judgment order perhaps the best one would be that no good deed goes unpunished in the record below the plaintiff submitted the expert opinion of one of the world's foremost experts on the subject of anti oxidants and vitamin e after a thorough analysis of virtually all of the relevant science all of the relevant scientific evidence even some of the non relevant scientific evidence representation under king by oh that's about all we're required to do in fact we want the good every i guess i have a question about that the label the label says only that the vitamin e promotes immune function and helps support cardiovascular health it doesn't make any claim about preventing mortality from any cartons let along all consonants so i'm not really sure how the expert's opinion is relevant to the very limited structure function claim that's being placed on this label  i'd be happy to answer that your honor as is set forth in detail in his reports and his testimony while there is it's undeniable that a good bulk of his opinions come from these enormously large scale randomized controlled clinical trials studying disease and points these this is an unusual substance is the most studied substance in mankind but my precise question is the structure function claim that's being made isn't about preventing heart disease or cardiovascular disease or preventing any disease it's a sort of generic this will be good for you and when i don't see in the in the experts opinion the label he then goes through the science and while as i said a good book is based upon these large scale disease prevention trials he opines and he's the expert here that these these studies were so sensitive that if the vitamin e supplements provided any health benefits not just the ones that are on the label here but any benefits they would have been found based upon this huge sample and the fact is that they didn't and the fact is that he's not alone there's a consensus as as he cited from the u s preventative task force to the n h to everyone they do not the american heart association they don't recommend vitamin supplements in any amount and so yes i'm not not recommending them doesn't mean that these statements are false well your honor the point is is that the statements are false because they don't provide the representative benefits and he are i'm still having trouble with the apples and oranges nature of this because these are structure function statements on the label and the evidence seems to be about disease prevention which is another category entirely they just seem to be talking past each other well i would say they aren't because if you read dr miller's reports he goes through very carefully the progression of how he and others have arrived at the conclusion that vitamin e supplements provide no health benefits no benefits from taking them so even though it starts from these very very large scale long term clinical trials studying disease as he explains if if these vitamin d supplements provided any of the represented benefits on the labels it would have been found as a result of that it would have been found in these studies because every sort of a negative pregnant i don't find a benefit and they're for there is a benefit that's well i think if you study something to see whether it provides a benefit and it shows that you there is no benefit and here we have not just five thousand not ten thousand we have two hundred thousand stud subjects over a period of fifteen years in large scale studies funded by the un i and i can only say that he's the expert and that's his opinion and he provides the reasoning for why it is his opinion i do not see why one has to disregard it just because some of it or it starts from his analysis of us large scale studies that have disease and points but as he explains again if if the vitamin e supplements provided any of the represented benefits it would have been found in positive results in these studies foremost experts and wrote the first authored the first met analysis and i believe two thousand and five that showed that vitamin d supplements in four hundred i use or above pose a risk of harm and other researchers took that torch well there's a there's a difference between correlation and cause and i took those studies to be a correlation and not a cause that he not his article says that the supplements may not know this may increase all chorus more mortality and that also stated that overall these supplements did not affect all cause mortality so the flak so to speak from dr miller and updated the research because there were so many other studies that came in and others did too well maybe his his article says we are not able to determine the cause of the increased mortality that's been a lock of rich his article so we can there there's a slight correlation but nobody is drawing a causal connection there well i disagree i think that saying is that you shouldn't take it because there's a risk of harm and if you look even at the studies cited by defendant's expert abner and that's i think probably well i think it's with the job of it who presents the futility that there's no benefit that means that the labeling statements whatever they might be other than vitamin e four hundred are you if they talk about a benefit it's got to be false that's the science he's a highly renowned expert i think one of the world's foremost who says that this substance doesn't provide the benefits that are represented on the label why that doesn't meet the test i'm not sure we hear as light people can try to read the studies and try to interpret the data and try to interpret what the authors of the various studies that dr miller on the other side cite but that's a subject of experts testify only not the stuff checked of lay person's testimony or lay person's analysis we can cherry pick phrases from these studies and argue that he's wrong but that's the subject of the jury that's the that's the subject matter of a fact finding we have a highly credible expert who's opined that these substances do not provide the benefits represented that should be sufficient to go to a jury if there are no further are questions i'll good morning my name is robert andelman i represent the defendant appellee which i refer to as nature's bounty this case is before the court on an individual summary judgment ruling and so the issue at bar is whether  dock our create a triable issue of fact concerning the actual falsity of the structure function claims and he's vitamin e supplements based on testimony