fifteen minutes or to be shared by the defendants grab for the i'd like to focus on three issues this morning first and most important is the issue raised by the supreme court in footnote four in its recent board that decision would preserve rather than raise be more accurate to describe what they did in that they didn't reject it right they raised they identified the issue as an issue that they were not reaching and we don't we your honor we certainly don't dispute that the court did not reach that issue in fact i think the footnote quickly says that but the court explicitly said that the decision they were rendering important it did not resolve that question and unlike unlike mincing these cases squarely present that issue because today but that there are factual questions your honor about whether we would be able to establish a footnote for defense and i'd be happy to discuss those but the fundamental difference requisite of that you still are relying on significantly new information i mean that to me can't be commonsense point they're reserving and seems all nine justices agree with it which makes it even more likely to be common sense it's just a situation where the f d a has done x before some is liable but i assume it's something pretty catastrophic that comes out so dangerous to health and then you would sign scientifically significant info not before the f d a and so i don't even see that in your case so i don't even know what you're i mean you don't see much of anything in our case because the judge never let us get to get anywhere in the case was ruled this case were dismissed on the pleadings i don't see it in the complaint it was the complaint  the complaint relies on new post july two thousand i know from ation your honor that no the cases were not that i don't i don't believe for them for argument is limited to post july two thousand and nine and then you should maybe respond to my this for this drug and then suddenly something new comes out you got it you got to do something under state or federal law exactly regular honor and that's and i think what the f d a said to the court in bartlett is that when there's new information that comes out that the f d a hasn't that's new and scientifically significant that was not part of the f d a review and that leads to a recalculation of the risk benefit analysis so that it's no longer clear that the drug is safe then a stop selling theory of tort liability makes sense because both federal law and state laws prohibit the sale of an unreasonably dangerous drug it's misbranded under federal law and therefore it sales prohibited and it violates nine there was new and significant information that had not been considered by the f d a when it approved the drug's new and significant information that had not been considered by the f d a when it approved generic versions of the drugs  and in some cases new and significant information the f d a did not consider even in its two thousand and nine review and that that information remember in two thousand and five the british government said that they can't find any patient group in which the risk benefit  for this drug is positive and there is information from long before two thousand and nine that the defendants are attempting to hang their hat on this two thousand and nine review which is you will recall at which time the advisory committee actually will it i think it i think it's important evidence your honor it's not i mean obviously they're not the the regulatory body with authority but the f d a itself concluded that the drug was misprinted in two thousand and nine when it ordered stronger warnings including a black box warning including warning specifically about cardiac treatment so that all of those you know the f d a did not come to the conclusion that everything was hunky dory in july two thousand and nine and say we don't have to worry about this drug it's safe and i think upgraded the warnings to the was there was evidence that the f d a didn't consider and indeed public citizen petition the f d a to reconsider its action on the citizen petition in two thousand and nine because it had failed to consider important for me scientifically significant information out there there was information we will need to establish that there was new and scientifically significant information that the f d a did not consider that rendered the drug you don't need we do need to we will need it to prevail in this case and remember we're up on  unemotional to dismiss to prevail in this case we're going to going need to establish that there was new and scientifically significant information that the f d a didn't consider that rendered the drug misbranded under federal law and that prevail on this appeal you have to show that that's alleged in the line and it does allege in the complaint your honor paragraph three i want to believe it is you know like the allegations about the drug being this branded under federal law it also contains lots of allegations about the factual findings made by the european drug agency the british drug agency there's there's plenty and have to be new though as two thousand and nine just as we knew it had it has to post date the f d a approval of the product in the in the sense that it has to be it has to be information that has not been reflected if the f d a has made a professional judgment that despite that information the drug can be on the market the defense allowed to rely on it if it is information the f d a is not considered under believe it is i think i think we'll have to wait to get the f d a views on this question but the f d a says that where the product is misbranded under federal law a state design defect or other state wrong to stop selling wrong marketing in theory can survive if they said in the case in bartlett there was no new scientifically significant information you know and they may take the position that the information they considered in two thousand and nine answers this question and that you know that remains to be seen but that's a that's a factual question for resolution on motion for summary judgment or a trial it's not a basis for declaring this