this is an appeal from a criminal conviction out of the northern district of ohio mr burnett dari she was convicted of distributing controlled substances  darcy is a license pharmacist he had an internet business which was relying upon what was known in the industry as medical records based prescriptions  were writing unbelievable numbers since right i would disagree with that point your honor this was certainly there because this was an internet business there were large numbers of prescriptions being written if you just look at the numbers but i mean if you look at the number of prescriptions being written but when you consider the market area you know it's it's not an unusual amount the business model was designed to be convenient for people most of the prescriptions were for pain medications the doctors in question would have medical records showing that a person could have a chronic pain condition  you know every month or every few months they need their prescription refilled and it was up to the doctor to make sure that one of the wasn't want to find things that these prescriptions were not fact adequately supported by a real doctor patient relationship where there are two and that goes to you know our first basically three issues of the appeal there are two issues to look at here with the standard of care placed on the physician the prescription must be issued for a legitimate medical condition by a license practitioner in the usual course of their practice mr d as a pharmacy has has a slightly different standard of care he cannot knowingly issue a prescription that was not written within the usual course of practice at trial going to the element of knowledge the primary foundation for the whole case that the government had was that this business model of medical records based prescription writing was fundamentally flawed because there was no face to face meeting between the doctor and the patient mr di she looked into that issue and was able to determine that it was not in fact illegal at the time it's not just that he had a mistake but sixty percent of the jurisdictions that it's a number i drew derive from the government's brief sixty percent of the states had no no rule against telephone consultations with the doctor to get a prescription and the nature and structure of the controlled substances act is such that congress didn't want to impose you know not being medical practitioners they didn't want to impose their view of what is proper medical practice upon practitioners and the states so they adopted the standard that i reviewed earlier and it's basically state set state by state by medical board subject to congress coming in and having authority to issue specific uniform rules if they choose to do so in terms of a face to face consultation being required congress alternately did choose to impose that standard because they didn't like the inconsistency is that the state had  that is the right hate online pharmacy act which was not passed until after all of the conduct of ledged in this complaint you think congress i'm stand this is an extensive record but when i look through the record and when i look through the citations that the government cited in their brief when they talk about things like park rover being one of the people that applied for a prescription for his excessive barking or ron burgundy being one of the doctors these were not e mails that mr darcy had in his possession i don't see any indication that he had that was us meds and apparently one of the doctors there  her office wasn't was reviewing medical was revealing prescriptions but she wasn't having doctors review this prescriptions she had her sister and someone else who had there were even registered nurses who were doing the face the phone consultations mr didn't know about that what was the foundation to argue that mr di she knew that these records were that these prescriptions were issued outside of the usual course of medical practice looking through the record is that he knew they were not having face to face meetings that he knew that they were you know patients were not in the same state as some of the doctors who were writing the prescriptions but that knowledge that mr daschle had was knowledge of a practice that was no that illegal in our brief we say guns out was versus oregon that was a case where the department of justice to it and ministry to rule argued that  assisted suicide medications are per se outside the usual and customary course of medical practice in the supreme court said that they can't make that determination by administrative role if anyone would have to do it it would have to be congress and obviously because of the ex post facto law that couldn't be retroactive what the government did here is through an indictment they made the practice of having a face to face meeting a requirement that did not exist that sixty percent of jurisdictions the state's allowed and then they impose that standard on mr daschle through this indictment and through this jury verdict now and i can certainly say that without that reference that other evidence isn't present that mr di she possibly could have been convicted anyways because you're saying sixty percent of the states had no rule against telephone conversations but that client was issuing these medications to people from those forty percent of the states or did he limit his sending prescriptions out to the sixty percent of the states didn't prohibit this you know i don't know on the record about patients in other states what i do know is one of the main doctors dr fernandes where she was did not have that requirement and florida did not have that requirement and i would give the analogy if a patient lives in ohio and they have a doctor in kentucky because they're right on the border if they go to kentucky to get a prescription and they go to kentucky for their doctor what matters is where the doctor is not where the patient