If you've watched TV in the past six months, chances are that you've seen a handful of lawyer commercials asking you to "call now" to begin your Xarelto lawsuit. Every example of these commercials that I've seen does an okay enough job explaining what the supposed side effects of Xarelto are, yet all of them completely fail to explain, in big picture terms, why the makers of Xarelto should be held liable for these side effects or how it benefits society at large for such lawsuits to exist.
In the absence of such an explanation, it's easy for a public jaded by non-stop lawyer commercials to think that this is yet another money grab by greedy lawyers who have found some technicality by which to hook a big corporation.
But make no mistake about it, there is a very good reason for these lawsuits. In this article, we will attempt to explain why the makers of Xarelto are being sued and how such suits are genuinely good for everyone.
What is Xarelto?
Xarelto is the brand name for the drug rivaroxaban. This drug is designed to act as a "blood thinner." It was first approved by the FDA in 2011, and it's used to treat the increased stroke risk associated with certain types of atrial fibrillation (a type of irregular heart beat), deep vein thrombosis (blood clots), and to reduce the risk of clots forming after a knee or hip replacement surgery.
Naturally, blood thinners are a very important type of drug. People who need them and don't take them or who don't get the proper dosage run the risk of their blood clotting, resulting in a stroke or a pulmonary embolism, both of which can obviously cause horrific injuries or death.
Xarelto is not the first drug of this type. The longtime champion of the blood thinner market Coumadin (also known as Warfarin) was developed decades ago to accomplish the same goal of thinning the patient's blood as a means of preventing blood clots. However, Xarelto is meant as an alternative to Coumadin, and it presents several benefits to patients. Among these are:
- A lack of dietary restrictions
- Fewer dosage adjustments
- No need for regular blood tests
Further, initial clinical research revealed that, in addition to being easier to manage than Coumadin, Xarelto is generally more effective as as a blood thinner.
These are all pretty big improvements. Prior to Xarelto and other modern blood thinning drugs like it, patients taking Coumadin had to avoid certain foods containing Vitamin K because Vitamin K in large enough doses acts as an antidote to Coumadin. Eating foods like cranberries and leafy vegetables could counteract the mechanism that makes the drug work, so users of the drug had to avoid these foods. As anyone with a food allergy can attest, it's not always easy to determine whether food you're eating (especially at restaurants) is free of the "bad" ingredient that could cause you to suffer, and this made Coumadin a tricky drug for users to take effectively.
Due to these complications, patients taking Coumadin had to undergo fairly rigorous blood testing to ensure that they actually had enough of the drug in their system for it to work properly. As you can imagine, this is all rather inconvenient.
Since Xarelto and other newer anticoagulants function by using a different blocking mechanism than does Coumadin, they are not affected by Vitamin K consumption and are more consistently metabolized, resulting in protection from stroke that is far more predictable. This is a tremendous accomplishment of medical science, and the makers of Xarelto deserve credit for developing this drug. However, it's a little more complicated than that.
Xarelto's main selling feature may actually create new problems.
All anticoagulants carry the risk of developing uncontrolled bleeding, which makes perfect sense since they work by reducing blood's ability to clot. This is somewhat risky, because we need our blood to be able to clot so we don't bleed-out due to a minor cut. But you can't just turn off the "bad" clotting which leads to blood clots, and leave on the good clotting, the mechanism that keeps us from bleeding to death.
Therein lies the dangers of anticoagulants. They may spare you a stroke, but if you injure yourself while on the medication, you are at a much higher risk of uncontrollable bleeding, which can easily lead to death.
As we mentioned earlier, with older drugs like Coudamin, Vitamin K consumption would counteract the drug. Therefore, doctors could follow the reasoning of, "My patient could have a stroke, so I'll prescribe him a blood thinner. But if he starts bleeding to death, I'll administer a Vitamin K antidote, which will allow the blood to clot again, stop the uncontrollable bleeding, and then I'll administer more blood thinners after the bleeding event is controlled, which will start the process over again."
But as you'll recall, one of the main selling features of Xarelto is that it is not "turned off" by Vitamin K, so you can eat all the cranberries and other Vitamin-K-rich foods that you want. What a great feature. It is so convenient to not have to visit a doctor so frequently for blood tests. There is just one minor caveat: by making Xarelto unaffected by Vitamin K, they also made it a blood thinner that can't be turned off. As of today, there is no antidote for Xarelto. If you start to bleed (especially internally) while taking Xarelto, there is a good chance that you can bleed to death, and there's nothing a doctor can do.
Our laws allow drug makers to kill you, as long as you're warned of the risk.
