call the second case for the day seventeen dash five zero zero one zero wild man vs medtronic wild man wilbon you can correct me when you come up well man all right ok whenever you're ready counsel thank you others may please the court the spine stimulator injury is a industry is a big business it's not enough to get your device p m a approved you've got to beat out the competition and that's why medtronic created this statement that's the the gist of this case the nine year device like statins that's in the briefs this is part of their marketing it's part of their advertising it's from their website it was never process the longevity of the component parts was never given to the f d a but your own i'm talking specifically about the statement that's on their website right and i know that statement because it's prominent in the briefs but my my question to you is p m a processes are very lengthy a huge amount of data is given is that you're confident statement that nine year longevity as to anything other than the battery was never given to the f d a or that goes to one thing that's in the defendant's brief is what they actually submitted and what the f d a approved their statements and this is page seven of the defendant's birth the labeling at the better can last for months or years and then there is a statement says better life nine years and so what we're stating here in our case is look if you withhold that in your advertising and in this statement that actually constitutes awards and under texas law that is misleading that is untrue what they tell the consumers like mr wild is that our device is reliable but it wouldn't be misleading or untrue at least under preemption theory had the f d a looked at it and said you're right not only the battery but all the rest of it but if the f d a had cleared an approved this yes then  what evidence or even at what allegations do you have that it was a component part not the battery that caused your client's problems because dr gurwitch which you allege he says he was sending wildman over to look into getting the battery replaced well they say the device dud there's actually a statement here that in it's on page four of our complaint says medtronic states the entire device is dead and they use the word device and that's that's where the problem devices we know this component x is having problems when you don't even know you don't the device people often can find out what the problems are generally with products and that's a problem this is with a twelve c motion ascensions twelve b six we got knocked out before we could even do discovery metromix has the device and we do have experts lined up but they have to analyze everything and medtronic presumably downloaded data and this is the devices not the battery and that's what brought them so we can actually see we're talking about it's a computer that's installed inside the body that compartment there is the battery you've got microcircuits or you have the b wires that run up to the spinal taps of the spine you have the charger you have the program this is all part of the device and if any one of them fail then the device fails and some of medtronic did is they took that tiny little statement from the f t it says three months to nine years or better life nine years and they said well our whole device then will work nine years we guarantee it and that's with the song on the pleading issue so you've given it your best shot in the pleading well your honor you know in hindsight obviously every plaintiff would go well you to draw a reasonable inference well this isn't the facts section where we talk about what mr wildmon did that's statements there and then in cause nine under the facts section a it's a person or two mr wildmon relied on this  write but when you say as you just quoted you have to look at the pleading and see what reasonable inferences can be drawn that's rival concern because dr girl it says it's the battery so doesn't looking at what your allegations have been the natural conclusion is that the battery went out well the doctor actually couldn't know at that point but he says he says i'm sending him over to dr mena to look into getting his stimulator battery replaced it doesn't necessary say the battery went bad and they're just going to try something and it could be the lead it could be the truck or there's been other issues here that are in the record as far as these devices were different parts and fail in the device goes so you're saying to get past wildly in a ball you just had to allege that junction would only apply your argument is if it were the battery at that point you would acknowledge that it would be preemptive right well i disagree with that although i can understand distinguishing between the battery and the device and saying well you know better be preempted but anything else would not and that would be a decision that you'll reach in this case but i would suggest that this statement is so overbroad as to be false and misleading because the f d a never approved a guarantee that the bettors glass nine years they said three months under rated be no reliance writing because it would have been permissible for them just to promote the battery in that manner because that's f d a approved so if it is a battery defect how would you have a reliance on the do your causation whichever way you want to look at it but we're talking about a device that is surgically implanted in the body so if your doctor tells you well it might last a few months max last nine years which is a true statement as to what the f d a approved robin would not have had this device put it man who wants to have to go through a whole surgery only to have this thing last for a few months but when you make a statement like a bumper to bumper warranty like if you buy a car in this think they've built more than most cars cost for this thing to get in but if you get this bumper to bumper guarantee you