it please the court i am brian wolfman and i represent appellant catherine jones i'd like to reserve three minutes for a bottle if i can i want an address three issues today that none of miss jane jones's claims is preempted because the medical device claim to trigger preemption was not in planted in ms jones and moreover not approved for the uses employed in her surgery second that ms jones is claims may go forward under the cap parallel claims doctrine and finally that ms jones is claims regarding class two medical devices are not preempted under any circumstances unless the court has questions on the topic will rest on our briefs on the pleading issues me let me turn first the no preemption issue federal preemption is premised on the concept that federal regulation alst state law conflicting state law but here there is an absence of relevant regulation because f d a never approved the device implanted in ms jones and never approved infuse l t cage for the uses employed in her surgery so you're here basically arguing that off label is not regulated so that the essence of it yes it is not regulated on the federal side in this sense that that that has there is a little bit of support for that in the case law of most cases every object purposes of the law because they are allowing an absence of regulation so for instance here take this case for example there was no safety in effect in this review of  insertion of the biological device without a cage there was a safety in effect in this review of of this product for lateral or post year surgery there was no safety defect in this review of a number of other things for as it did may not have been safety or effect and i agree with you there may not have been well though i think the warning does say it's only to be inserted with must be inserted with the cage but the statute talks about federal requirements and there are requirements with respect off label use perez and stengel sort of recognize that in our circuit so in rejecting cases we're not free to reject the ones that we've already decided i don't think stablish at least if there are federal requirements with respect to our favor then look at your second argument about parallel about parallel uses but parallel requirements but for example the federal statutes say the manufacturer may not promote off label uses so there's a requirement was yanked off label uses so why are we in preemption land well i think there are two answers to your question  back up a second there are there is no question there are requirements of some sort on virtually every device and so the question the preemption question when we're looking for conflict as the federal regulation here says we're looking for a counterpart federal regulation to the state regulation is it on the same relevant matter and so let's go back and illustrate this through lower versus made tronic that's a case that found no preemption when at when a device is approved through a finding of substantial equivalence there were certainly that was a device no one doubted that that heart device was a device there are also zero holding is that with respect to a product that has not gone through premarket approval there was no preemption well carol no i could live with i want to go back for second maybe we're talking of course each other with respect to the class three device that went through premarket approval in this case don't we have a preemption issue you have a preemption issue but there even though it was used for an off label even though it may have been used for an off label  still have to find a parallel state faced state and for me my answer is no again my answer is no because there was no federal regulation for the on the relevant topic the relevant topic being all the many things i just stated that how do you never subject to p m a no i understand your argument and my problem is is is in our circuit in which we have devices being used for off label use use and we nonetheless do a preemption analysis those would be simple cases would they not if we simply said they had never been approved for the use for which briefs in those cases you look at the arguments of those cases no known was focused again let's so we should have decided those cases you say simply by saying well we don't have to worry about preemption these are just being used for off label  uses i would have to review those cases to see if that would love that you're right you're the facts but you're assuming that those were off label uses nose cases then your position would have been we didn't have to address the preemption issue no and here's why not necessarily and here's why it's not the off label use so much that one triggers preemption it's the promotion of off label uses the cause of the causation but not but that is regulated that's right that's that's my problem with it because there is a regulation that prohibits the promotion of off label uses so that to me requires us to think about whether the state claim is parallel well one way to view that one way to view that is to say that one of ms jones is parallel claims is that her all her state law claims are parallel to the prohibition and that but that's your second argument and it may be it may have more purchase but i'm again i think not those arguments were not presented to the court and i'd have to look back at those cases to see if that was the focal point of those cases but let me just say one other thing and this to me this sting wishes this case from all the other the tenth circuit which is the only presidential court of appeals opinion on the topic which is that here the actual device the device that is described at twenty one  r eight eight point eight eight three zero was never in planted it in my client right that's the device with the sponge the biologic the titanium cage that product was just not implanted in my client so there was just simply no p m a approval for the products that were implanted in her that now just to be clear that argument doesn't conjunction with titanium cages article titanium cage that is correct now what why shouldn't we treat the entire device that was approved as the graft in the titanium well that is that is our position and if you if  there is that device received p m s a but that's not the product implanted in arkansas so that that takes me to the question that maybe goes to your second thing are you making a claim in this case that your client suffered damage because the polymer cage was used rather than the titanium cage well that's one of her arguments well i'm going to tell me what i know