failure one claims are granting drug manufacturers because of the basic proposition under federal law that drug branding drug makers are responsible for keeping their labels up to date the court recognized a very narrow exception however where there is quote clear evidence that the f d a would have rejected a proposed warning that would have addressed the theory of liability by the plaintiffs of  change and had proposed to label language they use the word stress fracture in a number of instances six instances and had proposed having atypical femur fractures included in the adverse reactions section of the label as well as in the proportions and warning section this document is the best evidence of what the f d a says position was with respect to a label that would a period their course comes after this document and the press release was not a was in response to an a b c news expos that i think can best be read as understanding that what the f d a was trying to do was to reassure the public not to mediately stop taking fosamax while it was continuing to determine how best to work on the label but this may twenty second document the reason why it is so important for you is because under the regulations and i would ask you and your clerks to take a look at a regulation that was not cited in the briefs it's twenty one c f r three fourteen point one zero one zero that elation says that when the f d a rejects language offered by a manufacturer it has to give quote all reasons for the deficiencies that the f d a perceives all reasons and then what it does is it says you have to do this in what's called a complete response letter that letter goes to the manufacturer which the f d a sets out all of the reasons and then the manufacturer has a chance to respond as to the precautions language quote your justification for the proposed precaution sectional language is in adequate identification of quote stress fractures may not be clearly report was that normal doctors are basic general practitioner who's non work repeated surgeon who's not looking at x rays of these kinds of of fractures is going to be misled or not understand the relationship between defenses reaction when reasonably have been we're going to hold off as it says hold off no the hold off is simply it particularly when you view the unit in the context of f t s later explanations about the stress fracture language is simply asked you to look into a crystal ball you're making reference to the later memos i'm talking about as of april fifteenth two thousand and nine that they're being told don't you know don't do it live here at this thing absolutely not they're being told hold off because we're not convinced that you have got it right on the language and that's why when you look at the letter the letter which comes a month later yes she writes it is under the regulations is the quote complete response and so the fear theory of this case is that the response that the f d a made in its complete response letter rejected for scientific reasons when that's not anywhere possessed presented in the in the letter  regulatory standard is for having an adverse reaction or a warning and remember the f d a has already accepted the atypical femur fracture language in the adverse reaction section right that regulatory standard is much lower intricate are lower in terms of there being a belief a reasonable belief that there could be an association what the f d a is saying in the press release is we haven't shown causality you should therefore continue to take  causation but we've met the regulatory standard for a reasonable basis in the evidence to determine if there's an association the label is always got to be updated by the company because the company is in the best trump the prior regulatory action because you asked for documents that occurred after all of this and we submitted those i would urge you to look at the eklund exhibit one fifty four which was one of the later ones that we sent to you in that outline in the summer of two thousand and nine after this complete response letter f d a says we're happy to talk to you further about the language but we would a reaction and that's why i started my argument by asking you to look at a fifteen hundred to his advantage complete response letter under the regulation three fourteen point one one zero has to give all of the de plaintiffs proposing language merck has to propose the language and this the burden is on value creation is an affirmative defense at the summary judgment stage they have to prove that there is no reasonable evidence on the other side alternately it is and that's why the judge taking this away and not focusing on what the best evidence of the f t s position with the n t is required by regulation to put all of the reasons and the only reason that it cites for rejecting why focusing on this document and you look at these other points judge restrepo and i can see that the language in that press release is a little bit unusual but if you line up what the regulatory standard is and never and in fact the only time that it didn't get into a warning it required warning and and that was very clear from the late two thousand and ten period how would you define the standard i would define the standard of clear evidence yes i w as evidence from which a reasonable person would determine that that is the only way to determine what the f d a is action was and that's why these formal regulatory requirements are so critical to the reasonable person good come to one conclusion that's correct that's correct i mean it's something beyond the preponderance of the evidence the lies seems to lie somewhere between that and i guess from beyond a reasonable doubt read the district court you're all over the place with this concept and we're trying to figure out how the how would you define that word sure i think the way you would define it at the summary judgment it was as if it were it is is the troubling what the haven't showed the f t s action was and we're there's a dispute about that where there is the dispute about that judgment use i think that the courts surely is going to have to give some guidance to the jury in determining this but that's why the regulatory requirements and we should have