florida law are materially the same on this does not have to identify the specific defect to the violations of federal regulations identified a communications sufficiently allege a parallel claim court in fifty pages of briefing defendants only mention good three times each time is merely a passing reference and two of those are in footnotes i realize there is a question in this case about live or die on preemption that might die on preemption but they don't live on preemption they're going to live on their own ok i'd be happy to address that came st as far as the state law claim goes the district court simply got the l mr sharpe's device short circuited because of insulation abrasion that caused the wire to be exposed and ms sharp alleges and her complaint that that insulation abrasion was caused by manufacturing defects say that it was a design defect but whatever the term the f d a used the actual communications the warning letter and the form for eighty three dollars confirm that it's a manufacturing defect and what i would like to focus on here is the so if we look at paragraph bottom it was missing a weld on the lead you know you have the coating abrasion is coming off you have an insufficient crimp and as you go up you know they're in correction conduction paths they've swap labels they're missing crimped again there's a fracture in the inner core so all of those you know whatever the f d a language they used it's it's clear from that the new allegations which are based on you know defendants on documents  a communications that the problems were in the manufacturing process correct i'm talking about the form eighty three that was issued in two thousand and nine and i know that the defendants you know make a lot about the fact that that came you know five years after four years after m sharks device was implanted but again if a review of the complaint shows that those allegations are actually i mean that for forty three in two thousand and nine was based on an inspection that went back all the way to two thousand and two and looked at the defendant's records and identified these problems as early as two thousand and two i got in two thousand and three again in two thousand and four and again in two eleven and the f d a found that basically it was a continuation of a lot of the same problems that they had identified in two thousand and nine and in fact part of the two thousand and eleven warning letter was that they hadn't sufficiently addressed these problems in the manufacturing process that they had been called out on in two thousand and nine and so again i think that the two thousand and twelve recall is a combination manufacturing defects and perhaps design defect although those are not identified in the f d a documents that we've been able to to see you know and access through publicly available sources violations that were purportedly found around twenty thousand and ninety five years after the manufacture of the device but alleged g m p violations cannot cure the fundamental pleading flaw of having failed to allege design specifications not only but you know when we compare this case to similar cases that we've decided before all she needs to do is plausibly demonstrate that the device suffered gables leads to a ferment and i think it does there's a conflict between the two the court should go on punk but i don't think that's necessary because here this case is clearly distinguishable on the facts from good delia st of all to delia pretty much  moreover unlike here the plaintiffs expressly alleged the violations found six months later existed when the device in question was manufactured there is no such allegation in the nd amended complaint that is operative in this case so i think lab indicate that this particular device is very susceptible to safety violations in particular with respect to the lead why is that not enough thank you so i want to start with the intended design issue that was raised and i have a couple of points on that st of all the idea that the five of the complaint where plaintiff specifically alleges that it had and purity and perfection that was a deviation from the quality manufacturing standards for the device leaving the device in a defective nine we go through pretty systematically what the f d a approved design was consistent insulation diameters lubrication curing and sterilizing we identify what the what changes violation what is the defect that that caused when those come in so when when when did they come into effect because at least my notes in your chart the specifications in your chart came into effect in two thousand and five i don't believe there's anything in agree with that characterization is that you know something i didn't mean to talk over you what did you say i just you know i respectfully disagree with that characterization as well as the is there an allegation that there was a p m a or other position that it is not clear that those post two thousand and five yes i mean we believe that i mean i think what is implausible in this case is that when the p m i was originally approved of the defendants were allowed to manufacture the lead with any insulation thickness they wanted with any lubrication that they wanted and using whatever curing process they wanted you know the consensus in this  deny that the specifications identified there postdate the implantation in two thousand and four but you say if you look back at sixty five paragraph sixty five in essence that's the original p m a and it sort of anticipated all subsequent violations of those that that parent those following paragraphs are not dependent upon that st allegation there were allegations about failure to warn and other claims that are not raised in this and that paragraph provides context but there's nothing in the subsequent paragraph that ties that only to those supplements that were filed after two thousand