Everyone’s seen the commercials urging patients who have taken Xarelto to contact the law firms’ numbers onscreen immediately to join a xarelto bleeding lawsuit. Well, the drug companies are actually countering the wrongful death lawsuits and complaints contending that a third party is supporting the nationwide lawsuits as a witch hunt.
In addition, Bayer and Johnson & Johnson contend that doctors have not prescribed other drugs (namely 50-year-standing and trusted blood thinner Warfarin in its place.)
The first xarelto bleeding lawsuit began in April in New Orleans. This patient experienced severe gastrointestinal bleeding within the first month of taking Xarelto. It landed him in the hospital. There’s no antidote, and doctors had to do a costly and dangerous blood transfusions. He could have bled to death.
This claimant calls out manufacturer negligence because they did not inform doctors or patients that there is no antidote to the drug; meaning its blood thinning properties cannot be reversed once it gets to work. He was fortunate to survive, because his doctors were able to counter Xarelto with a blood transfusion in time.
Hundreds of the 10,000 other Xarelto wrongful death lawsuits time was not on their side. Many of those patients died from exactly that bleeding issue.
The Pharmaceutical Companies Respond
In response, the drug companies came back swinging with responses that seem weak. They claim Xarelto is more effective than Warfarin and is safe. Warfarin has been trusted as the main blood thinner for at least 50 years. In theory should not Warfarin also cause bleeding deaths because it too is a blood thinner?
Actually, Warfarin can cause bleeding out episodes that lead to death, if it is improperly dosed. There’s no money in suing about a long-standing blood thinner, though. If patients take too much Warfarin, they can bleed to death. Though, hospitals use Warfarin all the time without much in the way of dramatic effect other than achieving blood thinning.
The patients could file malpractice lawsuits against doctors. Yet, the question begs, why are the pharmaceutical companies only citing that the doctors did not choose to prescribe something else? Judge Fallon dismissed this argument, and the lawsuits are collectively filed under MDL 2592.
The pharma companies are also counter-claiming that a third-party is funding the xarelto bleeding lawsuit in encouraging people to join the suit. FDA is still backing its approval of Xarelto, but has issued a black box warning for the drug. Black box warnings have been issued on other blood-related pharma products over the years.
The Philadelphia Xarelto mass tort seems to be edging closer to the trial stage, and as this is happening, Bayer AG and Janssen Pharmaceuticals have hinted they want to know who are third-party lawsuit funding are. There are people providing lawsuit funding against the companies. The defendants want to know who are the people funding the plaintiffs in the Xarleto lawsuits.
Janssen and Bayer filed a motion in April. The motion was requesting the court to compel discovery in regards to third-party lawsuit funding. The motion, filed with the Philadelphia Court of Common Peas, was filed at the beginning of April.
Bellwether cases in the lawsuit have been placed on a shortlist. Defendants now want to know more about third-party ligation funding. They would like to find out more details before the selection of bellwether cases for the trials.
As of now, there are around 1,200 cases on the tort docket. However, 24 cases have qualified for bellwether status. The defendants in the case feel that in order to determine which cases on the shortlist will be tried first, then they should know who is providing the lawsuit funding.
Xarelto arrived on the market as an alternative to Warfarin, which is a well-known blood-thinner that has considered being the gold-standard. Xarelto has been proven to be effective at helping prevent blood clots and stroke in older patients. The downside of Warfarin is that strict dieting is required and there are other factors that are required in order for patients to remain in a safe zone and to avoid bleeding events, as well as serious hemorrhages.
The FDA approved Xarelto as an alternative to Warfarin, and it did not require the same amount of monitoring that Warfarin required. This is one of the reasons why the drug was touted as an effective alternative to Warfarin. It was also touted as an easier and safe alternative to Warfarin.
However, the side effects associated with Xarelto have caused a lot of problems for many people and the drug was brought to the market without an agent to reverse the thinning properties of the drug. With an infusion of Vitamin K, Warfarin can be reversed, but Xarelto doesn’t respond to Vitamin K infusions. This has led to serious issues, such as bleeding complications and there have been some deaths reported.
Plaintiffs allege that the manufacturers of the drug claimed that it didn’t require the same extent of monitoring that is required with Warfarin, but given the lack of an agent to reverse the drug’s effects, it seems that Xarelto does require a lot of monitoring. Plaintiffs also claim that the manufacturers knew that the drug couldn’t be reversed in the same manner as Warfarin, and if they knew this information, then they wouldn’t have taken the drug. Some plaintiffs said they would have consented to Xarelto if they knew.
The request to find out who is funding the plaintiffs’ lawsuits is a new trend, and the defendants said the motion was filed because they need to understand the context of the selection of bellwether cases and it is in the interest of an orderly processed. The defendants also said it may help determine if the individuals or entities have a stake in the outcome of the lawsuit. In other words, part of the reason is because the defendants want to know if any lawsuit funding has something to gain.
Lawyers represented the plaintiffs countered, saying the requests were broad. They said that it reaches into the territory of attorney-client privilege. As of now, it’s not clear if the defendants’ request will be approved or denied.
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.
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.