six thousand on which a book series reports of diabetes should not be dismissed as not being new information as a matter of law absent the crux of the district court's decision dismissing plainest case so that the limit are labeled including diabetes no later than two thousand and twelve and that the six thousand report do not chance to choose your information this determination was erroneous and diabetes is not in the us label despite that label european union makes clear that lipitor is an important identifying risk of diabetes there is one image and there is one of beautiful fact that both the district court and wiser avoid to this day diabetes is not contained in with the toward label this of serious on labor that's this is a perfect example of the district court making scientific determination that conflict with those the practice of the only real complaint was written to comply with new york state law did not discussed in seem to fall given the procedural posture the case of the time of the motion for judgment of the pleadings plaintiffs never had a meaningful opportunity to amend point looking to defendant's answer concerning preemption defended included nothing but  listing of thirty adverse event reports and showing that you know the effects that happened they changed the label based on so it's not you just can't say as a matter of who was is the issue here your honor that six thousand reports cannot constitute new information and cannot say that it needs to be it that the way leads to be changed it's what defies it do in response to receiving six thousand reports which they themselves acknowledge are not in the label certainly  don't agree with that all as being a proxy person pharmacovigilance the point is that the courts have to be focused on that pharmacovigilance safety surveillance is nothing more than the collection of adverse event reports and the submission to the f b i and that's the end of the process were adequate by themselves the question is what defies it do in response to the six thousand that were submitted reports did they properly analyze them is it isn't the st question whether on the face of the complaint there does the pleadings show that the that the information contained in the adverse event reports shows a different type a risk of a different type or greater severity or frequency than previously included in the submissions to the f d a di thought it is is it a book if it is not in the label your honor no nobody doesn't say in the label it says if the studies have fencer analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the f d a you're treating it as if it's said th what is contained in the label as presently approved but it doesn't say that it makes a comparison with what has been shown to the f d a previously and i don't understand at all how you argue that what is how you substantiate the argument that what is contained in these adverse information reports shows a greater severity or frequency than previously included in submissions one of those reports that's where i got them from and based on my analysis of the information already in the f b i s possession the label was trent the point being here is the company has the obligation to not just collect and submit read reports they must analyze why you're handling your what you're saying is this the the language that i read here should simply be disregarded no what i'm saying is it's more than just simply the reports it's the analysis of the reports and clinical trials are not designed to detect rare adverse effects it's a it's an absolute fact that for students come out from bush marketing surveillance which is what happened here the point is is that it is not you know the supreme court made clear in white vs levine that analysis of new information constitutes new information the company is required to analyze by the court you know what you're suggesting there that can stick their head in the sand as long as they that that is the crux that it is not just simply bringing in the adverse event reports and sending them and more is required but isn't the crucial isn't the crucial issue whether pfizer was authorized to make a label change on its own without f d a approval because even if you are right even if you're right that they should have analyzed more and and and asked the f d a for permission to change the label based on what they ha learned from these reports still that would not allow them to change the label without permission and as i understand it the regulations do not permit unilateral change of the label unless the standard that i read to you they have required under three hundred and fourteen dot a t p to analyze this information that is the source of labeling changes they don't just happen spontaneously it's because somebody reviews the information so the company goes and reviews the information you know what will be learned from discovery is just what do the company do with respect to the ever mt increase in information about diabetes that one of the things to point out it's extremely important in the european union in the u s label so certainly you know there the you can certainly take that fact that that's it and it's a statement of causation that exists that there's adequate studies that there's adequate adverse events doesn't just happen that somebody throws it on clear that all adverse events information from any source must be reviewed in terms of whether the this is the label needs to be changed and even if you take the statement from white versus le we stand for the proposition labels are dynamic you know it may be adequate to date it may not be adequate tomorrow and it's the manufacturer its responsibility to see that the label is updated over time not the f d a is responsib pfizer was swiss wrong and violated statutory and regulatory duties in not reviewing the state and not analyzing the data as a possible source of further submissions  to the to the f d a seeking permission