What should I know about Xarelto® bleeding injury lawsuits?

circulatory systemXarelto® is a popular anticoagulant used to prevent blood clots and strokes in patients following total knee or hip replacement surgeries. It is also used to treat deep vein thrombosis, pulmonary embolism and atrial fibrillation. However, some patients claim that Xarelto can cause irreversible internal bleeding that can be fatal. Manufactured by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, patient lawsuits filed against these companies claim they failed to warn people of the risks associated with taking Xarelto.

Below, you will find answers to your questions about Xarelto injuries. If you have additional questions, or you wish to speak to someone about your specific situation, please contact our office today to schedule a complimentary initial case consultation.

What is Xarelto?

How does Xarelto work?

Why do many people choose Xarelto over warfarin?

Is there an antidote to Xarelto?

Why are people filing Xarelto lawsuits?

When was Xarelto approved by the FDA?

Has Xarelto been recalled?

Why did the FDA issue a black-box warning for Xarelto?

What are the manufacturer warnings for Xarelto?

What are the most common adverse reactions and side effects associated with Xarelto?

What are the severe side effects of Xarelto?

How does Xarelto cause uncontrolled bleeding?

What are the symptoms of Xarelto bleeding?

Is there a Xarelto class action?

What should I do if I had a serious bleeding event while taking Xarelto?

Have Xarelto lawsuits already been filed?

How long do I have to file a Xarelto bleeding injury lawsuit?

How much does it cost to file a Xarelto lawsuit?

How long will a Xarelto lawsuit take?

What damages can I recover in a Xarelto lawsuit?


Q: What is Xarelto?

A: Xarelto (rivaroxaban) is a popular anticoagulant, or blood thinner, developed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. It belongs to a class of medications known as factor Xa inhibitors, and is designed to prevent blood clots and strokes in patients with deep vein thrombosis, atrial fibrillation, or pulmonary embolism. It's also often prescribed after total knee or hip replacement surgeries.
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Q: How does Xarelto work?

A: Xarelto binds to a substance in blood called factor Xa. This prevents the formation of thrombin, an enzyme in blood plasma that converts fibrinogen to fibrin, which is a main component of blood clots. Preventing the formation of these substances prohibits blood clots.
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Q: Why do many people choose Xarelto over warfarin?

A: Compared to warfarin, another type of anticoagulant, Xarelto has a much higher convenience factor. Warfarin doses vary from person to person, whereas Xarelto doses are largely one-size-fits-all. Additionally, patients on warfarin must submit to monthly blood tests to ensure the medication is working properly and must avoid foods that are high in vitamin K—such as kale or spinach—which may reduce the drug's effectiveness.
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Q: Is there an antidote to Xarelto?

A: Currently, there is no antidote to Xarelto. In August 2016, the Food and Drug Administration (FDA) declined to approve an antidote from Portola Pharmaceuticals designed to reverse the blood-thinning effects of factor Xa inhibitors, such as Xarelto.
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Q: Why are people filing Xarelto lawsuits?

A: Lawsuits filed by former Xarelto patients or their family members claim this drug can cause irreversible internal bleeding that can lead to hospitalization or death. In the lawsuits, some patients claimed that Xarelto's two manufacturers, Janssen Pharmaceuticals and Bayer, failed to warn patients of the bleeding risks associated with using the drug. Other patients claim outright misrepresentation by the manufacturers regarding the safety and effectiveness of Xarelto.
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Q: When was Xarelto approved by the FDA?

A: Xarelto's first approval by the FDA approval was July 2011, when the administration gave the drug the green light to prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery. In November 2011, the FDA approved Xarelto to prevent strokes in patients with abnormal heart rhythm. The FDA further expanded use of the drug in November 2012, when it met approval to treat and reduce the occurrence of blood clots.
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Q: Has Xarelto been recalled?

A: While the FDA recalled several thousand bottles of Xarelto in 2014 due to contamination concerns, as of December 2016, the drug has not been recalled over claims that it caused uncontrolled bleeding. However, in August 2013, the FDA issued a black-box warning for Xarelto that cautioned patients against stopping the drug abruptly—an action associated with a higher risk of developing blood clots or deep vein thrombosis. Additionally, in January 2014, the FDA issued a warning/precaution for Xarelto and its generic version, rivaroxaban, indicating the organization is aware of the bleeding risks.
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Q: Why did the FDA issue a black-box warning for Xarelto?

A: In August 2013, the FDA issued a black-box warning for Xarelto that cautioned patients against stopping the drug abruptly. Discontinuing the drug cold turkey and without the guidance of a doctor prompted a higher risk of developing blood clots or deep vein thrombosis. Additionally, in January 2014, the FDA issued a warning/precaution for Xarelto, announcing the organization is aware of the bleeding risks.
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Q: What are the manufacturer warnings for Xarelto?

A: Xarelto is not for everyone. Manufacturer warnings from two companies, Bayer and Janssen Pharmaceuticals, state Xarelto should not be used by patients with:

  • Active pathological bleeding
  • A severe hypersensitivity to the drug's ingredients
  • Hemodynamically unstable patients with acute pulmonary embolism

The manufacturers also warn Xarelto:

  • Increases the risk of serious bleeding
  • Can cause epidural or spinal hematoma in patients who have had spinal/epidural anesthesia
  • Increases the risk of developing of blood clots or deep vein thrombosis if stopped prematurely

Additionally, patients with renal impairment should only use Xarelto under the close supervision of their doctor, and periodic blood tests and dosage adjustments may be required. Xarelto's safety and efficacy as not been studied in patients with prosthetic heart values, women who are pregnant or nursing, or children.
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Q: What are the most common adverse reactions and side effects associated with Xarelto?

