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Lawsuit Loans 101: Pre Settlement Funding Can Help
Manufactured and marketed by Bayer and Janssen Pharmaceuticals, – a Johnson & Johnson subsidiary – Xarelto is one of the newest oral medications within a new anticoagulant category, which is more commonly known as a blood thinner.
Xarelto – generic name Rivaroxaban — works by blocking certain proteins found in the blood to avoid blood clots from forming. Approved by the FDA in July 2011, the drug is intended to:
Reduce the risk of stroke and systemic embolism in patients suffering from atrial fibrillation
Treat Deep Vein Thrombosis
Treat Pulmonary Embolism
Reduce the risk of relapse of Deep Vein Thrombosis and of Pulmonary Embolism
Prophylaxis of Deep Vein Thrombosis after hip or knee replacement surgery
Several various side effects and symptoms may be experienced by users of Xarelto. However, its most alarming side effect is bleeding. Because the drug is intended to stop blood clot formation, continuous bleeding may occur even in the smallest cuts, which could ultimately be fatal.
Marketed as a safe anticoagulant, rivaroxaban has been facing several lawsuits since June 2014 from the drug’s users, in addition to family members who have filed lawsuits in behalf of loved ones who died from the side effects of the drug.
Plaintiffs have often claimed that both Bayer and Janssen Pharmaceuticals failed to warn the public about the drug’s side effects and health risks, in addition to multiple counts of negligence.
Another problematic matter about Xarelto is the inexistence of an antidote. Unlike older anticoagulants, vitamin K cannot serve as a solution to the adverse effects of rivaroxaban.
In addition, the United States Food and Drug Administration has yet to recall Xarelto. However, the institution has released warnings, including the requirement of a black box label for the drug.
One warning stipulated that users of the drug who abruptly stop taking the medication have an increased risk of obtaining blood clots.
What is Xarelto?
Bayer is the manufacturer Xarelto, although it was marketed in the United States by the Johnson & Johnson subsidiary, Janssen Pharmaceuticals.
The oral medication, with generic name rivaroxaban, is an anticoagulant, more commonly known as a blood thinner that helps in the prevention of blood clot formation by blocking particular proteins found in the blood.
Xarelto was approved by the United States Food and Drug Administration (FDA) for patients who have undergone knee or hip replacement surgery, in order to lower the risk of blood clots, and to reduce the risk of stroke in patients with atrial fibrillation, a heart rhythm disorder.
After an expedited regulatory review, the FDA approved the drug in July 2011 for general use to treat pulmonary embolism (PE), prevent or treat deep vein thrombosis (DVT), which is a certain type of blood clot.
DVTs can potentially result in blood clots within the lungs, also known as a pulmonary embolism. A DVT can also occur after certain kinds of surgery.
This drug is one of the newest anticoagulants in the market, and is even classified under a new type of oral anticoagulant, which is prescribed in a uniformed dosage.
Regardless of numerous lawsuits and reports, Bayer and Johnson & Johnson still advertise the drug as safe and a better, more convenient alternative to warfarin.
Symptoms and Side Effects
Common side effects from taking rivaroxaban include: back pains, bleeding gums, bloody stools, bowel or bladder dysfunction, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, leg weakness, nose bleeding, numbness, paralysis, lengthy bleeding from cuts, red or black tarry stools, red or dark brown urine, vomiting of blood or substances that look like coffee grounds, and burning, crawling, itching, numbness, prickling, “pins and needles,” or tingling feelings.
On the other hand, less common side effects include fainting, pain in the arms or legs, and wound secretion. Rare side effects such as burning while urinating and difficult or painful urination may also occur.
However, the most serious side effects from the drug is uncontrolled bleeding including abdominal bleeding, brain hemorrhage, abnormal liver function, and reduced platelet levels. What’s very alarming about this side effect is the ability to lose functionality from organs that are near the bleeding area due to interrupted blood flow.
Not only that, but pools of blood may also develop in the body, which can cause other severe risks to one’s health. Because of the drug’s nature to prevent blood clots, bleeding will continue until the drug is fully eradicated from the body.
There are also some other drugs that may react negatively with rivoroxaban. These include:
- Crabamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
- Indinavir (Crixivan)
- Itraconazole (Onmel, Sporanox)
- Ketoconazole (Nizoral)
- Lopinavir/ritonavir (Kaletra)
- Phenobarbital (Solfoton)
- Phenytoin (Dilantin-125, Dilantin)
- Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
- Ritonavir (Norvir)
- John’s wort (Hypericum perforatum)
Lawsuits and Litigation
Many lawsuits filed against Bayer for the use of Xarelto are often because of irrevocable bleeding, which are potentially fatal. Not only that, but hospitalization could run pricey, and could eventually lead to emotional trauma for the patient and family members. The first lawsuits filed in the United States with regard to the drug were in June 2014.
Bayer and Johnson & Johnson are currently facing over 400 federal cases, which were all consolidated in New Orleans, overseen by Judge Eldon E. Fallon, in addition to a group of cases in Philadelphia mass tort court.
Virgina Stuntebeck is one of the victims who filed a lawsuit in Philadelphia Courts against Bayer for the drug. Stuntebeck suffered from serious internal bleeding, which was caused by the manufacturer’s anticoagulant.