ultimately resides here instead of using a vehicle they're using the internet to contact a doctor if the doctor who's writing the prescription if it was it within the accepted usual and customary course of the medical practice of the state where that doctor is then it doesn't matter where the patient is were all of the doctors in states that allowed telephone communications with patients and no face to face i believe  so unfortunately i do have to concede that this is a lengthy record and i didn't do the trial so i can't say that a hundred percent certainty but i do believe that is the case now the sort there were doctors that were convicted and that's correct if they were doing it legally in the states why would they be convicted while looking at some of the doctors as for example d sister i believe and another person who were making phone calls she knew they were medical professionals she knew they were doing that and also a lot of the doctors they knew they didn't actually have the medical records but they are under a different standard because they're the ones actually writing the prescription mr darawshe the standard is whether he knowingly filled those prescriptions or filled those prescriptions knowing that those doctors had issued them outside of the usual course of the medical practice all mr darcy knew was that there were face to face meetings these other doctors they knew a lot more you know they knew that they didn't have good medical records they knew that they had people who weren't licensed medical professionals doing the consultations but they weren't providing this information to mr and in fact mr di actually had an extensive practice of trying to follow up and determine if these doctors weren't back fulfilling their obligation which is part of what he's required to do but he can't you know his he has a duty to be vigilant he doesn't have a duty to be perfect if there are concealing from him that nine licensed medical professionals are doing the reviews or that they don't even actually have medical records when they say that they do he doesn't know that and that's the standard here it's knowingly and that is the problem with this face to face meeting mr darcy never denied that he knew these were telephone consultations so by to determine whether or not that was illegal and he got an advice from an attorney that that that wasn't illegal that that particular aspect of the practice was not illegal and i understand that there's more to it that the doctors were doing that the records that had but in this particular case for this particular defendant were looking what mr darshini and the problematic part of the of the government's case of using this face to face meeting as an automatic violation or as a violation of the usual course of medical practice is you know they're using they're letting a jury as a matter of fact decide what the legal standard in this and of course there's always questions where you have a mix question of law in fact some are worse than others i would say this is one of the most difficult and problematic ones in way by design because congress didn't want to impose a medical judgment across the board and want to let doctors have  medical professionals be making these decisions here many medical professionals who are following this practice even one of the plaintiffs there is the government's own expert said conceded following this practice based upon that it's impossible to separate this face to face meeting requirement from the whole trial there may have been sufficient other evidence but this case should be reversed and remanded for a new trial and i see that my time is up with their question my name is dan hurley and i represent the united states with respect to counsel it's just not true that this case was about face to face mr darrow g tried to make an about face to face he tried to make it about face to face with each of the d a investigators who came to speak to him he made about face to face when he talked to his lawyers the government's theory from start to finish was that this was a breach of the standard of whether these prescriptions were issued in the usual course of medical practice whether there are issued for a legitimate medical purpose and there is evidence in the record that was the theory in the t three affidavits that's in the indictment if you look at page five of the indictment the second paragraph which is laying out the government's theory of the case it's specifically says the consultations were cursory in nature did not involve the exercise of medical judgment how does he know that he he has an obligation to know that your honor because the way the statu written it forty one says you cannot distribute these and then there's an exemption for practitioners doctors in pharmacists and under the law he has an affirmative obligation to satisfy himself that these prescriptions were issued for legitimate medical purposes the government had a mountain of evidence that put him on notice that these were not issued for a legitimate medical purpose we're not asking mr dyer gee to second guess their judgment is the pain severe enough this the right dosage when mr baji knew was that there were fernandez was a psychiatrist in puerto rico and he knew that he admitted knowing that and she was writing some of the neighborhood of six hundred eighty prescriptions week that were filled at his pharmacy now he doesn't know whether she has other prescriptions being written heaney admitted on cross that he filled six hundred eighty four prescriptions in one week in january hydrocodone if that doesn't put him on notice that she's not forming a relationship with these patients by the phone by the internet however you can't form a legitimate medical relationship with six hundred eighty patients originally perhaps but she's not in the business of pain clinics there are special categories of doctors who have subtly different standards under the