good morning ladies and gentlemen george barrett is one able to be here in person today but will be participating by speakerphone speakerphone sometimes have problems with a way and with two way communications so if you hear something you might want to stop them wait to hear from george barrett or i may suggest that you stop now i'm sure we can work through this the st case for argument this morning is medical good morning your honor may please the court catherine hancock dorsey on behalf of plaintiff appellant medical mutual of ohio the summary judgment record here shows that defendant specifically targeted medical mutual and its pharmacy benefits men manager medco and later express scripts with marketing materials that their topical t r t testosterone replacement therapy drugs were safe and effective not just for treating the f approved use of the drugs which was for primary and secondary hypogonadism but also for treating the symptoms and conditions loosely associated with low testosterone levels the purpose of those marketing materials to and i drugs were safe and effective for those uses and in fact the league did believe that there were no cardiovascular risks and it maintained those drugs on its formulary without restriction resulting in an almost payment of prescriptions that it would have otherwise not paid for had it known about the cardiovascular risk it's certainly a statement of your position but the district court found that there was no evidence to misrepresent that any misrepresentation was material to medical mutual's decision must to persuade us that that's wrong just restating the position you began this litigation with doesn't really cut it of course your honor and i think that analysis was fundamentally flawed here weren't focused just on prior decisions prior authorization decisions and prior decisions about the formulary focusing on the t r t drugs those prior authorization for these t t r t drugs but focusing on those past decisions none of those involved say evidence of safety arrests including the cardiovascular risk about those t r t drugs so there was a  safety investigation announced in two thousand and fourteen and then though adopted a prior authorization it knew then knew that those drugs were not safe enough active and post potential cardio vascular rest and because of that significant safety concern and imo then adopted a prior authorization from the district court also in addition to its analysis being focused just on those prior distinct authorizations which were  initials ok we understood you didn't respond better to english words fair enough your honor the district court ignored whether our medical mutual relied on the concealment of cardiovascular risk it looked only at express scripts and med co's reliance on the on the cardiovascular relist and that was at a forty two dollars of its opinion in the appendix and so the district court failed to realize that m m o's prior utilization met medical mutual the district court failed to recognize that the prior utilization management decisions did not involve the concealment of safety risk which was at issue here and i'm a medical so sorry your honor i could not have been expected to discuss the safety risks of which it was not aware if it had no evidence that there were safety wrists or that the there were concerns about the state  safety and effectiveness of these drugs it naturally wouldn't have had a conversation about those in deciding whether to adopt or utilization management it's not it's not surprising that there would be no direct evidence that they would have  committee the committee that decided these utilization management decisions at medical mutual they that evidence in the record is that they considered a lot of information but part of the information they considered was defendant information about their drugs and there was evidence in the record that medical mutual relied they said they relied on that at least in part on defendant's statements about the safety  which the district court of knowledge acknowledged in its opinion at age twenty seven but there was also information in the record that the clinical information was medical mutual's primary consideration in making utilization management decisions and that was in a number of deposition testimonies that they always get that medical mutual always considered the clinical information st including defendant's information and the district court did not even acknowledge that evidence in its opinion we'll i don't understand everything about it for you or about things are sort of accumulated in there isn't that how they the formula or the approved legs they have a formulary which is put together by their pharmacy benefits manager express scripts in this case so they put that together but then medical mutual is the one who decides whether any restrictions are appropriate on that formulary such as utilization management limitations or step therapies so here what we're not challenging that that the drugs were put on the formulary that there was reviews much information they have pharmacists and doctors they review articles clinical information information from the manufacturers they take all that information and they decide what drugs should be placed on the formula y and that and the evidence in this record is that medical mutual adopted the formulary full sail from its pharmacy benefit manager from express scripts so it just adopted the formulary but then medical mutual makes its own decision about whether to place limitations on those drugs incisional on the work or would you like sorry utilization management utilization utilization management limitation which is just a phrase that describes all sorts of restrictions and limitations that medical mutual could put on a drug on it that's already on its formulary