sure as heck want your car less more than a year and a half if they guarantee the cars you might want to but if the f d a for whatever reason has looked at the data and says it will th can represent that absolutely or if it was approved and if the statement was approved where they state the whole device is going to last or devices are liable for nine years and they rely heavily on gomez arc decision and go to say even express breaches of warranty can run afoul if the contention is that the statement you're disputing is really the safety and efficacy of the whole device gomez referred to i think they called it the new that's the the information for use of the device that again it's looked into that the manuals on how to use in this case is one of the only case the only case i've seen where you're looking at the marketing the advertising way beyond what the f d a approved to the point it is false in a security area of tort liability you're saying is premised on an f d a violation and that being at three fifty two misbranding is that your logic it is misprinted that's true your honor it's a parallel claim also as far as parallel under regal yes your theory if they were found liable that would be supportive of the f d a process not adding to it yes and when when well but disagree if there's any other aspect to your answer so really what's going on here is your tort theory reinforces three fifty two the f d a saying it can't say things beyond what we've approved of that yes your honor and the fact that under the law and it's discussed in  these express warranties can in certain circumstances be enforceable they got to be truthful accurate and not misleading inconsistent with optical federal and state law and that's what we've got is that they went away beyond what the f d a approved in order to gain a competitive advantage and they misled into the merits and the the problem is as ashley had even if the district court was wrong on preemption the your honor of the we put the exact statement in which is different than all these other cases where morgan pay for martin that they all refer to all they do is refer to vague statements that it didn't comply with these f d a manuals safe and effective we said minute this is the exact statement they violated the f d a rules on it this is false and misleading and he relied on it that's really all we need to do in the understand your position but i think there's enough meat on this bone when you've got one quote didn't care in the home case which put the device if that's the specific expressed more two that were referred to why get the other nonsense that all these other cases get into which are just knocked out right and left then sure they have big long complaints but the courts have been knocking them out because the complaints refer to free as the warranty itself  allegations or what doctor told me something about how great this was but what we don't know exactly what was said here you're saying at least the representation you've nailed exactly right we're trying to get the cause of the failure you know and that will die now we can't yes i mean that was their main focus relegations absolute and they put a lot of weight and he put a lot of weight in this godfrey case which refers to a louisiana it's warranty it's a strange case of who talks about when a warranty off label use is it no you're approved so you don't get to have your limited warranty but a limited warranty under the jessop basis of this circuit case can't be a basis for a twelve b six or a twelve c motion and we're not required to amend our pleadings to address their affirmative defense on it and they're limited warranty is it's interesting because it's got some unusual terms it's actually in there are always here that came out of that's right preempted under the m d a if the allegedly breached representation conforms to the labeling that was approved by the f d a in the p m a process that is the case here the face of the documents show that the advertising that was supposedly relied upon by the plaintiffs and the f d a approved labeling recognized the same thing which was that device life and battery life are the same thing for this device not necessarily for every device distinguishing manufacturers who may state their batteries have a long job where the nine years it's important to understand that many other factors and components are involved in determining overall long jeopardy of an implanted device how do you get around the distinction you're  very product is making that's i don't need to get around that is the distinction what the web page is saying is that for some other devices other components might be the determinative factor of the devices longevity for the restore altria is the battery life that determines the lifespan of the device and where you draw on that from in the website representation you read that to say that it's actually the battery that is all that matters the battery is the determining factor the limiting factor life span of the device that's certainly the theory the district had but just even looking to you to your left if these it sends twenty to achieve this distinction medtronic rigorously verified invalidated the many components that impact device longevity not just the battery i mean i just don't see how you read that to say it's just the battery it says it's not just the battery and i mean what it's going to me why how you can read that to say it's only the battery and there are the components like the case for example and there are wires internal wires to the device and what that would be just saying is that the lifespan of an example this is just that now i'm very confused yeah your position is that every separate component had its own p m a no or your position is that f d a for this device made a class three determination the whole thing with all its component parts is safe and effective for nine years the latter and the only player is