fully informed of the risk of atypical femoral fractures ignored that risk and its own statutory and regulatory responsibilities because it didn't like the way merck phrase its proposed warning that cannot be right if a manufacturer as merck did here informs the f d a of a possible risk and unsuccessfully asks to revise its label in light of that risk then failure to warn claims based on that risk are preempted as a matter of law that will follow us from the statutory  regulatory framework governing the f d a conduct and from the presumption of regularity the presumption of regularity of course assumes that federal agencies do their jobs correctly the f d a is job in this case includes protecting the public health by working with manufacturers to revise drug labels when necessary mr different skeet to give you a hypothetical because i think we couldn't could all agree that if you had proposed a warning but let me just say majors major fractures versus stress fractures and if you had proposed a warning that dealt with major fractures and the f d a had said no we don't think that the literature supports that then there's nothing you can do and you should be immune from any suit and i think that that's pretty clear the question is sort of you know did did you propose a different kind of warning so let me give you a hypothetical suppose that you manufacture a drug and there's some evidence whether it's enough hard to know but there's some evidence that it causes ovarian cancer and you drug manufacturer proposes a warning to the f d a but instead of saying that the drug causes a very in cancer you say it causes a very insists now ovarian cysts are nothing that anybody wants to have but they're an inconvenience they're not a very in cancer and the f d a says no we don't think that that's the issue at all does that mean that you are off the hook now with respect to revising your label to say that your product causes a variant cancer i don't think that you're necessarily off the hook in that situation because you have been warned about the relevant risk but in our case there's no question that merck did warn about the rug risk the united states has told us that that is how the f d a understood the warning the third circuit acknowledged that merck proposed to warn about a typical femoral fractures and you have to look at the context in which this warning came about ok so that makes it a much smaller case right that we can agree on things on either side we can agree that if the f d a said you you don't have to warn again about major fractures you are off the hook and on the other hand we can agree if the f d a rejected the warning that had nothing to do with the thing that was really at risk you're not off the hook and then the whole question boils down to what was your proposal what was their response would you both talking about the same things in other words would you both talking about major risks or did the f d a look at your proposal and say they're not talking about major fractures there are only talking about stress fractures and there's no reason to think that stretch fractures are a real risk and no reason to put that in the label i don't think that's quite right justice kagan because you have to look not only at the warning that was proposed but also at the information that was in front of the f d a about the risk and this is where again the f d a is complete response letter has to be understood in light of the f d a statutory obligations under three fifty five zero four the the secretary is obligated if it believes that something should be included in the labor included in the  the warning it shall promptly have a back and forth with the manufacturer producing but that's the reason i asked that question about the ovarian cancer and the variances because i think you could say something like that well look it's true that our proposal had talked about ovarian cysts but we gave them all of this data and if they had really looked at all of the data they would have seen that it could it there's a real risk of all of course in ovarian cancer and the fact that they didn't tell us immediately to change our label means that where exempt from suit and i would think that that is not a good understanding of the statute the idea that they have to look through all of your data even though you pinpoint an entirely different risk in order to find out what the real risk is and and that if they don't manage to do that you're exempt from  suit that seems to me a very counter intuitive reading of the statute and indeed not just counter intuitive it seems to conflict with the statutory provision the rule of construction that says that manufacturers have primary responsibility over their labels and for that reason i think that would be a different and more difficult case than the one that we have here but here at the complete response letter has to be understood both in light of what it says but also against the backdrop of the f d a as regulatory duties and the back and forth wadi f d a please point me to where in the complete response letter you say that they were thought stress fractures were the same as the a typical fractures as i'm leaving the response letter and this is what they said to you you justification for the proposed precaution section language is in adequate identify in adequate identification of quote stress fractures may not be clearly related to the a typical forget that word fractures that have been reported in the literature discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature nowhere did they say that the a typical fractures are not supported by the literature and nowhere did they say don't change the rest of the letter tells you make changes and we'll come back and talk more about this i look at their argument that the conversation that your person had with them was saying to them we're thinking about this now come back with something else and maybe we'll give you what you want maybe we won't but i don't think from the complete response letter if you're textualists that you can look at it and see that they were saying no to an a typical fracture