported in Institute for Safe Medication Practices - Xarelto Safety

Perspective on Drug Hypersensitivity

Since 2012 QuarterWatch has reported prominent signals for the bleeding risks of three anticoagulant drugs, dabigatran (PRADAXA), rivaroxaban (XARELTO), and warfarin (COUMADIN). The concerns arose in a setting of a race to market replacements for warfarin, a generic drug first approved in 1956. Both dabigatran and rivaroxaban were marketed as providing the same or slightly better results than warfarin in preventing strokes and other blood clot-related events, but were easier to use because weekly or monthly blood level tests were not required or available. Reported in Institute for Safe Medication Practices - Xarelto Hypersensitivity

FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device

Because of the concern about the Alere INRatio device, the FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET-AF study results. The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal. The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation. Reported in FDA - Xarelto Analyses

 
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