Amid growing concerns about the link between the blood-thinner Xarelto (rivaroxaban) to dangerous bleeding risks, a new serious side effect of the drug is coming to the forefront: post-surgical infections that could send people back into the hospital.
Attorney Ellen Relkin of New York-based law firm Weitz & Luxenberg joins us on this week’s episode of Drugwatch Podcast to explain what makes Xarelto dangerous and why patients and their families are filing lawsuits.
Bayer and Johnson & Johnson’s blockbuster drug jumped to the front of the pack of all blood thinners in its class, including Pradaxa and Eliquis, with sales that last year exceeded $1 billion. And the drug makers announced late in 2014 they would begin studies in the hopes of widening the approved uses for the medication.
But while the drug proved effective at preventing blood clots, it also raised concerns in the medical community for an increased risk of uncontrolled bleeds and the lack of an antidote.
Now orthopedic surgeons across the country are noticing patients who use the drug after hip or knee replacement surgery may not heal correctly following surgery and tend to have higher rates of wound leakage and infections.
“A study was presented to the American Academy of Orthopedic Surgeons, and it showed a significant increase in these deep surgical site infections among Xarelto patients. It’s much greater than a 10-fold risk. Many orthopedic surgeons are avoiding the drug now, but some of them are still using it,” Relkin told Drugwatch. “There are safer, equally or more effective ways to prevent clots following a hip or knee arthroplasty.”
Bayer and J&J face more than 400 federal cases currently consolidated before Judge Eldon E. Fallon in New Orleans and a collection of cases in Philadelphia mass tort court. Complaints filed by patients and surviving family members say the drug caused uncontrolled bleeding and they were not warned.
Relkin has practiced at Weitz & Luxenberg for more than 18 years – and has more than 30 years of litigation experience. She focuses on drug and medical device product liability as well as toxic torts where people have been exposed to dangerous toxins and chemicals.
Last modified: July 13, 2017
Michelle Llamas: Hi there and welcome everyone to this episode of Drugwatch Radio. On this episode I've got Ellen Relkin of the law firm Weitz & Luxenberg with me today. And she's going to be telling us a little bit about the blood thinner medication Xarelto. So, welcome to the show, Ellen.
Ellen Relkin: Thank you, glad to be here.
Michelle: All right, now so, before we start, let's talk a little bit about you. What is your role at Weitz & Luxenberg?
Ellen: I'm of counsel to Weitz & Luxenberg, and I'm one of the senior lawyers on the drug and medical device unit, and we represent clients who have been injured by defective drugs and medical devices.
Michelle: Ok, and how long have you been with them?
Ellen: I've been with Weitz & Luxenberg for, wow, more than 18 years.
Michelle: Oh, yeah, so you've definitely got your experience for sure. Now, how did you become involved in products liability law?
Ellen: I've been in practice for 30 years. First area of practice I was involved with was what we call toxic torts or environmental law, representing people who had polluted groundwater or were exposed to hazardous chemicals. And that was very interesting, challenging work, but then I also got involved in representing what's called DES daughters. DES was probably the most notorious medication. It was used to prevent miscarriage, supposedly to prevent miscarriage, in women during pregnancy and caused horrific birth defects in their daughters. And that litigation went on for several years, many years, and I was involved in that. I felt a particular passion on that because I learned that I was almost a DES daughter, but my father fortunately did not let my mother take DES when it was recommended that she do so. So, ever since then I've been passionate about representing victims of drugs that cause serious adverse effects, many of which are unnecessary.
Michelle: Yeah and like you said there, usually these drugs are advertised to protect against something, right, so patients think, "Oh, all right, this is something that is going to keep me healthy and safe." But then come to find out later, there's other things hidden there, so glad to hear that you are helping people affected by these products. But, so we are talking about Xarelto now, which is a blood thinner, what is your current role in the Xarelto litigation?
Ellen: I am one of the court-appointed members of the plaintiff's steering committee. The way litigations work with products that affect many people is there is typically a multidistrict litigation, where cases from all over the country are sent to one judge to efficiently manage the litigation. There sometimes are parallel state court actions as well. Typically the MDL or the multidistrict litigation has the most number of cases, but it can vary. Dealing with hundreds and sometimes thousands of cases, you can’t have every lawyer be in charge of what they might be doing on an individual case. So the court appoints a steering committee – here, it's a steering committee of 12 – to manage the litigation called the discovery and the exchange of information and to see the case through to what's called bellwether trials to try to bring the litigation to a resolution by verdict or settlement.