warning they were certainly saying no to a stress swarm so read me something in the complete response letter from that letter standing alone that you could draw you make two points just to sort of meyer first the complete response letter is not a statute that can be read in the same way as a textualist would read a statute it has to be understood against the backdrop of the statutory and regulatory backlog but if we're going to focus just statutory backgrounds basically says the only way that you with eyes someone to change the label as i understand it is if it's minor changes this would be a major change and so by regulatory standards they would have been acting improperly if they had approved your language with telling you make some cosmetic changes because they didn't think this was cosmetic i respectfully disagree and warranted to work with the manufacturer and if it disagrees with the proposed changes by the manufacturer it's obligated by the statute it shall initiate discussions to reach agreement so it can't just say no to a warning if it disagrees with the phrasing of it and in records where is the in the back and forth do you have references to the typical stressed a typical fractions so the term a typical femoral fracture is what we're calling today the risk respondents are concerned with that term denied even really begin to be settled upon until the task force report that came out later but what is clear both in the back and forth and on the face of the complete response letter is that merck proposed to warn in both the warning and precautions section and the adverse reactions section about low energy fractures at the sub truckin terek region of the femoral shaft that's a joint appendix five eleven so the letter begins by noting that that is what merck proposed to warn about in both sections of the label so we know that's what the f d a is thinking about we also know from the f d a streetman of the adverse reactions section of this purpose of the proposed warning that when it wants to revise it justified warning does so for the adverse reactions warning the f d a proposed at it's but for the warnings and precautions section it didn't we know the same thing from the f d a as october two thousand and ten interaction with merck at that point after the taskforce had completed this study and when the f d a carried out its obligations under three fifty five zero four by initiating a process with merck merck again proposed some language that included stress fractures and the f d a redlined it so that's what the f does when it thinks a warning is justified but it disagrees with the manufacturers proposed language council doesn't put i think the question that we're all kind of struggling with here seems to me to be this or something along these lines really was tension your way do we create a moral hazard that encourages manufacturers to supply the f d a with a lot of information overwhelm with data but maybe not the most are f drafted and maybe deliberately in our fleet drafted warning that it thinks is recently calculated to be refused so that it can avoid having to shoulder or bear its own a itself which is would be in the position of having the problem that you're describing it doesn't seem concerned about that problem but the other comfort that i would give you is that we don't dispute that under the statute both parties both the f d a and the manufacturer have certain responsibilities we're not trying to absolve the manufacturer of its responsibilities but when you have before you an impossibility preemption case where the f d a rejected a proposed warning the only way to understand the meaning of that rejection and what it means for a possibility is in light of the f d a as part of its obligations the f d a does have some obligations and where it is provided with a warning that it understood to be about the relevant risk and rejects that that necessarily establishes that it was impossible for the manufacturer to simultaneously comply with but will will be both but the way you answered that question you said a warning that it understood to be about the relevant risk and and that's really the question of the back and forth about the proposal and about the f d a his reaction to it is whether the f d a understood to be the warning to be about major fractures given that your proposal talked i think in six different sentences about stress fractures so let me address the stress fracture language because i think that may be causing some of the some of the confusion you the the risk that work warned about was about these a typical i wouldn't say about low energy fractures at the sub truckin terek region at joint appendix seven forty six merck explained to the f d a how it was using the term stress fractures and it explained to the f d a that term stress fractures included the very same kinds of things that respondents are concerned about including insufficiency fractures and complete fractures those are all kinds of low energy factors which is how merck was using this term and moreover the woods if i understand that if i understand this sort of terminology and maybe i don't  essentially there's a world of things where you can have a traumatic incident that leads to a fracture and then you can have other fractures that are not caused by trauma but the fractures that are not caused by trauma can be small fractures stress fractures the take care of themselves with rest and elevation and large factors were all of a sudden you're staring at a bone that's popping out the wrong way  so those are really different things they're both caused by something that's not a trauma but one is an inconvenience and the other is a serious injury the serious injury the complete fracture is something that begins as what looks like a stress fracture and can progress to completion and so what mark was trying to do in this warning was to explain if somebody comes in complaining of the some kind of pain that might be consistent with a stre fracture doctors ought to figure out what's causing that and if you rule out the typical causes of stress fractures exercise steroids alcohol use things