warnings above and beyond that which is what is required by the food and drug administration we do not contend that the state law claims pled in the action required the allegan jump through some additional hoops that they bump up against the requirements of the f d a mandated warning our position on this matter is quite simple and our position as an aside offends my my mother's career commitment education and my own bachelor's degree in english our position is that out again has a duty an obligation not to unworn the public and doctors traditional label marketing cases occur when a pharmaceutical company has has promoted a drug for use which it has not been approved our position in this matter is that with alec indeed here was much more dangerous and much more accomplish when they required that black box warning on the drug this case is not about any law of the state of california bumping into the food drug and cosmetic act it's about allergen tampering with that  warning and their voluntary affirmative conduct in undermining them warning most of the district court's analysis and orders on this matter as well as al against pleadings and brief on this matter dedicated to the f t c a process in the history of lexapro but the complaint is more focused on the again the voluntary affirmative conduct of the defendants out again in this matter and can you after allegations had settled with the federal government one of the specific for adolescents undermining that warning that it was very dangerous not it wasn't prohibited obviously because it was issued but that black box warning was undermined by them continuing to say that this is a safe drug for  that the for them not to alter their sales approach on the drug once the black box warning was was issued undermines that warning and when you say you know the marketing out there something specific you can point just i mean we laid out a an entire marketing scheme and they just continued to promote it as the go to drug for adolescents suffering from these major depressive disorders without without regard to the fact that it had this high level of danger to these teenagers and young adults so they the purpose of the corporate integrity agreement and hopefully other pfizer was to prove for them to stop stop marking the drug as a safe drug if they transgress the agreement we believe they did how we believe they did by by again not not issuing the letters and this was in our our prior version the complaint of court dismiss that because we are what we allege was that my clients were rd party beneficiaries of their corporate integrity agreement but the corporate integrity agreement required them to disseminate information a doctor so that they would know this something has changed out letters to all their sales people in the letters to the two to the community and with the same vigor that they promoted the drug is being you know the go to drug for depressive disorders they were supposed to take some action to counter what is there any case law you would point to that would uphold the proposition that there's a cause of action even when the required warning has been given up i guess of causation between his stance and what you're alleging here i don't believe we have a causation problem the allegations were that kennedy had she was a young girl just just for the course information she had he prescribed and there's some other contributing factors it's far as the dosage and things of that nature which aren't really all of those problems but most of those suicidal incidents happen shortly after someone stops taking a prior drug and starts taking the lexapro so the only change was introduced in the introduction of this drug she had not been on it for a very long time well under the california unfair competition law do you need to have a causal connection for you to have a cause of action absolute either with theirs and that was under the california law or you would have to have causation establish where the other right we believe causation is required we believe we allege sufficient facts to establish to get past a motion to dismiss on causation of certain knowledge the most difficult part of our case of course is proving that that was introduced and the drug creates the suicidal ideations that she was not able to resist it is not a very complex causation argument is that the drug had that impact on her and historically she had not had that problem so  everybody took that drug and passed away a bunch later a causation is automatically established absolutely not i believe if someone had had a history of being on a history of these type of depression depression and and is because lexapro has such a long history it was generally accepted as the go to drug for these types of situations and they looked elegant maintain that that misnomer in the marketplace  i guess i don't get it you had this enormous little warning doesn't that break the causation change i mean it's right there you read it varies you don't take this drug if you have these problems i don't see how you can establish causation  against out again in their marketing scheme as a simple duty to warn we actually allow the legal process to hold them accountable for their conduct and undermine the very thing that the f d a so sought to accomplish when they require the black honour's questions and you perceived and mr traylor conceded again some issues that i think of significantly narrowed the scope of the appeal before i get into those i do want to express my undo either the marketing efforts of the company prior to the agreement that was subs only reached with the government and that the company did not fulfill its responsibility under the subsequent agreement with the government as a result it is alleged dispensers of the drug prescribers of the drug and perhaps even takers of the dru weren't properly informed of the risk what's your response to the argument well the conduct that was alleged to have occurred in the late one thousand nine hundred and ninety s and early two thousand is incredibly undertook an extensive years long analysis of the issue multiple analyses in of all the clinical trials and multiple populations they started with the pediatric and adolescent population they ultimately moved  to the adult population from two thousand and four to two thousand and seven the f d a craft of the warnings these are f d a crafted warnings that apply to the entire class of drugs it was widely publicized the likelihood that there's a physician in the united states that prescribes any and i depressants doesn't understand that there is this black box warning for suicidality associated with adolescents and young adults up to age twenty four it's just not reasonable or in the context i think well that's a factual proposition is that one we can take up at this point that is that a physician has to be aware well how did how do we know at this stage of physicians has to be aware attached to this drug is such that those who prescribe the drug those who dispense the drug were aware of the risk of aware of the warning and it's a risks that the f d a decided was worth bearing but the allegation as i understand it from plaintive is that marketing efforts either efforts before i confess i may not be articulating this very well but marketing efforts before and marketing efforts or failure to undertake some kind of corrective are for example or words permitted this condition do exist that is a condition whereby somebody prescribing or dispensing the drug might not have been aware of the increased risk the alleged conduct that was in the late one thousand nine hundred and ninety very early to thousands had nothing to do with suicidality the alleged conduct had to do with the promotion of primarily selects of precursor to lexapro and lexapro the drug was effective in adolescence and that takes us to an interesting point and response to a point that mr taylor ma promoted the drug is safe well after the black box warnings were implemented in march of twenty thousand and ninety seven years before lexapro was prescribed to kennedy the f d a decided that notwithstanding that risk notwithstanding those warnings the drug was safe and effective as labeled to treat adolescent the pression it was only the nd drug on the