and evidence that only relates to disease and death and based on the testimony of an expert who admitted very frankly in his deposition that he wasn't interested in structure and function he was interested in what he continually referred to as clinical and points which makes sense because although he may be a renowned professor in his field his field is not vitamin efficacy his field is epidemiology study of disease and so for dr miller without an impact on disease no claim could be made and he couldn't have been franker about that in his testimony though his point was if if the structure helps reduce mortality rates and fine him but if it doesn't then  there's no impact on the structure even though it may have some structural benefits right there's no evidence in this record that having an impact on structure and function of the munir heart system would have a reduction in mortality from all causes deaths accident suicide gunshot wounds what have you he never drew that line and with regard to that piece of it the mortality piece he had to do with the immune claim he didn't look at a single study that was designed to test whether spite of many had an impact on immunity and he was very honest about that all he looked at in regard to immunity was studies related to all cause mortality the problem is congress  defined this notion of structure function and the f d a then implemented congress's determination in the nutrition label and education act and when when congress did that it drew a distinction between structure function claims and disease claims a disease claim requires evidence of an impact on disease or disease state and the f d a even in its final rule implementing this provision it's that's at issue said if the claim is that a substance has an impact on disease where you have disease studies that support it that's called medicine it's a drug under the law congress determined that it would be useful for consumers to know about impacts short of disease where things aren't drugs the problem with dr miller's testimony is you can't take it you can't separate it from his promise and his premise was you cannot make a claim with regard to heart unless you have a reduction in cardiovascular disease and you can't have a claim with regard to immunity unless you have a reduction in infection i mean it's in his portion of this of this testimony and this is in the record that we concluded it as the i think it's like to eighteen to nineteen to twenty where i said to him are you saying that that in order to make the claims on this label it would vitamin e supplements would have to work like medicine and he said yes that's right because in his view as an epidemiologist unless there's an impact on disease it's relevant the problem is he didn't know what a structure function claim was and he line that the statute on the regulations have drawn seems somewhat odd when you first think about it there's you know but it does draw that line that correct interpretation and if so what do we do with that i think that that's a little bit of a lawyer spin on what the testimony was because when you look at dr miller's testimony what he meant by that when i pressed him on it is it doesn't impact as he's he actually conceded that vitamin e supplementation has an impact on structures and functions of the immune and how system and i even said to him it is it possible that  could have an impact on the function of the immune system without having a reduction in disease and he said yes i think it's an s c r to eleven so he concedes that and what we provided was in our burden in this case but what we provided in this case was evidence and i really encourage the court to look at dr bruno's decoration it said one forty nine went through probably one fifty two where he explains exactly what the impacts are with regard to vitamin e function of these monocytes cells which are important for immune function employ improves the structure of endothelial cells and the ilia lining which is part of the cardiovascular system it has and those were also supported by randomized controlled studies vitamin e have these impacts of you know and improving end of the illegal cells he said yes in fact he even said that that's a fair surrogate endpoint for heart health but then he said but there's been epidemiological failures with regard to the surrogate end points so what do you mean by that he said it doesn't impact is he's and so everything circles back with dr miller to his view that if you don't have an impact on disease you can't make a structure function correlation by itself would not be enough but if it's statistically significant and that's what they have and says why isn't an off to create a genuine issue of fact and i'm glad you raised because i really think that the whole harm issue is a red herring in this case the label doesn't say anything about that mortality one way or another it's not a failure to warn case that's not what's alleged so i'm not sure it has anything to do with the specific label claims it's also not the evidence so he cites these two met analyses but  he didn't consider the four other men analyses that were conducted afterwards they concluded differently he didn't consider the fact that that's a that's the factual dispute but it's more it's more i mean the question is do they have enough to show that the label they don't they they don't because the label doesn't say anything about that but also on this issue of harm if i can the national association of our national cademy of sciences which used to be called the i o m or the institute of medicine publishes what dr miller agreed authoritative standard for the safe upper limits for vitamin e and it was one hundred times what he claimed was safe so there's no scientific support for what he said if you look at the end i fact sheet which again judgment stage i'm not i'm not quarrelling with you about what the proof ultimately might be but the question is are these studies that he cites sufficient to overcome their courage and initiative the reason you're not going to and you're answering my question no because we have other evidence now it's more than that because if you look at the mh baksheesh and he said the mh was authoritative the n h says the studies that dr miller study looked at were older people who were sick many of whom were in developing countries with nutritional problems the end i age says if you look at the sub population of healthy people within those studies that there's absolutely no harm from vitamin d so because i