tatutory interpretation here there really were no factual findings by the district court in this particular case and that this court has really the responsibility is to perform or a noble review  biomaterials access assurance act can i as and you may be jumping into focus on this but st of all i found it's not the st time that we've been given in artful language by congress but i found this one pretty dense and difficult to navigate but as i tried to boil it down part of the question was could you put this implant in to a body standing  would be attached to a head that lima did not produce first of all am i correct about your great about that your honor and then if i'm correct about that why is that is not dispositive of this case to say that that they were us lima was a supplier and not a manufacturer because it was because well a moment you factored in supplied was an implant a medical device that had separate five ten j clearance by the f d a and so when we're asking under the b aaa whether or not this what lima supplied was in fact an implant you have to look at that particular device now if the f five goes into the hip i guess is one implant connected to another yeah they asked tabular is the socket the femoral head is the ball and what claim of manufacture would be what's called a femoral when you get to medical device when you get to manufacture f d a has a whole different set of rules and if you open up a dictionary you might find of yet a whole other set of rules that we've got to focus on what the language is statute is and as i understand medical device is any device component of any combination product that right well look at great definition yes but if that if that's the definition of a medical device then a medical device seems like it's a component part which then would provide immunity because then you would be a bio material supplier if you're supplying a component or if you're and i honestly this is why this statute i really have a difficult time making heads or tails of a because it seems like you're going in circles when you begin but better but if what you're saying is right medical device is a component is and implant it as a medical device that you're required to obtain federal i'm saying hey clearance for and that the implant in this case is the femoral stem any femoral stem manufacturers they develop  femoral system that is designed that's right i think the ephemeral stem is a component part of it and i don't think there's any definition that i've seen in any case authority or under under the statute itself well  part and and the what seems to be is you've got d j i know i know they settled it out i understand there was never a finding that they were manufacture but i think they sort of s writing on the wall my suspicion as i read this case is that they saw the writing on the wall that they were going to be found to be a manufacture or at least a likelihood that they would be manufacture so they some of them can you have to pull manufacturing use of the same medical device well i think you can have a medical the fuse i mean use the wrong term shows how mixed up of the same implant because medical device is different than an implant right yes medical well the medical device an implant i design or manufacture anything for use in the manufacture of an implant the implant itself was the femoral stem sister and i don't think that should all three i would agree with you if we were sitting around the table just having a conversation  or even look at it it's a dictionary but unfortunately the statute says manufacture is any role in the preparation propagation compound in the processing of the implant which could include repackag part of my question was how do you read manufacture well how do you read a manufacturer is it we look to the do we look to the dictionary definition or are we supposed to be informed by this very broad definition of manufacturer in the uk at well have you looked at the term and you factor there is an exception to this statute for manufacturers so there is an exception to the immunity provided by the statu a bomb material supplier in the store in the beginning opposing counsel is arguing that effectively this statute covers anyone involved in the part participating in the development of an implant and that's not what congress does intent was well i don't know what congress  is not a bomb material supplier so the statute itself isn't even in place because a manufacturer doesn't get the exclusion or doesn't isn't excluded from the statute until their bio material supplier so they've created this limited exception for someone that might be might not be really a manufacturer might be a problem propagator or prep or it prepare our compound or they get the f d a clearance for the particular product and they can be a manufacturer under this statute but that doesn't mean that there's not someone who is not a bio material supplier that doesn't even fall within the statute because the statute is not even invoked until it's determined that the that the defendant is in fact a bio material supplier and there are very clear and unambiguous definitions contained within the statute for one to be a bomb material supplier they have to directly or indirectly supply a component part or raw material for use in the manufacture of an implant and there's no way i could be doing that here that's what i don't understand if they were selling this same that you can just put this in ends is if lehman was saying that but that's not what's going on i mean if you just acknowledged and as d j o acknowledged i mean d j o went to the f d a and said hey here's a whole series of heads that can work with this component part that's produced by lima so why doesn't that just why doesn't that just meet the definition of a component part because you're not a bomb material supplier until you participant to you supply a component part raw material for use in the manufacture of the implant and the manufacture of the implant is yes will construction of the implant and there is no question no dispute in this case whatsoever that lima manufactured all three so do they know i'm going to ask them this but i want to get your position on this d that they make this the screw they make the neck and they make the so they not only they design it so the question is how broadly or how narrowly you know we we we define manufacturer and how do we define manufacture and do we look to the clause that talks about manufacture and propagate and the other why aren't we looking at that because i think that's what church nelson's looking at you have a hard time you know and you separate out and say hey you know manufacture is not defined so you have to go to a separate definition of manufacture which is in the statute so we go to the plain meaning a manufacturer in my understanding you eighteen it's as directly or indirectly supplies a component part of raw material for use in the manufacture of an implant we have to assume the congress in that particular position and at that particular point in describing the preemption of the scope of what is a bio material supplier it intentionally we have to assume that it intentionally did not include all of the different things that are added to manufacture under the f t c a section three dollars such as propagate prepare or distribute congress didn't include that when it was talking about who components component parts supplier is or bomb material supplier and we have to assume the congress did so intentionally now yes it create in the st initial inquiry this statute does not even apply until there is a determination that the defendant is a bio material supplier