Prescribed MedicationWhen we’re prescribed a medication by a doctor, there is an expectation that the medication will help address a health issue and improve your quality of life. Unfortunately, in far too many instances, prescription drugs are not helping people; they are hurting them. A prime example is Xarelto.

Xarelto is a blood thinning medication. It was approved by the United States Food and Drug Administration (FDA) to reduce the risk of blood clots developing in patients after they underwent surgery. For example, if you went in for a knee or hip replacement, there is a chance a doctor may have prescribed Xarelto.

Xarelto Approved through FDA “Fast Track” 501(k) Clearance

It often takes years for a medical device to receive FDA approval. This is necessary to ensure proper studies and testing have been conducted to ensure the device is safe for use by the general public. However, drug manufacturers have exploited a loophole in FDA’s approval process known as “501(k) clearance.” This 501(k) clearance is a fast-track approval process requiring minimal human testing. In some instances, no human testing has been conducted before a medication is approved to be sold to patients across the country.

Xarelto Side Effects

The side effects a patient can suffer from taking Xarelto are extensive and varied. Thousands of patients have suffered serious side effects, including:

  • Internal bleeding;
  • Numbness in your extremities;
  • Inability to move your feet or legs;
  • Bruising;
  • Headaches and migraines;
  • Bloody stool;
  • Coughing up blood;
  • Death due to a hemorrhage in your brain; and/or
  • Death due to uncontrollable bleeding in your organs.
Multiple “Black Box” Warnings about Xarelto Side Effects

The FDA has not recalled Xarelto, but this drug has been the subject of multiple safety warnings over the past few years, including two “black box warnings.” Black box warnings are considered to be the strictest warnings that can be issued by the FDA. These warnings often mean that it is reasonable to conclude there is a safety risk associated with taking the prescription drug.

The FDA announced its first black box warning for Xarelto in August 2013.  The black box warning stated that patients who prematurely discontinued Xarelto usage were at a higher risk of developing deep vein thrombosis, potentially life-threatening blood clots, or a spinal hematoma.

In January 2014, the FDA issued another warning, this time about the bleeding risk associated with Xarelto.  This warning was especially troubling because it declared that there is no antidote for Xarelto. This means that if you or a loved one take Xarelto and suffer life-threatening side effects, there is no proverbial counter-punch that can be utilized to fight the drug. This is in stark contrast to other blood thinners where a doctor is able administer Vitamin K or protamine sulfate to counteract the blood thinning properties of the drug. Neither Vitamin K or protamine sulfate have any effect on Xarelto.

In March 2014, the FDA issued a second black box warning about Xarelto concerning patients who were undergoing an epidural for a procedure. The black box warned that a patient needs to have Xarelto fully flushed from their system before undergoing an epidural. Failing to do so could cause serious side effects.

In December 2014, the FDA issued an “Adverse Reaction” report on Xarelto concerning a condition called thrombocytopenia which causes patients to suffer life-threatening internal bleeding. The FDA warned that Xarelto may be causing patients to develop thrombocytopenia.

Too Little, Too Late

Years after releasing the drug on the market, the makers of Xarelto have begun including a warning on the Xarelto box about the life-threatening side effects associated with blood clots and internal bleeding that may be caused by taking Xarelto.

Patients Across the Country are Filing Xarelto Lawsuits

Thousands of patients have taken action by hiring legal counsel and filing lawsuits against the manufacturers of this deadly blood thinner. The injured patients claim that Xarelto is a hazard carrying side effects that are unlike the side effects of traditional anticoagulants like warfarin or Coumadin. For traditional blood thinners, as mentioned, most adverse effects can be reversed by using vitamin K. With Xarelto, once problems arise, there is no antidote. For context, imagine if a fire started in your home and water had no effect on the flames. Once the fire starts, there’s no stopping it until your home is burned to the ground. That’s effectively what Xarelto can do to your body. This is why plaintiffs in Xarelto lawsuits allege serious injuries like cerebral hemorrhaging or deep vein thrombosis. Other patients died as a result of using Xarelto and their loved ones are fighting to get some semblance of justice.

The lawsuits also allege that Xarelto manufacturers like Johnson & Johnson failed to adequately warn patients and doctors of the serious side effects associated with taking Xarelto. Reports suggest that drug manufacturers were well aware of the side effects, yet did not nothing to properly warn the public. In fact, many doctors have publicly expressed concerns in media reports and in medical reviews about the lack of information regarding Xarelto and the risks associated with it use.

Xarelto lawsuits also allege:

  • Xarelto manufacturers marketed the blood thinner as superior in the field of anticoagulants despite multiple studies showing higher rates of gastrointestinal bleeding and transfusions in Xarelto users compared to patients prescribed other anticoagulants.
  • Xarelto manufacturers continue to market the drug as a safe anticoagulant.
  • Xarelto caused serious bleeding complications such as stomach bleeding, gastrointestinal bleeding, blood clots, wound infections, and hemorrhaging.
Multi-District Litigation Formed

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federally-filed Xarelto lawsuits into one court in the Eastern District of Louisiana. There are now more than 13,000 cases pending in this district court.

