then we will proceed to the second case of the date which you see in re testosterone replacement therapy products liability litigation appeal number seventeen dash twenty fifty six itestosterone and as the court is aware this is an appeal from the dismissed so in the law to district litigation of plaintiffs claims that the pleading stage on the ground of preemption because the district court found that it was impossible for fives or unilaterally to add warnings about cardiovascular risks to the deputy label without running afoul of federal law because the review in this court on this issue is to no i'm going to focus on pfizer's arguments rather than on just a court opinion the fundamental flaw in pfizer's argument is  inability to identify a single statute or regulation that would have precluded the label change at issue pfizer cites multiple sections of the us code in the code of fed federal regulation that require the label of the generic drug to be identical to the label of the reference listed drug and as we know in this case depo t is the reference list of drug pfizer argues that  it's not so is that only one of the statutes or regulations that pfizer cites and indeed only one of the statutes or regulations cited by the supreme court in the mensing decision has any the changes that are made to a label after a drug is approved all the other ones pertain only to the label that has to be submitted with the application the section that does apply to changes made after the label is approved doesn't say that it has to be identical to the approved r l d label that were to prove that pfizer relies on just not appear in that section and let me step back and go through which sections we're talking about so pfizer cites and relies on five sections which are the section cited  support of the holding that generic manufacturers are precluded from unilaterally and warnings to their labels those five sections are too subsections of twenty one u s c three fifty five one is j two a five the other is j four g and three sections of the code of federal regulations twenty one c f r thirty five i'm sorry three fourteen ninety four three fourteen one twenty seven and three fourteen one fifty ok all of these are cited in our brief and in the pfizer brief the first four of those pertain exclusively to the application process so three fifty five talks about what the the abbreviated drug application must contain it talks about the approve the conditions for approval of the ndaa three fourteen ninety four is about content and formatted the end of so it's how you make the application three fourteen point one twenty seven this grounds for refusal so all of those do say that you have to submit a label identical to the approved label of the are ok but they don't have anything to do with what happens after the drugs approved and i should note that the mensing decision specifically recognized this distinction between the regulations that govern the application process and the ones that govern the label after the drug is approved so if you look in men saying at five sixty fo us six thirteen the court goes through all the differences in the application process and then they say none of this is in dispute everyone agrees on it and then this is the quote at six thirteen what is in dispute is whether and to what extent generic manufacturers may change their labels after an initial f d a approval so that was the question there that's the same question here now in man comments in the federal register in one thousand nine hundred two and those comments were as follows somebody commenting on these new regulations that were about to come in the regulations that we're talking about one of the comments was wouldn't it be good if and holders could make changes to the label unilaterally after approval and the f d a said we think it's really important to have uniformity that the label for the generics has to be the same as the label for the brand name for doctors will get confused about whether they're the same so the f d a comment was we need all the labels to be the same and that's what the supreme court was citing in mensing where you would have had a divergence where you had a true generic and you also had a brand and the supreme court in mensing also cited page six fifteen the other regulation the one that's at issue here which is three fourteen point one fifty that is the only regulation cited by mensing or by pfizer that limits the ability of a generic manufacturer to make changes after approval remember the one thousand nine hundred two common in the federal register is f d a comment the actual regulation that implements this is three fourteen point one fifty and that's the one that limits the ability of the of the generic manufacturer to make changes if those changes would cause the label to diverge from that of the are all did ok and that's the provision that says if your label isn't the same the is the only goal but i wanted to finish with one fifty because what's really important is what it doesn't set ok because what one fifty sags is that they can take away your approval if they find that the labeling for the drug product that is the subject of the abbreviated new drug application is no longer consistent with that for the listed drug referred to in the abbreviated new drug application that approved label business that we hear so much about in the brief that the r l d has to be identical to the approved r l d that's not here what this regulation says is you lose your ability to market your drug if your label is no longer consistent with that for the listed drug it is not possible for deputies label to be inconsistent with that for the listed drug because depo t is the list a drug so under three fourteen point one fifty it is not possible for pfizer to loose the right to sell death by making a unilateral change to the label because it's label will always be consistent with that for the listed drop and those are the only words that appear in that regulation and there are some issues about differences there are allowed for patents but in terms of of this it doesn't say approved and yes when i think uniformity as between generics and brand name drugs every time the f d a has spoken about this what they've been concerned about is maintaining uniformity between them and i think it's important to remember that one of the purposes