you're honest my clients were medical sales reps who were taking part in a widespread fraud on the medical community committed by nasa mo corp who used their prestige in their s p o to set technology to convince people that a new technology unproven and based on simulated accuracy data that a standard that the device demonstrated that it never would do you this is a key t by saying that along the way they did do that yes and then you're arguing that who was defrauded later so all the health care providers who submitted claims to the government for reimbursement all these nephrology clinics where the vast majority of the patients are on medicare also the sales of the devices to the veterans administration themselves so there's a let me ask with respect to those doesn't that don't aren't the marketing materials the materials given to the people who buy them i'm not sure why anybody would buy this device but they sensually say look it doesn't work all the time it's sort of like i guess the analogy i keep thinking of was the thermometer you hold up your kids had to chose it is he's ninety seven point two you really don't think he's ninety seven point two but you know he doesn't have testified in the record shows that they said this thing is accurate within one gram per deciliter it for standard deviation and that the fact of the matter is it wasn't but they told people that was they told people this thing is substantially equivalent to a co op senator and it wasn't that's why people bought it because they loved the fact that it was noninvasive and they figured hey if i can get the same results from something where i don't need a finger stick of course i'm going to do it and by the way medicare reimburses at seven dollars  disclose that the f d a came to the recognition case discloses that the f d a came to massey mo conducted an investigation and then went to the kindest way to put it took no further action so so what was given to the f d a in that early in we had meetings with the f d a with the department of justice that led to the declaration from joshua since saying they hadn't made a final right and i don't know if i'm able to orally make a notice for judicial notice file a motion and when you consider what i will say is if this is something that is issued determinative i will absolutely make a request for a beautiful judicial notice and put before you documents that will answer you know my question was simply what are we to make of it do we this is on this record does it does it is it is it is it a point that we ought to consider not consider in my opinion no because as peggy pant stated in her declaration the f d a doesn't have to act they can choose not to wait there are cases in the to give warnings to the ultimate consumer if the doctor or the user has been given sufficient warnings i read those warnings they basically say look this is a a grossly accurate way to measure it's not a there's no you shouldn't use it you shouldn't use it for diagnostic purposes you shouldn't use it if you know you know give you a rough sense of what's going on and then you might decide to do more alas my judge wardlaw i'm not sure i'd spend money for it but why why is it a fraud you might get medicare reimbursed for it maybe and then any other method but put that aside why is it a fraud so here's my my my problem with that line of the line of thinking is if you're those properly let alone if you dosed the wrong amount and so but the guys are getting it to have the art you have been given this disclosure that it's not very accurate so that's part of what they're being told but they're also being told by a rep who's in their face with the accuracy bolt and look this is what we can do this is what the device does this is how good it is these are the results you get and then massimo's controlling the data as it comes back in most of these studies so that the doctor doesn't even see the deviations unless this is part of the reason why in the arbitration justice neil had such a problem with the way that they marketed the device is that they were saying one thing and the fine print said another and to me that sounds very much to me like you're committing a fraud on somebody who's very busy who's running dozens of patients through very very critically ill patients through their practice every day titrating very dangerous medications to then on the basis of a box that was certified by the f d a using a computer simulation instead a real devices and the only evidence there is in the record of any real world testing they did shows that it failed virtually every time to meet that spec or come close to it the first device that they sold the pronto when they finally tested in the real world during their beta testing in mid two thousand and nine they were claiming accuracy of one gram per deciliter the pronto was at one point six and it was off high or low by six in many cases and so the other interesting thing is the pronto was cleared by the f d a using the old radical seven's data that they collected in two thousand and seven but when they paired the radical seven next to the pronto head to head in the same thing those  were five grams off of each other in some cases so it wasn't even performing as the same device to me yes we've asked a question or stupid in a different way let's assume the reps simply went out and selling these to users said this is a very complicated device here's the here are the disclosures we think you'll find it useful and didn't say more and any fraud in that case so you're saying they'd tell them hey this thing's off by five or no no they say they just said they just give them the disclosures that are in the materials they say here's the device you know i'm not a doctor i think it's a great device but you want to look at the disclosures and a fraud i would say yes for this reason and the reason is if you are a health care material say no it says it says in gross form it's it may not be accurate but it does say that it's not a pretty pretty good disclosure it does not say it can be off by five or six and i guarantee you if you walk one for ninety nine for forty nine to four fifty eight and it seems to say as to what total hemoglobin to devices record within the range of sixty eight grams per deciliter or at least point plus or minus one point zero g d which i'm not sure i know that at the first tender deviation which in compas sixty eight percent of the population right and that's the disclosure right and so so somebody buying this is being told this and this will be accurate within with those numbers i just read you with respect to two thirds of the population but not if not the other third reich but the third standard deviation is something like point three percent world be off by three it's so tiny it's a one third of the population the device did not perform within the narrow parameters if they were informed that it could be off by you know as much as two within a ninety five percent of the population within two which is still not ideal for titrating eva but