have two sets of arguments one is the errors that the district court made and a lot of those are specific to this case but i hope the court will take this opportunity to provide guidance to other district courts with the published opinion that interprets the case national council against health fraud versus king bio pharmaceuticals kin bio as it's called the law that decision district courts have explicitly disagreed with in many different situations including in this case so why is this something that we should be publishing about this is a state law question that's up to the state courts we usually don't publish on questions of state law not sure why this is our job to fix well it is i think the court's job to fix in the sense of how king bio should be applied in the district court stage in diversity cases and there's certainly a lot of diversity cases in california consumer fraud law and especially within this context of nutrition supplements and i think the fact that district courts are explicitly saying multiple times that they disagree with one another including the district court below here saying that i disagree what exactly as to whether or not king bio applies when you have a s where you have the situation where there is a claim of clinical proof in the plaintiffs says there's actually no clinical proof this district court said you simply can't have claims like that that's a improper lack of substantiation claim so i think that or is a unique  aspect of that that the california courts themselves can apply because it involves federal pleading standards and to just give one example of how they're going to be a little bit different why couldn't the state courts solve this well liked it did you bring this case in federal court or sticker initially in federal court so if you want a clarification about california law couldn't you file it at the court can you explain why california courts couldn't answer their own question about california law well i'll give a good example of which is that the california's version of the there is but i thought this question that we're talking about here is whether clinically proven falls within california's lack of substantiation issue and that seems like a state law question right what's the federal component of that a question you're trying to get us to answer as phrase there it would be an issue of state law and i think the other argument in that case is there's just so many different decisions that are coming in different ways and uniformity is an important aspect a question for the california supreme court i would not be opposed to one but i think that it's it is we have enough evidence on our side that it's not should not be necessary but you say there's a predecessor legal question pardon you to say that there's a predecessor a legal question i e would all the evidence in the world matter or is this a lack of substantiation and part of that i understand you have another part in which you are specifically alleging the falsity of the statement but as to that that part the part about the clinically proven it doesn't matter what you feel led shift doesn't count the more extreme version of their argument that the defendant makes in the district court has the power to do it in it is the type that could be referred however i would hope that the court do it simply because i don't think it's a close issue i think it's unfortunate that there's a few district court who are doing this but they are a minority and it is something that this court can resolve and what about california law tells us that that is not a lack of substantiation claim well by itself says that in the sense that king bio parts of the doesn't answer it one of the things can bio says is that the falsity of an advertising claim may be a stablished by testing scientific literature or anecdotal evidence and we provide all three of those things and i think there's simply no support in that decision for the position of the district court in a few other district courts that you you can't bring and i think we have evidence that involves scientific literature and anecdotal evidence  of what substantiation claim here in california as brought by a public entity is that a public entity can go to a employer to a company and say you said x substantiated i e the burns completely the on the defend are the potential defendant right and you're not you know as i understand it you're saying here with that when you're say clinically proven is false you're going to prove it's falls yes we intend and i think we have allegations that we need twamley that we there's a reasonable possibility we will be able to prove that it is in fact a false statement that it's clinically proven and well doesn't that depend on whether this really was referring to the vinson study i mean if they can show no we're not talking about the princeton study then doesn't it become a lack of the stench ition claim because you've got to show there is no study and that's lack of the same situation where we're prepared to show we're prepared to prove the negative in the sense there is no clinical studies and how are you going to do that how is that not a lack substitution it's not a lack of substantiation because what i actually think sometimes that framework of using that phrase like a substantiation is not actually grounded in king by a which was actually about burden shifting  if i could go back to king bio for a moment that was a case that was brought it winter trial it was not brought by an individual plaintiff but it was brought by a special purpose corporation created to sue them and they had a trial and the parties conceded at appeal that the question of who wins or loses the case depends on who has the burden of persuasion at trial and the let me read just one line from king bio appeal plaintiff acknowledges the trial court correctly imposed the burden of proof under current california law but contends the law should be changed to impose the burden of proof on a defendant in a false advertising action that are here is that there's been all this debate back and forth about whether you have sufficiently established that this fencing report was and which was describe your report was in fact a report that was being r then after this is basically over or at the time of the the last part of the proceedings you then come forward with this  amendments put everything in your complaint i don't want to hear about anything that's not the complaint put it on the complaint so where are we at that point i mean what why did this happen why isn't it in the complaint and what do we do with it when he was absolutely lucid about the fact that he wanted everything in the complain demonstrate it then you have a pretty good demonstration how about where you match up every claim they make about their study and everything that's an invention report and you have a little chart and it's pretty persuasive but it's not in