No drug is without its side effects or risks. In fact, many drugs that have been approved by the FDA are approved with the full knowledge that they can cause dangerous side effects, even death.
For instance, consider the drug Remicade. Remicade has been approved by the FDA to treat many different different illnesses and conditions. While Remicade has a variety of side effects, arguably the most significant is cancer. When you consider that Remicade is often prescribed to treat conditions such as rheumatoid arthritis, it's natural to think, "Is the risk of cancer really worth it to treat arthritis?" The answer to that question along moral or ethical grounds is complex to say the least. But ask any attorney and they'll tell you that the legal answer to the question is decidedly simple: If the patient is adequately warned that their arthritis treatment may kill them and they choose to take the risk, then the manufacturer of the drug bears no liability for the patient's death.
That may sound harsh, but it makes good sense if you look at the big picture. In contemporary America, we receive medical care under the doctrine of informed consent. Informed consent is the notion that your doctor isn't your mother or father, therefore they shouldn't tell you what to do on the basis that they know what's best for you. Instead, patients have the right to weigh the options presented to them and make the decision that is best in line with their moral and philosophical outlook on life.
For instance, a doctor may be inclined to take mercy on a patient who is suffering from a terminal illness. They may think to themselves, "If a complication arises during surgery, I'll just let him die, since his life is so painful." While some people may view that as noble, the doctrine of informed consent holds that the doctor can't make that decision for the patient.
It's easy to look at such a situation in the abstract and think to ourselves that we know what is best for some hypothetical sick person, and doctors probably think similar thoughts. But in a nation where the individual and their rights are cherished above all else (and rightly so), a doctrine of medical paternalism (the belief that doctors know what's best for their patients) is simply incompatible. What may be perceived as an act of mercy by a doctor may in fact be seen as a hell-worthy trespass in the eyes of the patient.
My father, when he was very ill, was uncomfortable with the idea of signing a Do Not Resuscitate order. As a devout Catholic, he would rather suffer and endure great pain in this life than risk an eternity in hell on the off chance that God viewed his signing of a DNR as tantamount to suicide. Under the doctrine of informed consent, a doctor does not need to see eye-to-eye with someone like my father, but they do need to respect their right to feel the way they do about their own health and well-being. It is therefore the doctor's role to advise and inform, not to make moral decisions. The same holds true of companies who make health products.
In applying this concept to drug injuries, the law recognizes that sometimes patients are willing to risk death in order to ease their pain. While I can confidently say that I would rather have arthritis than die from cancer, therefore I would not choose to take Remicade, other people may feel strongly that the risk of fatal cancer is worth it if they are relieved of their symptoms. The law holds that, so long as patients are adequately warned of the risks, the manufacturer of Remicade or any other drug is allowed to sell said drug.
The primary argument against the makers of Xarelto is that they failed to ADEQUATELY warn their customers.
If I walk into a restaurant and see a wet floor sign, I can either decide that I'm not capable of negotiating the wet floor and turn around and leave, or I can decide that it's an acceptable risk based upon my knowledge and experience with wet floors, and walk across it. The restaurant has put the ball in my court, so to speak, and has allowed me to assess the risk and make my own decision. The law doesn't require them to have a restaurant that is completely free from risks, only that they must adequately warn me about the risk of harm when hazards aren't blatantly apparent.
I know that if I walk around the sign, I may encounter a floor that is slippery. But considering my reasonably good balance, the fact that I'm in good health and athletic enough to traverse the wet floor, and given that I wear reasonably grippy shoes, all of my lifetime of experience walking on wet floors tells me that I will probably not fall so long as I go slow and maybe shuffle my feet a little. If I miscalculate and fall, knowing full well what the risks are, the restaurant can rightly conclude that they are not liable, because I chose to accept the risk and ignore their warning sign. They fulfilled their legal obligation simply by posting the sign.
But if I walked into a restaurant where someone had spilled WD-40 all over the floor --which is far more slippery than water-- and had put up a standard wet floor sign? if I attempted to traverse the WD-40-covered floor only to fall and break my arm, it would be a totally different story, and the restaurant would likely be found liable by a jury. But why?
The reason why has to do with the adequacy of their warning sign. I, like most people, have seen perhaps dozens or hundreds of wet floor signs in public, and I cautiously made my way across the many wet-with-water floors they warned me of, each time adding to my understanding of what precisely it was that I was being warned about. With each new wet floor I chose to cross, I gained an increasingly informed understanding of the risk I was taking. Walking across a wet floor was not free from risk, to be sure, but it was only risky enough that my stride had to be adjusted, but no so risky that I had to avoid the floor altogether. But in this hypothetical, I crossed a floor that was wet with WD-40, thinking that it was just a normal wet floor. And because a regular old wet floor sign was used, I was unprepared to deal with how freakishly slippery the floor was, so and I bit it, hard.
