From Orleans, LA comes the news that the first trial against the medication, Xarelto, will be held in early 2017. Others are due to follow. There is a huge portfolio of xarelto claims against the maker, Jannssen Pharmaceuticals Inc., and Bayer, which are still pending. The number of cases is nearly 14,000.
The plaintiffs allege that Xarelto caused blood to thin so much that it caused serious complications to patients. As there was no antidote to the blood thinner’s power, it caused serious harm. The first plaintiff to have his trial states that he was prescribed the medication for atrial fibrillation or Afib in early 2014. One month later he was in the hospital with bleeding so severe he required many blood transfusions.
He claims the makers mislead the public about the medication’s safety. They also failed to indicate the dangers of the drug to the medical community or to the US Food and Drug Administration. They only referenced certain results from clinical trials to get the pill on the market. The issues of the medication were not disclosed.
Xarelto was compared with its rival medication, Warfarin is also known generically as Coumadin. This medication requires routine blood tests and dietary restrictions of the patients who take it. Xarelto came out as being a much easier medication to take with as much safety and effectiveness as Warfarin.
There were tests done on the two and allegations were made against the readings taken of patients by Inratio. It was believed the readings showed patients in a control group taking too much Warfarin thereby casting a better light on the Xarelto. The FDA feels that any variations in the readings done by Inratio were too slight to skew the results for Xarelto. Originally, Xarelto was approved for DVT or deep vein thrombosis.
Eventually, Xarelto was introduced to the market to be a better, easier way of managing Warfarin patients. It seemed to be too ineffective at reducing the risks of DVT or stroke from atrial fibrillation. It helped manage the levels of Warfarin used. Too much of the Warfarin itself risked hemorrhages, and bleeding.
In their xarelto claims, plaintiffs made note of the lack of an antidote available to combat the excess Xarelto bleeding. With Warfarin, patients are taken care of with a vitamin K infusion. The treatment does not work on Xarelto, leaving it to be a risky medication. Plaintiffs further claim that the makers of Xarelto were irresponsible for claiming that Xarelto required no monitoring. Because it did not have a reversing agent, the opposite became true.
Xarelto came on the market with big expectations. In the first year on the market, it brought in close to $600 million. By the end of 2013, it yielded $2 billion. The future of the drug remains to be seen as these xarelto claims lawsuits come to trial.
What makes Xarelto different than the other blood thinner medication is that it is actually a Xa inhibitor, meaning that it works to think out the blood by blocking thrombin. This is the chemical found in the blood that leads to a blood clot. Being able to block thrombin, Xarelto works to break down and then prevent any blood clot that can be a problem if you have gone through either knee replacement or hip surgery, are going through deep vein thrombosis or have been diagnosed as having atrial fibrillation.
The major side effect linked to Xarelto use is internal bleeding that is uncontrollable. Internal bleeding can be a lot more dangerous than external bleeds, as it is more difficult to identify. Since Xarelto will keep the blood from clotting, internal bleeding events can result in the need for hospitalization right away, or even death.
Along with severe internal bleeding, one serious risk that has been linked to the use of Xarelto is that it can lead to blood clotting if the person stops taking the drug before they are supposed to. This is something reported as happening whenever a patient is transitioning from Xarelto because there is no reversal agent, back to the drug Warfarin, which happens to have a reversal agent in it.
Back in 2013, the FDA put out a report that was focused on adverse medical events that are linked to the use of Xarelto. The report noted that about 2,100 of the people surveyed had reported adverse events concerning Xarelto. Out of that, 1,821 of the people cited Xarelto as being the main cause of the event.
The major four side effects to be reported in the study were:
– Deep Vein Thrombosis
– Pulmonary Embolism
– Gastrointestinal Bleeds
Some of the other adverse events that were included are cerebrovascular incidents, thrombosis, edema, dyspnea, and hematoma and hemoglobin deficiency. With 891 of the cases that were reported, hospitalization was necessary. Unfortunately, 183 of the cases resulted in the death of the patient.
