eleven ninety nine and twelve o three to five what is indicated there is that even before the launch of the prada g s k had studies which showed that there was a statistically significantly increased seventy three percent information the f d a had they had more at this point with respect to this particular risk they had more the canadian officials unlike united states physicians were given as early as one nine hundred ninety nine compelling data regarding  label in two thousand and one say with regard to any kind of risk to the u s late yeah so with respect to a skinny cartier bresson it was silent with respect to congestive heart failure there was what we say was a can cause can it congestive heart failure it was not until two thousand and six where two thousand and five excuse me that that label was strengthened to be able to show that in fact it does cause congestive heart failure how different was the canadian label initially than the american label in this respect i don't know your own i do know the information regarding the risk in the car or just risk but not regarding congestive heart failure also continuing with your question about risk in a cart me scheme a cardiac events thousand or that also showed it increased risk in the risk of a scheme to cardiac events that was not disclosed until by j f k and only in adequately until the fall of two thousand and six when they be that you really only wanted g s k to include the warnings that are currently on the bandys label generally speaking that's right though you normally are pointed to at an earlier point time that's that's generally correct in the van akker your honor of course you can't have a forty two study if only thirty seven studies of it exists at a certain point in time what we want to g s k to do with respect to the label i'll talk about a minute something more broadly but with respect to the label at the outset at jump street in one thousand nine hundred nine that label should have had disclosures regarding what g s k had internally regarding a scheme to cardiac bands number one and number two certainly quite early on certainly by two thousand one there should have been far more grave warnings regarding congestive heart failure as well just take also should have warned regarding study after study after study that it had regarding the propensity of end of india to increase fluids in people and there fore create the potential for congestive heart failure all of that should have been warned quite early on and it could have been the case message the other thing we want is that c s k should not have gone out into the public and said this product because it reduces insulin resistance can actually help diabetic patients with their heart conditions in other words it can reduce that so what we say the g s case should have done is disclose the truth earlier on which of course the f d a never in any way did it from doing number one number two it shouldn't have marketed this product as we do sing insulin resistance which will therefore give you better heart can result if any of that happen it with a no sales at all so so i understand correctly you claim you want to escape congestive heart failure earlier than it did in the end in a more compelling way than the way that it did yes didn't the february two thousand and one label include have and should have warned regarding the propensity of the product to create increased based on the results of the studies pre launch yes yes and so in our in our brief your honor you'll note that there is a section physicians as the drug that they are supposed to use in the first instance in order to control blood sugar levels but when people found out about let this happen it dropped from from standard the care to not to not to be used and pretty perilous daily over a short period of time ended up being a drug that was absolutely not to be is at its height how much more was it prescribed in metformin it was this it was prescribed in conjunction with metfor quite often but but but also sometimes in lieu there right but it was the standard of care what needed to be treated so people doctors were treating people with for their blood condition with this product not knowing that it had a propensity to actually give different color when that depending upon whether or not you're able to mask who it is that's delivering the message so one thing that has become clear with marketing cases like this regarding the pharmaceutical industry is that of a drug maker can't have somebody else make its pitch for some ostensible neutral you know party who is who is make making the communication that communications going to be it get accepted far more than if it was just the drug rep itself who was trying to make the patch so i summarize it is this what rico tells us is that if you're accomplishing something through a group of separate people that you couldn't accomplish as well or the same way on your own and those separate people here are a if the big drug company is a separate company b m s a separate company g s k t s k is trying to treat a kinetic like it's at times a competitor and therefore similarly an honest broker for this product when it goes into the marketplace but it wasn't because it was peddling something that was false the same thing with the doctor after who we identify and then there are also consultants and p r firms that we identify all of whom much like in the first circuits  right and in other cases like it the distinctiveness requirement is being accomplished in other words you're accomplishing your objectives of marketing the product and selling it through third parties in a way that you could not accomplish if you're doing it on your own seventy five and nine zero one in the joint appendix you will see that in the medical review after the time of the approval j f k had produced studies eleven twenty twenty four ninety three ninety four eighty recognized if there had been thumb fraud on the f d a choir to the approval that doesn't speak to the question of whether