it's one of the arguments i'm not sure i understand the claim well i understand the claim that kate when when the when the graft is implanted without a cage we've got a problem in other words because they're the label says it must be done with the cage is there a separate argument here that there's question about the nature of the injury that's right and so that let me go through that if these are references to the to the s c r that six seventy seven the palmer cages were used she was harmed by the  peak ages that's a page six ninety she says one of the reasons she was harm is that the peak cages migrated that's at seven eleven if you look at her opposition to the motion to dismiss it for twenty nine dash thirty she says the cages difficulty here but it seems to me that the argument was that a case that the cage polymer cage was implanted without the graft and therefore migrated isn't it wasn't that th possibility but no not my missing what the what the allegation was not out there now a geisha it's multiple fold there because there were three surgeries and one surgery in two of the surgeries the the the polymer was implanted with the non p m a polymer cage and the last surgery the polymer was and planted without any cage at all right and it's and as i read the complaint it's the migration of that polymer cage that your client complains of well again in the third surgery there was no cage at all right so my question is is there an allegation that a polymeric cage implanted with the infused graft migrated yes that the migration is noted at seven eleven of the s c r and that's one that was implanted with the graft correct there was always there was always the the biological material it's just that in one surgery there was biological material alone with no cage so i have one more question about the about the factual allegations as as i prepared the use yesterday you appear to me that there was not a claim of improper manufacture that is that the devices themselves were defective just looking at them before they rather that something went wrong once they were implanted i correct understanding of a complaint that was let me answer it this way and i hesitate to give and i want to explain why i have it's hesitate to give a definitive answer these are pro se pleadings and there's no question that if you don't we have to understand what i did too but not as manufacturing defect yes but there could there may be some confusion confusion in the mind of the pro se litigant because if you look at the opposition to the motion to dismiss she does she does claim there and recall at that time she had also asked to amend her complaint there is an allegation there in the opposition to the motion to dismiss well what whether or not there's an allegation the pro se client is now represented so i guess my question is do you seek leave to amend to assert a manufacturing defect yes it in addition to then let me explain why because what that what the opposition to the motion to dismiss said is that in addition to  claims that the product malfunctioned and typically a product malfunction is a failure of the well off and that is a failure of the of of the the device to live up to its specifications and i think she thought it was an allegation though that it was misused by the physicians and that it migrated rather than that it and you're saying that it's possible that it migrated because it was understand i know you want to save some time but i want to focus for a second on on the parallel claims issue let's assume you're in parallel claims land and we don't buy the argument that preemption doesn't apply stangl at least that the failure to report untoward results with the device to the f d a can give rise to an arizona negligent failure to warn claim so i guess you the same question is that one of the claims you'd like to assert that is one of the claims she would make on remained i mean there are a lot has happened since and there's ok so let me just but but let me just go further here locally and yeah that's what i want to ask you about those christan go at least resolves that issue tell me what the other parallel claims are which federal requirement was violated in which arizona law you think is parallel ok there is this branding and misbranding is the this is on the federal side you have an advertising claim like you have a claim that they promoted it directly but let me let me finish the thought if you might i mean i don't mean i don't mean to interrupt but three fifty two is the claim is the provision of federal law that says labeling must be may not be false or misleading in a but he's a killer but at three fifty two q labeling includes promotion as well i think that's what it that's what i was getting to and i want you to focus on that because you're not attacking the label it exactly right we are not attacking this label i mean if if the label what i claim find that yes not only preemptive but the labels find the part of the argument here the argument here is that the promotion unlawful promotion overrode the label well i'm i notified i understand your argument i'm trying to fix focus on what you think the parallel arizona clay well there's a parallel arizona claim takes essentially two forms one is that the common law notion that part of the duty to warm a new warning you see this in the watts opinion of the arizona supreme court two thousand and sixteen opinion part of that duty is that the the duty not to nullify warnings that's exactly what that case is about it's a situation where there was a label and the manufacturer is accused of using other promotional materials to override the label website and one of my and my difficulty with that is this the avoid the label doesn't don't there's nothing that overrides the label and you're a legit promotion the label simply says when used for on label use here your instructions there's nothing that there's nothing in the legit promotion it says ignore the label that's right it just  the promotions and this is heavily alleged in her pro se complaint the promotions were counter to the label and and so for instance like that if they promoted you that might my difficulty is that with respect to off label right there's something that says you can't promote off label uses at all but it's hard to see in arizona parallel it's a violation of that federal so you know but i think with all respect i think that's exactly what watt does and one other thing that was parallel remember i said two things were parallel on the state law side of the equation one is a case like what that buys the