instead of taking it instead taking a drug off its formula formulary for instance  approved medical mutual would not have taken those drugs off its formulary because they had those approved uses that were important for its patients but what they would what they would have done had they known about the wrist earlier was to put a restriction on its formula so that those to which they did here that required a prior authorization so a doctor if a doctor prescribed the drug for you and you went to the pharmacy to get the t r t drug then the pharmacy would not fill it they'd have to go to the doctor and have the doctor fill out forms for this prior authorization to give the insurer information so that what it's really i mean doctors can prescribe for off label uses so it's not it's not strictly off label but the prior authorization means you have to the pharmacy and the doctor have to fill out some paperwork so that the drug is not being used for whatever condition the insurance that they can't be used so in this case when medical mutual implemented the prior authorization it stated in its in its prior authorization that the drug had to be used for primary and secondary hypogonadism and that was it and that also took into account the f d a later label change for the testosterone replacement drugs that they had to be medical mutual relied on the concealment of the cardiovascular risks which which was critical here and medical mutuals decision to to adopt its prior authorization the district court also weighed the evidence concluding that reliance on the two thousand and fourteen step there e p with a quote unquote stretch now a step therapy is where medical mutual in two thousand and fourteen agreed to get preferred status to two of the two of the drugs and original and x are on and what that means is when it when it gives the drugs preferred status it means that it knows more prescriptions of those drugs are going to be provided because you have to try those two testosterone replacement therapy drugs and fail on them before you could be prescribed another and when it adopted that step there a p it would not have done so allowing more prescriptions those two drugs in less it knew that they or believed that they were safe and effective so the fact that medical mutual preferred these two drugs again shows that medical mutual relied on representations that they were safe and effective it would not have agreed to be giving out more of these drugs if it had known that there was a safety issue and how can i ask a question can anyone hear me yet so you waited until july of two thousand and sixteen and for the topical p r t is that right yes the prior authorization was adopted in july two thousand and sixteen and that within two years after the defendant why do you were made aware that there is the potential problem why did you take so long to change the categorization right the delay can be explained your honor because once the f d a had kind of taking control of the situation and launched its own investigation it made sense for f d a which is the expert on these safety decisions it made sense for medical mutual to wait to see what the f d a decided but but we know that medical mutual was relying in considering this because as soon as the f d a announcement came out about the safety risk the medical mutual pharmacist dr  just recommended these two drugs for the stuff they were people ram which shows that m m o had medical mutual had been unaware of the safety risks here and they were surprised by the f d a as announcement and then it also so there was further evidence that medical mutual was keeping their eyes on what the f d a was doing them because dr joshi then suggested in an e mail that they keep our eye on this in other words they were going to monitor what the f did and she also then followed up with their pharmacy benefits manager express scripts to ask them if if medical mutual had ever had a prior authorization in place for the topical testosterone replacement therapy drugs so in essence your honor they waited till the f d a finished its investigation and made it and made the label change and then and imo acted medical mutual acted to adopt its prior authorization so i think there were other going back to again the district court court analysis here the district court also discounted dr candidate testimony that medical mutual relies at least in part on info from the mac manufacturers in these utilization management or prior authorization decisions and the district court discounted that because medical mutual did not identify a specific a specific decision it had made in reliance on that information but again the information here was that medical usual did not know of the cardiovascular or other safety risks and so in reliance on something it didn't know it did not adopt a prior relied on there might be circumstances where medical mutual would have other evidence before its committee that might tip it off to a safety risk or other information so that it might not rely on defendant's representations about their drugs but here there is nothing in the record that showed medical mutual had contrary information that would have tipped it off to know that about the defendants representations about the drug safety and efficacy were not true and so it's from that we can see that from the record that and medical mutual did rely on the information they were given and the other thing is the district court again ignored the evidence that clinical safety was medical mutual's primary consideration in making utilization management decisions but district court suggested that rebates were for an issue but again the district court didn't even acknowledge the the numerous testimony that was in the deposition testimony that was in the record about how safety always came st in