A lawyer would say that, despite the presence of a warning sign, the sign failed to adequately warn me. All of my experience had led me to believe that "wet floor sign = a normally slippery floor," so I assessed the risk accordingly, only to find out that the restaurant did not provide me with enough information to truly assess the risk.
Here's another way to think about it. Everyone knows that rollercoasters and carnival rides have warning signs that say something along the lines of, "May cause neck injuries." But practical human experience has told us that what they really mean is, "If you've already got a neck injury, a really weak neck, or some other condition that most healthy people don't have, then this rollercoaster can cause a neck injury, so it's nothing to really worry about if you're healthy." If the same generic sign that everyone has seen on every rollercoaster and carnival ride were affixed to a ride that is so poorly designed that it paralyzes 10% of all people who ride it, no reasonable person would conclude, "Well, it did say it could hurt your neck, and chin-down paralysis is a type of neck injury, so it looks like they're off the hook. You won this round, clever sign."
Nonsense.
If a restaurant has an abnormally slippery floor, they need a special warning sign that adequately conveys the unusual risks. If a rollercoaster is highly likely to break people's necks, they need a warning sign that adequately conveys the unusual risks. And, by extension, if a blood thinning medication presents an abnormally dangerous risk of causing patients to bleed to death, then they definitely need to offer a warning that adequately conveys the risks.
And that's exactly what the primary argument against Xarelto holds to be true. Lawyers claim that the manufacturer made a blood thinner and then let people assume it posed a similar risk to other blood thinners. But since the risk of bleeding to death with Xarelto is far worse than with normal blood thinners, so sayeth products liability lawyers, the standard warning that millions of people have learned to tune out regarding conventional blood thinners simply does not adequately warn of the risks of using Xarelto, in particular. They have therefore failed to inform their customers of the risks.
But why is Xarelto supposedly more dangerous than other blood thinners?
It's easy to understand how blood thinners of any stamp can cause complications which lead to bleeding events. But the thing that allegedly makes Xarelto abnormally dangerous is that, unlike other blood thinners, there is no antidote for it. If a patient takes this drug to thin their blood and then has a bleeding event, it could be fatal, or cause an inconvenient and costly trip to the hospital wherein one's survival depends on the availability of blood transfusions until the drug leaves the patient's system.
Surely, the makers of Xarelto warned doctors and patients about this, right? Unfortunately not.
The way that the FDA's oversight works, in a nutshell, is that drug manufacturers (or other outside entities that they hire) test drugs before they come to market, but the FDA themselves does not do the testing. What this really means is that drugmakers are on the honor system. If, during their testing, they discover some side effect, they must inform the FDA. When the FDA approves a drug, they approve it for a particular use and they require the drugmaker to disclose any problems or side effects that came to light during testing. That's why drug commercials on the TV say things like, "Talk to your doctor about Happy Pill," and then a muted voice chimes in and says, "Happy Pill may cause severe depression, explosive diarrhea, dry scalp, itchy eyeballs, mild tourettes, and a moderate interest in butterflies." All of those side effects are based on what patients involved in testing the drug claim to have experienced during said test, and the FDA requires the drug manufacturer to disclose that to you.
But that's not the whole story. Sometimes there are facts that a manufacturer knows about their drugs, because they actually observed these side effects or because they have special insight enabling them to anticipate that such a problem may arise, even though these side effects never showed up in their testing, and they are obligated to make this information known.
The makers of Xarelto, of course, were able to anticipate that their drug, like all other blood thinners, could cause excessive bleeding, which could be fatal, and they knew that they had no antidote, yet you'll find nothing in their product literature that warns anyone about this. Their warning isn't really much different than the warning for other blood thinners, though, as we've mentioned, Xarleto has a different risk profile.
Here is the warning that accompanies Coumadin:
As you can see, it makes it very clear that a big risk (if not THE big risk) of taking Coumadin is that you can bleed to death. Here's the original product insert for Xarelto that was included with the drug when it came to market in 2012:
The makers of Xarelto state in the aforementioned product insert paperwork that the drug can cause dangerous bleeding. But they completely fail to mention that Xarelto has the unique characteristic of being a blood thinner that has no antidote, no way to turn it off once things get serious.
There are two ways to think about this. On one hand, you could argue that Xarelto provided a warning that dangerous bleeding could occur, and that's sufficient. But the other perspective is that, much like the restaurant that uses a regular wet floor sig to warn of a floor covered in WD-40, Xarelto's warnings completely failed to impart enough critical information so that users could make an informed decision about the risks.
