The makers of the Xarelto drug have filed a lawsuit for patent infringement cases. Janssen Pharmaceuticals and Bayer A.G. have filed a lawsuit against the company Brecenridge Pharmaceutical, alleging that the company has tried to infringe on the Xarelto patent. Bayer is the maker of the anticoagulant in most countries; also Janssen makes it in the U.S.
Breckenridge has filed an Abbreviated New Drug Application with the FDA, which is for a generic version of the anticoagulant. Both Bayer and Janssen believe that as soon as the application is approved, Breckenridge will release their generic version of the drug. The existing patent for Xarelto, however, will not expire until the end of the year 2020.
The accusations of patent infringement cases were based on reasons, since Boehringer Ingelheim, the makers of Pradaxa, sued Brekenridge when they filed an ANDA for a generic version of Pradaxa two years ago. There are concerns that the company is too eager to enter into the anticoagulant market, and that it is throwing patent rights out of the window because of its enthusiasm.
Xarelto and Pradaxa are both big moneymakers, but there are a lot of problems with the drugs. There are lawsuits plaguing both of the medications, and concerns that Pradaxa could have some serious side-effects. Patients who experience uncontrolled bleeding, however, say that Boehringer Ingelheim did not give them sufficient warning of the risks. The company was ordered to pay out $650 million as settlements for lawsuits because of these side effects.
Xarelto is the subject of similar patent infringement cases, with Bayer and Janssen likely facing significant financial penalties because of the 6,000 lawsuits against it – which may be worse because there is no antidote, and the bleeding events can be life-threatening.
The generic version of the drug could escape some of the legal liabilities, since the makers of generics are not required to update their warnings when brand-name drugs change their warnings. They have the choice about whether or not they need to update their packaging to reflect changes.
The generic makers have limited liability because of the restrictions on them. For consumers, this means that they do not have so many rights to hold the generic makers responsible for their drugs. Janssen and Bayer, however, are not eager to hand over the rights to the drugs.
The FDA reports that there were more than 10,600 reports relating to adverse events after taking Xarelto in 2015, and that included 1,121 deaths and 4,508 injuries severe enough to require emergency treatment or hospitalisation. Xarelto is one of the poorest ranked drugs in terms of requiring hospitalization.
Xarelto is used in a lot of different scenarios, and the number of patent infringement cases is growing and growing. There will be a trial in March 2017, and it is expected that by then there could be more than 10,000 outstanding Xarelto lawsuits. Plaintiffs say that the makers misrepresented the drug. The initial approval was controversial. The manufacturers will, naturally, want to avoid a scenario of a third party getting approval for a less-risky generic version.
Xarelo is a new Novel Oral Anticoagulant category (NOAC) blood-thinner medication manufactured by Johnson & Johnson and Bayer AG. It is used for treating several different conditions, including deep vein thrombosis, pulmonary embolism and atrial fibrillation. However, Xarelto is considered to be a high-risk medication and ruled responsible for serious injuries like liver damage symptoms and the deaths of several patients. Hundreds of lawsuits have been filed against the manufacturers of the drug as a result of so many individuals suffering uncontrollable internal bleeding to the point that even after being hospitalized doctors still had no way of stopping it. Unlike other similar drugs like Warfarin, there is no known antidote for reversing the effects of Xarelto, so once life-threatening bleeding takes place; the patient is at risk of death or severe injuries.
However, there are also several other potentially very serious or fatal side effects for Xarelto that are still under post-marketing investigation currently since the drug was introduced in 2008 to the worldwide market. Risk of liver damage is one of the more alarming adverse reactions that is associated with the drug Xarelto. Liver damage symptoms caused by Xarelto have been investigated for being a potential risk for individuals taking Xarelto medication. There have also been several Xarelto-induced liver injury cases that have been reported. These include several cases of acute liver failure. The results from three big international pharmacovigilance databases were recently analyzed. The analysis revealed that Xarelto was suspected to be a cause in a large number of hepatic adverse cases.
In addition to gastrointestinal bleeding and internal hemorrhage, liver damage symptoms are the most reported Xarelto side effect. It can be discovered in blood tests by elevated enzymes AST and ALT. The 4 Record study results showed that of the 6,183 patients that were treated with rivaroxaban, 2.33% had increased liver enzyme (transaminase) levels that were over 3 times higher than ULN (upper limit of normal). There were two other cases where patient showed liver damage symptoms after being treated with Xarelto which were published recently in the Journal of American Medical Association, which further confirms this drug’s alarming potential hepatotoxicity.
Another thing that should be noted is that more than two-thirds of the drug, which is administered orally, is eliminated via urine or bile following hepatic metabolism. If liver function has been comprised, the blood levels of the drug may potentially increase due to the liver being unable to eliminate a sufficient quantity of Xarelto out of the body. However, this medication’s main selling points were the fact that blood monitoring was not required and its purported safety. These points were advertised widely over the internet and television.