these decisions about whether to adopt utilization management  for those reasons your honor is because the district court analysis was flawed and didn't look at the adoption of the prior authorization the steps they are and the information about that safety always came st in these decisions we think that the district court's decision was fundamentally flawed and that there should be a reverse the grant of summary judgment but one other thing i think we would point to your honor's that shows causation here is that the prescriptions after the prior authorization was adopted the prescriptions for these drugs dramatically during decreased and in fact defendants themselves predicted that prescriptions would drop by  medical mutual witnesses testified that they rely on any misrepresentation made by any of the manufactured defendants in this case not a single medical mutual witness testif what they would have done differently if supposedly the material or the material misrepresentation had not been made i think it's important right at the outset to understand the case and medical mutual lawyers brought it was not about cardiovascular risk they alleged and so what that the injury was any off label use of the testosterone replacement product for quote age related it wasn't about cardiovascular risk they didn't bring in case somebody half of people who may have experienced a cardiovascular adverse event so today they focus on cardiovascular when their case was actually all about suppose it each related use and the best indication of that is if the court goes to their prior authorization which they put in place it's at forty five exhibit thirty two dollars there's nothing about cardiovascular in there frankly there's nothing new but age related prohibitions in there all that requires for their prior authorization is a patient with symptoms consistent with hyper gonad isn't the teague loss of libido other potential symptoms and a blood test actually two blood tests on two different days that shows that you have a testosterone level below three hundred milligrams per deciliter that's it nothing about cardiovascular nothing about age related you just have to have symptoms and the blood test so they even taken any steps to adjust what they contend is the theory of their case now they already knew that they this case is about the air in action  district court somehow misunderstood that but we have repeated instances over the history of this the allegations in this case where met co the air force the benefit manager brought to them the issue of enter ports the use of testosterone drugs for suppose it into reports age related hyper goannas medco brought that to them in two thousand and four as a district court f no medical mutual the quine to restrict use for intra ports so there's a specific example where the issue was put in front of them and they chose not to take any action two thousand and eight medco comes to them again and says if you want to put a prior authorization in place as to testosterone products they decide to only do it as two injectable products not as t topical products the products sold by the defendants in this case two thousand and twelve medco comes now it's yes express scripts there pharmacy bennett manager comes to them and sa we've been doing a review of your programs you don't have a prior authorization for topical testosterone products medical mutual again silence and as the district court correctly noted what the case they brought is about were that had anywhere that decision making where that action or in action was driven by any material misrepresentation made by any t r t defend now today they talk about the decision they made in two thousand and fourteen to go with a step therapy and that somehow that had something to do with some sort of safety evaluation but to be clear what a step therapy is there were five testosterone replacement topical products because two of them put in my client was willing to pay higher rebates they became the preferred products it's just it isn't increasing the number of prescriptions for testosterone replacement products it's just shifting what the market share is going to be among those virtually identical prop products so it had nothing to do with sate the efficacy it had to do with rebates which of testosterone manufacturers were going to get the larger sales within this class of drugs  the so this step therapy had absolutely nothing to do with any safety or efficacy evaluation now i would urge the court in looking through the record the district court assumed for the sake of argument that misrepresentations had been made but then found absolutely no evidence of any linkage between any sort of misrepresentation and it decision made by formularies the record is clear the medical mutual doesn't dispute that medical mutual didn't make the for a formulary decision that was made by the pharmacy benefit managers and if you go back to two thousand and eight they put them on the formularies at least this early as two thousand and one when our product entered jail came on the market there was as the district court there was no evidence whatsoever as to what it meant co considered in putting that drug on the formular medical mutual just asked for speculation but as we know tim page forty two of our brief t r t manufacture and medco did not know whether any information the defendant provided to it was considered in making formulary placement decisions so and finally as we know page forty two made co made clear that they don't accept any information made by a manufacturer eight based value without doing their own due diligence that's why the medical mutuals of the world hi pharmacy benefit manages to make those type of the valuations so that's the formulary piece medical mutual had nothing to do with that or do they