nullification argument wholesale and the second is that the arizona pharmacy act has the because of action under the arizona pharmacy it is not but it would be negligent per se but now you're back in buchman land or don't you think i think absolutely not absolutely not this is not an interference with the inner workings of the f d a this is not fraud on the f may please the court ken kenneth king for defendant paly metron if you're honest i intend today to cover two principal points in my argument subject of course to a questions the court may have the first point is that the claims here are that the device manufacturer should do more than the f d a requires and dismissal here is consistent with the court holdings in stengel and improvising other circuits as well the second point is that the trial court below was absolutely correct in stating and finding that  replete ing allowing the plaintiff to repleat here would be futile well wait i have a question about the second point if i may can also has suggested that they would like an opportunity to plead a manufacturing defect as distinct from a design defect and it would appear to me that a manufacturing defect claim would not be preempted that is  everything is the design of the device is perfect pervy federal government if you make it so that it breaks and stead of holding steady then that's available claim you see your position that that is not an available claim that is that it would be preempted i'd have to see it first but while i'm ok in theory whether a manufacturing defect claim in your view is preemptive theory manufacturing defect claims can withstand looking and ok so we don't know if with discovering that is viable but in theory it could be hypothetically ok so let there is an arizona parallel claim to the f d a requirement that you report me call the monteux or results for use of the device to the f d a and mr wolfman says that's a claim that we that seem to be on all fours wouldn't they would have to have a basis for sure no i don't but we're at where we're and they may not be able to allege that there may be ruhleben problems with it that's not the question the question is whether or not such an amendment to allow a chance to amend to say those things now represented by counsel mr jones may not find any basis for making that allegation counsel would be subject to a level problems and cetera but certainly it's an they never asserted this claim that's a malpractise case no i'm sorry i'm just what you're saying yeah right but but that one would survive if alleged right it would be that we've already said those are be relieved right she filed the claim in in arizona and but it sounds like you are conceding that at the pleading stage if you asserts a manufacturing defect klein it not it's not so we have a manufacturing defect claim that could hypothetically exist as what i call a stengel claim that could hypothetically exist because stengel deals with arizona law so we know there's a parallel arizona claim mr wolfman says i've also got a false advertising claim misbranding claim and there's a parallel arizona statute there too and i'm assuming for all the purposes of all these questions that we're trying to deal with three sixty k that you're in dealing here with the question of whether or not amendment would be futile which is what the your said the second part of your argument what the district court said was under smiting it and i can't find anything here i could tend to agree with the district court on that reading the complaint charitably i'm not sure what it says but now we have counsel and he says what we'd like to do is amend the complaint consistent with responses below and other things to say to allege that  know in a fashion you knew to me was leading or inappropriate and that he says has a parallel in the arizona law on the pharmacy act and perhaps under arizona common law so assuming that's what his allegation was with that survive preemption analysis i again i have trouble because it's not alleged you know i realize you say simple with you but you're giving me you started by saying it would be futile to amend and so my question is if he were to man or mr jones which i meant to say you violated the false advertising prohibition if you will a federal law and there's a parallel arizona provision that for hits that under which i which you would be liable would that survive preemption misbranding includes includes advertising under the regulations and advertising incorrect notion yeah but a jihadi to refrain from off label promotion is not parallel to a duty to no no no it's not what i'm maybe we're missing it if i agree that there may not be a parallel in arizona law to the duty to refrain from off label promotion but he's suggesting more that your off label promotion was false and misleading and if it was would that would that survive a preemption  played here is alleged fraud by omission if it's not i know other than that i don't think that's a problem i mean i agree with you under fraud by omission if it's i'm asking a different question if so if it's something other than that hypothetically  have no right end to end in the used in case judge wilson says hypothetically although applying california law that arizona law a fraud claim might survive and the reason  we're putting on the spot on this stuff is that we have a pro se complaint and now we have counsel and counsel says i can fix it and it was dismissed without leave to amend and so that's why we're asking your the hypothetical sure i mean and  posts is somebody makes the alligator this is the first we've heard of it not part of the record is the fact that the f d a looked at this in response to an increase but now i think and said none of the not part of the record i made aware you made us aware of it in your briefs but on the other hand the other side did cite sango in its in its briefing and said that it that showed why they might have applied for a different proposition to justify parallel claims based upon the purported claims of off label promotion in the complaint which are not off label promotion claims at all you know we we have we realize it's a pro se plainti but the complaint is what we have to go by and that's how we we prefer the case knowing that he's not and that's why we both i think asked the question about your second point which is that the judge correctly held that it wouldn't futile to amend i'm sympathetic to your view that under the  face of this complaint it's difficult to discern the way around preemption but but it's pro se and you correctly focus on whether