it's not the same thing as saying this device can be off by six off by six means you can have a patient who is fourteen which is perfectly healthy for hemoglobin when in reality they're that says this is accurate for two thirds of the population but as to the others are accuracy numbers are wrong but these accuracy numbers don't apply haven't i got morning that i can't rely entirely on this  you've gotten warning that it may perform within those parameters but what you haven't gotten and what the sales force wasn't even given because management hid it from them is just how wildly inaccurate the thing could be it's sort of like going back to the original purpose of the false claims act was people were selling rifles and other munitions to the government that were faulty right so if you're going to war and you got a rifle and you know you shoot it and i can hit the bull's eye i know two thirds of the time but one third of the time it's going to be a foot off this way a foot off that way maybe you still buy the rifle but if you're told that and then you take the gun and you find out that you know two thirds of the time it shoots over in the corner near two thirds of the time it's true or whether one hundred times it's over here and every once in a while you're to hit the bull's eye to me that is in the teary really different set of facts about the product that you are giving and selling that has not been disclosed and if the disclosure in your gun case were this one shoots accurately two thirds disclosure seems to me to say look this is this is like that handheld device it's not don't use it to diagnose much but it will give you a sense if you see something grossly off on this device you want to do something but don't rely on it so it's like judge wardlaw measure wh people buy it but why is that a fraud so if that's the case if that's what they're saying about the product i just truly the message that the reps are giving about the product and the testimony from them is that that was not the message they were giving if that's the message they're giving that you shouldn't use it for diagnosis you shouldn't do this then why are there so many marketing materials in here about using the diagnostic c p t code to get reimbursed from medicare why there's so many marketing material saying you can use it to facilitate diagnosis and treatment without a blood draw if what they're saying is hey this is just an early talking about the initial clearance in two thousand and eight when margaret tomlinson in response to neil patel asking her hey we need you to vote and to follow the clinical laboratory standards institute standards  tomlinson the compliance person at nasa most says well no we don't need to do that this isn't being used for diagnosis it's just a monitor it's for somebody who's in surgery and they're already taking blood test for a moment we are into your  the person making representations no is that the omission of a for example you know ok tional or frequent five to six grams per deciliter error is going to cause the person not to buy and not to administer the test right in your own time law requires that there be evidence of a lie there's no evidence of any lie or there can be a knowing or we should also care to know if case law is very clear now with what you say is is is false because you've left something out of it i'm not talking about your duty to say everything i'm saying if i say to you it's a beautiful day outside look and i know that it's twelve degrees i made my statement is then made knowingly false or not well but that that he knowingly false we don't have that accusation here the mass of most submitted the data as required by i so ninety nine nineteen massimo was required to market it always did that now remember massimo did not have to aim to be at one point zero there was no predecessor device that non invasively measured hemoglobin that was simply the result of mas investigation as judge carney noted and as the decorations all show the doctor's daughter this device would be useful even at one point eight or even greater even the related us can see in their own testimony that doctors found the device to be very useful and the reason why the device is useful and the reason why people do buy is because it's not invasive it doesn't require the taking of any blood the hand mccue which was the other device on the market a point of care device required to prick the finger or the skin to withdraw blood and as judge carney noted in the records showed this device the massimo device is better and is more accurate than the he mchugh so there's the answer why the device is is is a useful device with a makes me ask a question based on what your opponent had to say let's assume that all your dealings with the f d a were above board and straightforward and everything else but that that i want to explore i'm trying to figure out what has to be shown in a false claims act case so let's assume for the record for the moment that the records show that massimo said to its wraps rw and others yeah we've made full disclosure but we're afraid if people read that they won't buy it so go tell them that this is terrific and there's no problems with ever using it and they told that to doctors and doctors bought it what would have to be shown to make that a false claims that think the doctor jermaine who said it wasn't useful for his study with certain kidney patients into the out of kidney patients the point is the studies require that this the data be gotten from healthy patients adult volunteers healthy patients under so ninety nine nineteen but to your hypothetical yes it would have been nice if they had somebody say that i wouldn't have bought the device and buying the device and therefore i made a claim much in the made they had no evidence from any doctor at any time that the doctor was an any way misled in fact all the declarations from all the doctors all testified that of course they understand you can't replicate laboratory data in the field and that's the misunderstanding with the presentation the doctors dr sanders dr goodman the doctor to man all the doctors that testified in this case they all said they understand that in the field with sick patients you can't replicate exactly the data that's given to the f b i because the f d a wants well controlled laboratory conditions from adult volunteers it's interesting that the gun example was used when you test a gun you test it in a vacuum you test it on a tripod you test it where the pressure on the trigger is as minimal as possible and then you say all the bullets fall within the two inch radius but if a person buys the gun and says hey i'm unable to get within a two  does anybody think the gun is the fact of no it's you're confusing the field usability with laboratory well controlled conditions with health you don't volunteer and that's the miscommunication we're having here so they think because the data wasn't replicated in the field it somehow shows massimo misled the f d a somehow that's not so the f d a wasn't