now we'd like to reserve imus for both please very well my name is clint kelly i'm from the nashville bar and i represent charlotte and brett payne in this pharmaceutical liability action we respectfully request that this court the summary judgment for one basic reason that the proof in this case when viewed in the light most favorable to the plaintiffs shows that if the may fracture had given adequate warning timely warning that the physician and the patient would change their behavior based on that warning and as a result a material issue of fact would have been created with regard to  honor i have laid out as best i can the diagram of the alternative chains of causation two chains the first chain is what did happen which in paine about that danger side effect which led to miss payne taking the drugs which then led to ms pain developing the injury that's what did happen here's what should have happened no borders should have given a warning about o n j in a timely manner should have given that warning to the prescribing physician dr johnson with knowledge of that morning he would have passed that warning on to miss payne mrs payne then would know about that morning and based on her testimony would have refused to take that drug and if she refuses to take the drug and this is the critical fact in the case she refuses to take the drug she is not injured no you don't have an dates but these events in your chain of what should have occurred according to you when should be things that happened according to the evidence by two thousand and three the warning was known to no bardas actually they knew earlier than that but we claim that by two thousand and three novartis should have warned dr johnson and other physicians about the risk of o n j is that the cross product two thousand three nevada is to know about this problem of course knew about this problem judge in the ninety's they've known about this problem for years they with hill this information in two thousand and three there was a conference in which they were told about the risk of zero in j and they withheld that information until two thousand and four when they sent a dear doctor letter out to other physicians to notify enterprise's physicians that there was an association between the risk of  and the drug even the court has acknowledged for the purpose of the summer judge and there's no dispute that morning was inadequate the only dispute here is would an adequate warning have made a difference in the outcome that's where the district court got home in up in fact the district court's order very simple district court's order says the plaintiff has no evidence to show that an adequate warning would have changed the outcome that is the no race because in this particular case we did have evidence that a warning would change the outcome simply because miss payne testified by affidavit she would not have taken the drug and dr kraut the oral max of max of facial surgeon in this case has testified that the drug caused the o n j those were the facts in light most favorable to the plaintiff that the court was supposed to take into account our position on of that the benefit of the debt which was supposed to go the plaintiff in this case went to no boras on numerous occasions first the court said that miss payne's testimony was speculative first of all that is at odds with numerous cases not only the cases in the n d l which by the way your honor that's the roadmap we follow judge campbell's decision time after time after time said that the warning if it changes the behavior of the prescribing physician and the patient such that the patient will refuse to take the drugs that is enough to overcome summary judgment but here the physicians practice did not change he became aware of the side effects and continued to prescribe is aware of the side effects during the time your client was taking the medication is that right actually your honor he was not a cop it is another fact issue respectfully disagree with you there in this case dr johnson testified at about the time when he noticed the injury to miss paine's dental area in other words where the when jay was manifested himself that's at the same time with the information was coming out th boris's drug causes so injury and he continues to prescribe a change in behavior order is the warning that's what differ here not only the warning he also has a spot on now have patients undergo a dental monitoring procedure which i didn't the source was he testified yana he heard it seminars and he had heard about it in lectures that was about as clear as he got about it but the point is he had to find help through another means rather than the way he should have found out which gist of the egg inadequate warning like but he began to hear around or so two thousand and four there about around the time when she was injured he said quote at about that time there was this testimony that's when data use the word data started coming out about the fact that a when j was a side effect or potential injury associated with the use of the drugs the district court in this case assumed he must have known about this before she developed the injury that's what he  even before ms payne was injured that owen j was a side effect of this drug and essence what the district courts thinking was if he knew about it and still later keep taking the drug than under tennessee law the learn intermediary doctor would bore the client that there was the way the court looked at it but dr johnson did not testify to that dr johnson said at about the same time he noticed the injury this is when the data starts coming out about the side effect of o j and he said when i found out about this i changed my private practice that's the change your honor that occur in this case where we contend the district court care or got hung up here he got hung up on the fact that dr johnson continues to prescribe the drug therefore the learned intermediary dr nissen supports the claim every case that offside in this from this litigation from this india even the schaeffer case from the southern district of ohio even the  pfizer k smith versus pfizer for middle district in see it each of those cases the doctors continued