to to change the label that would not establish that they were entitled to change the label unilaterally without permission and without information revealed matters of a different type and greater severity than frequently included than for than previously included in submissions to the f d a then they're not entitled to make the labeling change on their own but your honor is not a question of i think it's a matter of your not having pleaded anything that shows the meeting of that standard you haven't pleaded anything that shows that the information contained in these adverse information reports this newly acquired information reveals a different type or greater severity of risk than frequently included in the submissions to the f d a your complaint if i'm correct doesn't address that at all well your honor we claim that pfizer had an obligation to review and consider these events and they failed to do so that it was their obligation they have all the information they have information that's not available to me absent discovery so our contention is that they never properly analyze the adverse event information which would be the source of making the labeling change you know by well how to how do you comply with with i mean that  this is a problem that all plaintiffs have all plaintiffs allege matter not all but in many circumstances plaintiffs allege a matter that depends on information that's largely in the possession of the defendant acknowledge requires that the pleading contain allegations of fact which would make clause a bull the meeting of the the meeting of the standard and you're saying well we didn't have the information the defendants had the information well that's what many plaintiffs would say that but that's what there's no question that that twamley anecdotal made things harder for plaintiffs but that's what we're all stuck with us a plaintiff's  compares and how it compares to what has been previously included in submissions the nobody is saying or at least i'm not saying or thinking that that adverse events reports are incapable of showing concluded that the label needed to be changed we talk about the fact that in the european union lippa tor is and i get to fight risk for diabetes which is not contained in the u s label i don't know what more we need to say i mean the fact that you know it's almost conclusive that the in the european union the label contains exactly the warning that should be taking united states how can we stay active you know how can we say that you know as a matter of law that separate reports do not constitute reasonable evidence of a causal association they may and i understand that you believe what your argument is that in humility they ma to many might be a little complicated because obviously it's very clear to me that the panel understands the rubric of this and frankly this there's a we disagree about of a number of things mr altman i but we actually agree kind of on the framework right in terms of what the givens case has laid out the st is i think was correctly stated frankly better than i can a lot of this is you know an allegation that something should have been done that's a different claim right what we've talked about is failure to warn claims and the givens court said this in its very recent decision that there has to be bold adverse events and analysis of them not a claim that someone could have should have would have because the whole point here right is that d in order to get past frankly why st the given's case and the factors you have to basically show that this is very serious pfizer for example could have had to go into a c b e changes being affected and just change its label right and you would have had to show some type of analysis in is the various factors it has to be information that was new that wasn't provided it has to be of a different severity or kind of gravity and as you it has to also deal with causality and as judge lavelle i think lated very clearly none of this was alleged all we have is our allegations that there are six thousand adverse events out there i mean that's basically it and you know just to address the point of amendment i think this is kind of a distinction without a difference not it's not a case where the judge pauley didn't have any information about what would the men would have looked like in fact mr al asking this court or frankly any court to draw a bright line saying if it's adverse event recruit reports you can never have a c b i don't think anyone suggesting that right there there could be situations but what i think you have to have mr you know the examples that mr altman you know it with i have a lot d of respect for mr coleman that he gave us in these other litigation some of which i've been involved with him with he kept using the word analysis right i took these adverse events and then i analyzed them if you look at  in the given case there actually was reports and there were adverse events right but they determined that there was not enough to hass the standard for c b s so to answer your question directly your honor it's not just a number and just as a footnote right let's talk about those for a nd the six thousand adverse event reports there was a multi district litigation that i was involved in mr altman was involved in it started in two thousand and thirteen every time somebody files a complaint that becomes an adverse event right you have to file it and that ultimately that case judge gurgle in in south carolina after hearings and expert reports dismissed all of their experts are granted that the doubt motions in whole or part or all of all of their experts the cases were ultimately dismissed summary judgment affirmed by the the th circuit so just tell the court that just because this is not a situation where all things are being are being equal i would agree that the quality and kind of importance perhaps of fifty adverse events that to generated as a result of it's trial