right case to look at when i argue the case below the districts that are you really relying on the dissent and we are if you look at what the majority said in that case which was they said twice that the plaintiff had conceded that the device was manufactured in accordance with the standards and regulations of the f d a said that twice now that the the sent this regarded rightly or wrongly that concession and then went through the regal two part test or the regulations or standards that govern the device there were in that case and there are in this case and in that case it was plus or minus fifteen percent discharge of this particular drug in this case the believe the silicone bleed of the of the of the implants were to be somewhere between point  exception which is the plaintiff the defendant have conceded that the device was manufactured in cordons with the standards and regulations the council of your position is this case if you have evidence specifications the specifications that essentially were part of the premarket approval by the f d a if the device if the device that submitted and that ends up injuring a person does not meet the specifications or in which the device was approved then it's an exception to wriggle so if you i'm sorry but you're your expert dr fa fine she basically said yes that there had to have been a defect but she was unable to testify in any regard as to the nature of the manufacturing process because she had no familiarity with it is that right that's right and i have no familiarity with it i can't i can't say that no one i think can explain what what manufacturing process failed here what all i don't i don't understand why that would necessarily be why there couldn't be an expert out there who would say you know i'm familiar with the manufacturing process just like you could have it in a car case i'm familiar with the met manufacturing process for these kind of silicone implants and i can testify that because this had the bleed or the leak of more than one percent two and a half percent whatever it was here's what would have had to have gone wrong with regard to the  manufacturing why wouldn't that evidence have been potentially available well i don't believe there's an expert who would say oh i know how this particular this particular implant of all the implants that were produced by  egant was manufactured and here's why it leaks more than the specifications i think if you look at the walker case you see exactly why this is an exception to regal in water you had a device that was posed to essentially give a very paraffin toxic drug to a patient that had a plus or minus fifteen percent delivery acceptance rate in that case much more than that was the patient and the patient died of an overdose the that limitation that specification is a performance standard that not every performance not every performance specification impact safety but that one did and the one in this case does so counsel in the complaint your con allege that the implants contain a manufacturing defect which alec and that not in teen in the specifications of that product of the what it's supposed to do and how it's supposed to do it and what it's look regal doesn't need neither reagan or the f d a requires a device to be perfect nor does it require a device if it operates in accordance with the specifications that it won't injure somebody what riegel requires and what the f d a requires is that the device meet the specifications and regulations on which that device was approved particularly specifications or regulations that have to do with safety why is why the argument that regal stands for the proposition if the  constitutes per se a manufacturing defect yes ok some of the language actually this regal says essentially the tour claims based on a manufacturer's departure from standard set forth in the devices premarket approval applications are not preempt and legal also says that preemption is a disfavored conclusion for any they said no more than one percent and that the bleed would not be clinically significant so they gave themselves almost a forty thousand dollars were thirty thousand percent leeway as in their walker case walker gave it walk around the if the device manufacturer and the f d a said you've got up to fifteen percent leeway this have to be perfect but no more than fifteen percent and the reason for that the reason why that's an a specification it's not an aspiration it's a requirement because anything more in the walker case anything more than fifteen percent could harm a patient and if the device approve the device in this case if the if the if allergy and said we don't know how much it's going to bleed it could lead one percent five percent one hundred percent we don't know presumably the f d a would have well you can't you can't release this device particularly if you don't know how much it's going to leave because bleed because it could bleed to an extent that is clinically significant as it well i think recipe would say if there's essentially damage then then there's liability we're not saying that we're saying that the specifications are that no more than one percent sh and the manufacturer does those ten things and there's a failure of some kind there's an injury then there's no liability are you saying those cases are my is my reading of this case and correct are those cases incorrect i think neither i think those cases say that just because you have an injury does not mean there's liability but how is that how is your theory different than that because it's not simply that we're saying you know we're not it's not simply that we're saying that ms weber suffered damage because of whatever amount of silicone leaked bled out of this device we are saying that we had an expert say two eight percent of the silicone leaked they're saying is that sometimes unfortunately there are going to be failures and that's a lot that them but the manufacturer is not liable if they do the ten things the