interested in field data they want laboratory data under ninety nine nineteen there is the rub so to the extent they claim that the vice is faulty it's no good why would somebody buy it the leading case in the ninth circuit is the way in case the wang case which was the subject of subsequent  self critical assessment of their own work this is on page fourteen twenty one of the wang case and then the ninth circuit this court continues and says the government knew of all these the fission seeds just as you noted in the beginning of the argument massimo fully discloses the limitations of the confounders about the device and since the government knew of the deficiencies and discussed them there can't be any c n d report let's go to go to the doctors that's where i was focusing so let's assume as your polling argues that after you began after the f d a approval occurred you learned it the it was it was an inaccurate device integrator in the field to a greater extent than the clinical stuff showed is there any obligation disclose that to the physicians no you have to disclose to the physicians what the f d a allows you to say so we are required to disclose to the f d a what's in the indications for use and the accuracy specification you're data and in fact it was disclosed to the f d a in fact in the five ten k on the pronto seven we even disclosed that some of the data came at one point two one point one one point zero point nine point eight and the f d a was satisfied that point one was six talks about the third quarter twenty thirteen we were notified that the f d a in the united states attorney's office for the central district of california criminal division are investigating the allegations participate the government did file one brief they were only interested in one legal proposition the government did not stand by the related homicide case so yes i realize that so what so what i understand you to be saying is something that i'm just was approved under that protocol all your disclosures conform to the protocol as it was approved and you were not allowed to say thing else about the device correct you must follow the f d a rules and said it's disputed that the letters were sent to the f d a it's undisputed the f d a came out and conducted a nine day or so investigation i have may have two days off by one or two there's the record disclosed that the investigation resulted in no further activity or yes but did you actually get a letter or something from the f d a that said ok we're where we're happy yes and if you are too long i where is that in the record yes that is in the record yes ok i can visit the only concern that i have remaining concern about the question of what your sales force was told to tell the doctor who says or evidence said they were tell not to represent it could be useful for diagnostic purposes i know of no evidence where we told the sales folks to misrepresent the device in any way so the answer is no no no evidence like that amount of fact they're required to disclose the very materials that you've been alluding to the manuals that where it states exactly what the f d a allows you to say and and so even the relator testified that they did what they were supposed to and that the doctors  knew that you couldn't replicate the data the doctors know about the confounding factors but you can't replicate laboratory data in the field just like you can shoot a gun and get within one inch of the target that you could in a laboratory so the evidence is under spirited that we that no doctor was misled by anything that was said and all that's why all the doctors testified that they're well aware of the fact that you can't replicate laboratory data in the field not a referendum about how good our device right how did we live did we have the sea enter to mislead to cause foss claims against the government there is no evidence that we misled anyone which led to somebody making a false claim to the have a father who is a federal judge appointed by president johnson i have another brother who has a last name right you may be thinking of another read the name is not that the donald gray doll ray is he doesn't think just to address and some quick points the beta site testing results is shown an a or three seven seven seven and that shows what the results were after the beta site testing and it shows that  almost one point nine grams per deciliter off at the first standard deviation and that the radical seven was one point five off and that importantly since that same validation device validation testing for the radical them after the arbitration if you know what i want just looking for what's in the record here so be be careful i'm not going to go beyond the record if i'm just me say we went back to them and gave them whatever they wanted from the six hundred thousand pages we had from the arbitration and then joshua si showed an hour later testing or later testing or later field testing shows that it was inaccurate we're not required to disclose that to physicians because it's apples and oranges what's your response to that i think that is a bizarre position for a medical device manufacturer to take that they simulate their testing in the lab he dishes find out the device in the real world doesn't come close to meeting that and it can warn anybody withdraw the device under the food drug and cosmetic act that is an obligation they have as a reasonable and responsible medical device manufacturer we're not dealing with that responsibility revealing with representations they made to people so my question is very simple do they have an obligation when selling the device to say here's our f d a studies they're all accurate let's assume they've done everything correct so far we've been conducting some further studies and we're not so sure about some of the stuff or don't they have that obligation yes or no in my view as a responsible medical device manufacturer if you know that your device does not live up to the accuracy standards that you are stating to doctors coupled with the knowledge that the accuracy standard you're stating to doctors was computer simulated instead of being conducted on a real device you absolutely have an obligation to do that and to omit that material information is likely to lead to a sale for someone for whom one gram per deciliter at once and deviation is enough and to fail to do that is fraud and if you don't have any for that is it actionable under the false claims act that's the question so it's a fraud a knowing fraud that is likely especially in the case of nephrology patients most of whom are on medicare to lead to the submission of false claims to the government and in this case we have evidence that they did sell it into the nephrology clinics we have the eighty eight seven thirty eight c p t code which the evidence from dr bradford's declaration shows was only from massimo devices there were no other devices that use eighty eight seven thirty eight in the entire world so every eighty eight seven thirty eight c p t code hit is from a