it please the court i'd like to reserve five minutes for rebuttal if the supreme court's decision in mensing and bartlet mean anything it's that where preemption in pretrial disposition are concerned the courts are required to examine carefully and analyze in detail the very distinct state specific claims asserted they cannot paint with a broad brush when the end is denying catastrophic lee injured plaintiffs the right even to pursue a climb yet unfortunately that's exactly what the trial court did here since the last brief was filed in this case the supreme court has ruled in bartlett and a number of other courts in other states and circuits including this one and as of monday night the appeal in the philadelphia is you asked about bartlett what the court said in bartlett was not that there is a blanket restriction on blanket preemption of strict liability claims instead it's said that you had to look at them very carefully and that the new hampshire statute in fact it's specifically says that you have to look at the nature of the duty in the state law so what we think should be involved is that the court should look at the nature of the state duty as a practical matter i think if the new hampshire statute  of state law they could just refuse to stuff so right that that piece that piece of it i think is what i'd like what i'd really like to talk about today i think are the two remaining claims although i think again bartlett counsels on a very careful look at those claims and i think that i want to kill your request is sort of the question of the supreme court to sort of by that question i mean this court obviously can certify other questions and frankly we're a little bit concerned that two things that i wanted to talk about today are hesitant under erie to do what she thought was making new law we don't think that you have to make new law into that under that course but what we would advise the court to do is if the court is concerned about doing something that is out of the ordinary in tennessee that it's sort of that question and the court has the ability and has in the past to certify suicide onto those sort of awkward propose if the if the court has that hesitation what i'd like to do today is to talk about kind of what's left because there's been a lot of movement here we are dealing with a moving target here and talk about the court's decision in full jency and failed to communicate and to update claims that we've sorted in in the petition we think that directly on point and governs here to reglan case unlike the panel in smith under which i understand judge gilman participated the full jency court considered the same failure to communicate claim that in this case the failure to up and that's let me be very specific is the failure to update the generic labels after the two thousand and four reglan label change and to communicate that claim it's not the claim regarding communication of a differ warning prior to two thousand and four which is the one that the generic defendants have addressed anything on the record as to when the plaintiffs in this case took the drugs no because this is on a motion to dismiss and what would be appropriate for the court to do is to remand the case back to determine exactly when they took the what i don't know since there are so many points i can't you know i can't list them all but i don't i'm not sure that it lists the dates of usage i'm not sure that it does i don't recall them listing now and i don't think they do  because that there's no been no discovery in the case again what the generic defendants have asked for here is a blanket prohibition no matter when they use the drug and that's the problem that we've got is that there are going to be some admittedly there are going to be many that are not going to fall within this gap period but we think that the people that do fall within the gap period ought to have a right to pursue their claims and so what's appropriate is to remand the case for you know allowing just our us to put that evidence in the record  side what would be appropriate is is to go back and talk about you know and to to put evidence of the record or to amend the complaint that's exactly what the court allowed us to do after mensing but you know we were dealing with the world as it existed can change your cause of action you are not later because law gets changed your honor they haven't they haven't pleaded their cause of action all of them have pleaded that there was a failure to update a failure to communicate during that period what is not in the complaint frankly what i'm not sure needs to be in the complaint is what their dates of usage are i don't know of any court in the country that is required that to be in the complaint that usually been in the form of motion for summary judgment judgment that has been filed because it would require evidence i mean even if it's in the complaint still going to require evidence unless it's an admission so i think that's the appropriate form and not a motion just to dismiss where there's really not any if these i mean do we know from the facts the doctors for some of the plaintiffs prescribe reglan in fact the generic was substituted but they have if they prescribe reglan they would presumably have used the label your own or all of those issues as to what they relied upon what they used and that sort of thing you know is usually what comes out in a trial that is not usually something that's that's pleaded in the cases but with regard to your particular question about the learned intermediary doctrine it really wasn't raised in this case i know it's come out and in a couple of other cases but i don't think it really it really has any effect except on one proximate cause ation when you talk about what the doctor relied upon did they rely upon say the brand names label or did they rely upon the label supplied again that's a question approximate causation not preemption and that's that's our point here is that you shouldn't preempt those claims without giving the plaintiffs an opportunity to fit