preemption i believe that no matter what i say about the adequacy of our complaint which i know this court carraige defendant is going to advise this court that it doesn't matter because our claims are either expressly or imply italy printed under the medical device amendments or the m d a are you saying that this is a you have a parallel pleading i'm sorry i can use a parallel your yes ma'am yes ma'am these are these claims have been brought against a medical device manufacturer smith and nephew on the birmingham hip replacement to be h r which is actually the subject of an im deal in the district of maryland do you concede that your claim is preempted to be extent that you are claiming that the design of th hip implant even if it's manufactured cording to spec at that the design is defective i don't believe that if we if we have an allegation of design defect that we were not manufactured comes out as the device that the f d a approved so there's potentially was a quality control and whether or not they conducted adequate p m a studies to determine the of the device and whether or not there was adequate inspection to make sure that while the device was being manufactured it was being manufactured according to the process that the f d a approved that's what i mean by manufacturing defect you're talking about creepy i'm a activities that way as i understand the p m a process in order to convince the f d a to allow you to market the devise a class three medical device you have to convince the f d a how this device is designed how it is manufactured and what quality control steps the manufacturer intends to go through in order to assure the f d a that the device that comes out is the device that they approved have i got that all right that's what i understand the p m a process to be correct i think i think that the defendant obviously advises the the f d a of those processes but the f d a itself actually imposes requirements upon the device that are part of the medical device amendments as well as part of the p m a approval driver specific to that device i agree but as i understand your claim your claim is that notwithstanding all of that something went the i think there's a confusion of nomenclature here there are various kinds of manufacturing defects one kind of manufacturing defect is when oh the specs are that it's going to be manufactured a particular way and it isn't for example it's supposed to be a smooth piece of metal and there's a small crack in it another kind of manufacturing defect is a defect in design the the thing is supposed to be able to bear one hundred forty foot pounds of energy and it can only bear one hundred pounds of energy because it was in the design it was curved wrong it's manufactured according to spec and it breaks with one hundred twenty pounds of pressure on it when it's supposed to be good to one forty because the engineers designing it made a mistake that kind of design defect is sometimes called the type of manufacturing defect sometimes it's just english and are we on the same wavelength here and i think so judge and i think you're claiming that it wasn't made according to spec rather than that the engineers didn't design it right but i'm not sure that that's what you're saying women and for individuals under the age of sixty five yes that was never used to manufacture the originally for people under sixty five right the person under people from google more active people yes right athletes they wanted before for a full hip replacement to do this partial hip replacement that's correct that's correct so and i hope my example can provide you some understanding of our claim a little bit better and of course some of this information that i'm providing is the result of these claims being able to go that state law is satisfied by warning third parties where there is a reasonable degree of certainty that that third party will provide that information i can't tell whether you're saying that my understanding of your claim was right or saying that my understanding of your claim was wrong because there are a lot more words in your answer i had thought that what you were saying was your failure to warn claim was not telling the f d a about problems that risen you're telling me about the arizona law that says that's ok as a failure to warn claim but you're not telling me that that's your claim i think what i'm trying to do here because of course i'm pretty and it preemption issue under the m t a we have to have the parallel state law claim produce a deadly gas ad and that's supposed to be on the clorox that you sell to consumers and there's another type of failure to warn claim that i think you're making here and that arizona law says you can make we do have the parallel for state law duty of failure to warn that is satisfied by telling the f d a which they did not do so yes you're correct isn't it easier to come to prove a manufacturing defect than a failure to warn is it easier to  prove from a practical standpoint i think it depends on the case so you also say you've got a parallel claim for failure to far a manufacturing defect right so i understand a manufacturing she'll have to explain it to me too because i thought a manufacturing defect was if i want to manufacture water i'm going to go to wherever and say i'm going to take two of these hydrogen is one of these oxygen and put them through here and it comes out water and it turns out and said did three oxygens and one  studies of explanted device devices the device is supposed to have certain clearance tolerances so that it reduces the metal where metal on metal doesn't get chromium  and yes ma'am yes ma'am so what we're finding home office in your blood right so what we're finding is on explanted devices the clearance tolerances were not met that they were instead of my understanding is and of course obviously there's going to be some expert testimony on this i can provide my understanding of it is they were supposed to be one hundred microns but instead were two hundred seventy one microns and this is based on smith and nephew's own studies on the x plane a devices and that is that difference is what has caused the increased metal wear so that supports or manufacturing defect claim during the manufacturing process they didn't do that the clearance