good morning good morning my name is brant wizner i'm the tourney representing the plaintiff appellants in this matter may please the court to canton lilly's fraudulent conduct of concealing the bladder cancer risk was deliberate they knew that a physician's or consumers knew that it could cause bladder cancer but most people wouldn't use it this fact is supported by the drop in sales following the actual disclosure of the bought or cancer risk in two thousand and eleven the plaintiffs in this case were direct victims of that fraud they paid real money for real prescriptions directly caused by that failure to disclose the bladder cancer risk and frankly they were exposed to a carcinogen against their will and because of that the kid in the early made millions fact beliefs now in the opposition to the opening brief cargo thing asking your clients we're trying to plead a recall so how what is your best case to support your position that in the context of this case and there rect injury was shown for purposes of rico bush's strongest case that the rico can sure clients and there has been a direct injury shown for purposes of recall in similar circumstances i don't believe that this issue's ever been decided by the th circuit directly i think that the best case then that would be binding on this court would be the bridge case from the supreme court which specifically dealt with the idea of fraud being perpetrated on a rd party and how that fraud on the rd party caused injury to the plaintiff in bridge or on or direct injury exactly exactly so in bridge what happened was there was a bidding auction in the county and the defendants created false corporations so that they could get more access to those bids as part of the process so they lied to the city in the county now the plaintiff in that case was a competing company who wanted to bid on those those liens and they brought a suit against the defendant saying you committed fraud and the unanimous supreme court said even though the fraud was directed at the county the most direct a victim of that fraud were the people who were not allowed to get those lanes i e the plainness is it your argument that your clients were the most direct victims of the rd misrepresentations absolutely i don't what why wouldn't it be the people who were actually injured who actually contracted cancer why wouldn't those be the most direct victims well those are different injuries ron or rico doesn't allow for personal injury it just doesn't it's an economic injury solely statute they would have the economic injury of the amount of money they paid for the prescriptions as well as your client's short but i don't understand when it comes to the rico violation what would distinguish princip clients versus someone who did contract water can the fact that the injury the injury that was mis represented about actually occurred to those individuals and did not actually a cur in the in the case of your the case was very clear about that what gives you standing as an economic injury whether or not that economic injury also has with it a personal injury is immaterial to determining who is the most proximately hurt victim here and frankly these plaintiffs these people who bought and used in ingested actos they very well might get cancer i mean cancer has a very long latency and we don't know if five years ten years from now they ultimately do contract but are cancer but it doesn't count the case speak in terms of which are more direct injuries and which are more remote injuries absolutely and in specifically in the context of a pharmaceutical rico case there is no more direct injured then the person who paid for  drug because of the fraud because but i thought that in your brief you focused on the foreseeability of them being insured by getting cancer we did discuss that it is an important issue the direct injury or carmen i think it's the opposite your honor i think the focus has to be the directness of the injury there's no question that's what i think but not take it does not supersede the direct injury requirement that's correct but i think in a direct yes your honor you have to consider foreseeability i mean the supreme court was very clear about that in bridge the reason why there was a direct injury in that case was because it was a reasonably not even reason that it was a foreseeable injury here it's way worse there is not a question about reasonable foreseeability here it was specifically foreseen so in the case and i agree with you that this is kind of an amorphous concept but in the supreme court decision of himi group versus city of new york the supreme court said that proximate cause require some direct relation between the injury asserted and the injurious conduct alleged so would you tell me what the direct relation is between the what do you say is the injury that was asserted in this case the injury is the payment for a drug that didn't perform or act the way it was purported to do so and did the drug it for your clients not work the way it was supposed to whether it's your allegation in that regard sure they purchased a drug that did not have a risk of bought a cancer and they got one that did not  simplicity of your position that had been known to michael's blood because we would have bought a cheaper drug potentially or there but i don't know we don't know that though because the doctor had to assess whether or not the risk of bladder cancer was worth still taking the drug so there that's why i have some difficulty with the direct injury analysis because it's not clear that ultimately have the final decision about whether or not they take a drug that is their choice it is not the doctors and they have all put in their complaint and have alleged that if they had known about the bladder cancer risk they would have taken it and this is an implausible allegation right eighty percent of sales the creased nationwide when