are preempted by the federal medical device amendment mr taylor has standing to make the same claim because on its face florida's law requiring mandatory exams applies to anyone regardless of whether they are license or not the statute clearly says that failing to comply with any provision of the chapter subject somebody to discipline the state relies on a discretionary regulation which allows the board to issue a citation in lieu of other disciplinary procedures and it then says that citations may only be given to licensees but we know that's not true because the board itself issued mr taylor a citation after he had given up his li it's clear that not license to use can be issued citations and mr taylor is subject to penalty for not providing an exam if you choose to do so in the future even if the court does not think that he can be fined right now for failing to provide an exam we think he still has standing for two reasons one is that we do not believe that the licensure provision is sever both from that presale exam requirement the licensure law is entirely wrapped up with that presale exam requirement in contains myriad other provisions which essentially revolve around and incorporate that same requirement when somebody is lysis do they have to certify that they know what themselves require licensees to abide by his record there is nothing on this record to substantiate your point that when you get a license you somehow agree to be bound by all these terms and conditions well if you're asking if that point doesn't a question whether she subject to the exam requirement once he becomes license i don't think the state disputes that it says that though that the mandatory exam acquirement is mandatory oh you were just saying that they're tied together and i'm just trying to see how closely they were tied together i see i think they're tied together because for example in other parts of the statute there are requirements to make certain disclosures at the time of the exam there is a medical clearance requirement other way or in the statue other place that requires dispensers when they are performing an exam to make if they see any sort of red flag to to stop the examine say that the person has to go see a doctor so there are a lot of other provisions of the statute which assume that an exam is being given so it's not as if the court can simply excise the exam requirement and leave in place a comprehensible statute that we can be sure the legislature  enacted absent a mandatory exam i think the statute starts to fall apart because so many of the other provisions revolve around that exam acquirement the continuing education requirements the training requirements help me underst include when the department is probable cause to believe that any person not licensed by the department has violated any provision of this chapter or any statute or any rule the department may issue a cease and desist notice such a violation and b the department may impose an administrative penalty not to exceed five thousand dollars per incident is it your view that that statute covers your client for the on license practice not only that but there are specific regulations that the board itself has promulgated so those the board itself ha cited some of those rights but i just want to start with the statute itself that's why i think the statute imposes a requirement in certain penalties on on anybody who either sells or  without providing an exam sometimes judges ask a favorable question rather than one that would you would have to dispute i thought it was pretty reasonable and therefore he would have standing that's absolutely right and i think that's a fair inference from the complaint because the complaint states that the only reason he gave up that license was because of the presale exam requirement and he obviously wants to continue dispensing hearing aids absolutely that is only a way of earning a living i would suggest if my brother agree that we get on to the merits excellent moving on to the merits as i said  the question agrees that these exams are preempted the f d a itself has said that it's clear that these requirements are in addition to what's required by federal  law the only argument the government makes in contrary to that is that there is no specific and now i guess provision in the medical device amendments relating to and that is the law is it not  says that there is an express preemption statement and an implied preemption doctrine and this the court can apply imply preemption in addition to any sort of express preemption statement so i don't think that implied preemption now over rules the express preemption statement that the supreme court has affirmed in other cases did not the supreme court in lower require that  requirement the medical device moments that applies to all medical devices and specific is only taken down to the level of the particular device and so long as there is a requirement a political to a particular device that is  enough to preempt all other state laws that are in addition to anything listed there and the have to do with safety and effectiveness so i don't think there has to be something analogous and we know that's true because the state does not argue that audiological exams are not preempted it at mit's that ideological exams are preempted and there's no equivalent in the medical device amendments having to do with audiological exams it simply distinguishes between audio logical exams which are performed by a license license before selling or hearing your client didn't form the district court's that it was not preempted because of the exception or exemption in