s mistress is fraudulent concealment client should not have been preempted by the district court under the booking case by the supreme court in the bookman case that case involves specifically whether or not the device manufacturer in that case had committed fraud with respect to what it had reported to the f d a and its in its pre approval process to the five ten k analysis here we do not have a five ten case  mission for the lennox tell you right system whatsoever what we have is we have a multitude of component parts now i will admit that those component parts were five ten k per however the system itself that was implanted into this gentleman spine was not spinal fixation devices under the f d a guidelines are required to have five ten k approval for the device itself w device there was not and as of two thousand and ten or as early as two thousand and ten lennox has known that these particular political screws fail between the screw head and the three a because of cyclic loading which means when the screws are turned they can fail at that point between the head and the screw therefore that's why we need a five ten k only knees on a spinal fixation device so that the device in the component parts together can be tested even that would also include the minimally invasive tools that are required to install this device because those are also a part of the spinal fixation system and we don't have any five ten k s on those specific tools that your claim is fraudulent concealment is in the concealment relating to the f d a regulatory no sir it's not what what is the concealment the consumate is a stand alone mississippi tort claim where there's a concealment of material fact in that lennox never represented to the doctor the hospital the all the components together as one unique devise there was no five ten k approval so what they did is they played frankenstein with pre approve with the device with with component parts that are already approved to make another device that had not been tested and not met the rigorous if be a requirement and was not based on a per ticket device as a five ten k approval which would require under the medical device  deviation from the manufacturing specifications for what was actually inserted a c on that i don't see any of that evidence being presented to the district court there's two problems there first of all you don't just have to have a deviation from approved the system was not properly queerer by the f d a it just sort all relates to the f d a process well it relates to whether or not they submitted a thing to the f d a that's just a fact that there's no way that mr estes could give his proper informed consent with with this knowing the material fact being concealed now a minute ago we talked about manufacturing specifications and performance standards your honor that goes back to deviation in the manufacturing process for this device not that not the submission to the f d a but where is the specific flaw where's the deviation from what it should have been your own a we don't exactly know what that is not in your brief because and argued to the district court and it's not argued geodes your own of that is correct does not argue in that specific way that there is a manufacturer specification the what is argument is that our expert could never what manufacturing deviation there was because the screws were never returned no where we provided the evidence in discovery that we requested to see these other complaint files where these political screws were used to show historic performance failures and things of that nature to give our expert an opportunity to testify and to make a realistic investigation into causation we never could provide that because we don't have the screws they provided youth groups that were the same they provided us twenty seven complaints you know there were over four hundred different complaints and in fact one of the complaints that we reviewed there was a doctor in there talking about other provisions with that specific patient and in that specific revision it's this is referenced in my brief in my reply brief he talks of that doctor references these other claim numbers that these these other issues we were never produced as that in and of itself is that there's other documents in that file that we have requested that have been with him did you mr allan ross there at the surgery and he was bringing in a new device well you know we don't really know what he was doing because he says he doesn't call that's what his testimony is in the records that he doesn't recall and it's been extrapolated to say he lennox's thirty six representatives as if he's there he has a duty to report his findings so in other words he has an obligation to make himself knowledgeable about what's going on in the surgery and the medical records specific there is a screw fracture and that was one of the specific reasons why this device was being moved under his contract is specifically listed as this is in a footnote in my brief that cites the specific language distributor shall promptly inform report that to landings he failed to do that these broken screws this hardware that's that's undeniably relevant to future litigation and when it's relevant to future litigation there is a duty to preserve a duty to preserve that cannot be delegated about mr russell was there that the district court took him over his word that he did call what happened while he was in other words district court made a credibility turn the nation without considering the other evidence in the record one being his contract be the medical records and with that you're on a we have an issue that is a jury determination on whether or not there is bad faith or bad conduct or for whatever reason now i have argued in my brief that the show a deviation or a deviation from a performance standard and here the doctor did testify that under the former standards this screw would had to have lasted longer than six months and it only lasted five so there right there is a clear with the circumstantial evidence provided that we have the doctor's testimony we have the medical records that there's a deviation from a performance standard then we have a question of fact that the district court didn't even addressed even though she specifically mentioned or performance factors performance standards in her issa should also have a lot of been to can do allow to conduct that further discovery to provide more information on his claims he requested additional five k filings that used those same component parts and it's necessary to have those as