beautiful that's it and a good job before twenty seventeen in florida courts and correctly held that plaintiffs like who were injured by a defect in a medical device that was the result of a defendant's fail you to comply with federal regulations could not sue the defendants because those pla claims were expressly and impliedly preempted by the medical device amendment that was the law in florida before twenty seventeen that was the law that the defendants relied on in the district court to convince the district court as to why ms good delia's claim should be dismissed that was the only argument they made below now comes twenty seventeen and as judge martin you know we had a c changed a correction of the law in twenty seventeen we had the and i did think that was the way it always was but i understand the president was well i agreed it that's the way it was because that was the argument that i made that floored it gotten it wrong since twenty thirteen but judge martin in the opinion in mink corrected florida about the state of the law and explained that plaintiffs now can pursue claims on medical device the fact injuries provided they do two things they are certain common law duties one and two they show that there injury that is underpinning that common law or duty was a result of a defendant's violation of a federal regulation that's what you have to do to survive express an implied preemption mis delia in her complaint and which started to lar we expected that we would be here before the eleventh circuit when we follow lawson miska delia as pled the very claims that the court in the eleven had a defect she alleged that that defect was caused by zola's failure to comply with several manufacture and required regulations and the gist of those regulations are important because they say this is what zorra was supposed to do before they shipped the medical devices one they're supposed to identify any exist him and potential nonconformi effects with the devices before they send them out the door that's the first thing they're supposed to do the second thing they're supposed to do under the regulations in manufacturing these devices they have to investigate the cause effects and all of these things have to happen before they ship that device then the key part is once they figure out those exist and potential defects they have to do the important thing that's important to the consumer they have to fix them now what we've alleged in the complaint is that that the fact in the device that miss good deal you received it occurred because old failed to do these very things they didn't inspect the exist in the fax with the devices they didn't fix them they didn't do anything they sent them out and they sent it out in this good deal you receive a defective device that didn't function the way they told it would and she died her son and her husband got to witness her die now given mink i was surprised i that given the court's opinion in mink that the district court below there and that's what i thought we would be here about are these we wouldn't be here because it would be reversed but what happened is the defendants raised some new arguments today didn't raise below and to the extent the court wants to address them i will address them but i don't think they should be addressed they're only argument was below was based on an incorrect law what they argued now is that and this is a new argument on appeal that miska delia's claims should be expressly preempted and let me be clear let's note something they do not raise the impl preemption argument in light of the ruling and make they focus on express preemption and they say miss good billiards claims are expressly preempted because she didn't use the magic word soley she didn't say that her claims are based soley on violations those violations of federal regulations well i can assure you just to be clear that those are the only violations we've alleged because if we didn't we wouldn't have briefed the issue that those are the exceptions to parallel claims and i can stand on the record and say that we've only alleged that the defect was a result of zola's failure to comply with the regulations that the defendants acknowledge we don't say anything else and for the record i want to be clear we are not saying it's based on anything except violation of federal regulations with respect to two of the claims though it seems at least from my reading that did make these arguments below so for example they did make the so called lack of privity argument with regard to your express warranty claim below you think that was wrong but it was raised below you're on a zero actually did make the argument what the court it is the court said there was a lack of privity on appeal is when the issue came up because uls all did not make that argument below no your honor that was a voluntary decision made by the district court where it said the claims are preempted and by the way there's a lack of privity so the old did not make that argument what we point out is that below the district courts argument was erroneous because it ignored the allegations in the allegations in this case w how it works with what medical devices yes the devices prescribed by a doctor but the doctor says ok you're a candidate for the device what happens from there is privity zoltan and the client the patient enters into a patient services agreement which zola's produced in this case and pursuant to that agreement it outlines the terms of the party's relationship as to what happened so the old didn't raise that argument below because they couldn't because they understand that pretty because there's a contractual agreement between the plaintiffs and so let me happen when we ask you to turn to before you're out of time to negligent infliction of emotional distress florida law is a mess on this issue and it has been for decades and plaintiff's lawyers trying to slide in that the case that the margins in good faith on what constitutes a discernible physical injury and defendants oppose it in courts are sort of almost everywhere what is the discernible physical injury in this case that lets you plead and negligent infliction