claims act the case was pled where the defendant deliberately made and sold an unapproved class three device for contraindicated use they tried did not get these products approved by f d a but instead went through the far more cursory level if i understand the walk rightly if the device was unapproved and should have been a last three go by then wouldn't it be a false alternative so here metron it then turned around and manufactured and deliver devices to hospitals across the united states that could only fit in the contra indicated cervical spine level and used to their well known cervical brand name of that were things that confused me was the different sizes of the device and i couldn't figure out why wouldn't a trained or the predicts surgeon know the difference just based on the size alone that's a great question your honor in the end of the what they didn't know was the status of the device they knew that it was clearly a device that would fit in the neck and they were using for that if you look at e r three  even if that's an off label use assuming it's otherwise appropriately approved for some use that would be ok would it not it would not because here it's this is not what the defendant   there is a certain amount of medical judgment in here it is there not in the surgeon's decision to go forward with the procedure utilizing the medtronic device that's being handed to him by the sales reps in the operating room seems to me i could agree with you on part of your claim that the district court was wrong but damn i could also be of the view i think what like says polman is saying that that doctors  accepted standards of mental practice so i could see i don't think it would be inconsistent for me to feel that one of your clients doesn't make at but them on the claim regarding to in class three that you might be a rights here right being made is that legally inconsistent do i have to do i have to do i have to bite the whole apple no i well there's a campy area and campy seem to say that you can't take a claim in that area crowd i guess that's what i'm trying to i'm trying to say if i if that's what and i don't know that that's where i'm going to we have a conference on this i'm not speaking for other people but i'm wondering if you find that legally consistent that we would have to agree with you in toto are we could agree in par the whole medical judgment off label use area if you look at twenty one dollars c f r eighty eight thousand three hundred and eight dollars which they rely on it's only a few paragraphs and it talks only about fusion devices not using manufactured bone being class two that's not what we're it why would have to regulate those as class three something using natural bone bert and then say ah but if you're going to make it out of plastic or something else don't worry about class two they've never done that and that's not so these are clearly adulterated devices that ma assuming that you're going to be able to prove that c m s paid for virtually all of these claims i assume it did so because it relies on the medical judgment of the cases before i understand odor but but again regardless of what c b t code the claim was submitted under i'm really hung up on this notion that that the doctors were just duped in a way that i wouldn't expect an orthopedic surgeon to be duped if he or she had any experience doing these kinds of operations so let me try and clarify that your honor to the point the too large or too small a device or the part of the spine that it was intended to be used no i don't think they would have at all because these are it's a it's a very substantial equivalence is not an approval process at all it's taking the manufacturers word that they are making something for a particular part of the spine and especially where medtronic says in black letter writing contraindicated for the cervical spine so your position is that size dimensions alone would not additional questions mr carter he which is a false claim for reimbursement instead as we've just heard later attempts to plead arguments of regulatory violations before f d a that are not the standard for reimbursement alleged misrepresentations made in the approval process and has not taken any action and we find can you help me square that position with the statement by this court in the united states  with the significance of the allegations about the later approval is that the defendant was trying to cut off causation and say that later approval is shows that f d a thought this chinese fact a facility was so even we earlier drugs made in the chinese brazil of the were were fine and eligible for reimbursement and what the court said is well wait how can we know that for that purpose when the allegation is that you misrepresented to f d a the quality coming out of that chinese facility anyway anyhow and f d a had taken in forstmann action on the basis of that and the product had been removed from the market because of those with standards of medical practice regulator does not want to fight on the nd of those which is the standards of medical practice there are no allegations about that other than their own acknowledgement that were covered by class three why wouldn't that be a viable claim of fraud on the agency which then triggered the reimbursement from c m s well what but that is in fact what manufactured for the cervical spine to be a class three medical device and then tell the jury if the defendant submitted such a device under the guise that it was simply substantially equivalent to a class to devise well knowing in truth that in fact that they could only be used on the cervical spine which makes it a class three device that that constitutes fraud on the age and i haven't heard i haven't heard a convincing answer from you yet as to why the f d a would have cleared this device as a class two substantially equivalent medical devi without requiring medtronic stew go through the p m a process which is substantially more time consuming