claim preempted the end unavailable at the beginning of  state law you're always going to be up to be able to go up to the generic under this series and that right the well remember your honor that the in most cases toward  the vast majority of state tort litigation against drugs a against drug companies involves failure to warn and mincing clearly speaks to the question of failure to warn liability the that there is going to be a theory out there under state law under this type believe that it would apply common k across the board so they basically preclude all design defect liability against the drug companies they because they say all the proof pharmaceuticals  are unavoidably unsafe products so there are i mean there there would be there would be it would be a question of state law and it's not clear to me that the that there would not be differences between the two categories but the yes to the extent that a drug is mis branded under federal law then the in possibility conflict that the court identified in both mincing and bartlet disappears because if federal law prohibits the sale of a drug because it is misbranded either because it's ask them to consider it if you're unwilling to agree with us with our reasoning but it seems to me to follow like night follows day from the lodge the inherent logic of the courts and possibility pulled from the market is unreasonably dangerous and this was a case start on is a case where you've got a drug that basically didn't do anything except hurt people it was prescribed for mild moderate pain most of the suggest it was not effective in the least you take a few minutes ok let me do that the two other issues i want to touch on briefly your honor the first is the full gens issue the failure to update issue in the  this court has decided like many courts around the country that the failure of a generic drug company to provide a warning that matches the warning that the f d a has approved in the brand is a viable the generic didn't provide the warning that federal law required and contends that the failure to provide that warning caused his or her physician to prescribe the drug that would not otherwise have prescribed that that states a valid cause of action  judge reeves didn't dispute what he did dispute in the but that's because he was writing before fulgencio came down judge read through those claims out primarily on pleading grounds he said well we don't bother we haven't bothered to allege which generics didn't make this didn't fail to update their warning labels that's incorrect as you'll see if you look at paragraph ninety six in the alex complaint as representative we said the generic defendants did not timely implement the black box warning and that's because if you look at the f d a website that lists warning labels and approved amendments to warning labels there was no indication on that website that any generic it made the change now in their briefs the generic defendants now tell us provided evidence that one milan product had an updated label you know we were not disputing that if in fact  this updated labeling was changed and provided that there is no cause of action but the but we did allege that none of the general defendants make this change and we allege that that was the cause of we did it and we did so on a  different state laws and the court has expressed its view on this issue in at least tennessee and kentucky law i think the important question here your honor this is a situation this kind of litigation almost invariably takes place in federal court this is a pure question state law plaintiffs fundamentals in a bind were state federal courts are reluctant to would address unresolved state law questions and as they perceive make new law we think we're misrepresentation claims are well grounded in misrepresentation well your honor there are several but if the misrepresent misrepresentations are in the labeling the label suggests that if an untrue it suggests that the drug is you know is safe and effective when used in accordance with ordinary dosages untrue so these are all misrepresentation for the product you so on this is really odd to me just like putting a new label on traditional product liability warner well your honor i disagree and obviously as we've said in the brief there are at least a few courts that agree with us in alabama california illinois vermont the the premise is that it's traditional black letter tort law that you can make a misrepresentation and be held liable for it if it is reasonably foreseeable that someone is going to rely on that misrepresentation and suffer harm as a result it is absolutely reasonable to see that when a drug a brand a drunk company makes a representation to a physician representing about someone else's products you are misrepresenting about your own when you're misrepresenting about the effect of a drug and you know you know that eighty percent of the time that a doctor writes a prescription for the drug it's going to be filled with a generic  copy so it is entirely forseeable that your representations and remember it's a brand of companies that publish their label in the in the physician's desk reference that generics typically don't it's you know the whole system is structured so that doctors rely on about it  guess we could fight about whether it was reasonable for them to rely on that representation but yeah i mean if he makes if someone makes an affirmative and just to be clear your honor there are lots of cases in which we hold a manufacturer  products liability at the same time that we hold a nother party liable and under a different tort theory we often hold doctors liable for malpractise at the same time that we hold new drug or device manufacturers liable for them for product liability so it's not this isn't a new theory but the point i want to emphasize your honor we moved in the district court in many of these cases to certify this question of the state supreme court's we've moved in leave a few of the cases here for certification it seems to me that the alabama supreme court i think it would be fair to say surprised surprised everyone when it by a vote of eight to