ten years the amount of herceptin contained in a packet sold in the united states matched what you nine tech put on its label but in two thousand and nine that changed although the company continued to tell health care providers and patients that its packages contained at least four hundred and forty milligrams of the drug that was false where the ninety percent were under filled the consumer protection claims in this case the whole genome tech to what its label promised the district court held that these claims were preempted by the federal food dr cosmetic act under two different theories st that the claims posed an obstacle to the purposes and objectives of the f t c ebay and nd that it would be impossible for generic tech to comply with the state consumer protection laws without violating federal law neither theory of preemption is correct under the supremacy clause in our system of dual sovereignty federal laws the only displace the decisions of sovereign states where it is absolutely clear that a state law confers rights or imposes restrictions that conflict with the federal law but that's the supreme court reiterated just again last week in the absence of any such clear conflict federal law cannot serve as a basis for eliminating state law claims there is in other words no form of preemption that authorizes a free wheeling judicial inquiry into whether a state statute is in tension with federal objectives to displace state law before we get too far into the theory i'm sort of back on the facts do we have a factual dispute here as to what federal regulation applies and before we can say how that squares with the state action that is if there is preemption we have to know where we start and that all gets back to is this really liquid or is this solid right well well we think that this is a liquid but i think even if you accept in an text position on this and the district court did that it was a solid and so as a result it's twenty one c f r section two a one fifty one that controls the key problem with the district courts conclusion here in genetics argument is that the f t c itself is not an obstacle preemption statute in other words it may set of floor for what is required even if what we're talking about is a solid but it does not also s ceiling and under the f t c a state laws are entirely appropriate and in fact congress intended state laws to work in tandem with the f t c a to impose higher standards than might be otherwise required by federal law so that we get into this substantial variation that's permitted if it's a solid and if it's a liquid you have to be more precise as i understand it yes your honor that's correct but even if you take again gentex view that there is a reasonable variation  the statute to two responses to to that argument the st is that even if genetic was right that the f d a interprets reasonable variation to permit a downward limit below four hundred and forty dollars milligrams they say goes down to four or five we think that's wrong and i'd like to explain why but even if you accept the strongest form of their argument that is still a floor there is nothing about that particular requirement that in and of itself displaces federal law and i think regulatory rule making process to display state law but but you also have this court's recent decision in in utah native plant society which again was an obstacle preemption case of the same kind of preemption theory that we have here and what this court said in that case which is two thousand and nineteen is that in order for a regulation to actually exert preemptive effect the regulation must be manifestly clear that that's what the agency is intending and i didn't the problem i have here and i have a lot of problems with this case i things very difficult the argument that the state is making your make it seems to square with what the f d a is asserting should correct be the applicable measure correct as you know i don't understand how there's an obstacle if if you're agreeing agreeing with the f d a who regulates the drug briscoe that i think is exactly right what we know about the way the f d a interprets this regulation is applying it retroactively right what your response so the f d a doesn't take that position the f d a said and told an intact this is always been our view it is not a change in how we interpret the regulation number one number two even if thought that this was a change in the way the f d a interpret the regulation we have to get back to the st principle here which is the starting point for all of the manufacturers labeling under the f t c essay is state law apply so genetic has to know at the beginning before we get into litigation in this case not only do i have to apply we comply with the cia and it's implementing regulations i also have to comply with state law that is a fundamental feature of the f t c essay and there's only one way there are two but one way congress in the in this context can change that starting point which is to pass an express preemption clause if in fact congress didn't want to have to worry about what its obligations might be under state law it can do what it's done in other contexts in the f t c essay which is to expressly preempt state law and this has you don't have that here we have examples where congress has said you know what we're concerned with the possible this uniformity that might apply if state laws you know were to come into play here so we will expressly preempt those laws they've done that for medical devices they've done that for non prescription drugs what they have not done though is the same thing for prescription drugs in this context when it comes to genetics labeling here let me so you so if we agreed with you on obstacle preemption we'd still have to look at him possibility preamp correct and so the contention of the other party gen tech is that they would have to get permission from the f d a before they could make any modifications to their process or their label correct and that therefore it fails under him impossibilities preemption right so that that's their argument but it's wrong in several i think quite clear ways the st reason we know it's wrong is they were doing exactly what we say they should have done for a decade before two thousand but i couldn't find anything in the record that tells me what was what they were doing to achieve that result vials declined to take in undertake an investigation to figure out what the problem was that significant foreign possibility preemption because what we know from merck the lesson from the supreme court's recent decision in merck is that number one the defendant bears a demanding burden to prove actual impossibility and that means not just that there's a possibility of an possibility that's not enough what you need to show with clear evidence is the only way you could comply with the state law obligation would be to do something that would violate federal law well i mean let me ask you this in the licensing information that was approved by f d a things are generally in ranges right so on is it your position that they could increase the concentration of trust to use a mob i don't know if i'm saying that right let's call