i interrupt you for a home because i'm trying to get my head around all of this statutory and regulatory language and how it all interlocks together one of the issues concerning the processing that is one of their asserted unproven and justification for saying well after seven years we now think that our saying surgical procedure exception means something different than what  a way that is a very interesting  apologies good morning your honor is out and judge for the united states defendants cannot seriously dispute that their biological product which is marketed for the treatment of things like parkinson's disease and macular degeneration is a drug under the a and is adulterated misbranded defendants instead contends that the statute cannot be enforced based on a narrow regulatory exception used for skin grafts an artery bypass and things like that that is applicable if they remov t p and then return it that c t p in the district court correctly found otherwise for three reasons the plain text of the regulation the context structure history and purpose of the regulation and f d a is official considered an expert  view now i just want to begin with the plain text of the regulation which makes clear that this narrow exception is applicable when you remove the cheapies and then implant such c g p's now just as a matter of common sense anyone who observes the creation of the product at issue here would say that what was removed was out of post was fat you'd be standing there in an operating room watching fat be removed from somebody and claim to achieve the defendant's position is essentially that once they have manufactured their final product this stronghold vascular fraction product which by the way contrary to what my friend was just saying is not simply stem cells it's an amalgamation of different kind of cells that exist in the fact tissue that they can somehow step back in time and pick choose whatever combination of cells ended up in the final product in say that that's the particular h t t p being referenced back to and maybe if i could give your honor just a kind of concrete example just to illustrate this point in skin grafting doctors remove skin they may trim it a little bit they may wash a little bit of blood off of it to make it easier to sew back on but then they return skin instead doctors removed the skin and dissolved in an event of acid and then skimmed off some of that liquid and then returned it nobody would say that what they had returned was skin and i think it would be particularly strange just as a taxable matter to say that really what they had removed in the st place was whatever part of the slurry be ended up or injecting and i think maybe to to avoid some of that actual problem i think maybe for the st time at the virtual podium today my friend is basically falling back on an argument that depends not on what such h c t p means but instead on the definition o refers to being intended for employment for implantation transportation or infusion that only by definition the final product is in h t t p and that what was removed was never any t p in the st place and i think that actually just misreads the text if you look at the text that modifier about being intended for implantation is just under the rule of the last antecedent is applicable to the last part of that line in other words the whole point is you know article that contains cells or consists of cells or tissues where removed and just to point out i think both the defendants general position and this sort of definitional position that my friend was stressing at the podium this morning suffer from a kind of absurdity that the government has pointed out a number of times and i've never heard a response to it be the same would it be such yes yes after his position is that it would be such and i think again the skin graft example is a good one when you remove a skin graft you may very well clean something off of it you may very well it i should maybe put a footnote on it and say i don't know what would be involved in your honour's sterilization example so it's always possible that the process of sterilizing when in turn you know kind of fundamentally alter whatever was removed but assuming that it really was just some kind of b cleaning and trimming it would remains in my in my example it's just meant to eliminate any possible impure issues that the doctors or the entity don't want going back into the body yes yes i think that will remain such a key to being you know obviously i'm always read isn't to make any blanket statements on behalf of the f d a particularly you know because of the scientific complexity here and there might be some you know kind of hard anomalous example but ordinarily i think that would position about kind of how to apply this such each c d p term just can't be right and that's especially true then when you zoom out further and realize that this regulatory structure is essentially a three tiered structure where there are a category of items which are subject to less regulation because of reduced risk in contrast to what we have here where it's harder to absolutely no regulation and then just consider the history of this i mean f d a straps that you know its initial proposed approach a and these regulations all the way up to the draft guidance document in the final document the whole question of this is just to capture things where it's pretty clear that the safety concerns the effectiveness concerns are just lives of ordinary surgery and i think my friend just now at the virtual podium was suggesting that the government hasn't put on kind of sufficient evidence to prove that the sort of adverse events that the f d a found that were discussed in the brief were necessarily caused by their product but the question here is an interpretation to regulate ition the question is not to prove that every aspect of an underlying policy applies in a particular case and critically the policy is not the things definitely are dangerous or definitely are going to be contaminated it's simply that they contain the sorts of risks that means that they should be subject to some kind of regulation and to be clear the f d a is position is not that this product definitively could never be used or could never be marketed it's simply that this product is subject to applicable regulation and so for example it can't be adulterated it can't be branded ordinarily that we need to get f d a approval and in fact there are products like the ones that the defendants are selling here that are the subject of pending investigative new drug applications by other doctors and by other companies and what the defendants are essentially trying to do is just to circumvent that entire process and the entire regulatory structure by claiming that this is something like a skin graft that is removed and then returned when in fact what they are doing is is adulterated and misbranded so you know that it's not being properly manufactured it doesn't contain properly beling ordinarily in order to be able to get that proper labeling they would need to have f d a approval obviously that's not specifically ideas you in this case there are you know kind of are various kind of some parts of that regulatory structure but again i think what the defendants are doing is just trying to have be just entire process jan i have a different question for you and my question goes to b p meets the homologous use criteria of section pro seventy one point one and my question there is whether or not there isn't really a material issue of fact in this the district court als as i understand it that the defendants did not qualify for the minimal regulation solely because ok the district court explained in reaching that determination that quote providing the regenerative function in the donor is not the same as restoring not there were material issues of fact in this in this record concerning the terminations whether the s v p meets some obvious use and if that is right also means legal analysis about what to you as the kind of joe needed to function and so just as an initial matter what this report said in that what you know is that you should understand this by looking well i mean i think at bottom the problem is strong to ask your faction it isn't something that really exists in a human body i mean it's just it's her kind of collection of different cells that exist in that that are then kind of put together so it's very difficult to say that for all that secure fashion serves any particular function since really it is this sort of collection of different things in different places in fact i think that ends the government's understanding of life that is the appropriate referen cells you don't look at whether there is any function that overlaps you look at whether all functions overlap and so strong vascular faction even speeds that you can sort of try to figure out when it's when it's you know kind of dispersed throughout that a big chunk of what and i think what they're just report made clear in the body text of its decision is that there is no dispute that the kind of regeneration that goes on if it's during parkinson's disease or during nap generation is the kind of regenerate regeneration that goes on this is my disk getting a little bit confusing why me is the expert when you need to say that the cells are exactly doing that where they are in the joiner immersed in the back and i certainly don't understand him to say for example that cells that are located in not that that is all of what the stem cells to you but even if i'm mistaken then there's an additional legal response and that's the kind of high level generality of argument that we were talking about just a moment ago which is it's not sufficient for the purposes of  just to say that the donated to shoo in the don't eat and where it's donated to you will be engaging in something like regeneration and because at that level of generality every cell foots the bill and that's not really what i'm all  regulation chat and there also has been no showing of any change in research or science that justify this change if they want to do it perhaps they could justify it after research after the comment and the r