look at the implied conflict prevention l c s that the court is required to go through it is in my mind it is truthful or process and what the coup or should look at is whether or not the common law frames in question why first of all we're talking about a comma walmsley in the common law claim that the states traditionally this is a field in which they said traditionally protected the safety and health of their citizens on top of rooted common wall personal injury suits feel as i said traditionally occupied by the states that provide a long tail form of compensation to injured victims the holding in seneca was based on principles of really based on principles of field preemption and the current sit in say making it's holding in seneca found that the regulations with respect to drug advertising were so extensive and s these pronouncements about yes our eyes basically decided the labeling issue and there's an actual conflict and if there's an actual conflict it doesn't matter what the presumption was it's gone the difference the preamble doesn't matter it's  a request by somebody else for the same morning well you're saying it have to be their request i'm a doesn't have to be there requires a model you're saying that ok i'm saying more than that i'm saying first and foremost we don't we have you have to have a   depressant you actually said more than that they said we don't want you to change the label that we have for the course it will confuse people and people who might yes or no abuse of discretion but if there is a con but you i gather you can see that there is a conflict right but when we're talking about a conflict we're talking about looking at regulations rule versus and comparing them to the common law claims and nothing in the federal regulations specifically in fact the regulations say just the opposite the regulation specifically mandates that drug companies come forward to straighten the time and the incident that you're complaining about what new thing happened that you're alleging when that what new thing do you allege happened but what's the thing that happened between that time when they said and they knew that these drugs cost suicide and you're talking about the same information that had been out in the public domain the public street the published studies were you know we're talking about the information within the control of these you have to understand will lancet in your complaint that there was some information that was proprietary to them that they got between the time that the f d a last rejected the warning and the suicide because in that time period some had information which showed that their drugs can cause suicide prior to the suicide question and any time prior to the suicide none of the drug companies came forward and strengthen the label of activity at f a a and f d a because of prozac and that's where they came to their conclusions about us our guys and they kept saying there's no there's no sign typically establish a never made the decision that there was no substantial relationship and therefore would not have approved that labeling at that time based on the facts before going prozac and nine hundred ninety one hit the decision had before two thousand and three that established this that they didn't let anybody know about that and i want to know how that is in the front of the f d a claim well we're not this is a fraud on this is i'm not saying that they did not manipulate the drug before of america is approved it must compete must be the same as the bread then what are you telling us i guess maybe more than a generic drug manufacturer has the right test doesn't happen next time right under this statute and under the regulatory scheme to come up with a maple that differs from that i guess it follows the smith look there may be items out there that cause some confusion as to what the manufacturer should do we have the f d a right now telling you this is how we interpret doctor had made the decision whether the benefits outweigh the risk of west the doctor knows what the risks are and so you'll file for example in the last recession they call you live today on five different occasions that they had studies which they failed to analyze properly or they had analyzed property and it and they should have told the f d a about those studies in order for f wait a minute let's go back to this because you're not being consistent you said they have the information they could put it on the label and that's right they could put it on the label as i read it before the f d a approves but information about increased risk of suicidality as i understand your position it is that the drug companies can then or should then increase the morning once label really case leads you basically to meet in skidmore we look at a number of factors you look at the consistency of the agency's position its level of formality the expertness of the agency with regard to the issue in question and when i was last in law school i remember that opinion by justice chief justice john marshall where he said it isn't phatic with the promise of the judiciary to say what the law is have a problem with finding any inconsistency with the to the narrow preemption claim in this case i mean the claim of it the claim is actual conflict between what the f has ordered in the label and what the and what the plaintiff says should have been on the label and that's a case that actual conflict i don't know that the f d a has said that in that situation previously that there there seems to be a conflict i'm nice not sure there was ever a conflict between their view on something that approached this case and you know before and now i mean  look at the cut if you look at the idea of preemption very narrowly which is what the government is arguing here i'm not sure it was addressed you know there's a battle of language that is going on in this case which i think is is is interesting to observe really does is approved by a process of negotiation and indeed with regard to the relationship between the drug companies and you have to it seems that when they're relating to each other they talk in terms of agreement and negotiation but it was only when they get to litigation that terribly definitive that's why i'm not sure that such a great conflict i mean they do talk about well it should happen this way in practice it happens this way in practicalities that's the kind of language they used in the preamble we hold and the practicalities are important that they can't understand the regulations the have to give is issued in the drug company position is that is that in the in the practical in the real world there is a conflict within the meaning of the supremacy cla really a conflict with within the meaning of preemption