it yes it's your position they can move around within that range without needing permission yes yes exactly right and not only that we know that they have done that before are multiple examples where a particular facility came in under that four hundred and forty eight number and they they fixed the concentration the target fill weight to get it up without needing to go through additional f d a approval there isn't any regulation not only do we not do has jeannette to come forward with with no evidence to to demonstrate that there is only one way for them to comply and that is some specific change that would require f d a approve what about  the testimony of their dana swisher and dr again i mean there's some pretty specific testimony there in that they would have to make some changes that would have to be approved and i didn't see that you other than by saying well i must have been must be able to do something different how did you counter that so two responses your honor the st is that that testimony you can look and you can ask an intact there is nothing specific that swisher identified as requiring a change the reason there's all he said was there the only way to do it would be to go through f d a approval but he did not specify what specific change would be required and why it would require f d a approval and the reason is they don't know they never figured out what the problem was that's number one number two if you read that that declaration of the affidavit what you'll see is is there there characterization of the claims in this case are wrong they say the claims would require us  withdraw for forty then you need to be able to withdraw for forty that's that's that's all that these claims seek to do which is consistent with the way the f d a itself understands this regulation i just want to let me try to make sure  concentration of the drug substance correct so that would be might have to do with well you tell me what you yes of drugs so you can either increase the target drugs drug drug substance concentration and i'll give you a specific example in the appendix that one thousand six hundred and sixty two the singapore facility did exactly that to get up they did not seek f d a approval or you can increase the target feel weight which is how much drug substance goes into the vial and i'll give you an without going through f d a approval well there's also the question of changing manufacturing processes against us or tells us it's going to be really difficult yes but again without any specificity the burden here is on generic to come forward and show with clear evidence that there is no other way for them to comply i make one final point before i'd like to reserve the rest of my time for rebuttal and it's this even if it were true that genetic code it manufacture every vial every single vial that would meet for forty that isn't at itself enough to demonstrate a possibility because the claims in this case are only focused on the vials that are sold to the public so the since of some files that might not meet the standard itself is not enough it's only about the that go out to the to the health care providers in this case and ensuring that those vials themselves can permit withdrawal for forty is entirely consistent with the regulatory scheme and wouldn't require any additional approval with the  mistah you know i'd like to start you out with a question which is there is record evidence that for a period of time whatever was happening was resulting in a extraction level of the drug protein much higher than what was done in the later period and there's no evidence that there was any f d a approval required to make whatever change happen happen isn't that pretty serious evidence that you could go back to what you were doing before without f d a approval your honor that's a great question and thank you i think th i think that the the premise there is that there was some type of change made at one point in time that got us to a different you know average fill at closer to four hundred and forty or at four  reality is that because this me and you factual in process is highly complex fraught with variables at every step of the way we get it that is why the specification is as broad as it was why the f that over time these variables would be more evident as opposed to seeing a long period of time where there was a i would say a flat line but at least a reduction that was consistent your honor i would say that in a process such as this the variables are a change from time to time you can't pin point zero at this point in so replication this variable occurs i mean it is a highly complex scientific process your internal e mails believe that i mean you've gotten e mails where you're discussing how are we going to get to the level of extraction that we want and the methodology is that we're going to fluctuate within the range that was already approved by the f d a and that affects the outcome i mean it and that is something i don't think the district court ever even considered is whether you could fluctuate within that range without and forty the f d a at the time of approval concluded that for forty nominally for forty means for forty plus or minus thirty five dollars because the f d a concluded that that range was necessary and essential for this via logic lifesaving biologic to get to market and to and for genetic to be able to me in fact and for a decade you were on the plus side of that range and now for a decade or whatever it is you're on the minus side of that range and it all indications are that there was a conscious decision to move from this area to this area and it looks like it can be non without f d a approval your honor i think before we can or you can conclude that there was a conscious decision on the part of genetic you have to consider the fact that the f d a reviews regularly and inspects our plants regularly and and determines under c g m piece under regulations that good manufacturing practices are in order and what they look to is if there is any intent on the part of the company to not get to that one hundred percent rate and they concluded over and over again that by targeting four hundred and forty three dollars we are our intent is to try to get as close you satisfy the f d a game over we don't care about anything that could be brought in state litigation to police what the manufacturer is doing i believe in a case like this where you are dealing with  incredibly complex biologic and congress has authorized f d a to approve its own here saying there is an exception for biologic that would not permit us to apply while i am saying that why it shouldn't apply in this particular case because this is a purely commercial case dealing with a the manufacturing process yes of an extremely complex biologic i do not believe that state legislatures or state  s can out expertise the f d a in terms of what is so you're saying that area that the f d a sets not only the floor but also the ceiling yes well that's determined was necessary so you this product we would have to say we would have to agree with you on preemption to agree with you that the f d a sets of a floor to ceiling right i'm sorry i'm not tracking it