so we show here so we'll start with the day calendar coin versus thank you how we doing it it's good morning morning may please the court of the district courts erred in finding that dr klein was not in a regional source and the district court erred in finding that the complaint to properly allege the submission of false claims the reason the court made these errors was that the courts gave improperly gave the benefit of inferences to amgen rather than to dr cohen first with respect to the original source issue the two thousand and ten amendment to the original source definition in the false claims act which appears at thirty one u s c thirty seven thirty four b and as quoted at page thirty two of our opening brief applies to at least some of the claims in this case and i think there's no dispute about that under that definition an original source is one who contributes significant additional information to that which has been publicly  improve its quality and this is it could split on this isn't there as to whether the amendment is ritually act believe that is correct i know the seventh circuit held that the that the amendment is retroactive a number of courts have held that other parts of the of the public disclosure bar are not retroactive that your say that it lease the question of whether there was c e enter city that came after twenty ten that there was knowledge of what i'm saying is that there was knowledge of the falsity before and after twenty thousand and that there was and that there were false claims submitted before and after two thousand and ten so before i wanted i wanted to make that point before i got to the retro act retroactive issue to say that even if the statute is not read to apply retroactively some of dr coins claims will be subject to the two thousand and ten amendments now there is not i don't believe any disagreement among the parties or the lower court about essentially what it takes to satisfy the two thousand and ten amendment to be in original source the issue instead in this case i believe and in response to that your honor i would point to briefly point to paragraph seventy two seventy four and eighty seven of the complaint discussed in my opening brief at thirty seven to forty and in my reply at ten to thirteen and that question gets to my view that the district court gave the benefit of inferences in favor of am gentle let me tell me your father has absolutely  dr quink gave a medical presentation on behalf of amgen in two thousand and three amgen provided dr coined with information in order to make that presentation and the presentation was designed among other things to encourage providers to promote to a target of above eleven grams per deciliter of whole blood now at that time the n h t the normal her magic crack trial existed and we've alleged demonstrated that there is no benefit to quality of life however the materials that dr coin received did not make any met from amgen made no mention of the normal hermetic read trial instead it relied solely on association ok as a result a and that is information that coin brings directly from his interactions with amgen and a reasonable fact finder from going up on churchill question the information that you talked about was known to the government indeed your client elicited well for your request ok the information revised to say just what you're saying was concealed from the resume if they really really really late no and they haven't changed their practice an iota so that i think it was the issue materiality but it also goes to the issue when it is your client under earth that the government didn't know and that would have caused the government to deny that these claims first of all the practice to change i think in two thousand and eleven would what i would say is that i am zenz knowledge of the falsity of its promotion is is part of a step listing violation of the false claims act and that is evidence that he brings to the table based on his directive that i want to go back you know i can understand in some circumstances where the fact that one portable government knows doesn't mean that another one  but is that just automatic or is visit you ation here that you're talking about sufficiently related things so that you can assume that if one knows that isn't really going to be a big deal to have somebody come knowledge of any part ok amgen says well no they kind of get to your question and say well f d a is knowledge under these circumstances equates to c m s as knowledge there's no support for that there's no reason to believe that there is no reason to s at a time when c m s how to duty to speak there is no reason to believe and every reason to not believe that c m s had access to the n h t data and on a motion to dismiss the necessary by the by the medicare and medicaid people i think the answer to that it is no the medicare people have the right to accept and rely upon in what  default rule of just saying ok if f d a said it will go along with it but they don't have to and in this case are allegations well pleated are that they would not have gone along had they known the truth and you know whether whether this strong was being prescribed to improve quality of life were to were to reduce the mean it was regularly the best answer i can give you is this judge it was regularly promoted aggressively promoted as a means to improve quality of life and to the extent that it doesn't in anemia improve quality of life who wants to be then thank you your honor you may please the court good morning your honors david rosenberg among behalf of defendant happily jenning turning to the original source issue i'd like to begin by addressing