After years of criticism and speculation by drug makers, lawyers and plaintiffs have banded together to initiate the first in a series of class action lawsuits against the manufacturers of Xarelto (Rivaroxaban). So far, many cases have been filed in Mississippi, Louisiana, and Texas. A class action lawsuit is an action where a small class of plaintiffs sue a defendant or a group of defendants on behalf of a larger group of plaintiffs.
Rosenfeld Injury Lawyers LLC represents victims who were injured after taking a defective drug and other types of professional negligence. Our law firm has successfully prosecuted cases for our clients whose injuries were caused by the negligent actions of others including pharmaceutical companies. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if a bad medication caused your severe injuries or the death of a loved one. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
How a Class Action Lawsuit Different Than an MDL Proceeding
A class action lawsuit is binding on the entire group of plaintiffs, not just the small group of named victims. Alternatively, an MDL proceeding does not decide the fate of the cases behind it. It merely determines issues of law and fact common to the whole group of cases as determined in pretrial hearings and the verdict handed down by juries in bellwether cases.
What are the Elements if A Class Action Lawsuit
Class action lawsuits have four elements that include:
- The number of cases must be so numerous that it is unreasonable and impracticable to hear the evidence of each lawsuit in a single case.
- This consolidation of cases must have common issues of law and fact.
- The named plaintiffs must have similar claims that the other plaintiffs in every other lawsuit would have made if they argued their case in court.
- The plaintiffs must represent the interests of the entire class.
If the plaintiffs can demonstrate these four elements, then the class is said to be certified, and the class action lawsuit goes forward.
Many Patients Were Injured
In 2011, the FDA (Food and Drug Administration) first approved Xarelto as the newest anticoagulant medication available on the medical marketplace. The properties of this unique blood thinner seemed highly effective at minimizing the potential of developing blood clots caused by atrial fibrillation (irregular heartbeat) or for patients who had just undergone knee or hip replacement surgery. Some doctors also prescribe the medication to treat blood clots associated with PE (pulmonary embolism) and DVT (deep vein thrombosis).
However, by 2013, the FDA began issuing safety communication warnings forcing Janssen Pharmaceuticals, the maker of Xarelto to include additional information in their Black box warning. The FDA stated that there was a specific risk to patients who continue to take Xarelto prematurely, and not on the advice of their doctor. The FDA says that these patients have a higher potential risk for developing blood clots, spinal or epidural hematoma, and deep vein thrombosis compared all others taking the anticoagulant drug. Still, the federal agency has yet to recall the product from the medical marketplace even though it is obviously defective.
While the drug is shown to be effective, it also has uncontrollable bleeding problems that have led to significant controversy and thousands of plaintiffs filing Xarelto lawsuits. Because of that, the FDA updated the drug's Black box warning and issued the strictest alerts to notify patients and doctors that taking the drug has potentially severe or life-threatening consequences. These warnings include:
- August 2013 – The FDA mandated the first Xarelto Black Box warning changes informing the public that those who discontinued Xarelto use against the advice of their doctor had a higher potential risk of developing deep vein thrombosis, blood clots, and hematoma.
- August 2014 – The federal agency demanded that Janssen Pharmaceuticals add new language to their precautions and warnings over certain concerns that included:
- Uncertainty concerning the best time to use Xarelto when taken in conjunction with regional anesthetic techniques (neuraxial procedures).
- The risk associated with using Xarelto in conjunction with the spinal puncture or epidural anesthesia.
- Research results that associate abnormal renal functionality and taking Xarelto (rivaroxaban).
- Caution when using the medication in combination with strong CYP3A4 inhibitors including ritonavir, ketoconazole, itraconazole, indinavir, conivaptan, or lopinavir.
- Incomplete information regarding Xarelto (rivaroxaban) side effects in individuals with artificial (prosthetic) heart valves.
- Thrombotic adverse reactions that can develop when the patient prematurely stops taking the medication.
- December 2014 – The FDA required Janssen Pharmaceuticals and the Bayer Corporation to add hepatitis and platelet deficiency (thrombocytopenia) to the already comprehensive list of adverse events associated with taking the drug. The FDA was to include hepatocellular injury, hepatitis, and cytolytic hepatitis (liver-associated cell destruction).
Severe Xarelto Side Effects
Many patients are unaware that they are suffering from the serious side effects associated with taking Xarelto until it is much too late. In other cases, the consequences involved in taking the anticoagulant medication are obvious. The most common severe Xarelto side effects include:
- Vomiting blood;
- Coughing up blood clots;
- Black tar-like or bright red stools;
- Spinal blood clot;
- Hemorrhaging (internal bleeding);
- Subdermal intracranial (brain) hemorrhaging;
- Heavy menstrual bleeding;
- Hemiparesis where one side of the body is paralyzed;
- Urinary tract infections (UTIs);
- Other abdominal pain;
- Rectal bleeding;
- Sinus irritation and congestion;
- Decreasing blood platelet cells;
- Blocked bile flow;
- Muscle spasms;
- Adverse allergic reaction;
- Skin blisters;
- Abnormal liver function;
- Stevens-Johnson Syndrome (SJS);
- Headaches, dizziness, fatigue, back pain, and numbness;
- Incontinence of the bowel or bladder;
- Wrongful death.