f d a says to do and sometimes there's a failure right the f d a is willing to accept that risk and i read in those cases incorrectly you're not reading them incorrectly if this were a case in which the the breast implant ruptured as opposed to bled if this were a case in which it ruptured but it was it could still be manufactured in cordons with the specifications and standards and in fact allergen said sometimes these things rupture they can be hit they can be bumped sometimes they were upturned all the silicone comes out that's not what happened here here the silicone was intact the silicone implant was intact alyan said it will bleed but it won't bleed more than one more than one percent and the amount it will bleed will not be clinically significant this device did not meet those specifications so if you look at the regal analysis you say are there regulations in specifications performance standards for the device it's a yes no more than one percent bleed is the claim in this case different or additional to the federal regulations and standards no it's precisely that we're saying if you look at the standards that of the f d a and the specifications on which this device was approved it failed to meet those specifications and so there should be liability if you want to save time f good morning your arse thank you for the opportunity to present our position here today i'm gina marie slaughter and i am here representing our am i think district court in this case properly granted summary judgment on the plaintiffs manufacturing defect claim and the basis of her decision was exactly what you have all been discussing this morning the plaintiff has offered no evidence proof that our jan violated any federal requirement and so for that same reason we ask th it was two point eight percent which arguably the same if it was ten or fifteen percent yes so in your view it doesn't matter what the evidence is as to the defectiveness of the product that the plaintiff still has to come in and demonstrate that something went wrong in the manufacturing and that it's it's not enough that the product was disastrous  failed exactly your honor and i think the the real problem here is that if you argue that there's a defect in this case a manufacturing defect that's a products liability claim and that is not enough to survive production for a class to medical device that the way in your view the way congress set this up and weighed the policy was that basically no matter how disastrously the product the product fails absent evidence that there was a problem  specific problem tied to this product in the manufacturing even if the thousands of products were manufactured that congress decided no cause of action yes and i think that's exactly what this report supreme court held in regal you have to show a departure from either the device specific requirements here for manufacturing or their current good manufacturing practices the language are you relying upon in the reagle case is that the real case is that what you're not relying upon we've got is a supreme court in its approval application what do we do with that mine that's my point exactly your honor they have no evidence that any way we deviated from any of the specifications on the manufacturing that's exactly my point in the manufacture in this  didn't say this line which i'm reading for read from recall didn't say in the manufacturing it just say it with almost no deviations from the specifications in it's an approval application and so the point that opposing counsel is making is that in the premarket approval application there were there was a specifications that now have not been met so why doesn't that fall into this language from recall that i just you a couple of reasons one if you look at actually the label and the specifications and you look at pages twenty seven and twenty of their opening brief you'll see that what they claim that the f d a has mandated in this case that no more than one percent will ever bleed through and talk show is not what the after at all in fact if you read both the directions for use or the patient label under the potential consequences of a done as part of the process and there were multiple tests that were done because they couldn't find the correct way to test for it but when they ultimately found they put it in and even in vitro testing at a toxicology independent lab and they that's a separate section of the potential consequences of a job lead so for them to come here and tell you that this is mandated if you look at the way they actually capture to the way they used the quotes on page twenty seven is not consistent with any part of the record in this case from any source on any document and back to the regal case your honor what regal says is that a plaintiff who wants to impose civil liability on a class three device manufacturer must show a parallel claim and they define the parallel claim as a violation of a federal requirement the plaintiff isn't making a failure to warn claim here about we said it was this we warned about this and we didn't do that they're arguing that the manufacturing was a problem and every case in every circuit requires them to prove some departure from a federal requirement and other than listing for the court what the current good manufacturing practices requires and other than accusing us conclusory of departing from the premarket approval application process they've not given you a single fact of any departure and every circuit that has looked at this issue all conclude the same thing including the th circuit and the stengel case when you sat and bank you have to show a violation of a federal requirement the defect enough itself is not the equivalent of a violation and if you look at page twenty seven dollars of their brief and the problem with their whole interpretation of the case law they say the fact that the product suffered from a manufacturing defect standing alone establishes the violation of federal