one upheld this legal theory and said we agree the plaintiffs consumer brand name manufacturers i don't think courts federal courts can fairly assume what it is that state supreme courts are going to do our job is to anticipate what each of the state courts would do it is your honor but it's but it's also you also have a procedure available to you to ask the state court understand for some of those courts which which of the twenty two states does the law clears in your direction who well well your honor we have a there is now a federal district court decision in the illinois in favor of this theory that's the this would be the best the case where we would most likely predict in your favor with because because the in the dolan case which i believe we submitted to supplemental authority because i think it came after briefing the district i think it's the northern district of illinois rendered a strong i'm sorry your honor it's hard to say i mean as i said we're what we're talking about there are no we've cited you the cases that are clearly on point as have defendants there are the this is reasoning from re statement principles restatement provisions three ten and three eleven and reasoning from black letter principles of tort law that are adopted in virtually every state and there are no states to the best of my knowledge where the highest state court has rejected this cause of action so that's why i think it's you know it is a live issue in every state and unfortunately because the issues typically litigated in federal court we find ourselves in this bind of not being able to you know you will feel like you can't you don't  to presume a new legal theory that hasn't been officially recognized by the court but we have no way to get to the state court to have the issue recognized because defendants keep moving these cases to federal court thank you your honor i hope i have will have a few minutes for  reserve three thank you  you've all divided seven and seven i think eight hundred seven my colleague with generous with the extra is what was the court responding to let's look at the amicus brief that the government submitted and we talked a lot about the new evidence component and i really want to focus primarily on that but there is another critical component that the government articulated there which is that in order even if you had a federal misbranding situation in order for a state to be able to parallel it you'd have to have what the court called what the government called  defect jurisdiction where warnings don't play any role at all and as the government acknowledged in its bartlet brief just a year ago they're not aware of any jurisdiction in the country where there are state quoth of that action under designed effect they don't implicate warnings in some way or another and of course in all the jurisdictions here we have come and k issues but then the courts say even if you were in a pure design defect jurisdiction we would have to take into account the role of the f d a and that's the critical question i think judge sutton with driving at and my colleague here called this a leap year case i would say the judge something properly described this really is about an eighteen month case because there are two windows pre two thousand and nine and post two thousand and nine now pre two thousand and nine and this is where all of the allegations are i looked at the allegation and the paragraph three zero nine that counsel suggest there is nothing in there oh did he say three o one well there's a look at the whole complaint there's nothing post two thousand and nine other then ignalina meant the data dined with conducting a study which i'll get to in a moment but pretty two thousand and there are a lot of allegations about what the united kingdom did what the european committee advised us the good question what was the relevance of the f d a zone advisory committee recommendation and of course the relevance is that the actual agency itself made a determination looking at all of that evidence the determination they would like to second guess but it's a determination that the drug could stay on the market indeed subject to new labeling well of course that's exactly what happened in every case where the f d a strengthens the label that was the issue in men thing to do and interesting lee both the federal government as an amicus and men think and mr boger had himself in the mensing case argued to the supreme court that the drug with misbranded and both federal and state law prohibited you from selling prohibited tell us from selling a misbranded drug the fact is it can't possibly be that we can have steak  that claim that something is parallel to federal misbranding when in fact the f d a renders the judgment that you can stay on the market so really we're not talking about a leap year we're talking about this window after two thousand and nine and the september about a year how does this work well the drug companies brand companies are obligated to monitor all the literature and to provide all the information going right back right what was that they could have a duty under state law claim i don't believe that you would have a viable cause of action to stop selling something devastating well the question of course is would the generic company learn about this are you assuming that the generic company page of all the major newspapers you study shows third of the people die within thirty days of using this i think if that happened the f d a would take action i mean mensing actually posited that very question mensing thing the supreme court actually said assuming argue window that there is a duty by the generic company which we know can't change the label to actually come forward and tell the f d a right away that there's new information and that that duty flows from the   printing statute which justice thomas said in the journey opinion is even if there were that duty under the misbranding statute it would be all sheer speculation as to what the f d a we do with that and so therefore you can't change the label and judge justice alito acknowledged in the bartlett case in the men think it's itself