The attorneys at Miller & Zois LLC are evaluating lawsuits options for patients who have suffered severe bleeding problems while using Xarelto that have led to serious injury or death. This article explains the genesis of this litigation and discusses your legal options if you think you may have a claim.
- Get the latest March 2019 update on the Xarelto settlements and learn what we expect the value of these cases to be
Xarelto was sold to patients on a fantastic premise: the regular blood monitoring required for traditional anticoagulants such as Coumadin (warfarin) was not necessary. Xarelto was billed as the first and only once-a-day prescription blood thinner for atrial fibrillation patients not caused by a heart valve problem that did not involve regular blood monitoring. Atrial fibrillation is the most common arrhythmia in the *3] United States, impacting six million Americans every year. Anticoagulants reduce the risk of embolic stroke in atrial fibrillation. Warfarin has historically been the gold standard agent to reduce the risk of embolic stroke that comes with atrial fibrillation.
Xarelto jumped into this lucrative market arguing Xarelto was more convenient because you could take this drug and go to the doctor's office less. For people that are trying to manage their health problems and still live a normal life, this is an exciting premise. Having to miss work once a month or just having to be inconvenienced by regular trips to the doctors is a burden on patients. (Although it is worth pointing out that you can take warfarin and monitor your blood levels from home using a glucose monitor.)
The drug companies made three basic claims:
- the drug is effective against atrial fibrillation;
- patients on the drug will not need blood monitoring
- the dosage of the drug need not be adjusted.
So when Xarelto was introduced in July 2011 by Johnson & Johnson and Bayer with this exciting premise, patients had every reason to be excited. No one paid much attention when the FDA took exception to some of these claims, telling Johnson & Johnson they had gone too far
The FDA scolded J&J's for, among other things, claiming Xarelto would not require dosage adjustments. In fact, the product label itself said the dose should be lowered to 15 mg once daily for individual patients. The FDA also took exception to the second claim because the label also clearly stated that renal-impaired patients should have their renal function periodically assessed "as clinically indicated ... and adjust therapy accordingly." But this happens all of the time. Companies racing for market share get over exuberant with their claims. Should we be surprised when these same companies push products to market with properly testing the product or advise of all of the downside risks?
When they launched Xarelto, they quickly starting making, as these companies are wont to do, money hand over fist. Xarelto is Bayer's top-selling product, producing $3.24 billion in revenue last year and $2.5 billion in 2015. So Bayer and J&J (actually J&J owned Janssen Pharmaceuticals) sought and received FDA approval for the drug to treat pulmonary embolisms (PE), treat deep vein thrombosis (DVT), and to reduce the risk of recurrent DVT and PE following initial treatment. Then they sought approval for the drug in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome.The Big Problem
But it didn't take long to realize that this product causes bleeding. Of course, it is a blood thinner. Isn't every blood thinner is going to cause bleeding? Yes. But it is a question of degree. Plaintiffs' lawsuits allege Xarelto bleeding risks are far more significant than other options patients had. Accordingly, users of the drug had a right to know that this ostensibly low hassle drug might cause them great health problems or even death.
How much bleeding are we talking about? Approximately 8.6 percent of the patients taking Xarelto had clinically significant bleeding. So out of 1000 people, 86 people are going to find themselves in an emergency room, doctor's office or hospital with clinically relevant bleeding.
What else is important here is that pre-market testing arguably failed to show Xarelto was superior to warfarin. But the companies apparently believed the drugs once-a-day dosing and early market entry could still make a fortune, even if it were not a clinically better product.
Xarelto’s label now includes two “black box” warnings to warn of the grave risks with this new drug. The first warns that receiving an epidural or a spinal tap while taking Xarelto can cause paralysis. The second warning informs users with nonvalvular atrial fibrillation that the discontinued use of Xarelto may increase the risk of blood clots and strokes in those patients. But Xarelto still does not have a black box warning that tells doctors and patients that Xarelto can cause excessive and irreversible bleeds.
Bayer in some cases suggests that doctors and patients mistakenly used aspirin along with Xarelto and that combination is the real source of the bleeding. But there is nothing on the packing that remotely suggests this could cause harm to the patient. It would be easy for Bayer to put out a contraindication for aspirin and Xarelto. But they never did that.One More Big Problem
Again, Coumadin also causes bleeding that can lead to a GI hemorrhage. But besides the fact that Xarelto might lead to a great risk of bleeding, there is a difference in the ability to intervene once a bleeding episode begins. Doctors have concerns that the bleeding side effects cannot be as easily controlled as they are with other conventional anticoagulants like warfarin. Plaintiffs' attorneys argue that these companies knew or should have known about the lack of an effective Xarelto reversal agent to stop bleeding problems when they develop and properly communicate this fact in their labeling to both doctors and patients.What Are The Risks?
The risks of Xarelto can be summarized as by-products of excessive bleeding:
- Internal Bleeding
- Gastrointestinal Bleeding
- Brain Hemorrhage
- Hemorrhagic Stroke
Around the same time, Boehringer Ingelheim put out a new anticoagulant called Pradaxa. The companies were racing these drugs on the market because being first means something in this industry. This drug was also flawed and led to a boatload of lawsuits. Why? It is not hard to postulate that these two drugs racing against each other to get on the market might have caused these companies to put these products on the market faster than they should have.Xarelto Lawsuit Allegations
There is a number of claims that are being made in these cases. The first and biggest allegation is that there should have been a warning that communicated these risks both of the bleeding problem and the lack of an effective reversal agent once a bleed begins. Plaintiffs' attorneys will also allege that the marketing for Xarelto was over-the-top and induced doctors to prescribe the drug even though it was more expensive and more dangerous.
Some plaintiffs' lawyers might argue there should have been a Xarelto recall or at least a black box warning of the excessive risks. That can be and will be, debated in our courts and with the FDA. But the bigger issue is whether they gave doctors and patients a heads-up about the risks so they could make an informed choice. The answer here is clearly that they did not. At the core, that is what these Xarelto lawsuits are about.