and the last case in the calendar is given speed bristol myers  morning i mean please the court i'm lawrence laster representing your problems in this case is about procedural error multiple procedural errors that we've identified and discussed in our briefs let's start out with something pretty basic the supreme court gave us in twamley an eight ball the possibility standard on a rule twelve motion they said that in applying the plausibility test a court must take the allegations in a complaint is true  no matter how skeptical the court may be about those allegations well that did not happen here instead the district court below looked at extrinsic evidence and the moment the district court decided to do that under rule twelve b it was required to turn the motions in to rule fifty six motions and follow those procedures it did not do that and how we got  here is something of a function of the creation of the m t l but there isn't any authority as far as i am aware that says when your case gets sent to an end to the protections of this rules of civil procedure sander rule fifty six rule twelve teams go away just because you were made part of an empty oh these cases were not consolidated what happened in the procedural history which we lay out in the briefs is rather complicated but there were some cases pending in the southern district before the m t l was created and the judge asked those plaintiffs to basically pick one case and then they would rule on the motion to dismiss so that happened after that ruling then the m t l was created and then that plaintiff was given another chance to plead and they attached a bunch of studies and articles to the complaint so that ruling happened and then the judge did the order to show cause procedure which is not a it's not an improper thing we didn't object to that what we did instead was show cause the complaints of your plaintiffs now none of them have those documents attached they don't have pages and pages of studies from the british medical journal i don't understand why why going from a detailed complaint to a conclusory complaint  allows you to survive it pollen twamley you have to make a plausible claim and this is an area that's been highly live in gated that the kind the contrast between state tort law and the f d a is warning we quire mit's why isn't it reasonable for the district court without even looking at the knowing about prior studies that have been attached to an earlier complaint or in a different complaint why isn't entirely plausible for the it reasonable for the district court to look at your complaint and say conclusory allegations don't suffice to make a plausible claim that will survive or has a chance colorable chance of surviving preemption attack if that's what happened here if if that had actually occurred i think that might be possible there are there are two responses i would have to that one that's not what the district judge did here she talked about that a little bit but if you look at the orders both the foreign order and the orders in the specific cases that are still left she makes it clear that she looked at the sources she pierced the allegations in the complaint and went and looked at the sources behind there she necessarily did that and the second thing is it is unclear under the case law whether a complaint has to affirmatively plead around what the supreme court has identified is an affirmative defense which is possibility preemption that's what this is about and as far as i can tell i think there's one case in the first circuit where they indicated and it's cited in the defendant's brief where they allowed and possibility preemption to be discussed as part of a will probably six motion but it's an affirmative defense one of the things we talked about in our briefing st patricia's ago vias complaint was at some point on the preemption issue a summary judgment motion because that's when the supposed to happen so the district court did two things wrong here and i can and you can look at the quote she says it i'm she's looking at the sources behind the allegations the other thing is that there are allegations in this complaint about information that these defendants got post marketing which is the same thing as opposed to prove that they had reports about hemorrhaging that should have triggered additional studies you try to that's what judge coat found to be wholly conclusory right that's what she found to be wholly conclusive that's what i as a loser in chief got articles we won't tell you what they are when they were what they consist of but believe me there are articles and facts yes your conclusion with a complaint simply isn't actual evidence to support the inference she says that but if you read her whole opinion it's she's it's clear that that's not done in a vacuum that she necessarily looked at information outside the complaint and you're not supposed to do that you're certainly not supposed to do that in this context where you're asking a plaintiff to affirm relievedly plead around in possibility preemption that's a separate set of error right there the possibility preemption is a question of fact unless you are in a situation like say in the manson case mentioned versus pleading the supreme court said no matter how you plead it it's impossible because a generic manufacturer could not have changed the label as a matter of law that's different than our situation this is not a generic manufacture this is a wife versus levine manufacturer developer of the drug so the standard there is different there aside from this one fifth the first circuit decision which has on its unique facts where they were trying to warning could have been made in the first instance we have pled that there's no warnings could be made so you agree that you have to plead that we have to plead the elements of your cause of action yes and we've done that but preemption is not part of the ca there's no authority so far that says you have to affirmatively plead that your claim is not preemptive that's an affirmative defense but if the complaint contains facts that would on its face demonstrate the applicability of that defense then i guess you need to plead facts that would overcome preemption right if the complaint you're talking about likes similar to say