american lawyer

ivc filters were designed to catch blood clotsbefore they move to the lungs. they're typically implanted when the patienthas a history of pulmonary embolism or deep vein thrombosis. when you review the law suits that have beenfiled against the manufacturers of these filters, it's easy to conclude that the devices arelikely causing more harm than good in patients, so here's the problem. when a patient has surgery, one of the mostsignificant dangers is the development of blood clots that can travel to the lungs andcause pulmonary embolism, or clots that can travel to the brain and cause death.

ivc filters were designed to prevent thatand 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 andeasily removed after they serve their purpose, but, according to hundreds of law suits thathave 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 filtermigrates throughout the body and causes as much damage, or even more damage, than a severeclot.

as we see in the overwhelming majority ofthese defective medical device cases and drug cases, the company was well aware of the dangersand chose to keep that secret even though there were alternatives that would providethe same kind of anti-clotting protection for patients, with much less risk. according to documents from a law suit filedagainst [c.r. bard 00:01:41], the company knew that their filter had a much higher rateof failure than other similar devices. they knew that from the beginning. their own documents showed that their retrievablefilter had a fracture rate five times higher than an alternative filter and that theirbrand of filters was 13 times more likely

to fail than other types of retrievable filters. according to documents, that information waspresented to the company december 15th, 2004, but even six months before that, the companyhad already provided media training for its employees to deal with the controversy surroundingits products. so they already knew, clearly knew how seriousthe problem was. in may 2004, employees with the company weretold how to handle questions about the failure and dangers of these filters. documents show that the company schooled employeeson how to route telephone calls from reporters who were asking questions about what theyshould do, and they were told to preempt any

negative stories about their failing product. so, fast forward, from may 2004 and you wouldthink that bard would have done at least one of two things. pulled the product from the market, or replacedthe defective filter with one that doesn't cause death. but as i speak tonight, c.r. bard has doneneither. in fact, the problem exists ... so long, it'sbeen there for so long that even the dysfunctional fda sent the company a letter in july 2015telling them that their reports of health problems with their filter was dangerouslyinadequate and they even questioned whether

they were being honest about the numbers ofpeople being harmed by this product. another classic case of a corporation puttingprofit above safety. for the rest of the story, let's go to howardnations, a member of the trial lawyer hall of fame preparing to go to trial against theivc manufacturers very soon. howard, there's a team of lawyers throughoutthe country trying to solve this defective filter problem. how many attorneys are working on this caseas we speak? nations: i'd say we have 200 to 300 lawyersactively working on this. in the mdl litigation in arizona, there are20 firms in the leadership role, and then

the same thing in indiana, there are 20 firmsthere. and then there's a group in california inthat litigation. and the good news is that you have some ofthe finest mass tort and pharmaceutical lawyers and medical device lawyers in america workingon 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 productwhen it goes bad.

nations: well the injuries are the functionof 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 mostfrequent injuries where the sharp legs on the filter that are designed to hold it inplace, actually perforate through the vena cava and into the adjoining organs. now the adjoining organs include such thingsas the aorta. you can imagine perforating the aorta, theproblems there, or the adjoining [valve 00:05:05].

the next thing which is a very severe anddangerous, dangerous failure are the fractures. fractures are dangerous because you may havethem and not even know it. the fracture is where the legs' very sharpends ... the legs break off and move through the bloodstream into the heart or lungs mostfrequently, or into other places also. the problem you get into with fractures isthat the fracture rate is five years after implantation, so people may have a ivc filterthat was put in in 2010. they say, "well, you know, i haven't had anyproblem with it. everything's fine with mine." let me give you a quick story.

in 2009, a client of mine had a filter putin place. she's a nurse. six years later she had no problems. six years later she was rushed to a cardiaccare unit. they did emergency open-heart surgery. they had to go in and find a leg that hadfractured 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 dayslater, there's still another leg missing. so she's got one of those struts moving aroundin her body and she may have to go through this whole thing again. so the fact that you've had one in for fiveyears doesn't mean anything. papantonio: okay. one thing for sure, howard. from what i'm seeing on the case that you'reworking up, the company clearly knew. these companies understood the problem withthis fracturing.

they understood that it could have the potentialto lacerate organs in the body and move throughout the entire body. when did they find out and what did they dowhen they found out? nations: well this started with the race toget approval of the retrievable device. the original device was permanent. so there was a race between bard and [cook00:07:14] to have a retrievable device. so bard did a scientific study, a clinicaltrial. usually a clinical trial for something, especiallya 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 designednot for safety and efficacy. it was designed to test only retrievability. in that 33-patient trial, they had one migrationon patient #9, and they two fractures in patient 33. now with those kind of results in only 33patients, 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-onlystudy and they got clearance from the fda.

and they never really determined the causeof the fractures or the cause of the migration. when it was put on the market ... it was therecovery device ... when it was put on the market, over the next few months of it beingon 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 onthat, they were designing the product to correct the problems that they knew they had, butinstead of not putting it on the market until those problems had been corrected, they leftit 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 industrycreating needs for prod-. are there alternatives that can be used tosolve 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 avoidthe ... 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 designedto stop. you can have a filter in place that's tiltedand blood can accumulate around the tilt, and a clot can form there and it can createthe 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 lotof money with this. they know trial's coming up. at this point, as you're looking at thesedocuments, what do you say is the real story that you're seeing in these documents? in about a minute, give me your quick takeon what the documents are telling you, that the jury's really going to react to in thiscase. nations: well what the documents are tellingus is that, first of all, there was a race

to put this on the market, and in the raceto 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 analysisof that. in order to solve that problem, you have toget to a root cause analysis. they never got to a root cause analysis, asa result of which they did not solve the problem. they put it on the market so they could bethe first out, the first on the market. they did not warn the doctors about theirfindings.

they went ahead despite migration after migrationcausing death. they were getting about one migration deathper month and it still remained on the market. they never withdrew it. they were getting fracture upon fracture uponfracture. they left it on the market. papantonio: howard, 20 seconds, that's alli've got. they could pull this off the market anytimeif they wanted to ... 20 seconds, tell me if that's true? nations: they can absolutely pull it off themarket until they corrected it, because they

knew immediately. they knew immediately what was wrong withit and they started designing the fixes into their next product, which was the g2. and the whole time they're designing the fixesand 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 thefda approved this product despite the fact that it was a 33-patient study.

papantonio: howard, thank you for joiningme. go after them, my friend. go after them.