first case this morning is clover versus health and human services afterglow or we'll take a brief intermission and then we'll return to the other two kate morning  please the court counsel robert fishman on behalf of the petitioner appellate a little bit closer to one of the grounds we relied upon in support of our motion requesting oral argument was the fact that the secretary had raised a number of arguments in her supplemental on bond reply brief for the first time and so if i might i'd like to begin by addressing very quickly the two most significant of those arguments the first one being the claim this is repeated throughout the reply brief that dr twelve or should reasonably have known of the causal connection between the hep b vaccine and from the very outset ok and again it's repeated a number of times in the the basis for that claim it appears at page eight in the reply it is a institute of medicine report published in one nine hundred ninety four there are two things i want to say about this the first is that that report is not evidence in this case in fact the government did not present any evidence at all in this case concerning the question of when to the medical community understood the link between the vaccine and multiple sclerosis they never even contested the issue ok so i think you have an obvious have actually problem with relying on the one nine hundred ninety four report i think that you also have a labor argument based on the the well worn rule that arguments raised for the first time in a reply are generally not considered by appellate courts i think you also have to stop a problem with this claim because the the secretary has maintained throughout including most recently in their supplemental on bark reply brief to this court that there is in fact no connection at all between the vaccine and multiple sclerosis so to now do in about face in a reply brief and contend that actually there is a connection and it was established seventeen years ago i think creating a stop the problem finally if you look at the nine hundred ninety four report and i'll confess i have not it lawyer i look at records it's not a part of the record but i've looked at the parent that icle that the secretary includes to characterize what that report says and it doesn't establish a connection it says there is inadequate evidence to establish a connection so even if this court were to consider the evidence and i use that term loosely it doesn't support the claim that my client should have known about this it's long rows in one thousand nine hundred six the other argument that's been raised for the first time to the reply brief  the claim that excuse that there is nothing this arises in the context of equitable stoppel it really applies to all the claims and that is the argument that there's nothing there's no extraordinary circumstance in this case in the sense that the contention is the statute of limitations begins to run before anyone in the medical community understands the relationship between this vaccine and that's nothing unusual about that because that's the circumstance with all non table entries ok that also is a claim that's repeated a number of times utterly unsubstantiated there is no citation to any authority in the secretary's brief to support that notion that this is how the back scene after works i'm not a consensus into that you raised the bar a great deal it goes to another point made by the secretary for the first time in the reply brief which is to adopt a discovery rule would essentially negate the savings of statute of limitations the one that kicks in when a new injury is added to the vaccine table renders it meaningless it is the panel dissents argument that there is no statute of limitations  table cases if you have a discovery rule the assumptions be if it's truthful that it requires almost universal acceptance of a connection number one which i agree i think is incorrect the other assumption that underlies that cla know that the argument is not what what i'm saying is our contention based on market this is you need an objective recognition in the medical community at large but not  the senate which is not a consensus it's not universal and that it is not just was the basis of the original position i don't believe we ever used the term consensus we were relying on the language of market this which also does not use the term consensus so the argument we argument that steps away a little bit from the nuances and technicalities of discovery of supreme court precedents equitable tolling and asks how can you bring one of these clients when nobody knows that there's any connection between a vaccine and an injury one just as a matter of common sense to as a matter of procedure for the for the very reason your honor points to the counsel you suggest that there should be a discovery isn't there already a discovery rule in congress could have shown this to start the tolling as in most torts from the date of injury but they didn't instead they said from the first symptom of injury which kind of course being long after the injury in some cases so why isn't that enough itself congress has chosen discovery rule that we shouldn't supplant the short answer to that is yes congress included a discovery rule in the statute of limitations i would disagree with your honor that the discovery rule is limited however to first symptom as opposed to injury you have someone usually in a statute of limitations provision language reference in a tax and related injury quote unquote which occurs the result of the administration of the vaccine and i think when congress says statute of limitations is triggered by an injury that results from the occurrence of the administration of the vaccine it's a somewhat in artful way of say an injury that's caused by the ministration of a vaccine and so the discovery rule we argue that congress did in fact it is your traditional discovery not in the sense of injury because you're you're certainly correct it's symptomatic station but the same in terms of symptom and manifestation of the typical injury component