doctrine which is an expression of the supremacy clause so at the root of this this preamble is a construction of the constitution and they are not the true believers of that finally has to persuasiveness i would suggest that the preamble is not persuasive because he asks drug companies to take action or rather to not take action and out of that is inconsistent with f d a regulations that is inconsistent with the f d a his own past events regarding preemption tha let's make sure we have facts here you never presented evidence to the f d a and say please let us warn of suicidality what happened in connection with another drug which was then s s r i s s they said there's no substantial evidence is that what happened and therefore you were the only labels they approved never included this for adults up until two thousand and three or after i don't know but at up until the event in question you are correct there were three separate citizens petitioned to f d a were questionable warning  new methodology to the manufacturers for reviewing that information and da has repeatedly reviewed the information over that sixteen year period and has said what the latest label that has been approved at night in two thousand and seven understanding his claim his claim seems to be he actually said he lets fraud on the f d a end fraud on the public complaint what is the status of those kinds of claims under say it would be misleading to warn of a connection between suicidality they all say that i mean that the argument is well there's possible exposure to that kind of claim they haven't gotten that far they've basically decided if you're and we are not dealing with a speculative hypothetical here as to whether a conflict exists we know exactly what the plaintiffs say should have been up in the morning it's in their complaint and it's in their brief either if as th the drugs if your company had added a warning that you find would not be supported by the evidence says that basically  a approved you labels for paxil and for the last shortly before the tragic suicide should have brought about these lawsuits in our case for paxil a new label was approved less than two weeks before in terms of paxil all of the information about the drug and all of the clinical trials that have been performed on the drug or valuable on website time or available f d a all of that information is available and indeed judged b it's hard to believe that you can find a conflict either way where you've got a federal agency telling you what you can put push back so you could have there could be this situation where i drug company asked to put something in and it was denied with all due respect the two thousand and six preamble on the statements and that pm are not really implicated by this case as i think judge or a star or me suggested in her earlier question this morning i think the issue in this case is narrower and it's not one that depends on  substantial amount of deference i think that is my theory under under several theories and i think for several different reasons i think in fact in first part of the government's view here is informed significantly by its construction of its own regulations so that for example we have explained in our brief that the regulation simply did not permit a generic manufacturer to modify its labeling and that the c b e reg even as to the manufacture of the listed drug would m implications were pretty of state law close quote that's seven years ago the problem of those guidelines and let me suggest for example that a drug that were put onto the market to morrow without f d a approval which surely be subject to state as to the issue presented for the court this morning absolutely your honor f d a has a rule making dating back to the nineteenth seventy's stating next scientifically unsubstantiated warning should not be added to the label for a drug and i think where f d a has made declined to require such a warning had rejected citizen petitions seeking such a warning had again and again and again made an expert determination that the warning was so excited they are going to bring back judge so mandel theory of preemption that implicates the two thousand and six preamble that would suggest that where f d a has a proved a label for a particular device and don't label reflects a particular risk that any failure to warn a claim premised on a framework or the narrower for answer to the way you work well let me just be clear the government in its brief filed with this court and then in its presentation this morning it is relying on the narrower form of conflict preemption it is not a position before this letter that the government submitted those poor under theories of preemption are potentially implicated in at least one hundred possibly more cases currently pending before the supreme court the regal  thousand two thousand statement is very broad and ambiguous and two thousand and six covers the entire world and i read your brief is supporting only a very narrow grounds for preemption so that for example if we found in this case that i eyes or even for the entire class of prescription antidepressants starting in two thousand and three there was a suggestion that the use of antidepressants in children might pose an increased risk of suicide determine that it did pose such an increased risk required that warning to be added to the label and then in the course of investigating whether that risk might increase to young adult or even older adult users twenty four and that there is no showing no evidence supporting an association of increased suicide risk in adults aged twenty five to sixty four and that for adults sixty five and older there actually is a decrease your experience to my question that i  mean i think it would have a range of encroachment opportunities to be able to obviously it would have rejected the proposed change since it had consistently rejected precisely that change again and again it could have put actually taken in force from an action against the explained in the two thousand and six preamble but the whole process of developing morgan stanley believe is an interactive process with the agency and the manufacturer and manufacturers typically do not unilaterally make substantial changes to their frankly the notion that the regulatory scheme is intended to operate in such a way that manufacturers are obliged to come to f d a again and again filing applications to make changes that the agency has already rejected it is  complaint which are articulated in greater detail the fraud allegations they abandoned that theory they did not argue that theory as i understand it the district court and they didn't argue it in any of the briefs in this court until the very last page of their reply brief so i don't