are study could have a different significance so would i be would i be the fact and i just interrupt you we have placed what i be be correct in understanding this is the precedent and standard not as meaning that adverse events reports are incapable of of of addressing or affecting the cause it's causation it's that they don't necessarily address causation the fact that it's an adverse event report can indicate nothing about or little or nothing about causation that some can and some instances it depends on the nature of the adverse information report and some instances the adverse information report might give a very clear and might give very clear support for causation is that not correct i think i would generally agree with that your honor and the reason why the answer is to answer it directly i think that's correct here's what i would say though you know when we look at adverse events and those of us who kind of live in this world what the f d a says is this is a pharmacovigilance it's a safety you know so we want to encourage people to kind of file these they could be lawsuits and as a general matter this court in marina and courts around the country have said as a general matter right and the f d a guidance says this we don't look at adverse events reports to determine causation because that's not what they're for but we're not asking this panel to to issue a bright line rule that says you know no way no how if we ever see a case so i would leave open the possibility in certain situations but i would also say us kind of a practice say to you your honor as a practical matter they don't and that's why you had wyatt that's why you are given and even mr altman said what you need to do is is to do an analysis of the adverse event reports because again the purpose of them is just literally for people to say you know some adverse event report might say someone came into my office i was taking lipitor or and then they were diagnosed with diabetes right which is a common co morbidity for people who have high cholesterol and diabetes after an analysis it may well be to determine that there is a causal connection but the adverse event reports we certainly  not used by the f d a and if a company said we have a bunch of adverse event reports without analysis they went in to try to change the label under the c b they would be at risk of misbranding which could you know have some serious consequences but one other thing i would just sa duty on manufacturers can tick induct independent analyses of accumulating risk data what's your view of why it well i actually you know i think why it's i mean remember why  was around and the supreme court and this court in one thousand nine hundred and nine in two hundred one thousand in the givens case certainly quoted from relied on the why it's decision and basically said that to the extent that really what i've been saying what i think your honor has read for from these decisions that to the extent that there are adverse event reports and analysis under certain circumstances right here's the difference if you look at we site we rely on the the f d a materials that they looked at i think it's to sixty six and to sixty seven and i won't read them all to your honor but just to give your honor some comfort the idea that this was different these are some of the things these are not just adverse event reports but clinical trials they're titled things like of incident diabetes then there's effect of staten on fasting glucose and diaby at benteke in non diabetic staten therapy and risk of developing type two diabetes and it goes on so what is the point of point is these subsequent mr altman made the point that well these somehow are after but it doesn't matter whether it's before or after the point is is this different information and what we know from the record and what judge pauley knew was that the f d a took this seriously any time there's an issue of diabetes of course the companies take it seriously and the f d a did and they wrote for us that they looked at all these adverse events they looked at clinical trials they looked at analysis and they made a determination that there was not a label a labeling requirement for specifically saying diabetes they did make a label change about you know high glucose levels if you will and that's kind of the whole point of the preemption that the companies you know you kind of of articulated in and understand the dichotomy that you know we want the the f d a is kind of make sure that the labeling is appropriate this is not like buying chewing gum right because i'm not saying my client or any reputable company but we don't want someone to say this can cause diabetes heart disease x y leukemia right just even if it doesn't in order to avoid liability right so the idea of what and there's a problem of over warning so we want to make sure the f d a wants to make sure that there's actually a causal connection between what's on the label and what's not so that's why and again the gibbons case and why you have determined companies can't just willy nilly change their label or add things for any reason or even liability issues there are certain narrow exceptions that are not preempted and those exceptions are if it's done pursuant to a c b e change being effective and then there are very specific requirements again including the fact that it has to be new or different information than was signal that was provided and has to be something that has a causal connection it has to be severe it's kind of what we would want right as citizens we don't want to say that under no circumstances can a pharmaceutical company ever change the label if it looks at adverse events does an analysis in determines that there's a causal connection that would be a responsible thing but the argument the plaintiffs are making here is somehow even though the f d a has looked at the same information there's nothing new there's no allegation other than adverse