and then the third blow was in refusing to instruct the jury in accordance with georgia law that a design defect case requires proof by expert testimony so the point of having succeeded in keeping the jury from knowing what the board was lawfully manufacturing  process which is the only process by which board could have sought to market its surgical mesh product under the c f r is adopted by the f d a it is a class two product and can only be marketed through the i don't necessarily disagree that it may have some marginal relevance with respect to safety but i was that an abuse of discretion but this record in this case decided that even at that had some marginal relevance it just wasn't worth the effort under or of with respect to the that he he gave it your threat but he did at least now the words even if we assume that it has a minimal probative value here's why i want to keep it out that's well within the district courts bayley but in  trial and all that sort of thing but judge you have to realize what that means is that in every case in which there's been f d a clearance and a manufacturer has complied with the only process by which a class two device can lawfully be marketed all the plaintiff has to do is stand up and say i'm going to try to prove it's not about safety and effectiveness and that's the end because that's basically what the judge had before had had before him when he ruled was a point of saying we don't believe this is about safety and effectiveness and we want to show that to the jury and then the final  reason it through the in the a in a process founders and it all you're shelling is that there are previous devices on the market and that this is not substantially different from th dealing is showing that you're not unlike a previous device that's been on the market and there's no judith could determination that this previous device was a safe device let me let me say two things about that but first is that's not what happens now bear in mind that in one nine hundred ninety congress adopted the s t m a and although it was on the books when the word was decided the device and more was a pre nine hundred seventy six device but indeed never went through any kind of f twenty five process but let me read to the court if i might from page six thirty four of the joint appendix because this is the way the f d a and its in its guidance document for food f d a staff and industry describes the five ten k process because devices are classified according to the level of regulatory control necessary to provide a reasonable assurance of safety and effectiveness classification of a new device who the five ten k process requires f d a to determine the process under the m t a to the process by which more than ninety percent of all medical devices on the market are cleared by the f d a for or cleared by the f d a to be lawfully marketed like your argument before we were granted permission to market this device the subject of ice was components of polypropylene mesh in the college and quote have been adequately assessed by a bio compatibility determinations for safety and via physical strength characterization assessments for production of affected the product is substantially equivalent with respect to predicate searchable messages messages for safety and effectiveness and a page nine thirty four of the of the joint appendix which is the final letter from the a to board the f d a said the f d a finding a substantial equivalence of your device to illegally marketed predicative writes results in a classification for your device and thus permits your device to proceed to market this is the only regulation by which we could have sought lawfully to market our device and georgia law is very clear and there's no dispute on the other side compliance with a safety regulation a safety regulation is part of the risk utility an and isn't that a quintessential or of very balanced that is within the trial judge this person or are you saying that as a matter of law there is a rule or three has no role to play when it comes and there there's i don't i don't think we need to go so far as to say it has no role to play but i meant to get to this earlier and i apologize when the district court excluded the our five ten k evidence the court ruled that our motions in limine and to restrict the plaintiff's response to our fighting case evidence were mo asked us to do the f d a cleared our product to be marketed and the and we satisfied all requirements to have this product on the market period they are more than entitle to a jury instruction because georgia law is this doesn't this doesn't preempt us doesn't  would be on trial in dozens of medical device cases around the country on a rule that was adopted and approved and remained on challenge there's a process for challenging f d a was there's a process for initiating will make but the question for the court is is it a safety went after us hammer and tongs for not doing additional studies and this brings in the m s t s as well for not doing anything after we saw the m s g s for essentially ignoring warnings and marketing some unsafe product and the best answer to that of course is we were marketing we made the decisions we made because bear in mind a new georgia law all of this comes in safety regulations come in to show the reasonable ms of our choice the reasonable to support choice and i ask the rhetorical question is it unreasonable for a manufacturer that has gone through the only process by which the product can lawfully be marketed to believe that the that the product can lawfully be marketed in its current form the fair fight at a trial like this would have been for the plaintiffs to do everything that they tried to do in for us to use this is a piece of the answer and a critical piece of the answer