making about a separate devices about what all the leads to the wires that come out next to the body those are separate don't mean like you're arguing that anytime a battery is mentioned that gets protected even though it's mentioned in connection with the entire device but in this case that is for this device that is the case because the failure of the dip of the battery results in the failure of the device you can't have a battery failure without a device failure it would be a problem might fail earlier or be expected to fail earlier than the battery and so you might have a device claim that would not depend on the failure of the battery not about this particular instrument mentioned the battery and everything else the statement in the labeling the stamen the labeling expresses the same concept as the web page expresses that this is only one eleven what it says is that the device reaches end of service or less nine years after implant that's because that's when the battery expires so the labeling equates the whole the overall device life to the battery life the battery life is the determinant for limiting factor for this device or your interpretation of what those words mean is subject to other people interpret again another way perhaps but that's that was the other manufacturers that would say our battery will last for nine years but other components within that device might fail in less than nine years and so the consumer would not expect to get a full nine years out of that device and you turn around and say our other components will last nine years yes their answer to that is the f d a has never confirmed on the data you received that's true and therefore to the extent that was inaccurate you've mislabeled it and their warranty action supports allegations of the claim that's being asserted and the effect that that claim a successful claim would have on the p m a requirements here this claim is about the safety and effectiveness of the device and at the f t determine the vice to be safe and effective under the conditions of use it isn't really i mean ice that's that's had no fourteen gomes and they aren't saying this device isn't safe and effective as approved they're saying it might not be safe and effective as it wasn't approved i didn't say the device the component parts are all going to work for nine years but said that the end of service is nine years so to get to that conclusion it has to consider the entire device in reaching that what's your best case circuit case interpreting riegel this way that sort of final paragraph that seems to be implicated here which is the premise on parallels or adds to well there are a number of cases that recognize that i'm looking for a name that i'm sorry well i'm looking for a case that applies regal as expansively as you want it to which is to say that once we get approval that preamp representation was false but that was a representation that was approved by the f d a and that also comes back to that records that you've given us that one eleven or one zero one zero one of eleven in the our way is where the end of service means it states sample in the middle of the page under the heading charging system and states barry functions not restored when the nerve stimulator battery has been over discharging restored twice before not in the record of this case but that i think that sufficient materials are in the record of this case ok if there is sufficient materials in the record can you point to a portion where medtronic said and here is the lifetime of the wire and here's the lifetime  years i i want to also clarify something an argument that the plaintiff has made today and in his reply brief about the omissions from the web page which has to do with qualifications on the battery of life and i just want because that's a that's a totally different theory of this case and one that was not presented until the reply brief and so it's forfeit it's a different the main theory is that the webpage advertising went beyond what case in addition i wanted to follow up on on the adequacy of the complaint here on a device claim it is correct that the only component that's even mentioned as a possible culprit for the failure is the battery and this is not a gotcha point the failure of the battery and the failure of the device are one in the same thing for this device because the battery is the determining factor for lifespan if you could have pointed to something else maybe that would lead to a different result but when you have a a preempted claim for battery for a battery warranty and that will necessarily also result in a device warranty violation assuming the battery life and device life are different things you would have the ability to circumvent the p m a or the m d is preemption requirements by simply generalizing or making more vague a claim that is actually preempted and that also runs counter to the approved so just being hypothetical if that were the case of course that way all you would have to do you want to redesign your product you would have to rein in that warranty not not in this case for a couple reasons first of all the allegations are still that the device was not safe and effective the allegations are that it now functioned it quit working it failed to alleviate the pain from which it was prescribed and it caused him a physical and emotional injury that is what safety and effectiveness is about so this claim i would declare that the device was not safe and effective under the conditions of use prescribing the labeling that was approved by the f d a that's preempted not only under the m d a is printed under ordinary conflict preemption rules because it would ask the court to make a determination under state law that is counter to the f d a is determination but in addition texas law of express warranty the theory of a warranty claim is that the device shall conform to the representation so his claim is that the device should