of was to make generic drugs more widely available to put generic to make generic drugs more available to consumers and so it was important to the f d a and this is what you'll see in the one thousand nine ninety two comments that doctors  assurance that these products were really the same and so they wanted the label to be the same and but this is the only regulation that implements that the way both should be the same now other than d holder is subject to the same requirements as anybody else now all of the drug manufacturers are limited in their ability to make unilateral changes to their label and they're all limited by three fourteen point seven which we've referred to as the c b e regulation but it's actually much more it's the regulation that governs how do you make unilateral changes after approval is that only available to and d h well that's the interesting point so to the extent that there's some ambiguity about who it's available to there's another section that we have to look at and label in mensing the plaintiff was arguing that the generic should have made a change that would have put the label at odds with the brand name and so the duty of i by being identical would have been violated because they were two different drugs we have the unusual situation which almost never comes up where the and the drug is the reference list of drugs that that was not the case and then saying that that's why mensing comes out the other way because because for number of he says that lack complete diversity is a right yes what do you think we should do about that well our original proposal was that this court should dismiss those appeals and i understand that in five years proposal was that the question dismissed seven cases in their entirety i think this court can do that but i think if the court were to dismiss the appeal the district court could handle whether they wanted to drop a defendant or whether there was a way to preserve jurisdiction but i think certainly those appeals need to be dismissed well there's a you know all of them there's a final judgment now right dismissing on the  correct and the it would seem to me that the appropriate disposition would be to set aside those judgments when they say and modify them to make them dismissal for lack of jurisdiction or there are some that were supposed to order just dismissal of certain defendants i don't think that your honor that this court is in a position to order to smith's saul well there are two types of cases in this instance there are ones where there is final judgment and there are ones where there is partial final judgment rule fifty for the final judgment and on the ones for where there is a final judgment in terms of vacating the judgment the merits and making a judgment for lack of jurisdiction that might make sense the rule fifty four partial rule fifty four be partial final judgments it might be more appropriate to leave that to the district court to deal with the jurisdictional issues that are that are raised in those cases but we would need to set aside the fifty four b for lack of jurisdiction i mean that was the correct year and throughout i hope defendants will tell us their thoughts on that as unilaterally to change the labeling for their drug simply because the drug has been designated as a reference listed drug the answer to that question is no f d a has regulations require and the holders to maintain the labeling previously approved by f d a and f d a has consistently interpreted those regulations to preclude unilateral changes and all of the federal courts to have considered the issue including the fifth circuit and the sixth circuit have rejected the argument that in and of drugs designation as a reference list a drug somehow alters the analysis the district court carefully considered opponents arguments and it concluded that because federal law recruited athletes from a can unilateral changes to the labeling for their drug it preempted state law claims based on the sufficiency of that label so what's the clearest prohibition sure suggests hamilton let me explain how we think the regulations work and then i want to address  really a new argument today about the sameness regulations in our view the operation of the regulations here is relatively straightforward as ms pierce seen acknowledged what f d a has done and it did this some extent in plea of a versus mensing is to reconcile this c p e regulations with the same most regulations the c b e regulations are section three fourteen not seventy and three fourteen dot ninety seven now we acknowledge manufacturers actually you in the c b e process and what the f d a has said and it said this to the supreme court in place of versus mensing is that and the manufacturers are limited in what they can do they can use the e process to conform their labels to the labels for an n d a drug they can use the c b e process to respond to changes mandated by f d a what they can't do is make unilateral changes and of course in play versus mensing the supreme court relied on that interpretation in concluding that the end the manufacturers at issue were not entitled to make unilateral changes and therefore the claims against them were preempted e process if you take a look at justice sotomayor as dissenting opinion she had two points in the opinion points out that one of the consequences of the majority's ruling is that there might be a circumstance in which the n d a manufacturer has left the market and therefore no one will be able to invoke the c b e process at least to make unilateral changes so all of that is a bridge that the supreme court has already crossed the sole remaining question is whether there is some basis for attempting to carve out a drugs that are reference list of drugs or indeed carving out even a narrower category of prehaps waxman and drugs and in response to that i think our fundamental submission is that f d a itself has made clear that consistent with its interpretation that no end of manufacturers can make you know out of all changes that that principle of interpretation of applies with equal force to end the manufacturers whose drives are reference listed and i would point the court to the proposed rule in two thousand and thirteen at seventy eight federal register sixty seven nine eight nine and also to the regulatory impact analysis that is in our appendix