Xarelto Dangers and Patient Recourse
The market is filled with products that promise to improve your daily living and medicines that can relieve a multitude of symptoms. While there are many out there who are able to live up to those promises, sadly there is just as many whose claims are false and can potentially harm you. Pharmaceutical companies have been known to cut corners where accuracy is shortened and end up creating drugs or devices that cause more harm than healing. Patients rely upon and trust these companies to provide them with products that are just as they are advertised but, instead, end up suffering detrimental side effects or with devices that cause them great pain. There are laws protecting you from drugs or devices that impair your health. If you or a loved one has suffered severe complications from using a medical device or adverse side effects from taking a drug, contact a personal injury attorney to find out what action is available to you. You can also check the Consumer Alert Now website to see if there is a mass tort open on the product. These are some common drugs and devices that are currently or have been investigated for false claims due to causing severe and dangerous side effects for consumers. Xarelto is one of them on the list.
What is Xarelto?
Xarelto (generic name: Rivaroxaban) is a prescription medication intended to lower your risk of a stroke or blood clots. Its label states it is designed for patients suffering from a condition known as atrial fibrillation that should not have been caused by a heart valve problem. This medicine is an anticoagulant and works by blocking specific clotting proteins in your blood. The label also says it is able to lower your risk of Afib-related strokes and prevent DVT and PE from occurring again. You are advised to take this medication after knee or hip replacement to reduce your risk of blood clots. Xarelto is a new form of blood thinner designed to replace older products such as Coumadin. Manufactured by Bayer, it is marketed by a division of the medical giant, Johnson & Johnson. The drug received its approval in 2011 as a blood clot formation medication to fight against clots forming in the deep vein thrombosis and pulmonary embolism. It was designed to prevent clots in patients with non-valve atrial fibrillation, hip replacements, knee replacements, and those with PE or DVT. Xarelto is prescribed by your physician and taken in pill form generally once a day after you’ve received a hip or knee replacement. You will typically have to take the medicine twice a day if you are being treated for an irregular heartbeat as a preventative measure against blood clots or a stroke. If you already have an existing blood clot, you would take Xarelto twice a day for three weeks and then lower the dosage to once a day. Most doctors will prescribe this medication be taken once a day as a preventive measure for blood clots reforming.
Some of the conditions which Xarelto is used as a treatment for include:
- Treatment for blood clots in the deep vein of your extremities
- Prevent blood clots from reoccurring in the lungs
- Prevent deep vein thrombosis from occurring after a knee replacement surgery
- Prevent blood clots in chronic atrial fibrillation
- Prevent lung embolism
- Prevent deep vein thrombosis from happening after hip replacement surgery
- Prevent a reoccurrence of a blood clot in your deep vein
- Prevent a reoccurrence of a blood clot in your deep vein
As with all prescription medicine, you should not take this drug unless specifically prescribed by your doctor. Your physician needs to be aware of your full physical health and have knowledge of any other medications you are currently taking before providing you with a prescription for Xarelto.
Side Effects of Xarelto
Xarelto has listed a number of side effects and possible drug interactions such as:
- Nausea or vomiting
- Low blood pressure
- Muscle pain
- Can react to; anti-infectives, antifungals, antivirals, or antibiotics
- Can react to anticonvulsants
- Can react to herbal medications
- Can react to anti-inflammatory medicines such as NSAIDs or aspirin
Severe bleeding episodes have occurred in patients taking Xarelto, and it does now warn about the risk of spinal bleeding after you've undergone spinal surgery. This drug causes symptoms that could result in permanent paralysis or trauma. It also warns there is an increased risk of cranial bleeding in elderly patients.
There are additional side effects from taking Xarelto listed by the Mayo Clinic. These include:
- Bleeding of the gums
- Back pain
- Weakness in the legs
- Stools that turn black or red
- Blood in the stools
- Coughing up blood
- Dysfunction of the bladder or bowels
- Urine that turns dark brown or red
One of the main reasons there are so many side effects resulting in lawsuits being filed is it was released without a reversal agent being available.
