when it failed to ensure that plaintiffs received consumer warnings called medication guides if plaintiffs had received these warnings they would not have taken any old around the drug issue in this case we believe that the map the defendant should have used to warrant consumers is to follow federal regulations that are intended to ensure that consumers receive the gods but we have always been clear that we are making state law claims as an aside we couldn't plea that defendant should have done more than the regulation provided or else our claims really would have been preempted defendant claims because the claim that that there was a failure to provide the medication guides distinct from a federal law violation how it's a state law claims stinks help me understand that yes your honor and this is this really goes to the heart of our state law claims i'm sorry i hav my so under state law you have an obligation to provide a warning it's hornbook law that a failure to adequately provide the warning is a failure to war for instance if you have a warning a perfectly worded warning for yard guards but you don't put the warning on the product that might be and adequate that might be a warrant under state law although ordinarily it's going to be  to the finder of fact or for instance you might have a warning that is you know not reasonably calculated to reach the consumer in some other way so that it into smaller font or they just put it on the website and pharmacist d no your honor we are only alleging that they should have followed the federal regulations which were for the purpose of ensuring that the warnings reached the consumers the  federal regulations provide an adequate method for ensuring that the warnings reaps the consumer but under state law are fury is that if they would have followed these federal regulation these warnings would have reached the consumers but they did not provide sufficient warnings to the distributor or the means to reproducing the warnings to the distributor well then i might have i'm having difficulty saying then why then this is not just an action to enforce the f t c a i mean if you're saying if they followed the federal right then they failed to follow the federal regulations they should have that's our state law claim that doesn't that doesn't sound at all different from the federal claim yes your honor and just to clarify so if this had been a medical there is an express preemption provision and the medical device amendments and they also have the implied preemption issue under bachmann in fact but men was a medical device case and so under express have to follow they have to say that they violated the federal warning the federal regulations exactly and we're doing something similar here we're saying that they should have followed the federal regulations to avoid preemption under the mensing case but our claims are based on state law if they had followed the fed regulations that would have been sufficient under state law to warn the consumers  despite the caption and so we're focusing on taro in tehran ringback you say is actually the new york corporation yes rather in your saying that tehran it had a distributor but it failed to give the distributor the to adequately provide a warning and so there's going to be a back over whether their distribution map was adequate you have a nice do you have any specifics about its relationship with the distributor what was the name of the distributor and or did you have that in front of the district court we did have that in front of the district court your honor at the time it was indeed briefings i know and i do not recall that we cite the specific case in our in our complaint but it was in the briefing and your honor this is this kind of goes to the heart of it is in order to address whether our claims are preempted the district court needed st to determine the contours of state law we did say in our response to the motion to dismiss that under the parle decision and west virginia defendants had an obligation to adequately provide adequately warn it worded so to go back to my yard dark example you could write a perfectly word of warning but if you did not have that warning on the product and you just had it at a desk in an office somewhere that would still be a failure to warn and so deregulation i'm sorry go ahead just no no i want to get at some more specifics because a lot in your very lengthy complaint struck me as details about the plaintiffs and not so details about what tara did or didn't do is dangerous to and as a generic manufacturer you believe that they have an obligation an independent obligation and authority to change what was on the pocket  whole issue with the misrepresentation claims the f d a does not say that this is approved for atrial fibrillation so that is the whole problem with that information is that it is going above and beyond what they're required to do from the maybe they just do that and i'm just trying to understand how your you're navigating between that so you can see to church wesley that the medication guide needs to comport with men say it is to say what the federal the f d a says it should say nothing more nothing less and buckman do you also agree that but buckman basically says private actions to enforce the f t c they are preempted yes your honor but i do not believe that men says that if you are alleging a state log claim that parallels precisely the the f d a even if you talk about the f d a all the time as long as it is rooted in state law i do not believe that men preempt that i guess i guess i would where i'm wondering where that word precisely comes and parallels precisely you mean identical in all respects i mean i thought that the import of your claim that the f d a does say these things should be distributed to the guy should be given to distributors and presumably the eft there would be a federal law as to whether they were adequately distributed if if the f d a decided to enforce a failure to distribute you're saying that state law decker in new york law on overseas oh our duty to warrants fairly well laid out but it's a duty to warn so you know it's one thing