tolerance aspect of it correctly so your is your position that if we reverse the district court and say that you should be allowed to him and or that you had in fact your petition is clear enough under the requirements to go forward that you can go  manufacturing of manufacturing defect in a failure to warn it will probably go to india so correct i think i mean i think that practically speaking if it's remained at it would it would be sent to the m d l and is it your understanding that the district court said it would be futile to allow you to amend yes which means that there's no possible factual basis to come up with a claim for even though there are over two hundred ninety something of the same exact claims in india that is current fact i downloaded five of the petitions you cited and a couple of them have the exact same wording as your petition and i think and it's never right that that is correct and i think that highlights one of the issues in our pleading is obviously in some courts the court says this is enough for example in the the you know based on two of the allegations the manufacturing defect the court said yes these suggest an issue in the manufacturing defect namely that there's problems with these tabular cup component read your petition and say the have a cause of action i'm district judge had i saw this long list of regulations that a manufacturer of medical devices supposed to follow and perhaps because of my difficulty in reading i was having trouble finding the part where you said and they violated this regulation and the violation caused is bellman's and injury and maybe even as a bonus this is how it caused her injury  list a bunch of regulations that's not the same as alleging violations and then you can have a summary saying and they violated a lot of them but i still want to know what did they do that was against the law that hurt mrs goldman and how  that's when i was trying to read oh so for example we believe that our allegations that that state that smith and nephew failed to determine properly determine the life span f physician you know she had her or her she had to have a revision surgery and her revision surgeon advised her that the b h r with which she was implanted was defective that it was causing her pain and the excess tissue i'm sorry adverse tissue reaction caused by the excess metal wear so by not doing those things that we alleged and i gave her link and what the district judge missed is is that you're saying these violations caused her injury because they caused a defect a device to be implanted in her that produced her injury that is correct and then of course with our failure to warn possession of some of the nephew correct we obviously as i said based on discovering cases that were allowed to go forward as as your honor pointed out with sometimes even less facts or verbatim facts and we having trouble with your of course you can't keep if a surgeon reports that a device failed you can't keep that confidential it's not a trade secret you have to tell the f d a i think that that is part of our complaint judge as far as the adverse event reporting we do a e that smith and nephew withheld they are required to return to advise the f d a of any adverse event so that's your tie in there for the failure to warn yes sir did you allege in the complaint that had the f d a been informed the surgeon would not have used the device yes we allege that that because of this they didn't they weren't aware of the problem and problems associated with the device and i think that this court at least the concurring opinion and since watt furred in the stingel decision indicate that that way what your honor is talking about is certainly a proximate causation issue that we are going to be faced with down the road that we are going to  in the extent to which that's been pleaded here and then i'd like to go to this question approximate causation that judge kleinfeld asked about and the watch for concurrence and look at that a little more closely but let's start with the manufacturing defect i think is the court's questions brought out so far the key to a manufacturing defect claim in this medical device context is a claim that identifies a deviation from the specifications that f d a approved that occurred during the manufacture of the process and so the first question the court should ask as it looks at paragraph twenty of the proposed amended complain because that's the paragraph and it really didn't change between the complaint that was dismissed and the proposed amended complaint take you back to its acts and allegations that the district court said were inadequate and you'll manufacturing defect something that is not an attack on either did the design of the device or the procedures used to monitor the device once it's in production so if you look at the first four of those ten sub paragraphs of a three those are all design defect allegations that one council has focused on in the reply brief and this morning is be as in way and that not only is an allegation of a design defect on its face but it cites to the design control regulation of the c f r this is all what's done as part of the design put in something called d h f or design history file to document that the planning of the design has been done appropriately the next two of the ten these would be e m f are simply conclus allegations that there's a defect but it doesn't tell you what the defect is and then the last four are just general statements conclusory statements about monitoring procedures so they don't tell you what the design of the manufacturing defect is so when you look at what's in the complaint and this is what the judge had before the judge proposed amended the question you don't see any description of a manufacturing defect that that it can survive after the supreme court's decision in the regal vs metronomic case vs medtronic was on a motion to dismiss and supreme court made clear if wh is a design defect you cannot go forward so regardless of whether these allegations are enough to state a claim of a design defect they certainly aren't enough and if they have a design defect i understand they've under rule eight you've got to be able to read this and say oh i see the manufacturing defect and it's not there and it can't be an abuse of a