always look into whatever the manufacturer says  as as they testified they look at the whole eight pharmacy benefit manager looks at the entire clinical record here and i would point out on the issue of this cardiovascular risk which now seems to be driving the case although it's not the case they brought up they brought an off label case the point is really that the all the f d a said was that there was a possible risk happened there there have been subsequent studies shown to your t s are still out there are still being used and their own as i said earlier i would urge the court to go and look at their own prior in their prior authorization they acknowledge that twenty percent of men over the age sixty eight will have abnormally note low testosterone levels and that over the age of eighty a price list of fifty percent and then all their prior authorization requires is symptoms and a blood test and the blood test is based on what the f d a told abby and other men and to your team manufacturers to if the court looks at the issue of did the it there is actually no evidence in this record of misrepresentations made directly to a memo when you look at some of the documents that  conversation that someone it really had with mr mccloy bitch at ed medical mutual where he says nothing of substance was discussed and we primarily discussed insulin same thing with respect to abby they say well you wanted to show medical mutual your value proposition deck what they don't show and then they cite the redacted document at four hundred and thirty five exhibit twenty two we then  document because it had to do with other drugs not in this case and it makes clear the value proposition was about you marah abby's multibillion dollar drug which they beat every discussion with and the witness from medical mutual mr borgia testified as we noted are things that he can't even recall if they ever had a meeting about this and the meeting would have dealt with you mera and what our witness said in his e mail was and if we have time can we talk about contracting for injury gel we don't even know if their conversation ever took place and according to medical mutual they don't think it did so when you go back and you look at the underlying quote evidence it just isn't there so the district court actually gave medic you mutual a pass in assuming that it's some point over the fourteen years some misrepresentation was made but then it searched the record in eight in a careful analysis over forty four pages it could not find any linkage between some assumed misrepresentation and decision making by medical mutual or their former c benefit managers as i said earlier in two thousand and four pharmacy bennett manager comes to them and raises the point of the enter pause which is age related could be age related hyper go ninety's medical mutual takes no action they didn't seek to try to limit this alleged off label use same thing in two thousand and eight same thing in two thousand and twelve so this is not a case where the the plaintiffs can say know we didn't take any action because we weren't aware of anything we weren't aware of any issues there pharmacy benefit manager brought the issue of injured paws to them but even today you can today under their prior authorization if you have symptoms in a blood test they don't reimburse has nothing to do with cardiovascular effects it's nothing to do with age related hyper go fourteen a four hundred and thirty four page complaint by their lawyers saying that there was you know a massive fraud widespread off label use terrible terrible thing what they then did nothing nothing for over two years why did they go to a prior authorization because we filed a nd motion to dismiss relying upon a delaware case a delaware supreme court case that had thrown out one of these rd party payer cases brought by companies like medical mutual where calculated in action following a complaint is basically an admission that you were not materially miss misled in any respect that's the st time  the st time you see them talking about oh we have to get a prior authorization place it's after the defendants raised it in a motion to dismiss and then they're so worried about it they don't realize for over a year that their pharmacy benefit manager hadn't even put it in place it's a big year for them to figure that out and then they put the prior authorization in place but a prior authorization doesn't have anything to do with our promotion it has to do with a doctor deciding to use the drug and medical mutual or their pharmacy benefit manager deciding whether they're going to reimburse for it so it has to do with use and there's nothing that prohibits that use today  you're an artist this is not a case about off label use doctors are allowed to prescribe for off label use and in fact medical mutual has to pay for off label use prescriptions this is about the safety and  medical was misled about the safety and efficacy and didn't put restrictions on its formulary because of that defendant talk about the prior authorization that medical mutual implemented which is that exhibit fifty three dollars of the opposition for summary judgment that prior authorization makes clear that it is for primary and secondary type a go dad ism and that also must be understood in light of the f t s label change which made clear that the drugs were not to be used for age related hypogonadism and made clear that there was a cardiovascular risk if the prior authorization really does nothing as defendants contend that it's curious that the prescriptions precipitous leave dropped after that prior authorization took effect opposing counsel notes the two thousand and four for recommendation by medco and noting the concerns about andropause well the documents before medical mutual that were given to at that