commission good morning my name is lloyd smith i am counsel for the appellant belcher pharmaceuticals this is a single issue appeal we're here because the dish acord made a mistake in drawing a black bright line rule against belcher's claims based on mylan laboratories i think it's important to understand this to focus on the brief short reasoning standard packaging issue in this case a sphere is packaging that's at issue the package inserts is far from standard and rd palme wonderful and the cases that follow teach away from the  do agree that mylan isn't binding i can i can i mean i can address that in several ways st and i don't i don't take the facts of my winter the holding of milan actually goes against us when you consider the facts of this case i'll get to that in a nd but obviously as you said it's another circuit it's not binding and and i would hold it may be the most binding or analogous case the th circuit has is the high tech case that was cited by the other side which actually allows a label  that from which they could determine whether or not those claims follow the regulations and were false or misleading so i would point you to high tech the end of high tech in the reasoning there with respect to no conclusion of the label claim there let's plane of cannot bring a lemon that claim merely by pointing to the fact that an unapproved drugs has been put on the market but that a plane of can bring a lot of that claim that the defendant has misled consumers about the drug being approved ok so that's the line that we adopt if we were to adopt that line would you have evidence in the record that would lead you survive summary judgment yes your honor i mean i would say that this case is fairly unique we we actually have indications that that the defendant made some affirmative misrepresentation that the product was approved i would go back tomorrow and talking about standard package labeling right i mean in other words drugs are different this is a highly regulated industry and and we have evidence and surveys that people expect the indications consumers expect the indications to be approved and so i would say by putting those indications on the labels they are representing they have cardiac arrest and prolonging anesthesia indications and you should see in other words in the indications in usage portions of their of their package inserts where they where they list those  are misleading and i think there's a lot of other evidence to prove that they're misleading but i think mylan statement about standard package inserts often used for f d a approved drugs is is instructive enough when when you look at the  mean and since the drugs are understood to be f d a approved certainly i believe that indication showing or there's evidence in the record showing that these indications would be perceived as f d a approved when they when they were as you as you know the mylan itself is not about what's actually in the packaging it's about the the overall approval process which the plaintiffs claimed was improper had been fraudulent right are cases very different we're saying the actual statements in the indications and usage which mylan would refer to as standard package labeling of the type that's often used for f d a approved drugs so there is sort of this base assumption that when you look at  indications in usage it's been approved by the f d a we're saying there are specific statements in there that the f d a has explicitly told the defendants are not accurate and should not be on their labels but we also had outside evidence of this branded pursuant to the f d a regulations we have an expert we have consumer surveys we have internal mylan concerns about using unapproved indications and we also have customer e mail so so there's a lot of evidence in the record in this case that those indications were perceived as f d a approved and were misleading all right if there's no questions i'm just going to move on and hit a few you points that i think are important i think it's important in we've talked about milan and i have to distinguish milan and explained why milan leaves the door open specifically it talks about to state a claim under the land that milan was required to point to some claim or representation that is reasonably clear from the face of defendants advertising or package inserts and we've done that we pointed to explicit statements in the package inserts themselves indications and then also we pointed out the shelf life but i think it's also important remember the purpose of palm wonderful and the role that tom wonderful plays in this area of law wonderful has emphasized the importance certainly followed along on this and i see my time is almost out but there's plenty of district court rulings and points to the importance of allowing try to enforcement actions in context where the little label might be misleading in argument that creates a lose lose situation for a manufacturer like cost you're up in needs to comply with the grandfathering provisions and if it deviates from that label it will lose its grandfathering status and yet is under the grandfathering provisions of the food drug and cosmetic act so the mere fact that the drug is in commerce and hasn't legal doesn't imply anything one way or the other about how the drug  had to have that particular label on it and your argument would be that you can't put drug companies in a catch twenty two dollars if they if they market the drug with a label then they're subject to limit claim if they change the label that it's no the claim in this case is meritless beltran has not identified a single piece where the f d a asked for a manufacturer to keep the drug on the market and that the manufacturer was we are subject food and beverage labeling and the drug context could be different not only because many as many drug labels are preapproved but also because the f d a much more heavily regulate struggling behind than it does through it support the indications on the way he will accept the grandfathering provision is a totally separate maskhadov by which the drug can be distributed and hospital or wasn't all times quickly and hopefully as comprehensively as i can the grandfathering issue is a distraction that was fair didn't argue below that a drug was grandfathered in it's never stablish that it's legally grandfathered it's expert needed they've changed the labels several times and the drug was kicked off the market in two thousand and seventeen a grandfather drug would have had the right to remain on the market so the idea that they had grandfathered status and that somehow gets them out of claim just isn't accurate and for this court to decide on that basis i think you'd have to remain on to the district court about whether or not there has been a determination on whether they were grandfathered or not and allow the parties to  to set forth the arguments and make that determination have you all made an argument that they are not required to include the particular indications on the grandfather i don't think that issues ever been joined i mean certainly would say they are not required to put them in there we haven't approved label for for the very same drug the and we have different indications that we're the ones that the f d a approved so what would give them the right to put separate indications that they guess feel like historically had been on their label even though their expert has testified they change labels every time there's nothing requiring them to keep to keep it that way and there's nothing in the record proving that they were required to keep it that way and as far as them saying they just followed what the f d a told them to do well the f d a told on their indications were inaccurate and so far unsupportable they told them to get approval for their drug right and they knew this in two thousand and twelve and the shortage for the ampules didn't they were instructed to be on the mall market in two thousand and fifteen so i guess it's up to the f d a to explain why  what they expected them to have on their labels in two thousand and fifteen but they certainly never gave them permission any affirmative permission or prove any of their labels to keep on or prove indications on those labels due to a drug shortage  i don't think that's accurate to say that i would point out the reasoning a pom wonderful where the government at the end of the case tried to argue that somehow agency determination on enforcement measures  regulatory measures might create a ceiling on enforcement and the supreme court explicitly rejected that and said that no the lanham act unless the agency has explicitly spoken on a topic and explicitly stated that reasoning and in palm wonderful i think it's important unless your honour's have questions to address briefly the factual arguments that were made at the beginning of opposing counsel's arguments i think opposing counsel was trying to point to pro problems that belcher has with its case even on remand but what i would say that's not accurate we never really appealed a single issue it's about the indications about what's on the label it's about the shelf life and the district court didn't make any findings past the st element of the lanham act whether there was a false or misleading advertisement right and and that was it so the rest of the findings in the record went on to address some of the other some of the other accusations that were that were in the record that the district court just yes but we're here on appeal just about these indications and about the shelf life and about the district court's denial of those  statements as the basis of the lanham act claim only with respect to the st element of the claim itself in fact the district court actually acknowledged that belcher did produce evidence that some consumers  own laundry list of types of evidence that would present evidence of deception they talked about consumer surveys market research expert testimony or other evidence and as i've said before all of that evidence is in the record i know that a spirit takes issue with our survey and they filed a daubert motion to to get it out but there's been no ruling on that davern motion and as as the record stands that survey is good i see that my claims issue thank you thank you