see this is one of two cases why in this case is unique to any of the others because there is no agency involvement and there is no direct pharmaceutical an action good morning and may please the court of justice method like to take your statement head on to start and that is that respectfully i disagree that we do not have agency action in this case we have repeated statements the journal article in the new england journal of medicine which was an official f d a statement as their  that citizens petition the f d a again stated its views that there was no causal connection between the drug and pancreatic cancer after that we have an advisory briefing book on the  approval and that labeling for six and after the advisory briefing does not include a warning for pancreatic cancer again and that advisory briefing book the f d a stated its few after extensive and the kind of review by its own scientists that there is no causal connection we also have repeated new labeling for these drugs which are official agency action from f d a that there's no causal connection so i tosa citizens petition the rejection of the citizen's petition was a final agency action and if i may repeated approvals of very billings for these straw dogs without any reference whatsoever to pancreatic cancer cases where a judge can make that determination especially when the underlying facts never get to a point where there really are and where there's a true honor i can i'm in the position of respectfully disagreeing why not at least at least i'm predictable first of all it would not be easier and it would not be binding and then not binding is the really important part here the judgment  you could get a judgement but then why would you have gone through the practice of taking it to the jury in the first if i may your honor we want uniformity and i'm sorry i didn't mean no nine i was just going to say you're right there i'll take that your honor but we will end product labeling especially product labeling is uniformity it is important that physicians and patients understand what the risks of drugs are as important as it is not to underway is equally important not to over warn because you don't want patients and physicians to not have access to medicine that they should have access to to treat their problems but if we have a judge  the court and i would point out that when you are in court the jury of the jury is making a decision the jury has infront of a plaintiff who is almost always sympathetic one plaintiff is looking at that one plaintiff and is looking at one manufacturer that's not what the f d a does the f d a has to assess the cost and benefits the risk analysis for the entire population all patients all populations and has information not just from one manufacturer but for many manufacturers so the f d a has a higher clear view judges are much better able to do and assess what the f d a would be thinking and to a sas f d a actions against a complex regulatory scheme than would law faithfully as they routinely do in fact when we stepping back for a moment when we're looking at the right preemption analysis at the end of the day what we're doing is reviewing agency statements and agency action against a complex regulatory scheme it is the same thing that judges do every day when they're looking at agency action under the a p a this is what judges are trained to do we do not leave this with juries and i would just point your honour's to two cases from the u s supreme court that talk about why it's important or why some parts consider which actor is better able to look at a case and that is the miller case where the justices looked at whether the voluntariness of a confession is a question of fact or very it is it is a unique area but i think the analysis is the same because what the u s supreme court was focused on and reitman was the need for uniformity and which decision maker would be best able to make that decision and determined that in both instances that was the judge and directly your question your honor you asked why is it important it's important because you know for many unavoidably is better aided through having quotes make happened and why i read it and they use the facts and scenario there they don't analyze it so they end up getting a summary judgment without really looking into the tonal idea in the third district seem to be sense if they were doing a summary judgment houses all those courts would have given inferences to the plaintiff and that would be clear from the face of the decisions none of those courts that that none of them did that there is no evidence in all of those decisions that they were giving in france says under summary judgment standard to the plaintiff all reports treated the question as a matter of law and i would know your honor that after the fosamax decision came out circuit issued another decision the dolan decision in which again noted that mason decided the question as an issue of law the same circuit didn't say fozzie max was right we were doing this law in summary judgment analysis not just telling anybody the same circuit said it's an open issue you know our view is that the mason are treated as a question of law and i think if i may this is a good time to point out what you asked for very beginning is that the supreme court is taking up this issue in a month and so we might have more guidance from the supreme court soon but i would note that the very fact that the supreme court's about the fosamax decision the third circuit decision and that the solicitor general wait and that the circuit the supreme court should take it up in a ca right cases where questions of facts i would know your honor that this is an inherently legal the trauma nation even though there might be some ancillary factual questions involved and the supreme court and courts routinely deal with questions of law where they might have to assess some factual determination the market in case again on the patent claim the supreme court sad yeah there might be contested expert testimony ok courts can deal with that that's and suing factual issue with what is mainly a legal determination so that's not right for courts to do that but it's a sas factual issues when making legal determinations all the time they do that with personal jurisdiction and also just with conflict of law analysis they do he your honor i think i have my guidance from not with respect to supreme court quickly in terms of where the issue is for the court or the jury however the court takes it up whether through an evidentiary review whether on the papers or whether or elsewhere the question still doing really good in my job if i got one of those spot yes i would like a total victory right now but at the end of the day a question that's really a question for the court is is a decision for the court or is a decision for the jury and i view  is that it has to be the court and i could just go back to one more potential issue as to why it should be the court not the jury your honour's and that is the question in a riot is a historical record what would f d a have done with respect to labeling requests change when juries are looking at the issue under state law let's say you have a jury trial you write a jury trial mr brennan is there he's giving his opening under state law on why we failed to warn and i get up and i talk about but i talk about and i know him by the way we have this preemption defense and the real question is what would f d a have done not what the plaintiffs claim should have been done well the jury's going to go back to the jury room they're going to make up their own assessment as to what they think should have happened and they're just going to say well that's what f d a would have time if you good mils the two analyses and what goes away is an actual analysis left alone as to what f d a would have done aside from what the jury thinks should have happened so this is really a good hi good morning your honors my name's ken grant and i represent the plaintiffs have police the f d a has not reached a final decision or taken an action in this case  and for that reason there is a question that the jury should decide is this your honor pointed out there are material there disputes of material  facts judge gillespie has already made that decision that's not on review here the only question i would review here is who's the decision maker the