at page ten where f acknowledges the specific category of and of drugs that a reference list of drugs and says that the same rule applies in that circumstance and so at a minimum even if you thought the regulations were ambiguous f d a has interpreted it regulations to apply to reference listed and or drugs and non reference listed and of drugs alike and that interpretation should be entitled to deference now let me address the argument that ms beer scene made today because i think it is a somewhat different argument are some of these cases in which there is a diversity problem and our submission relying on authority both from the supreme court and from this court is that this court has the authority under these circumstances to dismiss those non diverse defendants from the underlying cases and not just from the appeal and his peers seen at least in her reply brief acknowledges that that is an appropriate solution i believe on the last page of her reply and so you know the court i think could technically vacate the judgments in those cases and remain and with instructions to dismiss the non diverse defendants from those cases for lack of jurisdiction but obviously we would ultimately all be asking how does how does this deal with the problems we've got  some individual cases where final judgments have been entered and others were there are a number of other defendants and it's only a fifty four b judgment we're dealing with so i think that this court could could do that with regard to those judgments as well in other words with regard to the i suppose so with regard to the fifty four b judgments if the non diverse defendants are still in the underlying cases you know i don't know that there's really anything to be done other than affirm the fifty four b judgments as to my clients this court could i suppose indicate the district court didn't have jurisdiction in the first place i mean it's a little bit it's sort of an odd situation because the district court would not have jurisdiction by virtue of the non diverse defendants who are still on the underlying case right i suppose that in that circumstance i had to get technical but it is true now it's emergence important because it is the last line of your opinion i think that you would probably vacate in that circumstance as well and indicate that there are non diverse defendants in there for the district court never had jurisdiction because as you say that goes to the underlying district jurisdiction of the district court to hear those cases now i do  want to get to ms pearson submission today because again i think it's a somewhat different submission from the submission that was in appellants opening and requires today she really focuses on the fact that in her view the regulations that apply to the duty of same  are regulations that in the main focus on the initial approval process and i think it is certainly true that some of those regulations speak primarily to approval now of course these are the very same regulations as ms beer seen acknowledge that were at issue in the supreme court and pleaded versus mensing and yet the supreme court relying on f d a as interpretation of those regulations concluded that even when you get past the point of approval and the manufacturers more generally do not have the ability to make unilateral change so this is another respect in which i think opponents argument really flies in the face of what the supreme court did in mensing but i think more generally again the f d a has properly interpreted its regulations to apply at every stage of proceedings whether it's at initial approval or at a later point to put it again somewhat differently and a manufacturer has a constant obligation of same as that obligation does not exist simply at the outset that exists as long as the end manufacturers drug is on the market and not to get too technical about this but one of the regulations that ms beer scene pointed to is three fourteen dot ninety four that regulation talks about applications but if you look at the definition of application which we cite in our brief it's in three thirteen three b that definition of defines an application to include amendments and supplements in other words to include subsequent actions by and the manufacturer and i think that tends to confirm that this obligation is a constant one and while it is true as mr seen points out that in three fourteen dot one fifty that provision does not speak specifically to the approved the labeling that provision simply provides that if labeling is quote no longer consistent with that for the listed drug approval for the end may be withdrawn i don't think that that creates any problems for our argument here today which simply rests on the fact that the regulations and cells again as interpreted by f d a key off whether the labeling is the same as the approved a label in other words with a label that has been approved previously by f d a and for that reason there's no reason for treating reference list of drugs and when it what is the point of treating india use an n d a separately for purposes of the c b process well of the purposes of tort law and the safety regulations for the federal government imposes on drugs it's a little hard to keep larger purposes in sight rules concerning the hatch waxman process that's sort of quick by washington standards i suppose but but those regulations by their terms have been construed and by their term and by their actual terms provide that only n d a manufacturers have the ability to kind of make full fledged changes now i think that the rationale for that is that any manufacturers are you know the ones who have conducted the full fledged safety and effectiveness studies and even prior to hatch waxman when the obligations for and drug applications were somewhat different i think it is fair to say that and the applicants did not engage in such a full fledged analysis and so even with regard to a drug like ours deputy i can say based on the regulatory file which was disclosed in full and discovery that  up john conducted a somewhat more limited analysis they conducted bio biological equivalence studies to establish that there wasn't that biological equivalence with a drug that had previously been approved through the n d a process now judge hamilton i'm going to acknowledge that there are way to be policy considerations