well that's not what they're arguing is that is what they're arguing under under the in part there a possibility argument rd they're arguing you're going to have variation but they want to go back to where you were mostly at what they what what they are arguing is you're going to have variation but the variation can only be above forty it cannot be below and when i would say is under and that's basically and i guess and they take it one step further and say and that's really not preempted because you can still sell your fear for forty in a bag you just can't sell your your below for forty product and then that is directly contrary to the bartlett case it's basically a c selling argument and it doesn't matter that oh you can see sell that product elsewhere but just  not the state of oklahoma or ever else these cancer clinic what are we to do what do we do with the debate whether this is a solid or liquid drug well my understanding is that that that the plane is argued it was a liquid in the lower core in the that did not raise that issue  appeal but i believe judge perm was correct in in finding that it will in order to to address preemption and whether or not there's an obstacle in the forstmann of state law versus federal law we have to know where to start and to know where to start we need to know what federal regulation applies and that would engender us to know whether it is a liquid or solid your honor her septum is clearly a solid and f d a doesn't think fifteen date there that they're thinking on that change but prior to them they say their thinking didn't change they say that that's always been there and i think that the f d a did their thinking definitely changed as evidenced by the fact that they regulated it approved it and regulated it as a solid drug for up until two thousand and fifteen and then when the guidance became final in addition to that f d a had proposed labeling changes from generic tack in its possession because they they they had they had a stock to still sell so they submitted labeling to the f d a for the one hundred and fifty and the one for forty was part of that you know that there so there were two dosages me two viable aisles and the separate labels submitted together the f d a at that point said change your label to for twenty for the for forty to be consistent with what they were doing with the one hundred and fifty well tossed so accurately reflect what you could actually withdraw from the vile and use with a patient well i now today in the telephone conference made it pretty clear that they did not think the label was accurate and so and so at that point in time gentex followed the f t s directive submitted proposed new labeling which it is be quire to do as we explain under a possibility preemption impassibility preemption argument we could not make that label change without prior f doesn't mean that you can now but you still have to show us don't chew that that would require a change that would require f d a approval to meet it now and i'm wondering where in the record you've established  council suggests that that testimony that you pointed to doesn't really if you get right down into it doesn't really make a point i but i would say your honor that mr swisher is declaration speaks in some detail to the changes to the manufacturing process that would be required he talks about the basically what the plaintiffs but what it is is it's a bell curve we target for forty three dollars there's a lot over here there's a lot of are there by virtue of the process itself w is going to go up we're going to be outside of specification if we go outside of the originally approved specification or if there's a chance we well i should correct that if there's a chance that we make a change we want to make a change issue and there's a series of slides from a scientist at an intact and where she looked at it every which way to determine if they could if they could you know get closer for forty every time and she  you targeted for forty four and stead of for forty three would you move it up but not end up with a whole lot that you couldn't sell i but i'm not as i just i don't know but i assume so i ask to know to prove impossib if they all have the same fill rate require a target they all have the same target but the but where they end up is different they fill at different rates they target for forty three consistently i'm now talking about a different field you know are the briefing in everything is all over the place and what we're talking about i'm i'm looking now on how much you fill the drug product my understanding your honour's that the machinery that ultimate that is used in the  still had the machinery has different they had rations yes thank you different calibrations but they actually have different targets per plant i mean that's in the record i think there is between  is different plant by plant and you didn't need f d a approval to do that right because you could very well within a range no we did need f d a approval to do that your honor because every time we open a plant just very briefly your honour's what you heard there was a classic case of an advocate asking this court to disregard controlling supreme court precedent genetic wants you to rule that f d a approval alone exerts preemptive force but if there's anything that we know about the f t c from while from work it's that f d a approval alone is insufficient to exert preemptive force because congress intended state law to act in tandem with federal law and you don't just have to take the supreme court's word for this court in survey me also made the same exact point the drugs regulatory history the f d a his decision to approve a particular label is not enough to wipe off the table state laws that would even do more than what the federal law floor requires i also think just to respond to your question about the swisher declaration it is entirely  asked specifically where in the record does anybody swisher anyone specifically identify a change that would be the only way to comply with the steel obligations and you didn't get an answer and the reason is because there is nothing in the record this happens lines what about the slide the sides don't actually identify the specific change that would require f d a approval and there's a reason why that's true it's because  corporate officials or investigators did not actually undertake any investigation to determine what the problem actually was without knowing the problem they cannot meet their burden here to show that the only way to fix the problem is t approval when you couple that with the clear evidence of genetics ability to meet this standard going back a decade plus its ability to continue to fix the target fill rate in various facilities you have i think a clear in a clear case of a defense has failed to meet the demanding burden and in the case where demit the defendant has failed to meet that burden and a possibility there is no preemption and you can look at the rd circuit's recent decision in a van dhea which came out after mark for a good  think set of guideposts for how that's supposed to work thank you thank you both for your arguments this morning the case is submitted