g s could have modified the label that would simply be a question a fraud on the f d a and that would be and we would hope the studies do not see the light of day there is no question your honor that there were discussions within g s k about the potential risks prior to the approval or all of that with prevented through the f d a obviously the f d a there's move more than a discussion at risk there are there's no question all of this and the f d a could have to fight it not to approve the drug or could have put a different warning on it but once the f d a puts the warning on the drug federal law mandates that if we don't market a drug with that warning the drug is myth branded the only exception if we could change the warning after the approval based on new information it was this information this conversation about these studies not seen the light of day that was shared with  information was presented to the f d a but if it with not if it pre approval then the remedy is not a question of preemption the remedy is fraud on the f d a and that's preempted the question what about your clients efforts the warning letter all of the thirty's relevant to the ultimate warnings in two thousand and seven two thousand and eleven two thousand and fourteen every one of those studies if either not even referenced at mit thing or is referenced at having provided to and here i want to make clear how can we be sure the f d a would have rejected any c b e warning per dose of well we we know that in in in a few respect first of all we provided the f d a with a actual prior approval correct that wasn't necessarily a command it was you can do what you want but my strong advice is you should wait and let the dust settle this figure this out correct around and what happened when we provided the p f a year later and we gave them all of that data from i think the forty two the f d a response with very unlike the response in the photo from x case where as you'll recall there was a question about whether the thigh and supported a stronger warning and whether the warning that the company that merck had asked for with given was the right language stress fractures versus a typical female hear what the f d a said what we're concerned that the overall finance doesn't support a stronger warning we want more unblinded they stopped in the middle of a long term study gave the f d a the information from record and then what the f d a did what it said we can only give a warning for a scheme of risk which they did in two thousand and violation and the and we did not provide on our annual reports and some of the years updates on studies but the f d a said in that letter in that warning letter if you look and  fine twenty four fifty one it says although adopting record in approach and these other studies we're not included in the mandatory n d a angle reports we acknowledge that they were disclosed in other reports  on our annual reports our annual reports we didn't we were supposed to provide information about every one of our studies and some of the thirty's were omitted from our annual reports even though they had been because which studies ruminated their work there were it says here and i'm reading from the warning letter although adopt in record an approach and one ninety three and four sixty eight were not included in the mandatory annual report we acknowledge that they were disclosed in other reports and or notifications to the f d a so all of the cardiovascular risk studies were reported to the f d a we asked for a stronger label and the label with unambiguously rejected because the thought ion with something the f d a was uncomfortable with the canadian authorities provided with the same information that the f d a was an early two thousand they were and i don't know how whether there were differences if not in the record your honor we obviously are obligated to follow what the f d a requires in in the united states and and we we use the label that the f d a required into that when it with approved the f d a added on congestive heart failure a special warning in two thousand and one and the update in two thousand and seven was an update to a black box but obviously the plaintiffs understand and can feed it that we don't have the authority to make something up black coffee if there was a european lead to was i i'm sure there was the product with all there again that that's not something that the that in the record with respect to the question of preemption the risk to the f d a we disclosed them all if i gave you the records like before the approval of the drug we disclosed i think t thirty seven in october of zero five when we had i think the forty two which we thought as being indicative of a stronger risk of if the mcgriff we asked the f d a to strengthen the label they said no we can't strengthen it but we want to do more analysis then when we gave them blinded the long term study of actual cardiovascular risk we gave them the data they came back in november of two thousand and seventy five now we are approving a stronger if team at risk label is a statement that the long term studies are inconclusive  with respect to the the preemption i think this is actually i have clear evidence if you can find because we ask for the very label that they say we should have had today they said that summary judgment and today we have the question whether when they would have projected a stronger label not a particular vehicle for getting a stronger label they're the theby option which you can do and we told the f d a we were we wanted to do an f e they said we strongly warn you against doing it it will pull the rug out from under what we're doing with our analysis so then we went and we filed a p f and in fact there is a regulation and f d a regulation it's twenty one entitled to do i can't tell you what the thinking was behind why we didn't move on the enterprise issue at the time the enterprise issue i think is clear because at j fifteen thirty seven the plaintiff allegation is that he had