and then as well causation the occurrence occurred as a result of the administration so i think  to four vaccines which added to the table after ninety ninety eight if a vaccine related injury occurred as a result of the administration of such axiom no petition maybe five except i think the definitional no i don't think so and so the question well all right we have a definition we have a clearer why are the first causation in the petition the substantive why is congress talking about things that litigation the it's a it's a good question and it's a difficult question to answer because there's nothing in the record or in this case that there really quantify is that really provide the court with just a little bit more than anecdotal evidence to support this claim i think it's a concern that is going to be actualized very very rarely because my understanding is most all claims brought under the vaccine that already happened that have for a long time associated illnesses with them and so this concern that the floodgates will open and they'll be all sorts of newly discovered connections and medical recognition does not seem to be it does not seem to be a particularly realistic one but whether or not it's realistic how could it be congress would be in law if your tax petition failed so why would there be different statute of limitations for the federal vaccine claim in this state it's an excellent question and i don't think there's i don't think there is a satisfactory answer to that and i would add that i think that's even true now in light of the supreme court's decision in brazil which would says basically this is the only chance you have to cover the vaccine what everybody including many members of this court have thought previously you don't like the result of a vaccine case reject it and go to state court invoke state discovery rules that door is closed in virtually and you're absolutely right congress has tweaked the injury component of the traditional discovery rule in the vaccine i don't think that it follows necessarily from that fact that they intended that it intended to do away with the causation aspect of the typical discovery rule particularly given the language of the statute of limitations that references discovery so i agree this is not an ordinary injury rule but it doesn't answer the question of whether that should relieve somebody of the need to understand the cause of their symptoms and i think the explanation as to why congress did what they did is provided for different purposes but is provided by the secretary of the group which which says they point to to injury is that somebody can have a disease they can have as a result of a vaccine for years and years before anybody in the world would understand that they had  why congress did what it did but it doesn't follow from that that as soon as your eye blinks you better file a claim under the vaccine act because the statute is running even though you have absolutely no basis to think that this injury or this blinking cases like this in the first instance based on statutory language i think my client should prevail based on the statutory language if you disagree with that but then certainly we get into equitable tolling and that clearly would solve the problem and it would also account for considerations you know maybe if the acknowledgment comes thirty years down the line thirty years as opposed to eighteen months that's going to be something that that will counsel against equitable tol a so yeah sure it's setting aside equitable tolling for the moment people argue to sign a standard that the discovery rule is in effect embodied in the statute already in the form of the language vaccine related injury now if we should reject the argument as a matter of statutory construction that the term vaccine related injury carries with it come poena of causation i ve knowledge of actual causation before the statute of limitations triggered do you think there is still yet another background discovery rule that would dispositive of the discovery rule because of course you have cases like who breaks that just say a cruel it doesn't say anything about injury causation or anything and the supreme court says well given the state of the law at the time of an accident and given that there is nothing inconsistent in the statutory language to prevent us from implying the discovery rule which has the supreme court is noted is the usual practice in the federal circuits then we can do so the trouble and be necessarily invoked here not necessarily but if you look at the if you look at circuit precedent and i don't think we cited that i'll be honest and i apologize for that the statute of limitations that federal circuit often and routinely imply a discovery rule into don't always speak in terms of a cruel thirty six years from the day to be injury or the claim that it's different language all the time but i don't think crew brooke turns on the or does it relate to that i don't think so and again it's it's a rico case it turns on a pattern of racketeering and in this case we're not arguing that the question of knowing when when your honor talks about malpractise somebody knowing that conduct not only was caused by a doctor for example but that the doctors conduct constitutes malpractise it's not a consideration in the back seat neck case and we're not arguing anything beyond a recognition of a causal relationship and there is no question as to malpractise here so could the distinguishes document between the need under discovery and we're not asked we don't need them we're not asking the court to go the second step we're just saying copy need to know that you've suffered a vaccine related injury or otherwise why would you come to the federal court of claims why would you file a petition with a special mass very different from the type of f t c a scheme that was under consideration in cooper so even setting aside the language of limitations provision there are other aspects of this game that cut against background issue whether this statute is a waiver of sovereign immunity and therefore needs