Just the same way that a wet floor sign is sufficient for a water spill but a floor covered in WD-40 can only be adequately warned about with a sign that says, "Warning, this floor is wet with chemicals and is way more slippery than a normal wet floor," lawyers suing the makers of Xarelto contend that, since Bayer and Janssen Pharmaceuticals knew darn well that their drug could cause fatal bleeding, that the drug they essentially made Xarelto to replace has always had an antidote, and that their new drug does not have an antidote, the standard warning sign that warns patients about normal bleeding risks with no further explanation is simply not good enough, because their drug poses a special and abnormal risk. Lawyers argue that they should have provided a special warning.
Our firm is not suggesting that the makers of Xarelto need to put neon warning signs on their products, nor do they need to go door-to-door to warn users of the side effects. What lawyers propose is very simple. An adequate warning would include language that says something along the lines of, "Xarelto, like most blood thinners, can cause excessive bleeding, which may be fatal. However, unlike other blood thinners which have an antidote that may be used to nullify the drug's blood thinning capabilities, there is not currently an antidote for Xarelto. If you experience serious bleeding while on Xarelto, your blood will likely be unable to clot until the drugs have effectively left your system. This may result in uncontrollable bleeding, possibly leading to death."
But this brings us to the more sinister part of the discussion. Why didn't they provide such a warning? There are really only a few answers that make sense:
- Either the makers of Xarelto truly don't believe that the drug is dangerous without an antidote.
- They knew there was potential for danger but didn't think anyone would be harmed.
- They knew full well that the drug could cause this kind of harm, but decided to bring it to market anyway.
The first theory fails flat-out for one very simple reason: The makers of Xarelto are currently funding research on an antidote for Xarelto! That's right, since before the drug came to market, the makers of Xarelto understood the need for an antidote, and since at least 2013, one has been in development, but it isn't ready yet. Nevertheless, they brought the drug to market.
As for the second theory, that's a tough sell considering that a similar drug called Pradaxa was brought to market shortly before Xarelto, and it too had no natural antidote. Pradaxa users suffered from serious blood loss issues. Boeheringer Ingelheim, the makers of Pradaxa, were successfully sued, and ultimately they developed an antidote in December of 2015. Even if the scientists and doctors who work for Janssen are too shortsighted to see that their product could harm someone without an antidote (which is hard to believe since they are among the smartest people on the planet), the Pradaxa debacle provided them a perfect road map of what to expect when they launched their drug, which should have made it clear that people will suffer and die, without question, if they brought the product to market without a proper warning or antidote.
The only theory that doesn't strain credulity is number three. There is tremendous profit potential available to drugmakers, and I don't begrudge them one cent, so long as they make their money while adhering to vital consumer and patient protection laws. But part of the issue is that patents and other intellectual property laws only provide drugmakers with a relatively short window of time in which to bring their products to market and make money before generic versions of the same drug are able to be sold at a discount by competitors. When you factor in the time it takes to get a drug through the FDA approval process and then circulated among doctors and advertised to patients to gain marketshare, it's easy to see why A) it's tempting for a pharmaceutical company to not want to wait to bring their drug to market and B) they would want to avoid putting a warning on the drug that scares customers away.
But while we can understand these motivations, we cannot abide them. When human life hangs in the balance, profit motives should be secondary. These companies are free to (and should) lobby for a greater window of time under which they would have sole license to sell the products that they so painstakingly and expensively create. No question about it. But until that time comes, you'll have a hard time convincing me that it's okay to ask your customers to bear the costs of these business limitations.
Lastly, it's worth noting that no matter how ignorant Janssen Pharmaceuticals may claim it once was regarding the danger of their product, they now have several years worth of data and several thousand lawsuits against them which all make clear that they should change their warning labels. Thus far they have declined to do so. I'll let you draw your own conclusions as to why that is.
There's a scene in the movie Fight Club where the main character played by Edward Norton talks to a woman on an airplane. He explains that he works for an auto manufacturer as a risk manager. When one of their cars malfunctions and kills someone, it's his job to calculate how many of their cars are likely to malfunction, how much it would cost the company to issue a recall, calculate the cost of a settlement with the expected number of victims, and then see which option is cheaper: recalling the cars and fixing them or letting people die and paying to settle lawsuits.
Like most scenes in that movie, the whole thing is exaggerated (I hope), but it hints at a subtle truth. If companies feel that they can make enough money while putting people at risk, many of them are willing to do it. That is, unless firms like ours hit them hard enough to knock that particular taste out of their mouths.