stop selling was also an option available to the generic company and in fact that was one of the bases for the lower court's opinion but that's an interesting hypothetical and it may be something that will have to litigated at some point it's not played here remotely what's played here is a series of complaints about what the information was which the f d a actually its disposal in two thousand and nine now post two thousand and nine what the f d a said is you are all permitted to continue to sell this product subject to an ongoing study that we're directing zana dine the brand company to do and then we'll evaluate that study and of course when they evaluated that study they then made a determination to suggest they didn't actually bring in this branding claim they didn't declare the  recommend that the companies withdraw the drug and all of them did i think it might be a different situation if after that determination the drug companies continued to sell the drug you might then assuming you a potential issue but we don't have a finding of misbranding we certainly don't have any allegation of new evidence and certainly with respect to the generics there is there is a generic for even doing this study there's no allegation that the study with made public that anyone would have known about it and so i think even between the two thousand and nine and two thousand and ten period you're really talking about interfering with the f d a is in fourth mint discretion and of course  thousand and nine you're talking about second guessing the actual determination so in addition to the mensing and the bartlett concerns there are also a series of buckman related concerns as well not so much in terms of fraud on the is as george reeves said in his opinion at pages nine and ten a pleading issue we understand that the sixth circuit in the full against the case made a determination which i gather is is now of this circuit with respect to in the event that there is a properly pleated allegation of not following the federal directive then a traditional failure to wharton claim might not be preempted said that the smith court had not fully addressed that and so i i'm not going to argue that issue today however there is a simple pleading defect in the judge recognized that and this is after the plaintiffs were given an opportunity to pleadings they amended their pleadings after this issue had been a lie as in men think mr bowker had actually peeved this issue up in a series of letters with the supreme court right before the mensing case with argued and then again the failure to update with teed up in the smith case in this case what did they allege a naked allegation that says generic companies didn't update what they don't do first of all it's meet the standard that the shed there's no allegation that in fact if the update had been made a physician under the learned intermediary doctrine would have reacted any differently there's no discussion of what within that warning the warnings in the black box warning that they're talking about here are warnings with respect to overdosing the actual clay and here is about a cardiac event different issues and also there is not just that they didn't identify th want to say that they did allege that none of them updated i think they make a allegation that has no kind of meat on the bone in that respect in other words i think it's not a fish an allegation to simply say on information belie one updated when there is plenty of information that was available to them to show that companies did but the more critical problem there is in acknowledge wildly problem which the judge recognized where he said this is nothing more than a sheer possibility that this failure to update which they don't even properly allege is linked to causation so i think there's two different parts of your argument one is that they don't sufficiently allege that they didn't update and they don't sufficiently allege how their particular non updating had an effect on people those are different i think they are different i think what about the first one i don't see where i don't see what your argument is specter the first of those because it seems they say on information belief or they don't say on information or belief they say all of them didn't update why isn't that a sufficient allegation well that getting into the causation which is your second argument that i understand i think it would be i think instantly judge reads pointed out there's no thessa fifty with respect to which companies are involved and since you have to tie it all to motley to causation that's what you said you greed those were different parts the different steps of your argument right that's  alternative determinations i was trying to support both of them in closing if i may your honor i think that you're right to point out that the supreme court did not address this it all what they were responding to with a hypothetical which the united states government actually proffered as a true hypothetical in a world that they say doesn't exist at this point and thank you ron  boils down to one very simple fact that the appellant themselves concede that they never at any point ingested a brain defendant's product that fact alone is dispositive and requires dismissal of all of the claims that issue today under each of the twenty two  states at issue more than eighty courts as mr berger himself will concede have addressed this issue including this court on two separate occasions in both the smith case and the strayhorn case as well as five other sister circuits applying the laws of seven other states it issued today in each of those cases that we cite in our papers the courts dismissed the claims against the brand defendants for two separate but equally important reasons first no matter what name is given to the claims they all sound and product liability product liability claims by definition require product identification proof that the plaintiff used and that her injuries were caused by the defendant's product that's absent here they took someone else's product someone else's product cause the injuries second even if the claim somehow