to be construed narrowly but weaving even that aside the supreme court has made very clear that the analysis does focus on the text in structure of the statu so where this is a statute where there were no limitations provision and no countervailing structures then perhaps this court would be in the position of considering as a matter of policy what their role should be but here congress has spoken and expressed its intent that a particular kind of discovery rule should apply in this scheme and has supplemented that with certain provisions so it will only work if the first symptom or manifestation has occurred but the condition has not been definitively diagnosed or definitively those is a question of fact as to how close is the could well at every there are two different scenarios in compassed within your honor's question so one is a situation in which the first symptom or manifestation occurs but there within a year the petitioner was diagnosed with unspecified d miley meeting condition and among the conditions named by her doctor that it could be for multiple sclerosis and  plead with specificity the existence of the vaccine the existence of the symptom and the existence of an injury and although the nature of the injury is not yet known at that time it could be a number of different conditions this court has permitted petitioners to proceed on that basis and it's concluded that under those circumstances as in the case the petitioner named a number of different injuries and the fact finding procedure involve at the statute certainly contemplates that a petitioners should have a reasonable good faith basis before filing the petition but statutory language in both the provision that authorizes the bringing of claims and the limitations provision the language vaccine related injury congress uses that throughout the statute and in a way that indicates that it doesn't encompass a notion of causation so for example  the precondition for bringing this suit the language vaccine related injury into which petitioner is reading causation is something that appears in the claim authorizing provision three hundred a eleven and that's clearly at the stage before any causation has been shown since causation is the ultimate merits question it also significantly appears in the three hundred fifteen which is the provision that discusses compensation in attorney's fees under the statute and what it that's function there is to say that if compensation compensation can be awarded for a vaccine related injury or even if the petitioner has not shown causation in fact so that the standard under the statute is that if the petitioner was brought in good faith and there was a reasonable basis the petitioner can recover attorney's fees so the vaccine related injury language aside from being defined in the statute is used in multiple places in the statute in a way that specifically do not contemplate causation either because it's at that stage of the proceeding where causation hasn't been shown time is indicative plainly indicative of a killer disease or is that a symptom which following the diagnosis much later one might look back and say ah there's your first symptom and example  the doctor wouldn't identify that symptom as indicative of them which is your position it's that hindsight is acceptable in this case not something that this court recognized you are but that acceptable in other words you you say that first symptom occurs if i have a soreness in my shoulder and three years later i'm diagnosed with m s that that was the first symptom even though i'm no doctor on the face of the earth would say if i win then with the source shoulder you have likely possible probable that's my first symptom well if it if it is a sign that would be objective we recognize also doesn't have to be  it doesn't have to be it does not have to be that it's objectively recognized at the time and and the reason why that has to be the case your honor is because the statute sets up two categories of claims off table claims and table claims and very often what will happen is it won't be clear at the beginning of a proceeding whether a petitioners claim is a table or off table claim so a petitioner may allege an injury that's listed on the vaccine act injury table and proceed through and it's only at the fact finding stage with a question of what was the first symptom and when did that manifest and depending on what the determination is than it may take on the character of a table or off table claims that's part of the reason why the limitations period has to be the same for regardless of what the weight of the medical evidence is on the vaccine injury link but it goes to your honor's question about hindsight so in the actual fact finding proceedings under the vaccine what will happen is that both sides will produce experts who will testify as to what the petitioner symptoms were and when they manifested and that's that's the sort of determination of what the simply the symptom was so the language the statutory language first symptom or a manifestation contemplates that it has to be something that is objective li observable but it does not contemplate that it has to have been observed or recognized at the time meaning as in this case once the petitioner was diagnosed with m s it's very clear that that electric shock sensation one month after her happy vaccine was her first symptom  tired that would not but your position to make sure that i have this clearly because this may be porton is that it's the symptom of tiredness or something that would not be would recognize at the time i think they rushed to the issue is whether it's it's a clear symptom so it could be that no physician did recognize and i'm talking about whether it's recognizable at the time as a symptom now the fact that the particular physician doesn't recognize it obviously that doesn't matter but would it be recognizable at the time  required or not which i understand your answer be so this seems to go to the after acquired evidence issue perhaps that congress spoke to in that claim revival provision so if we have a