reversal of the decision below going to focus with the court's permission on the first issue a brief which is preemption obviously the court agrees with us on preemption there's no need to reach the other issues allergens claim in this case is preempted because in the words of the united states supreme court it exists solely by virtue of the requirements of the food drug and cosmetic act or as of course has also said the court recognized that some state law claims that impose duties that parallel obligations or requirements of the f t c a are preempted law others are not and it set out the test for which side of the line the claims fall upon if the state law claim is predicated on a duty that is a traditional state law obligation which predated the  then the claim can proceed even though counsel isn't a case about medical devices twenty one u s c three sixty k a year something like that right medical devices and as i read that stuff sure provision preempts the state's ability to protect consumer safety which has been a traditional thing that states can do normally your honor that the supreme court expressed i'm right about that do i have the facts right yes or no because i think tell me where i'm wrong the supreme court's decision is explicitly predicated on implied preemption not expressed preemption that's interesting and you know made may be interesting but the statute upon which they were actually dealing has expressed preemption provision is right it does but by the vice president bachmann has nothing to do excuse me or our decision in bachmann had nothing to do with the express preemption clause for medical devices that the issue there was it was a state law claim for personal injury which you can have state law claims for personal injury notwithstanding the express preemption clause that's the metronomic versus war case if the duty which is in the in the case of personal injury the duty to use reasonable care in the production of a product so there's a case where expressed preemption the medtronic case did not bar can hear here is let me just lay out for you what's bothering me or there are sections the very statute that is an issue here which have expressed preemption clauses which we both agreed on medical devices is not the only one and yet when it comes to drugs which is the portion of the statute that were are trying to figure out whether or not to cover the product issue it expressly doesn't have a similar preemption clause that's correct my basic statutory interpretation class and back in law school taught me that when one section of the statute says something and the in jason stent section in the statute doesn't that i'm supposed to imply that it if congress knew and want include preemption in the earlier one it would've actually isn't really court said in bachman as well as very recently in the arizona case that the existence or absence of an express preemption clause should play no role did not intend to to imply if we preempt the state law because of actions so what the court said in buchman is look we understand that states have certain historic police policing  consumer safety is there is so why doesn't this fall we wouldn't need section of the supreme court isn't knowledge for causes of action brought on what are things the states are traditionally free to regulate ok so that that's the rub of the issue  its claim predicated on state common law deception or misrepresentation but to quote allegan arises purely as a result of athena's failure to obtain a new drug application which is strictly see a obligation and they say again this is a pages four nine eight and five hundred of the appendix it's a claim it's a case of pure statutory violation predicated on the absence of an approved new drug raploch a sion that is not a state law or duty that predates or exists independently of the f t c a it is strictly it exists solely because of or by virtue of the f t c acts and that's why it's preemptive now congress would you agree that congress gave glory to the states to enact even identical laws in this area the identity test  comes from did they give authority to the states to enact laws no there's no clause the express preemption clause that judge moore was referring to in the medical device area and there's one in the food area as well says no state may enact any non identical law but those are those have nothing to do with the drug provisions the drug aspects of the statute are silent as to what states may or may not do  except in so far as section three thirty seven a of the statute says quite explicitly that any proceeding to enforce the requirements of the f t c a can only be brought in the name of the united states no state can do that the only exception in the in three thirty seven is three thirty seven b which is a limited exception for food mislabeling allocation let's try to little differently or if congress has given them the authority to  act laws even identical laws in this area wouldn't they also have the right to have a remedy for those if congress had done that i would agree with with your honor but congress explicitly in three thirty seven so back to the point the judge moore made a moment ago that at least on the face of the statute there's no express preemption is there there were not we don't contend that there is express preemption there's implied preemption which is a little hard to deal with when you've got express pre emption right next door in the in the medical device there but there's no question your honor that there is an implied preemption or can be in drug cases there should be no distinction between the two the issue is whether the provision of a state law claim or allowance of a state law claim would exert an extraneous pull on the force and scheme that congress intended and the enforcement scheme here for violations of the f t c a requirement to obtain a new drug application also a drug under the provisions of the act and that turns on a regulatory judgment call now you hear the california supreme court as you know looked at this and the salmon cases the farmed salmon cases yes  quite expressively that congress gave authority for them to act even to enact even identical law right because