the supreme court's palm wonderful decision eradicated the core premise that underlay the district court's reasoning running from beginning to end of that summary judgment in addition to the lanham act preclusion ground which is clearly erroneous now and cannot stand it has to be reversed you see the district courts analysis of the falsity and injury elements of a lanham act case compromised by its erroneous view that unless and until the f d a has weighed in on the advertisement the propriety of it advertised with a product is safe or natural a district court has no ability or it's improper and is invading the province of the f d a to pass judgment on whether that advertisement is false or not so is your position that the lanham act claims and separate and  take action under the clarion yet that's exactly the holding in palm wonderful because the court pointed out that in these only partially regulated industries where you can go to market without the weighing in at all it's an honor system self policing were the court to hold otherwise not only would that undermine the fact that congress passed two statutes that each get equal dignity but that would leave the consumers in the partially regulated industries the ones that have higher risk greater need of an foresman with less protection than in the industry where there's no regulation at all and that makes and this case a perfect illustration of that we've got out a party that's peddling illegal poison to the market just by abusing the honor system it takes the f takes the f d a five years to figure it out once it does that product is gone from the market gone completely none of these sales are possible but the competitor in that market who had to endure it has no cause of action that is a clearly erroneous line of thinking and it permeated the district court's opinion on falsity the court made the conclusion it wasn't false when made of course it was false when made it's simply the f d a in taking a position it's the evidence that  on on so let me start with the easy one natural dr sachs qualified scientists testifies chart with the study their doctor sox's was his affidavit district and him she was stricken on the ground that his safety opinion would not aid the jury but the district court did not comment on his statement which is a pure factual assertion of a scientist that this product is not found in compound is found in nature and he testifies that it is at his report and again we also have one of the documents that were hid in discovery and surfaced later in the case it be our six twelve g and i's own employee writing to mr guest are you saying this product is an anabolic steroids in the classical sense that's an admission it's not natural and then we have all of these documents that show once they realize that we've got to reformulate the product we've got to come up with a plan b the f d a is coming we've got to get out of this cave there's clearly evidence that raises a trial issue a fact on whether it natural the district court didn't discuss that at all to discuss the evidence at all just said it's a non actionable opinion because the f d a hasn't weighed in we have to get into these all these other experts whose declarations were stricken or you actually you don't have to because it clearly has to go back on the safety and natural counts i do think you should open up the other issues again because one of the spillover effects about the district court erroneous lens in this case it these other issues the district court said early in its opinion there's no case here and then on issue after issue it kind of had the rearview thing to our client now that the controlling law that was the bedrock of this decision has been changed to see if we get a fair crack at those issues because some of the rulings well what i hear you think you do one is to find an abus on what a product assertion is based upon their supported test testing support for it as we have in this case when the rabbits izing we've got rock solid safety data fal sity can be shown by showing that the tests don't support the assertion well that's true but the problem is that the district court struck with one of the experts to use a crude term on the grounds that it was that the opinion was based on junk science not it would be destroyed use that term but that's what i interpreted the court to have done and if that's the case why isn't that inherently the role of the district court in the gate keeping function under doubt that was the market expert which i'll come to in a second but on stocks where you told me that you wanted to reverse all the rulings on striking the f word so let's take the one the expert you don't want to talk about which is the junk science  ok on the junk science expert the district court error was it criticized the market expert used various factors to winnow who were the reliable competitors the district court said this is arbitrary is making it up but that's in our view that's a point for cross examination because the analysis you have to do is the analysis that this market expert we had that we had that in bank opinion i think it was bearup in where we overturned a ten million dollar verdict for the plaintiffs on the grounds that the district court had not completed the gatekeeping function by making a finding at the dauber hearing that the science was reliable so that it could then go to the jury for whatever weight the jury would give it here the district court said it's not based on reliable science and therefore i'm excluding it and doesn't our case law say that we have to find that that's an abuse of discretion under seven o two in the book without conceding that point the market expert is only relevant to quantify the damages and summary judgment to try the case without him possibly without seeking a point i don't want to use up my time i want to get back to sox which was a clear of use of discretion because they're the methodology he employed was not junk science he did exactly what any scientist does he looks at the studies he's qualified to do