to say that they should have gotten the label to the consumer but then the question is what should have been on the label and so i have a heart i mean at its core it's a duty to warn it's not a duty to distribute claiming it's a duty it's a generalized kaamelott duty to warrant the has within  from that which is issued by way of you said no and because you're stuck with the rules same as so so tell me how is it that it met as to how it's distributed if it's that if it's a warning ultimately ends up being inadequate because of the rule of sameness as opposed to and that's precluded is that is that your honor we believe that the language of the warning would have been adequate if there was some sort of if there was a sufficient a reasonable mechanism for ensuring that the consumers actually saw it if you consider your saying that why is why is why is medical guy information why is medical side which doesn't talk about right that's one of your complaints you say why it's poisoned the well you can't have it both ways it's council you can't have it both ways you can't say that why they did something wrong and then say ok why this warning is good enough i mean you can't briefly i understand i'm way over judge carney to have another question i did have a brief question if i may i wanted to understand with a little greater precision your claim that taro fail to report adverse events as i understand that's based on a statistical analysis saying there should have been more adverse events than relatively reported and but not on any specific incident in which you can allege knowledge that in fact taro hadn't failed to report is that correct yes yes your honor although the district court did not give us an opportunity to replete in the sense that claim was not preempted and the district arguments on appeal and in the original complaint and is the reason why we are seeking to defend the district court decision as well as recommend g in his questioning this is a duty to warn case but it is wrong to use an analogy about widgets or manufacturing or any of the cases that are the lead cases in new york the judge wesley cited this is a pharmaceutical case and the duty to warn is not a duty worn to a consumer it's a duty to warn to the doctor and as a failure to warn cases well is is whether or not the adequacy of the warning was provided to the doctor but what we have in this lawsuit is an effort to transform  state law into a duty for pharmaceutical manufacturer to warn the patient the consumer and that is based on soley an f d a regulation and we might add that the f regulation that's being cited isn't even being cited correctly because the f d a regulation does not say that the manufacturers i think was raised in one of the other questions the manufacturer is not a guarantor of what the dispenser does there are many people in distribution chain with responsibility for the distribution of the medication guide but the medication guy is to be dispensed by the retailer at the point of sale and that is the obligation that gives it to the consumer but nevertheless in state law there is no such thing as a medication guide nor requirement that a pharmaceutical company must give something to the consumer they give it to the doctor and then we get into this question of sameness as a generic because there's a limitation of what a generic can do and can prepare in documentation the generic manufacturers such as tarot must follow the these states yes your honor we think that there's case law that we have cited that shows that it is recognized in all the states and in fact our position is an interesting theory to allow me because what we believe is being asked in this case or what have been asked in this case as in the other cases that have been filed around the united states is asking the federal courts to create exceptions to the learned and to mediate every doctor in each of the states that's unwarranted there's been citation to west virginia and in fact the court in in west virginia iran or was looking at a direct to consumer situation and there was direct to consumer advertising by the brand in that case and as was cited in our opposition brief we noted that in those decisions the courts in fact said it is a unique exception and but for that unique exception of direct to consumer advertising for the particular drug there is no reason to deviate from the general standard rule of learned intermediary which then re materializes and focuses on the adequacy of the warning to the physician and it's important that the plaintiffs continue to concede that there is no objection to the substance of the warning and of course there we don't believe there would be because the warning followed the exact warning that was approved by the f d a the medication guides  medication guides that are created with approval by the f d a with the brand and since it's part of the overall documentation that you generic must have filed as part of its an  the way we're working at the end but the assertion is is that that why it's created an off label market for this drug now the off label uses and so forth or the medical guy  from your experience does the f d a step in and require an alteration of the guide or to war against off label uses of the difficulties of off label use just how does this off label use well market develop well you're out of the the way that  traditionally off label use develops is through a standard of care that is formulated and evolving in the medical community the f d a does not regulate the medical community and it does not regulate regulate a prescription but it does regulate it does regulate what what the consumer gets to be told about the drug and and and apparently something else and that in certain instances that can be dangerous in new york i'm going to have i'm going to sooner or later i'm going every spots ability to warn about that now are you telling me that there's no duty to warn when when  manufacture becomes aware of a well known off label use there is no obligation your honor and in fact there is a prescription against the generic manufacturing issue and any type of literature or statement there that