xarelto logoThe Xarelto lawsuit represents one of the largest mass torts faced by Johnson & Johnson and Bayer Company. More than 18,000 lawsuits have been filed, alleging complaints ranging from uncontrolled bleeding and brain hemorrhage, to stroke and wound leakage complications. Plaintiffs contend they would have never taken the drug had they known of these potentially life-threatening side effects and the lack of antidote to reverse them.

The Showard Law Firm is a female-led legal team in Southern Arizona representing plaintiffs in Xarelto blood thinner lawsuits. Since 1990, we’ve taken on big and challenging litigation with the compassion and resources necessary to win. If you or a loved one has suffered adverse health complications you suspect may be linked to Xarelto use, call 866-307-2147 for a free case evaluation to start exploring your legal options.

Uncontrolled bleeding: primary Xarelto side effect

Uncontrolled bleeding is the primary allegation at the heart of this litigation. As an anticoagulant drug, Xarelto (rivaroxaban) works by inhibiting the body’s natural production of thrombin – a key component in blood clotting. Low levels of thrombin are good for people who are at high risk for developing blood clot and stroke. Without thrombin, internal injuries to organs, blood vessels, veins, or capillaries result in continuous bleeding, leading to serious side effects or death from blood loss.

Xarelto bleeding is particularly dangerous since patients do not make good candidates for surgery which causes additional bleeding. Until the FDA approved Andexxa in May 2018, there had been no known antidote to stop bleeding caused by Xarelto – unlike other anticoagulant drugs which could be counteracted with vitamin K or dialysis.

Sometimes the symptoms of internal hemorrhage are subtle and go unnoticed for months. Unlike other drugs in its class, Xarelto does not require patient blood monitoring, which could help detect internal problems before they escalate. Even if internal bleeding was discovered, health care providers have little guidance as to how to remedy the situation.

Symptoms of bleeding can manifest in many ways including:

  • Bruising easily
  • Bleeding gums
  • Heavy nosebleeds
  • Excessive menstrual bleeding
  • Coughing or vomiting up blood
  • Headaches, dizziness, or weakness
  • Red or black-colored urine or stool
  • Shortness of breath and low blood pressure
  • Wounds that do not stop bleeding with pressure
  • Cravings for ice, chalk, or clay due to iron deficiency

Other Xarelto side effects

Most commonly, patients experience minor Xarelto side effects like acute muscle and back pain, dizziness, leg weakness, and “pins and needles” sensations in the extremities.

Some lawsuits against Xarelto allege other serious and life-threatening side effects:

  • Abnormal liver function
  • Chronic Hepatitis
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Shortness of Breath
  • Spinal Epidural Hematoma
  • Stevens-Johnson Syndrome
  • Stroke
  • Thrombocytopenia
  • Vanishing Bile Duct Syndrome

FDA action regarding Xarelto’s warning label

Since 2013, the FDA has released several updates to Xarelto’s warning label:

  • August 2013: Added a Black Box warning (the most serious type) for spinal bleeding, blood clot, DVT risks.
  • January 2014: Warned about the lack of antidote and risks to patients with prosthetic heart valves.
  • March 2014: Provided healthcare providers with additional direction for limiting spinal bleeding.
  • December 2014: Included new adverse reactions like thrombocytopenia and Hepatitis.
  • May 2016: Update warnings of increased bleeding risk related to SSRI and SNRI antidepressant use.
  • October 2016: Gave healthcare providers updated precautions for preventing spinal bleeding.
  • March 2017: Added a Black Box warning of the increased bleeding risk with use of NSAIDs, Aspirin, and combined P-gp and strong CYP3A4 inhibitors like traconazole, ketoconazole, conivaptan, lopinavir, and indinavir.
  • February 2018: Included risks for pregnant or nursing women, advised patients to take medication with food, and added the results of the EINSTEIN CHOICE study advocating for lower doses with extended treatment of VTE.
  • June 2018: Shared information regarding the new reversal agent available to Xarelto users.

Despite the numerous safety label updates over the years, the FDA never taken the dramatic step of issuing any sort of Xarelto recall.

Xarelto Multidistrict Litigation (MDL 2592)

There is no Xarelto class action lawsuit—but, rather, individual lawsuits with their own lawyers organized into multidistrict litigation (MDL 2592) before the Honorable Eldon E. Fallon in New Orleans, Louisiana. MDL helps to streamline common issues of discovery in an effort to expedite case resolution.

Many of the Xarelto lawsuits filed against Bayer are being remanded back to federal district courts.  In February 2018, Judge Eldon Fallon ordered two separate waves of lawsuits, each comprised of 600 cases to be prepared for trial.  The first group was selected on April 30, 2018 and the second will be selected on August 30, 2018.  These cases will then go through case-specific discovery to be prepared for trial in their home court jurisdictions.

The Showard Law Firm currently represents two of these early trials locally in Tucson, AZ. We are actively fielding inquiries about the filing of additional lawsuits.