communicate with physicians is through the labeling for their prescription drug products to the extent they're claiming that somehow the manufacturer should have given a warning in another form that would be inconsistent with the f d a is determination that a undertake additional tests if we think it necessary we can require more studies to be done and we are entitled to see the results of every study that has been done on clinical test data we do evaluate that all in the course of both the pre approval process and the post because you know to be frank your honor this case poses such a stark conflict in terms of the competing interests at stake the very risk but the plaintiffs seek to add on the warning for the label is itself a product of major depressive disorder and it is absolutely impossible not to conclude that had physicians been improperly deterred from using this drug which seriously ill patients there would have been more suicides and so in these circumstances surely we need to have some federal agency with the expertise to look at that from a comprehensive standpoint and make a judgment about what is appropriate for the public health rather than to allow you know state juries and individual cases with one person in c post approval authority has recently been substantially extended by congress to permit precisely the kind of post marketing surveillance that outside observers have suggested if you don't understand where they're coming from there has been a thousand and three you agree that they had or they should add to the label but additional warning with respect to adolescence you've now extended bet as i understand it to correct that's correct so then there are various evidence or some suspicion that those older than twenty four maybe also have been certain cases and enhanced risk of suicide if they take certain less us or was correct that was the concern and i will say that f t a's judgment about the increased risk with young adults came out of its comprehensive review of all of the test data is on the current approved f d a labeling explicitly notes that there is no increased risk of suicide for adult users age twenty five and older at the drug but the scientific evidence does not show  internal evaluations had presented those findings to advisory committee meetings advisory committees had concluded that no labeling changes should be made and to accepted those conclusions those recommendations so i don't think it's correct to say that of antidepressants and in fact the advisory committee recommended against making any change to any anti depressants i want to point out that part of the concern about imposing labeling requirements like this in an individual case is that there was significant concern on the part of the agency and its advisory committee that the extent there was any risk it was a great risk that expanded beyond a particular drug it was a risk inherent to the entire class and that impos waxman amendments and the whole process of getting generic drugs forward there were some suggestions made during the comment period that the generic manufacturer ought to have leave to add safety warnings contr why then should you not be able to allow a statement to say in fact under that circumstance you should come out immediately with a warning because you have a job with a mission that there's a problem because that would put us in did the two thousand regulations say that there was no crawford no preempting or stable off the federalism concerns remain fully in place the what we're talking about here in two thousand said was not that there cannot be conflict it cannot be a direct conflict and that would represent from the generic manufacturers point of view a direct conflict in order to comply of the state port decide not to approve it change maybe you have to ask process by some more efficient process then finally in three and a litigating against similar to what they did for a listens you know the answer is there's no reason to if they could do that but there's not a reason to require it which is your reason there's no there should be a requirement is the f d a had addressed this precise issue in the actual rule making every single time all seven times that approved this drug for her ations in each instance it required is literally required that the labeling has to say identical to the identical language that was in the letter approving the drug from the da can't just something pool in the data from not having different drugs not just as a surprise but nine different antidepressants to say when we pool all the data from these various antidepressants does it indicate a signal that suggests that  very conservative approach i mean to get to its credit one state decided that there may be a risk for some of these drugs that decided we're going to change the approach we're going to move in fact to the bells in the different from really is general answer to i think there is no inconsistency between the position the agency took in two thousand to register and the position it takes on this issue the statement that you are referring to is a statement that addresses field our prior decisions about conflict prevention are out the window in fact one month earlier it over two felson in the in the southern district of new york to go right two thousand were there people making allegations that were state  that there is an increased chance of suicide risk for somebody older than twenty four they can't just go at a med and the label unilaterally they have to go to the f d a and specifically requires them to strengthen their label as soon as they become aware of a risk with their drug and if they don't need it the proof first and b ten doesn't say they have to g said they had to withdraw label they would they would have to they would have to withdraw all probable the generic if it was no longer consistent that's not what that regulation says second of all let's look at specifically what happened in this case with respect to the regulatory history but what they said was they need more information so what happens ten years later after they look at the same data that they were looking at all well in march two thousand and four they actually do all the drug companies approve this doesn't approve these warnings as a general matter they don't have to be other words they don't have to do that what the cheesecake did was they on their own independently strengthen their warning in a two thousand and four to warn about increased talking about that kind of more know and if you look on nothing about it there was specifically in bold letters a new warning with respect to increase suicidality and worsening depression in may two thousand and four but i want to get to this point before i come home for ever