Your doctor must be aware of your full medical history including whether or not you’ve suffered liver or kidney disease and if you’ve had problems with bleeding such as in your brain, stomach, or intestinal area. It is also essential your doctor knows if you have been diagnosed with any disorders such as hemophilia, anemia or thrombocytopenia. Xarelto will not perform correctly if you have any of these conditions. The effects of the drug mixed with these disorders could have serious side effects that could be life-threatening. You must also advise your doctor if you frequently fall or have an eye condition such as retinopathy. There are also deficiencies that must be disclosed such as lactase deficiency, galactose intolerance or any other hereditary enzyme problems.
Is Xarelto Dangerous?
Xarelto is a blood thinner, and these type of medications have been used in the medical field for a long time. The problem or dangers of the newer thinners such as Xarelto, is they are causing uncontrolled bleeding in some patients. Many of the older medications had an antidote if this condition occurred; however, there was no antidote for uncontrolled bleeding caused by taking Xarelto when it was first introduced into the market. There have been thousands of patients who have suffered from severe and in some cases fatal uncontrolled bleeding for which they have filed lawsuits against the makers of Xarelto.
Thousands of patients have found themselves in emergency room care after taking Xarelto due to the drugs serious side effects. More than 20,000 lawsuits are currently being filed against Bayer and Johnson & Johnson from allegations of blood clots, severe bleeding, and death. If you or a loved one is suffering from symptoms after taking Xarelto, contact a personal injury attorney immediately.
Legal Problems Facing Xarelto
There are a number of warnings issued by the FDA concerning Xarelto, which is forcing them to change their labeling. One of the warnings involves the uncontrolled bleeding issue suffered by thousands of patients. Another warning, which is one of the most severe warnings to be issued by the FDA, concerns the risk of stroke if you stop taking the medication to soon. This warning also includes the increased risks of causing damage while using epidural anesthesia and swelling when taking Xarelto.
Johnson & Johnson, makers of Xarelto, have applied to expand approved usage of this medication to include it as a treatment for the acute coronary syndrome. The FDA has unanimously rejected the application for this expanded use; however, Johnson & Johnson will continue to apply as there is a high value for this type of medicine in the market. If they gain approval for Xarelto to be prescribed for ACS, it will increase their already billion dollars in sales per year. Along with their claim, Xarelto can help treat ACS, Johnson & Johnson also states, their medicine will work in the treatment of PAD (peripheral artery disease) as it can reduce the risk of blood clots and heart attacks.
Why the FDA Denies Approval
The clinical trials performed to gain approval for Xarelto to be labeled as stroke prevention is being investigated by the FDA. The trial is comparing Xarelto’s performance against that of an earlier drug used, Warfarin, but they found a device known as INRatio was used to test the Warfarin patients.
The device INRatio has received warning letters from the FDA concerning its inaccurate readings and was recalled. They feel the results coming from this device may not have been accurate and resulted in Xarelto appearing to be a better treatment than Warfarin.
How Xarelto Gained Initial Approval
It has been questioned how Xarelto was approved without it having an antidote. If this drug was known to cause uncontrolled bleeding and had no antidote to reverse its effects, then how did it gain approval in the beginning?
A blood thinner obviously has a concern of causing uncontrolled bleeding, so then how did Xarelto gain approval? It was approved because it has a short half-life. A half life means that since Xarelto only lasts in your blood from five to nine hours and then your blood returns to normal, it was considered acceptable for use under FDA guidelines.
The approval process became controversial as FDA reviewers at first thought it should be denied approval. The advisory committee which is an independent group voted it should be approved, and their recommendation won, granting Xaleto approval for marketing.
Why Do Doctors Prescribe Xarelto?
Xarelto does not require patients to receive a monthly blood check like the drug Warfarin. Warfarin also has diet restrictions, so Xarelto looks much more appealing and easier to manage. Most other drugs also require multiple daily doses, while Xarelto is generally taken only once a day.
