good morning your arse brant was now behalf of the plaintiff a balance i asked for the court's permission to be to reserve four minutes of my time for a bottle yes thank your honour's may please the court this case sits on all fours with iran just like iran this case originated here in the district massachusetts when a drug defendant criminally pled and settled claims alleging project off of a promotion this case like that seeks to recover those prescriptions caused decidedly by that fraud and this case involves allegations that the defendant told doctors and consumers people suffering from a debilitating disease because when to run this properly applied it not only protects consumers but actually pretext on a struggling police because of the fundamental part of this case we have a drug company that used unfair and fraudulent tactics to gain advantage over its honest competitors so it's important that this case be treated like no ron we did give him a chance to go to a jury with the evidence we have for a trial on the in any f d a approval for the particular use that you say it was being marketed for that's correct but then for some period of time less a pro then did obtain f d a approval are you of the issue the reason we did that was because assessing cause asian in that context is difficult because now at that point they're actually promoting to pediatric specialists and we can't ascertain whether or not that was done for adolescents and just for lexapro so the sales that would have been for children program under that the judge didn't allow us to move forward with those and that's actually really important because the evidence in clinical trial data when it comes to children problem and under is categorically negative this is not an area where there's any dispute dr thomas locker and the f d a director who had a chance to depose in this case testified under oath unequivocally that to this day there's still no under twelve purchases because this is ramirez for example she was purchasing drugs for her autistic child for a period spanning from here seven years old up to fifteen and it actually wasn't until they learned that the child was actually able to need a kid effectively lawsuit alleging fraud what's your best argument for why those two disclosures didn't put you on at least discovery notice under the statue of limitations that would give you only four years in which to file suit because what happened next disabuses assert that that claim that was filed was actually dismissed prior to the entry of a criminal plea by the defendant  that point was the first moment that they had needed to engage an affable promotion prior to that they had consistently said there is no truth to this whatsoever and they keep him case being unsealed itself doesn't tell you that they mean it and we know because the case that was filed this miss because they didn't have enough information to prove their case it was after the criminal plea where they went under oath and admitted to the factual predicate he hears hears i guess work or i'm having a little trouble when you when you have to keep him action unsealed and you have other parties alleging fraud through off label marketing i could see if you represented consumer only perhaps you might not know what  what basis is there for looking at this record and concluding that a reasonable company in your position no plan wouldn't know what the drugs that it's reimbursing for putting on it's falling are being marketed for particularly with the marketing is the legend complaint seems to have been so aggressive well as a matter of law your honor i believe the case was pretty strong that the simple filing of a complaint that was not surrounded by publicity itself does not itself put a t p p on notice i mean would be a bit ridiculous to assume that third party payers are monitoring all federal dockets for the unsealing of key ten cases and then reading those unsealed documents to see if there's anything that could relate to a claim of all the rico i mean at some point reasonable becomes on a reasonable i think that's the point where changes is in two thousand and ten where there is a press release from the department of justice where there is an open admission of guilt by the defendant and that's the first time there's really notice to the world at large that there has been actual criminal and the potential fraud or misconduct on it on the significance of that point on that point as i understand it hinges the entire class with that analysis under the supreme court the china ira take a stronger in that case we actually there was a piggybacking of tolling after there had been an actual resolution on the classification issue here a company files a case and then voluntarily dismisses it before any subset of ruling rather be on a motion to dismiss or classification and so i do believe there is an area in a reading of china attack that allows  scare you would want to rely on the tolling for example if the two thousand and nine class actions were nothing and the statue of limitations started to run in two thousand and nine even your individual cl question and then you're right we would require tolling to be timely filed individually would have to american potholing i do think agra tech can be distinguished in so far as there was no dispositive there was no rule civil procedure that all that doesn't allow to abrogate the rights of anybody and based on procedure i don't think that the proper to be a proper interpretation of rule twenty three this is an area of law that is unsettled i don't think we need to get there i think there's a disputed inaccurate or insufficient label and so it's a piece of evidence that the jury can consider but it doesn't disabuse the jury process and in fact if that were to then on the counter right when they bring in enforcement action against the this case around our current number of reasons first in that case ninety percent of the prescriptions were off label in this case ninety five percent of the prescriptions were on label so totally different second in this case you have  because there was no pressure others to page forty nine of the rotten where the court found that the evidence was unequivocal that the drug was not effective and this is not that case why because it cannot be unequivocal that this thread was not affected because the a approved this drug is just how you getting allocating the burden here is if your client sold me a sugar pill marketed to cure cancer are you saying before and then i found three times if you if you've got an f d a approval in hand for a given use you can go and marketed people for their use and not have to worry about someone coming in and saying prove they're not you're liable for unless there's some new information out but we don't say that because we create the f d a must always be right forward and backwards we say because this is the way the process it is in this case because what we're saying is you shouldn't second julie shouldn't be entitled to second guess a determination and what you're doing if you do that is you put that quite some i think you are reading those decisions or you know passing familiarity with those decisions pre approval the approval demonstrates that the f d a has determined that the drug is effective and there's no reason why that determination even if occurs after the sales have occurred shouldn't apply to the prior because it's not like overnight the drug changed the  contingent on us in galloping the f d a approval with some retrospective in full no i think what our view is contingent on it's finding that the evidence is at least equivocal when you have an f d a approval and that when the evidence individualized evidence of injury and they  each did make the points that we would make on the yes which is first of all what we had in this case was the first week of claim was filed in march of two thousand and nine the case this case was filed in november of two thousand and fourteen over four years equivocal evidence in this case which requires from our perspective at least individual is evidence of an efficacy in the plaintiffs that the that the seven other words we have studies that show and i would actually take issue with one thing the plaintiff coun and therefore there was at least equivocal evidence in the record in this case that the drug was effective for under twelve i do not think so your honor because the question is again going back to what we're talking about before tort law plaintiffs need to show that the drug that they took didn't just have a propensity to be ineffective that it was actually ineffective in their usage when you add those last few words that proposition drug is not affected at all then i don't need to prove anything about how it affected me i take your premise if the drug was effective ninety five percent of the time or even five head you get negative study if you if you get a study that shows you're not doing better than a placebo that to me says it's like the truth you actually want i think imprinted depressed since i think the vast majority of studies are negative and that doesn't necessarily need an antidepressant are not effective at all but a means as in that particular study they couldn't show efficacy that's because this challenge infrared depressants to show africa's it and therefore the negative studies don't mean that the drug reference he actually testified a deposition we showed him all the data we showed in the internal documents he said under oath that was misled not describing the stuff anymore so this sadia that that that the doctor was prescribing it thinking it was affective that's bel the motion with the judge just down the hall i said right that's not true and i showed him the study that was positive no run in the case of then for some reason it didn't make it into the order i pointed out there is a recent two thousand and sixteen publication a net analysis done by nineteen independent researchers from around the world they came together they looked at all the data for select let's pro as well as all other antidepressants and they concluded that these drugs are not a factor they did not differentiate from placebo so they knew valuable piece of peer reviewed scientific evidence that we would present to the jury that they would weigh against for example the f d a approval in two thousand and nine for adolescents i would also point out force two months after he left as an expert witness and he testified under oath in two thousand and thirteen it's in the record that this study would be negative if they were invited and he also testified that there was absolutely no evidence of any e that's true and because of that fraud your honor consumers simply this is ramirez and third party pairs like the painters union they were specifically deprived of money they paid money for these prescriptions that never would