and expensive in order to get class three authorization for a device intended to be in that provision to where it's located we have provided for the court to take judicial notice of additional clearances these are not in the record but they are government documents of which the court can take you dish will notice categorical distinction between class c one class three depending upon whether it's cervical or harass the lama oh let me ask you this then if if we were to find that the plaintiff adequately alleged that fifty seven in which the application called out explicitly and eleven millimeter via levon millimeter device and sad is that this is the device this only fits the cervical spot well your honor that fact was called out in the application that it was eleven by letter and relate are ones to say that device is that it is approving if i understand related allegations here it is that the agency was duped into approving a device had it known what the device really theory was that the device that was a could only be missed in the cervical spine no even though they convinced the agency to approve it thinking that it was going to be used in the lower part of the spine isn't that  of the spine at the portion that which the device is to be and service and if they didn't submit a photograph or a diagram of the device how is the agency supposed to figure that out what you or your hon that nobody knows what they're doing except from the major the doctors don't know what they're doing because they're just taking something that was given to this court in th before it goes into surgery it's also implausible that f d a did not look at the dimensions of the devices they were clear and when both dimensions were called alex was fifty but counsel were at the pleading stage of the case and it seems to me this is the weakest part of your defense that this is the strongest part of the relator his claim that they're just that there is enough here that is was of all at least go forward with and if they meet the other that's not good well your your honor if it if it was not if the device was not cleared for sale it wasn't lawfully something that could be marketed then you would never that the defendants went on and only market it for use in this fine and the supreme court in buckland's that that is not a theory that a private plaintive in a server running in order to prove honor smith has the court my name is medtronic claiming that we're trying to substitute in our judgment for that of the f d a in fact if we took this case to a jury we would not be asking them to substitute in judgment on a device simply asking it's then why why are you able to bring this claim of fraud on the age of your honor i do not believe that buckman stands for the proposition that a private plaintiffs or that it revelator is preempted because the false claims act provides its own basis for liability also claims act or later is have their own prerogative to pursue fraud on public agencies whereas the itself nor the department of justice have shown sufficient indignation to become involved either in this case or in some other forum to remedy the alleged fraud you honor st of all while the department of justice has declined to intervene in the case they have also not moved to dismiss the case which is department policy to do if they do not believe the case is meritorious so we think the department of justice position is that the case is meritorious that they simply have limited resources to pursue it as the f d a we have no record of effort to gain knowledge about these allegations there's simply no record of that and so we can't read into what the f d a has or hasn't done the f d a has no authority to say what so we're also not talking about garden variety off label use here and off label uses when a drug or device has been tested and approved and proven to be safe and effective for its intended use but that never happens here so awfully well use of the doctor's decision to creatively say we know this product is safe and i'm going to apply it in this other fashion but it's not have to manufacture or say well this off label or this other use that we haven't tested is going to be ok field of device regulation is occupied by the f d a monitoring and approval process so as product liability claims saying that a device was fraudulent approved and therefore  the plaintiff has been injured is different than saying there was a lie and deception that happened here and that undergirds a false claim for payment so we also have no reason to think that the f t c a would preempt the false claims act they should be equivalent and they have their own special fields of what they're supposed to regulate so i don't think that is the congressional intent that devices were recently flared there's no retroactivity so just because the new device has been cleared for use in a certain region doesn't mean that retroactively other different devices should also be cleared the regulations say what they say and we think that they don't apply those devices anyway and we also don't know if medtronic had a predicate device that was for a pre market approved for these new devices and the other thing is that these new devices the labeling that medtronic submitted devices that we're talking about in this case are one size or they come in various sizes but it doesn't change shape or size the surgeon inserts it into the hole and hammers it and that's it so that's entirely different technology and the new devices are based on this entirely different design i did new devices fast two or class three they were cleared which i think was the point that counsel is making however what we're saying is that we don't know anything else about these devices and they really have no bearing on the kid devices that issue here because they're brand new and i think it also reflects the difference you know we don't know what the f d a is thinking at any given moment in time but what we do know is that the device we're talking