petroff yes good morning may it please the court i'm kip petroff i'm here with robert o'connell representing the appellant in this case i heard you say in the introductory remarks judge pryor this is our chance to tell you what makes our case more complicated or more difficult i'd like to take a moment to tell you what i think is very unique about this case probably the only case i've ever seen like this that i think makes it actually a lot more simple the facts are that smith a nephew that the hip implant manufacturer referred mr mink to a doctor for clinical study the clinical study had to form a consent form that was signed the consent form says in so many words and i quote this does not waive your rights in the event of neglect that's in the consent form which is exhibit b it's under financial obligation which is the section that you would expect any patient to look at it's talking about misrepresentation but probably more importantly the fill your to inform both doctor wasting and the patient and that's what makes this such a unique case your honor the patient had a direct relationship with the manufacturer in this case it's almost unheard of to have a direct relationship with the manufacturer unless there's direct to patient consumer advertising that does not occur in this case it's not a direct patient so what it goes to the whole claim that we're claiming the main claim we're saying is not preempted is negligence what you do under lore under medtronic first is lore you look for identity of requiring out here's the prostrating thing about this case we're going to talk about the negligence and the strict liability portions of your complaint i would have thought and just my review a disc case that it is possible to plead some kind of theory of negligence per se as a matter of state tort law that appears to suggest that there is no florida cause of action about that for negligence per se i think you're correct or negligent so what do we do about that i know i know that what matters is what the highest court of the state a said but we've also said that when the intermediate appellate court issues a ruling on a matter of florida law that's a pretty good prediction unless we have something really strong to the contrary that that's not the higher score on negligence per se your honor i don't believe that there is a cause of action that directly says all you've got to do is show they didn't comply with the federal law and then it's negligence i agree with that but even in lore even in medtronic versus lore it's a florida case the supreme court talked about the florida negligence laws and it specifically referenced the fact that the laws were not designed specifically to deal with medical devices so in the lore the case that's a device case that held nothing is preempted but it was a five ten k i recognize that in the lore the court talked about the florida law and said these are not the kind of laws that are intended to restrict what the federal government's doing so you still have evidence of negligence it's still the pattern jury charge has a negligence cause of action that would apply here so it's not i agree negligence per se wouldn't do it if you think about it when you do you have negligence for say if you've got a speed limit that's fifty five and you're going fifty six that's negligence per se but you know lawyer would take that and say well that's all you've got to prove you still have to prove negligence and that's exactly what we're willing to do in this case is to show negligence what you show is the identity of the requirements so is there a requirement that we're saying was violated if so is it greater th there's a shotgun pleading quality here i go ok and you've alleged you know this wasn't followed this wasn't followed this wasn't followed but it's not  what you're alleging in terms of duty breach of duty proximate cause and injury is that those requirements of the federal law establish a duty  if so how has that how is that a duty to your client how is there been a breach of that duty how is there been some kind of proximate cause of injury the duty i don't see where that's really allege your there's i have i can go into that your honor i've kind of anticipated that there are a number of allegations in the pleadings that talk about withholding from doctors common law and negligence not accurate reflections of existing dangers failure to update findings so the allegations are there but i think more to your point where's the duty the duty is in the eight page approval order there's a four page approval order which is exhibit a to our complaint and then there's four pages of general conditions attached to that that requires the manufacturer just like under common law to analyze complaints and see if there's a problem see if there's a signal see if the public the doctors need to be informed of that we are alleging a parallel duty right here this and it maybe it's a little different because those those duties are agreements the f d a got the the company to agree the four page approval order is full of you have agreed you have agreed you have agreed so but what we do we're simply taking those duties specifically to analyze complaints and see if there's a problem that's the duty and we allege they breached it that well i would call post manufacturing duty as is that really the whole of your case as opposed to the device is in fact effective because they did not comply with the f d a requirements and the reason i asked that is conceptually that was the easiest for me to understand a parallel claim the f d a says your device approved if you use this material use this juncture or whatever and you come in and say no you didn't and here's my evidence that i can sort of understand when i read your complaint i saw almost nothing of that i saw paragraph h talks about they didn't have the right hardness but you don't say why but except for that it's all what i would call after after production problems is that is that a fair statement it's  doubt that the post the post marketing analysis is obviously post approval we contend the minute that there was approval from that moment forward they need to monitor what's going on in the field  i don't think anyone really disputes that the manufacturing defect i didn't anticipate that first of all the court at the trial level held you know she ruled that she thought that the pleading was adequate to put on notice of manufacturing defect the proof the point about the manufacturing defect is they took a blood test before the surgery was put in they took a blood test very soon thereafter metal ions which is your body's response to excessive metal was going skyrocket we have the f d a you're just saying you must not have complied because my guy was hurt i don't know if it's recipe to loquitur your honor i know that in lore the supreme court expressly noted that there is a difference and this is on page two two five six and it's an important one they noted that the good manufacturing practices regulations take up thirty two sections of the code of federal regulations whereas the the medical device regulations are only ten pages that's an important concept because the manufacturing regulations are much much greater than the mere approval of a device design characteristics i think that's worth pointing