it's that there's no federal regulation at all and would a state law that required such a warning be preempted well we don't know that to whether or not the brand well we do have case law that still evolving over the extent of preemption on whether or not the f d a is requirements of the warning label is sufficient or whether there can be changes being affected to modify those labels and it becomes the brands obligation and in those instances if it's considered to be a dangerous aspect of it that is something that possibly the brand and those are some of the cases that are cited by the plaintive are particular to brand obligations are run are dealing with those brand obligations and working with the f d a and taking actions that are required but again it is not something that falls into the lap of the responsibility of the generic moreover the issue is off label is not use were potentially dangerous and and and and in your honor i believe that since the prescription of a drug like i am the owner i'm different than some of the other drugs and specially the ones that sometimes are choices that can be affected by the consumer but these are prescription judge dry serious prescription drugs that are totally controlled as a decision of the medical provider understanding the risks regarding that drug which is provided in the labeling and understanding what the are are indications for as well as being aware of what general research has created a standard of care in the community without a doubt i mean we believe that the evidence would have to show instances where the reports go no for and what would eventually be done is between the brand and the f d a and therefore arguments for instance in messing mensing that  bread the generic understanding that there was a problem with the drug should have either stop marketing it or should have told the brand or should have told the f d a and somehow that creates liability if they didn't is purely  something that the supreme court at the time said is not an alternative theory against the generic because it's speculative what the outcome would be the generic does not have that obligation and you can't link then causation in making that type of duty there is none there is no doubt and that goes back to the fundamental question there is no duty to warn to the consumer is a duty to warn to the doctor to the medical community there's nothing  there's no exception to the verbiage of the of the of the warning no argument that the doctors did not get the label or did not have access to the label which is all part of the general medical literature including we have to do we have to look i mean the district court did not do an analysis of each state do we have to do that analysis that you're alluding to that where did an immediate area to bent's would apply in all the case law would apply in all these circumstances or is it easier to just look at men saying im bachmann and just say there is a federal obligation to the extent and i'm there's a lot of claims in the in the briefing but to the extent that we're talking about the medication guide and the failure to distribute it  and secondly we believe that the court could look to the fact that the medication guide regulation by the f d a is not being properly described by the plaintiffs in that it does not per se create even a direct obligation to provide the guide to any consumer so what about what about the what about why me why it says that the federal law is  being given out i don't see how that really conflicts with the fed we'll see what seems to me that maybe comport to why it what iraq with due respect your honor one question then that you've raised requires a refocus on the wordin the exact precise literal wording of the regulation which does not say that the manufacturers have some obligation to their entire distribution network to make sure that they've acknowledged they've received medication guise that they understand the significance of medication for giving us room to do that well we believe that would why it has done is discuss in specific context of brands what their obligations are and how they can make changes and that they can make changes in the substance of warnings and that's what why it was focusing on and that in no if it's office stinks and from the from from the generics now as to whether or not a state can require that there must be some warning that's provided a to a consumer if a state chooses to create that exception then i would agree that a state can require that i guess a approved f d a warning must be provided to consumers but when one looks at the jurisprudence nationally and cases that have reviewed it over and over again we don't see certainly in any state that the learned intermediary doctrine is not a bar to that type of common law duty but you agree that we left with any obligation established by the turn on the t v and we get a lot of direct to consumer advertising now and it seems to me a state could say listen in the context of all this direct to consumer advertising we're not going to rely on the guy speaking a mile a minute at the end to give warnings we want to make sure that generic manufacturers as well as brand manufacturers fulfill their duty to our by ensuring that their distributors provide the f d a blast warning but you put your honor the presumption there is that there is direct to consumer advertising that creates in those cases that have been cited a unique situation because the issue here is and i think this is a concern that the f d a has and that is the most appropriate individual that requires the needed information regarding the drug a prescription drug is the information that's provided to the doctor and making sure that the doctors receive it is crucial to suddenly engage in this competition between with every prescription drug out there the need to ensure now that there's information flowing to the consumer when the f d a and the what we believe to be a wise rule regarding learning intermediaries is to not invade or in get involved with the relationship between the pharmaceutical its warning label and the doctors who must make the medical judgment