will go to the next case represent your today two ladies breast implants manufactured by mentor they live close to the state line one in kansas one in missouri what i encourage you to do and this appeal is one aspect of this that the penalty wouldn't wouldn't be facially apparent to the panel that relates to one of the supplemental authorities that was filed with your honor's about a month ago it was decided in july and  a california appellate level decision the three judge panel in california the reason that one is is interesting and probably useful here is the the lead counsel for my eyes is my co counsel in the underlying case here in kansas and for that reason the complaint in my eyes and the complaint in this case are material i've done a couple i borrowed my co coun complaint when i as a template when i created the complaint from ms brooks and his gail and the reason that that can be helpful to the court during its analysis is if one reads through the minds opinion you'll see complaint there is a duty to warn patients indirectly in the complaint by virtue of reporting to f b i there is a federal duty to report to us yea and there is a state law duty generally to report to report vance to the f d a that are required by federal law to order that duty to report adverse events the f d a has been recognized by the supreme court in rebuttal and the th circuit and stengel so the i don't know that there's a state law requiring adverse events reporting there's a state law requiring disclosure there is that is there is a common law failure to warrant the state of kan reporting to the f d a is reporting to the medical community now when when below let me let me stop let me stop you right there and so the idea is against the next step is that the medical community is somehow going to on their own volition go pull up the information you reported to the f d a yes and the idea is that the mob database is created for that reason to make  this idea that reporting to the f d a is going to lead the public to have more information about the dangers inherent in their products then you can follow through the mice opinion and see exactly the same exactly the opposite conclusion reached in so far as reasonableness of the inference the idea is if you're not reporting to the f d a or you are under reporting or falsely then if it is far more likely the medical community will not have that information so in in this complaint the allegation is that reporting to the f d a is the means of reporting to the medical community as is a crime by kansas state law out her honor said that you can't have a cause of action based on a duty to reaching a duty regarding labeling because that's been addressed by rio and elsewhere that is true but the allegation here is that not that they should have done something to their wanting is really the same kind of reporting requirement that if they know something is wrong with the warming because it's now inconsistent with known information they have a duty to report to you that  preemption and you're saying all of your claims that through the narrow gap what's an example of the claim that doesn't one i just mentioned would be a claim attacking the duty to accurately create a label or change a label which we didn't intend don't intend to attack in the most design defects probably would be preempted that would seem to flow from at least three go so there there's no argument here that preemption isn't entirely proper in some instances and in some others it probably is entirely improper i think the clearest example that would be most manufacturing these not seeing an argument policy argument laid out in any of this is that why there should be some preemption of manufacturing that is if the government approves the design of a product and so with it and it's got sense grooves and they just start manufacturing it with eight screws and there's a couple of missing all the time there's a badly needed bad assembly line resulting in a bad product all the time f d a wouldn't want that's happened there's no shouldn't be any prohibition on that happening that kind of manufacturing really shouldn't be preempted at all it's simply they didn't and regal says they have an obligation to manufacture products and substantially the way they were  unfortunately we have a limited clock and i don't want to chew up all your time on now but i do want to try to parrot things you take issue with the district courts negligent per se as well as learn an immediate area rationals i've learned  what what do you have as far as a claim out that doesn't involve a violation of the federal regulatory scheme i mean if that guy didn't get what would you have i hope i don't have any of those because that would be probably be preempted if i was prosecuting it as the state ought claim with no parallel federal claim we wouldn't be here at all federal clean and no parallel state more a violation of federal and state but straight my state might be stricter than federal preemption under more you only have one way to survive is if you allege violation of the federal requirement in the state looks very unlikely in the state of kansas and for that reason your honor so the extent she was dismissing something she characterized this as a cause of action that we didn't really intend to be bringing on at all putting it in the style of that that she had her or her implant explanted in a short period of time she was very sick in six months and it was taken out in less than a year and when it was taken out she did not know dinner order is in the complaint at eleven months and that there's a good point that's been made by other corps that a lot of the information is privileged or kept private by the f d a so just every is important in determining specifically what would happen but it seems to me that your allegations are so general convey that if the complaint regarding manufacturing defect in this case is adequate then there isn't a single manufacturing defect claim that could it could be dismissed as inadequate you've got to do something you've got to say something about what of the one case before the implant was in play and in the plaintiff in that case so why wouldn't your argument that you've adequately alleged manufacturing defect by whistleblowers to f d a about manufacturing issues that wouldn't exist in any other complaint and it's something we have to be able to get discovery about to find more about this complaint as allegations and about that that m corrected or no longer pursued by the f d a so you need something that relates to the manufacturing at the time the manufacture of the implants your clients received this to misuse their the dolly try to each response like and your honor's concerns st of all with respect to the mavs decision let's keep in mind the mice decision was the reversal of the trial court sustaining mentors demur under california or california's more liberal