suppose you know can i ask you a factual question right looking to see if there was some specific allegation in your complaint as to what you claim was a defect in the pump this was there of a faulty valve or was there a faulty suction device or was there a faulty insertion  coupling with the catheter i couldn't see that you you ledged what was wrong with the pump can you tell me that reaction that is a major issue in this case i magine it is yes it is but the problem not was a defense if you if let's say we don't have we never had the position of the devices and then explanted from my patient from my client in a surgical procedure by hazard it's never she was unconscious we never touched the device she never had a position but the point is not theirs it doesn't matter what do or it's a problem with a device workers if it will it's a we have it in we discovered the pompous bat are you claiming that this device was defective because a reason because it mis functioned in a manner that a reasonable patient would not expect know their address california law product numerous numerous conditions upon which p m a was granted is a matter of fact p m a conditional approval letter is that patched to enough soaped and the most important part of trying none of them to that effect we have a when i requested what happened with the devices very simple question what happened was palm's three pounds was supposed to be sent to you to make sure your maker person come to the store choose pick the model and the salesman says you said ok we'll give you thirty percent because it's not doesn't work person comes home america doesn't work that practice of hiding pomps so he reliability statistic would be almost one hundred percent of total with the help me here sure you're saying that they violated federal like me but just let me finish the other part and there is a regulation requirement to report adverse events and you say they didn't they say they did that c r forty five through fifty six are those adverse event reports so can you help me with number one why are they wrong about saying they did report them and then secondly the part about requirement to analyze  st of all i don't believe they reported this if you're referring to my knowledge a report as a public website that's not reporting relooking at s c r forty five through fifty six that's in the record that are very complex but they are headed adverse event reports and they they claim that those are the adverse event reports so tell me why they aren't is it come out of reports like a small small things that's i  regional agent of detroit brian corman if specifically supposed to be present in the surgical room to receive those pumps xtina they get implanted so he can assure  that at least in this instance in clifton this case the reporting requirements were violating the requirements requiring and no analysis in the report the f no knowledge otherwise she has no way of learning any statistical data at all i didn't quite get the answer to the world was question to you do you claim that the federal regulations scientific studies concerning the device it's attached to the government twenty one here it is in other a clinical investigation of scientific studies concerning to you i mean applicant known as a reasonably should know twenty one  grossly misstates the obligation under federal law for that matter whatever california state law i require in terms of analysis of the pump there is no federal requirement that medtronic analyze post x plant the pumps nor could it because the pants belong to the patient and they're explanted by a doctor in the hospital and contrary to what counsel just said that and they're trying to representative must be present at the time of x plant that's simply not the case sometimes on occasion  procedures and i don't think in the operating room itself but on hand and one case he testified that he had the pump and then he fed exed it back and true we don't know or understand what happened to that pump but i want to be clear as a matter of federal regulation  he has not the misrepresentation and state program for the matter of federal obligation under you that the p m a specific to this device or the regulations that were cited just now by counsel none of those regulations impose an affirmative legation our duty a that's a good answer but what what about the back and forth about these more or do the pages i was citing which you seem to say these are exactly what we need and he seems to say there's long  afterward and they're only on a website and so and can you credit help me sort out that bike so if i could be happy to do that because i think it highlights the confusion at issue between what's what an adverse event report is and adverse event report does not depend on some analysis necessarily of the pump you're right if an analysis were undertaken and it revealed some kind of defect or problem in the pump it would need to be reported in an adverse event report but these adverse event  in based on any type of infanticide could be a call in from a patient it could be a report from a doctor it could be the kind of report that's here which is the information coming from the sales representative or it could even be from a lawsuit in fact our adverse event reports were updated based on the lawsuit that was filed here so it doesn't require an analysis of a pompous possession of the pump my medtronic to effectively discharges duties to make adverse event reporting under the federal regulations now the federal right that the pages i was citing are what you claim to be the required adverse event reports that's right your honor so the pages friend they're very you know they're sort of stuck together so i was trying to figure out how many adverse event reports are there certain an excerpt so the record there are three adverse event reports corresponding to each of the poems but i should know that in the district court record and this was a mistake on our part in the supplemental record there you and i just want to clarify one more point of confusion and the reply brief and here today counsel represented that these reports were filed after the fact and only in response to litigation that's simply not the case  relevant code field in these exhibits is the date f d a received not the report date the report date as something that reference can reference additional reports and supplements to the report but the initial report is this date f manufacturer is required to fill out that has this missing content of the information and then the f d a reflects that back in the mod database for the public to be able to review and investigators to be able to review and  what to be able to review so this ma database is the official government report to the public but it isn't the actual report that the manufacturer makes that's a separate form submitted and in each case  f and that the fact that the pumps were not analyzed is