yes please christine thank you the district court on august fifth two thousand and thirteen the appeal has taken against animal and pharmaceuticals inc eli lilly and company well we know we know who they you're saying you're pleading you're saying well there's this temporal relationship and then by a process of elimination as you describe it we are left with the abdominal injections at the district court level is that there was a discussion with his doctor his doctor was a doctor of osteopathic medicine which as you know focuses on bones and joints only and so they talked and said it did happen at this time when you started taking this chemical and that's when it started and it grew into an abdominal wall cellulitis and slowed down when it quit we know that we didn't have the like you said in the complaint actually that the physician said they couldn't suggest any connection between the drug and the condition dr warner said and i cannot identify that chemically the drug use what caused his condition but i can identify any did in his affidavit was before the court identified that it did not start on this healthy athletic commissioner of baseball until the first shot of abdominal it started actually three or four years later and that's true well he was taken it orally before well i thought it actually i mean please correct me if i'm wrong but i thought i thought the problem started three or four years after the injections started actually the complaint alleges that the discovery of the problem was in two thousand and twelve and part of the problem with the motion to dismiss standard which is in our view can be interpreted as a motion for summary judgment and we think that's what happened in this case is that we have a statute of limitations to go by and when he discovered the problem in two thousand and twelve we had to go by what we knew now since then there is and we would like to summary judgment motion or to move on to trial to discuss what that proof is and see if the case is worth staying in front of the quarter not but at the time what we knew was that can and his doctor knew when the injection started and knew when the problem started which was right when the injection started and knew when to quit and we went further i had t examples in my complaint if i was a car wreck attorney and i had a quote in your brief i think we're familiar with that ok we'll leave that one alone and then we could just go back to basics for a minute i thought that this was a judgment of the district court just missing for failure to state a claim in the complaint it's well b six right so and we're looking at the third amended complain that's the document that's the operative docket ok so so we're not supposed to consider things outside the complaint that's correct and what is your evidence sorry what is your allegation of causation  egation of causation playing is that rather than just sliding the elements of an action ok he was injured the defendant was responsible i didn't stop there we went into the chemical nature of the drug it's derived from a lizard poison it's a poison that probably doesn't affect some can't really get into that but we've talked about pancreatic connection a light source so we think that we'll what the f d a alerted people about in the plane and that my client had had surgery for that condition i ok so your your position is you have the temporal proximity alleged in the complaint you have the f d a alerts paragraph twelve says the drug has been involved in f d a alerts indicating that cute pancreatitis an abdominal problems and conditions are associated with the drug correct and that that those those are really the two factors that you rely on to  allege causation in the complaint yes your honor do you have a case that you would say would be good persuasive value for us to say that this is adequate  thought and thought about it and when you're breed ashcroft versus it all and only the two supreme court cases that are relevant in this matter it is our position that the supreme court did not mean to turn rule fifty six into rule twelve b six and rule at eight stand that argument but judge moore if i may i think is asking is there a data point in terms of a case out there that are supportive of your argument that what you have here adequately implausibly causation not that i can find at this point your honor the court discuss that this was a a judgment based on terminology in other words decide whether a complaint is plausible or not and that's it then it's over with proof and summary judgment the court can't do that and that's what we have to now and it was unfortunate that we didn't have that much proof when we had to follow our complying due to the statute of limitations but we had to file the complaint then and the proof that we had were observations by a doctor and a plaintiff as to what happened and he had done nothing else different in his lifestyle because that would you could you seek leave to file another amended complaint that would add more in the way of allegations of causation i would good morning your honors may it please the court i like to focus on three specific points that were raised in opponents argument and i'll start with the last point judge moore made first regarding leave to amend the plaintiff's complaint appellants complaint at issue being the third amended complaint appellant never replied low requested leave to amend his complaint in opposing the motion to dismiss he never argued in the alternative that the complaint should be dismissed without prejudice he never argued that were he given the opportunity to amend his complaint he could cure the defects and therefore the dismissal of the complaint with prejudice although not raised as a ground for appeal by appellant if it were way raised would be reviewed under an abuse of discretion standard and this circuit has expressly recognized that it gives great deference to the district court's decision to dismiss a complaint with prejudice particularly where as here there has been no argument below that the complaint should be