Xarelto lawsuit settlement amounts

There have been no Xarelto settlements to date. However, Xarelto attorneys are demanding:

  • Tangible economic losses (past, present, and future estimated medical expenses and wage losses)
  • Emotional pain & suffering (multiple surgeries, long periods of disability, loss of function, death, etc.)
  • Punitive measures (the proven liability and culpability of the defendant)

Eliquis

Eliquis (Apixaban) is a Factor Xa inhibitor, a newer class of anticoagulants that works by blocking a protein involved in blood clotting. The FDA approved Eliquis in 2012 to help reduce the risk of stroke and emobolism in patients diagnosed with non-valvular atrial fibrillation and to prevent deep vein thrombosis after knee or hip replacement surgery. The blood thinner, manufactured by Pfizer and Bristol-Myers Squibb, was promoted as a more convenient and effective drug than Warfarin (Coumadin) and quickly gained blockbuster status.

While Eliquis has minimal contraindications with foods or other prescription medications, the drug can cause uncontrolled bleeding, leading to potentially life-threatening complications. Just like Xarelto bleeding problems, this adverse side effect has generated significant concern in the medical community while spawning a wave of litigation.  Blood thinner lawsuits concerning Eliquis allege a number of grave injuries — some fatal — including:

  • Cerebral hemorrhages
  • Gastrointestinal bleeding
  • Uncontrolled internal hemorrhages
  • Hemorrhagic stroke
  • Cardiac bleeds
  • Rectal bleeding

Plaintiffs are suing Pfizer and Bristol-Myers Squibb after suffering uncontrollable bleeding events brought on by Eliquis that required hospitalization, costly medical treatments, and in some cases, blood transfusions.

Common allegations raised in Eliquis lawsuits mimic those leveled in Xarelto cases. Plaintiffs contend that Eliquis lacked adequate warnings about risk for internal bleeding. The lawsuits also argue that the defendants failed to identify an antidote to bleeding events before introducing the medication.

According to court documents, Pfizer and Bristol Meyers Squibb:

  • Negligently promoted Eliquis without thorough pre-market testing
  • Concealed dangerous side effects from the public
  • Failed to investigate reports of uncontrolled bleeding from Eliquis
  • Negligently failed to recommend routine blood monitoring while taking Eliquis

Litigation also contends that Eliquis drug manufacturers not only concealed information about bleeding risks but provided false information to the FDA about the safety of apixaban.

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Compensation available to plaintiffs

By filing a blood thinner lawsuit, plaintiffs may seek compensation for a variety of losses stemming from their Eliquis injuries, including:

  • Lost income
  • Medical expenses – past and future
  • Pain and suffering
  • Emotional distress
  • Burial and funeral expenses in cases of wrongful death

Contact a Blood Thinners lawyer

There are many personal injury lawyers to choose from, but it is always best to work with an experienced Xarelto lawyer who is familiar with the facts surrounding the case and who has the resources necessary to win. Showard Law Firm preparing several cases for trial.

Showard Law Firm is investigating claims involving Eliquis bleeding injuries and wrongful death. Pharmaceutical makers have a duty to ensure the products they manufacture and distribute are safe and effective for their intended purpose. If there are risks of adverse side effects with their medication, they are obligated to provide sufficient warning or face legal repercussions.

As your local law firm, we meet with every plaintiff, offering compassion and expertise. Call today to set up a free consultation with a member of our team.

Additional Xarelto lawsuit resources:

  1. JPML – Pending MDLs, http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-July-16-2018.pdf
  2. FDA – Xarelto Drug Safety Labeling Changes, https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=238
  3. Yahoo – Judge’s Order Sets 1,200 Xarelto Product Liability Lawsuits For Separate Jury Trials, https://finance.yahoo.com/news/judges-order-sets-1-200-213200683.html
  4. Reuters- Bayer & JJ Win Reversal of $28 Million Verdict in Xarelto Lawsuit, https://www.reuters.com/article/us-bayer-xarelto/bayer-jj-win-reversal-of-28-million-verdict-in-xarelto-lawsuit-idUSKBN1EZ08M
  5. Clot Connect – How Do I Know If I Am Bleeding From Blood Thinners? http://patientblog.clotconnect.org/2011/08/17/being-on-blood-thinners-how-do-i-know-i-am-bleeding/

Additional Eliquis Resources:

  1. Prescrire International, Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience https://www.ncbi.nlm.nih.gov/pubmed/23866358
  2. HealthDay, Anti-Clotting Drug May Cause Severe Bleeding With No Benefit https://consumer.healthday.com/cardiovascular-health-information-20/heart-stroke-related-stroke-353/anti-clotting-drug-may-cause-severe-bleeding-with-no-benefit-655145.html
  3. Bristol Meyers Squibb, Eliquis Package Insert https://packageinserts.bms.com/pi/pi_eliquis.pdf

 

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