our first court case for this morning then is dolan against glaxo smith kline whose bl thank you in may please the court my name is lisa platt and i represent g s k with the court's permission i would like to start with the issue of innovator liability and three reasons why this court should reverse the district court's holding below on that issue by that you mean liability for the brand name manufacturer that's right right so just to be clear and so and my first point is the plaintiff has the burden to show that there is a duty by brand manufactures to users of generic drugs yet no illinois court recognizes a duty owed by one manufacturer to the users of another manufacturer's product is that right it seems to me that in in the business world there are circumstances in which third parties certify the characteristics of a product for example and so manufacturer and you might sell the product but certifier might certify it and manufacture be in this very weird hatch waxman world where the product has to be absolutely bioequivalent with identical labeling right i mean the i mean the rationale of the other side is that there's a federal requirement that mylan and other genera comp companies use the same label when they sell their drug and of course as you well know you've discussed in the brief in the mensing case in the bartlett case the generic manufacturer can do nothing with respect to the label the court has been absolutely clear they can even exit the market well that matter because clearly in the world of drugs federal law places the labeling responsibility the brand manufacturer so in that sense this suit is only saying that that the company didn't do what it was supposed to do with respect to its own label right and the reason why every federal court of appeals to consider the issue and the overwhelming one hundred forty decisions by federal courts have looked at it have said sure it's an absolute certainty that the label will be copied but that stretches the concept the concept of first the ability to far why does it though i mean actually maybe i should jump you to this point sure there there is a disagreement among the state courts about this claim and at one point along the way the suggestion has been made that perhaps we should just certified this to the illinois supreme court particularly since a the plaintiff started out in state court b we have california taking one position we have west virginia and virginia and some of the other courts taking a different position why isn't this really up to illinois i mean why you shouldn't certify there's three reasons for that and i recognize it's a separate decision on your part the first reason is that there's a specific default rule for tort cases for a federal court sitting in diversity and that's when you have a novel question of state law you reasonably restrict liability more than expanded i think that over the internet you go ahead and well this court has what i mean by under erie but this court is only certified in the last two decades seven cases to the illinois supreme court and all involved incidentally questions of statutory interpretation but we also sometimes expanded toward liability under illinois law it was novel questions if it seems like there are good reasons to do so i i mean your case under erie is ascertain to the best of our ability what we think the illinois supreme court would do and if we think it's on the brink of taking the next step then we do that if we think it doesn't want to them we do that we sometimes ask and remember the certification statute itself in illinois only came in in the early one nine hundred ninety s and so there isn't a very long experience with that and i think that's a fair point let me get to my second and third reason i mean  certification usually happens when there's genuine uncertainty and we have a when we have a split in the state supreme courts doesn't that create genuine and so i'm going to get to this we have a genuine and genuine and certainly an illinois law we actually have an illinois supreme court case smith that at least goes our way and they have nothing and i don't think smith has anything to do with your case let me get to the market share liability i think it does but assuming you think smith is neither here nor there the third point is under your rule and the seventh illinois supreme court rule it's a weak case to certify when there's other reasons that don't depend on state law so you would be burdening the illinois supreme court when there are multiple grounds here and i'm not even sure the illinois supreme court will allows it in your rule your decision that they cite state causation in the duty issue and then you would certify so we're talking a lengthy time here so that's not uncommon i guess on the other side it strikes me that this is a very important question because of the role that generics play in the market because of the role the brand name drugs play in the market because of the number of cases brought it about drugs that appear or for that matter devices but anyway drugs that appear to be unsafe or need better and could hardly effect more of the economy just what i couldn't agree more we think in a buy innovator liability would be catastrophic it's definitely california is the you know the only court that's gone completely towards liability all federal courts of appeals have said no no and more no because it would totally up and the pharmaceutical industry and the three decades of reliance interest that you know the interesting thing about that argument to me is when i really read this morning i  mints sing bartlett in the other cases the supreme court doesn't hesitate to say well we realize that this is a tough ruling for a very sympathetic plaintiff but we have to go where the law takes us and of congress wants to change the law be to be short and it would be an extension of smith but if i can't convince you on smith and we do think we have even if