the statute and end of that why isn't the right on that the lose on that for the reason just as simple as that you know we do not dispute that the state could enact a licensing requirement but that licensing requirement cannot embed within it preempted preempt the state licensing requirements expressly and explicitly the state of florida in this case had a licensing requirement and that's different from the other this was all decided on a motion to dismiss and we think that we have possibly alleged that we that they are not separable and that's because as i said there are so many other provisions within the statute including the definition of being a hearing aid dispenser itself specific regulation dealing with allowing a state to impose a mail order ban no your honor but again we don't think that that's necessary because  said the government does not dispute that for example audiological exams are preempted and there is no counter not no analogous i guess what i'm getting to with my question is i think  to add sort of this blanket exemption from the preemption provisions when the statute itself weeds in a different way because here is a law that up to about twenty one and sixty k the statute itself it says general rule except as provided in be no state or political subdivision may establish or continue in effect with respect to a device for human use which is different from or in a dish into any requirement applicable under this chapter and which relates to safety be the exemption requirements a upon application of a state or a political subdivision the secretary may by regulation promulgated after notice and hearing exempt from section a under such conditions as may be prescribed a requirement blah blah blah if the requirement is more stringent than etc but it seems to me what the secretary has done and maybe i misunderstood this is issue sort of a blanket exception without kata finding specifically they certainly do with respect to licensing but did they do that with respect to everything else and if the answer is no did they act beyond their power in the problem of getting eight hundred and eight point one if you follow the thrust of my question i do i'm just concerned that they didn't just promulgated specific exceptions or exemptions they then promulgated a general exception or exemption and i don't know that that's  specifically want to use the words it did in three hundred and sixty eight well i think if anything that weighs in our favor because it means that f d a has has exempted a bunch of things that it shouldn't have and that that the express preemption statement in the statute is actually broader than the take f d a is taken by by probably getting this blanket exemption for certain oh yes the net result of what i'm asking about is it's an argument you did make but if it's right you would win anyway or if already four or five for i agree i think that's right pardon yes it's i think i think those regulations tend to show and they both star case because they show that f d a considers class one devices including hearing aids to be minimally a danger to public health there they're trying to loosen up restrictions on hearing aids in order to make them better accessible in order to acknowledge new technology and they realize that they don't they just the biggest threat to public health is not getting a physical exam by a doctor and they don't even require that so i think it just supports the our interpretation will the regulations are non effective yet correct for over the counter regulations are not effective yet but they deal only with what we in effect know nothing yele them told us anything about that that's right does this case involve the challenge to the constitutionality of twenty one dollars c f r eight  fined five thousand bucks for acting without a license and if the answer is yes then it seems to me is injury would be direct and immediate and he would most assuredly have standing what's wrong with what i'm saying so that's correct for the licensing requirement your honor it's the state's position that mr taylor has standing to challenge the licensing requirement however as a district court held he lacks standing to directly challenge the presale fitting requirement so the state under the provision you cited for fifty six sixty five can enforce against an individual for then license sale of hearing aids but the state cannot enforce against unlicensed individuals failure to comply with the pre sale fitting required so mr taylor if he started selling hearing aids today he could not be penalized for violating the presale fitting requirement only the licensing requirement and so in pre enforcement done and they aren't limited to licensees at all and then goes on to say that the duly authorized officers cannot expand them so i mean i don't see that i refer to only licensees in hearing aid specialists for example in subsection five b your honor and let me let me pull this up so in five d it says at the time of the initial examination for the fitting and three and four require the way that you do fittings in the way that you do testing none of that is said none of that is limited to licensees and so on then at the very on seven there is a broad statement that the board can adapt and adopt an enforced rules and those have been expanded so i just don't think it's a rio correct reading that that everything is conditioned upon being a licensee i also point the court your honor to the enforcement provisions which in within chapter four hundred and eighty four dollars so there's the provision that sets forth the requirement that you need to have a license that's forty four fifty