dismissed without prejudice or that lead to men should be granted it i don't have the docket sheet in front of me did could a plaintiff have when filing a complaint that would satisfy your cards ation demands here the plaintiff or i guess in any case the plaintiff or the appellant could have a very specific allegation that he was diagnosed with a condition that had been associated with a medication he has taken and he attempts to do that through the f d a alert which i will discuss but he's been diagnosed with a specific condition that's been associated with the medication that when you say that has been associated with a medication that is a missing element there who has associated with what kind of entity would would  be drug companies feel would need to have associated because for instance if i had associated with it i'm sure you would say but that's not enough that's just a lay person i think that would need to either be a medical professional saying i believe there's some type of relationship here which as noted in mr jones argument and in paragraph five a claim of third amended complaint appellant specifically admits that there is no doctor that has ever told him that there's any relationship between this particular medical condition he suffers from and the medication he took here by ada so a medical professional finding some type of arguable relationship here a  a providing some type of either warning or alert that there is some type of relationship or association whether it be a causal association or a lesser association between reports of individuals taking this medication raising concern or alert on the part of the f d a so there are various ways there could be published studies or case reports dealing with individuals none of that is cited to here by appellant there could be complete journal studies or new england journal of medicine reports that even a case study could do that absolutely and in taking it to the to the extreme the gold standard for stablish in some type of relationship would be a clinical trial showing individuals who are given the drug this is an f d a approved medication obviously there's been extensive testing there's data there's information available about side effects so the problem thinking about this in a broad perspective would be that the first few people who are affected would have a much more difficult time alleging causation and then people who are affected by a product later when more people have been affected in other words you w have you will have two hundred people taking drug x developing a particular problem until you've had several thousand people taking that drug perhaps potentially your honor although i think that goes more to the issue of causation than to the issue of of being able to plead causation and before any f d a approved a medication goes to market their years and years of tests on both animals and on human subjects so there's all kinds of data test s clinical trials that are submitted to the f d a as part of a new drug application and that was all done so why isn't paragraph twelve enough so body paragraph twelve well it is not enough for a couple of reasons the plaintiff alleges here that there are at f d a alerts indicating that a key pancreatitis and abdominal problems and conditions are associated with the use of by ada the f d a alerts which are in the record and of which the district court appropriately took judicial notice pancreatitis in patients taking by ada described the hallmarks symptoms of acute pancreatitis which are unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting and plausible because it involves the same organ as the one that was the subject of the alert i don't believe it is your honor i have no information to suggest it is it certainly is not pled and there's no suggestion that because the f has warned of the keeping korea titus that any abdominal problem including particular falls within the umbrella it's almost like saying that a health ailment could result from by and therefore in wealthy i mean i mean i think that yeah the test at the end of the day is plausibility it's a test that the court determines whether it satisfied we talked earlier about sources that would lead to a finding that the plaintiff has a and i guess the question is is a close enough to allege a different condition with the same organ or is that just not close enough to be plausible in your opinion i don't believe it is close enough to be pot plausible your honor he's alleging a condition of the stomach complete stomach breakdown which he describes and related sores an infection pancreatitis affects the pain korea us and is a condition that is described very specifically in the f alerts in the record so i don't think it even pertains to the same oregon here other than the fact that pancreatitis results in severe abdominal pain and he's alleging problems with his abdomen as in there's something called pancreatic know what he means by that he's never been one i don't why isn't this appropriate for either him or motion for a more definite statement or for summary judgment for developing the facts of the case because he is on his third amended complaint and he is the one allegation that has remained constant and clear is that no doctor has ever told me that my condition is related to the medication he talks about a temporal temporal relationship and that temporal relationship is i started taking this drug and six years later i developed symptoms and i believe opponents counsel misspoke when he said that he alleged that i filed the lawsuit six years later because i was facing statute of limitations if you look at paragraph five of the third amended complaint specifically alleges during two thousand and twelve mr mcelroy began experiencing serious and life threatening abdominal problems and goes on to describe them resulting in a condition where his stomach broke down completely the very vague allegation about what his what his condition was a very specific allegation about when he experienced that so the temporal relationship here is six years later