they were looking at two pieces of statutory text that are absent here the express preemption clause which we discussed a moment ago that says states may not enact anything that's not identical to the provisions of the f t c as food is concerned this california supreme court read that to say well that by negative implication they can enact identical clauses and identical laws and in addition there's a second piece of text which is a saving clause which explicitly says anything not expressly preemptive is preserved that is not present in the in the drug area to overdress just briefly the jurisdictional question in this case for the contention which arose only after the court issued a request for additional br the thing was that because there had s patent claims divest jurisdiction only if the parties are left in the same legal position that they would have been had by virtue of the dismissal had the patent claims never been brought and we don't have that here in with respect to patents the zero two nine and four zero four patents there are district court rulings that revocable ian permanently affect the rights of the parties claim construction and in one case a company not to sue which was the basis for a development of standpoint of the co though that's kind of a private agreement between the parties rights you reach an agreement on a claim construction but the court from its standpoint there's no change in your legal obligation to see each other right well clearly as far as the courts concerned one patent the of tonight that is out of the case by virtue of the covenant not to sue and on that basis it's granted a  dismissal but as far as the claim construction ruling that the motion that the parties made said that they reached a private agreement and pursuant to that agreement we'd like the court to dismiss the case and the court granted that motion the court was fully informed fact the court  the record reflects invited such a stipulation between the parties and then signed off on it so there's no trying to pull a fast one on the district court here everybody knew exactly what was happening below and those rulings will go back into effect if but this is a heavily fact based determination whether a particular product should be classified as a drug or a cosmetic it's really a job for the f d a to do but if anybody is going to do it you have to start with the labeling and advertising for the product and in this case all of the labeling in advertising since two thousand and seven has made cosmetic only claims this product will make your eyelashes look better make them appear more elegans argument we contend that there are also facts that support athena's argument that's why we need to try that the law is quite clear that the the most important information the most important evidence for a court to consider is the labeling in advertising for the drug these are classic cosmetic claims that they can nibble around the edges and say well you know one of your own authorized resellers said something that's consistent with a drug claim or you still have some reference to a clinical conditioners for years thereafter and has taken no action against athena which we contend gives rise to a very strong inference that the f d a views the product as a cosmetic not a drug which is a factor  cosmetic when you automatically then be subject to f e m a requirements doesn't f d a review cosmetics well well no they don't so if someone wants to sell a cosmetic it doesn't need to go to the f d a and seek  any pre approval or pre clearance that just goes ahead and does it and the f d a is only way of indicating its approval is through silence which is effectively what has happened here but you have a chemical that grows eyelashes right  can take the exact same ingredients these essential oils put them in scope mouthwash it's marketed to fresh and breath that's a cosmetic claim f d a regulates that as a cosmetic take the exact same stuff put in a different bottle antiseptic mouthwash kills bacteria prevents ginger virus removes plaque that's a drug same exact and there are countless examples of this so the fact that a particular skin moisturizers if it's market i don't care claims there are advance for the product in the marketplace not what it actually does recognizing that there are substances that can can meet both definitions at the same time and the product gets classified based upon two thousand and seven probably went over the line they were there were efforts to stay on the right side the line but the advice wasn't great and they probably went over the line the regulators step then both the california state regulators and the f d a stepped in required its authorized resellers to refrain from any drug or hair growth or eyelash growth claims did many things to bring its product into compliance with these regulations and the regulators backed off  conclusion the court draws from that on the next page it's silence on this issue coupled with a certain awareness of the problems of state court that a geisha ins is powerful evidence that congress did not intend at the oversight to be the exclusive means of ensuring to us that our court didn't have jurisdiction over this case do you continue to believe that that's the case we do your honor after we looked at it when the court issued its order let me address the to pat what about that no no sir i think you're mistaken there are two patents in this case look at the complaint how preemption question we have wired since we were in the prescription drug context we have no expressed preemption we have only implied preemption we have the test that the supreme court has announced in those cases is whether preemption purposes under the prescription drug part of the f t c and i should add here that if we get more on your earlier question regarding the structure of the statute the wire our court also pointed out that the savings clauses that congress is included in the prescription drug amendment section two hundred two to the one hundred sixty two amendments in section three seventy nine are which goes to non prescription drugs over the counter drugs evidence is congress's understanding that parallel state regulations and you