of emotional distress claim under florida law iran if you look back at zero which was from the florida supreme court where i think the court tried to their answer to that confusion created by the various district courts we had the stomach pain we had some issues with it i think stomach pain and nausea and certain physical ailments now what i mean in and of itself can't be a discernible physical injury right because pain is a manifestation of injury well well i you're on i understand that point but you can have a stomach issue or stomach pain that can manifest into something else right you can have pain and then you go to the doctor you find out well that pain is actually an ulcer right also was it here well in this case your honor we have while you have to plead something well did you plead what we've pled is stomach pain what we haven't done is and i see where you're on is gone is is we haven't said ok the stomach pain is manifested into an ulcer something else to that effect or maybe you should be given an opportunity for leave to amend but but if you say all you have is pain but you have no idea where the pain is coming from you know now be discernible physical injury iran at that point we were satisfied that based on what the law said or what the confusion of the state of the law was that was sufficient now to the extent that yes we are given the ability we can give more details as to what that stomach pain is manifested into and look we have a rule eleven obligation if i consult with the client on amendment and they tell me will it has a manifested into anything or or physician says it's not then i will gladly tell the court that we certainly would not do that if there's no physical manifestation of anything but certainly at the pleading stage what we've done is we followed what zell is said we're supposed to do and if you look at zell those are the very things we've we've alleged so get back to the  argument the soli argument what mink is is is essentially the defendant's attempt to elevate form over substance they're saying because you don't say soley you can't forsee that's not what makes sense their next argument is there's no causal nexus between the violations of the regulations in the injury we've explained that the c f r say you have to do certain things before you send vest out and  know what we know is the court is not fully aware we've learned discovery did actually some of the problems with the vest because of these violations or more breaches than what's outlined in the warning letter now that information was from the f d a it's not before the court because no one had it before the case was filed so there's certainly significant injuries now they make one final point as to why which is also a new argument that we don't specify the defect see my time is up i can address that it's a new argument but i could come back to if it's needed yeah you've got some robot so we'll hear from you then good morning i'm alyssa writer from wicker smith on behalf of the apple these the argument this morning the plaintiffs seem to think that this main case wins the war for them allege a parallel claim in a medical device case and so yes point it was able to win that first battle with this mink case but here's the war that needs to be fought which is  mink does it why is it why isn't easy answer to that question that he should be given an opportunity to file an amended complaint to see if he can satisfy mink well there's one easy answer to that which is that they've never asked for leave it open i mean but they didn't ask because make came after it be different of minke was on the books at some time during the district court case and they didn't see to take advantage of it but  comes after the district court rules and if you think that there's still more that they need to plead more they need to allege why isn't the best option even under your theory of the case to let them do that on a rematch and well i would just say procedurally that came out before we filed our answer brief we raised these issues and in the reply the point of still has never asked this court for that relief that they be given a chance to amend and i would presume that's because they have alleged what they can about about their case and on its face it shows that what they've set forth cannot possibly be sufficient to evade preemption by well what if they missed ok so this court still is still notice pleading well you know didn't eliminate notice pleading you don't need magic words all the time so it why haven't they played a plausible claim that you caused them injury and by the way that preemption implied or express doesn't apply here under mink well i would say under tom you need some facial plausibility that a claim a viable claim exists well that they've certainly pled they were injured by your product that's that's an allegation that was made in the complaint you don't disappear you don't dispute that part of it right there is a conclusory allegation that mrs good deal of it was injured by a defect i would ask the court what is that defect you have to explain you have to explain what the defect is in a complaint in a products liability action where the defendant may have more of the information than you well  for one thing when we're dealing with a p m a approved device that goes to the preemption issue i'm asking you about causation and injury causation do you think that they have played enough putting preemption aside twamley to plausibly plead that they were injured by your product and that your product was a cause of harm if you look at the cases that they cite in their reply brief i'm not i don't want the cases so i want to know whether you believe that they have adequately pledged defect injury and causation putting aside for a moment welcome back to in a second preemption i think that they've made conclusory allegations that meet each of those elements but i do think under twamley that if you're going to reach the level of plausibility of the claim there needs to be something beyond just a bare conclusion and then no what's that a no you don't think that a sufficiently plain that they were injured as a result of