Details Of The Xarelto Lawsuits, & How It Affects Its Users
Since being approved in 2011, the anticoagulant has been subject to much Litigation. Bayer, and Johnson & Johnson’s Janssen Pharmaceutical have a Xarelto lawsuit against the product, with claims that the drug is dangerous to human consumption.
There have been additional claims that the medication has too many side effects. Some of these side effects include, but are not limited to:
●Severe Internal Bleeding
Due to the lack of antidote available for Xarelto there is nothing readily available to quickly diminish these side effects, as there are for other anticoagulants. With approximately 2,000 current cases in the class action lawsuit, and more expected to be filed, there is no near end for the suits.
Xarelto Lawsuit Phone Number:
The Never Ending Cases of Pharmaceutical Lawsuits
Multiple lawsuits are filed for multiple drugs on the market. The main reason for these Xarelto cases relates to the adverse side effects of the medication. Other reasons to file a pharmaceutical lawsuit include:
●Falsifying clinical trial results in order to conceal side effects
●Refusing to inform the public about risks associated with the medication
●Misrepresenting the drug’s safety consumption in advertising
●Negligent design, research, manufacturing, and marketing of the products
●Reimbursement for pain, suffering, emotional distress, medical expenses, lost earnings, or other economic damages as a result of taking the drug
One of the more better-known examples is the Eliquis lawsuit, causing approval for the blood thinner to be delayed for nine months, pending opposing claims of safety and efficacy. Results from that investigation included:
●Inaccurate and missing data
●Incorrect dose, and medication is given to patients
●Adverse events, including death, remaining unreported
Those harmed by similar blood thinners, including Xarelto, have filed thousands of cases against the respective manufacturers for failing to warn about the drug’s risks. After the controversial approval of Eliquis, legal experts expected it to cause similar complications. With current lawsuits filed, it is clear that each Xarelto lawyer has a lot of work to do!
Pending Results Do Not Always Mean Bad Results
One thing that is universal about lawsuits is that they take a long time before a verdict is made. The Xarelto lawsuits haves been pending since approximately 2014, as new data is still being collected for people to file a Lawsuit. Though there are a lot of adverse effects associated with this drug, it has helped a lot of people.
Until the medication is removed from the market for being unsafe for consumption, there should be no reason to avoid taking the drug. Your medical professional will be able to provide ample advice and information of Xarelto and you will know if you can file a lawsuit. They have the knowledge of the side effects of the medication and can let you know if they recommend it be prescribed for your condition. If you want to know more about these lawsuits or want more information on this anticoagulant
Xarelto, Bayer AG and Janssen Pharmaceutical’s block-buster anticoagulant drug, has come under fire in several high-profile lawsuits. Xarelto was marketed as a safer alternative to warfarin, the benchmark anticoagulant, but it has been discovered that using Xarelto can lead to uncontrollable bleeding events. There is no approved antidote for Xarelto, which makes uncontrolled bleeding extremely dangerous and in some cases fatal. Plaintiffs argue that they were not given proper warning of the drug’s perilous side effects and that the drug never should have been brought to market.
Xarelto poses serious risks, including:
- Gastrointestinal bleeding
- Bleeding in the brain
- Complications arising from uncontrollable bleeding
- Bleeding events that can be fatal
What Is Xarelto and What Is It Used For?
Xarelto (the brand name for rivaroxaban) is an oral blood thinner/anticoagulant designed to prevent and to treat a condition called deep vein thrombosis (DVT). DVT is a condition in which a blood clot forms in the legs or pelvic area that blocks the passage of blood and leads to excessive pressure on the vein when blood collects behind the clot. That pressure can cause the clot or a portion of the clot to break free and travel through the veins to the lungs, causing a pulmonary embolism (PE), which can be a life-threatening event. There have been people this has gone horribly wrong for and they had to file a lawsuit. Xarelto was developed to reduce the risk of DVT and PE and to treat some cases of DVT after clots have developed. It is also sometimes used to prevent strokes in patients with atrial fibrillation, or irregular heartbeat, and is often prescribed to patients after a hip or knee replacement to reduce the likelihood of the formation of blood clots after surgery.
How Do Blood Clots Form
Blood clotting is the mechanism by which the body heals itself after an injury to body tissues. Plasma, the liquid component of blood, is made up of several proteins and enzymes which combine with a type of blood cells called platelets to form clots while the body heals itself. Injuries set the process in motion and result in a chain chemical reaction involving several factors that lead to the formation of thrombin, an enzyme responsible for the ultimate formation of blood clots. Thrombin causes a reaction that leads to the conversion of the protein fibrinogen to a different protein called fibrin. Fibrin allows platelets to bind to form a blood clot to stem the loss of blood in the event of an injury.