or not it could be amended and let me discuss this point to first since were on that track these come this complaint is unique in some respects but one respect is is that she attached her medical records at least significant ones to the complaint as well as the state court complaint in which she describes her medical records in great detail there is no that this plaintiff can plead reliance of the elements of fraud in this case well and that's that goes to the parallel or zona claim i take it now the words if even if yours what you're saying is that even if there were misbranding to use the shorthand the parallel ours on the claim requires reliance on the correct it and i think that's right both under the consumer fraud act and common law fraud in arizona but is it true of a pharmacy act is there a pharmacy is there a pharmacy had client think there is an i don't first time i've heard i think the right a private action in the pharmacy i guess so i but but if you are dealing with a fraud claim under arizona law then you would have to show reliance sure and i don't think she can she's had she investigated her facts with this doctor extensively had extensive back and forth with  know and i understand the argue my question is is that a is that a rule twelve b six issue or is that a summary judgment issue i think it's a rule twelve b six issue so what if she were to allege reli effect says to you this is a safe product you know it's her allegation i take it is that somehow the doctors were misled and therefore if they hadn't been misled she might not they might not have used the devices the way they did  there's a letter written by the doctor in two thousand and twelve to the plaintiff's she'd asked him a series of questions about infuse and he responded and he states that as a reason for his his use of the device here quote i have personally used infuse in my spinal surgeries without any complications for over seven years including my fellowship at n y u in new york to this day i voluminous medical records such attach which becomes part of the pleadings under our federal rules but i'm just wondering whether or not you asking a pro se plaintive to discern those extensive medical records to come up with i used the word correct factual and legal allegations first of all she's attached and second of all she claims in the current complaint to have a medical consultant and second third of all she still has to plead some element of reliance and you further to the doctor's statement as saying that ok well he relied upon the manufactured representations he is used it successfully in that regard and he doesn't say relied on that he lights on his experience with the product over seven years including his fellow if that's not relevant really in a sense to the question of whether he also relied or initially relied on representations from the manufacturer in other words if i say well i i really enjoyed reading this novel it doesn't say anything about whether i relied on someone else's opinion to pick it up in the first place so i guess i don't understand what you're all about in your hypothetical if he had used it in year one and then in years two through seven continue to use it based on his own experience you're saying that alliance passes out of the major causation problem approximately first problem that's and there's no there's no inkling that what you have you are y can't plead reliance she had has extensive medical records at her disposal including this letter she hasn't come up with a basis after all these years including when she was represented by counsel to show any element here's what strikes me about this entire discussion that we've had with both of you it sounds to me as if in theory in the abstract there are a handful of claims that would not  be preempted if they could be pleaded and they question whether they can in fact be pleaded in good faith remains unknown it's strikes me that we don't know so that even if the plaintiff were given an opportunity with counsel counsel may discover that there is not a factual basis to allow the replating but he might i guess that's that's what i'm struggling with this what do we do in that situation i don't think a reliance claim could be pleaded in good faith because there's just absolutely no basis for it they still have to plead it i understand that i guess what i'm struggling with in general is not is the idea that there are theoretically some things that could be pleaded but we don't actually know if they can and then again on this so called stangl because it's the first time raised as i was sitting here i know they cited the case but for a different proposition when they made up they may not be able to pleaded i don't know it's it but if they pleaded it it would we know would survive a preemption analysis bond i'm not giving on bond even they may think it might not survive it in the supreme court but it was a right good enough to give enough facts and as we know them i'm not sure that's the case ok well let me ask let me ask the step out of the details for a second and just make sure i understand your position because i think on three sixty k a preemption so i understand your position is that there are requirements with respect to the off label use of this device and therefore we have to satisfy the parallel requirements quite right definitely ok so let me let me just give you a hypothetical and you don't have to tell me it's not true because it's not true but let's assume that your client knows that any use of this device off label is very dangerous to patients they have information that and they nonetheless promote the off label use of that device would there be a state law cause of action against your client you know talking preemption as to whether a fraud client i would wish it would be would there be a state law cause of action that survive thank you for correcting my question that survive preemption analysis against your client i don't know what i will say is gives us guidance to say that hypothetically there are fraud claims out there and i don't want you to i don't know what the state law claims are so i'm not trying to focus on the nature of the state law claims we'd have to find a parallel one but if there were a parallel claim to the misbranding prohibition in federal law would that survive preemption and how he's talking a fraud claim well i don't know whether it's for another words maybe let's assume the arizona pharmacy law said state law in the absence of preemption the facts situation i described to you would give rise to a course of action my