because just focusing for example on clinical trials which is a major point of the plaintiff's case you didn't do human clinical trials the f d a said you don't have to how on reasonable is it for a manufacturer has told by the f d a which has the power to compel clinical trials to say i'm not going to i'm not going to do clinical trials because this fucked finished product again going back to the m s t s it's a critical piece of this as well as opposed to complaints about the raw materials just finished product was deemed reasonably safe and effective by the f d a after being compared to predicate devices one more piece of the puzzle judge has a moment to get to this as well the device in war was a pre nine hundred seventy six device and ten years of analysis by the f d a we were it was declared by regulation a class two device subject only to the five ten k process and we compare our two predicate devices were both devices that had been cleared by the f under that regulation so it's entirely probative highly probative and the only prejudice that the plane of can can can claim is well that might on dueling influence the jury will wouldn't that always be the case of course and we would have that but the district courts for three balancing in every case it's going to be so influential to a jury that it can't come in because that's all the court had before it and if i could turn briefly to the to the m s g s point because it's the m s t s has a significant role to play in how this all played out at trial with the with the with the exclusion of the five ten k the m s t s as rank your say there's no legitimate argument from the other side in their in their brief as to how this this warning slapped on a product by a manufacturer with no scientific evidence no explanation of how  it came to be no testimony from an expert witness as to its reliability can come in as hearsay but with prejudice from the introduction of the m s g s was that once the plaintiff kept out the five think aliens but the product was lawfully on the market  allowed to present this one verified warning of don't use this raw material in a human being as as the key point in their case and once the plaintiff was was successful in defeating the jury instruction we requested which is that there has to be an instruction to the jury under georgia law that that that there must be expert testimony to support a product liability claim a trial and design defect the plane was able to tell the jury page sixty five thirty seven from sixty five thirty eight of the joint appendix all you need is the m s all you need to know is that bard was warned about this product and continued to use it you don't have to resolve the conflict in the expert testimony you can return a verdict against bard and you can award punitive a punitive damages against bard based soley on the m s t it was that that interesting thing about this is quote you can dismiss all the experts you can dismiss all the experts you can say well this expert is biased and that expert is biased but phillips they don't have a dog in this hunt they have the material and this is what bard brought in and then concluded in the argument at page sixty five fifty five don't send a message in the community that says it's ok it's ok not to heed the warnings it's ok not to tell about the m s t yes this was the centerpiece of the plaintiff's case what was the best answer to the m s t yes even if it was admissible we were we were marketing the product lawfully pursuant to f d a clearance and with the jury not being told that expert testimony is required it all came full circle to the under seal ruling there was no way the jury could  determined our liability with the damages i see my time has expired yes well the first but the first piece of that of course is that the m s t s was the key to the punitive damage award i don't even know how we can begin to do a ratio analysis when the when under georgia law under established georgia law regardless of liability  our compliance with the safety regulations is a key element in punitive damages how can a party engage in willful misconduct and agree just misconduct when they've compiled a party has complied with the safety regulations so that that that it was seven times the  relatively small compensatory wording least according with plan of seem to want of twenty thousand dollars as is not hard to understand regardless of what the that the jury believe the noneconomic damages were to the plaintiff the jury was repeatedly told that we were centrally as i said running a rogue operation and disregarding warnings and marketing this product and implanting it in human beings when to of course the evidence at trial was that every physician who does hands on work in this field uses how a propylene batch and plaintiffs never prove that there was there was any basis for that warning so that's the first the first piece run on the of the of the puzzle on on the punitive awards as it was skewed in the first instance but secondly it's seven times the punitive damages it's seven times a punitive damages and could only have resulted from the jury being unduly influenced by the by the way the case was tried thank eighty seven created this new provision which allows for seventy five percent of punitive damage award minus attorneys fees and litigation costs to go to the states treasury the statute limits the award of punitive damages to only on award appear damages per defendant for each act of a mission and there's no limit on the amount of the period damage award in product liability actions the goal and intention of this statute is clear on the face of the statute punish analyze and deter the defendant the statute is crystal clear on its face these damages are not intended to compensate the plaintiff the georgia