like that if you rule those out and they don't explain the symptoms that the doctor seeing then maybe consider stopping bisphosphonate use because perhaps there's a connection between bisphosphonate use and what will eventually progress to the completed fracture if we read your the letter to refer to stress fractures as something and not a typical fractures could you still win this case we could because regardless of how you read the letters the f d a has told us in this court and has all and all of the has actions in connection with this with this area show that it understood what we were talking about and the one additional piece of evidence that i would point to that i haven't identified to this point in march two thousand and ten months after the f d a issued its complete response letter it made a public safety announcement saying that it was continuing to study this issue of a typical family fractures it still was not convinced that the data supported a warning and that doctors should continue to prescribe in accordance with the existing label that shows it again that f d a the f d a was on top of this problem it was studying it and it had not yet even months later reached a belief that a warning was justified given that it was impossible for merck to provide one in accordance with the purported requirements of the march investigation starts if it does that doesn't pose a problem for us the standards for evaluating a c b e are the same as the standards for evaluating a p s it's essentially the difference between asking forgiveness and asking permission because we know that the f d a rejected the p a s we also know that a c b e would not have been authorised either and again that's what establishes a bus or perhaps especially that with respect to for purposes of this question before the march two thousand  letter but what about after that one once it starts launching an investigation into the product the task force period what we knew about that period well i think that the point though is that in march two thousand and ten what the f d a said is that it was waiting on the task force report nothing had changed it just said that it was studying the information when the task force report came out that's when the f d a acted and said now we are now we believe that a warning is justified and it initiated at three fifty five zero four process if mr stewart mr chief justice and may it please the court would like to begin by addressing an issue that both justice kagan and justice course each of touched on and i think it's important to distinguish between two potential types of confusion the first is that in october of two thousand and ten when the f d a ultimately decided that in addition to the warnings and precautions section of these labels was warranted it rejected mercs proposal that the warning include repeated uses of the term stress fracture and f d a did express at that time the concern that practitioners for whom that term usually connote a relatively minor event might read it as understating the seriousness of the potential risk of first of x that potential type of confusion needs to be distinguished from the question was f d a confused by merck submission as a whole and there's no reason to think that that was so at page six seventy of the joint appendix merck kind of in the introductory section of its proposals summarizes what it's the warning that it's proposing to add and it says at the very top of the page merck is proposing to add language to both the precaution and adverse reaction post mork marketing experience section of the label to describe low add both to the warnings or precautions section and the adverse reactions section proposed to address the same bret's and indeed the language that it proposed to add to the adverse reactions section included across reference to the proposed warnings and precautions section again reinforcing this that the second thing i'd like to point out in that regard is of what my colleague was referring to as the mercs own explanation for its use of the term stress fracture m explained to page seven forty six of the joint appendix in its proposal that it was using the term as an umbrella term to refer to fractures that could be partial or complete the distinguishing of it was that they occur without external trauma and so it's not a matter of something being a serious fracture or a stress fracture the term stress fracture encompasses both serious and relatively minor fractures again f d a is concerned ultimately was that practitioners who were used to seeing the term in connection with minor events might misconstrue it but f d a understood it to refer more generally to any fracture that was caused without external trauma no need to understand mr stewart like what f d a understands at any given moment and that was what are we to look to when we decide whether it's impossible for merck to change its label because one easy way of thinking about whether it's impossible for merck to change its label is to say did the f d a tell mark that it merck to change its label and it has responsibility over its label and to the extent that it thinks that the literature supports a change it should change its label well let me say two or three things about that the first is you look first and foremost to the letter itself and it would obviously have been better if the letter had stated without ambiguity the reason we are rejecting your proposed addition to the warnings and precautions section is that we don't think there is sufficient evidence of causation to warrant inclusion of this health risk in this particular portion of the label that would have been better given that the letter of the date that would have been better and it would been enough right we what we wanted to be here or maybe we would but it would be an easy case mark would when writing it but failing that failing in an ambiguous letter the court should construe the letter in light of merck submission in light of the surrounding statutory and regulatory scheme and in light of f d a subsequent actions why m manufacturer of a drug it has a tort duty to ensure that