have lasted longer than it did should have been safer than it was even though it's really his claim is really  the malfunction at the moment he's saying i was misled into accepting as your your advertising worked exactly as you tended to didn't buy a competitor's product about yours that is that is his theory but you know you because you mislabeled it and i don't see how that's adverse to any safety and effectiveness finding blue in this case what he's saying is that because of because the device did not conform to that representation it it failed prematurely malfunctioned so it didn't work and it hurt him he minimum we could distinguish off label uses and more injuries which arguably are not found to be safe and effective by the f d a i mean i don't i'm not fully conceding that but i think it's a different world and you know all of the cases that have concluded that an express warranty claim was not preempted involved it's involved off label use every single one of them that i have found that has been cited in this case just on the pleading issue you're twelfth's emotion to if i'm correct below you didn't say it was insufficiently played because it didn't name the other components that might fail you claim that there was no reliance that is an argument that we made i don't recall if we specifically articulate theory that that the only component that was identified was the battery but we did argue that the thrust of the complaint was a battery life warranty claim and that is what the district i mean the district court and that's the same functionally the same as what the labeling said because they are both expressing the concept that the battery life determines the device life in this for this device he said earlier today of course it's true that the battery the device is going to fail but is it possible for other component parts to fail with the battery fully functioning i believe it is but i'm not certain of that and there's nothing in the record that speaks to how at this stage of the case you have the device how can what information is the point of access to the rule allow it to make a allegation of what failed i don't know what information is access to he may not have the device whether he set has access to an expert who can educate him about it i don't know but twamley at ball there may have been a time when a plaintiff would come into court and say i can't fully plead a claim but i need to scupper e and then i can figure out whether i can get have a claim probably that ball closed the door on that claim and this complaint does not meet that standard and you can't go and get discovery first to be able to fill in the gaps in his complain there was a statement your honour's that he said that i was very surprised that you would state to the court said the leads are not part of the device and your caught on to that really quick the device doesn't work without the leads being attached and yesterday absolutely so many parts of these components that can go wrong in the f d a did not approve exactly what we've been talking about this nine year life on any of these components so their bold statement is false it's very misleading and it creates kind of a in their argument also that well you didn't probably pretty creates a catch twenty two for the planet now how are we supposed to plead and put more meat on the bones without having access to the device which medtronic took after the surgery we can't test it we can't analyze it we can't download the data from it which presumably they did it at this point in the game now if we were allowed to go back to the district court absolutely that the game one is what we would do is we've started looking at this evidence but how can the pla panelized for not having this additional information as to what precisely went wrong and cause this to fail but there's no doubt when medtronic and it's in our pleadings and the doctors there's no doubt that they said the device failed it absolutely died and it had to be removed and this was some years after the device was installed the they make a big deal about this well the end of service is nine years that does not say that the device has guaranteed for nine years or make any of this language which is really strong and it's not just what we think it'll last nine years it says the result is a rechargeable stimulator that delivers reliable performance over the entire period of predicted service that's an affirmative positive statement that's not wishy washy and that's  when we all have computers and any little part of the computer fails it goes down they could be a software issue it could be all kinds of glitches so how can they when he sites want to lebanon one sixty five and this the f d a approved statements there it's your position that looking at them closely in context they're exclusively focused on the battery like he's picking and choosing some things there and yes i believe so i have to look at those that want to live in there but i'm looking at one thirteen in the already way and it says the battery of an implantable nursed in the later can last for months or years depending on the following factors do they disclose that to mr wildmon absolutely not because that would hurt their marketing but a lot of these factors are not under the control of even mr wildmon talks about the program parameters which are set by the doctors and in metro nick reps actually do these settings the system impedance hours per day of stimulation and they mentioned at the record does contain portions of the p m a filing know whether or not it contains any evidence about the longevity of non battery components i saw absolutely nothing and i'm sure they would approach it up in their brief and pointed out with a big star next to it saying hey look you're some poems that were approved everything that we've seen so far which is points those tiny little statements that are contrary to their nine year device lies we call the