no different than dropping a soldier in the middle of a battlefield without a weapon or even to st ask for my ability for the design defect in possibility preemption arises whenever a private party cannot independently under federal law what state law requires of it or stated differently when a party cannot satisfy state law duties without asking for the federal government's permission or  so that grandfather device no one had looked at it for safety period and also it was being it was a class three device so the pacemaker that had come onto the market was being compared already categorized as class three which meant by definition argument about safety so in one thousand nine hundred and eight the f d a classified all surgical mash in class so by definition a class to devise means it has a reasonable assurance of safety now that may bother you and remember later there and let me see if i can give you an analogy that i think helps we know the motion picture association has rated little mermaid or frozen ajimobi then it comes out in frozen to comes out a little mermaid two comes out and the n p a says the substantially equivalent in terms of content now you know it's safe to bring the kids whether or not it's ever been rated for g e here's what the manufacturer did in lore why i think this is critical and lore it's like a movie studio it releases a movie and it says hey we're substantial equipment to an existing louis that no one has ever looked at or rated for content but we know it had a lot of sex in it you know anything about that movie so here you just absolutely had you don't have the grandfather device and you don't have unsafe grandfather device so i do think that those previously cleared class two devices which the f d a over and over is saying it's safe but it federal law did not prohibit your client from redefining implan great detail that state law and federal law impose a duty to make a safer product or to give safer warnings the only question is whether you could do it unilaterally that's all that matters for preemption is that there is a way to independently meaning not for the f t s permission if i could just turn because i do think we have there is no response to the design defect but i recognize reefer liability sake we need to win both design defect and that are warner although i think it's an absolute at a minimum you have to surgeons and so under your case law all that matters is that ordinary public surgeons understand the fundamental nature of the injury a product can cause or the general dangers posed by the product so what the plaintiffs had to was point to an unknown risk that was different in kind from that they already knew and your cases over and over and over say you don't have to know the extent of precise degree of that risk or the particular nature of that r they don't owe a duty i know that's unfortunate and i you know that's just your law it is unfortunate that manufacturers don't have a wonder one relationship with patients but the doctors responsibility was to compromise or whether or not to implant this and to form an opinion and nothing stopped her from suing her doctor but cause pain when you're using your project and it have sex it is expansive all that you would say ok fine there's a special duty now with medical devices that you have to tell surgeons in a way that maybe they would give them a how to talk to your patients kind of question  or pamphlet so i hope you don't take your case law into a direction that sort of changes the notion of the learned immediately doctrine where drug manufacturers device manufacturers have always had a duty to run to very sophisticated  professionals who in turn have you know pretty strict duties on how they're supposed to talk to their patients why didn't the surgeon testifying lie it's a good question neither side decided that there that was worth the risk i think  course i know their own experts say yeah obviously implanting a foreign body divided action cause kind of scarring and inflammation and all kinds of problems and we know it can lead to chronic pain and he think that you're going to have meaning you have to get on site the five cases on the goal post the b b gun the coffee i think there was a helicopter blade there's a lot of cases that are talking about you know interpret in the very statute that issue in this case is that you don't have to the product is not unreasonably dangerous as long as they know the general danger or the fundamental nature of the injury and so i think you would just have to say well maybe there's a special exception for doctors  doctors maybe are good as we thought they were but no matter what on liability if you think that the liability verdict i just don't understand how anyone could in good conscience are holding a punitive damage award at ten million dollars when the jury never saw the elephant in the room or even heard it instead of hearing that the f d a looked at this defense they heard nothing they heard a one sided fiction that at the time circuit has excluded this evidence and punitive damages cases however if you say this evidence was there was a legal error here i don't think you create a conflict because you have to state statutes that churchgoing they care about compliance jersey law just peter damages now i appreciate that there are they have trap works that have gone the other way there on appeal but you would be the st court to say when you have indiana any jersey actually try to protect defendant very situations and one amount you get to the jury that there's no i ability and then the new jersey state is just because all these drug manufacturers and drug devices are in the state this is a protectionist statute to protect this defendant and they don't even get to defend themselves with the evidence so i just think you're free and clear on the th