think you can't create an issue of fact where you have an outlier and what  it's not just that there that an argument from authority alone but n h says you can't draw good science doesn't allow you to draw the conclusion he draws and this is true of his disease studies too because those studies only look at sick at risk older people dr miller said you cannot generalize as a matter of good science unless the populations match well that one of the problems was he generalized from six popular studies of all sick populations to the healthy let me ask you a different question about that would the label be false if there were such evidence it wouldn't be because all this label says a specific label of issue which i think it's notable that this doctor hasn't given the court the label the label we provided is that when eighty seven it says promotes immune function and healthy heart that's not proven false by even if it were true a small impact on death from all causes and i still think and helps support cardiovascular health that's that's not the actual label that so he didn't buy the four hundred i unit he bought one thousand one hundred that's what four hundred right but he didn't buy that he bought the one thousand and they specifically didn't give you the label on what he bought and he it was an exhibit on their menu complaint they include the amended complaint but not the exhibits and that's why we provided it actually when eighty seven and what it's specifically said was promotes immune function and healthy heart and that's all says it is a bedrock principle of science you cannot draw any conclusion from a study that doesn't have as a pre determined end point the matter you're trying to conclude and none of the studies none of the studies were looking that he reviewed in his mete analysis were considering immune function of vitamin e so he is violating what he said was the basic rules of science he's relying on and studies that weren't designed to study anything short of disease or death the label doesn't make claims about that and with regard to munity ironic he said i don't think you can make a true not misleading statement about immunity unless you reduce infection and it works like medicine that's why he's then able to draw these other conclusions back from that that's his premise it is fundamentally different than the premise that congress mandates and if i can just in the period i have left i'd like to ask the court to take a hard look at the preemption argument that we've offered as an alternative ground here and it's not a giant general broad ruling on preemption it's a very specific ruling you could have a structure function claim that is challenged as false and misleading under state law if you had evidence that challenge to the actual substance  can't do is have a challenge to a structure function claim based on evidence concerning disease and death because congress and the f d a have said that's not what's required all you need to do  show an impact on lesser events what he's calling surrogate and points otherwise it's a drug otherwise it's medicine and i understand dr miller thinks that it has to be but that is a not identical standard  a company like nature's bounty or any of these vitamin companies they do business around the world and around the country and congress made a determination here that there should be a uniform set of rules that apply what they're asking in this case is really that you drop it when they say it in a reply brief in essence doesn't matter if it's structure function or disease they say just look at dr miller but but it does matter because those are the rules under which the statements were made and any had a right to rely on a safe harbor within those rules and what the plaintiffs attempting to do in this case isn't to pose a different set of rules divorced from the specifics of this label divorced from the regulatory regime in which it was sweetly first off of the preemption there as we set forth in the footnote in our brief israel an open question as to whether there's a safe harbor for the statements of the fed this make and i submit that they stopped on the brief i think one of the points that maybe as the eight hundred pound gorilla in the in the room here is that these statements promotes immune health or supports and unity helps a healthy heart or whatever it is supports a healthy heart these are borderline statements that really go when you say healthy you say immune you're coming right up to the line of whether or not you're making a disease claim or not so i just want to point that out because that's why the science crosses over a little and i would that you you've heard counsel make some statements about what dr miller testified about i don't think that those are accurate statements i think if you take a look at this testimony as a whole and even the snippets they cite that he doesn't say what they say can't now argue that it was wrong to go the the fact is that proves that experts in this field go to that to determine whether or not these labeling claims are supported by the science or not  it is true that dr miller said that immunity health is tied to the prevention of sickness it's the definition you can't avoid it and therefore the most potent proof that this doesn't cause a new health or help in your health is the all cause mortality analyses and council focuses in on dr miller's two thousand and five report others have updated this and included healthy populations in it his was the first report of a jawa vick included all the studies including healthy populations and reached this conclusion furthermore  there's a good reason why dr miller didn't know what a structure function claim and he's not an f d a expert he's a scientist he opines on whether things work as they are represented that's what he's done for his entire career so he's not there but then i won it's directly related to the prevention of heart disease it is base a biomarker of heart disease in fact their own expert admitted it so when you want to see whether or not what you've seen in terms of a mechanistic effect really has a health effect you look to see what it's related to so for instance a function that supposedly related to lowering the the risk of arthrosclerosis well you've got to look to see whether there's arthrosclerosis doesn't have an effect on that and what dr miller said is while they had great promise when they spurs saw this it turned out to be a false lead it doesn't do what it says it does so with that your honor i think