it's not on all fours it's certainly on all three because smith involved the identical question here of whether to recognize a duty to another manufacture but that was when no one knew who manufactured the drug and we know that the defendant here didn't and also i mean we know that counts manufacture we know who has the duty to create the label i guess that's the absolutely and so what the illinois supreme court said was  the drug manufacturers could reasonably foresee when they sought f d a approval of a drug that cause birth defects they could reasonably foresee that other manufacturers would not only enter the market but with the exact same design and exact same label and the court said only there's a duty and i'm just quoting from the opinion it's only a duty to your own customers notwithstanding that the plaintiff would be left without a remedy because the desire to create a remedy for an injured party was outweighed by the just the potential that the added exposure would reduce animation and lifesaving drugs and we think we have that in spades here but if i can't convince you on that i mean i don't think i could i don't think you're in a position to certainly say illinois law would when the only thing you have on point so i don't know what illinois would do so then i can turn to the other issues which i do think you have to address and that is we have to end appendant reasons why their failure to warn claim is preempted underwired versus levy and its progeny the first argument on that that that under the supreme court's decision in mensing and this court's recent decision in g s k could not have changed the label unilaterally because it lacked newly acquired information so i wanted to ask you about that because in want to give the court actually considers the breadth of of the phrase newly acquired information and it says it doesn't need to be brand new data in fact it includes new analysis of old data and i think that was never mad a couple of concerns about this part of your case one of them is it seems to me that the f d a and your client were talking past each other that nobody really know what was on the table the f d a is saying we don't want the class wide s s r i label to be different you're trying to say oh never mind about all of the s s r i's let's just look at pa aside and i couldn't disagree with you more on there we're talking past one another but that goes to clear evidence our point which is completely independent is did g s k after the f d a and there's the other side doesn't dispute this mandated a labeling change as  august two thousand and seven that disclaimed any suicide risk are for adults page after twenty four and you're you see is right on it is what new information meaning new analysis of old information they don't point to anything except a two thousand and eight article that was published in two thousand ten that is identical word for word verbatim it couldn't be more closely one big mare of what was given to the f d a in two thousand and six so they've left you with nothing they actually have no response to this they're not going to be able to cite new analysis of old information there's old analysis of old information f d a had everything they say to the state judge what that label still says the exact same label on paxil and there is no new information your suggestion is that the current manufacturer is also liable because they've had new information to a study this issue exhaustively for years including this very same information in the two thousand slash two thousand and ten article and they just don't have a response on this except to try to model it and confuse you that this is a clear evidence issue the only dispositive fact is there is a statutory federal requirement that paxil carry this label it's still that requirement today that label has to disclaim a risk of suicide risk there is not a single manufacturer alive that can change that label unilaterally and what i mean by unilaterally is not going to the a and saying can we change your mind i know you're talking about this process that your client went through for a while and then the f d a thought about it and they said no and then we have this exchange of of communications between the f d a and that i find ambiguous so even if you find that ambiguous that all goes to could we have convinced the f d a to get its our permission if you sat down with them and said oh let's make sure we're all talking about the same thing right which i think they have a terrible argument but even if they were right on that they have to show you that we could have called the printer without asking permission printed out a new label put it on the packaging no prior heads up the mere fact that they've been arguing about what we should have and could have and might have told f d a in a meeting just proves our point we had to get f d a permission to change it they have to prove and dependently that we were lawfully able and still that the current lawfully able to change the label and they can't and i think the f d a is brief on this is very positive for us they just don't have an argument which is why they buried it in their brief they really want to talk about what the f d a might have done and that's not the issue it's what g s k could have lawfully done and they would have violated federal law and so would a appetites whatever they're called now they are illegal they would be acting illegally if they called up the printer and change the label paxil so despite all of these suicides of people in the higher age range above the age of twenty four say it's your position that there's no suicide risk it's so let me just turn to that it is the f d a position all the data that they relied on was in front of the f d a they did a two thousand and six med analysis of one hundred thousand patients three hundred seventy two clinical trials including paxil paxil was the main drug issue so it is mind boggling that they would