market to ever receive that  teen is prozac was the st so it was it's the only other drug on the market besides phlox a teen that is approved to treat adolescent depression so the so the f d a says and that this is all in the believe you have perceived this i mean there isn't a single promotional piece in front of the court there's not a single statement from a sales representative or any other company representative that's been indicated that's been put before the court or represented was made there's just simply no facts to support any of the conclusion re laundry list of allegations and parade of horribles that are in the complaint the allegation that force didn't comply with the corporate integrity agreement will judge fitzgerald notes in his decision that that agreement was discharged in two thousand and fifteen that the it's not plausible that the federal government we entered in to that our allegan entered into a corporate integrity agreement with the united states government that lasted for five years didn't comply with it for those five years didn't do any of that the allegation is we didn't do any of the things that the corporate integrity agreement required us to do yet in two thousand and fifteen the agreement ended none of that is plausible i think it's in your not judge fitzgerald was not and you are not required to assume the truth of that allegation particularly in light of the absurdity  allegation in light of you know what is known to have transpired and is a matter of public record and is in the record in this case the setting aside any potential preemption issue does the the warning by itself negate what advertisement and marketing of aspirin a safe does the warning itself negate under california law it's a decade so misleading advertisement that the the warning is inadequate as a matter of law judge fitzgerald found that appropriately to answer your question it would depend on the conduct alleged in this particular case there is nothing other than conclusion reallocations that this took place and again it goes to the absurdity the plausibility of what the plaintiffs allege your honor can get if we can please get context specific and talk about this case if you'll indulge me the allegation is that the companies spent hundreds of millions of dollars over fifteen years undermining an f d a mandated warning for suicidality that's the allegation in the case yet nowhere in the complaint does plaintiff identify a single statement that was made the contents of any misrepresentation who said it when they said it to who who relied on it why i mean there are the all of the complaints have always been and that's why the judge fitzgerald appropriately dismissed the action that outlines what it is this conduct you know consisted of and if you think about it in terms of you know the extravagant allegations  being made here that this occurred over fifteen years hundreds of millions of dollars and the plainest can't come up with a single example not one over where this took place that they can put in the complaint for five years during this period of but i mean this is a highly highly regulated industry the notion the hundreds of millions of dollars of efforts undermining the the suicide warning went on for a period of fifteen years and no one noticed to the point of plaintiff as something i would be standing in front of the government right now trying to explain that conduct if it occurred your honor it didn't occur that's not plausible and in order to meet their pleading burden mr taylor has conceded that we are now at the point where he's abandoned the inadequate warning claim i mean that was extensively argued below and we're finally at the point that we recognize the two black box warnings in nine other paragraphs directed to suicidality is an adequate warning related to this particular risk but there's just no basis there's no plausible basis and certainly no facts in any of the complaints aside from conclusory allegations that here the corporate integrity agreement obligations you didn't do any of them yet in two thousand and fifteen that the corporate integrity agreement ends i did just it's not it's not plausible in this particular context your hon would like to point out that the plaintiff has abandoned their negligence claims at this point all that's left are conduct are claims of intentional fraudulent conduct whether they're put under the bucket of alleged off label marketing or put under the bucket of other conduct undermined in the morning and as a result in plaintive concedes as well that the heightened pleading requirements of rule ninety apply in this case i mean for all of the allegations he's got to show them who what where when how or why of what transpired if you don't have any other questions and thank you i really appreciate your time and attention getting just just a couple points i'd like to make the the history of lexapro as is significant historically but by way of background i mean we this is a situation where a compan faced quite as i criminal proceedings was finding its very large amount of fines for the conduct and basically doing the same thing that is left here our position is that they continue to do a different variation of off label marketing even after they were fined and held to require required to address this black box warning on on the drug it's not that they permit it the prior  thoughts and feelings about lexapro being safe for teenagers to exist they are firmly went after it they took actions to make sure that the the the the marketing and the promotion of this drug was was that the reputation i should say of this drug has to go to drug for these types of situation and was maintained despite the black box warning opposition is not that they stood idly by opposition is they to voluntary affirmative actions to actually undermine and take the legs out of that black box warning what facts have been alleged in the complaint that makes that allegation was of all we have i believe was nine paragraphs with subsections in the complaint to describe a continuing education and things of that nature the marketing scheme that we lay out in the nd and complain is very lengthy and detail now we have not conducted discovery so you know do i have the smoking gun that's that you know a corporate or a corporate memo that says you know we're going to continue to do this despite the black box warning no i don't but we are in the early the pleading stage of this matter and i don't believe  year that would seem to suggest that the federal government was not dissatisfied with the fende and it's compliance with the agreement what supports the proposition that the have been that they paid the fine i just don't know that information but what we do know and what we have asserted in this case is they continue to go out and speak to doctors and speak to pharmacies about this drug in a manner to undermine that black box warning th all produced a sea change and we can like it or not like it but the supreme court's requiring some specifics even more when you're dealing with an allegation of fraud and i've gone through the complaint i see the broad allegation about how defendants have done this and haven't done that i don't see any facts are there any facts that we believe that we laid o i mean if there's something here i want to know it but right now i got to tell you my impression is that that that there are specific facts alleged in the complaint so that defendants argument that the plausibility requirement of it all hasn't been satisfied seems to have some direction so you've got something i can take a look at i'd like to do so yes still i believe we start on paragraph thirty nine of the nd when the complaint competitive edge i'm sorry forty one a competitive edge over of the companies that were developed and i depressants which were generating revenue as well well i'm looking at those paragraphs to see allegations but i haven't seen facts and i just may be a different understanding of what the pleading requirements are but that's that's my concern of you know where the sales conference may have been or who spoke at that sells converse and things of that nature and would ask the court and if that is what the analysis today boils down to there we do believe the liberal