Blood thinners increase the risks of intracranial hemorrhaging; however, Xarelto has proven to cause fewer hemorrhagic strokes and intracranial hemorrhages. These lowered risks make Xarelto an attractive option for doctors; you just need to discuss all options and risks before beginning a regime of Xarelto.
Makers of Xarelto, Johnson & Johnson Bayer are working on a couple of antidotes, and the FDA wants them to be cleared for approval quickly. Portola shows positive results in the B3 data as an antidote, and it is expected to receive FDA approval. This drug was considered to be on a fast track, and it was supposed to take only a year to gain approval.
Perosphere is another possible antidote on a fast track, and Pradaxa created the antidote, Praxbind with a different mechanism than Xarelto which is also being considered a good antidote.
Xarelto’s Legal Problems
There have been numerous patients who have suffered severe bleeding internally following the use of Xarelto, some of those have even been fatal. There are also a large number of patients or their families who have filed lawsuits against Johnson & Johnson and Bayer claiming the company is aware of the dangers Xarelto can pose and have hidden that information from doctors and patients.
During 2014 there were three separate lawsuits filed by patients who suffered adverse side effects after taking Xarelto.
- In July of 2014, a suit was filed in United States District Court under the request of the Vermont District Courts when a man died from uncontrolled bleeding of the brain. The family reported this man had only taken the drug for ten days when his death occurred.
- In June of 2014, a lawsuit was filed against Johnson & Johnson and Bayer when a man suffered from uncontrolled bleeding that resulted in his death. This suit was filed in the United States District Court under the request of Southern Florida District Court.
- In February of 2014, a patient filed a lawsuit in the Pennsylvania Court of Common Pleas due to uncontrolled bleeding in his subdural brain.
Bayer and Johnson & Johnson were charged with withholding information and warnings which consumers needed to know. Charges stated this information was withheld from both consumers and healthcare professionals who needed to know about dangerous side effects and how detrimental they could be too patient’s health and safety.
The United States Judicial Panel on Multidistrict Litigation consolidated the injury cases filed against Johnson & Johnson Bayer in December of 2014. The cases were consolidated in MDL (multidistrict litigation) in the Eastern District of Louisiana and are heard by District Judge Eldon Fallon. As a plaintiff, you retain your own attorney, but the same court handles all cases with an experienced judge presiding. There has been a mass tort filed in Philadelphia, Pennsylvania against Xarelto.
The judge decided the main focus in the MDL would be to coordinate discovery from Johnson & Johnson. Millions of documents were reviewed on how Xarelto was developed, researched, and marketed. Judge Eldon Fallon also created a small group of representative cases in the MDL which would be prepared for trial to determine how juries would react to the evidence presented to them. These early trials had been selected to begin in August of 2016. The courts were likely to suggest patients and families who suffered from Xarelto to settle out of court rather than going to trial.
Janssen Research & Development, a subsidiary of Johnson & Johnson recently faced a lawsuit in February 2018. The lawsuit states there were severe side effects inflicted after using Xarelto that were not listed as risks before the plaintiff, Kristina B took the drug.
Kristina lives in Florida and began a prescription of Xarelto on February 9th, 2018 and continued with it through February 26th, 2018. On about the 20th of February, Kristina began to experience vaginal bleeding. Her case was filed as part of the MDL which states patients suffer serious internal bleeding and other adverse side effects. Like Kristina, thousands have reported these same dangerous side effects.
Kristina’s lawsuit was filed on multiple counts. Her case is stating there were manufacturing defects, design defect, breach of express warranty, negligent misrepresentation, violation of consumer protection, fraud, and strict liability. She is refusing to settle out of court and is, instead, demanding a trial by jury.
How Would You Settle Rather Than Go to Trial?