the complaint well the the ongoing and we put some of the evidence in our opposit well even if the court didn't want to consider this internal document because it was produced on the opposition to the motion to dismiss i would hope first of all they would also disregard a lot of the other stuff this was supposed to be a motion to dismiss i think our very first complaint was sufficient in making the allegation that it is the vinson study and should have been accepted as true but the district court just kept saying make this like a summary judgment motion we had discovery and so it's your problem you don't have this piece of paper at the time you were a father last  exactly what happened here and i don't think it's a problem often but in this case it certainly was where i kept feeling like the defendants are producing and disputing things in the complaint and i it's hard for me to convey that to the district court you know this is our allegation it is that we have some evidence that we can accumulate through public sources that supported and we put it in the complaint we get further evidence in discovery but the complaint itself says a very specific allegation that puts them on notice what our claim is our claim is that you're using the vinson study for support of your clinical prove claim and yet is not clinical proof for it and that's what you're relying on and that's a specific enough allegation that to comply with ni it doesn't need to have every single possible fact in support it needs to create a plausible expectation that discovery will lead to support for it so can i ask you just about the lack of clinical study of the differentiation between foundation as well as falsity is that your point in generally speaking lack of conical study is a foundational question that goes right to the foundation for the opinion that's been asserted that's relevant to the lawsuit but your point is i think that the lack of clinical study is a claim unto itself yes that what you're basically suggesting so i'm just trying to figure out a claim you have a claim for a lack of clinical study is that really the source of a complaint i mean is there some recovery from a lack of clinical study lack of clinical study theoretically would be required and you'd be required to show damages as a result of the fact that there's no clinical study it's one of the only shot in the other hand and how is that an independent claim  which would justify damages well it because it's something that could induce consumer reliance so there's the claim that this pill that's just a bunch of herbs causes rapid weight loss significant reduction in body mass duty on the part of the manufacturer of the product to conduct clinical studies theoretically so there's no violation of any right on the part of the plaintiff here we or that they're obligated to give us studies in any way it's only that they were required to tell the truth on the label we allege clinically proven is a simply false claim and we intend to prove that it's false and we have a lot of allegations they give rise to the idea for your allegation is that it worked for this particular person right it definitely didn't work for him and we do have deep to the district court so that allegation didn't than pass ninety but we say he took it the amount he took when he took it and it didn't work i'm not sure what else ninety would require however we also say that the active ingredients in it the ones they call the active ingredients are actually not work they have been studied and they show to be worse than placebo so we do have a geisha is beyond the anecdotal that it doesn't everything you just heard is moved for two reasons the first is any challenge to the propriety of king bio or the reach of king bio which by the way was adopted by this court in the kwan and angle case cases at the ninth circuit was waived they adopted the reasoning of kwan angle and king bio and attempted to differentiate themselves from those cases by making this it literally false age and challenging came by other claiming they're trying to deal with the open issue and came by the over the open issue which is the exception to when you can bring one exception it's a different strain or that's their claim i mean it doesn't help just to and i allies are say as an exception it would help if you analyze if two assumptions vincent is the one and only stand no i'm talking generally first as a general matter why can't you bring a private party bring a cause of action for false advertising by saying you said it was clinically proven and it wasn't i think i'm going to prove it i'm not asking you to prove that it was clin just assuming in line with rule eight nine and eleven they allege that that would fit into what i call the exception for the scientific literature testing anecdotal evidence exception of  so you're agreeing that you could make i have a cause of action for a false statement as to clinical testing they just haven't done it that's correct you could know what i'm not and you're not claiming that king bio precludes such a cause of action by a private party so long your honor as you me rule eight nine and eleven and that would have to look your allegations would have to be something like i have searched every medical journal in the universe and there is no statement anywhere in it that  i'm sorry the cases the plaintiff cite you would need more but you would need to rise to the occasion with either presenting scientific literature that shows that these ingredients don't work is that proving a negative in other words you need to come forward with a firmer evidence that that's not what was said what was said was we have i mean essentially when you say this is clinically proven you mean we know of evidence clearly proving it it doesn't mean you have to go out to another study i agree judge and this is why there's two ships passing night and there's all these great questions from these judges about what why didn't you put the stuff in or why the district court in it so that's a different stuff i mean what we needed with all due candor if i could just point to the record if you are one eighty nine to one ninety four this was sent to plaintiff's counsel a year before he filed this this is the one of the niners of mir's declaration which testifies to the list of clinical study this that substantiate this product that were sent to plaintiff's counsel a year before he felt his first complaint so can he get around this which is clearly a substantiation case simply by ignoring it and being within the of rules eight nine and eleven or is that as the judge and the three of you to ask today fran you're curious why these documents didn't didn't make their way into the complaint and  all that were available to the planets council and we would have sent him copies if he had asked for them now district court found it because he opened the door in the second motion forward to seeing