judge or the jury what i want to do based on counsel's statements in the court statements is to go through the evidence that was presented by the parties to demonstrate that the analysis that needs to be made is a classic analysis  that is that jurors are equipped to make not necessarily judges not of words there's no legal training necessary to to make these decisions the first piece of evidence merck introduced or presented was just in new england journal of medicine article and as counsel pointed out the f d a or the article said f d a was still looking at the issue of judge cholesky pointed out that this article could be read either way either way so when the article is presented at trial the jury will have to decide how much weight do we give this to england journal of medicine article and what do we think the meaning of it is based on their view of the article and based on expert testimony that they hear there's nothing even john marshall law school it's a very narrow area expertise in your area it's a very very few people are willing to deal that's exactly right and the way to deal with it requires additional training because function of a judge to construe a legal instrument we don't have a legal instrument here we just want to back up to to make sure the court understands and i think it does that there are two by saying this is our decision that is something that distinguishes this case from fosamax in the sense that this case is a stronger case for giving the issue to the jury because there is no decision ladder which one might call a legal instrument in this case because merck never asked the f d a to give a can create a cancer warning so what we're what with the f d a to you that's the question and there's no legal training that is going to assist the court in figuring out what the f d a is going to do i was i also want to address the other evidence that merck submitted  we're talking about one drug in this case to nuclear and counsel kept referring to these drugs these drugs well the citizens petition the council mentioned and the f d a is response to it applied to a drug known as fifty thousand which is in the same class but it's certainly not the same drug so again the jury will have to look at that and consider how much weight do i give the f d a the action as it pertains to a drug that's in the same class but it's a different drug again there's no specialized legal training needed to make that decision but i want the court to understand citizens petition involve a different throu it's you could have the same circumstance with separate judges making different decisions for example what we have here is in d m v out in california  jurors oftentimes make the kind of decisions vacs that's could lead to different results in different cases and that doesn't overcome the seventh amendment i'll give you an example one issue in this case is going to be whether she knew via has the capacity to cause pain create a cancer defendant is going to say look we're not even going to get to the issue of whether she knew via caused my clients think we had a cancer because she knew via can cause pain very cancer and off now that issue is going to be presented to a jury there's never been any suggestion that in issues like that would be presented only to the court as long as material facts are in dispute yes that issue could be decided one way by one jury another way by another jury so that's not an impediment in the certainly doesn't overcome the seventh amendment right to a jury trial we also have scientific evidence that the that the plaintiffs have presented in this case we also have expert testimony that the plaintiffs have submitted in this case  classic functions of the jury weigh all this evidence how much weight to give it how much credibility to give it these are classic functions of the jury and again don't require any specialized legal training like construing i also want to point out to the court that preemption absolutely can create a question of fact the united states supreme court in a case called boil the united technologies help exactly that in that case there was a government contractor preemption defense that defense essentially being that the government contractors can have the same immunity as the government guys provided they meet the requirements of the defense and therefore common law claims against the government contractor are preemptive what the united states supreme court said in boyle is that it is for the jury to determine the fact which are dispositive of whether or not that defense applies so there's absolutely no question that preemption can create a question of fact the united states supreme court has told us that  attempts to distinguish it only by saying that that case involved garden variety facts not sure what that means but the fact in that case one of the factual decisions in that case is what the government knew about the dangers inherent in in the project of the project if the government contractor was undertaking it's not terribly different from deciding what would be f d a have done these are just basic questions of fa want to make one last point pointed to price and be philip morris as somehow supporting his case i just want to point out that what the court said there was that the statute being applied to the fact that few facts that are essentially undisputed because we need not evaluate the credibility of witnesses or way conflicting testimony to determine whether the actions of the f t c have resulted in specific authorization of used by these terms the cigarette manufacturers we ma on the issue and yes it is a matter of law grad event as a matter of fact this case is the polar opposite and we're going to have conflicting evidence we do have conflicting evidence we're going to have conflicting experts and it's going to be  just three brief rebuttal points first it does require legal training and here's why because when the clear evidence standard is applied is applied against what f d a would have done what f d a would have done and applying the f d a is regulatory framework and applying twenty one c f r two on is there reasonable evidence of a causal connection is there some basis to believe there's a causal connection and those are how that's a matter for the court so it's not that this is just some factual analysis like who got hit by the car at the crosswalk it involves reviewing agency action and applying it against a complex regulatory  stated is a legal standard with respect to the issue that judges may issue different opinions or cases may she different opinions but it's not common where you have one issue which is a legal issue on preemption and what judges do  they issue opinions that other judges can then rely on and maybe precedent setting for other charges so juries don't do that juries issue opinions or they issue burden x which may not even be admissible in the next case the next jury may not even know what well i don't think that you would be able to if there was just a jury verdict it would not the court would not be able to take it into consideration because there would not be a sure claim pursue preclusion because you would have different parties so that's the the of the room that's the issue which is you don't have a basis to make the jury verdicts finding a producer and he california state courts and these matters and the  proceeding made that point expressed and we cited that to you in your papers and i think that is something of great concern where you need uniformity in product labeling it can't be that a defendant doesn't know whether or not their claims are the plaintiff claims are preempted because you're getting different decisions from different juries that cannot be undertaken and reviewed by other courts and so i would say that and finally i would just make the final point that there is a reason that the vast majority of cases have treated by it preemption as a legal issue and that is because the wired courts themselves treated it as a legal issue for the court the trial court expressly stated it was a legal issue that it would review the vermont supreme court stated that it was a legal issue and the supreme court treated it as a legal issue that the supreme court decided the supreme court didn't say this goes back to the jury the supreme court decided the issue reviewing the facts for itself and with that thank you very much for