themselves within those those climbs with that i'd like to move on to  the question the second question we're talking about which is the question of brand name liability we i think that when you sort everything out that the trial court actually violated the erie doctrine the court was concerned about violating the erie doctrine by allowing the claims to go for we think that the court actually violated the doctrine by not allowing them to go forward and imposing really a blanket privity requirement under the tennessee products liability act and tennessee law negligent representation that just isn't they are first the court really misapplied the t p o why we supplemented the record with cases that demonstrate that there that the substantive provisions of the talk about claims against manufacturers and sellers and the brand name defendants in this case have done a lot of discussion and cited all of the substantive provisions that deal about claims against manufacturers and sellers and they claim clued that that means that there are some blanket priv requirement it doesn't and one of the cases that they cite says it doesn't and what they say is that gaines case that we supplemented with what they say is that when you don't qualify as a manufacturer seller which is exactly the claim that they ally doesn't it doesn't apply to you and that's a pretty simple concept so under that we can sit or that doesn't apply here if the t p l a doesn't apply then you simply go under restatement rule five fifty two under negligent misrepresentation climb and that's something that this court has done there's a case called agra store leasing eight sixty nine if second to sixty four where the court considered both case and a five fifty two case in tandem the contract your honor that's the definition of a products liability climb but the substantive provisions of the acts a in a products liability claim brought against a man factual or seller it doesn't apply to all products liability claims and so the way that it's been interpreted in tennessee is that unless you qualify as a manufacturer or seller it doesn't apply to you and so in the langford case that they cite a purported manufacture because he couldn't prove that he qualified as a manufacturer under the act it was held that the law didn't apply to him same thing was true in the gaines case they actually treated the same defendant they allowed some cases to go forward where they acted as a  as a manufacturer but the case in which it acted as an inspector they said no because they weren't acting as a manufacturer seller it didn't apply in that case so they allowed the case they allowed the claims to go forward what i'd like to do then is to talk shall not be a requirement to maintain such an action and that's the law in tennessee the tennessee supreme court has repeatedly reaffirmed that law in fact in some of the cases same cases that the tennessee that the tennessee tr court here sided in the ritter case for example it says in response to the second certified question privity of contract is not essential to a tort action of negligent misrepresentation based on information negligently supplied for the guidance of others in the first national bank of brooks farms case which we supplemented on monday the court said quote where there are no direct contractual relations between the purchaser and the manufacturer in a situation where the purchaser has relied on the manufacturers booklet and trade name  making the purchase we have concluded that the manufacturer should be liable in this situation while this holding represents some development in the law we believe that this development is needed to keep pace with modern conditions and is supported by substantial legal authority throughout the country that's the supreme court of tennessee now it seems inconsistent you've had a ton of cases cited by them on this pretty requirement and then you have these very clear directives from the legislature and the tennessee supreme court and the way the only way that you can reconcile them is that in mission that they made on page fifteen of their brief and that is that the question is not a broad band on privity a broad requirement of preventing the tepee away it's basically comes down to  causation that's all it turns on and proximate cause ation varies from claim to climb from case to case and from state to say you know how do you how do you distinguish our smith the y i mean the smith was and kentucky's product liability act with it is that in a really different from yes yes it is it has the same definition of products liability and that's what everybody focuses on but the definition of manufacture in seller is very different and i checked on monday to ken kentucky does not have this blanket  know abolish abolition and so that makes it very different there's so there really wouldn't be a circuit conflict here because you're really dealing with a different statute well  right i think it rosenthal fell under kentucky law as i understand it because it is because that's is an interpretation to well the preemption always is based on the question of what's the duty under state law and actually i'd like to t a product defect case to go forward you know a traditional products liability case to go forward based on the proximate cause ation and privity but when they filed a motion for summ a breach of warranty claim based on lack of privity they denied that motion for summary judgment and a few seconds i have remaining i'd like to talk about the the reason why this case is different from smith and the specific duties under state law  would allow this case to go go forward there are really two sources of the duty there are federal sort of fit one is federal one is state the first is the post mensing f d a regime that we discussed in detail at page forty to forty three of our brief but i think it's you can see this most clearly in looking at a federal regulation it's very quick one twenty one c f r three fourteen three b that i looked at last night the court can take judicial notice of it it