our expert testified in his affidavit because it we have to know how it failed and to be able to know how it failed we can't just look at them plans involving political scores we also have to see if there's something involved with those plates and how those plates move because if those plates move to certain information as it relates to the minimally invasive tools that will be used because those tools will have a bearing on that on that cyclic loading and so if they knew that there was some cyclic loading problems their complaint files standing state tort claim upon which the plaintiffs relied on they soley stated that there was fraud based on deviations from the f d a regulations and so what they were saying is that we have  so the reason why bookman does not apply in this instance is because we have a free standing state tort based klein and the fifth circuit has already stated in here is the boston scientific if you have a free standing tort claim that can exist outside of the third rule drug and cosmetic your state to work claim exists outside of the f d a approval if it's all based on this premise that the approval was done through the improper there for them to rely on they didn't comply with the federal regulations and as it states in regal medtronic the supreme court case that was done after bookman in two thousand and eight i believe if you don't have that compliance with those federal regulations you don't that i think is imperative that this court focus on but first i want to i want to clear up the record it is undisputed that all of the hardware all of the parts that six five ten k submissions and one of those submissions included the actual type of pedicle screw which is a candidate screw in this case the prior submissions included other hardware that was used were to be used in conjunction with other parts that were utilized and mr asked us about the rods and the brackets it was clearly communicated that that was an integrated system and the doctors would implant those devices with with other devices and it's one of those and another course probably familiar with when the doctor gets in there and the terms what rod he's going to use what screw what plate depending on the patient and specifics of the the vertebra that he's dealing with so there's no question that the part had been cleared and had been all other parts have been cleared that is undisputed in this case  the the there was a five ten k by part number as they were all done and included the screw part number and all of the other hardware partners and it was to the doctor who would like very good well the doctor may choose a certain surgery technique where he knows he's going to use a certain combination but these days these ar and he is doing that with cleared parts that had all been submitted through the five ten k process the claim that the plaintiffs the novel claim that the plaintiffs present to this court is that it was not done that the submission was not done as a bland or marketed tell you rod system that's not the way it's done at the f d a and there's no evidence that that was ever done by any manufacture their claim as and i want to make sure the record is clear those parts have been cleared by the f d a through an appropriate five thousand case and mission their claim is that they believe they should have been submitted claim is the classic buckman case that claim the fraudulent concealment claim and i think your honor so focused on is fraudulent concealment of what just because the ways present the claim as a state claim regardless of how they label that claim fraudulent concealment however it is dressed up the substance of the claim is what the court must focus on is what bug buckman instructs this court and other courts to do and it's the analysis that the district court in this case under which and looking beyond the name or the label of the form of the claim the district court found that the substance of the fraudulent concealment claim was whether or not y x fraudulent concealed the sufficiency of this five k process whether they can still specifically that it was not cleared through a brand or marketed telluride name versus part of that claim cannot and never has existed at mississippi law that can't that claim is the type of claim that buckman and all the other cases that no one told him that the entire component didn't have to improve i mean i can't even envision that it would matter or it wouldn't it's not a realistic fear that the component they're putting into your spine isn't district court argument your honor was that they fraudulently concealed from the doctor and the there was no evidence to support that the doctor would have done anything differently had he known that it had been cleared not by the market in the way that it only been cleared by the parker so i would doubt submit to the court that the plaintiff's attempt to state his state court claim as a fraud i can you know the other cases the shields case and the hughes case in these other cases have been cited in all of those cases the courts found that there was an anchor in state wall  for the claim whether it was a claim that was for off label use or in the hughes case specifically where that when the court found that that claim that the burning risk that  interior bleeding not of an exterior bleed i mean i'm sorry burning not from an exterior burn from machine malfunction and so those courts appropriately found that those r s that were not contemplated whether it was at the f d a level whether through their labeling there that those risks or real failure the warning claims that could exist and that were anchored in state law here in contrast this is the buckman example where the only basis is this fish and see of the submission to the f d a whatever you want to label the claim the substance is that we didn't do it right we didn't station at least submit just to the there it is our position that the the the fraudulent concealment claim whether it is whether it's frankly whether it's to the physician or whether and i think the their position in their district court briefs was that the form that we fraudulently concealed from the surgeon the implanting surgeon that we had not cleared this up the tell you rod under that tenure rod independent clearance even though the parts had been cleared that we didn't do an independent clarence with a system and so on but some of the what they some of the parts that were used in mr s s even those  parts have been cleared all of them have been cleared and that's undisputed that is their position in terms of fraudulent concealment