its shows are either safe or that adequate warnings are given when it's not the act does not take away that responsibility it does say that you have to get approval from the f d a but if there's any ambiguity given that we're already creating something that doesn't exist in the possibility of preemption why shouldn't we take it at its at its face well and so the f d a says no if you're a manufacturer who understands there's a serious risk to a drug shouldn't you continue to try everything possible including making the corrections that you were told to make including doing what the task force did telling the f d a you're wrong instead what merck did was say i'm absolved i don't have to make the changes i don't have to talk to them anymore i just have to let them then being the f d a figure out what to do seems to be sort of turning responsibility on its head well as you say an important feature of the statutory regulatory scheme is that while the manufacturer has responsibility for its label it can make changes only with f d a's approval not true it could go the other route and make the change itself and wait for the f d a to tell it it's wrong that's true but the reason that f d a sometimes disapproves proposed additions to warnings and precautions or to other aspects of the label is not simply that it regards the warnings as unnecessary f d a has expressed a concern about the potential ill effects of over warning that is if a label contains information about every possible health risk or every bad thing that has ever happened to a person who use the drug people may be deterred from using a drug that would actually be useful the really important warnings tend to get drowned out so what happens here to the incentive for manufacturers to continue working expeditiously with the f d a to effect changes when they're necessary well our point is that if the better reading of the letter if the better understanding of f d a is intent is that it rejected the proposed addition because it felt that the medical evidence wasn't there then for it in the preemption regime that would create an incentive for merck nevertheless to add the warning through the c b e process and wait for f to disapprove it would in our view be counterproductive it would create the incentive for the type of war over warning that f d a would like to discover what when and if if the f d a had said in response in the complete response letter the medical evidence insufficient and then merck turned around within a short period of time and filed a a c b relating to the same thing what would the f d a done i think it would surely have disapproved it and it would have been inappropriate for merck to proceed in that way because the e process is supposed to be invoked only when there is new evidence that the f d a has a previously considered and if the f d a had said in response to the p a yes application we don't think the medical evidence as they are then unless some substantial body of new medical evidence had emerged during the interim it would have been inappropriate for her to use the c b route and it would be inevitable that f d a would discipline i could mr siward you're saying two things there it's sort of two points on a spectrum that you're pretty clear about one is if f d a had told them we just don't think we understand that this proposal is about major risks and we don't think that there's enough evidence in the literature to support that that's that's easy merck doesn't change its label and there can't be a suit against mark on the other hand suppose that the f d a and i understood this to be your point suppose that the f d a had said you know what's the real problem with your label is that you're talking about stress factors and we think that the issue is these major fractures and that's why we're which acting at and we're going to continue to be considering the possibility of major fractures if the f d a had said that clearly is not off the hook would you agree with that i would agree with that with this cab yacht that you would expect though the letter given that the documentation in burke's submission included a lot of information about the more serious type of fracture even if f was concerned about the wording of the label you would expect expect it to express a view one way or the other as to whether there was sufficient evidence of it all doesn't know yet let's assume so this is something that it just doesn't know yet and it's rejecting the letter for another reason now you might expect that f d a would continue to work with merck about the major fractures you might expect a lot of things but the only thing that the f d a has told merck is we don't like this label that you've done about stress fractures because we really think stress factors are not a problem i guess if f d a had said that on ambiguously it wouldn't trigger in possibility but it seems very unlikely and really inconsistent with the statutory and regulatory scheme to suppose that f d a would do that that it would receive a submission about the risks of these more serious fractures and yet would make no determination even if it in its own mind as to whether that risk was sufficiently severe or whether the evidence of causation was sufficient to warrant an either would or wouldn't take america off the hook my real question for you is suppose we're not in either one of those worlds suppose we have an ambiguous letter who should decide how to construe it i think the court ultimately  should construe it but should construe it in light of the statutory and regulatory scheme which would have compelled f d a to initiate the process for changing the label if it had determined that the evidence of causation was sufficient to support an addition of some warning to the warnings of precautions section thank you counsel  fredricka thank you mr chief justice and may it please the court our position is that brand name drug makers are responsible at all times for keeping their labels up to date if the f d a rejects and in adequate warning or is uncertain about whether and how to mandate a proper warning those federal decisions do not make