to prescribe the drug said they would still prescribe the drugs but the prescribing practice changed in that they start giving mornings when they find out about the side effect that's the change it got lost on the borders and it got lost on the district court but it wasn't lost on all these other courts including the indio court which recognized you can still prescribe the drug but if you start changing your practice in the way you prescribe it that is enough to get past learning intermediary doctor what needs to be tried the issue whether your clients allegation that he or she would not have taken the drug if the doctor had given her the warning precisely or that is the credibility determination that's for the jury it was not for the district court that's exactly it i want to revisit one case from the middle district and see which i think has a lot of similarity here to this case which is smith vs sponsor and  the district court judge in that case revisit some tennessee law about the learning to mediate doctrine and its interplay with product liability law in tennessee and the court noted the key in korean every one of these cases involving learn intermediary doctrine is whether additional warnings if given would have prevented the patient from being injured that's the key question so the fact question the proof question is how do you prove that how do you get that in evidence what the court said in that case was this wasn't a case involving the neurotic drug name iran today dr mackey prescribe neurontin to this gentleman mr smith mr smith takes the risk of suicide pfizer said that's not enough said you can't prove it make any difference and in the smith case just driver said no if there's evidence that the patient would not have taken the drug after being hypothetical statement by a witness as to what they would have done in a situation that's different than it was whether they would have reacted to a warning in the past it's a way that's a hypothetical question and it's speculation that's not personal knowledge now there are other types of evidence that a plaintiff might be able to present in this case for example plaintiff could present testimony that during the time that she was treated she questioned her doctor about side effects of prescription drugs in this case actually testimony to the contrary i mean the record if five one page six one five sixty five seven and this pain caused by cheating question her doctor about a side effects of prescription drugs or these drugs in particular  a failure to disclose the tennessee courts have been very clear in that that it's the finder of fact that most considering give weight to the patient's testimony support tension as to whether the patient would consented to the procedure upon full disclosure of the risks how is your how is this photo here to warn case any different from where there are two responses first of all in the ash case the c was also very clear that a plaintiff testimony alone would not be sufficient doesn't matter of law that was in fact the issue in the case the court held that you need to have objective basis as opposed to just the plaintiff's testimony as a matter of law to be out to make an informed consent case exactly for the reason that and after the fact testimony after an injury took place is too speculative to hang your hat on sewing a second in that case that was an informed you're standing in the shoes because you've made that balance who's it going to be the manufacturer or the doctor states get to kind of pick how that balance works and what the state says is that you duty is to provide the information to the doctor then the dot there is the one that has to make that information so known to the patient said why don't you have the the court has a section discussing the fact there's different laws for prescription drugs and for over the counter drugs for over the counter drugs the law looks to how one is going to impact the patient but with a prescription drug laws different and the courts have recognized and said no you look at how the warning would affect the physician in this case it's undisputed and the plaintiffs acknowledge it in their brief that dr johnson would still have prescribed the drugs that said page nine of the brief there's no question about what the physicians risk benefit analysis was under learn intermediary the whole point of that doctor is that you look at the impact of the warning on the physician and not a letter comes whether he he or she changes her you're well  but what behavior is being changed and here the issue is would he have continued to drive the drug it's undisputed they only would only issue whether he would have prescribe the drug differently in a way that would have availed the plaint some warning signals here if you start having depression if you have suicidal thoughts i want you come back to me because then we can do something to change your behavior change the change or medical treatment and that is exactly the situation that arises in readiness and medicaid says when it is a case of a dental issues like yours rise to inject when there isn't a dental extraction in that case if the physician has warned the patient this and be aware of dental issues when they arise come to me and we can deal with it  then that that happens the patient can take action the physician can take action and in fact in this case it's clear that that is what happened the physician and just to give us a clear timeline here the patient's own jay did not manifest until two thousand and seven what happened in two thousand and five was that the patient need a dental extraction and a visitation because he was aware of the back that there was this association and it went on the label your honor in two thousand and three all his patients who would go on the drugs see a dentist and have any dental work that might be needed done in advance before beginning that's exactly correct your honor and this was a case in which the owen j was  some sort of dental procedure that could have been avoided by that than that would have been a proximate cause of a chain the printers could make in this case but here are the plans expert stated that her in jail was spontaneous it was