says when it defines a reference list a upon which the applicant relies in seeking approval of its abbreviate breviary an application in other words it is the f d a appointed quarterback nobody moves on the field the generics cannot move to change their label in tell the r l d holder or the brand name changes their label and that's the post mentioning mensing regime when you combine that with the generic substitution laws which i sent the court on monday so you can really see how difficult it is for a doctor to to not to avoid generic substitution you can see that there is clear for see ability and therefore a clear duty on the part of dr to move forward with these cases now that means that the ordinary operation of negligent misrepresentation law doesn't have any impediment here in fact if you look at the ritter case which is cited by the court they list all of the circumstances in which five fifty two has been applied let me give you part of the list it's been applied without privity to a construction manager an accountant a pest control company a surveyor a seller of a log home kit and a landlord so the appropriate question i think to ask here is not why would tennessee why would a tennessee court extend the doctrine of negligent misrule representation and a claim of negligent misrepresentation or fraudulent misrepresentation to generic drugs i mean to brand name manufacturers but the question i think that's more appropriate is why would they immunize brand name manufacturers from the normal operation of that misrepresentation law especially where the u s supreme court in levine didn't and in that respect i think the court could look at kellogg content and white in the living they took the brand manufacturers draw right what i'm saying is that they did not immunize they understood that brand name manufacturers because they had the ability to change their label should not be immune under doctrines of preemption and so what the trial court here did was essentially confer that immunity on them by immunizing them from negligent misrepresentation cases and if you look at the justification for kellogg's for conti and for weeks it's all about this proximate cause ation issue for example in kellogg they say to recognize that a brand name manufacturer owes a duty to use reasonable care to avoid causing injury to consumers of generic bioequivalence of its drug does not run a new cause of action or an existing one and activity inappropriate for a district court sitting in diversity to undertake just the concern that the court here had it continued the broader public policy issues are worthy of debate but a necessary for determination whether kellogg's claims against wyatt as a brand manufacturer can proceed this court has simply applied basic precept except for it actually it was an outlier at the time but the law has actually cut a caught up with it conti was decided not on some broad principle of preemption it was decided on proximate cause exactly what the defendants in this case say is really the issue here in that case they said there's a problem here and that is is that if you have someone taking a generic drug who is doctor relies upon the brand names like you are labeling or representations they can never make proximate cause ation and as a result are absolutely barred from recovering against the generic manufacturers of the argument are co honour's i'm richard oath i'm our own counsel for defendant have a pharmaceuticals i'm going to speak first on behalf of the generic defendants i should say the generic defendants other than the leave a bar group of defendants and i will have eight minutes mr defendants and he will also have six minutes very well thank you thank you your honor i see we've discussed mensing in bartlett the there are obviously only three things a manufacturer can do theoretically to make a drug safe or to avoid liability for selling it on safe drug change the design change the label or stop selling the drug mensing two thousand and eleven held warning claims preempted because generic manufacturers cannot change the labeling bartlet held preemption applies to a design defect defect theory because manufacturers generic manufacturers likewise cannot change the design fact no one can change the design of a drug molecule has whatever inherent risks it has and the only way to make the drug safer is to change the labeling which mensing holds a generic defendants cannot do and cannot be sued for barlett also hell difference to your argument what the underlying state law designed to fit to climb i don't believe it does your honor i also but i also believe that you know why would not if what you're looking to is the underlying law that creates a why wouldn't one state might have say we're going to hold you know might might have created a cause of action that can be pursued in another state why not wouldn't it vary by the particulars of state's law what the bartlett court says is that if the state law imposes a duty on the defendant any duty has a footnote that says of liability were truly absolute that might not raise a possibility preemption but any state law that involves a duty tennessee product liability act has a duty not to sell or opposes liability for selling an unreasonably dangerous drug that is foursquare bartlet in fact i credit council for conceding that in their reply brief they said the tennessee law was virtually identical to the new hampshire law in bartlett and it is and justice alito is opinion for the court in bartlett said unreasonably dangerous is the same is imposing a duty to me to sell a safe drug he said mensing for that matter could be characterized as a duty not to sell a drug without adequate labeling the point is the defendant to manufacturer under state law would have a duty to make the drug safe to make and not unreasonably dangerous to make it safe that can only be done by doing something federal law prohibits generic manufacturers from doing changing either the design of the drug or the labeling of the drug and as to drugs really the only thing that can