it impossible for merck to comply with state law duties to market safe drugs i'd like to start if i could with section three fifty five zero four i which is set forth in the a dent into the red brief on page eight that provision explains why it is not impossible for burke to provide an adequate warning of a typical family fractures prior to twenty ten when the f d a mandated label change it's the mania facture responsibility to maintain its label so mr chief justice in answer to your question about the back and forth all that demonstrates is that at best f d a was uncertain about exactly what merck was proposing but this statutory provision which is barely discussed at all on the other side's written presentations in this case makes it clear that even when f d a got the power in two thousand and seven for the first merck is mark became a libel at some point after the issuance of the complete response water or on the day after the issuance of the complete response our position your honor is that the complete response letter sense doesn't affect the underlying judi's at all because the warning that was proposed was an inadequate it would not have but what if the f d a had said the wording of your of your warning is bad because this term stress factor is misleading but beyond that the data does not support any warning relating to low energy femoral fractures i think it's important to keep in mind what the regulatory duty of the agencies would be answer to vat is that it will that likely point stronger in the direction of preemption but please look at section three fourteen point one one zero a one of the regulations because that regulation tells the f d a in its complete response a letter you have to give a full answer or a full justification because that's part of the back and forth the give and take with the manufacturer and so just as course it's to your question about the moral hazard it's not just if the manufacturer deliberately mislead the f d a by putting in its also if the if the scum pany is negligent and doesn't fully understand itself i would ask you to look at the amicus brief by dr lane in this case dr lane was a consultant for merck in two thousand and eight prior to merck submitting its p buy at least part of what you're selling for purposes of this question that the complete response letter and what is it through fifty five zero four are doesn't thank you doesn't completely answer our question we have though the march twenty ten safety statement from the f d a which pretty clearly says that they do not think that there is science enough to support a causal link between the drug and a typical femoral fractures so whatever was missing in the complete response letter from the f d a seems to come in march and ten why shouldn't we read the complete response letter in light of the march two thousand and ten safety again we're getting into the agency musings of the type that justice thomas very eloquently wrote about  it is not impossible for the manufacturer to have done the right thing what doctor lanes as you would i will not dispute the elegance of justice thomas opinion and and wife but i'm not sure that helps me very much  and and i know i'm in all seriousness if we're if there's some ambiguity about the warning letter about the complete response letter isn't that resolved by the f d a his own statement against interest perhaps months later why doesn't that tell us exactly what it was up to because the standard is lower and if you look at that press release in march of twenty ten when the f d a uses the phrase causal connection that's not what the regulatory standard is we set out the regulatory standard on page six of al green and that is a much lower one when is for the precaution letter it's to provide reasonable evidence of a causal relationship or a causal association reasonable evidence is something that dr lame knew in twenty two thousand and eight and was urging merck to provide a better explanation and that's why on page seventeen of dr lane's amicus brief here he says what f d a needed was quote a medically accurate education will and that's why it set up the task force of the same time to go study the issue and it's it up to that point we don't have enough but we're going to go study up and so why isn't that tell us everything we need to know about what it's complete response letter was about because just a simple justice justice course if that's the whole point of impossibility preemption are we going to let dr monroe who is five layers down from the only presidential appointed person at the f d a write a letter that displaces huge swaths of state law now what what the u s g is defense for that is not really i mean are you really serious about that argument that what would be preemptive is not the latter what would be preemptive is what f d a would do and that is that's the question the only argument relating to the safety of the safety announcement is that informs it it helps to tell us what f d a meant when it said no you cannot add a warning to this label justice alito we know the answer when that those words are used in mercs about application are too broad because it is a subset of those now which is it it's inaccurate it's to go it isn't too narrow that's the problem so so what cure millions or thousands anyway of people who need to be cured or helped no when you put on it at the same time there will be a smaller subset that can be hurt so our solution to that is labels now when you say displacing state law or some you're talking like a lawyer which is what you're supposed to do but what worries me is if you go too far in allowing the tort jury to find mislabeling by not including things you're hurting the vast majority of women here or or whatever who can be benefit from this medicine on the other hand if you don't go far enough you will hurt that minority now that's the general framework in which i'm trying to figure out the answer to the question and that's why just as courses just question was was quite relevant all the earmarks here our that merck took this as a letter saying we're not certain enough this is really going to