not precipitated by any dental attraction and therefore his  another one of the experts also knowledge in this case under these facts and it distinguishes this case from the other cases in the o j litigation that have dampened its way and there's been a lot of cases on both sides because of individual facts  this case any warning about a dental screening or about being careful they don't is irrelevant it has no connection no proximate cause ation connection to the patient's injury the first event that occurred here see the one she would have at that point said no more now there's no test in this case no evidence that's been presented in any event that four years of taking the drug as opposed to five years of taking the drug would have changed the outcome of a few years later so your position only issue here is whether or not the patient would have taken the drug and here is undisputed now i think that the patient would take the drug for these four years and the question is whether or not the speculative after david means that last year or two she might not taken the drug we would that was not competent evidence under fifty sixty four that just a court acted within its discretion disregarding it but that's the only theory they've got and your honor also with respect to the it wasn't that the plaintiff in that case was presenting an afterthought act statement would have been possible not case that he would have taken the drug if he did more and what happened that case was there was objective evidence there was he had  contemporaneous evidence of the patients practice when talked to his far brother lied think was a pharmacist and was inquiring about side effects of the drug so he had objective contemporaneous evidence which again is directly contrary to the evidence here at oregon fifty one dash eight at ten forty one zero four one one this pain has very very clearly she never refused any drug that dr johnson tried to remember she was being treated available on the market that could treat that those conditions and in fact it's undisputed that they're extremely effective in doing that plenty of experts in this litigation have testified that these drugs prolong life that they are very effective in  avoiding own destruction caused by cancer and that they are in fact weather experts talk about the fact that it boxes the cancer into the bone these are this court itself the sixth circuit in simmons and thomas have recognized that these are very  the fact that dr johnson put mrs paine on a drug holiday so that she get a dental attraction is conclusive evidence that he was aware of the risk of oh in jail while she was being treated he would not have put her on the drug holiday that's the whole purpose of putting her on the drug holidays because you're aware that this is a possible risk and he testified he had been aware that for a year now again if you look at the medical records here is his in intent was you disagree with your opposing counsel as to the knowledge of the doctor that well your honor i don't think there's any any credible basis to claim anything different the doctor put took her off the drug for dental  traction if you look at the records it's very clear also and this is the record thirty seven dash forty three three six five seven the reason that she didn't go back in the drug had nothing to do with dental issues it was reno's renal issue it's a separate side you know before i forget about this my first bottle is from the no borders we have a fundamental disagreement to facts here in this case dr johnson testified he took miss payne off so med in two thousand  there was some data coming out about that that are read and submit it can be associated with us to necrosis of the jaw that's why took her off i don't understand why there's a factual difference which clears a bill the other difference just wrong about what happened i wish the supreme court of that sit in you're right it is a matter of tennessee law a plaintiff can testify whether or not she would take the treatment offered or prescribed by the physician it is an objective standard that the jury decides with a reasonable patient under circumstances would have agreed to the treatment but the patient's decision is relevant you don't have to have other evidence out there about what would happen or not happen is just wrong about that there's even no statement in the ash case about there being so called objective evidence is an objective jury standard now with their independence so your position is that there was or was not independent knowledge of the doctor about the problems with them prior to two thousand and five there was not there was not the other issue many many times cancels expressed how good this drug is how great it works the fact that she may have been on for some time and whether or not that had anything to do with this that's all great jury argument that's all great material to be weighed by the trier of fact not the district co this was a jury is judge black's got this nailed down the issue for the jury is whether they believe this pain would have stopped taking this drug that's the question and whether or not from our position the surgeon dr  the drug that caused the injury the court with respect has to accept that as a fact for this appeal the final issue i want to raise i believe counsel for a board of said that there was no case in th judge rice went through an exhausting review of the m d o cases and in that case miss schaeffer testified i would not have taken zometa if i had known that i would have job death novartis said that's not good enough judge rice that speculative and judge rice disagree no borders sided pain vs no barge the case it's on appeal right now judge rice said i respectfully disagree with the court's decision in pain versus  is judge rice agreed that the patient's testimony about whether or not she would take the drug is and admissible component of the chain of causation that if she hadn't taken the drug she would have been injured if one versus no of artists i mean this court with respect would be a road and the reason that the court in our view should rule in our position is it follows a roadmap set by the n d o court and the clear decisions of