this and he says do they support the proposition the district court falsity in this instance is on whether those studies support the assertion clearly his opinion is helpful to a jury on that how is a jury supposed to file a jury supposed to do that without an expert opinion that was a clear abuse of discretion the second clear abuse of discretion is on the survey expert this court in southland gallo multiple times has made crystal clear that the correctness of the survey whether it's biased all of those examination point because the junk science point the methodology a consumer survey is a well established method for determining market confusion a lanham act case that doesn't you know i hear your argument but at some point the district court has to make a reliability determination and if the questions are written in such a biased fashion and if the sample survey size is so small that it that the results are statistically unreliable why can't the district court say i'm not letting this in it just doesn't meet the unhelpfulness in a very extreme case that might be possible but if you compare this case to southland and gallo it's no different because one of its conclusions of bias the district court made was erroneous fact finding the questions aren't biased if the jury finds the facts to be as the survey expert said above up so again when you're performing a gate keeping function on summary judgment you're not allowed to weigh the facts you have to consider the possibilities of all the facts the jury might find and the questions are biased if you take a look at them given what's on the table actually you're confusing the summary judgment standards with the district courts independent obligation and the rules of a no two to make the determination as to whether the experts testimony will help the jury or add further confusion of the issues that the jury has to decide and whether or not it's sufficient lee worthy of believe based on general scientific principles that attend yes but balanced against that is the point again made in this court's precedents in reversing district courts that excluded surveys identical subject to the same criticism south on saddam callo was the point that in performing that keeping function you can invade the trial function so the facts as the jury might find them is how you have to evaluate whether the survey is biased it's not biased if the questions are within the range of facts that the jury might find that's the only way you can properly perform gatekeeping without invading the juries what i hear you function doing is that virtually any time someone is an expert the district court has to permit that expert to come in because whatever flaws there may be in the expert's opinion for the jury of story absolutely not this is exact errors that were made i couple of cases because the methodology of survey is well established that's the distinction in this case i want to reserve the rest of my time for a bottle but i want to emphasize the point that none of the expert opinions matter because impression that this entire case turns on palm wonderful for turns on issues of falsity of the alleged assertions but it doesn't it doesn't at all the district court had several other independent bases for granting judgment to guess fahri among those with the district courts determination that thermal life failed to establish the fact of injury fail to establish the amount of injury and fail to establish that the alleged misrepresentations were material in the first place now we could spend hours going through all of the ways we can get to judgment progress bar and because judge wake provided a very very thorough forty page decision outlining reaction your honor i don't think so i think what they're my life is suggesting the supreme court said in palm wonderful goes far beyond what they actually said in palm wonderful they were looking generally not get to a did not overturn it was congress's expressed determination that the f t c and to share cannot be privately enforced and there is a there is a massive amount of president that says that you can't enforce the f t c a or dish through the lanham act you can't backdoor congress's prohibition and now the supreme court never got to that counsel the district court said that there is no way on a mac claim here because the f d a has not rendered a decision that there is a missing labeling and palm wonderful clearly says that's wrong and that well i think i think he i think you have to focus on ultimately do we have any choice but to send back the ruling that there is no viable lanham act claim here because it is your card just got it wrong the supreme court later said the laws differently different than what we in the district court thought the law oh well no your honor for several reasons the first is the palm wonderful decision and the issues in palm wonderful have nothing to do with the other independent bases for judgment including the judgment on the fact of injury just amount you in line upon wonderful that if the label conveys a misrepresentation that could support a lanham act claim even though the f d a has not made a formal regulatory determination that the label constitutes mislabeling under the food drug and cosmetic that well you know i think what i'm focusing on is is their claim that this product shouldn't have been sold in the first place that under the shade that they didn't have the right to sell the product now remember what some of the misstatements they're claiming because already made is that this product wasn't to share compliant so they couldn't sell it under just say that it was illegal for them to sell it and they're claiming that th misrepresentation about the legality of selling the product that now that's safe and natural that that's the primary basis for their claim that that's simply a misrepresentation of fact what is not in fact save nor is it stated that the product was to share compliant legal ok so those are two they're also claiming there is there's misrepresentations with respect to safety in actuality so