council have to tell me how to pronounce the name i pronounce it and devote their bones ok i figure out if i'm incorrect they just stay incorrect for the remainder  heard in dismissing plaintiff's complaint on preemption grounds we believe the facts present the court with a situation that has never been decided in the various preemption cases that have gone up to the supreme court that have been heard by the ninth circuit another circuit court to claim hinges of all right and so their claim hinges on federal law i'll know that this was never approved by the f d a this is a situation where the company one did not pursue a p m a a pre market  clock is ticking i'm saying well let's not restate the question a way that's different from what i said i'm not positive those nasty i don't want to talk about that i'm asking you what happens if we take all the stuff in your complain that the product didn't work and that it's not safe and there's no evidence anyone else suffered from that you're bringing this is a purported class action the injury and damage actually failed or cause harm or did anything to the plaintiff there's nothing there are no allegations in the complaint to that effect the website is likewise true that there is no evidence that it is a palpable with respect to what it would cost it would be determined with respect to doing this i would like to respond if i could just to you said we're up against preemption and i do think i understand the court desire with respect to the hypothetical that presented however i do believe that there are cases in the boss of me straker case of the seventh circuit the h versus boston scientific case out of the fifth circuit both say that by mcclellan the ifo in this circuit that have indicated that you may utilize certain aspects of violation of of the f d a with respect to claims regarding preemption in struck with a talk about the definition of an adult product so i don't believe your hono that the distinction is as you have indicated i believe that the that preemption does not apply here for the reasons that we've stated i only have a little bit of time i'm going to respond to your question and seats reserved the republic i want to get back to the one area where i think there may be some issue here you have expressed a claim for breach of an express contract and it is feasible that someone could contract beyond the scope of the f d a requirements if the hospital had entered into a contract with globus medical saying you will provide us with an f d a approved product and the contract said that and they agreed to that term and provided a product that was not f d a approved potentially you have a breach of contract climate that was material assume it would have been it does you have alleged or asserted in your new your in the third amended complaint now about a contract but there's never been a contract identified a specific contract that actually states that as the term of the contract much less identifies your particular client as a beneficiary associated with that we believe that when you go back to the preemption line of cases you have a situation here where globus did not see did not receive a premarket approval the substantial equivalent approval that the f d a in the context of doing that makes no determination about the safety and efficiency effectiveness of the product but rather says it's substantially equivalent to something that was on the market before the d s and there and that product hasn't been reviewed by anybody to be safe and effective and so even if they had that it wouldn't necessarily conclude that the lack of it does not therefore relieved to the if you're talking about identifying a product that existed on the market as of one nine hundred seventy six thirty years later so when you're talking about even though you're right as to the reference to safety and and if you see you're talking about finding that it's substantially equivalent to a product that has been on the market for in this instance would have been thirty years performing on the market and presumably would have had no issues so there is in my mind an underlying element that there is that can be relied upon in substantial quibble and see and hear what you had was when they finished when they found the f d a finally came to them and said you're still selling this we told you not to they took it off the market they decided it's not worth it we're not going to go and deal with the p m a we can get substantial currency so for the reasons that we've set forth i'm well over my time now we believe that it was improper for the court to dismiss the away it's set forth in paragraph fifteen of the complete this is a one hundred percent human tissue product that's not a device and so who do you think is confuse the plaintiff is it because they're  this this product removed there's nothing left in mr bond body regarding this product it's one hundred percent allograft human tissue product it's bone it's turned into bone it's being completely metabolized that's the beauty of the product so it's not a device there's nothing to remove there's no allegation of how does being on any of the issues presented to us because it goes to whether or not there is an injury basis for this cla ok i don't get it but ok if you think this is the best use of your time you go ahead your honor i i think this the questions and the responses that i've