out because the manufacturing defect has been alleged there's a separate paragraph on it i've i know dealt with when you say specifically i mean i'm looking at the circuits will licky gable's case were as i read it there they're pointing out with approval that the district court did not allow a claim because a fact finder could find liability even if the manufacturer completely complied so that's why i was looking in your complaint for pacifically how they didn't comply because otherwise you're saying i'm not going to prove they didn't comply i'm just going to prove my guy got hurt with all due respect we are at the very early stage of the  proceedings just as lore was and the court pointed that out that the contours of the case are not known at this early stage but the fact is we have plausibly allege something that doesn't occur absent a manufacturing defect and that is this drastic poisoning of the system from the metal that's something that the allegation is that the material was not as hard as it was supposed to be i agree that that's that's relatively vague and if we had more facts we would allege them but at this stage that is all that we have i have to admit that as far as manufacturing i would point out though that manufacturing defect is referred to not only as failure to meet the specifications but also negligence and it is important to remember the current man the good manufacturing practices act is way way longer than the sections that deal with approval i would point out that the the consent to participate exhibit b to the complaint if that's not a contract then i don't know what could be a contract in this context in this context what you do is you look to see has the manufacturer already said to me that the problem with that contract claim was that the district court treated that is the sum total of the contract and your complaint alleges that there was an oral dime form is i think that's the i think i didn't mean to interrupt i think that's the appropriate way to go i realize that cuts against me the oral contract frankly i wouldn't i don't we haven't alleged one there's nothing it says oral contract three times your honor but there were no there's never a fact that says the fact of the oral contract was the you say the written contract is strong the exhibit exhibit b says i'm out of time but i mean three requests exhibit b says good clinical outcome for years before this device was recently approved the device was approved five and a half years before this man signed up for this and they're saying recently approved good clinical practice other cases have good morning may please the court joseph len from carlton field my counsel table with me is david walls on the brief and also of carlton fields i'll turn right away to the second district's well look he gave bill's opinion which i think answers every question in this case because it says right on its face that florida does not have currently a cause of action that satisfies the requirements of a parallel claim it says in one place the common law damages claims cannot survive preemption and that's the only state appellate court that has commented on this and it says that common law damages claims cannot survive preemption in this whole clear to me that that resolves you i think you may be right but i don't understand how that resolves a claim for breach of contract or misrepresentation that does not depend upon or via an alleged violation of the federal  well i think it does in let me turn to these clinical studies with the clinical study this is required as part of the post approval the only reason there is a clinical study at all that it's required as part of the post approval order so i think any so called contract claim that goes to these post approval requirements are also express preempted the same way that any common law tort claim would be what the f d a is a post approval study requirement require monitoring for ten years and payment for all the tests and payment for your anything needed to bring you up to snuff which is their allegation it does all of that requires that the federal act requires no i'm i have not said yes to that altogether what it what i was going to say is current the consent form is consistent with the f d a requirements and in fact is that main does that it just doesn't violate it in some way most certainly doesn't study at any time short of the ten years and so right on its face and they have now said that that is the contract such as it is they have said that this is the contract on its face it says that this can be discontinued short of ten years i don't want to be heard though to acquiesce in this idea that there is a contract and i need to emphasize that is that's why i had thought you might want to say i do want to eat and then it even if it's not that claims not preempted i thought your argument might be something about whether that form satisfies the requirements i certainly want to argue that as you know the district court says that the allegations were insufficient as to the existence of a contract and certainly the existence of a breach the district court also casts serious doubt although she tell me whether that's right or not and i know what the district court said was that it why do you contend t back that they haven't pointed in their allegations to certainly where the breach is on the face of a contract that says that it can be stopped short of ten years which apparently is what the allegation breach there's no they don't specifically point to where in the contract all of these duties that they say are breach our promise to continue for ten years and the face of the contract doesn't establish that more importantly i think is the agency allegations i think are on their face insufficient and that goes to the fraud claim right now i think it goes this contract to the extent it has anything to do with that the nephew is only connected to smith the nephew it all by dr weiss dean being a so called agent this consent form the way these things are set up is smith the nephew needs to stay clear of these studies smith the nephew needs to be clear of these studies and set up an investigator an investigator review board to organize these studies and the way they can the way they are attempting to connect to smith the nephew is by making this allegation of agency and the district judge decided to assume argue window that there is an agency relationship but she dropped a footnote that says that she understands why we feel very strongly that there is not the consent form itself is signed by dr weiss dean as the investigator and absent that allegation of agency traditionally there is no connection at all between the manufacturer and the patient they are creating a situation that doesn't exist in the way this is supposed to be set up and we don't think they've properly alleged a breach we don't think they properly alleged the agency relationship and let me say this before i forget very important i think the district judge actually made a holding at the very end of the opinion that these contract claims the contract misrepresentation claims are preempted as a matter of implied preemption and they have not appealed that in their initial brief they do not appeal that point and that's an independent  sufficient grounds for a firm and that