they disclose the bladder cancer risk now from the rd party perspective the same rationale we're not saying every single doctor wouldn't have prescribe it we just have to show that at least one wouldn't have and i believe we can show th you have only have to show that one doctor would have declined to prescribe a sense that i wouldn't take a stronger they would just be the rico statute i mean if you have standing you have suffered an economic injury if they paid for one prescription that would not have been paid for absent the fraud then they have standing is a threshold issue now whether or not we can prove it for the class or for all the plaintiffs that's for a conversation in the future when we get to the rd party peers have an  the bridge case addresses this exact question right in the bridge case the the county and the county had to make a decision about whether or not they believe these were legitimate corporations and whether or not they would assign specific liens to them that decision making process notwithstanding didn't oblivious proximate cause by unanimous here this isn't a categorical across the board thing that would apply to any drug right these are diabetics who have already an increased risk of bladder cancer by virtue of the condition and so giving them a drug that increases the risk of bladder cancer is potentially contra indicated i mean that's shown in the facts we allege in pretty serious detail exactly how the sales of this drug plummet not just nationwide but specifically within papers after the disclosure of that information i mean the idea of proximate cause ation the principle behind it is the find a judicial limit on liability that is fair and practical and kind of relates to common sense these defendants the liberals and intentionally knew that concealing this risk would increase sales and when the truth came out the sales plummeted there could be no clear example of profit because who would you please louise argument that they stopped the promotion of this drug in thousand and six allowed to continue fraud to last through two thousand and eleven the district court judge doherty who actually oversaw the trial and the n d l for thousands of these personal injury cases her orders are very clear that a substantial collaborative role in concealing this risk and that case they went to trial you know they argue the same thing and judge doherty said that this doesn't that doesn't apply because of what you've done for the last eight years hiding this r might be an overlap of a month or two but all of the plaintiffs i mean they were using it for a substantial period of time prior to the warning and soon as they were made aware of the risk they all stopped using it so i think it's a it's a question of fact that the jury would have to straight to a question of fact for a jury right our witnesses are plaintiff will take the stand and say listen i didn't know about the soon as i found out i stopped using it and sure the label changed you know in the th year of me using this drug i didn't read the label every single time i purchased it table is randall christian representing the lily he will be speaking for three minutes addressing issues that are specific to lily park will you please put twelve minutes on the  clock thank you yes your honor i think judge robinson in particular i think you did accurately state the law in the supreme court there must be a direct relationship between the alleged rico predicate acts and the alleged harm and as this court and others have held in similar cases due to the numerous intervening actions of independent actors there is no direct relationship between non disclosures of scientific information that were allegedly made to the f d a as far back as two as one thousand nine hundred and nine about risk factors that did not affect these plaintiffs or those that they paid for and independent decisions made years later in many cases by doctors to prescribe the drug by patients to take it and by rd party payers to reimburse for it though if there is a couple of circuits that have gone the other way and if interpret that the supreme court case law and differently as to direct injury can you trust those cases and particular to st circuits case in  specifically talks about doctors prescribing and explaining how that's not to attenuate it because there were written misrepresentations were made and as a result of the misrepresentations the plaintiffs circuit those cases actually have fundamentally different allegations than these cases those were fraudulent off label marketing cases those were cases where the allegation was that the the drug company went out and affirmative made misread present patients to doctors to rd party payors directly about the drug saying that it was affective for a use that it was not effective for and that that the argument there was that that directly caused the doctors and a rd party payers to either prescribe and pay for the drug now of course we disagree i think with the some of the now sits in those decisions but ultimately they are fundamentally distinguishable in this case we have no direct misrepresentations that were alleged to be made you have a non disclosure of information that again took place as far back as one thousand nine hundred and ninety nine to the f d a and the argument is that had what are you saying that different here they're saying material emissions regarding the efficacy of the drug caused them to purchase the drug so how is that different from the allegations in the other cases because the misrepresentations were that th were not made directly to any of the doctors or you can make it a minimum mission directly to some of the the duty of disclosure that they're alleging here is one to the f d a they're saying you should have have informed the f d a about certain scientific information had you done that the argument goes perhaps the f d a would have