hurt people and we don't want you to put it on obviously somebody must have picked up the phone when they got that letter and they must have  somebody n f p a and say do you really mean that what do you mean because i can change those words stress factor in two seconds or do you mean you don't know enough about it now appointment of the later task force suggest that they felt they didn't know enough about it and therefore merck couldn't have done that now that i'm looking for your answer i've put out a pretty abstract than yes a somewhat pacific but more abstract question i would like you react let's let's not look at what the lawyers knew let's look at what the scientists new merck scientists and this is on page fifty five fifteen of the joint appendix they knew exactly what the f d a was rejecting they said in their internal back and forth the f d a doesn't want her stress fracture wording ok those scientists have been interacting with dr lane who a year earlier had said these are a special type of fracture which don't exist in the general population ninety plus percent of all people who get any typical family fracture are on a bisphosphonate or understood these mr stewart to say it is a particular type of fracture it's a particular type of stress fracture and that the f d a understood the use of that term to be broad enough to include a typical fractures as well that's not ac what he said i don't know if that's what he said but we would dispute whether that's correct and the reason is because if you look at dr expert report which is in the joint appendix and if you look at dr lanes of micus brief they say this is a very specialized form of fracture that generally doesn't occur in the general population you agree that the question is what the f d a understood right i think that that question comes second  the first question is what did the mania factual know or should have known at a particular point in time and then the next question is what did the f d a understand about that because if you take the statute that i started my argument with it's always on the manufacturer to stay up to date remember the manufacturer has a period or information about these drugs to the f d a the budget of the f d a drug safety division was less understood and if when they told the f d a about and we had the different citations to the joint appendix from your friend on the other side about the the notion that stress fracture included the things that would be a typical fractures and i don't i don't understand your response i understand the supremacy clause and state law but the question is what was being to munich cater to the f d a so how is it how should they have read and how did the f d a understand their own response and we know the answer to that because we're hearing about it from the government's counsel today so i'll read to you from page five fifteen of the joint appendix this is the merck scientists who just received the complete response letter they say quote however f d a it believed that our justification to support the proposed precaution text was in adequate it believes that stress fractures may not be clearly related to atypical sub pro fractures so the scientists are interpreted in the complete response letter to see say this stress fracture a language that we offered he is the n adequate the f d a has rejected that language and the reason why the wording matters is because as we've pointed out in our brief and i think it's at page forty one footnote twenty page forty footnote twenty one there is a lot of back and forth between drug companies and the f d a over the wording why because the f d a understands that the wording has to properly educate doctors about the risks associated with these drugs and if the doctors can't understand the gravity of a warning where  their patients may be walking down the street in half or femur snap that's what we're trying to get at the proper wording of these labels sorry that's why congress made the decision to keep the manufacturer at all times what mr stewart cited was page seven forty six of the joint appendix where merck defines a stress fact fracture in this way a stress fracture also known as an insufficiency fracture is defined as a partial or complete fracture occurring with either normal or increased activity but without and identifiable external traumatic event  doesn't that encompass the type of fracture that you're talking about not really would says we're complete get it does justice alito but the question is if you are an f d a scientist who has been looking at the stud this is what you know in in very simple terms this is what troubles me about your argument this is not a situation i think where the and that merck is proposing to warn about one thing and the data shows that there's a danger about something that's totally unrelated and therefore the f d a may not focus on this second thing like justice kagan is example of perhaps of ovarian cancer and ovarian cyst but if the f d a sees this proposal morning and they think this the wording here is bad we should be talking about stress fractures but we look at the data and we see that there is something that should be labeled differently and it should be there should be a warning about that it would it would shock me if the what the f d a should do in that situation is to say well you know you got the warning wrong and so we're not going to issue it and we're going to do we're going to prohibit that but we're not going to do anything where if they understood that there was a danger of something else that is at least related to what the men in your fracture was proposing to warn about surely the public would expect them to do something and just what troubles know if you look further into the records of what happened here there's an april two thousand and nine e mail chain between the f d a and merck in which f d a says it wants to quote work with  merck on precautions language if it is warranted it's still trying to understand because these are a specialized highly unique set of injuries  in what happened here is that the f d a looks at this letter and it says this