question is under those circumstances would we be outside of preemption if there is a you keep saying fraud and i'm say keep saying misbranding so let's assume that under state law something that violates the federal misbranding prohibition also would give rise to a cause also violates some arizona whenever i'm making up a law i'm trying to find a theoretical position can misbranding give rise to a state law cause of action it's not preempted if there is a if a state law cause of action exist that circumstance federal law federal law says you cannot promote off label uses if your client does promote off label uses that violates federal law and if there is an identical arizona law that says you can't promote off label use is and if you do you can sue would that be parallel and therefore permitted  if the laws are identical it could ok so now let's go back to my question there's a federal statute that says you may not miss brettan and let's assume there's an arizona statute that says you may not miss brand that gives rise to a private cause of action if you're damaged by this brandy put aside whether or not ms jones ever saw that it's raining or light or whatever she might lose under the arizona statute under is not a parallel statute also disclosures at least as i interpret the argument well the argument is that you actually said something to doctors and what you said to doctors about off label use was incorrect and therefore violated the federal prohibition on false advertising not simply that you made off label promotion but that you made an incorrect off label and when i say your course i mean medtronic not the lawyers i'm not sure they can allege that i'm not sure they can prove it but  i'm in hypothetical land if one were to say that and it seems to me and one could identify a parallel state law they gave rise to liability under those circumstances and i'm having a hard time seeing why that course of action would be tentacle requirements then you have a parallel claim but they must be identical what must they be saying go stangl deals with the requirement that you report bad results and it finds the parallel hours on a lot to be a failure to warn negligence claim they're not identical or the floor says i i know it's think i may be wrong and think i may be wrong but let's just let's assume that i have to follow my colleagues for the moment and and other cases cited in this circuit used genuinely equivalent which is saying the same  so i just go back to the hell that's it and that's why i resisted your letter that's why i resisted your fraud and now suppose fraud has all bunch of other elements that the federal statute doesn't have correct and that's why you need thank your honour's i just want to take up briefly that the discussion you've just been having i realize this is a process a complaint and it takes some time to go through it but  not only does mr johns want to repleat he says that in her in her lower court papers but that the claim of over promotion is extensively discussed in her complaint and it's at odds with the label of the misbranding type argument but if you take a look at she says that her particular surgeons were linked to medtronic swep sites and vice versa that there was medtronic was recommending them they were recommending him if you if you looked at those websites you saw the off label use is promoted medtronic representatives were in the surgery room put this is at six seventy eight their seventy nine take a look also at seven o one through seven of the three eighty five percent of all surgeries were performed off label that's a six eighty seven and then she makes the ultimate conclusion that it would be impossible for any of these surgeons not to have gotten these promotions so i prefer to think of this not so much as a question of reliance which i don't believe is required under the consumer fraud act however however according to consumer fraud act f foresman by the attorney general however private courses of action arizona supreme court says it's required but but but i i think the question here is i don't want to dodge this because i don't think it's a question of the lines i think it's a question of causation and it is stengel with respect to the failure to report type calling do you have a that is ultimately you have to show that it caused this injury so i think it's just a need or a way to resolve the problem of reliance to say yes there has to be causation other words what i'm calling over promotion or the impermissible advertising has to have alternately cause the injuries which is what i think that's reasonably well pleaded in her in her complaint intensive fact intensive inquir taken i know you've done it already but take a hard look at the complaint for a pro se person there's an awful lot of detail and the final point i want to make that's relevant here is a legal point medtronic in its papers cites plausibility and this is if you look at those pages that i've cited to you this is easily a plausible claim in light of all the circumstances all the pleadings in her complaint and all the supreme court has granted certain the merck case i know that doesn't deal with devices that deals with drugs but it deals with failure or failure to warn allegation i think it's fair to say we never know what the supreme court will say when it takes a case should opposing counsel respond as well of course that that the question in that case of questions different i just write about i think it but i think it's sufficiently different that the and just just i want to make sure i'm on the same page with you which is that fear question trepidation is that the supreme court often takes a case to make a statement about something and it's going to be making a statement about preemption under the m d a in that case because perhaps they'll be a broad statement about preemption in this general area that i'm concerned that that is possible but let me just say this and i think you know i don't want to belabor the point i think all the parties in the case in their search and in their search papers noted that the issue there is quite narrow it's when when when one assumes that the aid the manufacture has gone to the agency and said give me this new label and they say no correct them that's true right and so everybody agrees that it's a narrow application of why isn't that why i think in about drugs generally does not preempt drug oriented claims i guess i ok you can do it twenty ha the case just argued them is submitted and we appreciate very much the helpful and thoughtful arguments from from both counsel