pleading this was not in federal court this was not a twamley all possibility pleading standard and the court did not find that the claims were not preempted the court said the plaintiffs has said enough at this initial stage in our more liberal leaning state so again to the extent we're going to look at my eyes it is not a twamley at all possibility leading type situation  mr the gali has admitted to acknowledge that there are twenty federal courts that have dismissed the motion to dismiss stage identical allegations and identical complaints finding that their allegations are either express impliedly preempted or do not satisfy twamley at all i'd like to kind of get to i think what judge carson was getting at is there is no kansas state parallel law that requires a medical device manufacturer to report adverse events to the f yet that duty is purely a creature of federal law created through the medical device and that means to cut medicare plaintiff has never pointed to that parallel state law statute or regulation they simply say there's a generalized trauma like duty to warn the medical team or as judge rail found your mentor just charged that duty as a matter of law with respect to its warnings that are f d a approved and leakage gel bleed and rupture they know all about it that is why it's actually all over the judicially noticed warnings that mentor provides this dish and it's job lead and leakage and rupture are the most common adverse saying that what we told them through the free market approval process over time for clinical trials what we told them about what we knew about gel bleed or leakage or rupture what we told the f d a is in dispute that is and the defect is that it caused the injury to the plaintiffs here and the injury was caused by leakage so so say there was a defect in manufacturing they were using an inferior material to in compass the gel or they you know they treated it to high temperature or something like that how is a plate if to bring a claim like th circuit case and they say parallel claims must be specifically identified in the initial pleading by setting forth facts that point to specific violations of p m a requirements that's in their brief as a proposition  it is entirely correct and if you look at their complaint there are no specifically identified p m a requirements there are no facts that show that mentor violated those requirements when big moments that they cite they said to regulation generic regulations your honor but if you read their complaint for instance you gave the example what if the shell was not the right kind of silicone mr the guy i gave an example of you have a widget comes out this summer light supposed to have ten screws it only has eight plaintiffs have not made any factual allegations in the complaint along those lines those valve was in the wrong place the silicone was not of the correct grade they have not and how can they without publicly available sources sure or or things reported by the f d a and you know the i think where you're going to is the director i'm cackling or the talks about bausch and should we give plaintiffs  also says that it does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions and that's what this complaint is conclusions the conclusion is we have to play just with breast implants they believe they experience adverse events therefore there implants must have been defectively manufacture that is not an inference that flows from those allegations as we talked about those are inherent warned about known risks of that device before pre market approval was grand and so the f d a had an opportunity to investigate those did investigate those and granted premarket approval in any any way and again i believe that runs into a fraud on the f should have stopped it but through incompetence itself that would be a way to proceed no your honor again as as the supreme court has told us in regal and bachmann that type of claim is is preempted and that type of client cannot survive and again i'm not we're not saying there are is absolutely case longer cases that get around preemption that narrow get at the judge billups i believe talked about  with a manufacturing defect claim where there are laws about factual allegations in the complaint that the implant came off the assembly line wrong it did not meet design specifications here we have our implants that  an expected adverse event in the plaintiffs as well because i had a failure i think there must have been a manufacturing defect but if you go through the complaint no where will you find the facts of what was violated or what the law and the other aspect was insufficiently planted to conclusory in speculative because what the players claim really is is if the mentor had done its post approval studies differently use different methodology population sets statistical analysis they may have found additional adverse effects if they found additional adverse and some of those adverse events may have had been reported the if they reported those adverse events yes if the f d a may have placed them in the publicly available ma database now actually sitting here today we know they would not have mentor was enrolled in a different reporting where those were not going to want it and if they had if their doctors use them our database but inform themselves about risks of products rather than the f d a approved warnings in the box that my database and those adverse events would have informed their treatment decisions in some moment of the premarket approval process and that's exactly why judge radio granted the motion dismissed because under currently existing law on preemption it mentor complies with its premarket puzzled by mr dali statement that that there was an abuse of discretion we have glenn we have to believe nine other panels of this court that have considered the exact same argument like this are making here which is that without making a motion for leave to man enough and there are i think ten panels of this court that is sad that is not an abuse of discretion i will point out that the district court at footnote two of its opinion said i will not grant the plaintiff's motion to amend at this time i think giving the plaintiffs a hint that if you want but i'm going to give you a minute if you have something more to say and responds you're never gonna get a thank you for that with respect to leave to him and just ask you to distinguish one from this order the reason i started to outline is that this is exactly what's outlined in the kaplan your decision about bausch that when one is defending against dismissal on that is based on an affirmative defense where the defendant has this burden here so it's not like a typical of the twelve where you're just looking at whether my allegations are ok not the strength of their defense that i've not had any discovery against the situation the proposed amended complaint would have had to