supreme court also spoken on this issue not to compensate the plaintiff or to create a windfall the point is to challenge our statute under the takings clause of the fifth amendment but the district court here properly rejected the plaintiff's argument finding that the plaintiffs have  no property right in award of punitive damages the takings clause prohibits the government from taking private property without just compensation however the fifth amendment does not create a property interest rather it protects existing interests as a district court properly held the first threshold issue that the court must look to is whether the plaintiffs have a constitutionally protected property interest in the damages plaintiffs do not have a property interest in punitive damages awards under the statute and they the plaintiffs here can't overcome this threshold issue the state quite simply cannot confiscate a property right that does not exist on the fr and the only support that the plaintiff offers for their position is a district court case which came out before the georgia supreme court case mcbride vs general motors corp and in that case even in mcbride the district court stated that they carefully considered the briefs in an effort to perceive how the georgia supreme court would rule with regard to the state constitutional questions  john i think that they they would probably have a right to file a proof a claim but i think it's possible the state would also have a right to file a proof of claim i don't think that necessarily means you have a property interest in punitive damages punish i think it most they might be entitled to twenty five percent although i would dispute that they do have a property interest but for bankruptcy court i don't know that you would really have to have a property interest to necessarily follow a proof of claiming a bankruptcy georgia supreme court looked at this issue and said that it did not violate the takings clause they recognize there's no no property right and they also recognize the stated intent of the statute which is to punish and deter the plaintiffs in their brave have ignored the overwhelming authority in the nation not just in georgia  the georgian court but throughout the nation numerous states alaska indiana oregon missouri iowa north carolina have all looked at this there are statutes which allow for this split recovery structure and of off down those to make constitutional standard case i think ten thousand and ten thousand of the plaintiffs that have have had this mesh come from the state of georgia the product certainly in this case was sold the state of georgia and all georgia citizens were punitive damages awarded are necessarily contingent and discretionary they distinguish between compensatory damages which are mandatory once liability is found in punitive damages which are never guaranteed as a matter of right no matter how egregious the conduct and again pointed out that it was very it was hot punitive damages are highly speculative the inquest holding is consistent with mack trucks as well as other supreme court cases throughout your state supreme court cases i want to point out one more state court case which came out of the florida supreme court gordon versus state what makes that case significant is that there was a petition for cert  to the u s supreme court and it was denied in that case they rejected the argument that its statute which allocated sixty percent of punitive damage to state was unconstitutional  in addition to that they actually mention in that bryant case which the plaintiff relies upon and said they quote found it completely persuasive the plaintiff does attempt to argue here that when the georgia general assembly an act of this statute in  even if we accept the plaintiff's assertions as true they would still only be entitled to a maximum of twenty five percent because the statute in an ev itself notifies the plaintiff on the front end that the that they are entitled to thank you donna may it please the court my name is anthony just when i represent donna and dan sisson who asked this court to affirm the judgment that was rendered in their favor and reject the evidential challenges to the evidentiary rulings by bar and which were not an abuse of discretion visually i think i want to start with where they spent most of their time on the f d a question and i have to introductory points the first point is the argument bard wanted to make to the jury that somehow or another this five ten k approval was something significant under the relevant f d a statutes they are not permitted to make that argument in the marketing of their products and that's at twenty one c f r eight zero seven point nine seven which we cited in our brief page fifty six the regulation makes clear that marketing that even creates the impression that by ten k determinations of substantial equivalence no to fishel approval of the device or that a has declared those statements misleading and if the if bard were to use that to try to sell these drugs to get doctors to prescribe them or patients to ask their doctors for him it would be guilty of illegal misbranding so what barb wants you to allow is you don't allow them to make that same statement to a jury that they can't make to a trained doctor well but it georgia law allows them to make that they've been i mean that's different than a marketing well the point is the point is the f d a itself s question you should ask is regulatory compliance with what kind of regulation argues that any kind of safety regulation is somehow relevant under georgia law and that's not the law and i think i want to start on that point with not a georgia case but this court opinion in tally versus danica metal that all in tally this court distinguish between regulations that