the retroactivity issue the court raised the district court properly noted that because even the more generous two thousand and ten standard dr coin cannot prevail on that the court did not reach need to reach retroactivity dr  one case that is found retroactivity the seventh circuit did so based on the notion that this was simply a clarification not a change of the law but if that's true it's singularly surprising that he does not describe or recite to any of the robust law in this circuit that preexisted that clarification in this case is exactly like schindler elevator which was decided under the one thousand nine hundred six version which is a direct and independent knowledge independent knowledge to be direct and independent knowledge that the company knew that he was promoting something from a  not in this case because the allegation in the complaint is that that is learned from the material that he received from the government his interpretation that study thought he said he learned because he was he was part of the promotion no and he actually thought that opposing counsel said that some time after twenty ten he was told to give a speech which  promoted you know wave it was not true and told in effect that it was not true no what that's what he said he said but if you look at his brief it's actually a paragraph seventy two as in two thousand and three and what he alleges if you look at page nine of his reply he says almost three paragraphs he allege show am gen's knowledge that knowledge that it was  not published as i want to cite this correctly tended to show that amgen knew that its presentations regarding quality of life were false but we know from the brief and from the complaint itself he alleges paragraph thirty eight and paragraph forty seven he specifically alleges a paragraph thirty eight the reason he thinks amgen new the statements in the label about quality of life are false because of his interpretation of the normal study he says based on the results of that study amgen new so he's not adding anything and to come back to the materiality point he needs to win excuse me the retroactivity point dr coyne ignores all the prior on that point counsel argues counsel suggests that it's undisputed that the two thousand and ten amendment applies and least some of the claims is not correct that is not correct because there is no claim whatsoever identified in this case assuming there is a c is it is it your position that the two thousand and ten amendment applies to none of the things the two thousand and ten amendment would apply if there was a false claim described after march twenty third of two thousand and ten let's i thought he was that after two thousand before the government knew he knew that what they were doing after two thousand  says something about an article that amgen didn't write to be clear that is not independent and does not materially add to the core of this case which is his interpretation of the foyer response and so to be clear he cannot come in look at that two thousand and ten interpretation and say it's retroactive because it would change the result the supreme court has twice said in the graham county case and hughes aircraft case if applying a new standard would change the result and remove a key tam defense that cannot be applied retroactively that's why i started out your honor with nothing before two thousand and ten helps some unless he wins under a direct and independent knowledge standard which he doesn't even try to do so he comes in and he says well what about after march twenty third two thousand and ten the only thing he's a den affine are a two thousand and three presentation which has no relevance to am now if the court looks at the allegations and paragraph seventy two it says nothing about engines knowledge of falsity he tries to add that knowledge again by bringing in the for a response that has to be independent and materially add to that for your response he says i made this presentation everybody agrees it was an presentation if the court looks in the record to his june thirteenth letter to the court below june thirteenth two thousand and sixteen he's says there is no allegation of off lab promotion in this case and so in two thousand and three the only allegation is that i mean by off label he is saying that the label has two pieces to it one is indications which was approved by the f d a and the other is quality of life which is the basis of the claim that this was front and actually it's not the basis of the claim in the complaint it is the basis of the argument response in the motion to dismiss but just like your honor wrote in polanski the approved indication is to treat anemia by raising hemoglobin to ten to twelve the other part of the label to which he refers which says response to a pigeon and clinical experience says talks about the rise of rate of are you are you arguing that it wouldn't matter if average and knowing that above eleven was doing nothing even if it were approved by the f d a and it pushed to do more than the level that this would not be a fraud even vote the more of an eleven cause  pay which may otherwise would not have done because if you know that seems to be a difficult argument for you to make if there is vet then the question is does this fellow tell us something about that between eleven and twelve that c m s did not know of the bases of his old particular knowledge he does not your honor because of the reason for which this drug was approved and the reason for which c m s paid in this case anemia is a deadly disease that increases the risk of death and the risk of trance the need for transfusion which causes all sorts