let's take the first two safety into shape compliance ok in order to make those determinations thermal life wants the jury to put on its f d a thinking cap and look at the law and evaluate whether under the shade this party had the right to sell the products in the first  this far is alleging that and we dispute that but but for the purposes of palm wonderful today when we're looking at the claims of legality and to say a compliant compliance palm wonderful did not strike down congress's position that safety and natural why can't there be a viable lanham act claim if the theory is that a false representation is safety and natural products were was made on the label and in the advertising for the product doesn't that under palm wonderful survive as a potentially viable lanham act on your honor to the extent that they want to use those those issues natural eddy and safety in order to allege that the product shouldn't have been sold at all or was not compliant with the shia then under palm wonder palm wonderful does not  attempt to privately enforce to share your orders and to the extent that that's what their life is trying to do they can see that the supreme court's ruling in palm wonderful if that's the case then any good lawyer could try and  fit the argument that a representation is a safety and naturality is nothing more than an attack on the label itself under the food drug and cosmetics act and the supreme court said no in palm wonderful you can state a viable lanham act claim without having to become a private attorney general in forcing the labeling regulations under the f d a law i guess i would say as well as if they're not trying to  share and they're not asking the court or the jury to interpret the shia or to determine the legality under the shade then then pom wonderful might allow that claim but what i'm what goes to what the district court is going to allow in as evidence at trial not whether or not the lanham act claim survives a motion to dismiss on summary judgment so don't we have to send the lanham act claim back at least as to those two factors  know your honor because you don't even need to get to the falsity allegations all you need to look at first is that the district courts well reasoned ruling were galled regarding injury because the district court said they can't even prove the fact of injury one of the essential elements of a lanham act claim is proving the fact of injury that is the harper house case the actual evidence of some injury resulting from the deception what about traffic school i think traffic school absolutely supports our position your honor in that case that the court said that in a ward of profits without proof of harm is uncommon remedy unless it's a comparative appalling off case what the district court did in this decision the reason why he rightly focused on the issue of actual damages and the fact of injury is because this is a multiple hitter market there are literally hundreds of other competitors there are three hundred other to stop strewn boosting products so in order to prove damages thermal life can't just come to the court and say that presumption well i don't i don't think they get a presumption of injury and what traffic when we say we generally presume commercial injury when they are competitors and is likely to mis consumers right so what so what harper school says it will let's let me back up for a second what what harper house says is actual evidence of injury now there are some exceptions which is what traffic school is talking about when they're making that statement one such except exception is when you have a comparative case when if sparrer he had said thermal i says this about their products and they're wrong or compared their products directly to the thermal life products that would be a comparative case where you could use that presumption this is in a comparative case the other situation where you can use that presumption is when there is is when there is a attempt to palm off on somebody else's product and that's what essentially was essentially one of the things that has happened happening in in if i believe in traffic school i mean so your honor here we don't have a pot temp to palm off all we have is one consumer making a statement about their product in a market with hundreds of other of other of other manufacturers so you can't just thermal that can't just presume that there's injury and  and i believe our reading of traffic school suggests that you can you can award profits unless there's proof of harm that would be a very uncommon remedy especially in cases like this where it's not a comparative case you want to address case what happened is they trotted out an expert that said that some high level process had been run on the hard drive under when that expert was deposed he couldn't he couldn't he couldn't definitively say that there had been any impropriety he just had suspicions this far he went out and got their own expert to look at the hard drive that expert established that there had been no there had been no attempts to wipe any documents that there had been no attempts to spel eate any evidence and the proof is in the putting your honour's there were thousands of documents that got that got ultimately imaged and recovered and and taken from that hard drive so there was no spoliation your honor at the end of the day thermal life had tens of thousands of records and they had the opportunity to look at all those records before they presented their argument for this before the district court and they in fact one of the first things they did is come in with a binder with all of these extra documents that they received from the c s i production and said look you're honored take a look at these and judge wake did so they haven't been harmed at all george didn't correctly the judge we excluded james berger his report on the grounds that he didn't use reliable principles methods and so on in his survey if that was that was one of the bases your honor what were the other what was the first basis was that his expert report