have specific substantive requirements that a device be safe and effective and regulations that are administrative requirements that may relate to safety but don't impose this to fix this if it requirements what they what this court found was because those kinds of regulations like five ten k lack any independent substantive contact they don't impose a standard of care now that this court's decision we believe is consistent with what georgia law is and let's and i don't we haven't had any discussion of georgia law and i'd like to take some time to explain why we think georg what you would say is just not very much i think you i think the district court was correct in determining on the facts of this case and the record made below that really had no probative value this what the determination was that this product i similar to another product that was market that was similar to another product and contrary to bards argument there was no premarket approval that this is this is not a case where somebody went and got premarket approval for a product and then that product and a mass to regular surgical mash to other mash products to way back to products that started in the fifty's and sixty's there never was the formal premarket approval testing that that that was happening so we would say that determination that this product is like another product that was like another product really in the context of this case and i think it's important to listen to what the georgia law requires was irrelevant and at the very least even if it's that it would ever relevance it is so minimal that the district court standard in that you do but again my question regulatory compliance with what would be allowed to introduce into evidence that there are all of their lot all of their drug their trucks have driver's license that's regulatory or for  that matter let's go a little closer to safety that their factories met the f d a requirements for cleanliness that's a safety requirement to be relevant the requirements and standards have to be the kind of of standards that are relevant to the  that the plaintiffs bringing not to some other thing that we're good people and we comply with the law and i think the jury contrary to what bar is arguing i think the jury likely assumed that the product was on the market legally because nobody told them it was but i really want to get to talk to georgia law on this because i think it's important to understand the cases board cites about georgia requirements all deal with specific performance standards like this court address and  explicit citation to the restatement third which the defendant cite as our argument for why regulatory compliance is important but i think it's important to drill down and understand what the author of the restatement we're talking about under the restatement the section for a product's compliance with a political safety statute is properly considered in determining whether the product is defective with respect to the wrist sought to be reduced by this data to regulation comments to this this section make it abundantly clear that it's something more than some general standard that is relevant to safety common a set as a safety statute or administrative regulation they're talking about are ones that stablished binding safety standards for the design and marketing of the products comments she says for the purpose of this section the safety statute or ministry of regulation much be such that compliance in that case would be compliance with ret regulations that reduce the risk of harm from the product being tipped over the four ten k evidence here doesn't reduce the risk of the harms that would cost the pla such under the under the ga law we're not relevant in the in the case now we cite a bunch of different kinds of cases where the courts have looked at five ten k and see that it isn't about not five ten k clearance and the device was marketed under general general so in the courts and the courts denied the the use of that evidence in a plaintiff's case and we also have a tally which was the medical medicaid reimbursement case all of those case the defendants when i say those are relevant those are something else but all of those cases bear one legal conclusion in common and that's these cases and they go for decades pre and post the enactment in one nine hundred ninety of the safe medical devices memo and they say and they're all based on this conclusion that a five ten k substantial a clue fluent clearance is not a safety regulation and so that you take that conclusion and you applied in the context of georgia law like the district court did in this case you come to the conclusion that that they didn't say the mesh had to be made out of a certain product they didn't say the match had to have performance standards in fact let's let's go let's talk about their last argument they raised in their reply brief about how the f d a classified these devices as class two and did this ten years of study studying well first of all  argues that that the f d a concluded that the panel found there was generally accepted satisfactory levels of tissue compatibility that's not what the panel found the panel actually recommended stablish inc a performance standard for surgical mash and said that the materials you should meet a generally accepted satisfactory level of tissue compatibility they didn't say they had met it they said we need to establish a performance standard to assure they met and that's why they made in class two there has never been and there never was and there's never been an adoption by the f d a of any performance standards that apply to surgical masks in general or that or they  tests that may or may not have resulted in the bonding of some level of safety but the problem is that the jury would have