done something different than it did when it did it but then you have to look at all of the prescribers and the key fact here of course is that numerous prescribe ors to this day continue to prescribe actos to their patients based on their individual circumstances notwithstanding that there is currently a limited warning label about bladder cancer and that alone shows that the causation is not direct whatever one thinks the the neurontin in the vandy cases they were different factual circumstances i think again the analysis i think was was probably not correct on certain of the issues in those cases but we do have a different circumstance here where the causation is much more attenuated there were numerous independent intervening causal factors st there were the decisions of the just set of physicians to prescribe the drug based on their patients individual characteristics and they continued to do that to this day nd there are the decisions of the f d a which is responsible for approving all warning labels on drugs a manufacturer is not allowed to go out and market a drug and that was the allegation in fact in these other cases inconsistently with its label rd there the decisions by the formularies to cover the drugs and forth there are  independent market competitive market factors that determine how a a drug is the prescribed on a day to day basis and there are the decisions of the patients themselves who obviously have different information given to them at different direct ongoing fraudulent marketing that was alleged to have directly influenced the the defendant's own actions as well as the physician's actions so again i think those cases are distinguishable but  supreme court pretty clearly and says even in those circle stances there's too many intervening causal circumstances and i think that one of the key facts here not that i talked about the traumatic drop in sales once the nation was known and the risks became apparent isn't that relevant to the question of proximate cause ation it may be relevant your honor it's not dispositive i think that the judge briars decision in bextra involve a sixty five percent drop and in that case he made clear that that wasn't enough and in this case that drop occurred by the way very close in time to when this drug went generic so you had situations where the drop could have well have  been due to the fact that people are waiting for the drug to go generic but even notwithstanding that i think that the painter's allegation is that we can solve all of these problems with a regression analysis and he admit and i think this is the key admission on page fifty five of their brief they say there are dozens of variables that influence actos sales beyond the simple non disclosures that are made in these cases and i would turn i would point the court to the supreme court's decision  in that case the court said there was not proximate cause where a plaintiff had alleged that the defendant's tax fraud scheme had caused its sales to drop and the court said the reason it's not proximate is there's too many it's too much speculation to determine what percentage of the sales would have dropped but for the cause but for the tax scheme so to hear in fact even stronger more strongly here while there may have been but fo causation and i think that eighty percent is probably some evidence of but for causation the proximate cause ation is let lacking because there are as the defense is the plaintiffs themselves admit dozens of factors that influence actos sales and i named a few of them for you before that beyond these non disclosures and so just as in anza the causation even if it's but for is not direct and as judge rollins pointed out the people who were directly harmed who were sold a drug that they claimed caused them personal injury have sued and have recovered and i would point the court in that regard to the  circuit's decision in oregon labors which holds in a rico case that personal injury plaintiffs are in fact the ones that are bar most primarily best suited to sue and that was a case involving health payer saying that they should recover for the cost of treating smoking smoking as smokers and the court said no it's the smokers even though rico doesn't allow you to recover for personal injuries the smokers are the ones who are the most directly harmed and so we have that here too we have plaintiffs in this case are patients who used a drug safely and effectively as to them and an insurer that insured those kinds of patien but this category of plaintiffs also suffered economic injuries so the two aren't related that's how i understand their theories in other words yes those people relied on the misrepresentations they they had cancer and so they got the recover ace they were directly injured but the theory here is that we were directly injured as well economic because they would have purchased it but for the misrepresentations and admissions aren't those two distinct categories of injuries that could also fall under direct injury they may be distinct but one is certainly more direct than the other and i would again point the court to the organ labor's case which is a binding th circuit precedent and in that case the court said that the smoker plaint the smoke or injured parties the smokers were themselves the most directly injured even though their injury was different from the economic injury that was alleged to have been suffered by the  the insurance companies and in that case that the court found no proximate cause asians so the question is not simply whether there are different kinds of injuries a question is who's the most direct and in what the supreme court has said is we don't go beyond the  quote st step and i would submit that those who were actually injured and of course we have a standing argument that says that nobody here was injured but the ones who were actually injured are the ones who have