of illness this drug was approved to treat anemia by raising hemoglobin ten to twelve and to reduce the risk of transfusion and that's the only reason for which it was paid and all of the statements about you know that because i just heard your adversary say that it was promoted to improve quality of life for people who are in the mic and therefore no one knows the extent to which presumably they discovery no one knows the extent to which  this was prescribed only for the quality of life and vantage actually there is no space under american medical response case there is no specific who what where when and why nine b of any sort of allegation of promoting like that there is no specific claim and we have no unique no edge but if there was a discussion of an i'm labeled those of eleven to twelve and a reference of to quality of life the question would be under the false claims act is that a false or fraudulent claim is it material and for the reasons your honor pointed out we know it is not and the relator never deals with either of the reply worry for anywhere his failure to address the fal paragraph seventy seven of the complaint where he ignores what your honor pointed out which is since two thousand and seven f d a and c m s clearly have known there is no allegation of quality of life benefit of the label quality of life was  ed is a useless term there is no reference after two thousand and seven to any quality of life it's still approved to treat anemia by going to ten to twelve and c m s is still paying for it for the same reason that the record is clearly only approved use the only basis of payment there is no allegation may continue with there is no allegation of any communication where c m s said it was going to reimburse this drug for quality of life and he actually a paragraph sixty two of the complaint talks about quality of care which has nothing to do with his argument is that he knows that that engine your client promoted  as a quality of life some weeks ago and he knows that because he was in and listed to do it no he actually alleges that in two thousand and three they made a promotion that was consistent with the label and that would still be an there's nothing false or fraudulent that claim to say that you should dose to eleven or to well because are some independent guidelines reflect that there is no falsity as us is prepared to pay that claim i want it's an e was one to have seeing that it was very error and it and new polls would be enough or are you saying that that would not be enough because it was still underneath the twelve that was permitted i just want to know what your argument is because you seem to be going back and forth between that isn't what was done that isn't what he knew all of which i can understand and based on his reading of the repair work he got from the government the second point i am making is that the false claims statute which would require a false claim which would be a submission of a non reimbursable claim if a physician treated anemia ten to twelve based on their determination that that's what was needed to treat it it may be that f d a or c m s would have other causes of action but the supreme court as recently as escobar has said not every potential claim of a misrepresentation the government is a false claim and to be material here as in polanski there would need to be some representation of something that was false or fraudulent and as to the reimbursement and just as in the plan still you are making the argument that even if there was a false advertisement of a part of and to use this for quality of life between eleven and twelve and that this fellow who of that and no one else knew it but that would not be enough for i mean you're making other arguments which may be good but i find that a rather difficult argument whatever may have been implied in that have read the list and i don't think it requires that all i  saying your honor that if there was a representation as to the quality of life benefit of a drug and i want to emphasize again there is no allegation of any such representations after two thousand and seven when quality of life is not part of any discussion reimbursement or otherwise that there would be possible claims by the government directly for misrepresentations to the government but there would not be for a relator such as doctor calling to come in with information he's received from the government and claim that they had paid for a claim as to which there was it was false or fraudulent because they pay only to treat anemia not to improve quality of life to say that he could have just as easily said the normal home adequate study shows that you don't sleep well or you're less thank you i wonder run through a few points quickly number one there was no nine rule nine argument made at the district court counsel mentioned that number two i wanted to clarify something it was in two thousand and three that d cohen provided what you call an advertisement promoting this drug and it was at that time that he learned that amgen was not relying on the and h t data now the n h t data we  allege demonstrated there was no improvement in quality of life the two thousand and three presentation that dr coyne gave based on engine materials demonstrates that amgen knew otherwise why would they have used association on data and not data from the normal hermetic rat trial that's what's significant about the two thousand and three promotion by dr klein with respect to i would say falsity that the n h t data read correctly demonstrates that there is no improvement in quality of life thank you thank you thank you both ok we will reserve decision thank you your