and how do i did why do i think this is related why do i think this is caused by some process of elimination we don't know what his process of elimination entails and the only thing that we can infer is that this is his subjective belief that if he went through some process and rule things out a doctor didn't go through a differential diagnosis and rule this out he has no diagnosis no specific diagnosis of the condition at sufficient completely do you have cases that you would rely on or that you would need to distinguish don't believe there are any cases i would need to distinguish your honor i think the cases that we would realize most heavily on  ball and also this six circuit decision in hensley manufacturing versus pro pride that is a trademark infringement case but that was dismissed because there was no alleged likelihood of confusion and fair use and that was dismissed at the pleading stage and the appellant challenge did on the grounds that he had alleged that facts may exist to establish confusion or no fair use and this court said response in bonce to that quote mere speculation is insufficient it was the appellant's burden to establish or to allege those facts if they indeed in the product defect claim that it's unreasonably dangerous and i know from your brief that think that's inadequate in a drug case just a hypothetical kind of drug case and what would because they think they need to establish that this extensively tested an f d a approved design of a drug is somehow defective and that sometimes comes or comes up in a case where a drug is subsequently withdrawn from the market or it's determined that there is  something about the drug that wasn't discovered or potentially could have been discovered sooner as two warnings defect case that's much more common in the prescription pharmaceutical case and we also allege that plaintiffs have failed to establish and failed to adequately plead it was a warning defect i understand that i guess i'm just trying to you know for purposes of i guess comparison and i'm trying to imagine a template of an adequate allegation of the fact designed  for a pharmaceutical at minimum i believe that that claim would need to allege that something specific that's wrong with the design that causes a specific condition that is unreasonably dangerous and  cannot be appropriately addressed through appropriate warnings thank you summary i would say that appellant allegations in the third amended complaint again his fourth opportunity to allege valid claims here at best established that there's a mere possibility that by ada somehow caused his alleged injuries and his alleged right to relief is speculative at best his claims don't his allegations don't bring his claims across the threshold from conceivable to plausible as is required  and his allegations don't justify a reasonable inference by the court that appellant as is entitled to relief here against a pelleas and that a pelleas are responsible for appellants alleged injuries and allegations are insufficient to unlock the gates of discovery and under trombley in a fall the district court correctly affirmed that a correctly concluded that his claim should be dismissed and the district court's finding should be affirmed thank you thank you your honour's to start off with we didn't fall three complaints because we wanted to we won and then we realize that the suppliers had some connection to the case and we followed the second one then we were removed to federal court and the third amended complaint judgment to order me to follow it to separate the insurance company case which is the state court case upon remand from the products liability case which is before the federal court so we went we were just taking our time to find out more things when we were following complaints jones if i may i'd like to just pick up where i left off and i just want to give you a chance tell me if i'm missing something there was the problem with the new twelve b six is that we didn't have the luxury of an endocrinologist we know a lot more about pancreatic nicu lightest now than we did when we f the complaint we filed the complaint months after he died i know very well i mean we've got to decide this case based on the record we have in the complaint now have an endocrinologist that supports our case so it was the only thing i could allege in the complaint he was seeing a family physician a day he wasn't seeing an endocrinologist and when we went to get the appointment with the endocrinologist we had to wait eight months so it would have been after the statute of limitations  years here as opposed to closer in time i don't think that anybody really knew what was going on because at the college dell medical clinic this was some of their first cases of using the drug because it was relatively new it came out around two thousand and five and nobody really thought about these things for years until you know there was a conversation and it came to the conclusion hey this is the only thing you've done different and now you've got a life threatening condition  if he had known that if dr winners or him had known that pancreatic the nicu lidice was the subject of an f d a alert then that would have been warning to them and they would have probably stopped it but you have been alleged that pancreatic thank you latest was the subject of an f d a alert i would just that this f d a alert is acute you're alleging that your client had i think the subject for proof from a doctor i can't go any further than that  that just doesn't happen spontaneously they don't know anything about that time it's a new drug he'd been taken in orally for a few years and then that done really there came a conclusion in two thousand twelve that that was the only thing different in his life that caused the condition that he had when he stopped the thing stop growing he's now had surgery and we've saved his life and the other action which is a state court action now we're just seeking relief for pancreatic clinical what's the state court action the state court action is against the