Negotiations in a settlement look at what they think a jury would award for compensation in each individual case. They look at what would be the weakness and the strengths in each of these cases should they go to trial. They consider these factors:
- The medical expenses which incurred as a result of taking Xarelto
- How long and how severe the injuries are from taking Xarelto
- How much pain has occurred and will continue
- If there have been any mental or physical effects resulting from Xarelto’s use
- If there have been any lost wages or if your earning capacity has been affected
- Any loss suffered by family members as a result of the patient's injuries caused by Xarelto
The risk involved with taking Xarelto has become a dire reality for many people relying on how it should treat their symptoms. Most of the injuries suffered include pulmonary embolisms and deep vein thrombosis. There is also the increased risks of heart attacks and strokes along with severe hemorrhaging, gastrointestinal bleeding and other bleeding issues.
If you have suffered any of these conditions after taking Xarelto, contact a personal injury attorney to discuss your options in receiving compensation.
What is Involved with Filing a Xarelto Lawsuit?
There have been more than 20,000 lawsuits filed against the makers of Xarelto as of September 2018. They claim Johnson & Johnson and Bayer failed to provide doctors with necessary warning information regarding possible risks that would aid them in knowing which patients they could safely prescribe the medication to as a treatment.
Janssen Pharmaceutical is a subsidiary of Johnson & Johnson and is named responsible in many of the cases. Both of these companies are said to have marketed Xarelto as a ‘one pill fits all’ form of medication. This statement is not true as the drug does not fit all patient’s needs. There needs to be monitoring for coagulation of the prothrombin and international normalized ratio to watch for symptoms that severe bleeding may or is occurring. A personal injury attorney can file a lawsuit on your behalf if you, or a loved one, has suffered from Xarelto side effects. Some of the issues filed in the lawsuits on file to date include:
- The manufacturer, Janssen was negligent
- Bayer and Janssen did not properly complete the testing, and they have failed to issue the necessary warnings concerning the risks of uncontrolled bleeding
- Bayer and Janssen falsely promoted Xarelto as patients not requiring monitoring while using the drug to determine their suitability
- Xarelto is a dangerous and unreasonably defective treatment
- Evidence was concealed by Bayer and Janssen from the government, public, and healthcare professionals regarding the safety of the drug in its marketing material
One of the critical issues in all lawsuits is the fact that Xarelto does cause uncontrolled bleeding. Patients should have been tested before receiving this drug as a treatment to determine if it would be a good anti-coagulant for their needs. It is also stated in these lawsuits; patients should be required to obtain retesting on a regular basis to ensure Xarelto continues to be an effective treatment for individuals.
There have been thousands of personal injury cases filed against Johnson & Johnson and Bayer along with the subsidiary Janssen Pharmaceutical. Many of these cases have been placed into a class action case that will allow multiple plaintiffs to join under one claim against the manufacturer of Xarelto. There are specific requirements you must meet in order to have your case placed under this class action suit. If you feel you, or a loved one meets the eligibility for receiving compensation, contact your attorney for help in filing a claim. Plaintiffs are not required to be the patient who has taken the drug. Families are able to file a lawsuit if they have lost a loved one due to the serious side effects of Xarelto.
The class action lawsuit filed for the multiple cases replaces the individual personal injury lawsuits. The federal courts decide when enough individual claims are being brought against a manufacturer that all of them can be combined, so the ‘little guy’ is not faced with going up against a giant alone.
There is a statute of limitation in which you are allowed to file under the class action lawsuit. Don’t wait to contact your personal injury attorney if you have suffered, or a loved one has suffered from taking Xarelto.
Finding Help for a Dangerous Drug Xarelto Near Me
Receiving a prescription or medical recommendation for a drug or device does not always mean you are getting a safe product. Contact Consumer Alert Now at (800) 511-0747 if you have questions before beginning a medical treatment or if you are suffering side effects from medications or device usage you've already started. Check with them for any possible lawsuits that may have been filed indicating the drug or device is not safe.
You can check Consumer Alert Now website www.consumeralertnow.com for more information on current news regarding products and drugs that are causing adverse side effects from their usage.