your product i do think that they have alleged that but i don't think that they have made sufficient allegations to make a plausible claim because we can't divorce our view of this from the fact that it is a medical device case and that it did go through the premarket approval process and so therefore in order for them to state a viable claim there has to be something on the face of the complaint that shows that it would not be preempted and nothing in the complaint on the notice of violation of warnings that the company received from the f d a after the proof yes there are about four paragraphs alleging four different general code setters there's the predicate right for the argue the plausible argument that the defects if there are defects as identified in the warning from the well i would disagree with the court on that because here's the problem there is no causation there's no causal link there's no nexus between those four sections that are cited which are very general sections in current good manufacturing practices regulations these are things like for example one of them deals with that a member of the executive management team h attend meetings yes but others deal with the handling of complaints regarding failures of the product correct so those were not attended to a failure may have persisted well after the company was on notice and why is i mean seems to me that's the purpose of discovery find out that sort of thing but if the stand well let me just first say that there is nothing on the face of this complaint that explains how any of those four violations are actually c failure to document results for corrective in preventive actions as a result of a high noise artifact and over abrasion causing the life vest device to in appropriately the illiberal shock treatment to patients and didn't the complaint alleges that she died because a shock treatment wasn't given the complaint did allege the latter however what you just read to me was something in a warning letter regarding excessive shocks providing no oxy in appropriately deliver shock treatment to patients that could be that it delivers them in properly doesn't deliver them at all or delivers them in not sufficient amounts to do any to make any difference but it seems to me you're asking for an expert report on causation in a complaint to show flake facial plausibility and i'm not sure that's what requires maybe well it maybe maybe if maybe if all they said was there's a defect my wife passed away and she had this device maybe that would be too conclusory i'm with you there but it seems to work and seems to me at least that putting preemption aside for the moment they've adequately allege that a defect in your product specifically was involved in the chain of events that led to someone passing away but i don't think you can put preemption aside if we're looking at a motion to dismiss on the basis of medical device amendment preemption and the thing is that well what have i missed in that respect what have they not they have what did they need to allege under mink to get through a twelve b six motion well make says that you can assert a common law cause of action that avoids preemption so long as there's a common law judio to the plaintiff they did allege that and the common law claim imposes only requirements that parallel federal requirements and the violation of those federal requirements cause point of time so there is at least two things missing here one is despite councils representation stood a that that he doesn't intend to litigate anything beyond the federal regulations the face of the complaint does not exclude the possibility that these the product could be found defective based on something other than federal regulation that's the first thing and that means that any of those claims should be later be asserted are going to be preempted but it doesn't mean the entire cause of action is him except for that the complaint needs to be narrowed down so that it meets the standard otherwise you asked a district court to require repleat ing to narrow the complaint or did you move to dismiss in toto we asked the court to dismiss it because the complaint pled only claims that were preempted but an let me just finish up the rest of your question before you asked what didn't they do with that make says you have to do and the other thing is that you have to show that the violation of the federal regulations was the cause of your harm we have no way of knowing from this complaint what the defect was that maybe you can help me with this so i'm reading from the complaint i just picked paragraph sixty five more specifically so manufactured the subject of life in violation of the federal regulations noted  what should that have said that it didn't say in your view in my view it should have relied on some particular federal regulation that is specifically linked to the problem so for example in the  at gables parallel claims must be specifically stated in the initial pleadings and then this is a quote a plaintiff must still age that the defendant violated a particular federal specification referring to the device at issue now and make the court similarly sa that the point of may proceed on her claim quote so long as she claims the breach of a well recognized duty owed to her under state law and so long as she can show that she was harmed by a violation of a political federal law now on the face of this complaint we can't do either of those things i mean this this actually segues to another point is that i think is important to note which is in the main case the plaintiff alleged not only violations of these general c g m p s but also that the specific p m a specifications for things like the hardness or the durability of the metal had been violated and so you could look at the face of the complaint and have an idea although maybe not every detail of it but you had an idea of what the defect was and how it was that the violation of these federal spec specifications related to the device had caused injury on the face of who is so i guess just to go back to my question you in your view you would have to designate a specific regulation the cause