can avoid the product identification requirement they would still fail for the separate independent reason that the plaintiffs cannot show any duty flowing from the brand defendants to warn about the risks associated with generic products to those who take competing generic products no relationship between brand and plaintiff no duty whatsoever for a second reason just a reasonable foreseeability well your honor if i could i  think that that's not the case here and frankly i think that this court's decisions in smith and straight horne set out the proper roadmap this court's supposed to look at and going to the second point first which is due to this court said that when determining whether  duty exists you must first look at the state law on the issue this court by itself can't impose or recognize a new state duty absent one being created or recognized by the state appellate courts at issue and i think our job was based on all of the previous decisions of this corps and the court of appeals decisions it's a virtual certainty that they will rule us lee but the state court hasn't done use hasn't done so you would say we have to rule against i don't see not a fair way to predict things well i don't think that i would say that your honor i think this court in smith and strayhorn and even before that in its combs decision said that that's got to be a kind of extreme way of interpreting the extreme on those scales of theory it would seem to me well your honor i would agree with you under erie this court is to predict if this specific question has not been addressed but i think that's a far cry from what the appellants are asking you to do today they're asking you to recognize and create under twenty two different states laws and entirely new duty when one has never existed in any of the twenty two states an issue and i think that's never having existed i suppose would be relevant because it never has been existed that's because all the litigants of assumed but there was no basis for so the absence of its existing sort of suggests that it doesn't exist  that the courts in those states have traditionally rejected the concept of the duty and i think the case law that we cite in the brain defend its briefs for each of the twenty two states issues suggests that when the state courts have looked at this question of whether to extend the duty beyond the traditional product liability realm from manufacturer to those who take its products to a completely separate manufacturer who makes a completely separate product when each of the states at issue has been asked to expand or recognize this new expanded impose duty they've rejected doing so and so i think in that respect your honor that is why for instance this court in smith and strayhorn refused to expand the duty absent clear guidance from the supreme court's of first kentucky and then tennessee and i think it's the same reason that this court should refrain from doing so here with the other twenty states that issue the appellant's point to no state court authority whatsoever recognizing much less suggesting that the court would even consider recognizing this new duty and far from it as our briefs well your honor illinois presents an interesting question because mr bo grad raised the don't decision and i think the first question that you asked was well what state court decisions do you have i think dolan suffers from a few problems first i think it does exactly what this court cautioned in smith strayhorn colmes a federal court shouldn't do it recognized a duty where the state appellate courts hadn't previously done so so that's problem number one but problem number two frankly look again that can't be a flat out preclusion because they're supposed to be predicting well your honor i think even if that's not a preclusion if you look at dolan itself i think frankly as a matter of illinois law it's wrong and i think that in a product liability case are and are not and it specifically said each manufacturer talking about drug companies owes a duty to plaintiffs who will use its drug or be injured by it however the duty is not so broad as to extend to anyone who uses the type of drug manufactured by a defended that's exactly the scenario in which mr bogart is asking you under only to recognize a duty there is no dispute that his clients took generic products manufactured by separate generic competing companies they never took a brand name product manufactured by lilly zan and i nor am i the three brand defendants in these cases and the fact the mere fact that the brand drug and the generic drug in bioequivalent under federal law does not mean that you can verify or impose liability that specifically the type of situation in illinois rejected in smith when it said just because you make this type of drug you can't be held liable so in that respect your honor i think not withstanding the fact that mr bogart sides to the dolan case it's a federal court decision it's not a state court decision in any event it's so it's not binding federal court decisions as opposed to state court decisions number of aid gets real quick  that number of eighty gets smaller your honor but the overarching principles stay the same and i think that's important each of these gates if you look at the state appellate authority they look at these claims and they dismiss they would dismiss them for two reasons first they're all product liability claims and i think that judge sutton you asked a very important question you asked mr berger what is the misrepresentation at issue here and while he pointed to a number of statements all of those statements are contained within the f d a approved label that by law accompanies the product the label the brand defendants submitted by definition in by law only goes with their product the label containing the misrepresentations about the generic product is a separate label it may have the same language but it is a separate label from separate competing companies that disseminate it with their product that type of failure to warn claim is exactly the garden variety traditional product liability claim that's existed for decades under under common tort