medical rules for what their standards are these are people that these sites to do they did not allow refills because then they didn't get the extra feet mr djerejian knew he was getting paid someone a bit of twenty to forty times his normal filthy when you're getting paid that much for a controlled ignorance which is the minimum of the law that's exactly right your honor and there were not just the six hundred eighty four people a week from one doctor who's outside area of training who is issuing nothing but hydrocodone prescriptions from puerto rico for patients all over the country he knows that they're paying him far more than they should he knows the patients are paying two to three hundred dollars when if they had a real pain management issue that was being overseen by a doctor with a sufficient relationship they could go get it for twenty bucks from walgreens or rightly or wherever dads were paid him two hundred you know how did that work they're paying us mats they get they go to the website they select the drug they select the dosage they select the quantity it goes through the system the physician then either says i approve or i disapprove there isn't even an option for the physicians to say that's too much lower dose we need to wean you off etc that then gets referred to g and pay or the customers pay us mads and there is evidence there she was aware of this two to three hundred dollars per prescription depending on when it was filled the testimony was they could get that they could get the drugs he was reimbursed for the cost of his immersed for goods as well yes and is that typical of pharmacies asking is there evidence in the record of course that as i understand the record the pharmacy gets a fee and then they either get reimbursed or the fill fee incorporates the cost of goods here the evidence showed dodgy both got his cost of goods reimbursed he got his shipping reimbursed and then he got twenty dollars per prescription whereas in the industry the standard was between fifty cents and two dollars and something as a filthy dirty got twenty dollars as a filthy for each prescription that he felt just putting the pills in the bottle and shipping it out he get twenty dollars per prescription when normally they would get fifty cents seventy five cents a dollar whatever their gee also knew that almost all of these prescriptions were for h gene knew that some of these prescriptions when they moved to what they called the fifty fifty plan this is when there was a crackdown and some of the pharmacies were getting a lot of heat from their suppliers because they were dealing in such astronomical quantities of hydrocodone and everybody knew at the time there's a lot of abuse going on these are addicts who are getting these pills this is not legitimate medicine these are addicts getting these pills they came up with a fifty fifty plan this they will work include a prescription for a non controlled substance so the ratio looks better so it doesn't make it is obvious that they're just writing scripts after  don't mean they've got a big lobbying group i guess i go to congress i'm exempt themselves from that but they're not exempt your honor and in fact they have some of these same obligations and there was testimony in the record that the the suppliers of mr geraghty were being shut down and that is why some of these issues came up there are references throughout their phone calls between hazlewood who managed the website and reveal who managed the process and the doctors and he was in the loop of some of this that the suppliers were being were shutting down supply because da was coming in them and saying you're not going to be allowed to do this if you can engage in this practice or you're general matter than at all subject to the exemption that applies to practitioners meeting doctors and pharmacists but the testimony was these rules because these substances are so addictive they apply for a maker to take or and it's about a year and a half but as you may recall he stopped feeling for a period of time so he filled then he stopped then he filled again and so it total spent as i think about a year and a half it was from late two thousand and five and then he the only purpose for that prescription was to provide cover for the volume or quantity of hydrocodone prescriptions done she knows that's not a legitimate medical purpose that prescription that combination of prescriptions is not being issued by a doctor who thinks in my medical judgment this person needs these medicines down she knew this was so that they would have cover to get more hydrocodone why did she know that as opposed to thinking  case there were conversations between dire g and his award about this plan and so the record is clear that our g knew that that there was this fifty fifty plan and then began filling these prescriptions which included the controlled substance of hydrocodone and the non controlled but still prescription required don't you knew those prescriptions are invalid he knows that those are not the exercise of medical judgment and yet he kept feeling and i would suggest no one of these is dispositive but when you have his exorbitant pay the prices that are being paid the volume that's being written the number of patients that doctors are seeing the fact that they're almost all for hydrocodone the fact that there's a fifty fifty plan when you put them together is he on notice that these are not being written for legitimate medical purposes the answer is of course he is he has to be and  wants to only talk about face to face but that's not the issue here the government has never said it's closing argument conceded it's not about face to face it's a bomb under the regulation and on the statute this is medicine resist pushing pills that's what this is about and the combination of these factors that he had an obligation to assure himself that it was about medicine the sinner's not does he know