In some cases, however, this process goes awry and clots can form inside the blood vessels. This type of clot is known as a thrombus and can be very dangerous. Thrombus clots can dislodge and travel through the bloodstream to vital organs, where they can block the flow of blood those organs need to function properly, which is called a thromboembolism. This is especially dangerous when it involves the lungs, brain, or heart.
Who Is at Risk of Forming a Harmful Blood Clot?
There are several factors that can put someone at a greater risk for forming a thrombus that leads to thromboembolism. There are two types of blood vessels that can be affected by a clot. This problem could be a reason to file a lawsuit. When a clot forms in the veins, which carry blood from the organs back to the heart, it causes what is known as deep vein thrombosis (DVT), a very common condition that can cause severe pain and swelling when pressure builds up behind the blood clot. DVT poses a serious danger due to the possibility of the clot breaking free to travel to the heart and lungs, causing a pulmonary embolism (PE). Several factors can indicate an increased risk for developing DVT, including:
Reduced circulation due to restricted movement. This can often occur during long flights or bus rides in cramped seating.
Vein injury such as with a broken bone or surgery (such as hip or knee replacement)
A prior history of DVT
- Blood disorders that cause thickened blood
- Taking certain birth control pills
- Advanced age
Clots can also occur in the arteries that bring pressurized, oxygenated blood from the heart to the organs. Clots that develop in the arteries are more common in patients whose arteries have hardened due to a build-up of plaque along the walls of the artery, a condition known as atherosclerosis. This results in a build-up of blood pressure that can cause the plaque along the artery walls to burst, setting off a molecular reaction that can lead to the formation of a clot that can travel to the brain, causing a stroke, or to the heart, causing a heart attack.
The History of Coumadin (Warfarin) and NOAC Drugs Including Xarelto
Prior to FDA approval of Xarelto, the only FDA-approved blood thinner/anticoagulant available was Coumadin (warfarin), made by Endo Laboratories, which was approved for use in 1954. The two drugs are not usually interchangeable and work in very different ways. Warfarin works by preventing the body from recycling the vitamin K present in the blood stream, which is a key factor in the formation of blood clots. With less available vitamin K, the blood takes longer to clot. Patients who use warfarin must have frequent blood tests to ensure that their dosage is correct and must watch their diets for foods heavy in vitamin K. Regular blood tests are required to determine how long it takes a patient’s blood to clot. This is measured on the International Normalized Ratio (INR) scale. A high INR indicates an increased risk for an uncontrollable bleeding event, whereas a low INR indicates an increased risk for abnormal blood clotting.
When the FDA approved the sale of generic versions of warfarin in the 1990s, the price of the drug dropped dramatically, which led pharmaceutical firms to seek out new anticoagulants that would increase their profit potential. They sought to address two of the chief problems with warfarin: the high risk of potentially fatal uncontrolled bleeding events, and the requirement for frequent blood testing that made using the drug inconvenient for the patient. Xarelto was one of the drugs that resulted from this effort.
Xarelto was approved by the FDA for use as an anticoagulant in 2011 and is one of a group of drugs known collectively as new oral anticoagulants (NOACs). These drugs were the first anticoagulants released since the approval of warfarin in the 1950s. The chief benefit manufacturers Janssen Pharmeceuticals (a subsidary of Johnson & Johnson) and Bayer AG touted at the time was that Xarelto doesn’t require frequent blood testing or dietary restrictions because Xarelto doesn’t affect the levels of vitamin K in the blood. The active ingredient in Xarelto, rivaroxaban, works by binding to factor Xa, a substance that prevents the emzyme thrombin from forming. Without thrombin, the protein fibrinogen cannot be converted to fibrin, without which a blood clot cannot form.
Possible Drug Interactions of Xarelto
Xarelto can also affect the way certain drugs function, while other drugs can impact the way that Xarelto functions, including:
- Other anticoagulant drugs such as warfarin, Pradaxa, Eliquis, etc.
- Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, ibuprofen, and naproxen
- Antibiotics and antifungal drugs such as erythromycin and fluconazole
- Some heart medications
- Some medications used to treat circulation or blood disordersJohnson and Johnson failed to mention many of these and this action has cause individuals to file a lawsuit
Possible Side Effects of Xarelto
Xarelto can cause several side effects that range from irritating to deadly. The most common among these side effects are:
- Coughing up blood
- Bleeding gums
- Bloody stool
- Back pain
- Vomiting blood
- Difficulty swallowing
- Difficulty breathing
- Bladder dysfunction
- All anticoagulant drugs, including Xarelto, pose the risk of serious side effects, including:
- Uncontrollable or irreversible bleeding
- An increased risk of stroke after discontinuing use
- Internal hemorrhaging
Who Should Not Take Xarelto?