situation where there is something that is a definite symptom that's only recognized to be a symptom say several years later so for example in this case limit syndrome is a definite symptom of happiness but say at the time no one had yet know that learned syndrome had anything to do with m s but by the time the petitioner was diagnosed medical science recognized that lehrman syndrome was in fact a symptom of m s and add the fact finding proceeding there was evidence knowledge of relationship yes your honor in congress designed that statute in the way in part because in an administrative scheme like this you have to have rules that can be administered to the problem with a scheme that relies on discovery will be based on the weight of medical evidence is that as a practical matter it first of all imports a series of complicated inquiries into the threshold timeliness question but more importantly that t weight of medical evidence is something that is not is not really administer of all standards or what congress determined is that in situations where the limitations period may have fully run if knowledge of a vaccine so it's a scheme that contemplates that the only thing that has to happen for a petition to prevail is on a table claim all the petitioner has to show as a matter of fact is these systems of the vaccine and the injury and the symptoms within the time in the table that's a very relaxed entered as to off table claims the petitioner has to show causation in fact but only as to the petitioners particular case and their only cause a mechanism that's legally possible  as a matter of law so the position that the government hasn't had occasion to take a position on this issue so far so in state proceedings certain state courts do allow petitioners to file states soon after take on a second question first and then and this is so that the state limitations provisions well so under under the federal statute the running of state limitations provision is told so that if a petitioner is able to bring suit afterwards the petitioner gets the benefit of the generous rule but if a state has a less generous rule or the suit happens to be in one of those states that say a timely petition is a prerequisite to bringing a suit this is no different than any other situation where congress enacts an administrative scheme that's designed to surface steve sure that's and that's something that's actually built into the vaccine at that the vaccine act provides that if a petitioner properly proceeds through the act and is ultimately denied compensation that petitioner has the right very particular provision of the vaccine act that related to preemption of certain common law causes of action against vaccine manufacturers a product liability product liability action so that broader question of whether an individual could have a remedy in state court and that individual doesn't have a remedy under the vaccine act it's one that congress has spoken to directly and congress has said that yes that can happen and that's absolutely that's and there was a lot about the sugar should consider and so forth so on but i couldn't find anything here's the standard it's not in the statute your honor but what i want is the state so the secretary in this has been explained in federal register publications that accompany the addition of a new injury vaccine so that what the secretary does is it looks to scientific evidence such as for example institute of medicine reports or findings that are generated through the vaccine adverse event reporting system so to take the example of rotavirus that was a situation in which through the vaccine adverse event reporting system a number of incidents of battle collapse were reported and the secretary examine this epidemiological data that showed a strong statistical association between the vaccine in this injury and on that basis add it to the table applying what standard so a valuating the the sort of causation is explored there scientific evidence analysis looks to things like biological plausibility case reports case series  i don't believe it's laid out in the statute or regulations but it's explained when the secretary either adds something to the table or chooses not to add something to the table the statute provides for him to go to the statutory language require and the combination quite so who who makes that determination how do we know something is associated with a vaccine for correlated with a vaccine does the association or is associated with the vaccine doesn't that imply that at some medical determination exists to associate to have an association between the vaccine  it contemplates that there that they have to be associated that someone can't bring a claim for an injury that has no relationship at all to a vaccine but the association at least at the beginning when the claim is brought doesn't have to be something that's based on medical causation because that's that's what the ultimate merits question is the ultimate merits question is does medical science recognize that connection or caus this particular petitioners case so it took years to do just analogous well association captures the fact that this has to be something that is linked with a vaccine so in the beginning the petition well you better for example in this case as in the border edge case which was the happy paradigm case that was recently resolved with an award of comp compensation to the so in both of those cases we have petitioners who received the vaccine within one month had an unmistakable symptom of injury received within the year the diagnosis of an average nonspecific put that into the statute by giving individual thirty individuals thirty six months to determine whether or not they would have a claim but the fact that a statute of limitations might start running before petitioner has complete knowledge or proof of all elements of a claim that's that's the way that many statutes of limitations function including the medical malpractise discovery role because that will operates in a setting where although it contemplates that one has to know both