and you have to apply a commonsense interpretation of the definitions in order to do that and  any manufacturer can be jail because they assume those responsibilities and they are involved in more than just the manufacturing even though they're not involved in the manufacturing they're in the preparation counting in process  be aaa applies in every medical device product liability case anyone involved in the participation preparation of a medical device is covered by the b a why do we only have five cases throughout the entire country on this because this is a general understanding that only applies bio material suppliers as defined in the statute if they're not a bomb material supplier which a federal head manufacturer is not which ephemeral stem system manufacture is not in the statute doesn't apply and there's a reason for to apply if you read the congressional purpose behind this what the concern was was companies manufacturing a piece a component part that is used in some other device that they have no control of and being thrown into litigation also i totally get it and if we were going just based on the purpose of think you'd have a strong argument the congressional purpose underlying stance you and if you read that congressional purpose there could be no explanations why congress intended the manufacture of every component of this implant such as lima to be included in that statutes immunity pr civil action brought by a claimant whether federal or state court on the basis of any legal theory for harm allegedly caused directly or indirectly by an implant as far back as the complaint there has been no allegation no differentiation that this is an implant and that they are suing for personal injury so we are through the gate way of one thousand six hundred and three dollars and the question is there are three statutory roles which one do we choice for the surgeon and you agree that the head is a separate implant i agree these are components that there are three major components and that is your honor the the head would be cleared separately i agree with that but the head by itself much like the stem cell or the socket cell means nothing no well i just i can i push back on that implant isn't the definition of implant a medical device that is intended by the manufacturer of the device to be placed into a surgically or naturally formed or existing cavity of the body for at least for a period of at least thirty days and again i just come back and say i don't know what congress was saying because it seems to say everything was your honor i'm glad you went there because i think that's a critical solution but i think any answer to judg i'm sorry i'm sorry i just saying i think it's an implant but i'm not sure that that answers the question of whether that meat lima a bio material supplier or not well the to me the critical part of the definition you're on to read from sixty you know to use of five implant is that it's a medical device that is intended by the manufacturer of byes to be placed in the body for more than three days so it's to me very important congress has deferred to the intent of the manufacture here everybody agrees that's d j o so i'm not sure every well yes no only supplied them to d j o which did a lot of additional work before that device was ready for him and station including the all important statutorily required labeling which is the buzzword for the instructions if i wanted to just a neck and i think you may have answered this but someone maybe not in the united states somewhere that you were allowed to want to just by the neck were just by it's through from the implant system in i supposed to the entire system with do you sell that do you do you make those in do you sell those your honor you have to differentiate i don't know what happens in europe and i submit is not relevant because of the several laws etc etc insurance and in the united states no my client in the time period in question did not sell anything to doctors or so called reps in the united states they only sold the d j o and d j o sold after it did edition so you know you make your client lima your interpretation of what you're encouraging us to look at for the definition of manufacture is the f d a is definition of statutory yes or ok even though that's  definition of statutory manufacture there are a lot of individuals a lot of companies that would qualify as involved in the manufacture of the product that would not be the manufacturer of the product that we agree compounding and so forth and it has two other elements you have to register and list so that's a critical part of the definition and it is a specialized definition for this be true that is true want to remind the court that there are two ways that the components are maybe one is if they are required to register and list with the secretary and here the f d a was asked that question in the citizen station instead no revision because the st one had broken or worn out but on april twenty one he got a new artificial titanium hip implanted into his body intended be there for more than thirty days it's really major a hip system and that's what he came out with he got a new hip and that's what happened on april st two thousand and eleven my client's in titles with immunity provided in this statute it was not i don't think the problem you voiced is a political and happens the the manufacturing process that is called out in this statute under subsection six is very ornate and it requires and requires registration and listing that's the one stop shop concept under this statute that the the entity to whom the f d a turns for regulatory matters like the one stop shop for regulatory matters and for civil tort liability the statute funneled all of that down to the statutory manufacture and he must stand and defend the process so like a building where you have  eight congress said hey these guys are willing to do business to sell their their components to us because there's so much liability exposure and so that's why we have a special rule in this industry wanted to make sure we had some components so that people could get new joins there are there's a big big market because a lot of folks are in a lot of pain i can tell from his counter might over time  one would well that's not entirely true the people who would have immunity on unity under my argument in this particular case are those that are intended under the congressional purpose to have a given that someone who supplies a screw as part of this total implant has no control over differences you just made i don't understand where the limit is why is a screw why is a screw maker entitled to immunity but not someone who puts three pieces together that still supposed to be a part of a five part or a four part  implant that goes into somebody's i mean isn't the answer isn't the question that we need to ask was this intended to go in solely on its own into a patient and if the answer is no they get immunity the answer is yes they don't get it i think you'd have to rewrite the congress defined a can a component part to mean a manufactured piece of an implant not an entire implant in its entirety which is what lima manufactured in this particular case all three components of that terminal stem system so that your honor i would ask that the court reverse the decision of the lower court remand this case for further proceedings thank you thank you thank you to both counsel for your help or arguments in this complicated case the case is submitted for decision by the court the panel case on calendar for argument today is cheney birth is the united states life insurance company in the city of new york