control over the entire enterprise and the other members of the enterprise simply and this is a paragraph or two forty six of the complaint work to enable j f k to fell so what j f k with doing for example even though griffin myers if named if part of the enterprise bristol myers weapon out there like in a big group in conspiracy trying to promote its own advantage j f k with we really know what happened because the discovery allowed on the recall  said sentence of their opposition to the summary judgment discusses the benefits theories of j and thirty five you're on record certain says g s k falsely promised better cardiovascular outcomes compared with our diabetes drugs and build a baby into a blockbuster success correct your honor their theory of benefits when they mention benefits three times in two hundred eighty eight paragraphs in a complaint it is the way in which we misrepresented avandia and didn't disclose the risks was we over comest in part some benefit the key thing is our benefits claimed would have said to the court below all g s k should have done with token less not talked about the benefits instead their claim threw out what we should have spoken more we should have disclosed the risks they said in their thumb reach eichman the essence of this case the essence of this case is look what happened in two thousand and seven that's the chart where and even fed it to morning as soon as the risks were disclosed the bottom fell out of the market they they didn't bring a pure benefits claim their references their three references in the complaint t benefits were simply to show how we were hiding the risks and in fact when we challenged them at the motion to dismiss and said if you don't have a misrepresentation here what it takes come back with they came back in their motion to dismiss greek and they said of course we have  misrepresentation and misrepresentation if you didn't disclose the risks to district court discuss the benefits of the motion to dismiss and our court represent  city thirteen again your honor the issue is not whether they have some references to benefit the issue is whether or not the benefits were referenced by them as a way to conceal the risks not whether the there was a question of benefit their theory all along was we didn't disclose the truth about the product and if we can't disclose the risks earlier because back preempted then they don't have independent benefit claim five years manage this case she engaged with the discovery she engaged with all aspects of this and she said this is not a fully formed theory she didn't say they never mention the word benefit she said this was not an independent theory because they never said to her precedent for this if pierce turns nine sixty nine f up second three thirty nine it's a two thousand and thirteen case but there are other cases throughout that that address that at summary judgment when courts are faced with a late breaking claim of fraud and the question is if that really in the case what the courts do the trial courts in their discretion do they review the complaint and they look and see if it meets the nine b standard and judge ruled in her opinion said they didn't plead the benefits with particularity they didn't think who may think benefit who relied on it what the actual statement was how their how that person buying conduct would have changed she found doing the proper analysis at summary judgment that this was not properly in the case had they moved for rule fifteen it would have been clear she would have denied it and it would not have been an abuse of discretion we didn't address the benefits theory early because we didn't know that this was even part of the case the complaint reference but it with a clearly articulated theory of benefits that figure that said in the complaint we allege that you promised that if have cardiovascular benefits and we hear how here's what you said and here's who relied on it and here is how that representation affected our purchasing decision that would be a non preemptive claim and it would be a clear benefit line when we moved to dismiss the case there with banks well what is our stood after monitoring and watching the thief for five years what yes they had referenced the word benefits they could have even a few sentences about benefits but when they were talking about benefits it wasn't as a independent theory it was part of their theory that we should have disclosed the with probably shows with the record show you are absolutely and but that's my point because then at that point i read the record and i read the complaint right and we tried to pick up and move from there right and it's obvious that this is an issue as i indicated to the court i don't think this is a concession i think this is a practical way to look at it it's the two sides of the same coin if you talk about cardiovascular risks and you don't talk about the fact that there are words that have sense of benefits it is the same thing this complaint  a response to each of the facts that i proposed by g s k and there are two extensive decorations with enormous amount of exhibits by dr abramson that goes on and on and he goes through it in detail what it is that how it was marketed and that was all before the district court judge i mean you can't tell from the opinion because there's not really much mention made of the materials that we had submitted but going through each of the declarations of dr abramson you can see how what it is that what was being marketed here were cardio protective ostensible carty to protect the benefits of something that actually had enormous significant serious cardiovascular risks and so i think that that's how it was developed through obviously through nursing school and i tried to have my longwinded wire answers about what the case was about and he interrupted me said that this is the drug that was marketed as carbon protective and it turns out that it wasn't like yeah joe that's the case is about so it's this going throughout this case