Xarelto Lawsuit Update

Many individuals who have alleged suffered serious adverse effects after taking Xarelto are filing lawsuits against the manufacturer, Bayer, and the marketer in the U.S., Janssen Pharmaceuticals. These plaintiffs allege that the company did not warn the public about the effects or the inability to stop the bleeding and that the companies failed to warn patients and physicians of the increased risks of fatal internal bleeding.

Lawsuits Update

As of August 2016, over 5,200 claims have been filed in federal court, alleging serious side effects include strokes, blood clots, and hemorrhages. These cases are in the MDL (what is an MDL?) and are currently in the discovery stages. The judge has set four bellwether cases to be tried in consecutive months starting in February 2017. The outcome of these cases is likely going to guide settlement negotiations and trials in the remaining 5,200 claims that are filed and set the guidelines for new claims to be filed.

No settlements have been reached yet. Settlement discussions are likely to begin after the first bellwether trials go forward, and attorneys and experts have an idea of what to expect.

Settlement Value of Xarelto Lawsuits

When these settlement discussions to settle the Xarelto lawsuits begin, how much money will the plaintiffs' lawyers ask for and what can we expect for an average settlement value?

Let's start off by stating the obvious. No one knows the settlement value of these case or even if they will settle. Also, because the scope of the injuries varies wildly by plaintiff from minor injury to death and disability, the settlements will vary. Most likely, there will be several tiers of settlements with different amounts depending on the severity of the injury.

The trial value for many on these Xarelto lawsuits is in the millions and will be capped only by state law that puts a limit on damages. Many of these cases involve fatal and life changing injuries, and juries do not shy away from giving large damage awards if they believe the pharmaceutical company made a mistake.

But if history is a guide, most class action type mass torts cases like the Xarelto litigation reach a nearly global settlement. Most plaintiffs do very little other than fill out a fact sheet that sets out the basics of their claim

This settlement often occurs after a few trials give the parties a better gauge of what the true settlement value of the cases might be. In other cases, the drug company does not want to take a risk and works to reach a global resolution to the cases before letting the case go to trial.

The range of settlement value for the average Xarelto case is probably between $75,000 and $300,000 depending on how well these cases go from here. This range is based on what similar injuries have settled for in the past in the mass tort context. It also takes into consideration what Bayer, Johnson & Johnson, and Janssen have paid in similar recent litigation, most notably the Yaz cases where the average settlement was just north of $200,000. The question now -- that a few trials might help answer -- is just how good the liability case is against Bayer and how willing Bayer is to roll the dice and let these cases go to court.

Again, this is rampant speculation, and the settlement numbers could be much higher or much lower. We go down this guessing path because there are a lot of people out there considering filing suit and what to have some idea of what the monetary value of these cases might be.

Xarelto Side Effects

Xarelto is one of the newest blood thinners (anticoagulants) on the market, FDA approved in 2011. Blood thinners are used to prevent blood clots from forming due to irregular heartbeats or after hip/knee replacement surgeries. Unlike older anticoagulants which require doctors to prescribe specific doses for each, Xarelto is prescribed in one uniform dose.

Xarelto was approved by the FDA for reducing blood clots, DVT, and PE following hip or knee surgery on July 1, 2011. Xarelto was later approved to prevent the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation just a few month later. The following year, Xarelto was approved for the long-term treatment of DVT and PE on November 2, 2012.

Xarelto is an anticoagulant that targets a particular clotting factor in the blood. It is prescribed by physicians in dosages of 10mg, 15mg, and 20mg oral tablets.

There are many side effects associated with taking a blood thinner. The side effects commonly associated with Xarelto include:

  • Numb or tingling muscles
  • Loss of ability to control movement
  • Abnormal liver function
  • Reduced platelet levels
  • Hemorrhaging
  • Bleeding from the rectum
  • Difficulty breathing or swallowing
  • Back pain
  • Headache
  • Leg weakness
  • Bowel/bladder dysfunction

Patient talking with DoctorThe side effects listed above are not cause for serious concern when taking Xarelto. However, the drug has recently been linked to serious bleeding and complications with wound infections and leakage. It is important to recognize the symptoms of serious bleeding that may occur with taking Xarelto, as this requires immediate hospital attention. These symptoms include:

  • Frequent nose bleeds
  • Unusual bleeding in the gums
  • Red, pink, or brown urine
  • Severe uncontrolled bleeding
  • Bright red or black stool
  • Vaginal bleeding or menstrual bleeding that is heavier than normal
  • Wounds with pain, swelling, or new drainage at the site
  • Coughing up blood or blood clots
  • Headaches, feeling weak or dizzy
  • Blood in vomit or vomit that resembles coffee grounds

Bleeding as a result of taking Xarelto can be irreversible, and can lead to hospitalizations and death. Other blood thinners on the market, such as Warfarin, have methods of reversing a brain bleed that is a result of the drug, such as treatment with Vitamin K.

Other complications that can arise from Xarelto are serious wound infections and leakage after hip or knee replacements. This can result in the patient returning to surgery or intense antibiotic therapy for up to months.

Even the most ardent of Xarelto detractors are not pushing for a recall of the product. Instead, lawsuits involving this drug are alleging that a warning of these risk should have been on - or have been more prominetly placed in some cases - the package insert so doctors and patients can make an informed choice.

Xarelto Research

The FDA approved Xarelto for patients recovering from hip or knee replacements to reduce the risk of blood clots, and to reduce the risk of stroke in people with atrial fibrillation. After a fast-track regulatory review, the FDA also approved it for the treatment of patients with deep vein thrombosis or pulmonary embolisms.

In 2012, the Journal of Bone and Joint Surgery published a study in which they studied 13,000 patients who were taking either Xarelto or Heparin after a hip or knee surgery. They found that those who were taking Xarelto had almost four times the risk of wound complications. Another study by the American Academy of Orthopedic Surgeons found that people who took Xarelto had significant rates of having to return to surgery within thirty days.

The FDA put Black Box Warnings (the highest kind) on Xarelto for serious complications associated with the drug. They noted that if you were on Xarelto and had spinal injections, epidurals, or surgery, you were at an increased risk of forming a blood clot in the spine that could cause paralysis. Further, the FDA noted that spinal clotting had increased for people on NSAIDs or patients with a history of spinal problems or surgery.

Phase III clinical studies were done to examine the safety of Xarelto. 73% of the 16,041 participants in the study who took at least one dose of the drug experienced side effects, with the most prominent serious side effects being anemia and bleeding. The FDA then released a warning that patients who suddenly stop taking the medication can be at an increased risk of developing clots.

Getting a Lawyer to Help You

If you or a loved one has suffered serious side effects these pesticides, call us today at 800-553-8082 or get a free, no obligation online case review.

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