be done is to change the labeling to make the warning adequate or or that is stronger so i understand counsel basically to concede that the bartlett decision undercuts their reliance on the first circuits decision and bartlett leaves them without a stop selling argument which was one of the three arguments in their summary of argument that they had advanced i didn't hear the first there was a second argument that i didn't hear made today and i think this therefore been abandoned which is that there could be a state law duty to ask if the  cannot change the label there could be a state law duty to ask the f d a to change the label mensing addresses that to that issue was in mensing and justice thomas opinion for the court there said that that's not a matter of state law concern defendants communication with the f d a there's also no argument that that is what state tennessee state law requires the tennessee products liability act imposes liability for selling an unreasonably dangerous drug and it doesn't say that state law would be satisfied by asking the f d a but the mensing court went through this analysis and held any claim based on not asking the f d a to change the label even assuming such a duty is preempted plaintiffs are left with i think only one argument that they made in their brief that they're still making against the generic defendants and that is what they just called the duty to communicate although as i heard it described an argument it sounded like a duty to have the same duty to update the label after the brand label was changed to the brand label in two thousand and four as the court knows  that assertion that that there was a failure to update the label that assertion was not made by the plaintiffs as to any of the generic companies that i am arguing for today  both in the briefing in district court on the motion to dismiss and in the appellate briefing the only assertion that plaintiffs have made is that a single generic defendant plea of a do not update its label to incorporate that change mr pack will speak for plea of a and i'll refer the court specifically in plaintiff's opposition and i think i'm referring to straight horn the lead case but they're all the same obviously in their plaintiff's memo in opposition to the motion to dismiss and district court document number eighty seven at page thirteen of twenty five it's in the addendum at page fifteen eighty two the statement there is  specific to plea of a and also in plaintiff's principal brief on appeal of page twenty seven it's verbatim the same statement that was made in the district court briefing there's been no assertion that any other generic defend in the case complaint as to when any plaintiff used medical provide or whose medical open why they used and there's no allegation that the failure to update the label or to communicate the two thousand and four label change caused an injury to any plaintiff but i think as to have an activist in the o generic defendants who i'm arguing for the argument simply has not been made and i know that there's many precedents i could cite from this court  that issues that are not raised before the district arguments not made for the district court not made in plaintiff's principle refund appeal or for that matter in the reply brief those arguments should not be certainly entertained as to any of the defendants that i'm arguing for the to the extent and i did not hear it today but to the extent that plaintiff argues a duty to communicate meaning something other than u pdating the label for example a dear doctor letter to doctors i think that is foreclosed first by mensing by page twenty five seventy six four closed by this court's decision in smith that specific argument was made in the briefing in smith when after the smith court ruled plaintiffs filed a petition for rehearing and said the court had overlooked that argument and the smith court judge will miss out on deny the petition for rehearing said all of the plaintiffs arguments had been considered and that has been the decision both of the fifth circuit earlier this year in a case morris that i argued and the eleventh circuit in a case both agreed  formally behind your argument if we have a recent remain and are well i don't agree with the decide the remain and but also distinguish it via the consumer expectation test which they remanded for consideration under tennessee law tennessee product liability act looks at both the consumer expectation test and the reason we put a manufacturer the consumer expectation test though does not apply to complex products going to forget the name of  the case by no judge gilman author an opinion for this court in two thousand and six where it said the consumer expectation test did not apply to a forklift judge anderson below said it doesn't apply to a prescription drug since consumers don't really have expectations about what the drug does or doesn't do tennessee recognizes learned intermediary doctrine so i think the court below was right to say that the consumer expectation test does not apply to prescription drugs it's the reasonably prudent manufacture test which which embraces or involves a risk utility analysis of the product which is exactly the same as the new hampshire law that the court applied in bartlet which is why the plaintiffs here conceded that bartlett forecloses their claim under the tennessee product liability act so one the consumer expectation test is not the test that would apply in this case but my aunt but i think that the eight circuit did not need to remain and because whatever state and we can invent we can take those tests or we can invent one that nobody's thought of if the generic manufacturer cannot redesign the drug under federal law can't change the drug because the brand drug is the basis of its approval and can change the labeling then the only thing a generic manufacturer could do to not to avoid liability and to not have a drug cause injury is to not sell it and that's the only thing it can do on to how do you respond to that i guess we could call