a statute of limitations kind of situation where you could see the facts in the complaint that would establish all the elements of an affirmative defense is that is that yeah that's right ok and that's not this situation because we have pled allegations of information that this defendant had that they should have had an obligation to warn about which is what we did we played the elements of the client newly acquired information that would then trigger or would it would avoid to the need to would avoid preemption right it that would have led you to the possibility that you could have done a change is being affected the c b e changed to the to the label which is what makes a wife worse is living type of case different from mensing versus plea i got  thank you judge livingston i'm a please the court neal katyal for the defendant pelleas the plaintiffs have only one claim left which is failure to warn and there is only one route for that claim not to be preempted which is that defendants have to be able to unilaterally change their drug label and under the supreme court's recent decision in mensing that means plaintiffs have to plead specific sufficient facts to allow the court court to draw the reasonable inference that there was information not previously submitted to the were reveals risks of a different type or of greater severity or frequency and as the district court found the plaintiff fails the complaint doesn't identify any newly acquired information about this critical lifesaving drug and indeed information about the types of risks and their severity and frequency is all over the label and was submitted to the f d a your adversary makes the argument that this is really the preemptions nature of the affirmative defen is really heavily regulating the spear and there's only one way for their claim to survive they have to be able to show that we actually could change the label in the drug label is a very complicated balancing of things and so that's why for example the first circuit in the selects a decision which my friend acknowledged is a very clear case in which on a motion to dismiss very similar facts to this the court there granted the motion to dismiss it was upheld by the first circuit because they said it be impossible to comply unless the complaint comes forth with newly acquired information and it's not you know my friend said well but that's not the rule in mensing and if you read his brief you know you think well maybe plead the verses mensing said there are a verse but as our brief points out they quote page six thirty four of men saying which is actually the dissent the majority never said that and indeed there were three cases that came to the court the supreme court in the mensing case two of them were actually in motion to dismiss cases and both of those cases on remount after the supreme court's decision those motions to dismiss were granted it still seems kind of strange though that i mean these even granting that the allegations here somewhere it conclusory you would think that if they need to show we need to in order to recover that they were entitled under f d a regs to change the label unilaterally that can be difficult to establish that takes studies and you know adverse event reports and recently discovered information so on it seems kind of not very suitable to addressing on a motion to dismiss such kearney i agree with you sometimes that will be the case and you know if the complaint alleges newly acquired information and the like then it's a very different ballgame what you have here though as judge code found after exhaustive study of the complaint is no allegation of newly acquired information all of those risks like bleeding disclose sixty five different times on the label and the accompanying information so there might be some case like that i just don't think this is even close to that case and that is why you know that is why judge cote reached the decision she did and i think it picks up on what judge sullivan was saying earlier which is look ordinarily affirmative defense is absolutely the burden of proof is on the defendants and the like it's not part of pleading but when something is evident on the face of the complaint a affirmative defense then it's a very different situation indeed you were on a decision with a judge pooler wrote in the chen case which are brief sites in which exactly that point was made that if you know an affirmative defense there the fair labor standards out in recreational exception you know if that defense is evident on the face of the complaint then that is really where the burden of that is then that is something suitable for a motion to dismiss and if you accepted my friend's invitation you would be creating a split with the first circuit and this just seems like exactly the wrong case in which to do something like that it's not just by the way chen i mean even this court in the ritchie case which was a preemption case said it's suitable to discuss to decide on a motion to dismiss i think when both of you sat together last in the honeywell case department versus honeywell you affirmed a motion to dismiss on the pleadings as well so i think these things do happen again only under the narrow circumstances judge sullivan is pointing out in which it is evident on the face of the complaint so that's one set of arguments for why my friends failure warren claim isn't isn't i think viable and then the judge coat reached a separate alternative ground an independent ground which was that the labels are adequate and she goes meticulously through the adequacy of the labels i detected a kind of implication that the label to be effective i mean it's a very very long but  isn't you know that really imposed amendment oh heavens no we could not just because a new drug comes on the market or something like that we couldn't on our own do that and change you know in change the label that would be something the f d a would require us to go through a whole set of proceedings now on the no antidote that was something that we disclosed to the f d a and that is why judge cote says quote you know the with that the word quotes of this is is available that's in the label itself and judge code quotes exactly that language so the things that they point out and i think this