and provide the information to the patient rather than the patient make its decision and that's crucial the medication guide was its best a supplement and in fact the f d a in its guidance with to the regulation which is quoted in the reefing even noted that they did not intend by creating this process to interfere with basic state law obligations which they understood involve the learned intermediary in the fact that it's a sacrosanct it's a sanctified relationship between the pharmaceutical company it's requirements of giving medical information to the doctor to make it's reasoned decision and the doctor deciding how to deal with the patient why di required package inserts at  you that they require it i know that unfortunately for one i'll admit online if it's recorded that i very rarely read it and in any event the package inserts not going to create the liability of the package insert was clear but not clear enough to me as a consumer because i'm relying on the decision making advice of my doctor it's one thing to have an an argument against a manufacturer why do you have an argument for failure to warn him if medical device medical prescription case is because you're contending that the information was improperly can fade to your doctor who couldn't convey that information to you it's not that you didn't get the package insert and didn't understand it it's only that you did not argue that the doctor did not get proper advice of the risks and could not make a reasoned risk of valuation of providing this medication because the benefits outweigh the risks it's important for the doctors to understand that and make that decision and that's the essence of the tension in all the pharmaceutical cases that you have generally seen in the nd circuit as throughout  the judicial process regarding the adequacy of the warnings of brand drugs it's not whether or not the patient understood it's whether or not the doctor would have altered the prescription habits and change their advice to their patient and so it goes through the doctor it's not direct and it's only in a very unique situation as you raised with your reference to direct advertising that it does create a certain complexity in those unique situations that were recognized in only those unique situations and only those we believe would would have created that exception  are necessary in the regulations it says that they are necessary for consumer safety i would like to point out that mr lieberman virtually conceded that states would be allowed to require consumer warnings  if it was a f d a warning and that is exactly what the medication and unprovided warning under state law is no warning at all the drug manufacturers must have a reasonable use that's why i asked you if the overall claim was one of duty to warn and you said yes well it's one thing to say that the that they finally did the duty because it had provided but when when the information that's going to be provided still fall short it's still his fault the claim falls sure you are just a touch on that because that's very important the medication god this patient guy does say specifically that this drug is only to be not supposed to be taking this for non life threatening in new york to the doctors receive to the doctors receive that well they don't know that going to be that's going to be a fact question and it does go back to the learned intermediary doctrine  it does and you cannot determine the scope of state law without doing a state by state analysis which the district court would not do just really quick and that's part of the problem your lawsuit your lawsuit is a  people from all over the country one of them in your and your priest talks about new york law consistently and yet you've got plainness that are other jurisdictions are more likely new york choice of law would pick their jurisdiction decide  the duties to to warrant it's very hard to to pick out through this patchwork quilt are anything other than that so so we're clear you say that the medication guy tracks wise medication guy because the rules in this is that yes your honor notwithstanding your brief takes complains about the adequacy of the warning repeated and nd of all you're saying that dick and the reason why it's adequate is because it says only for use with regard to one particular condition correct yes your honor and just to clarify or complained about what wyatt they weren't just not giving adequate warning why it was advertising this drug and i understand that in a massachusetts and california you could do something about that but new york doesn't have that kind of a statute i knew you haven't put that with regard to any other jurisdiction it's an interesting theory i think it's very interesting in a particular light of the relationship between generics and the patented medication that would make super some very interesting high court decisions and various state i courts but but that's not this case breathlessly said that the learned intermediary doctrine does not apply when as here be the when as here the f d a requires a direct consumer warning and mr lederman practically admitted that such a claim would not be preempted and we have to quote we have to point to us from north carolina and so my point is that dismissing us on preemption without conducting a state by state analysis of our plaintiff claims would be a massive expansion of batman and earlier one of one of us said that well maybe it's just impossible to get through many thing and bachmann but the supreme court has said that that's not true but it is possible even in a even in a medical device case where you have this expressed preemption possible i think believe the lord a surgeon and the the fangled decision did want to clarify something about it daniel why don't you clarify that ends in summing up yes yes your honor ok so mcdaniel involved one plaintiff from a single state tennessee and the mcdaniel decision was implicitly tennessee is an affirmative defense for the learned intermediary doctrine in some states it is such as minnesota where we just won on a motion to dismiss with one hundred and one plaintiff alleging very similar cla