events there's no allegation that there was you know any analysis done that would be inconsistent with what the labeling says so essentially we have the paradigm kind of twamley it all kind of fishing expedition i see my time is up but i can just wrap up in a minute if yes your honor would just give me or as i would say two things and this is you know a little more belt and suspenders if you will  mr altman was involved and had cases in this in this n p l that we talked about there was ten million dollars pages of documents it was about diabetes so the idea that that we would need to scullery to figure that there was expert reports on both sides i was alvin your honor so i don't want to be presumptuous and say it's answered all questions we probably wouldn't be here for if there was complete agreement but here's what i would say about giving totally consistent with with levine right and then i think what would given says that's really important to remember in gaiman's you had not only adverse events but you actually had studies and some level of analysis right in the court nonetheless determined even there where you have a wealth more information than here that it didn't rise to the level of kind of new information or that would allow a c v so i think it does give pretty strong guidance and i think that's essentially where the analysis starts and ends here you know with all due respect to mr altman in the plaintiffs have raised other issues about albre but but basically the question here is have you st pled information and you've been given multiple times that would show that a company a responsible company could go and change its label based on that information and the answer in judge pauley was lawyer that he didn't supposed complaints you see a person used a product and then hears when they were diagnosed or believe that they had an injury right that's typical in my world where the cases there was none of that right so it's just i have these folks so we we did in the absence of those allegations make a general statue limitations claim and basically what we said was under new york law which this was played under it's three years we recognize that if you plead exceptions there are some but there are no exceptions played though you know plaintiffs were given an opportunity do that judge pauley looked at that so if you just take a straight application giving the the benefit of the doubt here is the date when the complaint was filed we don't know when these people used it again  many of the cases that were filed in the m t l it was people from two thousand and twelve and before i believe mr altman that clients that he filed his case in two thousand and sixteen so again i don't know when that is but but i think there is a there's a dual ruling which is wherever they are if it's two thousand and sixteen they that would be the only date that they would be barred based on the filing of the complaint and that's based on the information that we were given in the in the complaint your honor so for brother counsel to get up here and say that if we put a warning in there that we believe should go in there and it's truthful that we could be hit with misbranding just it just defies their whole position now coming back to what he s supreme court specifically addressed that and said that what you did day doesn't necessarily mean that what you've done that it's ok to mark and so the fact that in two thousand and twelve the f d a made it made a pronouncement doesn't mean that's good for all   analysis analysis analysis now says where's the analysis and i don't want to project out to the endgame in the european union the label sets that lipitor increases the risk of diabetes based on point you know it's somewhat they'll be able to address that i think what's more important was what is the trigger date is really what the question is you know what is the date by which you can say the label is adequate and i come back to one of the things olympic diabetes is under that regulation pfizer was without authority to amend the complaint without permission of the f d a unless on the basis of this newly acquired information unless that newly acquired information showed that the studies events in analyses revealed risks of a different type or greater severity or frequency than previously included in submissions to the f d a is it your position that unless that standard was met you didn't have authority to amend the complaint no matter how much analysis you did you didn't have authority to amend the complaint unilaterally without and so without permission of the f d a that is that your position with cancer is yes your honor and i think that standard is essentially the the predicate for the levine case and the givens case and the of cases so so yes your honor so that even if you i mean even if your adversary is correct in saying you should have been doing more analysis even if that's correct i'm not suggesting it is or isn't but assuming that it is you still didn't have authority to unilaterally amend the complaint based on based on the newly acquired information unless the newly acquired information met that standard that that's exactly right and that's really been the point is that you know what counsel seems to be saying is i agree the adverse events don't meet the standard but you should have done something maybe coulda woulda shoulda right and then you would have had it but the point is looking straightly and this is what judge pauley looked at is that everyone agrees you cannot based on this record they would not have done it couldn't do it without more and that's really the basis i think of what these these cases talk about it's a limited exception to the preemption rule about how and you know it's for the reasons we talked about i think good policy reasons and so yes your honor it was something that the company could not have done unless it made those determinations which it did not thank you thank you that