sued and have in fact recovered substantial amounts and those that yes before your time expires what's your position on the on whether or not there were plaintive who continued to take the drug after the sixty two of the excerpts of record you have the three plaintiffs who continued to purchase actos intil even after the f d a warning label was put on opposing counsel says there may have been a little overlap what's your view on that was that a considerable period of time after seen on the label or was it just in one of the cases it was i believe fifteen my after but i would also point out of my time is  factor in the going to use me as your counting up i would just point out that five out of the six plaintiffs don't even allege that they read or relied on the label themselves so as far as the consumers go you have no clear understanding as to when they got information and all of that not only did they say they didn't rely on it all of them said they didn't know about the risk even after even after the f d a had publicized it so that's another reason why proximate good morning please the court ran a christian on behalf of the eli lilly and company lose their griese with the arguments made by counsel for tecate and those apply equally to lilly however there are additional reasons why this court can affirm the district court's decision to dismiss this case as to lilly reasons based upon the implications of fundamentally different and the more limited role that lilly had as a co promoter of the drug activists where it helped assist market this this is basically a failure to warn case the plainest position is that the actos label should have said something different about bladder cancer because lilly could not have made those changes or any other changes to the act as label those plans claims as to  preempted when you look at the u s supreme court's decisions in levine and mincing together the question of preemption in the context of prescription drugs boils down to this question could the actor being sued for the allegedly inadequate label have independently change that label to what the plaintiff claims was required and that question is very easily answered by determining if that actor could take advantage of what's called a change is being affected provision that is the only mechanism by which a pharmaceutical company can unilaterally and independently change the label without prior f d a approval and the law is clear only the new drug opposition holder can make this unilateral change because lilly was never the n d a holder it had no more ability to change the act as labeled in any of the many factors of generic act as do today and that is no ability at all in the argument that lilly should have done something else outside of the label regarding the risk of bladder cancer such as statements to doctors or talking to the f d a about trying to get the label changed is also contradicted by the mincing court the f d a is definition of a label is extremely broad in includes any communication with a medical professional regarding the drug in the mincing court rejected the ability of a plaintiff to allege all the hypothetical factual scenarios a company could have engaged in that might have led to a label change the only path to liability contemplated by the u s supreme court was the india holder's responsibility for the label and the unilateral ability to change it something could not do in conclusion lilly's role was narrow and limited it could not have changed the label and it could not communicate outside of the f d a approved labeling for these reasons and for all the reasons to  document from lilly and it's a frequently asked questions document to be used with treating physicians during their promotional activity question number seven i heard actos causes bladder cancer is that true and then lilly proceeds to give an explanation that irrelevant rico is not about label changing it's about acts of racketeering that's wire fraud and other types of crimes specified by the statute there's so so what are you saying was the excerpts of record one hundred and fifty there were instructor sales representatives to mislead physicians about the risk of bladder cancer now that has anything to do with the label and so this idea that because they have no control over the label they're immune from liability under rico does not comport with the case law and frankly the palm wonderful decision it's basically states these are two federal statutes so we're not even talking about preemption we're talking about potential preclusion and congress has never articulated any idea that rico and the f t c a statutory framework do comport with each other because they do address the last one other issue and this was specifically the attempt by my colleague to differ neurontin avandia he kept saying that those cases involve direct misrepresentations that's simply not true if you read the two subsequent neuron decisions those involved situations where there was no direct fraud to the rd party payer at the time of purchase it was it was simply the failure it was the off label promotion and the conduct done on the side is certainly was making these refs misrepresentations are you saying that they're responsible for the entire time that to cato was acting i think it be through the time of the label change when the truth finally came out and  in june i believe of two thousand and eleven and by the way just a sorry no not a time really point to one thing you ask questions about the timing of people's continued use after the label change i just want to clarify the very specific dates of each prescription for each plaintiff and this is provided the pleading stage is on the supplemental excerpts of records page twenty eight dollars through thirty three dollars and it details the exact dates when actually each prescription was filled and you'll see that there within a month or two of or