Patients who are allergic to rivaroxaban should avoid Xarelto. Xarelto should also not be taken by patients with an artificial heart valve or active or uncontrolled bleeding. Xarelto poses serious risks to patients who undergo spinal tap or epidural procedures because it can cause blood clots along the spinal cord that can lead to paralysis, especially in patients who have a genetic spinal defect, patients with a spinal catheter, and patients who are taking NSAIDs or other anticoagulants. If you were not aware of this, contact us immediately to file a lawsuit.
Xarelto can also cause bleeding events in patients who have genetic or disease-related bleeding disorders, high blood pressure, intestinal bleeding or ulcers, or hemorrhagic stroke.
Safety Concerns Over Xarelto and other NOACs
While Xarelto and other NOACs did help address the obstacle of frequent blood testing posed by warfarin, they posed significant health risks, thus failing to address the chief concern warfarin raised. Pradaxa, the first of the NOAC to reach the market in 2010, resulted in such a high rate of severe side effects that physicians began to move away from NOACs and back to warfarin by 2014.
One of the chief risks posed by all anticoagulant drugs is that of an uncontrolled bleeding episode. When this occurs, the key point of comparison for anticoagulants is the remedies available to halt bleeding. Antidotes are the first line of defense against a deadly episode of uncontrolled bleeding, and Xarelto does not have an antidote. Without a reliable antidote, bleeding events in Xarelto patients can become life-threatening relatively quickly. Warfarin has several antidotes, which can reverse the anticoagulant effects of the drug within 15 minutes to 24 hours. Without treatment, the effects of the drug will wear off on their own within 3 to 5 days. Xarelto does wear off more quickly than warfarin, but in cases in which a rapid reversal of effects is required, such as a serious injury with excessive bleeding, Xarelto can pose a far greater risk than warfarin.
In 2014, a review of cases of serious injury and death reported to the FDA showed that Xarelto patients had the highest rates of severe side effects, with as many as 525 cases reported, a far greater number than warfarin. It also failed to adequately treat blood clotting disorders more often than warfarin.
Xarelto is a profitable drug, bringing Johnson & Johnson and Bayer AG over $1 billion in 2014 and over $2 billion per year in 2015 and 2016. Sales for the drug are expected to approach $4 billion in 2018. Several major lawsuits brought by patients against the drug’s manufacturers argue that the company prioritized Xarelto’s profit potential over safety, putting patients at risk. Plaintiffs have filed a lawsuit against Bayer AG and Johnson & Johnson’s subsidiary Janssen Pharmaceutical, demanding that the manufacturers compensate them for their medical costs, pain and suffering, and funeral costs for patients who have suffered fatal side effects.
The most common complaint brought against Johnson & Johnson and Bayer AG is that the drug caused uncontrollable bleeding events and that patients were not properly warned of the risk of such events. Because there is no antidote for Xarelto, episodes of uncontrolled bleeding can be extremely dangerous and even fatal. Attorneys have argued that Bayer AG and Janssen Pharmaceutical knew of the risks of uncontrollable bleeding and of the lack of an antidote but rushed the drug through clinical trials in order to get it to market anyway and did not adequately inform consumers of the risks the drug poses.
Were patients made aware of the risk of uncontrollable bleeding events and that there is no antidote for Xarelto, attorneys say, they would not have chosen to take Xarelto and would have opted to use warfarin, which has several approved antidotes. They also argue that the claim that Xarelto requires less monitoring than warfarin amounts to negligence on the part of Bayer AG and Janssen Pharmaceutical because additional monitoring might have helped to prevent some of the internal bleeding events patients have suffered while taking Xarelto.
The first lawsuit after Xarelto’s 2011 release came in 2014 in Pennsylvania, when Virginia Stunteneck filed the lawsuit Bayer AG, claiming that the drug caused gastrointestinal bleeding that required emergency treatment and hospitalization. Her attorneys argued that Bayer AG knew of the risk of uncontrollable bleeding and the fact that the drug has no antidote and that they intentionally misled the public in order to increase sales.
Subsequently, a medical device that was used during the ROCKET-AF clinical trial for Xarelto, the INRatio, was recalled by its manufacturer, Alere Inc. Plaintiffs in several Xarelto suits argue that the device did not function properly and provided readings that made Xarelto appear more effective than warfarin. this was more than enough evidence to file a lawsuit. Their attorneys say that this is further proof that Bayer AG and Janssen Pharmaceutical were reckless and negligent in their rush to bring the high-profit anticoagulant to market. Bayer AG and Janssen Pharmaceutical currently face over 4500 cases that have been consolidated into a class action suit in Louisiana, as well as suits in several other states. There are at least 7200 such suits in progress, with the first round expected to go to trial in early 2017.
If you or someone you care about has suffered injury after taking Xarelto, contact us to learn if you have a Lawsuit.
Our experienced partner attorneys can help determine if you are entitled to compensation.