adults and their position is not that we were fraudulent concealing from the f b i something about that the plaintiffs are arguing now that it was fraudulent concealment to the plaintiff but that of the same thing of the sufficiency or insufficiency of the f d a submission neither one of those entities are needed neither the company enormous to resole had the duty or the right to take possession of the broken screws that war removed from mr estus in the revision surgery fracture screwed issued and he didn't know that it was a lang's fracture which it issues his testimony was that he was in the surgery for revision he was selling the revision hardware another company's hardware and that was a purpose for surgery and that revision surgeries are done for a number of different reasons he didn't know why this woman was down and so the only the only person who had a right to take the possession of the screws a surgeon back across b and then of course the patient mr asses we did not have a right to take that screw nor did mr reese so mr rhys i want to distinguish his contractual obligation to the company is to report any customer complaints or any kind of harm and it related to any kind of hardware failure he has a contractual obligation to report those that does not mean that he that that meant he had some duty or rocket to take possession the actual broken hardware so the it was broken hardware at the time of the surgery excuse me on line to know that i mean they had their representative there are he represented at some point but the new device was through another contract he was an independent contractor under and he you know he is not in the field of surgery in these cases i mean the sales rep for this for a sells rep for a political screw devices is not in the field of surgery he was not in the field of surgery that day he didn't realize there was a screw that was broken and the doctor the doctor who was doing the revisions surgery he never there's no evidence that he indicated to mr or saw that there was this is of a more moving a fractured screw as and planning another skirt and so and he never certainly never reported to lights that he had screws so the district court found that spoliation cannot apply in this case because one what the party has to have knowledge or should know and we never had possession of the no duty to preserve the evidence if you don't have possession and you don't even know that there's a there's a product malfunction you have no duty and even even if you get beyond that analysis and the district court went down each one of these there has to be a bad faith it can't just be negligent allowance of the destruction of the evidence or documents or what have you so none of the requirements for spoliation were present in this case and the district court properly found  you know did not exist with and it was doing so in the context of looking at the manufacturing defect claim i can address the discovery and how that if that happened and presented a risk of broken screws that's something that they would have likely discovered and they would have discovered it because we produced every single complaint in the history of the company of a broken particle skirt whether it was used whether was broken through instrumentation or whether it was broken through you know a patient falling out and so i want to make clear that every fractured screw that we never did that they never requested a script and so we did not that was not that was not a subject of the motion to compel the only subject of the motion to compel was that we didn't produce  parts that had broken and that we didn't produce five ten k outside of the five ten case that we produce and i think we produced six five ten k submissions and so their complaint was five ten k submissions that were submitted to the f d a for parklands after this device and all the components that were used with the screw and all the industry used they solved the plants requested that they get those five ten s and the district court asked the plaintiffs to state a relevancy reason for both parts that failed fractured hardware other than the pedicle screws and to state irrelevan them and our position is route twenty six is not and the district court found that was not there was not a basis for compelling us to produce them that there was no relevance and there was no stated relevance in that rule twenty six and it does not operate to allow the opposing side to get whatever they want to prove the other guy's not lying so our position as you know it's an abuse of discretion standard as you know and certainly not one that they can meet in this case fixation system is not my classification nor is it my client's classification of this device it's not my client's cat classification that it's an integrated device either it's his classification that it's an integrated device that we take these parts and  together at the doctor's discretion but that's not what they stayed in their statement of the case in their brief they specifically state that the implant at the latics tell you rod spinal fixation system which includes  crawford knocked out dr crosby implanted various parts he chose to decide but that he and planted a fixation system and that ticks ation system in response to just want to question was never submitted for five ten k approval argument is premised on the fact that they should have but didn't get the whole system approved and your own are tricked and that and that owned that issue if there was a god a line that says they could submit this piecemeal approach to the f d a they would have already cited that regulation by now and they have not our experts testified specifically that they must submit a five ten k for this and fact there's you might be right but the whole point of bachmann is the f d a should be making those documentations you submitted to the f d a to say that you had or you misrepresented something to us and that situation you but when relies upon misinformation to the f d a whereas here we have no information at all and there isn't f d a approved put into his body because we're talking about yes we're talking about his ability to wall which is slowly debilitating with every day that goes by that he does not miss a dose of that's a new argument that before you arguing that the doctor wouldn't  proper the proper the proper request is made that is done in fact do you have any evidence that that would have happened i asked the surgeon whether he would have turned over the broken screw no you don't know we don't because his deposition took place before we ever found