Without any blood monitoring, it results in patient not being aware if the effects from the drug have increased to the level of growing potentially dangerous due to an increased risk for bleeding accidents. Therefore, this requires that an appropriate adjustment to the dosage be made.
Since being treated with Xarelto can potentially be associated with symptomatic and severe liver damage symptoms and consequently bleeding risk, the physician and patient both need to be fully informed about this potentially significant danger. The drug label should include a warning about the potential symptomatic liver damage; otherwise patients who suffer liver injury as a Xarelto side effect have the right to file a lawsuit in reference to misleading information being provided by the manufacturers.
Have you taken Xarelto and now you are wondering if you have suffered any side effects from it? Maybe you are wondering what the side effects of Xarelto are. If you are curious about the side effects of xarelto, then continue to read the rest of this article, as some of the side effects will be discussed below.
There are quite a few common side effects associated with Xarelto, and this includes pain in the back, bleeding gums, as well as blood in your stool. The pain in your back could vary in pain, and so can the amount of blood in your stool. Asides from those three side effects, other common ones include bowel or bladder dysfunction, as well as tingling feelings or the feeling of pins and needles. You might also experience some itching or burning.
Those who cough off blood or have a hard time breathing or swallowing may be doing so because of using Xarelto. The drug can also cause you to have a headache and you might feel dizzy, as this is another side effect associated with the drug. Another common side effect that some users may experience is weakness in one or both of their legs.
Nosebleeds, prolonged bleeding from cuts and numbness are other common side effects associated with Xarelto. Not only that, but other common ones include stools that are tarry and are red or black. If your urine is red or dark brown, then it may be because you are using Xarelto, and if you are a woman, then you may experience an increased menstrual flow.
There are even more common side effects that the drug has. One of the most serious and common ones is throwing up blood. Sometimes you might vomit material that resembles coffee grounds, and you might experience paralysis.
Xarelto can cause less common side effects, which includes fainting. Not everyone will experience this side effect, but some people may. Feeling pain in your arms or legs, as well as wound secretion are other less common side effects of xarelto.
Asides from the common and less common side effects, there are a few rare ones that some users may encounter. One of the most rarest ones is burning while urinating. As for how much it will burn, that depends, but generally speaking, a burning sensation may be felt by some users of Xarelto
Another rare one is having a very hard time urinating. You may feel like you have to urinate, but you may find it difficult to do. Asides from being difficult, you might even find it painful to urinate.
If you experience those side effects, and you are taking Xarelto, then you should contact your doctor. The side effects may be the result of using the drug. Even if they are not, it is still a good idea to have a doctor look at you.
There are some side effects of xarelto which are not really familiar, therefore it is not really proven that some unknown incidents are a result of using Xarelto. With that said, it is possible that some other side effects associated with Xarelto are pain in the stomach region, as well as swelling and your vision may become blurred or your skin could blister up or peel. Very dark urine is another potential side effect, but unproven one.
There are two more side effects that could potentially be linked to Xarelto and this includes blisters. If you take the drug and notice that blisters have appeared, then this may very well be because of Xarelto. Muscle spasms may also be experienced by Xarelto users, and if you do experience such symptoms, then you might want to consider getting medical attention because it may or may not be the results of using Xarelto.
As you can see, there are a lot of different side effects of Xarelto. If you suspect that you have suffered from any of the above side effects, then you should visit your doctor as soon as possible. They will be able to examine you, speak with you and determine whether or not Xarelto resulted in side effects.
Xarleto lawsuit is one of the latest class action cases that are likely to be filed against a pharmaceutical company. It looks like pharmaceutical companies are not anywhere close to carefully checking their products before they roll them over to you. Once again, there is a new class action lawsuit in town. The tendency for the pharmaceutical companies is to focus on profits alone while ignoring the welfare of the end user has come to the fore. You could be a victim so know the things beforehand about the join class action lawsuits of Xarelto.
Xarleto is a blood thinning agent and is commonly prescribed for patients with atrial fibrillation; also referred to, commonly, as irregular heart beat condition. The drug, technically referred to as an anti coagulant is also used to prevent Deep Vein Thrombosis often denoted as DVT. Knee and hip replacement surgeons also recommend the drug to manage blood clots associated with the operation.
Xarleto is manufactured by the giant German pharmaceutical company; Bayer. In the United States, the drug is marketed by Johnson and Johnson. According to the figures released by the manufacturer, about 7 million people have used xarleto. What the legal fraternity has a keen eye on is the process of the introduction of the drug in the United States and the subsequent fast approval for its use. The speed at which the procedure led to approval raises eyebrows as has happened in the past. It seems as if the need to make more money clouded the proponents of the drug, including the FDA, to avail the drug to the public before it was sufficiently tested and found safe for use by the innocent public. You must join class action lawsuits of xarelto lawyers with the good intent of stopping this heinous trend of pharmaceutical companies putting financial gain before safety. If we don’t act in solidarity, we shall remain victims.