disk discretion in the district court why or why doesn't that just mean it should have been  dismissed the original complaint said this is conclusory i don't see the claims but you can i give you leave to a proposed an amendment so the plaintiff filed a proposed amended complaint and that's what i've been pointing the court to is the proposed amendment complaint now the player didn't change anything on the manufacturing defect and that's what frustrated could have entered again i suppose if they're educated so if they understood what the problem was from just  national complaint well they made other changes and i'll talk about those in the failure to warn in a moment but they didn't change the manufacturing defect and i think that was what was so frustrating the district court as i told you these this wasn't good enough you come back with the same thing he said i don't know whether you're unwilling to or you can't but you're not stating what the manufacturing defect is and so is the case comes to this court you know plaintiff wants to introduce new ideas talk about a  just and so forth but they could have told that to the district court they didn't it can't be an abuse of discretion for the district court not to consider was there is this the aspect of a case where a judge said wiggs said i'm frustrated here because i don't see any evidence of you going to any of these other courts that have been or protective orders and ask for permission to lift the protective order so that i can include more specification here to be clear judge tom the district court didn't say that they never mention to the district court that there were things that they thought they could say the reality is they could have said anything they said to this court they could have said to the district court they just never said it to the dispatcher and your argument here is that i can look at this proposed am complaint to your fifty nine and sixty five and see that because there is no red line insert here they did there was no change to these exactly they didn't they didn't make a change they haven't pointed to anything new you couldn't tell the district court they needed access to any information they didn't give the district court the opportunity to say you know well let me help you or let's let's deal with the problem they just came back with the same material after he gave them the chance to do something different ok let's turn then to the failure to warn claim because i think that may be a tougher argument for you to say i'm looking there's a lot of additional red line here you are sixty sixty one and sixty two on the toughest sixty three and as i understand their theory their theory is smith and nephew were getting a substantial number of complaints from the feel about problems and they either word delaying forwarding those complaints on to the f d a or they were under reporting the severity or the seriousness of the complaints now why doesn't that sufficiently allege a plausible failure to warn claim and i guess the last part of their saying is had this information been relayed to the f d a in a more timely and more truthful fashion my surgeon would have been warmed by the fact of these these reports and would not have used this particular device during the surgery and the answer to your question judge hominis what's missing is precisely that last clause of your question to me so when the court goes and looks at paragraphs twenty two and thirty two of the complaint those are the respective paragraphs that have the causation language in it and it is purely conclusory all it says is as  is they didn't timely report and they under reported the severity of the complaints that were coming from other surgeons around the country who were experiencing problems with the device and had and my surgeon would have known sooner about problems with this device and would not have chosen this device isn't that sufficient to establish a failure to warn clayton isn't your honor this is a critically important question so i'd really appreciate the opportunity to talk sure about that so if the f if the court would go for example to the modern database we cite this in footnote twelve of doctors about changing you know the warnings that f d a has already given but this is i take it the medical community has access to the database they do and that's why the caution is there to make clear that you know these kinds of reports these are reported constantly about every device about an hour do i consider this is there in the f d a eventually may decide to put a warning on the on the box and  and also at the reports are in so many medical databases secondary databases said that are accessible to doctors on the net before they use a particular device just like reading reviews it's different your honor because you don't see the denominator you see the numerator so this report of this problem that report of that problem exists complain doesn't tell you what the problems are but you don't see the benefit profile it doesn't say we only let a device out that has zero risk it lets out the devices where the benefits outweigh the risks and it puts warnings that are considered warnings that reflect the risk now let's look at what happened in stengel is critical to distinguish the causation that was found adequate in stangl from the lack of causation allegations here and i would ask the court in particular look i don't think you understood my question my question was even if the f d a would not have put a black box warning on the thing because of number of complaints that were that would have been made had they not been suppressed and even  so wouldn't doctors be free to make their own decisions on have risk and benefit based on the public knowledge that they would get these warnings that had been given to the f were warnings given that's yet and yes exactly so here for example it's within plaintiff's control to plead causation she knows who or surgeon is she could go to her surgeon she could say did you know that there were a certain number of complaints i found that were belatedly submitted or you know whatever the allegation when she found that it changed where when she found what she's alleged them in her complaint and i think where would i find them if i were looking for something like that you could