not evidence of any kind of violation of federal requirements and i also want to just talk about the purpose of an adverse event reporting for a moment couns case an adverse event report is not a measure of performance rates or or performance for the product there's a controlled study and it's here in the record of the product performance review where there's a controlled study with thousands and thousands of poems that determine the performance rates and that's where the ninety nine plus percent rates come from there is no allegation that controlled study was in any way problematic in this case the adverse event reports as as i've described through the process  adverse event report and required them to be taken out and replaced so they break that down judge between what require them to be taken out and what require the report the reporting threshold is very low basically anytime there is some kind of adverse event some kind of injuries some kind of problem with the with the device federal report must be made so that threshold is extremely low what led to the replacement of the pumps this case sounds very bizarre because there  four pumps and a very short time window but keep in mind that of those four pumps and the record there's really only one pump that had an identified failure which was pump two so pump one lasted the duration that it was expected pump for at least as of the last record check was working properly it was the last pump she got pump two was the one that after just a couple of weeks didn't seem to be working but as counsel admitted there's no reason to believe it or no necessity or even pleading that this was due to a defect and there's lots of reasons why pumps might not work in the body when you plant a pump as a sensitive device it can not work if it were exposed to heat cold electromag field was implanted wrong upside down not inserted correctly there there could be many many reasons that are not based on a manufacturing defect or anything the manufacturer did that can cause a pump not to function as intended so we don't know the answer to that and he has applied it were based as clean on pump to on a defect inherent in pump to no pump three which was also explanted after only six months the doctor in his deposition admitted he he didn't know what was wrong or even if there was something wrong with the pump there were discrepancies in the amount of medication that the that were in the pump but he never identified a malfunction even much less a defect in and replace it again so that was not because of an identified failure of the pump even it was a doctor decision making without any data to support that the pump was not working as intended and in fact the data showed that the motor which was the problem supposedly with the  nd pump was functioning and in pump three so i think that even though it seems like on the face of it while there are a lot of pumps here in a short window much less than you would expect really really have one pump where there's even a potential malfunction issue so i think that that you know brings us if you don't know that questions on this failure to analyze theory to the fraud and misrepresentation claims and keep in mind that these claims went to  have the opportunity to develop the record here and simply failed to develop a genuine issue of fact on three of the essential elements of this misrepresentation claims essentially the plaintiff is arguing that there was some  palms would be better she was arguing that there was a promise that these devices would be analyzed and she's alleging that at and now claiming she wasn't really alleging this but now claiming that that the pumps could be fixed not just analyzed but could be fixed in time for the new pump to be replaced and that the pumps were the best those were the three allegations the best on the market the three allegations  and what the court found was there was no falsity these are dr coleman the sales representative said allege statements that there was no falsity in these statements nor did coleman have the cyan to reason to believe that these were falls and there's good reasons for that that the plaintiff herself admitted she didn't think mr coleman lied when he thought the medtronic pumps for the best and it's appear that that was a reflection of his actual opinion as well as the doctor's opinion at the time the new pump would be better st of all that sort of just an opinion of future fact but there is good reason for that the product performance studies show that these are very reliable pumps they rarely break they have over ninety nine percent effectiveness rate within their timeframe that they are expected to live and honor's but if you look at it between two hundred and ninety two thousand and fourteen the f d a approved over one hundred supplements to the p m a for this device and in fact redesigned the battery to make the battery life better so there was good reason to think the pump she got in tw fourteen would be better than the pump she got in two thousand and i because it had had substantial numbers of improvements during that time there's also a lack of detrimental reliance she said in her deposition she admitted she was not relying on the analysis as to each pump and when a quote here is quote you weren't relying on any analysis of a pump before you got a replacement because you never had it answer correct this page one that's also page one hundred and eleven of her deposition and the supplement ex of the record ninety five to ninety six and so she tried to get back track on that statement by submitting two days before her summary judgment motion a declaration that contradicted those statements and said that no what she was really what dr coleman are mr coleman said was that not only that the pumps could be analyzed but they would be analyzed and the particular defective found would be fx she changed that in her declaration to say that he that was a promise that he made they would be analyzed and that the defects would be fixed and that was there for a long well that just simply is inconsistent with her deposition testimony that she did not rely on any potential for analysis in making the decision and of course it would have been plausible for her the defects and of course we don't have any defect in this case in the st instance so i think that these claims of misrepresentation of fraud the district court properly granted summary judgment finding no genuine an issue of prepare those ones in the body knows what we have is a complete denial of receiving bombs ever by any crony so how could have been that reported and who reported it should not be admissible it should be disregarded even if we have that dismissed any further issues leaving only to issue of personal mr presentation and the personal misrepresentation come back to that is basically he said she said and that is a tribal issue where she realized what he promising but he said and i