it's not medicine because he's under these rules he has what's called the corresponding responsibility he has to satisfy himself this is the practice of medicine this is a legitimate medical purpose in the judgment of a doctor acting in the usual course of practice and each of these factors together show him that's not what's going on you can exercise medical judgment as to six hundred eighty four people in a week and if they're paying you twenty to forty times what you would pay at the corner pharmacy then that's a pretty strong sign these are addicts getting their minutes doctor medical professionals to do  the screening of patients they can play a role but at the end of the day the prescription has to be based on the doctor's medical judgment and so we're not saying that if anyone else and when you go to the doctor you first meet with the nurse the physician's assistant so it's not the fact that others are involved but at the end of the day it's through a friend and his prescription and she's writing that prescription that's a representation and in her judgment this person needs this and so could she this doctor didn't have this in the system do all the interaction with the patient and then the doctor just look at the medical records and say yes if the doctor is sufficiently informed about the patient the patient's condition if the doctor is forming that relationship and this is where the testimony dr nelson was that there still needs to be some doctor patient relationship that the doctor can't just outsource it all to the physician's assistant the doctor has to be exercising medical judgment and six hundred eighty four people in week no matter how efficient the one hundred people a day is what it is if you work seven days  h and one hundred patients a day if you're just reviewing records and you work ten hours that's ten patients an hour i realize this is a very lengthy workday that i'm hypothesizing here and i mean the issue is can they do that one day i'm sure the next day maybe but they're probably can pretty tired but by the third week by the fourth month then i don't think they can be exercising sufficient medical judgment to do this day after day after day and this case isn't about any particular prescription or any particular week it's about this is the whole set up here and dodgy did have sufficient notice and he admitted he knew that he claims to have reviewed some of these records and found that these records were totally invalid they were either false they were totally inadequate but if you're a pharmacist and you get hundreds of prescriptions  down for people all over the country and you see these records are no good you can't fill the next hundred hydrocodone prescriptions you have an obligation to see this isn't medicine this is pill pushing the internet problem is not as great because the right hand act made it easier for the government to just say defacto this is no good whereas before we had to prove as we did here there is no what's even medical purpose et this is still a substantial issue throughout the country and in fact there's evidence that the hydrocodone addictions are actually causing a substantial heroin problem because heroin is actually much cheaper the attorney for the government pointed out that no one issue here is dispositive in the first part i talked a lot about the face to face meeting i want to go over a few of these other things the attorney for the government talked about the number of prescriptions being issued and is judged more correctly pointed out it is certainly possible for a doctor who is working hard to issue these number this number of prescriptions the question here isn't whether or not d fernand is who is fulfilling her duties i've looked through the record it would appear fairly clear the case against her that she wasn't but that's not the case for mr darcy mr dodgy is charged with having knowledge that she wasn't doing her job properly the fact that it is possible for a company to have been issuing this number of prescriptions in a day certainly does require a duty of diligence and mr darcy exercised that duty of diligen he had a procedure in place and in fact the government tries to use it against him and several here today in a trial they talk about how he found out that there were some false prescriptions or there were bad prescriptions or where the medical records didn't back up the the other individuals names but from us meds they're talking about how they're always trying to improve their medical record retention policy in their medical records what they have the government says that that's window dressing or who's that window dressing for that's window dressing for the pharmacists they are providing this information the pharmacists their talent and we have medical records this is all based upon our usual and customary practice mr d'arcy is a pharmacist he's not a doctor he doesn't know what medications go together he is entitled to trust with reasonable inquiry but he isn't still entitled to trust what a physician writes and dr fernandez was a licensed physician additionally mr di she was completely upfront with you know throughout his operation in this business he had his florida pharmaceutical license renewed he did stop briefly because the had told him that they had questions about his practice he consulted an attorney and upon his review it was what was required was a bona fide relationship which his review satisfied him with sufficient now it turns out it would seem looking at the record that that a lot of these prescriptions weren't issued in the usual and customary course of the medical practice but what the evidence doesn't show is that that mr darcy knew that or that his even though his due diligence may have not been perfect that it was not sufficient and i see that my time is up to my circumstances thank you thank you both for the argument and now mr oakley i see that you're appointed pursuant to the