say the f d a wasn't looking at paxil paxil was the one they were worried about and they say in their me yes see these paxil numbers but that is scientifically not relevant because it could be chance and we're discounting it because of the number of comparison is recent isn't is that it clear that your position was that the science did warrant a more explicit warning right i position was i mean we had all those disclaimers the opposition was more information is better so we try to put in the information and about there was a risk and they were in the attempts so again and this is our point on to have you address the problem of how that was presented by you to the court to the jury who's who's the decision maker and on what evidence your record oh short so we think preemption is a question of law for the court the third circuit has disagreed and held it a fact question that issues in a pending petition the federal government in their recent brief i mean gave one thousand different reasons on why it's a question of law i think it's a it's a standard federal  straight on we have two independent arguments the first issue our newly acquired evidence we've met our burden there's a federal law that's called the lathe that's mandated and we've said there's no new evidence there's they say well there's a late there's a there's a article that's all they cite after august two thousand and seven and we're telling you that there's a table that's identical it's just a classic legal question like construction of a patent or was a confession voluntary or was there probable cause or did you a miranda rights all these things are legal questions yet they can turn on historical facts the second issue which i think you're going to is hypothetically what would the f d a have done what have they rejected the label that they suggest and we have the correspondence that i can get to and we also think that legal question for the court in terms of how that played out at trial the judge proposed to charge the jury we objected not only because and the plaintiffs have always said that this is a legal issue they don't think it's effective she either we said first we think it's a legal issue  second we don't like your instruction we proposed our own instruction that was just a verbatim quote under wyatt for the clear evidence to support rejected that so we think it was properly preserved but i don't think this is complicated on the legal question if i can get also again i don't think they have a response on the newly acquired evidence i also think it's devastating on the clear evidence and i get what they're trying to say they say you know we could have put in a different place we should have met with the f d a and you know and your warning wasn't clear enough the problem for them that the timeline is unambiguous and that the f d a would have rejected any any and all paxil specific warnings because the label they want was the opposite of what f d a had concluded about paxil the label warning they want is that paxil increases  suicide risk for adults of all ages f d a looked at it one hundred thousand patients paxil specifically cited on the reply brief to page twenty four and said we discount the packs of data we want to disclaim that they on three separate occasions said unambiguous lee that we're rejecting we're taking you have to take out the paxil warning you have to put in our class warning which as a warning to pack some patience that s s r i's do not create suicide for one reason and one reason only they wanted a consistent universal standardize warning that disclaimed suicide risk for all s s r i's again paxil their argument is that it was the highest blip so the notion that they you know we didn't look at paxil is is is just not clause i can certainly see why they wouldn't want the class warning to overstated but if a particular drug had an extra problem you know so everybody's free to take all the other assess our eyes with less concern but maybe  paxil the doctors want to take some extra steps judge with that just doesn't work in the f d a is brief is just devastating on this and it doesn't work for three reasons one i just told you they looked at paxil and on the merits said no no we don't like the plaintiff's argument they testified at that advisory committee meeting we don't think paxil creates that risk second the what they want is even worse they wanted a warning that said it's one thing to say as our eyes are good but maybe this one presents different risk they want  would be the point of patterning each one they did a hundred thousand patients three hundred seventy two clinical trials about like eight or nine s s r i isn't any depressants paxil is what it leading months the third reason they're not claiming they're identical drugs of course not right we're claiming that the f d a individually concluded no risk no risk no risk we want all patients who are depressed not to not take these medications because of a fear of suicide and let me get to the third point and again on regulations require the f d a to sit down with the manufacturer and craft that warning the f d a can't reject it because it was worded wrongly it was in the wrong place now my recollection is that there are some criticisms of some of the studies  e presented to the f d a and invited the f d a to rely on those studies that those studies themselves had some problems sure and that was cleaned up by two thousand and one again their problem is that this suicide was in two thousand and  understand that they want to make j f k look bad and the study you know can really can all kinds of things are doing that so please let's not well it is nonsense in this sense there is a they have have to obfuscate because there is a label a federal label that says as our eyes don't present a risk we lawfully couldn't change it it would have been illegal and then on the new evidence and what the f d a would have done f d a had all the information i don't know