three and that says any person that engages in unlicensed sale can be penalize that provision however does not mention penalties for the fitting requirement in contrast the provision stating that disciplinary action that can be taken against licensees does mention the course of the problem that i see with that is for eighty four or five hundred and sixty one says the following acts constitute grounds for denial of a license or disciplinary action w violating any provision of this chapter that's correct and your honor disciplinary action refers to the board taking action against the licensee either revoking the license or requiring them to engage in continuing education so it's the state position that only the board can enforce that fitting requirement in the board jurisdiction is limited to licensees your honor i didn't mean to take it too far on the merits and i think it would help me to go right to the merits yes your honor so in smith v pingree the old th considered a challenge to one of florida's pre sale fitting requirements the room requirement that the fittings take place in a particular type or room and in reaching that conclusion the court held and one point four two one does not address fitting and so therefore it's not a federal counterpart for force feeding regulations and that is on point precedent that mr taylor has not made a showing that we cannot have that we need to set aside the prior panel precedent rule and ignore his attack on pingree fails for two reasons of his attack is that engaged in implied preemption analysis which was improper and it's been abrogate d over time but st under the prior panel precedent rule even if a decision of this court is at odds with the reasoning of a later supreme court opinion this court has held that that's not sufficient the prior panel decision stand so his argument on its face is not sufficient to set aside this court's decision but get into the substance of the argument in express preemption cases the analysis to determine the scope of preemption is dictated by the statu so and in this case section three hundred and sixty k requires an analysis that work that courts look at federal counterparts or specific federal requirements to see if the state regulation is different than or in addition to that looks in some ways like conflict or field d preemption analysis you've got to look to see if there's a federal regulation addressing the same subject matter and so if pingree leaned on implied preemption principles that doesn't necessarily make it with the statute the statute dictates an analysis that looks at the federal regulations and so this gets to a basic was more than do thing different or additional to it also says and it pas relate to safety ineffectiveness best correct your honor but it's ours it's the state's position that the different or addition to language is dispositive in pingree got it right and during the justice stephen states that you need to do a careful comparison of a federal regulation in the state requirement under the m t a to assess whether indeed the federal requirement is a federal counterpart and this also under a requiring a federal counterpart to preempt a state requirement and that reading even looking beyond pain free is fully consistent with this court's approach and broader jurisprudence related to preemption this court has recognized that there's a strong presumption against preemption and that applies even when the court has interpreted the scope of an express preemption provision and so the court needs a narrowly interpret the scope in order to make sure state sovereignty is respected do you agree with the steven made by the appellants lawyer that that the constitutionality and the enforceability of the regulations the c f r regs are not at issue here correct here are they have not been challenged and so setting aside the regs would not be possible because they have not been challenged as you state this is general exemption you can do it that way and anything would go you don't have to specifically codified i so i think it's one thing says easy for me because you've got a specific provision in there but can they throw up a blanket rule this way for everything else i don't want to answer to me is that's an interesting question it's academic they never raised it never briefed it never argued it and it was never ruled out and that's absolutely correct but i'm just curious so that strikes me that they've got a general rule here that swallows up the statute i agree that it's not an issue here but your honor i don't see it as a general rule this was at the statute this statute requires that in order to trigger preemption there needs to be a requirement that's different than or in addition to a federal requirement and so the statute or the regulation is inter breeding that in saying that means there needs to be a federal counterpart that the state is different than or in addition to so it goes back to this idea of subject matter can grow and so in lower for example and in regal verse medtronic the court was looking at whether specific federal requirements addressing design labeling and manufacturing preempted state tort claims addressing design labeling and manufacturing those have subject matter concur concurrence and so the supreme court said yeah there is preemption here at least in riegle they did so and so i think that the regulation is fully consistent with how the court has interpreted the text of section three hundred and sixty dollars k if so it's not giving just carte blanche to the f d a in and i wouldn't i would see it as a general preemption regulation your honor the supreme court in lower