proposal and says this is a terrible proposal whatever the problem is the problem is not stress fractures and and so we're going to reject that but we do think that there is an issue and we don't know the answer to it yet we do think that there is an issue about this these more major fractures and and you see this because eventually they do a task force and they and then the task force decide something so if the f d a is in that boat right where it it it gives the sense the letter and the letter  says what you've said is just inadequate and wrong but we don't know yet what we're really dealing with and we don't know whether a change in your label is appropriate and we're going to continue to study that what should the manufacturer do at that time the manufacturer should continue to study the problem she continued to provide information to the f d a should the manufacturer change the label possibly i depends justice kagan on what the manufacturer knows and it's understanding of the science here heck let's take justice alito if we could follow your heart authentic a little bit further suppose f d a had approved this label gray all this language about stress fractures that's now in the label al klein it can't be preempted them right true but would it be about the approach that you're taking is that in this particular area in this particular area of medicines i don't really see how we're going to benefit by fifty different states really giving different signals to the manufacturers and i can see a lot of ways in which from a health point of view we're going to lose that doesn't mean the law wrong it doesn't mean that you know it's just a question of emphasis and here we have an emphasis the next page in the one you cited the f d a says in two thousand and ten f d a is review of the data did not show an increase in this risk overall of at risk in women using these medications so there are indications in this record that they thought that it is more dangerous to put the route the label to put the risk in the label then it is to leave it out and then they set up a task force that they were wrong and here's why here this is a really interesting about half force the f d a clearly didn't have all of the relevant information because what the task force finds is that there are about one hundred seventy some articles that have been written on this subject only five had been given to the f d a or that that was evidence that the f d a was aware of and so that's why the statute imposes the duty on the manufacturer because the manufacturer is going to be tracking this all over the world there was a there was a report from a merck employee in singapore in two thousand and six who said i've now seen several of these specialized atypical femoral fractures i think this could be an indication that we need a safety signal and just as prior i accept your your basic point but what started this whole thing was the first  lawsuit against merck for these a typical family fractures was in march of two thousand and eight and that's what started this whole back and forth the f d a became aware of this lawsuit and started to track what's really going on here what if you had a situation where  in light of the exchanges you've talked about merck goes ahead and puts on its label by the way you should be very careful about these a typical femoral fractures not not and it turns out that doctors say well gosh if that's going to happen i'm not going to prescribe for max and as a result of that drug which is important for many women is no longer being prescribed can somebody who thinks they should not have put that warning in be able to sue because they gave too many warnings and that prevented doctors from prescribing a drug that they otherwise should have been prescribing so mr chief justice the answer is that the manufacturers always responsible for its label but the old forewarning problem is one where the f d a is balancing these risks and benefits at all times and here we know that wasn't a problem well no i know you're changing no but a hypothetical you your point i well maybe i don't know i gather your answer is that the manufacturer has the responsibility so if the manufacturer knows this it should put in this warning and if it turns out that that was over warning then they can be sued for that well there has to be an injury that comes from the over wanting the injury is that doctors are not prescribing frozen max to women who would benefit from it and they are not prescribing it because merck put in a warning that the f d a would determine  over warning not mr chief justice respectfully there is not a state law to work there there has to be an injury because of over warning or else there is no suit the injury is the physician decides not to prescribe for those remarks to a woman who would benefit from it right but that's the label turned out to be misleading because of the drug manufacturers decision about what to include which they should have included even though it's not required by the f d a i thought that would be the same cause of action but my point here mr she  hypothetical thing that the f d a had exactly accepted this airplane would be exactly the same which is that this language about stress fractures doesn't tell the doctor or worry about the pro draw more pain than worry about how long your client has been on bisphosphonate worry about what the particular features of the x ray look like when the when the patient complains about this that wording was all in the twenty ten label that f d a mandated it the f d a doesn't like our language what do you suggest merck could have done without changing its label until the f d a would have approved it and why do you believe that you the label is adequate what could they have done they could absolutely the study they meaning because the study obviously changed the f d a as mine you're saying we you could have done it yes there was plenty of information by that point as to sort of my work and dr lame goes through this he goes through the chronology it's a beautifully done amicus brief to explain what the scientists knew and when they knew