circuit as a matter of a pure circuit split but indian allies peculiar product liability cases it's all statutory although it preserves  claim for product liability action requires proof of defective or defective and then recently dangerous product and negligence or most set a higher hurdle it seems  and over and i don't know maybe four or five cases and three of them have been post the t r w case so your case all the way i read it anyway anyone i think to read it is you have to have expert testimony that there was a  design that would have prevented the injury but you know no i'm sorry the indiana supreme court has precisely the opposite and it's another area where i think we've read or are out in front of the indiana supreme court different panel predict indiana in the end a lot differently each time it makes it very difficult to try cases in the circuit because you have three cases unanimously say indiana law requires a safer alternative and detect even if you  doesn't require a safer alternative and every single case it should require in a medical device case when a manufacturer puts a product on the market that's helping millions and millions and millions of women with a very serious medical condition and so you know their social utility and so the question is it's not like this was some sort of you know a toy gun with poison at the end and you're kind of thinking really what you put the poison at the end i mean this was a medical device and so the notion that you know put now you have well i guess the twenty five million the regional verdict yeah the original verdict there may have been one for thirty five i hate to be quoted it's not that high but i think in some of them you have more severe injuries more repeated surger used and that was cleared in two thousand and ten jury never heard that but that two thousand and two f d a decided it had the same safety profile and i don't think you know just what i know from preemption juries aren't allowed  to just say what we disagree with that and somehow or at the conscious violated federal law now they're going to get up here and say well at the combine onto the market without asking for f d a permission you know i think they were told oh you can't do that because you had a change in design you have to get our permission so they made at the time go through this you know they submit three hundred pages and massive data they don't like that it wasn't clinical data i mean the plaintiffs definitely don't like the f d a is medical device scheme but that is a medical device that we have being the same as seeing whether any implanted medical device they don't talk about how contraction in this situation leads to permanent lifelong injury epicurus argument is that as long as the general type the supreme court said that it was converses interned for the five hundred and ten k process to maintain the status quo which involved or which included the possibility for state tort law liability for five decisions relating to other f d a regulations to dirt to determine if preemption applies but even if the court does wiretapping mensing and bartlett show why there should be no conflict preemption here and why is the court said that because the change doesn't equal conflict preempting and if you look commencing that becomes more obvious because the generic drug manufacturers and eventually mensing had no option they were in the impossible position where they couldn't comply with state law and they couldn't make any changes to the whether or not they they followed up i think a regulatory process doesn't have anything to do with whether or not device was unreasonably dangerous under indiana law arm with regard to the exclusion of the evidence and indiana law  in which the product qualifies for this exemption is this what really matters for the truth is and lower that in the court made no distinction between grandfather devices and nine grandfather devices in one part of the court actually says gran because they argue that it cannot be unreasonably dangerous if the the normal consumer if especially in this case understood the risk so it does overlap design defect a little bit but our mice far is what dr bailes knew that deals with failure to work right at his his i mean there's there's been bottom line question about whether he would have been using this device or not used it at all to begin with been two subsequent our jury verdicts one dealing with a pro left where the court where the jury awarded thirty million dollars to the plaintiff in compensatory damages and fifty million dollars to the point of punitive damages and there was another jury  may please the court if i can start with the indiana presumption judge why it's relevant to both design defect and failure to warn is the presumption goes to both claims so you're the jury's entitled to find it at the commerce not negligent if there was a be a safety standard the other side is correct but it weighed there was no overall agency looking at the product as a whole so here you had the f d a making a it provides reasonable assurance of safety and it looked at the precise nature and design and declared them safe that they declared as unsafe they don't actually tell you what was defective about this but they looked at the type of mash and looked at the design and said it was safe on safety if we can target that because i really think that's critical for there to be a new trial it's a straight legal  class three device that had never been and had gone through any free market approval or any safety review other than to determine that it was so inherently unsafe it needed pre market review here on the  it's also true that this court on three separate occasions has cited the very statute and said you do not need to understand the extent for specific degree of the pain or the particular degree that a