The Xarelto lawsuits claim the manufacturers of Xarelto failed to warn doctors and patients that the drug could cause irreversible internal bleeding, and that a substitute medication was just as effective at reducing clots but without the life-threatening danger of excessive blood loss.
The lawsuits also allege the manufacturers 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.
Our law firm is accepting clients who suffered severe bleeding while taking Xarelto. We have been handling claims against pharmaceutical companies since 1955, and we are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
Why Are Xarelto Lawsuits Being Filed
More than ten thousand lawsuits are pending in federal court 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.
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:
- Xarelto is defective and unreasonably dangerous.
- Janssen was negligent in the manufacturing of the drug.
- Janssen and Bayer failed to properly test the medication, and failed to warn of the potential for uncontrolled bleeding.
- 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.
- 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.
Additionally, 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.
Attorney Mike Papantonio Discusses the Xarelto Lawsuits and the Link to Severe Bleeding
What Type of Compensation Can I Recover in a Xarelto Claim
As of January 2018, more than 19,000 cases 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.
If you have suffered a severe bleed while prescribed Xarelto, we will be seeking the following damages for you:
- Past and future medical expenses related to a Xarelto complication, including hospitalization, surgery, rehabilitation and follow-up care.
- Past and future pain and suffering arising from your injuries.
- Past and future wage loss, if any.
- Punitive damages, if appropriate.
As of this time, there have been no large group settlements involving Xarelto and the link to uncontrolled blood loss. However, in December 2017, a Philadelphia jury 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.
We are one of just two law firms that have been appointed as Lead Counsel by the judge overseeing all of the federal claims involving Xarelto. This means that we are directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this drug.
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.
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:
- suffer from non-valvular atrial fibrillation (irregular heartbeat) and are at risk for systemic embolism and stroke
- have undergone joint surgery in order to prevent deep vein thrombosis (DVT) that may cause pulmonary embolism
- 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)
What is Coagulation and What Role Does Medication Provide
Coagulation, or blood clotting, is an important process that can protect the body from blood loss and infection when one suffers an open laceration or wound. It is part of the healing process. When blood clots form internally, however, it causes a condition known as thrombosis. This can put a person at risk for stroke or heart attack.
The coagulation process is found in most animal species, including all mammals. Among mammals, the coagulation process involves two components. One of these involves specialized cells known as platelets, or thrombocytes. The other requires a specific protein called fibrin, or Factor Ia (“one-a”). Together, these components work to stop blood loss resulting from injury to a vein or artery.
The Coagulation Process
The mechanism of blood clotting consists of three distinct stages: (1) activation, (2) adhesion and (3) aggregation. The process begins as soon as a blood vessel has been damaged. Leakage of blood through the interior cellular lining of these vessels (the endothelium) triggers changes to platelets in the blood as well as the cells of the interior lining. The platelets provide a plug for the injury (similar to self-sealing fuel tanks used on some aircraft), causing primary hemostasis, or “blood stoppage.” At the same time, endothelial cells turn into a protein called Factor VII, which begins the formation of fibrin, reinforcing the initial platelet repair as it activates additional clotting factors.
Between the endothelium and the outer surface of the blood vessel is a layer of collagen, the primary structural protein that exists in connective tissues between cells. When damage occurs, this collagen is exposed, causing a bond with platelets, allowing them to adhere to the injury site. When the first platelets are activated, it releases signaling chemicals that begin a chain reaction, activating additional platelets. These signaling agents cause additional biochemical reactions that transforms platelets, flattening them and causing them to spread out (like a patch for a rubber tube). They also prepare the injury site, increasing the tissue's ability to bind to fibrin.
Coagulation Cascade and Fibrin Formation
Secondary hemostasis occurs as clotting factors begin transmitting biochemical messages to each other. These clotting factors, identified with Roman numerals, are normally dissolved in the blood. When activated, they are transformed into long strands of fibrin, which bind to platelets. This creates a type of “net” that captures additional platelets, reinforcing the initial repair.
Once the flow of blood through the injured wall of the vessel has been stopped, additional reactions take place to shut down the process. This involves additional proteins and enzymes. One of these is called Protein C, which is a natural anticoagulant. Another is antithrombin, a type of protein that inhibits the action of clotting factors. When antithrombin is absent or deficient, a patient runs a higher risk of thrombosis.
Once the healing process is underway, the clotting process must be stopped. This occurs through fibrinolysis. In primary fibrinolysis, fibrin is broken down and its components are reabsorbed into the blood. This task is undertaken by the enzyme plasmin, which literally severs the strands making up the fibrin mesh. The fragments resulting from this process are then released into the bloodstream, and ultimately filtered out by the kidneys and liver or eliminated by other enzymes known as proteases. Secondary fibrinolysis is the result of medication such as Activase (altplase), Streptase (streptokinase) or TNKase (tenecteplase). It can also result from a medical disorder, including bacterial infections, cancer, hypoglycemia, or hypoxia (oxygen deficiency in the blood).
Thrombosis can result from a number of causes, including impaired blood flow, cholesterol, and certain types of surgeries. Often, cholesterol plaques that adhere to artery walls can burst, releasing chemical messengers that activate platelets, causing the formation of clots. Clotting can also occur when blood pools in the heart or other parts of the body, increasing the chances that platelets will begin adhering to each other.
Blood clots can also form after joint surgery. In order to prevent this, patients are often prescribed anticoagulant medications such as Coumadin (warfarin), heparin, or a Factor Xa inhibitor such as Eliquis (apixoban), Pradaxa (dabigitran), or Xarelto (rivaroxaban). With any of these prescription drugs, there is the danger of uncontrolled hemorrhaging. However, with warfarin and heparin, hemorrhaging can be controlled with doses of Vitamin K, which plays an important role in the functioning of clotting factors. The Factor Xa inhibitors act directly on clotting factors. Once a patient starts bleeding while taking one of these medications, there is no reliable way of stopping it, although administering emergency dialysis can sometimes mitigate the effects.
Xarelto Lawsuit News
A Philadelphia jury has awarded nearly $28 million to the plaintiffs in the first bellwether trial to take place in state court over the blood thinner Xarelto. The mass tort is focused on claims that the drugmakers failed to adequately warn about the danger of suffering a severe bleed, especially when patients took Xarelto in combination with Aspirin. Reported in Law.com - Philadelphia Xarelto Jury VerdictDocument 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 DataReport: 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 EventsTrial for Bayer drug Xarelto under scrutiny over defective device:
European and U.S. drug regulators are looking into whether a defective blood clotting test device affected a trial involving Bayer's top-selling anti-clotting drug Xarelto, hitting the German drugmaker's shares. The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the elderly. Reported in Reuters - Xarelto Scrutiny
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 TrialData 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 TrialNew anticoagulant drugs provide stroke prevention with dose of danger:
Xarelto is one of four anticoagulants approved since 2010 that make up a class of lucrative new drugs marketed as more convenient than warfarin. While warfarin has a blood thinning action that can be halted in a bleeding emergency, none of the newer drugs has an approved antidote. Reported in Journal Sentinel - Xarelto Danger
For additional news stories, click Levin Law Xarelto News
FDA and Scientific Studies Regarding Xarelto
Xarelto Medication GuideXarelto 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 FibrillationIn 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 InformationXarelto 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 studyWe 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
Rivaroxaban (XARELTO) Safety ProfileIn 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 HypersensitivitySince 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 deviceBecause 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
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.