Michelle: I see so there steering committee really helps streamline a lot of the processes in a large number of cases, like in an MDL, is that correct?
Ellen: That is correct. Typically in an MDL, most lawyers are not involved in what's called the liability part of the case, taking discovery of the defendant, getting their documents, taking depositions, because you just can't have hundreds of lawyers doing that. Court-appointed smaller steering committees and their executive committee are charged with that. The steering committee also appoints sub committees. I've been appointed to co-chair the bellwether committee. What is that? That is the committee that reviews the potential cases to determine which would be the best, most representative appropriate type of case to bring to early trial.
Michelle: When we talk about bellwether trials, these are the cases, like you said that…is it kind of like a way to gauge how the rest of the cases might go with sort of a test trial in a way, a test case?
Ellen: Exactly, that's the idea. When you are dealing with so many cases they obviously can’t all go to trial at the same time or really ever if you're dealing with hundreds to thousands of cases, so, the court wants to pick first couple, two, three, four, five trials, most representative cases to see what a jury would do, which would help inform the lawyers on both sides as to how these cases fair before a jury and whether the litigation should settle.
Michelle: Gotcha, so this kind of helps when we are talking about settling these cases.
Ellen: As a practical matter, there are not enough judges, juries, I mean if you are dealing with a large litigation – now there are not yet hundreds or thousands of cases in Xarelto, although we expect there will be more – but you just can’t. There are not enough court resources and it would be extremely expensive and it would take dozens and dozens and dozens of years. So, you pick some early cases to try and see what happens.
Michelle: Yes, it's definitely no help to anyone, including the plaintiffs, to be able to wait, like you were saying, years and years for all these things to go to trial the way it would if it wasn't having bellwethers and things like that.
So, now, let's talk about Xarelto itself. So, now this has been…this is a newer product, compared to some of the older blood thinners on the market, what is so dangerous about this drug.
Ellen: So, Xarelto is one of what's called the novel anticoagulants. It works differently than some of the others. And, you know, all anticoagulants to some extent their purpose is to prevent blood clots, therefore it makes the blood thinner and therefore bleeding it a potential risk. However, here we believe the risk is higher and in certain ways more dangerous.
And here are the reasons. The traditional anticoagulants that have been used for many, many years, decades and decades, have an antidote. If someone presents in the hospital because they're bleeding you can administer and antidote in the emergency room and the bleeding stops. There is no such antidote for Xarelto or some of the other novel anticoagulants. And that is very scary. So someone is in a car wreck, and they happen to be on Xarelto for other medical reasons, they have atrial fibrillation or have a tendency to have blood clots – which are some of the indications for this drug – and they start bleeding, they could bleed to death because it can’t be stopped. There's nothing approved to stop the bleed.
Another problem with the medication is it has what is called a low therapeutic index. In other words, it can be safe at a certain point and dangerous within a very close range.
Michelle: Oh, wow, okay – that's worrisome, because where is that threshold, right?
Ellen: It's kind of prescribed as a one-size-fits-all, I mean someone can be 110 pounds or 200 pounds, old or young with varying kidney functions and get the same dose and have a very different impact. Unlike the traditional blood thinner, Coumadin, where you have monitoring of the drug where the patient gets their blood checked periodically so the doctor can assess whether the levels are appropriate, you don’t do that with Xarelto.
In fact, one of the main marketing pitches for Xarelto is we don't need to do that, it's safe…
Michelle: Yeah, convenient!
Ellen: It's convenient. You look at the advertising and they show people traveling, you don't have to worry about it on vacation. Well, you know what? I would rather have my blood monitored than be driving blindly when we don't know what is going on inside of the body.
Michelle: No, you’re right. And like you said before, okay, so you are on this vacation, and you get into an accident or a car wreck and there's no antidote for this thing. That's kind of like, ok, goodness – so emergency situations: not very good for Xarelto, it seems like.
Ellen: No, certainly not. And even, it's not even emergency situations. Just sometimes the body responds differently depending on the time of day you took the pill, what you ate, etc., and you could be at a dangerous therapeutic level where you are getting too much anticoagulation going on. And you can have bleeds going on, whether it's in the brain, which is an intracerebral hemorrhage, eye – retinal hemorrhage, stomach – a GI bleed, any number of places which can cause minor to major to devastating impact. It's a very serious drug, and with some serious risks.