summary judgment for us on preemption in light of the seven injury record if you understand the context of this particular document summary judgment should be will for the plaintiffs and we should be entitle to go on with the case and try to prove our occasions this court in cases such as in re federal mogul warren versus thor tech or taj mahal travel and there are others this clearly stated i think as you several of you have suggested preemption is an issue of law it is purely an issue of law and i would recommend to the court two cases which came up after the briefing was complete which i think are very helpful to understand this concept six five five but those two courts of federal district court and a state court sitting together dealing with a masterwork proceeding spent a lot of time looking at this issue and basically what they're saying is this is an issue of law like other issues courts deal with why jurisdictional determinations and so on the court has to sort through facts and make a determination that but it is a legal issue and listen in this in this area i mean you've got a pretty high hill to climb to that you've got something the supreme court calls clear evidence it's all through the prism of summary judgment which means you've got it we've got to give all deference to the other side's was issue but i think your honor you letter or or request from her your honor that's that's right and that's the clear evidence test that you all referencing earlier but that's a that's a determination the court needs to make that's the legal issue you can debate about what all those there's a series of things and some unfortunate not been mentioned and quite a surprise to ignore i think the first thing is the documented one nine hundred seventy the documentation of the conversation which mark had in april two thousand  with dr monro who was a division director at the f d a who sad more paul said what's with our proposal to change and he said in that conversation that the conflict in nature of the literature is not providing a clear path forward and more time will be needed for the f d a to formulate a formal opinion on the issue of precaution around these data so couldn't work respond to that with a c b no because he's saying then you have the e mail your honor that you were mentioning earlier which came a short time later which said asked us to hold off and i think it's clear to get the full quote and this is the f d a e mail that they would need to work with more to quote decide on language for a warning in precaution atypical fracture language if it is normal and then we will go to the letter that i'm sorry they what is being said here at the science isn't there at that point yes they were raising issues about stress fracture issues and so on but your honor you have to take account of the fact they also had language problems with our adverse reactions section and they just said here change that they didn't do that with this section because the as the record indicates they had a problem whether the science supported making a change in their social one about the the  hid the letter of a fifteen hundred really hard so that's all you need would you mellish on that that that's that's what i'm talking about your honor and i don't think the letter says that i think it says the science is lacking first and foremost yes they raise issues about the language but you have to read that letter for what it is and in the context as the other communications from the f d a saying we're not ready to move on this yet your honor you also have to to your honor's you also have to take account of the fact that after   to make a proposal and then go back and work with them to change the proposal in a very tight time frame they didn't do that here at this point that's exactly what they did when the  more report came out which they said is new have against that justify the change that happened later so this is entirely consistent with the record that we're laying out that they would not have this is clear evidence that they would not approve this owning or because they didn't move forward under five zero five zero four at this point you know this is a record is sizable has a lot of reports from different side to this and  a sort of a lot of these independent reports sort of beside the point are resource look at what the f d a might or might not do well your honor i think it's important though to to look at these these other reports because this is as several of you mentioned in the march ten statement by the agency is also critical on this issue because it did say at that point the data it had received in this referring at that point to the data that it is they have to find reasonable evidence of a causal association that's what we're talking about but they're in mind in that statement today to the even today that the labeling doesn't say there's a causal relation right  women using these medications this is all the data that everyone had submitted to that point and then they said we're going to work with these independent groups that you're talking about particularly the a s b m r to see if we can sort this out and then when the as b m r report came out several months later then the f d a sprung into action involved five zero five zero four said this is new evidence that justifies making the change and here's the change that we want you to make and i think this is clear evidence that they would not have would not have urged this change would not approve this change earlier stage documents provide the best proof that there is clear evidence that the f d a would have said no i think it's the internal memo a nine hundred seventy that i referenced earlier that that talks about the conversation that they had with dr monro and i also want to know that in that document the f d a also dr monro also told mark that they wanted to approach the issue of giving a precaution from the perspective of all manufacturers that's another reason they were saying wait they didn't want to do this separately from our colombo was the only manufacturer that had proposed anything and that's another clear reason why the f d a would not have approved the change at this point is because they were question of whether there is preemption