to redirect its attention to this particular analyses and determine for itself exactly what the regulation meant and it seems to me that the this report decided that it just wasn't worth the effort well and i mean what i think is the best argument that supports that position the risk of unfair prejudice is particularly acute in these cases because the f d a takes such actions based on considerations that are foreign to most lay jurors and that are distinct from the a political liability standards that govern plaintiff state tort law clients although jurors conclusive evidence i didn't say that we didn't say that the district court didn't say that that was barred argument in opposition to the f d a evidence we wanted to put it we believe they were right and the district court correctly found that they were right on  three on four or three for that issue and their argument that well if you accept this argument well you would have four or three in any case i think that's an exaggeration of the record in this case this is not a case where someone generically said five ten  e bad this is a case where the district court recognized and made specific findings that there was another side to the f d a approval of these particular classes of devices so whether or not  by the district court who had before it the record of both sides and sought to avoid the precisely the problems that bart worried about in fact in and that quote continued parred said in order to counter this inference bard would need to present polypropylene was being used along with old number of other materials so the f d a says well you can continue to use them these manufacturers came up with new products new devices the f d a said it's the same as those other products which have never been studied in particularly approved by the a under the rigorous premarket approval so that's why yes it's something but it's not a specific safety regulation that says you need to make your pelvic mash this way with this size pores without these arms that cause other problems and without this pig college and then causes adverse tissue reactions just rose so the f d a doesn't get the opportunity to tell the jury that product is safe so what's the basis for allowing a supplier of the raw material to tell a cure that the product does not say so but well it's a mysterious argument let's be really specific about what first of all what the statement says the statement doesn't say the material is on say what the statement says it all but it says do not use this material in medical applications involving permanent permanent implantation in the human body or permanent contact with internal bodily fluids and what do you think that tells a juror that tells the jury that manufacturer hasn't decided to manufacture doesn't believe that this product is appropriate for that use it's not saying it's not appropriate for that use and what what what's the foundation for allowing that evidence ok well first of all i think the district its conduct in the con but the problem with that is that the use of the statement one or beyond that i mean i heard the closing argument the the plaintiffs in this case went far beyond using the statement or some other was not and which gets to gets to the next argument we have and that's b s and and that is the judge made really for rulings on the on well i'm the motion and lemony said if you come in if it's not hearsay it can come in under eight o three said in that same very same ruling is to the extent things can come in for some purposes and not another it's incumbent upon the parties to object to trial in this case the first two times m s g s comes in they come in th plaintiff we asked whether she knew about that and she would have the product in plan and she said no no objection comes in through the plaintiff's implanting physician same question would you have implanted if you'd known that he said no then the next time then the statements get introduced by have to be met me what they're arguing in their briefs here is that we didn't meet those requirements it was income and what the rules say on motions and women e is that when there's a conditional ruling it's incumbent upon the party to clarify any the party objecting to clarify any doubt and what's important to is nowhere in this record did bart ever ask for a limiting instruction or instruction it did not say object why is this coming in and attempting to clarify given the district court's multiple grounds were saying where it could come in and given the district court explicit warning to the parties that that you you need to object to clarify why it's coming in for example if it's it error to put it in under the expert exception without having the expert testify that they relied upon it that's an objection bard needs to make at the time the experts testified they can't just wait until their appellate reese to make those arguments and you know and terms of and finally i think the probably the third argument second argument is probably not hearsay the second argument is that that it comes within the exceptions and to the extent that there is that that the record doesn't establish that that that that comes within with the exceptions it's because bar didn't do its and an eighteen or probably a tie the you know the with respect to seventeen when it went in through their expert witness and that and that so that it and it's very clear that if you look at an m s d yes it is a it is a compilation that's generally used in relied upon by the public and persons in particular occupations m s t she as cheats are a lot upon by manufacturers such as bar d there is evidence in the record of that and we think that it fits within that eight zero three seventeen compile  ation i think that's probably that's probably what i would say that's