what would happen the so called meeting that we were supposed to suggest they had already said we looked at your data you want the same warning they said it four times over they say you know that may one may seventh june twenty first and june twenty second we want to consistent standardized universal label and they were done and over with so i just don't know what happened at this meeting except you know and again that doesn't they still have the problem with we would been begging for their permission and i do think it's bad for them that the label still says this and this issue was one of the biggest health care crisis starting in i think two thousand and three when the pediatric data came out it was a massive public controversy the f d a was very concerned on this they were focused on the specific issue suicide is obviously a very serious issue and these drugs are designed to help people who are depressed so it's not like the f d a was treating this casually and  good morning may please the court brant was not behalf of the police when you don't i had an introduction prepared but i actually just want to get straight into preemption since that seems to be the where we ended off the last part of the argument i want to clear the f d a is not submitted any brief in this case and i'm aware of so i believe the brief that opposing counsel is referring to is a document that was done was prepared by the f d a well the summariser scientific conclusions about us arise generally so i would appreciate it if you could maybe start where ms blatt left off and talk about the g s case efforts to change the label in the mid two thousand and f t s ultimate decision that it didn't want those that prompted a widespread concern within the f d a that all as a start manufacturers were doing the same thing at that point they requested all the pediatric data and they initially had a label issued but warning about pediatrics who was that ality subsequent to that the a said ok we now want every manufacturer to give us all their placebo controlled trial data relate which is a subset of the data i mean we it's the f d a wants placebo control data then that's what you have to give them that's the gold standard protocols the way normal clinical trials done but g s kainat centralized database didn't have that data and this is really important because they reported to the f d a a single adult suicide in the placebo controlled trials we found at least two or three it did adult suicides in the placebo controlled trial so the data they gave the f d a was itself deficient and that's clearly in the record but that said they reviewed the data that they submitted to the f d a in two thousand and six concluded up we have a problem so they changed the label and they did that uniformly and he added this risk information that's under the authority do it quickly and unilaterally right exactly under the seamy correct your honor right at that point that he  didn't stop them didn't say take it off or we have a problem with that it was on the label for about a year then two thousand and seven the f d a issued its analysis and in its analysis it was analyzing all accessorize it did not analyze a single s  significant risk this confirms it now is for all psychiatric conditions the initial analysis done by g s k was just for n b c so this confirms what they already knew in their two thousand and six data which as we have shown at trial confirms what they knew when the classified warning came out the f d a was trying to implement warnings for about forty different manufacturers just he was one of them and among so many factors manufacture all sorts of antidepressants not just a other things that were studied in that med analysis they said implement this classified warning immediately and that was the predicate for when j f k responded to email and then form a letter saying hey we think that the pass all information should be in there and they proposed putting it smack in the middle of the class labeling the f d a finally said well so that would show is that your position and that that warning as a same response a concern of mine that that warning didn't belong in the class morning but it did belong as some sort of paxil specific for all i care lexapro specific that's now before us that particular warnings precisely so  what was what was g s k supposed to do when the f d a says i guess june twenty fifth two thousand and seven we do not believe that your product specific analysis should be included in class labeling revisions that your proposed putting it not in the middle of the class labeling provisions on cross examination of g s case company when is that trial i asked him quote nowhere haven't pointed to this jury a document that says you are prohibited from putting any paxil specific information anywhere in the label the she said very frequently manufacturers add drug specific information to classified warnings he actually gave examples of it and that trial over the course of two hours he specified eleven different locations matter of law and the jury gets to hear the evidence there was a considerable amount of testimony on this issue and they are headed to the jury in fact the jury asked several questions about the various f d a correspondence during its three day deliberation and  on the facts one of the issues that wasn't addressed and i believe it's an important issue is the standard of review for preemption we've argued that it actually is a clear error standard in so far as your it seems so counterintuitive to me i mean preemption is a question of what's the scope of the state what's the federal law cover it sounds a lot like a question of law to me it could be a question of law for which there are some historical facts there are going to feed into the ultimate determination  it's inconceivable to me that you would have a court in illinois saying that there's a federal preemption based on the facts before that court in a court