they have not raised as a point on appeal we said that in our answer brief they don't come back and say oh no oh no we did raise that on appeal they don't point to where in the initial brief they've raised that is an issue instead their response to us boils down to that the district judge was wrong it would have been a non sequitur argue implied preemption but mr ally i want to take you back to your preemption argument and he of obviously a very broad view of express and implied preemption and can you give me an example of any state law claim that would survive your view  f preemption in florida yes i think that the second district court of appeal has said that absent the legislature creating a cause of action making it tortious in florida to violate a federal regulation and i can't write that statute for you but the second district court of appeal has left open the possibility the legislature could create this but as of today there is no state klein and a lock on that survives preemption i think the second district court of appeal has said that right on the face of their opinion that no common law claim for damages will do it as a matter of state law but i mean it well  you i believe that's what the second district has said and i believe it's consistent with what every district court in the state in this circuit has said on the same situations i think it's important to look he said it was the only decision we had no no the only state appellate decision in florida there are there are discussions a you know the district court is there a federal district courts throughout florida that have said the same thing so we have a uniform of authority from the north sea and hawk case from the florida supreme court the well licky abel's case from the second district and this whole line of federal district court cases that is uninterrupted that florida does not have this type of cause of action the second district leaves open the possibility the legislature could create it but it doesn't exist right now so i mean what do you do with all of these cases from the spring  state law claims you know that parallel federal claim federal requirements or seek relief under state law for politicians a federal law without any additions  without any differences that those survive regal does it made of the possibility that those type of claims could exist on a state by state on a state by state basis so some states have said those claims do exist almost every jurisdiction says that that is a very very narrow type claim i think judge the rose says that it's almost a unicorn kind of claim some other jurisdictions have found that given states have those types of causes of action we have a very robust policy in florida that there is no cause of action that exists for the violation of a statute on its own of action darian florida law is that what that is i think that what it is is that the sole basis of your claim can't be the violation of a statute unless there's been legislative inten to create a cause of action so yes no implied cause of action exists there has to be a cause of action where the legislative intent is that that cause of action is for the violation of a statute in the norse in hoc case which is the murthy case from the florida supreme court if the plaintiff's theory were right well the statute it issue it was a building code it was a state that would yet so what the florida supreme court was saying was there is no implied right of action honor but what the norse in higher court said just to be clear is they tried to bring it as a negligence negligence per se type of action and the florida supreme court said that cause of action doesn't exist and what is being tried here is to do the same thing under other state law common torts and the second dca says that no common tort or no common law cause of action for damages can survive preemption i also would like to note that as we do in our briefs the duty to train in the duty to report adverse events that was not brought to the district judge's attention that's all new on appeal those two claims you can find you can find a little bit about the claims in the second man to complain but nothing said in opposition to the motion to dismiss brings any of that argument that you see in their brief here to the district judge's attention and we would argue that that was waived for that reason too if there are no other questions i would ask for you to affirm the judgment a this this study that is exhibit b to this complaint was a two thousand and eleven study that the patient signed that's five full years after the post approval there is no evidence that this is the study that was required they're saying that there are a lot they're saying they're suggesting to you what sure looks the same it three hundred fifty patients eight sites but i find it really hard to believe that this is the mandated study five years out that they're still trying to get patients  in they want you to simply assume that but you don't assume the fact is it's a study that they presented saying it's a recently approved device enter into it you'll get all this free care you'll get all this  expert care taking for years and years there's an expense to that mr mink cancelled his other surgery he canceled it with a different doctor in a different product he went with this company it's in the pleadings because of the availability of that study it's a benefit it's a huge benefit and then they say well the company has a right to terminate the study that's true if this is the f d a mandated study but the big point is there's no evidence they terminated the study they terminated mr mink there's not one word in this record that says we terminated the study and therefore mr mink you're out if you take a look at the letter it's exhibit he from the company again direct communications with the with the consumer direct communications it doesn't say we canceled the study it says we can't find anybody else to to monitor you which if you think about it we're talking about blood tests this company this this big company can't find somebody to monitor a blood test and do some x rays it be like a primary care physician i mean there's plenty of surgeons in town to to suggest they can't find somebody i think is is frankly ludicrous but the fact is they terminated mr mink they decided that they didn't want to use him in the study i think there's reasons for that but it's not in the record but they didn't terminate the study how could they how if they did they'd have to follow certain protocols you don't just dump somebody basically they bait and switch mr mink they baited him in to taking this device with this company newly approved help practice help perpetuate innovation in medicine that's what he was told ten years of future medical and the monitoring from experts that's pretty important you don't get any of that he went in with that intended he got none of that your honor they say we didn't address implied preemption it's on page ten of our are opening brief implied preemption in so many words talking about the manufacturing defect i think it's extremely important to remember what the supreme court said in lore that the things to me the whole thing about preemption with respect to the contract claim is kind of a red herring the real question it seems to me to t