is in or they have to give the  the regulations that your there has to be something either there has to be a specific defect alleged and then perhaps in that case you could rely on just these general c g m p is as a defect that causes as a result of the defect it didn't shock but we have no idea what that defect was is was there a bad battery was there are bad wires was there that have to you have to plead that to you may not have to plead that level of if you have your ticket you have you have a car that overturns when it shouldn't have overturned and people are injured and there's a lawsuit filed you have to get down into the nitty gritty and basically explain in minute detail exactly what the defect was and exactly how it went wrong before you can get past the twelve b six motion if you are going to be faced with federal preemption then you have to wire the lawyers or it's different every dick why are there different pleading rules in the preemption contex that don't otherwise exist in products liability cases because you don't have a viable claim if your claim is preempted by the medical to fire a lot of defenses federal defenses that are not preemption that eliminate a cause of action and the rule laid pleading standards don't deviate from case t case in some scenarios you have to plead x or you have to plead y but you don't apply rule eight differently in these scenarios i mean the case that comes to mind is a case far removed from a products liability case but the supreme court had a case called leatherman decades ago and federal courts for grafting on to mono liability claims and civil rights actions a standard that wasn't required by rule late heightened pleading and the supreme court basically told lower courts listen if that standard is not in the federal rules you shouldn't grafted on i don't understand why we're doing that here at the twelve b sixty it's one thing for you to argue when you get the summary judgment listen the way discovery has played out they can't show this they haven't been able to show that they can't connect this  dot and therefore they're preempted i get that argument but you're trying to say that they can't even go forward on a complaint until they have this really high level of specificity and i'm not i'm not sure that that's warranted if that's the way the court rules then essentially you're telling every medical device manufacturer that they will never be able to dismiss a case on preemption grounds until they get to summary judgment still just not true because here there are allegations about warnings from the f d a there are references to the sub part of the federal regulation of the federal code of federal regulations where the regulations that have been violated are in place there's an allegation about the sort of problem that zola was alleged to have been having and there's an allegation about why that defect may have caused the death so this is not in at least in my personal view a bare bones boilerplate complaint there's a lot more there but maybe i'm wrong well i would just i see my time's up i would just ask the court to when it's deliberating about this case to go back and take a look at the complaint and take a look at the warning letter and i think that the court will see that there is nothing in the warning letter that syncs up with these allegations and that the complaint leaves us to just basically guess at why any of these violations would have actually caused this problem and i think it could be a good opportunity for the court to at least go back and look at this footnote three and mink where the c g m p s are referenced and you'll see the cases that are cited and in that footnote talked about that those courts had allowed a parallel claim to be alleged based on the violation of a c g m p because the particular c g m p s were not so vague as to make it unfair for the case to go forward and our case one where the c g m peas are so vague and because there is so limited allegation as to what the defect might be that it is unfair for the case to go forward you understand your argument thank you very much ron i will go in reverse and be as brief as i can this writer said we didn't allege to specific p m a regulations that was a debate that existed before mink and as judge moore and you know in a footnote in make it says that is not a requirement in fact if you read the express preemption statute it says any regulation that p p m e so make is also resolved circuit the plaintiff in that case never alleged any specific federal regulations that were violated and that's why there was preemption and we agree if a plane if does not allege specific federal regulations that were violated because the injury those claims are preempted that's what we're looking gable set we're looking gable's is not important here because we have outlined the specific regulations second counsel said if you go back  the warning letter you can see that it only relates to certain injuries actually what the warning letter explains is that it's only a snippet of the problems that were observed and more detail problems are outlined in information that is produced and discovered it is not before the court but we certainly have it the want to let it clearly says this is just a snippet not all of it so counsel wants you to ignore whatever lot of problems exist and rely on this one snippet in the morning that i didn't think i needed to address this question but regarding specific defects i will this court has an opinion bailey that explains in product cases you don't have to le defect in this case it's simple why this is a medical device now if we open the device before discovery we would have some spottily ation issues and certainly we were working  protocol to open the device together so no one would have a supposedly ation issue what kelso is saying is we should without mean able to open a device and figure out the problem is tell them exactly what the problem is that's what discoveries for that's not injury but i i think i got from the complaint that she had passed away yes i care honestly time thank you that concludes our arguments for the week we appreciate your presentation and