in new mexico saying well here we don't find preemption well i agree with you the federal the food and drug statute and the supremacy clause these are legal questions that courts decide it's not are of law yes except for well there is a lot of legal issues that all would be subject to a noble review there are factual findings because the levine and preemption that there are certain requires a showing of clear evidence and there has to be a finding by a trier of fact whether that's the core of the jury that in fact there is that evidence and once you start talking about communications e mails testimony by their own company witness testimony by experts you are now weighing evidence and making a factual finding i don't well meant you should be more specific i can certainly see in mensing and in part load for example the court saying the legal structure here simply does not give the kind of room for the generic manufacturers to change the label that would be necessary in order to hold them liable either is a matter of negligence or supporter of product liability or any other sort by ability and bartlet you know they said to underscore that that holding and say it's  here i mean in in our case we have what you're basically trying to do is you're trying to focus on the one duty the duty to provide an adequate label such that the drug is not quote unquote misbranded and obviously when it first comes to market there's a label that the f d a has approved there's a process for review there's a process for change all of that lies in the hands of the brand name manufacture not and  specifically excluded from the generic so we have to decide does that mean that if there's a bad label the brand name manufacturer has the burden of the addressing that problem no matter who actually in the sense was its agent  manufacturing the product i think that's correct and that's getting into the label munity which i'm going to transition to just one second i would just point out that and why i feel of the the seminal case you're on branding preemption which is the preemption being asserted by the defendant it's stated actually a reference to the trial court in the purging a supreme court's actual determination specifically stated a both the trial court vermont supreme court rejected this account as a matter of fact and then it went on to say not hstanding the evidence that wyatt had presented that the f d a would have rejected it it went on to say we accordingly cannot credit why it's contention that the f d a would have prevented it from adding a stronger warning inherent in the levine decision is deference to a factual not talking about a legal structure and it's a little odd to me that that's not what you're relying on the the legal structure allows the f d a to take into account not just newly acquired information but a new analysis of old data and so the f d a is hands are not tied if further investigation shows either a particular drug or perhaps class wide label or something else should be changed absolutely and in fact brainy manufacturers have a very product discretion to implement the c b e regulation i think why they live in makes a clear and one of the things that was interesting in a wide field dina's twenty adverse event reports that had occurred over twenty years that was enough because they could have looked at it to change the label so there's new evidence rule that's being a spouse as an argument here preemption really doesn't work out we present to the jury i think twenty eight different adult suicides in just kids clinical trials one by one went to the date time how they killed themselves and i think that you know that's an evidentiary basis for saying that they could have changed a little bit a lot of really even after two thousand and seven ok so w have you from after the f d a says don't use i'm stuck on that short but what do they say no to they said no to putting that language in the middle because white morning and in the same paragraph say let us know if you absolutely i actually don't know what the f d a was thinking that's a very good reason why the f d a modified that i think it's telling that my proposing council stated i don't know what would happen at that meeting that is not clear evidence i mean that is an admission right there that they have not met their formative defense burden at that point preemption should be rejected so on this record at least as it's been presented i don't believe preemption stance so let me ask you if you could because what m says about certification is that one wouldn't certify there's an independent reason any way to rule on the case one way or the other i think that makes a lot of sense of course and we've been discussing the about that sure the last two grounds that g s case six reversal of the first relates to whether or not we presented evidence of general causation i mean to be clear we presented three different expert witnesses reviewed literature is that sufficient for much a jury could conclude it causes suicide in adults over twenty five and i submit that it is it's not a particularly controversial idea we're not the first case where a jury has concluded that for what it's worth there was another trial in two thousand and one where another jury concluded paxil caught suicide and actually homicide in that case so this idea that there's no evidence that it causes suicide in the face of where testimony doesn't seem like it really gets very far let me ask you about the doctor who prescribed this whose testimony i can charitably refer to is all over the block you know he says one minute it had he realized that there was a suicide risk for a man of mr dolenz age which i recall was about fifty five he never would have prescribed it then he turns around another point he says oh you know i knew all about you know suicide risk adults i saw this old warning and then he turns around again he says you know i would never describe it so what we make of this