there clearly a plaid the same regulation that we are considering  was the authority of agency to promulgate that regulation challenge in low are the weight of the regulation was contested in the lower i believe your honor i'd have to double check that but that pinion did discuss the regulation and afford it significant weight notably though in the later decision in rigo v medtronic as well the court said we don't even need to rely on the regulation because there is a need for a specific federal counterpart court retreated from the regulation a bit in regal but nonetheless this court does not need to rely on the regulation because  obviously there's nothing that's abrogated it and to further illustrate that smith the painter is on point if this court were to hold otherwise now in mind that mr taylor has stated that  k we now must compare the federal regulation to the the challenge state regulation that is expressed preemption now so that the difference between express preemption implied preemption now says that its core is an express preemption you have congressional intent that there needs to be preemption and then you assess the scope of preemption but implied preemption now says there is no congressional intent and so you discern congressional intent through field or conflict analysis  a regulation section eight hundred and one point four two one and it was excuse it was in analyzing the same florida regulations addressing minimal procedures for the purpose of fitting and judge anderson had a point a question about the differences between medical evaluations and the fitting process and noted that they seem very different so pingree is dispositive on that point because it distinguished medical evaluations from fitting dispensing a hearing aid the st step in the process is a medical evaluation to identify the cause of someone's hearing issues and that's performed by a physician and the point of that is that make sure that somebody just doesn't get a hearing have hearing issues to actually identify if there's an underlying issue that they have a that can be addressed through other treatment later in the process after the visit has said you're a good candidate for a hearing aid they go to a hearing aid dispenser and the hearing aid dispenser needs to fit that hearing aid make sure it's programmed to properly and it consistent with the individual's hearing loss in needs and that requires some testing but there are two distinct parts of the process no different than labeling in manufacturing are th initially candidate evaluation and then the fitting and dispensing piece of this and so your honors even if the court gets to the merits pingree disposes of most of mr taylor's claims because i take his argument to this court in the briefing and today in oral argument that most of the his arguments are that the licensing requirement in the mail order banning bootstrap the fitting requirement but there's nothing wrong with the fitting requirement those challenges fail on the merits and so the court has a couple of ways to dispose of this matter no standing to directly challenge the fitting requirement and then say that the presale fitting requirement nonetheless is not preempted so the licensing and mail order being a challenge fail and also if he raises an independent challenge the mail order ban that fails because there is no federal counterpart but if the court does get to the merits as one final point you we'd asked that the court the proper disposition in that circumstance would be to send it back down with instruction to dismiss with prejudice since the district court didn't address one of the issues due to standing which means a dismissal without prejudice what is the impact of the two hundred and seventeen at there is no impact at this point your honor because there is as no binding effect and so there's no role for that or impact on this matter your hon honor of course pingree relies on implied preemption in that's clear from the text where it's going through whether congress has chosen to occupy a field this is implied preemption language and that explains exactly why pingree was wrong knock it over and we would be we would be obliged to follow it so you've got to establish that it's abrogated to the point of you know the hollow shell has been the e the way there's just not been there can you say that about pingree your honor we can because under express preemption pingree comes out differently let's take a regal and more for example when they decide whether there is a specific federal counterpart in the medical device amendments and they don't require an actual analogous thing when they make the distinction between specific and general they only take that to the level of whether there is an f a requirement that applies to all medical devices or whether there's been something promulgated with regards to a specific device and so under that standard you don't need an analogous f d a provision pingree said well there's nothing in alley guest so so states can fill in the rest of the statute and that's just clearly wrong under supreme court precedent i think i think subsequent cases do get it entirely not only in the standard but also in the reasoning and the how come the only other point i'll make is that new jersey had new jersey itself after the new jersey supreme court said that the analogous exam requirement was preempted new jersey applied for a waiver from f d a and again f d a said in fact the same exact identical thing that we challenge here in florida law is preempted so f d a agrees audio metric exams in addition daddio logical exams are preempted by the medical device momen