it the fairness or the equity question that you've got people who have been who have been prescribed perhaps the brain and drug and they are in a state that and complaint or recalls of faction by the mere happenstance of whether they took the generic version or they took the brand version there's there's no question obviously charged tranche i wouldn't for a moment i've i've seen some of these plaintiffs i've defended other cases it's can be a horrific injury we don't know about these particular point his injuries but clearly it's a horrific injury and there is an issue in both the mensing court and the bartlett court recognize that the last paragraph of justice alito opinion for the court in bartlett says that again that you know this seems harsh and it certainly seems i think justice thomas in mensing says doesn't and one level doesn't make any sense that people's rights should depend on whether they're prescription was whether they were dispense the generic drug versus the brand drug and both decisions have said you know congress can step in and legislate the f d a can try to do something there been bills introduced in congress since mensing they have not been acted the f d a has said it may propose a rule making certainly in time perhaps there will be some adjustment of that but this court just as the supreme court  mensing in bartlet has to pause law as it finds it so i'm not here to say that it's fair i'm here to say it's the required result of the argument goes to that argument certainly has not good morning jeff jeff pachter please just to follow up on one point that you asked about with mr o'hara which is the consumer expectation test i do have the cite to tennessee court that said that that doesn't apply it's the ray versus big corporation nine twenty five southwest second five twenty seven that's one that said consumer expectation test of on you think fulling versus pfizer is the rationale  that the court undertook is wholly limited to the consumer test as opposed to a development in the law that is beginning to analyze the underlying state calls of action differently from what it is perhaps been in the past i think i would say this your honor that it is limited to the consumer expectation test because that's what the a circuit said the point is though that you have to look at what the action items are that can be taken to mitigate the risk unless you are going to say that we're under an absolute liability regime which no you know i don't think any state says in tennessee clearly doesn't say that then you're back to only three things that can be done ok and one of them you you physically can't do you cannot change the drug you can't change the molecule because if you do that it becomes a different drop so it's a physical impossibility from that standpoint it doesn't matter if you apply the consumer expectation task or risk utility analysis or some other nomenclature for those two things those are the two general basic tasks that you see and then there is the issue the second thing you can do is change the warnings that's dealt with by bartlett and meant seen and the third thing you could do is take it off the market and what the supreme court is has sunit said unambiguous really and i think this court said in smith is that that's not a solution to the problem you can't you can't avoid preemption escape preemption by taking it off the mark your honors i heard counsel say that for guns is on point to this case it's not and i heard counsel say that full gansey was a failure to communicate case it was not claim that says you didn't update the label and my harm as a plaintiff came from the fact that you did not update the label that's not what the plaintiffs allege here in fact the plaintiffs routinely in their complaint and certainly on the issues on appeal talk about a failure to communicate that is a process or an action that is different from updating the label if you look at pages thirty two to thirty four of the brief the brief and thirty seven where the plaintiffs describe what activities give rise to their claim they routinely say we're talking about things other then updating or revising the label we're talking about communicating that label and some other fashion as a matter of fact a paragraph forty six of their complaint the plaintiffs would and that would be the  record seventy seven the plaintiffs say that merely making the change to the label is not enough if you don't send it out so the plaintiffs claim here but  enough in the end the question is whether it's enough for preemption and that's that's an important distinction i'm looking at paragraph eighty seven each of the drug company defendants negligently and carelessly breach the above described duties which are described at length by committing never generics and or a missions including but not limited to that several of the generic defendants were negligent in failing to include information present in the liable for the and in failing to implement changes to their own labels to ensure that the information they provided was current and not did and goes on to explain it to them in some cases they aren't saying that the duty is in that our injury flows from the fact that you didn't update the label ok they're saying it comes from the fact that you didn't want you didn't update the label or communicated in some fashion or some other fashion tell people about this to two thousand and four warning change or take the product off the market see the labeling that goes out from generic drug companies this is why they did what they did this is why they stayed at the claim it goes on containers that go to warehouses those then go to the pharmacies every one of the claims that they talk about is a failure to communicate the risk  physicians and consumers physicians and consumers do not see generic labels that's part of that what counsel alluded to but what can through many of us a prescription filled we get the bottle with the information on it and then we get printouts on and on that give us all of the dangers and all of the