because we do have a learned intermediary here it's a good problem it's a good question the issue is  prescribe her got confused during cross examination that's simply what happens if you look at the actual record of the questions asked of him or a paragraph each and it went on for i think almost two days it was it was and they kept asking questions about the risks associated with pressure and things i and everyone knows that depression and anxiety are themselves associated with suicide right and he kept answering questions about that but then he would slip in something about an antidepressant and he someone's been on it for two years and has a bitch related that side effect there's really no reason at that point to take someone off of a drug that they're already doing well and that actually would be against the standard of care he testified to explain that on the stand but ultimately at the end of the day when a jury is presented with potentially conflicting testimony that's why we have various they figure it out and he decide which aspect of the testimony they want to believe it which ones they don't and j to our closing argument devoted fifteen minutes to this specific issue i mean they went on and on and the jury just didn't agree so the question before this court is is there any evidence that they did make a difference in this describing clearly is evidence in the record but that can't disturb the verdict there's no reason to do that now stan the fact that there is some conflicting evidence and it was a big issue at trial something that we lost sleep over but it's ultimately something that the jury decided and i don't think at this point he needs to be reversed turning to the label community issue one of the cases that we cited in our brief and discussed at length at different points was the happel decision illinois supreme court decision it was not addressed whatsoever in the reply nor was it addressed in the opening brief and it still is actually one addressed the cases particularly helpful because it showed that a duty to warn can be ascribed to a non manufacture and that case was a pharmacy that was filling a prescription for a customer and there were chunk different drugs being filled that were contra indicated and because the pharmacy  we know the product liability has enormous policy implications terribly important for public safety we know the brand manufactures brand name fractures have ample incentives their financial incentives to develop new drugs that can be incredibly profitable there also are financial incentives to avoid to liability at least as i understand the way drug markets work at this point the theory that you are relying on here would impose approximately an on average a ten fold increase in exposure for brand name manufacturers on the theory that ninety percent of an average of all prescriptions are filled by generics what marginal benefit for public safety do you see from a ten fold increase of exposure why i disagree respectfully or are that is a ten fold increase when you think it is i think it's the that the exposure is based upon fault right the theme nope it just the sheer number of incidences i don't see how you can disagree with that part if there's if and these numbers may even be wrong but roughly if if after generics are in the market the brand is still capturing ten percent and the generic manufacturers collectively the other ninety right now you are at least in a jurisdiction where the state tort law is the way it is say and for junior west virginia right now the manufacturer is paying tort liability for its market share your system would have it add on the other ninety percent so there's a and then you'd have to get an incidence of problems and so on and so forth fair enough there's just two quick answers the first answer is there are regulatory provisions that allowed and gave the order to withdraw from the market and no longer control why isn't that a bartlett issue and who is then responsible for the labels at that of bartlett issues because it's not about conflict preemption and we're not saying that they have to draw from the market to avoid exposure i'm just saying the policy issue of long term tenfold increase they can actually mitigate that i would drive the market or of generic drugs actually are that today penicillin no one owns the original and the a for that it's an orphan and yet and so there is a way to limit exposure if you want to be by withdrawing from a market crowd seems like an extraordinary these drugs yes there are dangerous side effects and there are people who will suffer enormously and who use them but they also produce great benefits and if your answer is well you should just withdraw from the market that's a pretty troubling answer well the short answer no longer going to i think the more compelling answer is that they're not insured for the industry they're only in insure for their fault an insurance costs so i say let me just maybe help you out or at least tell you how i'm thinking i can think of a lot of lawsuits against generics that would not implicate the brand name person at all if you had bad sanitary conditions at your plant if you were using unsafe distribution methods if you in some sense as the generic manufacturer were doing something wrong with the manufacturing process there's no way you're going to sue the brand manufacturer is not their fault it's not under their control clearly that lawsuit goes against the generic manufacture you're looking at this one funny thing actually i think you could probably sue the generic manufacturer if despite representing that it's bioequivalent it turned out that that it's not so that's off the table you're focusing on the on the label correct and that's that's what i was getting and that is the negligence and the reap the repercussions for that negligence us that there are tons of risks that only appear until after you get into the generic phase of the work and that's