the second man who complained not there and this district court judge found that you've a sieve in suspicious because the vinson study isn't here and we can concede that for a limited period of time before as discredit this study was relayed upon but what about the seventeen other studies how is this not a substantiation case how is this not order that based on his a base of nisson suspiciousness of not pleading these documents he didn't think there was a ruhleben basis to make the connection between the literal falsity and the clinically proven so essentially what you're suggesting is based upon the seventeen studies seventeen other studies other than vince and others they cite from vincent which you recognize was based on fraudulent information which you're basically suggesting is there's no viable claim that there were no clinical studies as a result of all so the issue becomes irrelevant and that therefore any attack on these underlying studies really are foundation know but the only way to get to the actual falsity allegation which is where you judge started which is holding me to the to the fire over what does king bio mean or not mean and  gather that there is a least a line of thought that it's still too similar to a substantiation claim the you can't do it and i would be inclined to agree with your concession actually so right and i think then it's an element of pleading an element of proof of what exactly testing scientific evidence and anecdotal evidence means however let me just clarify something essentially your position is that when his allegation that you were allied in the fencer report was true at one point but you also invited a lot of other things and so we really don't have to worry ourselves very much about whether he adequately relied on  that on the other side but that what you just said logically is correct in other words it goes back to where i started for the vinson report to be relied on to have any materiality here you need two things one is it is the one and only report relied upon and the second is does that under the king by a standard does it rise to the level of having absolutely no clinical that it rises to the level that you don't need to get into the substance of the of the study that prime aphasia it doesn't provide clinical support and i think we can see that with with respect to the vincent study at this point but so could we go back so if so you seem to be conceding that this type of claim is possible you could have a law about whether some is clinically proven so how would someone all that i think we've got interrupt it or something of i don't know i don't know that i got your answer for how someone would allege that that that kind of claim properly i think you go to the cases that the opponent cited for but that's about the underlying claim right you're jumping to so he says clinically proven to cause weight loss so i think your answer to me now is well if you point to studies that show it really doesn't cause weight loss that's enough but i don't understand that because what if you have a one other study it says it does it seems like you've got it i don't really understand why you're saying that as a your answer to how you would show clinically proven is a yeah i think clinically proven is a difficult one for appellants but but i have to agree with the judge that is possible in other words if you have a scenario let's forget about pleading illness or proof just for a second if you have a scenario where you put on your box a clinical studies demonstrate and then you have an internal document that says well we don't have any clinical studies regardless of whether there are clinical studies out there in the world to support that product if we knew when we went to market we didn't have any knowledge of those that's literally hopes that's actionable and so someone could just allege we think there must be an internal document and i don't understand how anyone would know about the internal documents or how are they going to allege this claim or remember the almost approved the pleading standards for a literal falsity are not the same as  to get around the thing by zero exception so they could they could say like they did here so they have an internal memo there was early discovery here they got the list of all of the clinical studies t support the product they also got an internal memo about the vinson study by a ph d within the company and they got a couple of other documents those documents might have demonstrated as they represented to the court the vinson was the one and only study study and the claims made as to what the study in question shown to side by side tables you're talking about there in the motion this is first of the the what the district court says not making the cla a review of overview review by a piece in chemistry of the various clinical studies out there it was updated shortly after the vinson study was published because it was part of the subset substantiat i don't know i have an answer for this and it may be that maybe that's why that by pleading one they would have felt obligated to plead the other but i don't have an answer but that's what that document is it's a reference to multiple studies including the vinson study by an and that is they don't push it because what is literally for what does in the court might not like hearing this but this is a marketing company which is rapid mean rapid in connection with what they would have you believe it means chemotherapy evidence means if you go through the cases i think it's pretty clear what it is not to find biking by i think it's pretty clear what it means is expert reports using their professional experience using their judgment because one little get says it that that rises to the level of the exception what i call the exception i know you don't like that ticking bio because if that was the case and if they're right your honor you are overturning because any  court of california as well as the seven thousand five hundred section of the california code and you're always making sure that you're not falling back in to a claim that can only be brought by the government  thank you well there was a lot of talk of declarations there they want to pass a sneers for part i have not been focused on at all was the declaration from one of their employees that they sent to me i disagree with the content of it i disagree with the stuff about this seventeen and we looked at all three of them and there was a fourth one that reviewed it and then there was the ensign that was withdrawn and we look through all those three and those are the ones we do but we don't have an obligation to put in our complaint the if i could say one more sentence there are three things in king bio says that you can use to prove your claims testing scientific literature and anecdotal evidence and we put that into our complaint in detail ok thank you both very much we had a lot of