should read  a case which involved an unfair trade practices claim very like the california unfair competition a lot claim in this case so that was sort of the genesis of that to return the depleted and what the test is for preemption here bucket and this is another quote page twenty five eighty one of the strippers been when a party cannot satisfy its state duties without the federal government special permission assistance which is dependent on the exercise of judgment by a certain limited jurisdiction and under hackler vs cheney the court can draw any inference from agency inaction in the prosecutorial space second and i think more importantly actually this judgment very well publicized very well known to have the a has been on the books for a long time now and we've heard no displeasure from f d a that it disagrees with the finding or with the proceedings as a matter of state law in other words there has been no suggestion from an f d a that it disagrees suggested that it's going to now investigate and hold them to a standard by which they have to pass the new drug application everything had chosen to enforce that is that it hasn't done anything or make your own heard and it court based on california state unfair competition ma preclude the sale of products beyond the boundaries of california your honor the question under california law and this is a california state claim is whether the the effects of the conduct  felt in california by a california resident they can complain about them this is the unfair competition lots of it is unfair trade practices that you have that injunction prevented sales and there there was a sale within the injunction and there's a reason that this came about this was not out of the blue in judge moore to go to your question specifically how can a court do this we had in this case a real world test of the effectiveness of a more limited injunction athena voluntarily said we will stop selling these products in california when it became clear after the summer a judge ruling that they had a drug they supposedly changed their web site and so forth we went out and proved and there's an extensive affidavit hundreds of exhibits in the record  that cited in our brief that showed that people were able to continue purchasing the product in california in every sale in california farms allergy and the district judge made a specific finding in the record that there was no practical way to stop the harm in california without a joining of the in a outside of other sales because of athena's own inability to do it in other words this was a guess by the district judge athena had the opportunity to show that it had ability to comply with more  d and it totally failed and there's an extensive factual record on this and they put in nothing in opposition and the said the district judge judge selma made factual findings on this that and every sale by the way this is a very limited market but t is the only approved product to grow eyelashes every product they sell takes a sail away from addiction and that it's that you can't with no one else are competing with other than the other snake oil dealers ok no that's right because their product is sold at a much lower cost than yours and finally think it's actually quite economically correct for you to argue that every last sale or everything else there's a lot you can lot of people wouldn't pay that much higher price or go to the doctor and get a prescription but  is about thirty percent premium or honor their product is still very you know the hundred dollars or so for a two milliliter bottle they're competing at the same be going to the doctor get a prescription for years you know i mean there's a lot more involved that you know you can't preemption point because the other aspect of this test and future greatest goes to your question whether states can adopt parallel or identical state laws well that well that does have a tinge of expressed preemption the regal and lower cases both make clear that violation with respect to new drug application and is there that we disagree it is there that we disagree on the facts and on the law and i would like to point the court to california health and safety code section one one five five zero which is the statute that the district court found to have been violated by the receptors and that prohibits the introduction of a new drug in the commerce and we can talk of you'd like about why this is a new drug but i think your earlier questions  regulatory approval from the california department of health services so that the athena can satisfy this state law without ever talking to f d a without ever sending a letter to f d a without ever going to washington f d a they shut down they still are violating this law because california is not shut down and they have not gone to the california department of health services under one one five five zero be as would be required in terms of whether or not this is a drug because it's been a difficult issue in the case for me quite frankly the summary judgment i want to factual question like this when there is some competing evidence to the contrary in this case makes it a little bit harder said tell me why we it is ultimately a question of fact and here the facts were absolute disputed or let's start with the labeling the first product they put on the market or the labels a formula lash grow why is that relevant if you're going to start to cite to us a good many facts which go into your favor and then we heard mr zealous and tell us well there are facts that go the other way how do you deal with george morris question that this is summary judgment and we shouldn't stay one step ahead of the sheriff says it works better than the last one so they're building on this installed base of a new drug but then what this is less than actually say was the was the disputed fact he said the new the current labeling makes eyelashes quote look and quote appear that i was the only thing you said today in the court as being conflicting evidence and it is certainly true your honor that the current labeling says that but the court doesn't have to ignore the world how is a clear liquid applied by drops to the skin at night makes