regulations and establishes a parallel claim that is not the law the law is a departure from the federal and that was because it's a similar argument where there was a idea that plus or minus fifty percent of the flow accuracy of this pain pump would be what the error could possibly be and mr medication in that case it was two hundred and sixty eight percent above what it was supposed to be and when they looked at that case one of the things that they concluded was we can't impose a standard that doesn't exist we know that these things are going to malfunction we understand that and so if we apply this heightened standard then we are impermissibly doing so under the rico case basically what the plaintiffs are asking this court to do is to assume that there's some sort of defect without ever showing any evidence of any kind of departure and that is the sole basis why judge bolton decided that they could not pass the summary judgment stage there burden of proof on a class three medical device case is to show that we violated some federal requirement there is no dispute that's what the law holds and they have failed to do that in this case  down to the district court was because the district court had not allowed the plaintiff to proceed on a proposed amended complaint the bank court had determined that the original complaint that was filed by the plaintiff had not properly pled the claim that would survive preemption but that in the proposed complaint that hadn't been permitted they had alleged a violation of a federal not you see a current case that there must be a manufacturing that's your point the floor the point is that the th circuit agrees that in order to prevail in a class three medical device case where the plaintiffs are seeking to impose liability on the defendant they must show a departure or violation of a federal requirement that that's the law the plaintiff acknowledges that except they claim that just by showing the defect they have somehow managed to prove also that there's a establish that the defect actually caused the injury a plaintiff and most importantly they haven't proven that any alleged violation of a federal requirement causes and ultimately are are when you listen to the plaintiff's argument they've just admitted to you that they have no evidence when he said i don't think that anybody could prove up his claim that there's a specific departure from the federal requirements either through their courage from a man he said a manufacturing defect he did state that or harmless because he's a equating the approval process with the fed a more requirement he's saying that the in the process of getting approval these specifications were incorporated because the specifications have not been met that's the deviation from the federal requirements well he has not told an here or below what the deviation is in the process and it's he made a manufacturing defect claim which means he has to point to something that we didn't follow and as judge owens indicated if there are ten steps that we're supposed to follow and we didn't follow one of them then he has a viable claim if he has evidence of that but he doesn't have evidence of that we've given the manufacturer documents we gave him a specific device history record for this device which identifies what were in place when inspections were in place and how we put the implant together so he has that information and he still has not shown any evidence of anything so your are it's our position that given the lack of evidence in this case of any departure from federal requirements that this ruling of the lower court should be affirmed if if it's not then every class three medical device plaintiff will simply argue that they have a defect and therefore it's a violation of federal requirements and they're able to survive preemption and that's clearly not the law thank you and they have to answer any question only a small quantity less than one percent would bleed think of what councils are you suppose you had a diabetic and you had a situation where insulin they had some internal insulin either in the stomach or in the arm and it was really it was and the f d a specification says that this device will not cause more than one dollar to fifteen dollars milligrams of insulin per hour to be released into the body and a diabetic puts it on and fifty milligrams per hour are released and the patient dies because  no claim under recall when that when the device is it's not that there's no claim it's the manufacturers position is that to make that claim you have to tie the failure to a manufacturing defect which is something that in many types of cases the plaintiffs are able to show but but sometimes they can and legal and can and wriggle doesn't require it i mean there two i mean that the plaintiff does not have to suddenly have a film of the manufacturing process and say oh oh you see you see this step you must have missed this step there's a wall in it like maybe you can find an expert to say that the truth is that's not the requirement but of all the council says that they produced all of the documents regarding the manufacturing process and how this particular device was manufactured so why wouldn't that give an expert the opportunity to go through and determine whether or not there's a defect in the manufacturing process of sure the manufacturing process the way it was supposed to work the way it is listed in its internal  documents i'm sure that that itself doesn't that doesn't you know there's nothing wrong with the way it's supposed to be but i think if in the end device is distributed that does not meet the specifications that the manufacturer said it must meet in order for to have f d a approval and then then that it clearly is outside of riga where again all real requires are there regulations and specifications if there are there is this case allege that image as a result of some additional regulations or specifications or or is it parallel to what the