and again i would urge the court to to look at this very careful analysis of a lot of law in those two california decisions i referenced it is not a jury issue  not well i mean it's because these it is not it's a question of law and this court needs to look at the record or whatever court's dealing with it as a matter of law and make a determination as to whether the a question of law also your honor it's i think we also need to take account of the fact is i'm sure you appreciate the bill a lot of preemption pieces decided out there no one says to the jury and you're to give different answers in different pieces it is a question of law that needs to be resolved on this issue i mean if we if we send these cases back and put this question the jury in each one you have different answers what about the claims that are there that are based on the adverse reactions argument as we noted in the breeze half with those half of the claims that are there that doesn't work because there was a change made to the adverse reactions he came forward before the district court to put forward a specific design defect theory on this everything that was brought forward as a judge who actually noted him back to failure to warn you didn't tell certain people they shouldn't seven fifty one after one fifty the court faced the same issue on the design defect in the court said we don't have to sit here and imagine every possible design defect theory and say that it's rule the alibi the preemption argument it's the design defect claim with respect to the adverse reactions claim they were offered the opportunity to say here's my doctor now as part of your show cause yeah and and if if if if my doctor had seen this t basically did it it did not reverse the bird it gave everyone the opportunity to brief falling on this issue which is treated the four motions that market already filed as being the summary judgment motion which the court to determine took it far enough to shift the burden and everyone has a lot of response classic compliance with rule fifty seconds thank murder scientist five weeks before the quote complete response letter so these are document this is a document these are notes we don't know whether this is a red baiting transcript we all we know that these are them are person notes that even those notes in talking about the conflicting nature of the literature we would concede that there is conflict in the literature our point is that the best evidence in the literature said there was a problem with  fractures and that's why even that conversation even if it isn't accurately transcribed can't be clear evidence that the f d a was rejecting particularly in the regulatory context when five weeks later the f d a is charged with giving all deficiencies in the label that merck has identified and it doesn't use the word science in that letter it's talking about the language it says quote your quote only we're the f d a is unequivocal that it is rejecting a warning because of lack of reasonable scientific evidence of a causal association between the drug in the medical risks does the rejection constitute quote clear evidence that the f d a would have rejected any warning of the medical risk that is distilled from where we think the cases are but isn't it true articulation of what the standard is i think that's the best that we can do in these circumstances and tell me what you a ultimately me and dated would be sufficient to warn people about the atypical femur fractures and the question is you put the white question to my friend is hypothetically since merck never presented a proper label how we determine and that's why when the supreme court says this impossibility preemption is such a demanding defense we have a hypothetical here we don't know what the f d a would have done at birth earlier offer a properly worded warning label if we were to agree with the district court of preemption what would happen to the other claims i don't think you would reject those because the judge in the glen case didn't decide the design defect claim on the basis of preemption what the judge  we did once we presented to the judge you know the five hundred or so other cases for which there had not been discovery that there are design defect claims or these other kinds of claims and the judge realized he couldn't cover them with preemption like the every clain and these can't be class cases jeffress repost because of the am cam versus windsor case which said that tort cases which have individual injuries can't be done as a class so that's why there was no master complaint here there was a there was a series of complaints there was a liaison counsel there was but this one all a series of individual cases where these people mostly women postmenopausal women were have complained that they had suffered these catastrophic  cases had not been gone had not gone through discovery while the glynn case was being done the judge had said let's not do discovery until i decide this bellwether case but if that point this thing happened so quickly that  new discovery we were putting in declarations to say this is if we were permitted discovery this is what we would be trying to show and it was it was a forty five day scramble among the pros a priority hundred prior to that forty five day window for the time of the first with rational factual question about clear evidence i think that in the first instance depending on how you explain the preemption ruling rejecting their preemption defense we probably would move for summary judgment that there is no preemption well reasoned decision everybody understands kind of where this goes there's a limited in finite amount of evidence on that but it is not the case in the in the supreme court's decision in boyle technologies from the early ninety's makes clear that there are a fact questions in there are fact questions under the preemption analysis that questions are within the province of the jury it is correct that the jury is not deciding the ultimate legal question of preemption in those amendments even where the f d a can require only will change it does not displace the c b e regulation specifically by statute it says that the c e regulations face in place so the burden is always on the