the best the difference it's different topic in this case the jury came back with a verdict on ability yes right initially and then there was a separate proceeding for damages ye in that context was there any request or argument to bifurcate the damages proceeding into an actual damages first and then later a punitive damages see was it all done one time what happened parties closed with respect to punitive and then the jury came back with the word punitive damages that the it or argue at that point after the compensatory verdict came back they obviously  problems there was significant evidence and did nothing there was significant evidence that bard's both internally and externally people requested that that additional studies being done there was significant evidence of the limited animal studies that were done that turned out that turned out badly all of that all and then and then with respect to causation bards own lawyers agreed there was sufficient evidence of causation for some of the alleged effects to go to the jury and it's important to georgia law under georgia law we don't have to prove each defect in causation just that the product of as a whole is one reason we don't say i'd like to also touch on since the since you asked just judging reprehensible not only to them s t s we have the failure to remedy the defect the failure to test and the failure and the dismissal of the bad test they had all of that the district court found added to represents ability case that i'm aware of that have been cited that says that a ratio alone maybe if you had a ratio high enough a ratio alone would be enough to to overturn a punitive damage case but this is a single digit multiplier in a compensatory damage and ward compared to other compensatory damage awards or it is not reasonably high and so multiply eighty seven times multipliers consistent with a number of verdicts in fact in campbell  when when the u s supreme court group we mandate state farm versus campbell the the court entered any punitive damage award at a nine to one ratio and then surplus did not so we believe that on the fact how reprehensible all this is the facts of left first of all i think it's important to note that one of the concerns about punitive damages is that that the defense will continue to be exposed to numbers of punitive damages awards in this case if the georgia statute the other provision of the respect to the with respect to that to the georgia statute you know when it when we did time i was under the impression i was going to get a rebuttal and i say five minutes and i think i don't know if we went in the ok so i deal with the idea with the you were just after them ok well again unless the court has any other questions we believe that judge goodwin very carefully ruled on these discretionary rulings that were cracked and we to twenty five of a reply brief where we address the the surprising preservation argument i say surprising because the district courts in women who orders show that this to court knew the difference between saying we'll see how this plays out a trial and a definitive ruling i prefer the court for the joint appendix at eleven sixty two through sixty three which are definitive rulings by the district court that the amnesty s is admissible for its truth under three hearsay exceptions it is true i point did not seek it but my opponent grabbed it and ran with it throughout the trial you came in with dr raven the first witness testified they presented the chemist yes to dr even the beach initial treating physician from assistant did you know about this would you have done this surgery which you've done thousands and thousands and thousands of times in consultation with barbara would you have done th surgery if you had seen the m s t yes no i wouldn't i wouldn't have done it we objected the objection was again overruled they don't presented to missis and during her testimony to elicit very prejudicial testimony from her about how she felt about the m yes so we and then they then they used it as in the cross examination and direct examination of our vice president for research and development mr le roy and that's were actually the prejudice crystallizes from surprise to hear them argued yes once the m s t yes was there and judge the as the cat was well out of the bag mr wright testified that we had been buying from from this company for years and years and years it had not been on the m s t yes we had not seen it on the amnesty s until after the manufacture of the evolved a plus in two thousand and seven was the first time we saw it and when he tried to answer the question why didn't you do something about it he explained a number of things about bars internal procedures and then said and we comply with worldwide regulations at which point the district court jumped in without an objection from the other side warned bar that it would have he called a mess here with the testimony continued and mr le roy was instructed not to make any mention of not to make any mention of five ten k clearance and explaining why bart had continued with the same manufacture of the process we raise the issue again in our motion produce trial interesting lee our opponents made no objection to the district court that the issue was not preserved and the district court addressed the issue on the merits in the new trial motion as to the closing argument this is the first time i've heard has it doesn't appear in the briefs that we should have objected after testimony that was ruled admissible several times by the district court was presented after the district court instructed our witness not to respond to that testimony but the most powerful response but after the district court rejected our request for an instruction to the jury that the plane was required to present expert