one of the reasons why it's really important and absolutely essential that the brand name manufacturer have a reason to update the label if there is no reason and they're the ones doing the bio monitoring then you really are putting to public the reason that they have is because they're still manufacturing the product and selling it and face the liability for their own for harm to their own patients right that's one that's goes back to my question of what's the marginal value of the ten fold increase in exposure i don't think is a ten fold increase but assuming that is the market and i am it's a ten fold increase on average for claims based on information right that's correct and i'm not interested at all in manufacturing defects in those kinds of problems do both that's just not this case i'm sorry i'm over time now but the the the marginal benefit that i don't think it's marginal look at i mean people are dying taking the struggle and we have to pit the public policy interests of safe drugs against a drug company's problem people who have depression it's untreated by thank you may please the court i mean judge jam out and you had it if drug manufacturer abandons their n d a because the game is just not worth the candle there's nobody to that has the infrastructure the experience with the drug to collect and monitor the patients who took paxil it would be disastrous with no one with and they're the only ones not only with the duty to update it they're the only ones to with the ones who can change and for the change the label unilaterally sapir is new information new safety threat penicillin i think  was around when i was born these antidepressants are much newer drugs so i don't think penicillin such a great example on the new evidence point he he really didn't have a thing to say he said he counted twenty eight adult suicides i think those were all in eighty's or ninety's and an adverse event wouldn't be the type of new evidence under the regulation it has to be new evidence that suggest an increase in severely or different type of side effect you can't just be hey i heard somebody on the street said something was wrong here it's got to be something that would allow you to change the label on the preemption question whether it's a child or a fact there was no factual finding to defer here the only factual finding is that the f d a it's undisputed the f d a said please don't call us anymore you can set up a meeting if you want no one disputes that that happened and they also they conceded below it was a legal issue and their argument about this classified labeling it could have gone anywhere or classes just classes just the antidepressant class or s s r i class and so the whole just filed in the united states supreme court in a merck vs operate case and you have it it was just filed maybe on friday i don't monitor the supreme court reify allusive other cases no huge what are you talking about short so we submitted it to you in a twenty eight j letter it's a very lengthy brief because the supreme court called for the views of the federal government the f d a on two issues just hamilton the first issue was his preemption under the clear evidence standard illegal or factual issue and the government said it's obviously a legal issue the second one which is directly relative these are directly relevant to our case is what the plaintiff argued there was the drug company messed up because it proposed the wrong label and a could have you know you never know what might have done an f d a said are you kidding me we cannot reject a label based on a problem with deficiencies or form if there was a risk that they can be on a label we have to tell the manufacturer to put it on the label so it does render their argument laughable it also says if it's a warning it goes in the warning section don't talk about a suicide warning on the label and then when you're talking about you know i don't know whatever you're talking about something else with the drug you start saying hey by the way this also produces a suicide risk in the f d a i think this does get back to the point i was worried about for according to what i understand you to be saying there's absolutely no distinction in terms of risks don't put it in the class warning because three times they said this don't put it in the yes we want the standard warning for all s s r i she'll say oh i and that's that's completely consistent with what i'm saying we want you know if there's a standard warning for all s s our eyes and that's the standard warning don't market including paxil which is the drug that was part of the leading study it's like say we studied toyota and decided to try out honda and for sadie's don't  but we're going to try and we don't think they present a risk but now we're going to tell you toyota's present risk they decide then why do you if we found out the toyotas have been have a sudden acceleration problem when the other cars don't well there are a whole lot of things that are the same among them except sudden acceleration progs up all of the sudden acceleration was before the f d a starting in two thousand and one all the way through two thousand and seven the very their whole argument on why paxil so bad for you is the f d a is conclusions and the f d a said don't put it on the label we want everyone to hear that as a surprise do not or the studies do not show that risk they say it's just a statistical significance or denying to this moment that there's any evidence to show that there is a risk and enhanced risk of suicide in the adult population yes there statistical significant findings of of all the things that they said but the science manual says it doesn't show even an association in other words you can roll the dice and it can come up you know something and that you can get a finding of something but they still said no it doesn't go on the label ok thank you thank you very much thanks to both counsel will take this case und