argument your opponent has made that device is defined in the statute this is something that the district court accepted in fact quoted in section three twenty one h title twenty one and that that piece of the f as the whole as any other part of the system would be when when we are asked to decide whether or not your your claims of express warranty and negligent decided cetera  expressing preempted because that's the way they review devices they look at the components and they sign it a classification when used for a specific purpose when it is used outside of the p combination with different components it is the preemptive effect we have not just the definition of a device to include parts in components amber congressman out of its way to do  is the f d a may require the regulation requires a complete description of each functional component and one of more samples of the components to be submitted doesn't that suggest that the safety re district of new york cases are exactly the same as is the district of connecticut case not law fontayne the one that came right after it those are three cases from courts that are looking at specifically this  teen and i don't need to be this course not addressed that the definition of device which is defined to mean components in parts among other things and but they also don't talk  that be the labeling of it the design of it why wouldn't those claims if if allowed impose a different requirement under state law th it might have led to less how could the fear how could you help me out with some animal trouble i understand i can understand the assertion that wait a second the manufacturer can't seal it off and they were in on that encouraging our label use but how do any of the other claims survived expressed preemption if we accept the other side's within the meaning of the device there it's still try running up against this great bass statutory regulatory edifice but that the federal government has set in place this is joe i hate to read but it might help if it'll be awkward but might help if you spoke more slowly because what's happening is the mike is this cut in and it's it's like there's a delay so it misses the first part of your work so if you can just speak a little more slowly i think you told us you wanted us on page eighteen of the story i got that far components that are involved they all are all actually more of the class three lines there's not a situation like in our case where there's a majority class to first class two components  in there's a screw is missing it's not in there so but now the device in a sense is different than the one the f d a approved would you argue will we have a state law claim now her negligent design take the use of the device leave preemption leave off label marketing just assume if they had put something on the market to be used specifically  even possible in the world your assertion is the nokes are close enough of the poor little things that smith and nephew what you're able to say from the press release and other materials you believe exists that informed what the doctor said and that's proof that he was being a curse so i correct that's ok all right thanks what have you back on the bottle  yeah yeah and what the district judge focused on in his home in his september two thousand and six order as well is that we are tabular system is here advertised as a hip replace research system not just a hip replacement system and what we don't have knowledge of is what th i'm not sure but i think you might have those reversed its we should prove to fight remember correctly it was p m a approved in the b h or system which is a resurfacing but it was never and nobody disputes that it was never approved regulatory status it has never said it would but that you do have a bunch of other stuff in there to question is it could could you make an argument to a fact finder what business the question is is that sentence in there simply to replacement the second paragraph clearly discloses its regulatory status well one thing i think you say for sure is there's nothing clearly about this press release because if there was you know we probably wouldn't be having this discussion at course ok well i would start of course cockrel we just ended which is that i don't think the two thousand and nine press release is a three ball motion so i would say but if you're assuming it is it were just a causation allegation i think it is speculative and it seems in fact to be at odds with the theory that they don't have enough facts to know whether he read or not i think it's speculative but i will say the district name as part of the label so that's part of the scope of preemption but your direct question is why would you need it if it doesn't have anything to do with your three sisters i mean i wasn't privy to write this was named the way of was but we do know that david it's a day seven twenty six repeatedly and sometimes and before you can use this metal min could raise an implied or concrete preemption how she's weighing how how would that work it and in answering that keep in mind if you would distress a chance assertion that no no there is no implied preemption because itself is p m a approved and i think that's important but we're going to have to hear may approve components in the mix and match device and i think clearly that's think we ought to focus on which is that the f d a doesn't regulate use it's so the f d a isn't going to make a comment about drug use it regulates devices it doesn't regulate uses because it doesn't want to led us astray let's go with devices ok this is this is got to be about on the preemption point it's got to be about what is the device right the question but there were a question we're wrestling with this what is the device  that got p m a approval so how do you get from the us system make up to me approval to each individual piece got p m a approval so anything any place that piece appears is shielded from liability he never approached it in that way the only broached it is that's the legal argument you're making i think you can take it to a extreme like that screw where it may not apply but this is clearly here the component was installed another system often used by a surgeon who is using the component app use and then the waiter relegations your honor and but ever lawsuit we're talking about down the road that component was central to the allegation you can imagine situations which are much on like this one where what is being is that the right way to look at this it is but let me add some things which i think me how you look at it now where you know it is undoubtedly there would be warnings in labeling don't do that but i would urge you not to do that but i take that a very yes option i can't disagree with that assumption but i don't think it changes anything else in this case as to upholding the dismissal of the strict liability under that assumption it would allow strict liability of a defect claim warranty claim to go forward against his or three metal liner that has been approved and must be you what happened if you don't mind me doing that i mean i don't think the record clears up definitively trish appears to mention which i think is page eight forty seven use the states and it's perfectly forseeable that those products will be in the state of pennsylvania and therefore at a minimum at a minimum we should have an opportunity on the players side to get in there and take some depositions and fire at exactly the corporate structure is so we can understand who the responsible parent company is i think that the be the argument that the district court's analysis of this in toto is  it's if it's enough for the defendant who has the information to say we'll tell you what we want to tell you and you don't get to hear anything else isn't that an unfair advantage for a defendant in saying well you can't i just because we've traditionally we let some discovery take place that has facts it's not a system usually where one party gets to say this is the way it is and the other party doesn't get it as assertion is it well you're out of the facts the facts that