The FDA has updated their warning labels to notify consumers that abruptly stopping the drug or missing a dose could prove to be catastrophic. Also, the federal agency strongly recommends not double dozing the drug when missing a use or taking too much of the medication at once. In addition, expectant mothers, women hoping to become pregnant, and those breastfeeding should tell their doctor before being prescribed Xarelto (rivaroxaban).
Is There an Antidote for Xarelto?
Medical scientists and doctors are most concerned about the catastrophic side effects of taking Xarelto (rivaroxaban) that leads to uncontrollable bleeding. Their concerns are validated because competing anticoagulant medications, like warfarin, have long had an antidote should the patient begin bleeding out internally or externally.
When warfarin was first introduced into the medical marketplace in the 1950s, doctors knew that there was a potential risk of life-threatening bleeding that was caused with a regular dose or a warfarin overdose. Doctors could treat a bleeding patient with 10 mg of a supplemental K-1 vitamin administered through a slow intravenous (IV) infusion. This urgent reversal treatment is highly effective at managing acute major bleeding. However, there is no antidote to treat a bleed out in patients who are taking Xarelto (rivaroxaban) including a treatment involving supplemental K-1 vitamin IV drip.
Controversial Xarelto Clinical Trials
The FDA approved Xarelto because of the results of clinical trials that showed it was effective at preventing deep vein thrombosis and pulmonary embolism. This approval came about because of the Regulation of Coagulation Orthopedic Surgery to Prevent Deep Vein Thrombosis and Embolism (RECORD) studies that showed that the medication outperforms other anticoagulant medications including enoxaparin.
The studies revealed that Xarelto could prevent clot formation following knee or hip replacement surgeries. However, the studies also reveal that there was an increased potential risk of excessive, uncontrollable bleeding after taking Xarelto that might necessitate a blood transfusion due to decreasing hemoglobin levels.
An additional study aptly named Rivaroxaban Once Daily Direct Factor Xa Inhibition Compared with Vitamin K Antagonist for Prevention of Stroke and Embolism Trial – Atrial Fibrillation (ROCKET AF) revealed the drug could reduce the potential risk of embolism and stroke. The FDA approved the drug for this use in patients with non-valvular atrial fibrillation. Oddly, warfarin, the most popular anticoagulant drug used at the time, was thought to be equal to Xarelto even though the new drug had a greater frequency of G.I. (gastrointestinal) bleeding and caused a significant drop in the patient's hemoglobin levels.
Just before the FDA approved Xarelto, many research scientists opposed the federal agency in allowing the drug to be used in the medical marketplace. The scientists believe that there would be an increased risk of harm caused by excessive bleeding that could lead to a stroke which could be avoided if the patient was prescribed warfarin.
In February 2015, JAMA (the Journal of the American Medical Association) published a study questioning the legitimacy of the drug maker's clinical trials. However, 16 months later in October 2016, the FDA pushed back and reaffirmed that Xarelto was safe and effective claiming that the analysis of Xarelto clinical trials was not affected by methods and equipment used to validate the drug's safety.
Xarelto Multidistrict Litigation (MDL)
As of June 2018, more than 22,000 Xarelto lawsuits have been filed by plaintiffs in federal multidistrict litigation (MDL #2592) court in Louisiana. The federal judge overseeing ongoing pretrial proceedings has ordered bellwether trials to begin soon where the plaintiffs and the defendants in a few cases can test their legal arguments. The jury verdicts at the end of these trials will influence how all future federal cases will be heard in the remaining individual lawsuits that have yet to be resolved in multidistrict litigation court.
As of yet, there are no public settlements on the large-scale to resolve Xarelto lawsuits. However, attorneys working on behalf of their plaintiffs know that compensation offers will begin soon. The attorneys know that Boehringer Ingelheim, the maker of Pradaxa, another anticoagulant medication, has already settled more than 4000 lawsuits and paid out more than $650 million in compensation as of May 2014.
Many law firms know that the Pradaxa cases will serve as an effective model for defendants and plaintiffs involved in Xarelto litigation and will likely result in similar settlement resolution. Since the first settlement of Pradaxa lawsuits, the number of Xarelto (rivaroxaban) litigation cases have grown exponentially and will likely continue to grow in the years ahead. If you believe you have a case for compensation associated with your injuries after taking Xarelto (rivaroxaban), consider hiring an expert attorney who specializes in product liability and defective medication cases.
The Importance of Hiring an Attorney
The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that you are not responsible for the injuries you have endured. Our team knows that pharmaceutical companies are often more interested in generating profits than ensuring the safety of the consumer. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.
Our legal team encourages you to contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. We accept all personal injury cases, wrongful death lawsuits, and defective medication injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.
Our law firm gets results quickly because we understand you need money now. We probably offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.
For additional information see the following pages:
- What Is Xarelto and What Are Its Side Effects?
- Has The FDA Taken Any Action Against Xarelto?
- Has The FDA Made a Recall of Xarelto?
- Are There Any Class Action Lawsuits Involving Xarelto?
- What Claims Could Be In A Xarelto Lawsuit?
- What Kind of Damages Could I Get In A Xarelto Lawsuit?
- When Should I Bring My Xarelto Lawsuit?
- How Can Rosenfeld Injury Lawyers LLC Help Me?