I want to talk about a different risk that we've seen from this drug which I don't think is as well recognized. And that is the risk of surgical site infection. One of the indications for Xarelto is to prevent blood clots following hip or knee arthroplasty, which is receiving a hip or knee implant, and it's recognized that if you get hip or knee implants you're going to be immobile for some period of time therefore people who get that are at greater risk of getting blood clots, thus, anti-coagulation is used and Xarelto also got approved for that. Well, one thing that I think the evidence is clear from the scientific studies including a really compelling one that just came out the past couple of months is it has a greatly increased risk of what's called a surgical site infection.
What happens is, after one of these implants, there is a wound at the surgical site, and you can get wound leakage, and sometimes that can lead to a deep infection. Not just at the site, but it goes deep into the body where the implant is. And those types of infections can be devastating and very hard to treat. Often the treatment for patients is they need to have the whole implant removed.
Michelle: Oh goodness, start again?
Ellen: And they can't start again right away, they have to make sure that infection is cleared. They have to give them IV antibiotics. They have to put in what's called a temporary implant or a spacer, which is infused with antibiotics, or they get these beads that are comprised of antibiotics. Six weeks, eight weeks, there are even patients who wind up not having a hip in place which is called girdlestone, which is a terrible thing, until the infectious disease doctors are sure the body is cleared of the infection. SO having a surgical site infection or a deep infection is a really, really scary thing. That is something that is seen in an increased incidence with Xarelto.
A study was presented to the American Academy of Orthopedic Surgeons, and it showed a significant increase in these deep surgical site infections among Xarelto patients. In fact, I mean, I could go over the numbers, but it's much greater than a 10-fold risk. Many orthopedic surgeons are avoiding the drug now, but some of them are still using it. There are safer, equally or more effective ways to prevent clots following a hip or knee arthroplasty that doctors find very satisfactory, aspirin, compression stockings and getting the patients up and walking.
Michelle: Yeah, stuff that been in use for years and year and years, right, before Xarelto came along. These infections, they can be fatal in some instances, right?
Ellen: Oh yeah, I mean, if you become septic god forbid, yeah…
Michelle: And disabling, because if you are waiting for your new hip or new knee or whatever the case may be, you're obviously not able to more around like you normally are.
Ellen: Oh yeah, it's horrific. I spent the past several years working mostly on certain hip implants that had been recalled and have had some terrible outcomes. It's the same concept if you get a new hip in and it fails and you have to have it removed, but to add insult to injury, some of those clients, or patients who are my clients, wound up getting wound infections from the revision surgery. Some of them, we're going back and looking at their charts and lo-and-behold, some of them did have Xarelto and then, they are really on a very bad course. It takes months to years out of their lives where they're in hospitals, nursing homes, hooked up to IVs…
Michelle: It’s just miserable, it's terrible…definitely sounds horrible, and that's not something anybody really thought about either. Like something we were mentioning before, the bleeding is something that sometimes people think about, but this is definitely something no one bargains for. It's approved to be used in people after the surgery, you know, which is supposed to help them.
Ellen: It’s not listed in the package insert, you know. The doctor gets what's called a package insert which is also what's on the physician's desk reference which goes over the risks and indications on how to administer a drug, and the Xarelto insert really doesn't address the risk of deep infection.
Michelle: So, when doctors are looking at this, they aren't seeing this and this. And they are doing the best they can with the info they've got. And then this thing happens afterwards and now all these studies are coming out. I think Xarelto's been out for a few years now, right? Yeah, so it's been out there without these warnings essentially, for people, and that's definitely something that is a surprise when you go in for a routine surgery and you come out with extra complications.
Ellen: I was going to say, one of the reasons these studies are coming out is doctors, orthopedic surgeons, anecdotally were seeing these really bad wound infections some just said I'm not going to prescribe this drug anymore, but those who were researchers started doing these studies. That's why there are all these studies coming out because it was observed anecdotally and they said, let's compare. And they were comparing it to a control group who were not getting Xarelto.
Michelle: All right so we talk about all the stuff here that could go wrong with Xarelto. Let's take a quick break and when we come back we're going to talk about a little bit more about the litigation that's involved. Welcome back, we are speaking with Ellen Relkin of Weitz & Luxenberg and we were just talking about some of the problems that patients have been having with Xarelto the blood thinner. And of course, that has led to quite a bit of litigation that's mounting.