You may be asking yourself, “what the heck is multidistrict litigation? Is that a class action?” Multidistrict Litigation (MDL) is a tool available to courts to improve efficiency in the discovery process of large, complex lawsuits. In large MDLs, like the Xarelto MDL, it is quite possible that there will be millions of records sought and produced by the 13,000+ plaintiffs and the defense attorneys for the drug manufacturers. The MDL process streamlines discovery in one court with one judge overseeing the process. Once the parties complete discovery, the judge overseeing the Xarelto MDL will typically select a group of "bellwether cases" for trial. The outcome of these cases can often steer the direction of the larger MDL to either more litigation or to settlement.

Xarelto Manufacturers Breached Their Duty of Care

Pharmaceutical companies, including Xarelto manufacturers, owe a duty to patients to ensure the drugs they make and sell are reasonably safe for use. Failing to do so and putting a dangerous, defective drug on the open market may be grounds for a product liability lawsuit since this is a breach of the duty of care.

How Much Can I Recover from a Xarelto Lawsuit?

This is a great question. Unfortunately, the answer depends on a multitude of factors. Why? Because the amount of monetary damages that could be recovered on a lawsuit depends on the specific facts and circumstances of your case. As a general rule, larger harms and losses results in the potential for a larger financial recovery. For example, if you incurred $100,000 in medical expenses, lost wages, and other harms, you probably have a better chance of recovering a larger sum when compared to someone who incurred $25,000 in medical expenses and other damages. However, in other circumstances, the total number of economic damages is not the determining factor for a financial recovery.

For example, if you lose a loved one as a result of Xarelto, even if the medical bills are not astronomical, there is a chance of obtaining a large financial recovery. But keep in mind that wrongful death lawsuits can only be brought by certain beneficiaries of the decedent (e.g., a surviving spouse, child or parent).

In general, recoverable monetary damages through a personal injury lawsuit include medical bills, lost wages, and pain and suffering. If your medical expenses and other costs are likely to continue for the foreseeable future (or even the remainder of your life), you may be able to pursue financial damages for future medical care.

In some cases, you may also be able to pursue punitive damages. As its name suggests, punitive damages are intended to punish a wrongdoer for egregious conduct or behavior. Punitive damages might be awarded in a Xarelto case when a jury learns that Xarelto manufactures sold the medication to patients and doctors as being a superior blood thinner despite knowing that Xarelto posed a major risk of causing serious injury or death.

Another way to gauge the possible financial recovery that can be obtained from a lawsuit is looking at comparable lawsuits brought against drug manufacturers involving similar medications. Xarelto is a blood thinner drug. Pradaxa is also a blood thinner drug that is actually quite similar to Xarelto. Multiple lawsuits were filed against the manufacturer of Pradaxa a few years ago. Many Pradaxa lawsuits have been settled. Boehringer Ingelheim, the manufacturer of Pradaxa, has paid approximately $650 million dollars to settle roughly 4,000 personal injury and wrongful death claims. Does this mean victims of Xarelto are guaranteed to get a share of $650 million? No. In fact, no lawyer can guarantee the outcome of a case, especially complex product liability lawsuits like the ones filed against Xarelto manufacturers.

How Much Does It Cost to Hire a Xarelto Injury Lawyer?

Many people mistakenly believe that they need to shell out thousands of dollars just to sit down and have a conversation with a lawyer. Not so with me. I work on a contingency fee basis. This means you only pay me if I am able to achieve a favorable outcome in your injury or wrongful death case. A favorable outcome is often defined as a settlement or verdict in your favor.

The initial consultation is also free. This means we can sit down and talk about the facts of your particular situation and assess whether it makes sense to move forward with filing a claim. If it does not make sense to move forward, I will be forthright and tell you why. If it makes sense to move forward, I will offer my services as your legal advocate.

Clock is Ticking on Xarelto Statute of Limitations

If you or a loved one suffered serious bleeding problems while taking Xarelto, you need to take action sooner rather than later. Why? Because you do not get an infinite amount of time to take legal action against a drug company. All 50 states have a statute of limitations that will bar an untimely civil claim not filed within the application time period. In California, a lawsuit must be brought within two years from the date of you or your loved one’s injury. The statute of limitations varies from state to state, so the two-year limitations period in California does not apply to all cases in all states. Contact a lawyer to learn more about the applicable statute of limitations to your case.

Take Action Now

If you are experiencing serious complications or side effects from Xarelto, such as internal bleeding, or you have lost a family member who was taking the drug, speak to an experienced Xarelto lawyer right away. You should not go through this alone or try to take on a big pharmaceutical company on your own. These behemoth companies employ hundreds of skilled defense lawyers who work tirelessly to reduce or deny product liability claims. They frequently utilize tactics meant to slow down and delay the claims process in the hopes that some plaintiffs will simply give up hope and drop their lawsuits. Do not let this happen to you. Level the playing field by having an experienced attorney on your side.

Sacramento Xarelto Injury Lawyer Ready to Help You and Your Loved Ones

I’m Ed Smith, a Sacramento Products Liability Lawyer. If you or a loved one suffered complications from Xarelto, give me a call right away at 916.921.6400 for free, friendly advice.  I have over 35 years of experience in personal injury, product liability, and wrongful death lawsuits.

I belong to the California sector of the Million Dollar Forum. We are a group of advocates ranked top trial lawyers in the United States. Forum members have won million and multi-million case verdicts and settlements for our past clients.

Check out some of my Past Verdicts and Settlements.

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