it and and that wasn't communicated by and so then the the issue should be decided the juries in these cases should decide whether the f d a would have approved this we take the position based on merck would have to prove to a jury by clear and convincing evidence circuit was a legal document that a judge can interpret we believe that based on a sound interpretation of the letter it doesn't clearly impossible you're saying that you think that the question is was there official action by the f d a that prevented merck from changing its label and the answer to it is that the test that have you know is there official action by the f d a that prevented merck from changing its label to make an adequate warning that's important just because the warning that the f d a has to reject has to be adequate to address the risks arrest that law ok so that's what i was assuming but that's the question and that's a legal question is that correct it is a legal question but it has factual components but that's a judge can decide that question a judge can't decide the core legal question but in all constitutional questions there are usually fact issues and we can sign those to juries to decide what the fuck out of it was there are a lot of mix issues where because they dumper dominantly a legal question and there could be factual disputes on the brute facts but here i don't think there are really i think that the one disputed fact here that is sort of surfaced as a result of the argument today is what is the phrase low energy mean g have taken the position that low energy in compas is a typical farmer fractures dr lane says actually that's not accurate and so to the extent that there is a debate between experts over the meaning of particular scientific better as least as a hunter get to know and as i say we brief the case in wide of his courts cases about constitutional issues we don't see that there is something special about the preemption provision of the supremacy clause that would take it out of the normal fact finding ambit of juries but i would say that if you don't agree with me on that you still have to affirm and instruct the court below in fact this is going to be a legal question that judges are going to decide that does not affect the outcome of the case here summary judgment for merck was improper let us to say there isn't a preemption you want us to say that merck wasn't entitled to summary judgment on the issue of preemption which of the two merck was not entitled to summary judgment you know but you want to alter the judgment of the third circuit by saying that it was it was wrong in in saying this should be submitted to a jury that it's a factual question to be submitted to address as i say i think there are fact questions here but justice alito my brief argues that summary judgment for merck was improper because of the extremely bizarre way this case came up on a motion on an organ show cause there weren't even cross motions for summary judgment which occurs in ninety nine point nine nine percent of all cases so we're talking about how do you handle a wrong district court judgment with a third circuit doing the best it could in very strange circumstances and now the case is in this court you can affirm and you can say what you want to say about jury issues deciding but here our position is the complete response  a matter of law could not have made it impossible for work to update its leaves you want thank you counsel thank you counsel have three minutes remaining thank you mr chief justice if the f d a does not know yet whether a warning is justified or not that means you know the manufacturer in that situation can't change the label that's true whether it's we're talking about the e process or the p a s process and that's the situation here mr frederick focuses on low energy and stress fracture and any debate about that how about the manufacturer's duty to work with the a to ensure that the label is right and that it has all pertinent information to reconsider its initial decision mr frederick said there were only five of one hundred  seventy oracles provided to the f d a your own scientists their confused doesn't merck happen obligation to show that if presented with the proper language and the proper evidence that the f d a would have or don't you have to show would have still denied the right leap just natural justice no matter the process that you're describing is exactly what happened here it is that you never gave them a proper language and you never gave them what your scientists just a sort of error that p a s submission included one hundred thirty two studies about the risk that respondents  say we should have warned about the very same studies that respondents themselves rely on that all of that was before the f d a the f d a isn't saying that it was in any way misled and the back and forth process here if you look at joint appendix five await the e mail that mr frederick referred to an f d a official told merck to withdraw its request so that the f d a could close out this issue while they continue to study it and work with the f d a on work with merck on language later if it determined that warning was warranted in other words at the time of the c r l based on all of the information that the f d a had before and it doesn't claim that it was misled no warning was justified at that time in march of two thousand and ten the public safety announcement join appendix five twenty the f d a said quote the data did not show an increase in this risk in women using this medication period in light of that statement from the f d a there is no way that merck could have changed its warning because the a has told us that no warning was justified at that time as from dr lane the mercs warning contains the two hallmarks that dr lane says were necessary in the warning itself on its face refers to in for insufficien fractures and complete fractures it doesn't just refer to stress fractures with respect to the stress fracture of language dr lane himself in his amicus brief admitted that f f's start as stress fractures that's it page nine footnote eleven and also at page