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Uncontrollable Bleeding Leads To More Than 200 Lawsuits; Anticoagulant Xarelto in Potentially Serious Legal Trouble

People are born with or develop conditions ranging from mild to unfortunately deadly on a daily basis. Normally, the more common a condition is amongst the general population, the easier it is for medical researchers to seek and develop a treatment. One common condition that has had multiple forms of treatment over the years is atrial fibrillation. Atrial fibrillation (AFib) is a type of irregular heart rate that affects a sufferer’s blood flow. With poor blood flow, clots can form in the vessels more easily and further interrupt flow to important areas, tissues, or organs, otherwise known as ischemia. If it’s not obvious, one example of how ischemia could become a serious problem is if the blockage prevents blood flow to the brain, resulting in a stroke, or in your lungs (pulmonary embolism).

Luckily for the many people living with atrial fibrillation, there are medicines available (known as anticoagulants or “blood thinners”) that hinder the formation of blood clots, in turn dramatically lowering their risk of undergoing any of the serious conditions associated with AFib, including heart failure, dementia, and coronary artery disease. Warfarin (commonly know by the trade name Coumadin) was, at one point, the unchallenged leader in the oral anticoagulant drug field. In 1954, only 6 years after its initial introduction, it was approved for use as a prescribed medication to treat AFib and has been used as such ever since. Patients that take warfarin for AFib must be monitored regularly and have their dosage adjusted accordingly to ensure that clots are forming at a safe, healthy rate.

How does warfarin hold up? 

There are “bad” blood clots, which are what this medicine aims to prevent, but there are also “good” blood clots (such as those that form to block a bleed), which is why consistent monitoring is vital. Warfarin simply reduces a patient’s levels of vitamin K; vitamin K being an essential component to natural blood clotting. Therefore, if too large of a dose is taken and a patient’s vitamin K levels are too greatly reduced, their blood will be physically incapable of clotting to block a bleed. Predictably, if a bleed cannot be blocked by clotting, it will not stop and can lead to a great loss of blood—even death. However, since the main characteristic of warfarin is a reduction in vitamin K, it can be easily counteracted with vitamin supplements that replenish the same. While warfarin is still the leader in oral anticoagulants, it is far from unchallenged nowadays.

Xarelto is a product that was approved for the same use in 2011, but instead of lowering vitamin K count, it thins the blood. Because of this drastic difference, it’s not as simple as just taking a few vitamin tablets when things go wrong. As a matter of fact, there’s no medically-approved, regularly-practiced method to counteract the bleeding that can result from over-thinned blood. Xarelto, however, has a great selling point that they’ve really pushed on potential consumers. What is that selling point? Well, because of the way it works in the body, it no longer requires constant monitoring to ensure its safety. To Coumadin (warfarin) users, this sounds like a dream come true; many of them have switched over to the newer, non-regimented pill. Without the need to worry about vitamin K levels on a weekly basis, users can take the pill stress-free for the same benefits. Sounds pretty great, right?

Only AFib sufferers take it? 

Aside from atrial fibrillation, anticoagulants are used to treat or prevent dangerous clots that may arise from other conditions. A common example is people who underwent hip or knee replacement surgery and spend a length of time in the same uncomfortable position recovering in a hospital bed. The stagnant blood can form into clots in the deep veins of the legs, known as deep vein thrombosis, and will need immediate attention to ensure the clot(s) does not travel elsewhere. That means that many people that don’t even have atrial fibrillation are taking anticoagulants temporarily to prevent or combat troublesome blood clots. Since it’s normally only a temporary condition, should these patients be prescribed Coumadin or Xarelto as treatment? Well, believe it or not, when given the choice and being told that both pills have the same effect, but only one of them requires consistent monitoring, many patients happily choose Xarelto.

What many patients aren’t told, however, is that there’s no way to reverse the medicinal effects of Xarelto. Once consumed, the effects are irreversible; there’s no known antidote to “re-thickin” the blood, per se. That means that, while all anticoagulants pose a risk of causing internal bleeding (which is a serious and life-threatening condition), Xarelto’s effects cannot be stopped. With warfarin, vitamin K would stop internal bleeding; vitamin K is the atntidote. Internal bleeding left undiagnosed for even a short amount of time can put a Xarelto consumer on the fast track to the emergency room—and it has. Since the nationwide release and popularity growth of this pill, cases have been slowly but surely piling up. Innocent users of the “new and improved” anticoagulant were quickly finding themselves diagnosed with conditions such as: 

  • Internal Bleeding
  • Hemorrhaging
  • Blood Clots
  • Embolisms
  • Death

Now, 3 years into the medicinal market, the pill seems to be getting the companies responsible for it—Bayer and Johnson & Johnson subsidiary Janssen Pharmaceutica—into a boatload of legal troubles. Over and over again, users of Xarelto have ended up in the hospital to have treated their internal bleeding injuries that were caused by Xarelto. Not only do the bills rack up, but the physical and emotional pain and suffering does as well. The patients that make it out of the hospital alive claim that if they had known about these horrific side effects, they would have opted to take another, safer anticoagulant; Coumadin for example. The recent storm of lawsuits headed there way is based on exactly that aspect.

When did the lawsuits start?

The lawsuit that started it all was a Philadelphia resident by the name of Virginia Stuntebeck when she suffered severe internal bleeding which hospitalized her. Although it’s the patient’s choice to take Xarelto, it’s also unreasonable for Bayer to release a pill, marketing it as a newer, safer, updated version of the predecessors when they know (or should know) how dangerous it is, and that a highly likely-to-happen side effect will be irreversible. That’s where product liability litigation comes into play; understandably so, companies owe a relatively minimal duty of care to consumers once the product is out the door, but even just a small amount of negligence expressed by a company can put them in a bad light. When it comes to your personal health and well-being, companies having inadequate warning labels on their products can grow to be a real concern.

At this point, not even a year after Stuntebeck’s opening lawsuit, over 200 other plaintiffs have joined onto the case to form a class. The class action is headed by U.S. District Judge Eldon E. Fallon and is geared towards securing significant financial compensation for the unrightfully injured consumers of Xarelto. Pradaxa is another once-popular anticoagulant that has seen better days in the public eye. With a nearly identical story, Pradaxa lawsuits are plentiful—tens of thousands of them piling up since its first FDA-approval in October of 2010. Of course the companies vigorously claim that they supply adequate warnings and have never downplayed how serious the side effects can be, but the more and more plaintiffs that tag onto the class, the less likely they are to be capable of defending themselves in litigation. If there’s a judgment against Bayer and Janssen, the punitive damages could be enormous—surely one of the highest punitive damages awarded to plaintiffs in a drug-based class action. These damages aim to financially distress the company and “teach them a lesson”—a sort of punishment for companies that are rarely affected by costly settlements with injured consumers. 


It’s not okay for Bayer to defend themselves so vigorously to refuse deserving victims of their rightful financial compensation. It would be wise for them to recall Xarelto worldwide and focus on creating an antidote for its future re-release. However, as it stands, the more they fight, they more plaintiffs will tag onto the case. If they keep it up, Bayer could find themselves knee-deep in not only civil, but also seriously criminal liability. What matters most is that each and every plaintiff that deserves and needs compensation as a result of the damaging, defective, and inadequately labeled anticoagulant—gets that compensation. If you or a loved one has suffered any mental, physical, emotional, or financial losses as a result of taking Xarelto as prescribed, contact Sibley Dolman Gipe Accident Injury Lawyers, PA today for a free case evaluation and consultation. For more information regarding Xarelto and other similar product recalls, call us at (833) 606-DRUG [3784].

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
(833) 606-DRUG [3784]