A: Severe bleeding is the most common side effect associated with the use of Xarelto. The drug can also cause patients to bruise more easily. Additional side effects may include:

  • Muscle pain or spasms
  • Pain in the arms or legs
  • Numbness or tingling
  • Itching
  • Fainting
  • Loss of motor control
  • Back pain
  • Dizziness
  • Headache
  • Weakness in the extremities
  • Bladder or bowel dysfunction

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Q: What are the severe side effects of Xarelto?

A: Uncontrollable bleeding is the most well-known severe side effect associated with Xarelto. Among bleeding-related side effects, brain bleeds, intestinal or abdominal bleeds, and rectal hemorrhaging are the most common. Xarelto can also cause reduced platelet levels, abnormal liver function, and difficulty breathing or swallowing.
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Q: How does Xarelto cause uncontrolled bleeding?

A: As an anticoagulant, Xarelto is specifically designed to prevent blood from clotting by inhibiting the factor Xa protein that starts a chain reaction that allows clots to form. If a patient is injured—in a fall or from a bump to the head, for example—while taking Xarelto, the drug's intended function can have unintended consequences. Bleeding may be severe and refuse to stop, and in some cases may be fatal. Also, unlike other popular anticoagulants, there is no antidote to counteract Xarelto's effects on the blood.
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Q: What are the symptoms of Xarelto bleeding?

A: Knowing the symptoms of a severe Xarelto bleeding event may save your life. Call your doctor immediately if you experience:

  • Unexpected bleeding
  • Bleeding that lasts a long time or won't stop
  • Frequent nose bleeds
  • Unusual bleeding from the gums
  • Heavier than normal menstrual or vaginal bleeding
  • Bright red or black stools
  • Red, pink, or brown urine

Patients should also contact their doctor if they:

  • Cough up blood or blood clots
  • Vomit blood or a coffee grounds-like substance
  • Experience headaches or feelings of weakness
  • Have pain, swelling, or drainage at wound sites

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Q: Is there a Xarelto class action?

A: Currently, there are no class action cases for Xarelto bleeding lawsuits. Instead, the more than 4,500 Xarelto lawsuits are handled individually, with each patient's attorney negotiating the case and fielding settlement offers. However, although there isn't a Xarelto class action lawsuit, the cases have been consolidated into a multidistrict legislation in Louisiana, with Judge Eldon E. Fallon presiding. Due to the multidistrict legislation, Judge Fallon will handle all the Xarelto bleeding cases.
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Q: What should I do if I had a serious bleeding event while taking Xarelto?

A: First, talk to your doctor about changing your medication or adjusting your Xarelto dose; while Xarelto usually has a uniform dosage, some patients may need to have their dosage adjusted occasionally.

If you or someone you love experienced a serious bleeding event while taking Xarelto, you may be eligible to file a personal injury lawsuit against the manufacturers to seek compensation for damages. Contact a reputable and experienced personal injury attorney to discuss the details of your Xarelto bleeding case.
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Q: Have Xarelto lawsuits already been filed?

A: Yes. As of December 2016, more than 4,500 Xarelto bleeding lawsuits had been filed by patients all across the country. Because of the large number of cases, the U.S. Judicial Panel on Multidistrict Litigation consolidated the cases into multidistrict legislation that will be handled in Louisiana by Judge Eldon E. Fallon. Multidistrict legislation simplifies the courtroom process and provides consistency by assigning all of the related cases to the same judge, which will be handled in the same courtroom.
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Q: How long do I have to file a Xarelto bleeding injury lawsuit?

A: Waiting too long to file your personal injury lawsuit may harm your case. Statute of limitations laws determine how long a victim has to file a lawsuit. In personal injury claims, the statute of limitations is usually two years from the date the injury occurred, or from the date you discovered the injury. Lawsuits filed after the statute of limitations has expired are usually thrown out without being heard by the court. If you experienced uncontrollable bleeding while taking Xarelto, don't let the opportunity to pursue a legal remedy pass you by. Call McGartland Law today to schedule a free initial consultation to discuss your case.
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Q: How much does it cost to file a Xarelto lawsuit?

A: Most law firms that handle personal injury claims work on a contingency basis. This means the firm handles your case, but doesn't bill you it's resolved and you receive a settlement. In most cases,  plaintiffs shouldn't face upfront costs when filing a Xarelto lawsuit. Don't let concerns over whether you can afford an attorney stop you from pursuing compensation you need and deserve. Call McGartland Law today to schedule a free initial consultation to discuss the details of your Xarelto bleeding injury case.
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Q: How long will a Xarelto lawsuit take?

A: The length of a lawsuit varies widely by case, so it can be difficult to estimate just how long your case will take to litigate without talking to you first. Trials can last for days, weeks, months, or even longer, depending on the details of the case. However, in some situations, it's possible to obtain a settlement more quickly through negotiations. Call McGartland Law today for more information.
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Q: What damages can I recover in a Xarelto lawsuit?

A: Plaintiffs who file Xarelto bleeding lawsuits can seek many of the same damages as plaintiffs in other types of personal injury cases. Potential damages include compensation for past, current, and future medical bills related to the accident; lost wages if the bleeding caused you to miss work; loss of earning capacity if the bleeding will continue to prevent you from working; and pain and suffering. To learn more about the damages potentially recoverable in Xarelto bleeding lawsuits, call McGartland Law today.
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