testimony that we should have acted when the plaintiff took advantage of those rulings and made the argument that it made under the rules established by the district court there is no requirement that we do that it shows the prejudice wasn't an improper argument outside the evidence was an argument very  on the evidence but the evidence should not have been there and then the district court tonight and bush were to try i don't know what else could be expected of us to to preserve the issue for appeal but let's talk for just a minute about georgia law because i don't think it was accurately portrayed so you might read the georgia supreme court decision under the risk utility test compliance with federal standards or regulations standards or regulations is a factor for the jury to consider in deciding the question of reasonableness that is whether the product design selected was a reasonable one among the feasible choices of which the manufacturer was aware or should have been aware that is georgia law the f d a judge gregory is indeed something it is the process by which more than ninety percent of medical devices are are cleared for marketing in the united states it is what the f d a now describes if i might a page seven sixteen of the joint appendix as a multifaceted pre market review process that is expected to assure that clear devices subject to general and a political special controls provide reasonable assurance of safety and effectiveness reasonable assurance of safety and effectiveness and to facilitate innovation in the medical device industry and a page six thirty eight although the a five ten k process involves a comparison of a new device to a predicate device rather than an independent demonstration as for a p m a in both cases f d a is review decision reflects a determination of the level of control necessary to provide a reasonable assurance of safety and effectiveness this is a safety regulation with which we complied and the only regulation by which we could have sought to bring this product to market and that's what we wanted to prove to the jury in compliance with georgia law final point the jury was instructed in accordance with georgia law that is the jury was told that one of the district court excluded and opening statement for the court to the opening statement when when we can to get into other other f d a regulations because that indeed had been left open in the district court's ruling the district courts ruled words were to the effect of i'll make this easy for you nothing comes in about the f d a so the jury doesn't hear anything about how this product got to market why we were selling this product all they hear is that we were using an unauthorized material to create our product and when we don't defend ourselves by showing the software on the market what reasonable conclusion can be drawn by a juror who didn't hear anything about safety regulations we've distinct possibility the frightening possibility exists that this jury believed we were not lawfully marketing this product when in truth and actuality we were in compliance with the safety regulation and we with respect to the cross appeal i think that it's important to put this case in the procedural posture that in unlike the other cases is not a case where someone has a hypothetical amount of a claim that they may or may not get this is a case where my clients now have an actual judgment that the property rights the judgment says donna and dan sisson shall recover one million seven hundred fifty thousand dollars from barr we believe we under we believe that's enough of the property right to impose the requirements of the constitutional due process and that georgia can't willy nilly take that away without providing due process and just compensation under the fifth amendment and addition we believe that unlike laws the statute but in the statute as the court in mcbride explained has no rational basis to explain why product liability plaintiffs ought to be treated any differently than any other plaintiff at that that's getting a punitive damage argument with respect to any other punitive claim and it's really a car accident graph cause but we're talking about the single act of a person grossly negligent running into someone and you know because the way they were doing they were drinking district court in mcbride with the first court has to look at this got that got that right that's all i have that if the court would be no barge counsel made the argument regarding the jury instruction which was not  regional argument and if the court would like to hear a response to that i would be happy to do that if we're i think you women are young girls i mean the court in the trial court in this case gave the whole georgia pattern jury instruction which also has factors like the appearance and aesthetic it attributes of the product so so it was not that the court picked on bard by putting this regulatory evidence in more importantly you know we can talk about what you have a duty to object to you do have a duty objective jury instructions and this particular jury instruction was not objected to by bard on this basis in fact it was objected to by the plaintiffs by my counsel sitting at the table with me on the grounds that there was any evidence of nonevent in the course of this trial and not objected to by bar that the f d a cleared the product under five ten k because that is that is not a safety standard they are allowed to do is explain it testimony about how it was a liability issue and they had testimony you know there was a whole explanation about that statement and the m s g s that the jury got to hear and resolve and resolve themselves it was not in the court didn't just let the plaintiff put the statement in and then not have any other debate about the issue