It was in February 2013 when Stuntebeck had to be brought to the hospital for grave gastrointestinal bleeding. Similar to many other patients who filed lawsuits, Stuntebeck claims that both Bayer and Johnson & Johnson failed to warn the public about the risks of the drug.
In 2014, a woman named Ruth McGowan filed a lawsuit against Bayer. According to the lawsuit, McGowan’s deceased father, Thomas Dunkley, took the drug to lower the risk of getting a stroke. Approximately a month after beginning to take the drug, Dunkley suffered from severe bleeding in the brain. McGowan claims that Janssen and Bayer have kept the safety risks from the public, and improper testing for the anticoagulant.
In another case, Nancy Packard also sued both companies in defense of her deceased husband, William. Packard took the drug for six months due to atrial fibrillation, and suffered bleeding in the brain quickly after doing so. Doctors were unable to stop the bleeding, which ultimately led to his death. Nancy Packard alleges the drug makers of failing to warn about the inexistence of an antidote.
Several plaintiffs have accused the drug’s makers of multiple counts of negligence and failure to warn about health risks. Other claims for this specific lawsuit include: financial hardship caused by emergency visits, ongoing care, and lost wages; emotional distress from caring for loved ones suffering medical problems from the use of the drug; the load of funeral expenses due to uncontrolled bleeding caused by the drug; and holding both Bayer and Janssen Pharmaceuticals responsible for releasing a dangerous drug to the public.
In spite of the many possible side effects from the use of the drug, the most dangerous one is internal bleeding, which could ultimately be fatal.
Risk of bleeding is natural with blood thinners, Xarelto is the most dangerous one simply because it does not have an antidote; unlike warfarin which can be remedied with the use of a vitamin K antidote.
Even minor injuries could be dangerous to users of this drug because of its ability to prevent blood clots. The only way to stop the bleeding would be to flush out the drug from one’s system, which could take up to 24 hours. Even then, the effects of the drug last even longer within the body, especially in older adults.
Different types of bleeding may be caused by the drug, including bleeding from the rectum, intestinal or abdominal bleeding, hemorrhaging, and brain hemorrhages. Xeralto can cause more abdominal bleeding as compared to its rival, warfarin.
Patients who are about to go into surgery are also advised to stop taking the drug at least 24 hours before their upcoming procedure to avoid various complications. Additionally, pregnant women can also suffer from bleeding while taking the medication.
Patients using the drug are at greater risk for spinal bleeding when they use epidural catheters, use other drugs such as NSAIDs or platelet inhibitors that could affect the blood clotting process, have a history of spinal trauma, or have a history of spinal surgery.
FDA Recalls, Reports and Warnings
Xarelto also carries a black box warning, as issued by the FDA, for dangerous spinal bleeding, or epidural or spinal hematomas. Hematomas are pools of blood that happen outside of the blood vessels, and if such happens in the spine, the patient could be permanently paralyzed.
There have been thousands of adverse events reported that are related to the use of this rivaroxaban. Hundreds of which were occurrences of bleeding.
Blood thinners are dangerous in nature, but Bayer’s anticoagulant was the number one on the list of most dangerous published by the Institute for Safe Medication Practices (ISMP).
In addition, the drug is also part of a list of “high-alert medications,” basically stating that when used incorrectly, the drug can increase the risk of severe harm to patients.
Back in 2012, the ISMP published a safety profile on rivaroxaban. Within the same year’s first quarter, the institution found “356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug.” The report was more than twice the reported events the previous year, which were 128 cases.
Lawsuits have stated that there were hundreds of lives taken by the drug due to bleeding. The FDA reported thrice in 2012 alone that more patients have died from severe side effects from the use of this drug, in comparison to warfarin.
A study shown to the American Academy of Orthopedic Surgeons presented a substantial increase in deep surgical site infections from users of the drug. It is also noted that these risks are increased over ten times. Many orthopedic surgeons are now avoiding the use of the drug.
Another study that showed the correlation of blood thinners to these infection complications post-surgery was published in the Journal of Bone and Joint Surgery back in 2012.
The study observed over 13,000 patients who underwent hip or knee surgery that took rivaroxaban or heparin. Respondents within the group of Xarelto users had almost four times the risk of contracting wound complications.
To examine the drug’s safety, a Phase III study was conducted. It was found that 73 percent of the 16,041 patients who participated that took at least one dosage of the drug faced side effects.
Among the most common severe side effects were anemia and bleeding occurrences. Those who took a higher dose had a higher possibility of experiencing bleeding.
Participants of the study also experienced the following side effects:
- Rapid heartbeats
- Rectal bleeding
- Hemorrhages in the eyes
- Low blood pressure
- Gastrointestinal and urogenital bleeding
- Muscle pain
- Nose bleeding
Ironically, while the drug is supposedly used to prevent blood clots from forming, the FDA has also obtained several reports of individuals using the drug that have developed dangerous blood clots.
This prompted the United States Food and Drug Administration to issue a warning to patients who abruptly discontinue taking the drug, noting that they could be at higher risk of blood clot formation.
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