Papantonio: IVC filters were designed to catch blood clots before they move to the lungs. They're typically implanted when the patient has a history of pulmonary embolism or deep vein thrombosis. When you review the law suits that have been filed against the manufacturers of these filters, it's easy to conclude that the devices are likely causing more harm than good in patients, so here's the problem.

When a patient has surgery, one of the most significant dangers is the development of blood clots that can travel to the lungs and cause pulmonary embolism, or clots that can travel to the brain and cause death. IVC filters were designed to prevent that and that's a good thing. The filter's implanted in the patients' arteries, where they're meant to catch blood clots before they reach the vital organs. The filter's supposed to be retrievable and easily removed after they serve their purpose, but, according to hundreds of law suits that have been filed, many of these filters are fracturing inside the patient sending small, needle-like shards of metal throughout the entire body causing severe internal lacerations. Other law suits show that the entire IVC filter migrates throughout the body and causes as much damage, or even more damage, than a severe clot.

As we see in the overwhelming majority of these defective medical device cases and drug cases, the company was well aware of the dangers and chose to keep that secret even though there were alternatives that would provide the same kind of anti-clotting protection for patients, with much less risk. According to documents from a law suit filed against [C.R. Bard 00:01:41], the company knew that their filter had a much higher rate of failure than other similar devices. They knew that from the beginning. Their own documents showed that their retrievable filter had a fracture rate five times higher than an alternative filter and that their brand of filters was 13 times more likely to fail than other types of retrievable filters. According to documents, that information was presented to the company December 15th, 2004, but even six months before that, the company had already provided media training for its employees to deal with the controversy surrounding its products. So they already knew, clearly knew how serious the problem was.

In May 2004, employees with the company were told how to handle questions about the failure and dangers of these filters. Documents show that the company schooled employees on how to route telephone calls from reporters who were asking questions about what they should do, and they were told to preempt any negative stories about their failing product. So, fast forward, from May 2004 and you would think that Bard would have done at least one of two things. Pulled the product from the market, or replaced the defective filter with one that doesn't cause death. But as I speak tonight, C.R. Bard has done neither. In fact, the problem exists ... so long, it's been there for so long that even the dysfunctional FDA sent the company a letter in July 2015 telling them that their reports of health problems with their filter was dangerously inadequate and they even questioned whether they were being honest about the numbers of people being harmed by this product. Another classic case of a corporation putting profit above safety.

For the rest of the story, let's go to Howard Nations, a member of the trial lawyer Hall of Fame preparing to go to trial against the IVC manufacturers very soon. Howard, there's a team of lawyers throughout the country trying to solve this defective filter problem. How many attorneys are working on this case as we speak?

Nations: I'd say we have 200 to 300 lawyers actively working on this. In the MDL litigation in Arizona, there are 20 firms in the leadership role, and then the same thing in Indiana, there are 20 firms there. And then there's a group in California in that litigation. And the good news is that you have some of the finest mass tort and pharmaceutical lawyers and medical device lawyers in America working on this very diligently.

Papantonio: The reason I ask the question ... I want the viewers to understand how extensive this problem is. This isn't just an isolated case. And the damages are horrible. Would you explain what happens with this product when it goes bad.

Nations: Well the injuries are the function of the failure mode, and there's several different failure modes. First of all you have migration which can ... the entire filter can move up to the heart and cause death. Next you have perforation, one of the most frequent injuries where the sharp legs on the filter that are designed to hold it in place, actually perforate through the vena cava and into the adjoining organs. Now the adjoining organs include such things as the aorta. You can imagine perforating the aorta, the problems there, or the adjoining [valve 00:05:05].

The next thing which is a very severe and dangerous, dangerous failure are the fractures. Fractures are dangerous because you may have them and not even know it. The fracture is where the legs' very sharp ends ... the legs break off and move through the bloodstream into the heart or lungs most frequently, or into other places also. The problem you get into with fractures is that the fracture rate is five years after implantation, so people may have a IVC filter that was put in in 2010. They say, "Well, you know, I haven't had any problem with it. Everything's fine with mine."

Let me give you a quick story. In 2009, a client of mine had a filter put in place. She's a nurse. Six years later she had no problems. Six years later she was rushed to a cardiac care unit. They did emergency open-heart surgery. They had to go in and find a leg that had fractured and was perforating her pericardium. So her pericardium, the sac around the heart, was bleeding and filling up the sac. She flat-lined on the table. They managed to drain the blood. They managed to save her life. Then when they took the filter out, six days later, there's still another leg missing. So she's got one of those struts moving around in her body and she may have to go through this whole thing again.

So the fact that you've had one in for five years doesn't mean anything.

Papantonio: Okay. One thing for sure, Howard. From what I'm seeing on the case that you're working up, the company clearly knew. These companies understood the problem with this fracturing. They understood that it could have the potential to lacerate organs in the body and move throughout the entire body. When did they find out and what did they do when they found out?