A pulmonary embolism is something that happens when the blood flowing to the lungs gets blocked due to a blood clot. This is most commonly caused by a deep vein thrombosis, which is where a blood clot gets formed down in the veins of the legs or arms, then travels into the lungs where it forms a blockage. The symptoms of pulmonary embolism include severe chest pain, coughing up blood, and shortness of breath. The symptoms might only occur after serious damage is already done. A pulmonary embolism is difficult to diagnose, often leading to death.
This is internal bleeding in the abdominal area, which can be very serious. The abdominal region holds a lot of vital organs. In the event that there is an internal bleed, the blood can pool around such organs and then cut them off from the supply of blood that is freshly oxygenated. Whenever organs are cut off from oxygen for long, they will start to die. The signs of a gastrointestinal bleed can include coughing up blood or vomiting it up, resembling coffee grounds.
Internal bleeding in the brain has been always very dangerous. This can result in suffocation of the brain cells as they starve for oxygen. If they get cut off from oxygen for far too long, they can begin to die, leading to effects that are similar to a stroke. The signs that there is a brain bleed can include numbness in the arms, legs, or face, speech that is slurred, difficulty when moving or walking, harsh headaches, lack of coordination and impaired vision.
Many critics say that Xarelto is also far more dangerous than other available blood thinner medication because there is nothing that can be used as a reversal agent. If any patient that is taking Xarelto goes through internal bleeding, you do not have a drug that will counteract it to stop the bleeding.
A Texas woman has filed a lawsuit in the federal court of the Eastern District of New York against the makers of Xarelto, a new class of blood thinner. In it, she alleges that she sustained serious injuries, signs of internal bleeding due to the company’s failure to warn her about the potential risks of using the drug and that the company failed to conduct safety testing that was sufficient before placing the blood thinner on the market. Her lawsuit is similar to many others filed against Janssen and Bayer AG. The case is listed under the federal court docket number 1:14-CV-04524 and is available in its entirety to read below.
December 7, 2015 – BloodThinnerHelp.com reports that a Texas woman has filed a lawsuit in the Eastern District of New York alleging that Janssen Pharmaceuticals and Bayer AG, the manufacturers of Xarelto, failed to provide sufficient warnings to consumers about the potential risk of the signs of internal bleeding with this blood thinner. In federal court, the latest complaint was filed under 1:14-CV-04524.
The lawsuit contains details about how the drug was prescribed to treat a condition known as atrial fibrillation. This condition can cause strokes due to blood clots. As a preventative measure, cases of this type are commonly treated with blood thinners. However, just five months after taking the blood thinner, she experienced an internal bleed that was life threatening. While the complaint does not specify much of the details of the injury, it does state that specialized care will be required due to long tern health effects that occurred as a consequence of the bleed.
After the U.S. Food and Drug Administration approved Xarelto in 2011, it was released to the market for prescription. Initially, the new drug was regarded as an option that was revolutionary, because it did not require a special diet, adjustments by physicians, or regular monitoring. However, once consumers realized that there was no antidote, this early excitement was short lived. Currently, it is seen by many to be the market’s most dangerous blood thinner.
Because there is no antidote, if a patient taking Xarelto begins to show the signs of internal bleeding after an injury, there is no way to get the blood to clot by countering the effects of the drug. In order to keep the patient alive when this happens, blood transfusions and other extreme measures to save their life must be used. In addition, operations are sometimes necessary when pools of blood develop in the spine or brain in order to relieve the built up pressure in the body by draining the blood.
Vitamin K provides an antidote for traditional blood thinners. Because of this, the effects of the traditional blood thinner are counteracted and blood clots can form when an injury occurs. It is the difference between living and dying in these cases.
Federally, there have been about 2,000 cases filed against Xarelto for bleeding that cannot be controlled. In the Eastern District of Louisiana, the Honorable Judge Eldon Fallon is overseeing the consolidation of these cases in Multidistrict litigation number 2To 592. Attorney Joseph Osborne is working to make sure that everyone has the opportunity to evaluate their legal rights if they were affected by Xarelto as these cases are prepared for trial. There may be a significant compensation for individuals who suffered adverse health effects and any signs of internal bleeding due to using Xarelto. To those involved, free legal consultations are available from attorney Osborne.
Please contact our attorney today for additional information or to ask questions about the Xarelto bleeding lawsuits.