problems and that's the notice and those printouts are based on what you have put on the labeling information that you provide to the pharmacy those you're out of that's that's not quite correct ok the the patient education monographs that you get  are prepared by other companies they're prepared by third party providers that are not the pharmaceutical companies there's no evidence that they go and get generic the labels and do that to the extent so i guess my problem is now we're talking about evidence and that's not the question for us the question is have they stated a full ginsburg why and when they allege what are red under notice you disagree with the evidence or you know how it's we don't get to i don't get to testify nor do you so so explain to me again why in that context will concede doesn't create a limited cause of action in  panel made a big deal about this was that your failure to update the label that act is what proximately caused injury if you look at what the plaintiffs are alleging they are not alleging that it was the updating of the for the alleged failure to update the label they are alleging that it's the failure to communicate really the approved warnings to physicians and to consumers so the proximate cause allegations are print in this case then they were in full gansey and again not only said true in the complaint but if you look at what they pursued on appeal here they talk they never mention the word fair you'd update as their issues on appeal they don't describe that in the summary of their argument on thirty two through thirty four where they describe their claims they talk about it being things different from updating the label whether it's strict liability whether it's negligence whether i could i could go through but you'll see it there it is very clear that the claim they are trying to articulate is a failure to communicate claim not a update claim the morse court down in the fifth circuit handled that differently or reno in the eleventh circuit recognized those were different and fair to communicate claims as mr ohio told you have been routinely barred by courts  the smith panel which said on that it looked at all the issues including the failure to update claim on supplementary briefing but i don't think it said that i thinks smith had the supplemental brief don but the opinion doesn't reference the issues raised in supplemental pleading and that's that narrow window is exactly what is the address i know that paul gans he said that you only supplemental briefing but then there was a petition for rehearing raising it again the fareed update saying hey you guys you guys missed the point and on that or the panel has further reviewed and concludes that the issues raised in the petition were fully consider upon the original submission a decision of the court that include the submission to the court included the supplemental briefing on the the so that order i'm looking right at the order right here argument would require us to tell whether published decision they were wrong what i seek what i am suggesting or a question your honor is is this a very important issue we think that there are there is a conflict between smith and full gansey we think there are issues with the full gansey panel fan of the decision pardon me that that warrant another look you know in one part of the opinion where the court says the adequacy the federal statutes in a breach of federal duty doesn't have anything to do with the adequacy of the warning and one sanction of it and then at the end of its opinion says but you can use the breach of the duty to prove up the adequacy mean it says exactly that there is that conflicting language we think it warrants another look and we matter and are saying that the evidence would show that smith panel did consider yes ok yes all right thank you thank you very much morning good morning your honor is hank bullock for the brand defendants may it please the court i think that this court's prior decision two years ago in smith is highly instructive and frankly deals with almost every issue at play as it pertains to the brain defendant's smith was nearly identical to this case with one minor and i would argue meaningless distinction the plaintiff in smith was from kentucky where is the plaintiffs here are all tennessee residents but for that distinction the claims are the same they allege the same injuries from ingestion of generic drugs and they all concede that no use of a brand product ever occurred further the law as it was found by this court in smith under kentucky law is identical to the put couple law here under tennessee law each state has a product liability act which clearly defines what product liability actions are the language is almost identical and this court has already held that that very language any cause of action arising out of personal injury caused by the warning instruction or wavering of a product this court has already held that that very language clearly encompasses the very claims whether they are based in negligence in warranty or in fraud that are brought by the appellant here further as this court noted under kentucky law and smith similarly there is a product identification requirement under tennessee law it is imposed both by the tennessee product liability act the statute as well as the tennessee case law and in fact that product identification requirement the threshold requirement that the point if prove she used a brand defendant's product before asserting claims for redress that very product identification requirement was recognized and applied under tennessee law by this court in its parents decision so in that respect your honor if anything i would argue that on product identification grounds this court's prior ruling is instructive and requires a dismiss red herring we're not arguing that privity is required we are not arguing that there has to be a contractual buyer seller relationship and miss patty is correct that there are cases that say privity is not required but the application or lack thereof of  is to say