flashes look or appear longer and thicker the answer to that is the district court found mr lesson just admitted as the inventor admitted is because it actually makes them grow it contains approached the gland in analog is recognized by everyone in the field to c this case the test is objective intent it seems to be what they intend to sell it as are they intending to sell it as a cosmetic or they intending to sell it as a drug the question unfortunately at the bottom of the inquiry isn't what i t isn't a cosmetic resident judge a drug right now that are part of found it confusing and difficult to wrap my hands around certain is that i don't i'm not supposed to focus on what the product truly is but rather how they're selling it and marketing attempt to answer them first the court can't proceed nor with the product is if i put cocaine in a tin and call it face powder it's still cocaine ok it is still a drug in the in the absolute physical properties going to be ignored second they don't have to intend to sell it as a drug look at the statute what it is is use here dictate whether it's a drug or you're out or consumer use used in both ways which is you know it can be both but if it's a drug it is regular bill and therefore consumers use it as a drug that is put it on their eyes at night as instructed so that it grows their hair it's a drug and to answer your question just more the intent is not whether it's a drug but whether it is intended to affect the because they will be longer in dick or they in ten people to put the little drops of clearly quit on their eyelashes before they go to bed so it after three weeks they start to grow and if you stop using these products they will shrink and  supply you buy drugs in a three month supply and the intent conveyed in the labeling from the formula last grow and then we've got all of this externalities they sell it through this network of eleven thousand internet resellers and they've got testimonials on these web sites about daddy longlegs lashes my lashes grew out hit my eyelashes all of which is conveying to the consumer base precisely what this seller intends which is what this product does which is mak to some cosmetic like yes or no reason i ask is because a minute ago you said this could well be cosmetic but it's also a drug and it seems to me that if my recollection is correct that the f d a preempts a lot of claims involving cosmetics  california law and under federal law but more importantly in a culture this place under california law if it's a drug then the california department of health and safety requirements kick in so that if it simultaneously is not it's not circular at all even if it's if it's if it's a drug  this application is a nine you need for the instructions for the product direct the consumer to apply it at night before bedtime and interestingly the active ingredient in this product they have filed a patent application with the it usually hall that we're in a different city today the patent application says the disk product applied at night by drops will cause hair to grow so there's no question about what their intent is for the product to do and you get a clear liquid  it's not a miscarriage type product it's not a darkening product it's not taking products it's a medium for getting approached to go into an analogue into your hair follicles so that the chemical operation of that  molecule will actually cause your character to grow that is a drug that is a drug and or federal law it is also a drug under california law and under california law they were required to get a new drug application approved either by is because it was a traditional state bar claim for failure to warn you know it's a i think we understand him some are pretty well but i really the record here is a little more difficult for me when you tell me what your very best facts are that you think creates a genuine issue that should have precluded summary judgment sure start with the labeling and advertising which since two thousand and seven has consistently and unwaveringly made only cosmetic claims that will help the look in appearance of eyelashes tho es the appearance or luck of being full or thick or just like mascara the exact same claims you would find i was scared it's ok to put it on in the morning your honor with respect to that point judge moore referred to these skin cream anti prevent anti is anti aging or anti wrinkle f d a considers that a drug if you say it it leaves your skin feeling moist and supple and looking that way it's a cosmetic whether you put it on at night or in the morning or in the middle of the day  of discretion if it's contrary to law and here the california supreme court in sullivan said that the u c l california consumer protection laws have no extra territorial application so by law they cannot support those laws cannot support an injunction outside california with respect to the question about the ability to control the flow of the product into california mr perry is right and freedom made a voluntary under taking after the summary judgment rulin came down there was a hotly disputed issue in the district court as to whether they were living up to that undertaking or not the district court made no finding on that issue didn't resolve anything and simply made what i made a one sentence assertion that it would be easy to evade the injunction unless unless it prohibited sale in maine and puerto rico and florida in new york it would be easy to evade the injunction against sale in california there's no support for that there's no finding that supports that and it's improper like make just one other point mr perry argued that california has a separate machinery or or regulatory mechanism for submitting an application for new drug approval and so this idea that our claim arises under or exists solely by virtue of the f t c a is wrong the evidence in this case is undisputed and separate two to the weight of the record that california has never approved  new drug application and has no ability to do so it has no department that does that every single drug that's ever been sold in the state of california as been sold there by virtue of f d a approval this is a complete fiction