Nations: Well this started with the race to get approval of the retrievable device. The original device was permanent. So there was a race between Bard and [Cook 00:07:14] to have a retrievable device. So Bard did a scientific study, a clinical trial. Usually a clinical trial for something, especially a new product, would involve at least 300 patients and it would be done in multi centers. This particular one was 33 patients. It was done in Canada, and it was really designed not for safety and efficacy. It was designed to test only retrievability. In that 33-patient trial, they had one migration on patient #9, and they two fractures in patient 33. Now with those kind of results in only 33 patients, they knew very well that they needed to have a large study, at least 300 people.

They did not do so. They went straight to the FDA with that retrieval-only study and they got clearance from the FDA. And they never really determined the cause of the fractures or the cause of the migration. When it was put on the market ... it was the recovery device ... when it was put on the market, over the next few months of it being on the market, there were migrations and there were 13 migration deaths that were recorded, and there were 87 fractures. And all the time that they were working on that, they were designing the product to correct the problems that they knew they had, but instead of not putting it on the market until those problems had been corrected, they left it on the market with all the deaths and resulting injuries as a result of it.

Papantonio: Howard, let me ask you this. Is this even a necessary product? I mean, we see time and time again the industry creating needs for prod-. Is this even a necessary product? Are there alternatives that can be used to solve the problem where we don't get into things like we're talking about here?

Nations: That's a very insightful question, [Pap 00:09:11], because first of all you have anticoagulation therapy which is used to avoid the ... to dissolve clots as a regular therapeutic remedy. But there's no scientific evidence ever done, ever perceived, ever produced by anyone that shows any efficacy of the IVC filter. On the other hand, they are pro-thrombotic. They create the problem that they're designed to stop. You can have a filter in place that's tilted and blood can accumulate around the tilt, and a clot can form there and it can create the blood clot, cut it loose, and send it in a form of pulmonary embolism in the lungs. So are they efficacious? No. There's no proof of it. Are they pro-thrombotic, and dangerous? Yes.

Papantonio: okay. And the company I suppose is making a lot of money with this. They know trial's coming up. At this point, as you're looking at these documents, what do you say is the real story that you're seeing in these documents? In about a minute, give me your quick take on what the documents are telling you, that the jury's really going to react to in this case.

Nations: Well what the documents are telling us is that, first of all, there was a race to put this on the market, and in the race to put it on the market, they did not do the type of testing they needed. They did get the type of fractures, the migration, the type of injuries that you could expect in the future. They did not find the root cause analysis of that. In order to solve that problem, you have to get to a root cause analysis. They never got to a root cause analysis, as a result of which they did not solve the problem. They put it on the market so they could be the first out, the first on the market. They did not warn the doctors about their findings. They went ahead despite migration after migration causing death. They were getting about one migration death per month and it still remained on the market. They never withdrew it. They were getting fracture upon fracture upon fracture. They left it on the market. They never withdrew it.

Papantonio: Howard, 20 seconds, that's all I've got. They could pull this off the market anytime if they wanted to ... 20 seconds, tell me if that's true?

Nations: They can absolutely pull it off the market until they corrected it, because they knew immediately. They knew immediately what was wrong with it and they started designing the fixes into their next product, which was the G2. And the whole time they're designing the fixes and designed modalities changing, they were still selling the one they knew was bad. It's egregious. It's outrageous conduct. And the other outrageous part of it is the FDA approved this product despite the fact that it was a 33-patient study.

Papantonio: Howard, thank you for joining me. Go after them, my friend. Go after them.

Mike: The FDA has received hundreds of complaints about the intravenous filter designs to catch blood clots in the patients who can’t take blood-thinning medication. Recently, I talked with Attorney Jeff Gaddy about the dangers, serious dangers, about these filters and what the company knew about the dangers. Let’s take a look.

Mike: Jeff, it looks like the FDA let another one get by. I don’t know how many times we’re going to have to do stories like this until the public starts announcing and understanding that the FDA has become completely dysfunctional. This IVC filter never should have happened. First of all, lay out for the viewers what is the IVC filter to begin with. What is this product we’re talking about?

Jeff: Sure, Mike. The IVC filter is a medical device that’s intended to prevent pulmonary embolism. Essentially, it’s a device that looks kind of like a spider. It’s implanted in the inferior vena cava, which is the largest blood vessel in the body. This device is implanted just below the kidneys, in that vessel, and it’s intended to trap blood clots that may be traveling up that vein. The problem that we’re seeing with these IVC filters is that the manufacturers looked to get into the retrievable filter market and attempted to establish a niche. What they did was they took a permanent filter, which was a pretty decent product, and they weakened it.

Mike: In other words, Jeff, this is a story we hear about time and time again. You have something that works. The marketers come in there and they say we can make more money by doing something different. They don’t have to do it, but they can make more money doing it. It may be a medical process where they can get paid for it. It may be selling another product that they don’t have to sell so they can get paid for it. Time and time again, you see the same type of things. What you’re describing here is before the IVC filter even came in existence, there was a system that worked where you didn’t have to replace anything. There was no risk of breakaway. There was no risk of migration. There was no risk of an anaphylactic immunology reaction. Why even have this product out there?