Ellen, can you tell us about the reasons that some clients filed Xarelto lawsuits?
Ellen: Well, they’ve been seriously injured. I mean, that's the first major reason, obviously you don't file a lawsuit lightly. We're not filing lawsuits for people who had nose bleeds that got better. The people with serious bleeding events or these wound infections that caused significant injury and disability have sought counsel and our firm and others are representing them. Some of the legal theories that are at issue are what you see in most pharmaceutical product liability cases. The primary theory being failure to warn, which is the… almost every state has a similar – with some differences – law that says a drug manufacturer has a duty to warn at least the prescribing physician, some states extend it also to patients, but at least the prescribing physician, who is referred to as the quote learned intermediary unquote, of the risk of the drugs that they are prescribing so they can prescribe them safely or prescribe alternative treatment. It is our belief that the Xarelto warning did not sufficiently warn of the magnitude of the risk of the bleeding as well as the problems of it being this one-size-fits-all kind of crude treatment. It doesn't take into account patient variability as well as the issue that there is no approved antidote to stop bleeding when there is an emergency situation. Also, as I just mentioned about the wound infection, that's not warned about in any meaningful way at all in the package insert so doctors who just accept the word of the drug companies when they read the insert would not know.
Michelle: Right and I mean, that's the thing. Like you were saying, these companies have a duty to produce a product that’s reasonably safe. What we're talking about here then, is it something kind of like a defective product, then, that is going into the litigation? That it’s defective and they didn’t warn. Are those the main things that are going into it?
Ellen: Yeah, I mean the failure to warn. And you know, in all fairness, any drug that's going to be used to treat the risk of blood clots has to work by anticoagulation, and when you have anticoagulation, there is a theoretical risk of bleeding, but there's…you have to minimize that. And there are better way to minimize it. And by blindly saying, don’t monitor so we can market it to people that you don’t have to get a blood test without telling the patient that it's convenient but you are putting yourself at risk of a bleed, well, we think that's inadequate warning.
Michelle: Plus, we were talking about the fact that it's got no antidote, and they released it without one. I suppose that is another bone of contention there.
Ellen: That goes to its defective nature, and the fact that one of the theories of law with regard to a defective product is that there are safer alternative products and there are certainly safer alternative ways to treat the conditions for which it's approved, which is hip and knee surgery prevention of deep vein thrombosis, pulmonary embolism and the third which is atrial fibrillation.
Michelle: Where is the litigation now, what’s the status of what's going on with the Xarelto litigation?
Ellen: At this point our two major courts that are handling the litigation, the primary jurisdiction is the multidistrict litigation. When people file cases where their clients live, typically it winds up in federal court because the rules of procedure are if the plaintiff is from one state and the defendant is from another state it goes to federal court. The defendants are J&J, Johnson & Johnson, and Bayer who are from New Jersey and Pennsylvania. Most individuals are from other states, so those cases will go to federal court. Then, the deferral court system took all of these scattered cases from around the country. There was a petition to consolidate them into a multidistrict litigation, which was granted. And it was sent to federal court in New Orleans before a judge, Judge Fallon, Eldon Fallon, who has extensive, extensive experience with complex mass tort cases, he was the judge in charge of the Vioxx litigation.
Michelle: And that was a big one, definitely.
Ellen: Yes, and the drywall product liability litigation in New Orleans and he has many, many years of experience managing efficiently complex litigations, so that's where the MDL is. And then there is also a parallel state court litigation in Philadelphia, which has what's called a Mass Tort Court. And a lot of our lawyers from the steering committee are working hand in hand, some of us are the same people in the Pennsylvania litigation and some additional lawyers there as well.
Michelle: That's interesting. Does this happen often? There will be two courts involved in these big cases like this?
Ellen: Yes, generally my strategy – and I think many of my colleagues whom I respect – believe that while it's good to have a focus where we're not spread too thin all over the place where we can collaborate, it’s good to have at least one alternative and if not more venues because, just like I said, one judge can only try so many cases. At least if you have a second judge or second jurisdiction or even a third there is a greater possibility of getting more cases to trial, putting more pressure and moving the litigation further, so we think it’s a good thing so long as there is coordination. And what I see with defendants, they certainly seek to coordinate. They probably rather have it all in one place but to the extent that there's going to be a state court and an MDL they seek to have coordinated depositions and Judge Fallon actually just issued an order to that effect that he will be coordinating with the state court judge in Pennsylvania.