law and that claim under each of these twenty two states whether it's a drug the only remedy is under federal law because you know you're supposed to follow the duty of saying this and you deal with it with state law claims this well your honor that's medically that's an issue that might my colleague addressed i think that that would be a question that comes up under this court's full gansey decision as to whether the generic manufacturer could or could not be liable and whether preemption did or did not exist but i don't think either way it would affect i think it was straight to the difference in the labels that in fact the brand manufacturer only controls time without any substantiation now importantly the judge gave every point if in this litigation the opportunity to conduct a limited product identification discovery to prove whose product it was that opportunity was made available to plaintiff dickerson and even after that opportunity it essentially said i took product manufactured by anyone who has ever occupy this space and the court held that that wasn't sufficiently plausible to identify the particular manufacturer necessary to support the particular product identification or product liability claim that issue and so the court dismissed those claims honor i see that my time is expired if i could have a few seconds to sum up take thirty seconds as i said your honor this case is straightforward i think that smith and strayhorn provide the exact roadmap there is no difference between this state common law or statutory law any of the other twenty two twenty states at issue when deciding smith and strayhorn this court said it was relying on the overwhelming majority of cases to reject brandname liability in this context that majority has only grown stronger  mr lefkowitz can read what he wants into the into the f t s brief and pure design defect in the lake that's not what the supreme court said and logically it doesn't make any sense if it or a law prohibits the sale of a product it can't be impossible for a defendant to comply with a stable duty not to sell the same product the i also think it's important to understand the context of the two thousand and nine review this was not a case where the company had come to the to the government and asked the f evaluate the safety of the product this was an outside citizen petition filed by a private advocacy group so the question that was before the court was whether to pull a product to market over the strong objection of all the manufacturers it justice stevens in wife versus levine makes an important point which is that the f d a is view that whether something is misbranded is not conclusive because under federal law misbranding is the most if you look at the alex complaint in paragraph fifty six that plaintiff it least specifically identifies by month each time she got a prescription filled propoxyphene including a whole bunch of descriptions after july two thousand and nine if you look at paragraphs one thirty one and two sixty two and two sixty three she explicitly alleges causation and reliance could they have been you know could the phrasing in some of those paragraphs be more eloquent no doubt we were trying to write very large you know essentially an almost a master complaint but the paragraphs are there causative we don't i don't think that more is required than to say they didn't provide this if they didn't make this labeling change they didn't provide this information had they provided this information the doctor would not to prescribe the drug i mean that's you know plain short and plain statement of the kid claim for relief i think i think to suggest that the federal that it will entirely require more than that when we've clearly alleged a specific warning that was not added to the product dismissed the cases that issue there she would have granted leave to amend we have like was indicated in the brief that if the court is of the view that in any respect those allegations are insufficient because fulgencio was decided after  the district court's rulings the we would that the court could will grant us leave to amend to deplete that claim more clearly but i think the i think we've done it sufficiently already   because he hadn't taken the product after ninety two once he sold the n d a that they couldn't be held liable because the effects aren't cumulative the district court properly recognised that that was not that that was a disputed issue a fact and talked about in the illinois supreme court was a product liability case and what the court said is the failure to warn obligation does not extend to a manufacturer of comparable but different product he keeps wanting to characterize this is a brand new cause of action it's not it's classic black letter tort law misrepresentation claims we think the law in the black letter tort law not on these facts but the black letter tort law in all these cases  is clearly points in the direction of recognizing this purpose of ability like that or tort law that you're referring to is outside the product liability correct your honor i'm talking about misrepresentation liability along the lines of three ten and of having someone else that was potentially libel became a more serious concern when when that defendant was off the table and i should note as we did in the brief that the foster case from the fourth circuit which is sort of the granddaddy decision on the brand defendant's side of the question itself assume that generic drug companies could change their label themselves and we would be responsible for making sure that their label was adequate so the entire underpinning of the case for rejecting this is gone lastly i would just mention that why it is weeks the alabama supreme court decision that we cite and have talked about was itself before the alabama supreme court on certification from an alabama federal district court  as i said that court at least recognize that the best way to get the true answer about what state law would be was to ask the the highest state court judge reeve said he wasn't going to do it not because the law was clear but because it would delay things too much