Jeff: You hit on it already, Mike. It’s money. They had a permanent filter that was doing a good job of preventing pulmonary embolism in patients that were contraindicated for blood thinners. They went into the retrievable market, and in order to make the filter retrievable they had to weaken the filter. This is a device that’s put into a very dynamic part of the body. This is the largest blood vessel in the body, and there’s a lot going on there, a lot of blood rushing through. When they make these filters weaker so that they can be retrieved, they’re susceptible to a lot of these adverse events that we’re seeing, where you’re having legs of the filter break off, you’re having the entire filter migrate through the body, you’re having the legs of the filter perforate the blood vessel that it’s implanted in, and it’s leading to a lot of these adverse clinical outcomes.

Mike: Including death.

Jeff: Absolutely.

Mike: Here’s what always amazes me, Jeff. Here you are a hugely experienced trial lawyer, many, many trials under your belt. It’s almost like the company doesn’t understand that sometime somebody like you is going to be in a deposition asking these tough questions and they’re going to have to answer these tough questions. The way I see their attitude is they really don’t care. The question comes down to how many IVC filters can they sell, how much profit does that put in their pocket. After they do the computations, they figured out how many people did we kill, how much do I have to pay per person. The only case we hear about in that regard is the Ford Pinto case where they calculated we can kill X number of people and still make a profit on our exploding gas cans.

Jeff: Mike, you’re absolutely right. These medical manufacturers love to say that they put the patients first, but when we get in there and start to look at the corporation documents and look at how they really act, we see that that’s not the case at all. In fact, NBC News did an investigation into C. R. Bard, one of the big manufacturers of IVC filters, and one of the things they found was back in 2002 when there were initially some deaths from these retrievable filters, the first thing that Bard did was not run and tell the physicians what was going on, not take the device off the market, but hire a PR firm to determine what their response needed to be when and if anybody found out what was happening from their devices. That’s the theme that I know you’ve seen over and over again with a lot of these big pharma-type companies, and we’re seeing it once again as it relates to the IVC filters.

Mike: The first thing you do as a trial lawyer is you get all the documents. You don’t get them just from the company because most of the time the company destroys those documents. What you do is due diligence. You get them from other sources, you start reviewing them. What you’re already seeing with this case, Jeff, is it already lining up to where if this thing goes to trial the same story is going to be told, profits were put ahead of human health and that the marketers of the product were actually in charge rather than the scientists being in charge. Do you have a feel for that right now as you’re looking at this case?

Jeff: It’s the same story that we’ve seen time and time again with the medical device industry. They have a product, it hurts people, and they want to pull the ostrich and put their head in the ground, they want to bury their head in the sand and pretend they don’t know what’s going on. Like we’ve seen over and over again in this industry, money talks and that’s what drives their practices, and that’s what drives what they do with these devices.

Mike: Tell me about the involvement of the FDA here, Jeff.

Jeff: Sure. Sure. The FDA has spoken out on two different occasions, once in 2010 and again in 2014, about retrievable filters in general. What they said both times is they’re seeing a large number of adverse events, and what they’re recommending to doctors is is, “Hey, if you have any patients with these filters in them, you need to get them out as soon as possible.” Even one study came out and said once they’re in for more than two months …

Mike: They start biodegrading and then the cost to remove is ridiculous, isn’t it?

Jeff: Right. Essentially, it’s more beneficial to the patient after two months to not have it in than to have it.

Mike: Right.

Jeff: However, in the face of the FDA coming out and saying you need to get these things out as quickly as possible, the medical manufacturers continue to tell doctors that retrieval is optional.

Mike: First of all, I think you would agree, it’s remarkable that the FDA would do anything because once a product is on the market, like an IVC filter or whatever it is, the FDA usually does nothing, they will simply allow it to happen. The very fact that the FDA is saying you better take some action is in and of itself like a big red flag, isn’t it?

Jeff: Right. You’re absolutely right. I know you’ve been doing this for a long time and you see it time and again, that the FDA is often one of the last ones to recognize and announce that there is a problem and it’s up to the civil justice system to really keep these big companies in line. You’re absolutely right. The fact that the FDA has come out and said anything at all should be a big red flag that we have a product with a serious issue attached.

Mike: You’re handling a lot of these cases. What do you tell these people that come in and say, “I’ve got this in my body. What in the world do I do about it?”

Jeff: It’s scary because really they don’t just have a filter in their body, they have a ticketing time bomb. We certainly recommend that they consult with their physician, they get it checked out to determine whether or not the filter can be removed safely, and if so it’s not something that you want in your body any longer than it has to be.

When they talk to their doctor, very often the doctor is going to push back because he or she’s getting the wrong information from the manufacturer. My recommendation is be persistent, get it out. There’s not even a close call here. When you see your doctor about it, you need to be adamant. Go in their armed with the facts, and when they try to push back and say don’t worry about this do not stop there.

Mike: Jeff Gaddy, thank you for joining us. Good luck on this case. I know they’ve got a big problem with you working on it. Appreciate you joining me.

Jeff: Thanks for having me, Mike.