Michelle: Right now, then, it's in the beginning stages?
Ellen: It's fair to state that we are in the beginning stages. Although there have been a number of orders filed, four status conferences down in federal court in New Orleans, we have another one coming up next week. In June we have what's called a science day where the judge will hear from experts to learn about scientific issues at stake in the litigation. We now have all of what Judge Fallon calls the infrastructure ready to roll, the highways and tunnels which are basically the different forms – forms of discovery, forms of complaint, so now we can move on very expeditiously. We'll be getting documents from the defendants very shortly – all of the documents that were with the FDA and so forth. And the steering committee group will be working on going through those documents and typically in litigation like this we are talking about many millions of pages.
Michelle: Oh yeah, I am sure. I mean you are going to be pouring through so many medical records and so many studies, right?
Ellen: It goes two ways. We get from defendants their studies, their marketing, so forth. They get from our clients…we are going to have to fill out, or our clients will fill out with our help, extensive what's called fact sheets, which are lengthy written questions under oath so that they can understand the details of each client case and then they get medical authorizations to get our client's medical records because that is where the case lies.
Michelle: Of course, yeah, so it's just at we're exchanging information stage right now.
Ellen: Exactly, that's what discovery is all about. It's exchanging information.
Michelle: When people give you a call, say they call your office, and they're concerned about Xarelto, what kind of questions do you find yourself answering typically?
Ellen: Pretty much the same information I just relayed to you, how the litigation process works, they ask about that, they ask how do they hire a lawyer, what is our fee structure, you know some fundamental questions. I of course ask the potential clients questions as to how long they were on the drug. Were they on the drug at the time of the event? Were they on different anticoagulants before? Why were they prescribed the drug and of course what happened to them and how are they doing now. So we both exchange information and if we think it sounds like a plausible case and the client is interested in retaining us, we send them some paperwork and then we write away for medical records to confirm to see if the case is viable.
Michelle: Now here’s another question I get because people might have gone through attorneys before for other things like a divorce or real estate transactions, things like that. When we're talking an injury claim like these, the fee – well, the way that you get your fee is different, right? A lot of people say well, how much does it cost to file a lawsuit? So this is a different situation.
Ellen: Correct, this is not typically an hourly situation. Most people could not afford that. In mass tort complex personal injury cases involving medications, medical devices and in other personal injuries, it is typically on a contingency fee. The way that works is the law firm advances the expenses which can be substantial. If we recover or get a verdict which then gets affirmed and the defendant has to pay we receive a percentage of that as a contingency fee.
Michelle: The thing that I want people to know is that, they're not on the hook if nothing happens. So if you're injured I just want anyone listening to know that there's no obligation in calling and finding out what your options are because, let's talk a little bit about statute of limitations and things like that. This does have a ticking time clock on it, right, for most people.
Ellen: Oh yes, absolutely. But just to respond to what you said before. It is correct that the client is not paying any money in advance and they are only obligated when there is a recovery. So, if we – well, we don’t lose often, very rare – so if there's not a settlement or the case wasn't viable for whatever reason, they walk away. Typically, we are in the happier situation of sending checks at the end of the litigation and our clients are very happy. With regard to statute of limitations, yes, it varies state by state. And there are a lot of different details based on how the state calculates it. So, it's very important not to delay seeking counsel because clock is ticking and if you don’t file in time, you have no case. And I've been in situations where good cases have come in but the client said I was too busy, I didn’t want to deal with lawyers, but now I'm ready and I have to say I'm sorry but I think it's too late, we won’t be able to take on your case.
Michelle: So now, the important thing to say is again, don’t delay, call somebody and get some help because, you know, you need to be informed about what's going on here and if you do want to pursue a case, you definitely have to protect your right to do so. All, right, well thank you so much, Ellen, the information you've given today is going to help a lot of people – especially people that might be on the fence or wondering what to do about this. I think that you made a lot of things clear so people should be able to make a decision as to whether or not they might want to file a suit or what they should do next if they are concerned. So, thanks so much for being on the show today.
Ellen: My pleasure, thank you for having me. Take care.
Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.
Stay up to date on the latest podcast and drug and device news from Drugwatch.
You will now receive updates from Drugwatch.
Did you experience uncontrolled bleeding after taking Xarelto?