is maybe the most critical point on their whole failure to warrant claim whether on preemption or on the of the label is judge koch kept saying look tell me where in your complaint you're alleging newly acquired information that was not disclosed to the f d a they didn't do it there then on appeal they filed two briefs before you they've had two opportunities to say here's a part of our complaint here's a paragraph in our complaint that says newly acquired information they haven't done it there which is you know this is a critical lifesaving drugs this is a really important drug and you know these kinds of conclus allegations are extremely extremely dangerous if i could just ask at from interest it says there's no antidote but presumably if you taper off eloquence at some point your coagulation absolute rate gets back up to normal right absolutely so you know there's a no immediate antidote and then there's a box warning which warns you that if you do taper off you better substitute with something else because otherwise there's a risk of stroke or something that's at the very top of the label if there are any other questions failure to warn otherwise i'll just spend a moment on removal if there are any questions there are so just on the removal issue there's basically two independent arguments one is the strong caterpillar doctrine which says that basically you know the appeals from a failure to remain and are basically impermissible and then the second is just the language of the removal statute and i'd like to draw your attention to are twenty eight j letter the third circuit after our brief was  filed in a pretty detailed opinion just read the statute read the plain text of the statute and said look at says joined and served here the defendants were not served so we i think we end up drawing a distinction between a peculiar result  disagreed i think that would just push you in favor of caterpillar and saying look this is not subject you know suitable for appellate review you would want to create a split with the first circuit with the third circuit in a case like this but just on its own terms the absurdity doctrine require such a manifest standard i mean it's got to be as chief justice marshall said something monstrous to all person kind i mean and they don't even come close and i think the third circuit explains why the third circuit said look you know they were dealing with a circumstance of you know certainly fraudulent jointure and things like that and they filled it with the statute maybe you think it's broader than its purposes but there's no requirement that a statute should be read narrowly tailored to its purposes that would really undo so much of the federal code actually and in so that's one point in the second is our brief explains there is actually a really important reason why you could imagine congress drawing the line at service because service marks the point at which a state court exerts control over a defendant and for purposes of federalism you could see congress saying look ok we really like these cases in federal court their diversity cases and so on we're gonna rip them away from a state court once that process is really ongoing and that doesn't really start until service and that's what the supreme court decision and murphy brothers recognizes and but there's an argument to the country about when is a proceeding pending in state court and in some cases service needs to  made in that case is not only does this in this create terrible kind of checkerboard it very well may and that's exactly the choice congress made by picking all of this to service a process which they obviously knew varies from state to state both in hundred forty eight and certainly by two thousand and eleven when they re did the entire statute in result all sorts of circuit splits up and down but the one thing they left intact was the language of fourteen forty one b two so that's congress affirmative choice and i certainly think to be dangerous for this court to start monkeying with it if there are any other questions side of the language in mensing the dissent because it's better language but the majority of movements in court also talks about the manufacturer's federal affirmative defense of preemption that's a page six nineteen this is a brand drug mensing is not the law why vs levine is still the law for a brand manufacturer and the court in white said and talked about quote the burden in establishing a preemption defense preemption is still a defense that the chain case is an express preemption claim the whole field has been expressly preempted by federal law you can figure that out without having to look at the facts the law is clear you decided on a motion to dismiss this isn't possibility preemption there are factual issues if you read the first circuits decision all that court there does is talk about things that are in the complaint if you read judge cults decision you will be taken back in extra complete to the thirty two pages of the arts to decision where she plays amateur epidemiologists and statistician if i tried to do that they would ask me to have a dabbler hearing but the judge did that frankly that's not something a district judge should be engaged in on her own that's why these issues are decided at the at the summary judgment stage there's a bunch of complaints here let's look at that again paragraph already before and after approval in marketing defense became aware of many reports of severe hemorrhaging they did not alert or or perform or investigations paragraph forty four paragraph sixty seven paragraph one hundred two p hundred four just in the soko v a complaint allegations that normally would be sufficient to say that there was information that this manufacturer acquired that they should have disclosed as my colleague pointed out the third circuit has now had a decision on the snap removal question i would ask the court to look at footnotes three and four of that decision where the court says here's the things we didn't look at we didn't look at the fact this court it is happening all over the place as we said in our brief the issue is split next door they're not sure depends on which judge you get it needs to be decided one way or another we think it is an absurd or what's the other word