The main concern here is that xarleto has been seen to work well, I mean rather too well. It is true that xarleto effectively succeeds in thinning blood and consequently prevents clotting. Tests show that xarleto exceeds the limit because in the end your blood is thinned beyond safety. So, you must be wondering what the hullaballoo is about! Well, xarleto solves one problem and creates another one. The concern is that the problem created by xarleto could be more dangerous that the problem it tries to solve. Since xarleto makes your blood too thin, it then means that you stand a chance of bleeding profusely. If you are not anywhere near a medical facility, it means your life is at potential risk; you could die of bleeding. Your blood has been deprived of its natural clotting mechanism and will ooze out like a jet in greater volume because it is thinner than normal; thanks to xarleto.
Although there has been a need to develop drugs to mitigate patient conditions, including a need for blood thinning drugs, it is important that enough research is invested in a drug before it is applied in treatment. There are similar drugs that are on the market but have not drawn this negative publicity. One such example is Warfarin. The drug has been around for decades. Although, like many other drugs, Warfarin has its side effects, there was enough research, actually 60 years research, on it before it was released to the public. Xarleto on the other hand has an extremely short history. It was literally rushed to the consumer market. Furthermore, apart from the risk it clearly poses to life, it does not have its antidote pair that can slow or stop bleeding.
The big question that begs is; would anyone willingly accept to use a drug that poses a risk of
• Heart failure?
• Bleeding to death?
• Organ failure?
• Pulmonary embolism?
• Brain haemorrhage?
• Gastro intestinal bleeding?
Furthermore, would you knowingly use xarleto if you were told it has no antidote to reverse profuse bleeding?
If you have taken xarleto, or anyone in your family, friends accomplices; basically, anyone you know, you need to call your lawyer or contact our attorney so that you can begin a journey to join class action lawsuits of xarelto demanding for justice. Did you know that despite the risk the drug poses, you spend $3000 every year as compared to only $300 that other blood thinners cost? You need to join the Xarleto lawsuit.
Numerous deaths are recently happening, which are connected with the xarelto bleeding connected to its side effects, a questionable anticoagulant launched in the year 2011.
Losing a family member could have a destructive effect on the remaining children, spouse, parents along with other family members and relatives. Consequently, it is because of the drug maker’s fault of not investigating the blood thinner properly or not warning necessarily concerning the xarelto bleeding risk. That is why financial settlement can be obtained by filling a Xarelto wrongful death lawsuit for people who died from:
Xarelto (rivaroxaban) was manufactured by Bayer Healthcare and Johnson & Johnson on November 2011, included a completely new form of bloods thinner to replace warfarin (Coumadin), that has been used for the protection against strokes among patients with atrial fibrillation and thrombus.
Among other competitive marketing through the drug makers, Xarelto continues to be broadly implemented through the medical community and it has rapidly reached to the runaway success level, with annual sales approaching $1 billion within 4 years after it hit the industry.
Soon after it had been launched, issues emerged about the chance of serious and irrepressible xarelto bleeding, that has led to numerous Xarelto deaths as reported across the country.
Based on a research through the Institute for Safe Medication Practices (ISMP), during the very first year Xarelto was available on the market, and at that time above 2,081 adverse event reviews were filled to the Food and drug administration, including a minimum number of 151 deaths on Xarelto issues.
Xarelto positioned 10th as one of the most regularly named suspicious drugs in reviews of problems posted towards the Food and drug administration throughout 2012, exceeding reviews of will Xarelto bleeding and deaths connected using the blood thinner named warfarin and Pradaxa, that is a similar anticoagulant which was launched several year before.
Right after losing a family member for Xarelto bleeding, wrongful dying settlement benefits might be readily available for the financial effects connected using the dying, as well as for the mental anguish, emotional discomfort and suffering, lack of companionship, comfort, protection, care, attention, advice, counsel, training, education or guidance and so on.
Although wrongful death related laws and regulations differ from the condition-to-condition, most laws allow primary receivers to create a claim for damages connected using the dying of the:
If someone died from Xarelto bleeding, and left no any close person like spouse, parent or child then, such wrongful death legal cases could be available for the secondary receivers who have been financially depending on that person.
It is true that no amount of money can compensate for losing a family member. However, if your Xarelto death lawsuit has been avoided, you can find certain legal rights for your family. You should then come forward with an experienced wrongful death lawyer to investigate any possible situation to make sure your rewards are secure.