that underlie all of this and indeed issue will be aware from the briefs in twenty thirteen f d a proposed a rule that would essentially open up the c b e process to all and the manufacturers and allow them to make unilateral changes and i'm willing to concede that there might be policy arguments in support of doing that now of course f d a has not in fact promulgated such a final rule but the critical point for purposes of this case is well there are really two critical points the first is that the supreme court has made clear in this beer scene agrees today that the preemption analysis terms on the ability to invoke the c b e process to make unilateral change  second relying in part on the twenty thirteen proposed rule and what f d a said about the current state of affairs f d a again made quite clear both in the proposed rule and in the regulatory impact analysis that and the manufacturers whose drugs or reference list of drugs are no different from any other and the manufacturers in their inability to make unilateral changes in adam minima even if you didn't agree that that was the better interpretation of the regulations f d a is position on that issue would be entitled deference we know that from cleaver versus mensing itself because the supreme court in accepting the proposition that and the manufacturers more generally could not make unilateral changes rely on deference to f d a its interpretation of its own regulations and i want to say just a word about this issue of reference list of drugs because i think at least in her brief ms spears steen places a lot of weight on the notion that reference list a drug should be treated differently i think it's very very important to sort of think about what it means under this regulatory scheme to be a reference list and drop what it means is essentially that your labeling and indeed in some respects your drug is a benchmark so if you take a look at the definition of a reference list a drug and this is in section three fourteen not three be a reference list a drug means the list a drug in a five by f d a as a drug product upon which an applicant relies on seeking approval of its and its abbreviated application so there are two consequences to becoming the reference listed drug the first is that once f d a approved labeling that labeling is the benchmark including the benchmark for any and those that are dependent on your labeling the second is that if a new and a manufacturer wants to come into the market your drug is the standard for purposes of the bioequivalence analysis there are no affirmative obligations on a reference list a drug and a manufacturer that manufacture is subject to the same obligations with regard to pharmacovigilance and that's just a silver dollar word for the notion that generic drug manufacturer does have to monitor safety if there are adverse events concerning their drug they have to report them to f d a and as f d a itself suggested and cleaver versus mensing a and a manufacturer retains the ability to ask f d a to make changes to its label or critical submission is that an r l d and a manufacturer stands and no different a place from any other and a manufacturer it is subject to the same limitation on its ability to invoke the c b e process as f d a has said on your honor with all due respect to your question about the technicalities of the policies i just want to note that this is a preemption case and preemption is a demanding defense that requires pfizer to establish by clear evidence that it was precluded by federal law regulations from adding the warnings to the deputy label so the well as these aren't really the issue the issue is the policies are what the supreme court set forth in why a first slovene the obligation to change or label is not under federal law it's under state law the question is is there some federal law that prevents them from doing that and if federal law is ambiguous i would suggest the defendants fail to meet their burden to show that during the thirty plus years that this drug was on the market before these claims were brought that at no time were they ever able to make change their label i would say as well that mr sam again emphasizes that the anda manufacturers are under an ongoing obligation and that's true but your but this court has to ask obligation to do what and the only regulation that relates to an ongoing obligation is three fourteen point one fifty all the ones that deal with supplements just tell you that if you're submitting a supplement yes you have to comply with this regulation for the supplement but if you are just sitting around with your drug during the years that it's been approved there's enough no that no new application you're making what is your ongoing application i'm sorry your ongoing obligation the only regulations so this is the only impediment to what state law is telling them to do state law saying and all morning if you know about risks and they want to say we weren't allowed to and you asked mr your best what's the biggest impediment and i'm not sure i know what his answer was but i think the answer has to be certainly and menacing the answer is three fourteen point one fifty it's three point one fifty three point three fourteen point one fifty that in cleveland or mensing whichever you want to call it that's what prevented the generic manufacturer in that case from doing it because had they done it their their label would not have been the same as that of the r a d and so the inside of mincing was you got an oral d over here and you got it and a drug which was not the you got it and a drug over here and if the and a makes a change now the two labels are different the are of the land and three fourteen point one fifty is the only place where the f d a says you can't make them different because if you do we're going to yank your drugs now the f d a has many times but never in this context and if you look at what they've said they've always talked about the need for the duty of sameness but never addressed this specific issue but isn't this context analogous to when an n d a ends with drawn i don't think it is your honor because when the n t is withdrawn if no new r l d is is in place you have all these generics and they're all bound to whatever the r and d is if one of the makes a change they're going to be different from each other by maintaining the