about the unless congress definitively rebuts the presumption which it has in this case by specifically in acting express exceptions to the general limitations  so there too there's that have to be there's the exception that this court recognized in price so for a claim that's improperly filed in state or federal court that individual may still be exception and the second exception is the claimant viable provision with the eight year look back here it is there the reason why it functions as an exception is that there is overlap between the individuals who would fall in that claim revival provision and the individuals to whom the thirty six months limitation period would apply so the way that works is there could be an individual who in the thirty six month period has no reason to know that he or she has a claim the full limitations period runs subsequently recognition emerges vaccine injury link the table is amended and claims from the previous eight act authorizes claims against the united states so this court has said that to the extent that the vaccine act is a waiver of sovereign immunity need to be construed narrowly so so they're kind of those considerations on both sides  start back at the beginning and walk through i think the three big themes first judge bryce and when i want to make clear the concerns that you were discussing about the source shoulder nobody would know that that was a symptom of m of is not hypothetical it's the facts of our case ass but not the full year two thousand and six or i'm sorry so it goes even further than not a definitive diagnosis of the disease dr newman actually said in hindsight i can understand that the is by saying it doesn't address the statute of limitations it discusses the causation aspect and so to the extent that we're going to talk about a discovery rule or the plain language of the statute of limitations the short answer is why cut it doesn't say our position the plain language position is that there is more than just the symptom component to the statute of limitations there's the top causation component self and if we're wrong on that you have discovery which is a doctrine of course that would apply to the statute of recognition that the disease was not actually developed until later and that is what i'll characterize as the second this argument laid out in detail in our briefs before the mari we need to do something i need to clean up some some precedent but absolutely i want to address the significance of the table how it works what the standard is the impact of it being updated and i'm not being glib here as a practical matter the standard is it doesn't happen it doesn't happen ok it's been fifteen years since an injury was added to the table so let's talk about the he vaccines every one of those cases a different illness is found to be associated with the vaccine in two thousand and six five years on two thousand and eleven go to the injury table and look to see what's associated with what are associated with a hep b vaccine and you'll find nothing literally because there's not a one and there never has been so what are the standards i'm not really sure but there's an awful lot of recognition in the medical community today and even five years ago that had the causes all sorts of injuries and the secretary has not responded to any of that it's also worth pointing out that in one nine hundred ninety seven and i apologize i'm going to cite the court to  some authority that's not in our briefs but this is responsive to another reply brief argument that in pain p and g and harvard law did a study of the vaccine program in two thousand and three if you google bedpan vaccine you'll see her report what she says is with the exception of adding a number of vaccines to the table nine hundred ninety seven the secretary has sought to narrow the injuries covered under the table and deny plaintiff's the presumption of causation about forty four point seven percent of the claims compensated through february one thousand nine hundred ninety nine were associated with table injuries the secretary removed in  ninety five and one nine hundred ninety seven resulting in it being much more difficult to recover so the notion that the table is there to remedy these sort of problems practical proof problems fairness problems equitable problems it's an abstract argument and i think well i'll say ironic that the secretary herself is the one who says the table is the mechanism to solve this problem mechanism equitable toll i think it is very very difficult notwithstanding what bryce said to conclude that equitable tolling should not be available in this case based on the holland case well i don't know that could be the practical result but no i don't i wouldn't characterize it that way because when you start talking about equitable tolling there's lots of considerations that may come into play and so for example if the discovery comes further years later a discovery rule would say you're good to go in equitable tolling doctrine may say it's kind of unfair to the government we think other considerations outweigh that the threshold question equitable tolan is whether a statute of limitations is jurisdictional and here again i think that implicates a lot of precedents i think it is quite clear the secretary doesn't even take a position on it this statute of limitations is not a jurisdictional requirement we have a one page footnote in our supplemental brief on this point it is a brief in another itself but i encourage the court not to give it short shrift because it's in a in a in the course of doing so on page twelve the paragraph beginning we also know there is a statement rejecting equitable tolling saying we also know there doesn't have to be any medical recognition of a a link between a symptom and a vaccine that is the statement that the deceased the panel dissent relies upon for rejecting our position and i just want to point  out the as we know paragraph in brice has no analysis and cites no authority so the sort of threshold question does there have to be an understanding of a late is really a question