go to the ma database of the first warnings reported by your company to the f d a at there have been a part of and i don't know the specific date on it your honor but there's been a communication with the f d a is extensive in order to get approval to begin with so lots of studies have been submitted and lots of thing and a lot of been running since then subsequently doctors report various complications or problems arisen and of course not just reports are published right but they take a long time to get published because they have to be peer reviewed they have to submit articles they have to have a big enough case study and sometimes those those take a very long time to reach the public truth and even then they may reach the public before the f d a warnings read reach the public that's it and that's true but if we have an individual doctor who would look at that they could plead that they didn't but here's the critical distinction not and this is what is so critical and stengel at page twelve twenty seven this is judge fletcher's on bank opinion explains that before plaintiff was paralyzed medtronic had become aware of the risks but failed to inform the f d a the then sent a warning to the doctors be it too late to help this plane and now the vats the causation pleading that's totally missing here there's also not the link to the individual dr judgment watford writes a separate concurrence a majority of the on bank panel joins it and why does he do it to explain that the causation allegation is sufficient here to let the case go forward it would if in the absence of that he explains you don't have a parallel claim that's not preempted by buckman document based on section three thirty seven says you cannot use state law to inforce failures to follow the f d a reporting requirements so i assume they've pleaded enough to say the company failed to follow the f d a reporting requirements if they don't allege the costal piece does what the f d a says don't you know and reads the my database for this and that you know fashion notice play he certainly had notice of what the problem was when she filed a petition but that's a two step requirement in the ninth circuit it's not just notice it's has she pleaded a nine preempted claim sufficient to start up the whole motion of litigation and she refers to the m t l that the m t l is at the pleading stage as well so nothing that is slow about the ninth circuit there  sounds like you're trying to import rule nine specificity requirements for pleading fraud in to rule eight in the they don't apply no your honor the reason it might feel that way is that congress and the supreme court interpret and congress in regal and in buchman have ruled out whole sections of you know claims that might otherwise that's not of course that's not pleadings law that's preemption law the preemption stage as the court did in regal as the court did and bachmann i don't understand since her doctor already says the reason this implant went sour is that the piece that i implanted was defective and it seems pretty likely that if she were allowed to amend that same doctor would say if i had known about these reports which were suppressed i wouldn't use the device of got to do it the first time and then mail when a doctor replaced him and said these were awful i mistyped that second doctor said it's defective but and mayo clinic so we understand that but it doesn't say whether it's a design defect or manufacturing lud you know there's a problem but you don't know whether to traces to the design of the device if there's cord all that man roaming i mean your blood is going to come from the car cobalt and chromium metal that's implanted in her unless she's got some other cobalt chromium floating around but it doesn't tell you whether the device was not properly designed to prevent that it's a metal on metal device it doesn't tell you whether they used the wrong metal that would be they used the wrong is that in fact that's it that's a different than what this design was exactly to different design and so if if you're saying if you had metal off of metal that way right but if you're saying boy you should have never used metal on metal well that's the design f d a approved and under the supreme court's regal decision well first of all any answer to the question i have are pleading at paragraph fifteen of our propose first amended complaint we do allege at the time of the procedure neither plaintiff nor her surgeon were aware of the myriad of problems associated with the b h r obviously we meant that to be read in conjunction with our proximate cause ation additionally with respect to the issues on cause causation that were dressed you know some of those issues addressed some of the issues that we had before the court which were requesting letters from f the f d a i know that we cited two cases in our briefs that said you know we don't have to have anything from the f saying that they weren't doing this but we did some of those warning letters that he was discussing at page i'm sorry a paragraph eleven we did allege that they knew of these issues and they were not reporting they knew of this this  wide swath of issues and we're not reporting part of the requirement that was put upon us at the district court level was that we didn't identify specific unreported adverse events but some of that has to come through discovery  e that's much more robust i will admit that i will admit that there has been discovery that has occurred and there are many more allegation and much more facts that that we do have now that that is not protected any longer by federal  complaining or less even less robust facts had been allowed to go for these are difficult claims to plead because of the the issue that of protection by federal law of a lot of the information that we need we will admit including a supreme court case page twenty three of our reply and i know more cases in our opening brief the matrix initiatives case where they acknowledge that the adverse events may not prior provide certain proof of causation but they can provide a prominent degree of suspicion i think through discovery we would determine whether or not as the court stated in stingel whether or not the it would reach have reached her position in time to have made a difference and