that even if you didn't purchase the brand a product from the manufacturer but you were either a family member of someone who did or you're the household guest of someone who did and your injury was caused by that very product then yes of course you still have a cause of action so if i invite you to dinner and let's say my oven explodes even though you didn't purchase the oven you were still injured by that oven in my house you would have a right to a cause of action against the manufacturer that's not at all the case here the plaintiffs didn't get any injury caused by a brand product they concede throughout their papers below in their papers at this court and even in argument today they were very clear they have only ingest a generic product they have already said as a matter of causation that what caused their injuries was a generic product in that respect your honor privity or no privity what we're talking about here is product identification and that is what is required that's what the smith court said that's what the court below said and frankly that's what almost every court including every federal appellate court to address this issue has said now if your argument is based on proximate cause then don't you fall into tennessee's doctrine of  being within the range for sea ability there's a fairly strong tennessee doctrine being within the range of forsee ability and proximate cause case i think what you're referring to your honor is the concept of duty  and the plaintiff's argument here that if there isn't a product identification requirement you then have to look at whether there is a duty to sustain the claim and i think again this court's decision and smith addressed that separate argument when it held that one brand manufacturer does not have a duty to warn about a competing generic product this court itself recited that very doctrine under tennessee law in the barn's case when it said one manufacturer does not have a duty to warn about another manufacturer's product but in any event even if there is foreseeability that in and of itself isn't enough to create duty it's not enough to create proximate harm there are still other factors at play most notably is there a ship between the defendant and the plaintiffs and in this instance your honor this court has already found smith multiple other courts have held the same think there is no relationship between a brand defendant on the one hand and a plaintiff who takes someone else's competing product on the other and as all of the case law that the plaintiffs cite including the cases that they submitted i believe just monday in their rule twenty eight j submission as each of those cases makes clear before that liability whether it's on proximate cause foreseeability whether it's a product liability action or some other theory in tort always requires the distinction between the parties that we're talking about between a manufacturer of a product for example and a user of a product but in the drug arena there is not that distinction because you are not alive and you know you're not allowed as a generic drug producer to do change the labeling the generic drug producer is as we say in the family hoang with the libeling that that the brand manufacturer does so conceptually you're in a very good if you undertake reasonable for c ability in the context of a drug case you have to impose upon buy at the drug laws that are the very reason the generic defendants here eyeball to say not merely because they're relying on you but you know that when you create the libeling so explain to me why that doesn't make a distinction well your honor two points if i may and i see that my time has expired my first point is that that very argument has already been addressed by this court in smith to be clear and just to sort of summarize the smith case was argued preventing it actually then requested briefing and his briefing from the solicitor general it waited for the opinion and then there were a host and i won't get into the details i know that the generics and the plaintiffs have have argued about what was in the supplemental briefing but it is clear that the supplemental briefing contained and that this court considered what if any effect mensing and the generic regulating regulations had on claims as against brain manufacturers in this court already stated on multiple occasions both in its opinion as well as when it refused to certify after the fact that mensing does not in any way change that the issue is the common law as it pertains to a manufacturer of brand defendant drugs and it said in that opinion what with the previous law had said that it's it's simply not a basis for a duty that the generics may or may not have to use the brain defendant's label and so in that respect i would argue your honor that the mensing point that the generics are allegedly as you said hung with the brand labels that doesn't change the analysis whatsoever the analysis is did you take a brand defendant's product if you did then you may have a cause of action if you didn't then either under the product liability act in the product identification requirements or under the common law misrepresentation and duty cases you don't the other argument that i would make your honor is that let's be clear as to what the federal regulations state they state that a brand manufacturer must have a label and it must supply that label with its product full stop whatever the regulations require of the generic manufacturers to do that is an independent action and an independent course of conduct that only the generic manufacturers have can participate in and can control the brand defendants have no control over what label the generics use they don't know if we're when they make changes to their label or what they'll affix to their product so in that respect your honor i think there is even an argument that no it's not foreseeable to the brand name manufacturers what the generics will or won't do that's the very argument for a little disingenuous and because you know the law all the f d a requires