was irrelevant no he doesn't specifically say relevance but if you look at page five and six of judge wake's report he talks about what berger was looking for when he was setting up this survey the questions that the berger was supposed to answer is what is the effect of this statement have on the consumer does that encourage a consumer to go out and buy the product so if the if the if there's a safety claim does that encourage someone to go out and buy the product because it's safe but burger didn't ask that question what he asked is what he told these consumer  respondents are is the products are illegal what would you do if you found out or were told that this product was illegal would you continue buying it that's a totally different question why is that irrelevant because it's asking a question it's not issue the issue is if customers were told we're we're told that's something else later i mean that's their issue may not be your issue with that's their issue it's not it there's no question here about there's no question here that asks what happens if a customers tell if a consumer is told that a product is illegal or unsafe leaving that aside for a second do you i'm having a hard time squaring judge weeks ruling with the cases conducted musing generally accepted survey principles that's a jury issue that's not something the judge should throw out at the first instance it sure will your honor we did cite some cases in our brief that demonstrate why that's not so when surveys are so unreliable in those in there's a so many problems with the survey a judge a judge can rightfully look at and determine that it's unreliable in the first instance how to go on principle well one of the things in addition to the biases in the questions telling these customized on the question goes to the weight sure i think i think one of the things that you should focus in on is burgers inability to validate the survey role berger says it goes to the methodology validation goes to methodology and here is why when you outsource a survey and you don't do it yourself and you have a survey mill conduct the survey for you you have to ensure that that survey mill actually sent out the survey to people who are paul fide to take it who are relevant consumers who are qualified to take the take the survey and that they took it seriously that's why you validate a survey berger says it's an important part of the methodology in this case it didn't validate in fact what berger says during the deposition is that he's never had a survey not validate this is the first one and that's because people weren't taking it seriously so we don't even know if the survey mill actually gave the survey to anybody what we do know is that people responded saying that they were mickey mouse donald duck and and burgers own validation a third party validator said that it's very obvious that people aren't taking this serious so under the given that circumstances was perfectly appropriate for judge wake to look at it say this survey did not comply with appropriate methodology and i'm unwilling to accept it and if you think you're  cardoza thank you are on of the most important thing you didn't hear was any answer to the fact of how the legal error on palm wonderful spilled over and compromised the just court's analysis of all the other elements there was emphasis on the injury elements if you look at excerpts of record thirty two lines twenty three to twenty four moreover as concluded above she and i statements have not been shown to have been false at the time they were made the district court's analysis of injury discuss the wealth of evidence of the record showed a triable issue of fact that injury most importantly this is one of the most unusually compelling cases of injury because you have something you don't normally have and only in a mac case the truth was revealed and the product disappeared from the market completely that means had the advertisements truthful advertisements been made they would have sold any of these products at they would have been redistributed to the rest of the market and one thing we know we can argue about how much thermal life would have gotten but because it unquestionably was a direct competitor that had some market share it would be unfathomable to include conclude that it would at least get one of those sales and the task on summary judgment is not to show the unfathomable is simply to show that a jury could permissibly draw that  inference and then we have all and then you can have all of this other evidence the message board post the testimony of ron kramer all of these other things that show clearly a linkage between these products clearly the probability of injury everything it was a great cross examination that counsel gave but there is no absolutely no law that validation goes to methodology and not wait and in fact mr berger has been admitted hundreds of  surveys so this is it's a cross examination point it's a simple as that i do also want to point to the case your honor cited judge fisher and that's the traffic school case it all there was a comparative advertising case it points out that when they direct competitors in the advertisements are false the inference of injuries almost automatic and that's because you see in lanham act cases you have the reason you usually need surveys and so on is because you have literally but misleading allegations and then you have people who aren't direct competitors that's the universe of lanham at cases but in this universe direct and competitors directly false statements and unmistakable evidence of consumer confusion they bought a product that shouldn't have been on the market at all they absolutely wore misled those sales would have gone to the rest of the market thermal lifes in the market that's enough to raise  trival issue a fact before you even get to the message board before you get to kramer's testimony before you get to the expert evidence however your honour's comes out on that girls with thank you very much that used to look the case just are you submitted