that generics conform to the label of the really doesn't make a difference if if they are no liability stance well your honor that may or may not be the case but what i think doesn't make a difference here is whether those claims stand or fall against the generics this is a simple case as i said this court already addressed the very issues and smith there's no reason to depart from those issues and i guess they all you know i mean overall there's a good basic unfairness here or there sort of a catch twenty two and they don't have a claim against the generics because  preemption they don't have a claim against the brand because of the time the sleeper state product liability law that i'm a claim against anybody and yet they've been injured your honor that that may be that is the very nature of preemption and it's not my place to speak to that that's an issue with the federal regulations and in fact that's an issue that as i understand it congress has tried to in the f d a has said that it will try to fix and so in that respect if there is an unfairness that is the way it should be addressed through f d a regulations which i understand are at least going to be promulgated sometime this fall but the tennessee law is clear it's just like the kentucky issue and smith lack of product identification lack of duty each serves as an independent basis to affirm have not produced a single case in this entire litigation that says that for negligent misrepresentation climb not for regular products liability case but a negligent misrepresentation claim that there is any sort of product identification that is required smith doesn't say that barnes doesn't say that barnes isn't even a negligence ms for negligent misrepresentation climb it talks about multiple product manufacturers and in that case the warnings were held adequate as a matter of law so it has no application here smith has no application here because it was a pre bartlett case that was decided under a law which we discussed in some detail is very different it does it has different manufacture and seller language and there is no statute addressing privity and so as a result those those cases don't bind here i'd like to respond to sort of finish up on this discussion that we had before i said down on the legal grounds the issue here is not whether you embrace conti because those cases don't bind this court the question is whether there are any legal grounds under tennessee law for immunizing from the ordinary operation of misrepresentation law arald the holders and name brand manufacturers particularly in light of the duties that have been discussed in the last session and in light of the generic substitution laws in the free men or the postman sing regime that is a question that they did not answer why do you immunize them above all else and that's a question that i think this court is going to have to answer that you can't in going back to the generic questions on the issue of preservation on page thirty three of the of our brief we specifically talk about a or even to communicate or incorporate the actual approved labeling at page thirty nine to forty one of our brief we talk about generally about the idea of updating and keeping your labels current in addition to the did strange described at paragraph forty five we specifically talked about about failure to update with regard to fulgencio it is directly on point the court judge francis is correct that it filled the gap that smith didn't address smith dealt with with a different kind of claim and not this not this gap climb and they they centrally admit that that's the case  no i don't admit that at all i just described exactly where i had played it those were the paragraphs that i listed and judge strange is also talked about where we talk about failure to  update also mention the question buckman buckman has nothing to do with this case the generics have only raised buckman here in connection with claim based on the alleged failure to need to go to the f d a to seek approval for a labeling change and it wasn't  with a failure to update or communicate claims again paragraph forty five forty seven eighty seven she's described and in the brief mensing said that the question for him possibility preemption is whether a private party could independently do under federal law what state law requires of it in the case of a failure to update or failure to communicate the new labeling that is been updated there is no question of a possibility here what bartlet says what mensing says you can use c or generic manufacturers can use the c b e regulations that is changed their libels prior to seeking f d a approval the basis of the lack of preemption in the levine case you can use c or in all of these cases is that there are there really is a requirement after bartlett and i think this applies to the smith case as well that you have to look at the duties involved you have to look at the specific claims the smith case i think is fine but as i say it only goes so far as the duties there the condit case talked about the duties in california the weeks case talked about the duties in alabama kellog case i think was in ohio each of these cases many of these cases have been decided on different issues all i will say of the pro post mensing cases or virtually most of the mensing cases have been decided on grounds of  have actually been decided on grounds of allowing a duty on the part of the of the brand name manufacturers but the issue is to look at the you know look at the specific claims and when you look at tennessee law and the duty that it  imposes both with its generic substitution laws and the federal duty with regard to the post missing regime i think that you can say that there is a duty under the law and there's no impediment laws and in fact there is a statute that says that you don't impose the requirement that they've talked about it in terms of privity or in terms of product identification try to make a distinction between privity what they're talking about is some sort of blanket requirement either under