[00:00:00] Speaker 02: Our last case for argument is 23-1816, Howard versus HHS. [00:00:05] Speaker 02: Mr. Kalinowski, please proceed when you're ready. [00:00:12] Speaker 03: Thank you, Your Honor. [00:00:13] Speaker 03: May it please the Court. [00:00:14] Speaker 03: My name is Isaiah Kalanowski from Boston Legal Group representing Appellant Petitioner Mark Howard. [00:00:21] Speaker 03: We're really grateful today for the opportunity to clarify an issue that's been a very big concern with what we do day to day in the Vaccine Court and the National Vaccine Injury Compensation Program. [00:00:35] Speaker 03: So even though that's something the court hears all the time, I just want to underscore how important this particular issue is for our day-to-day practice. [00:00:43] Speaker 03: Over the last few years, there's been a dispute regarding how to interpret this court's precedent regarding the appropriate metric for evaluating petitioners' medical theories of causation. [00:00:53] Speaker 03: theories that form an integral part of every one of the actual causation cases before the court. [00:00:58] Speaker 03: Every case that's not a table case, and I assume the court understands the distinction there, every case has to do with this issue. [00:01:06] Speaker 03: So that's why I want to underscore its importance. [00:01:10] Speaker 03: respondent is urged, and the special ambassador, in this case, accepted. [00:01:13] Speaker 03: A requirement that the vaccine had issued more likely than not does cause this injury in a way that has been proven. [00:01:22] Speaker 03: And not just that the theory [00:01:25] Speaker 03: is plausible, which we would argue has been the standard of this court, but that it actually exists. [00:01:30] Speaker 03: We have proof of that. [00:01:32] Speaker 02: Let me just ask a question. [00:01:33] Speaker 02: Are you challenging the state of our existing precedent such that this is the kind of issue that really properly belongs before the in-bank court, or are you saying despite the articulation of that precedent, we can meet it? [00:01:48] Speaker 03: I'm asking you to reaffirm what has been this court's precedent for 30 some odd years, since the 80s. [00:01:55] Speaker 03: So I'm not going to repeat everything that we said in the brief. [00:01:59] Speaker 03: But essentially, going back to the very end of Alton, which we would say is sort of the centerpiece of our jurisprudence from this court. [00:02:06] Speaker 04: I thought your brief recognized that, if I remember right, that I think, as you put it, at least starting in Moberly, [00:02:17] Speaker 04: our precedent veered off in the wrong direction. [00:02:21] Speaker 04: I thought you argued we misinterpreted the pre-existing precedents. [00:02:28] Speaker 03: No. [00:02:28] Speaker 03: And if so, that's the way it came across. [00:02:30] Speaker 03: I have to apologize. [00:02:32] Speaker 03: Our point is that because the way Moberly is phrased, that's why it's cited twice in that string recite. [00:02:38] Speaker 03: Moberly, in one place, understands and acknowledges that the standard for the metric [00:02:43] Speaker 03: for proving general causation is a biologically plausible theory. [00:02:49] Speaker 03: Later on, it says, OK, but this petitioner stopped there, didn't go on to establish how, in this particular effect, this applied, and then says that proving plausibility is not sufficient. [00:03:01] Speaker 03: under those circumstances. [00:03:03] Speaker 03: But the problem was then that phrasing is then used as a way of misapplying what had been accepted earlier in that same decision as the standard metric for proof of general causation, the theory, the medical theory. [00:03:18] Speaker 03: So the problem is then that iterative process, the next time it's addressed in the case of WC. [00:03:26] Speaker 03: And I guess to make a long story short, [00:03:29] Speaker 03: I'm asking that what has been the law since before, often since going back to Grant in the 90s, but all the way through the 2000s until really this 2011, 2012 period, [00:03:42] Speaker 03: It was a precedent, is a precedent, and has still been, in later cases, still recognized in cases like Sharp that we cited. [00:03:50] Speaker 03: And there is this thread of misunderstanding about the court's jurisprudence. [00:03:55] Speaker 03: And I don't know, to the extent that later decisions in cases like WC [00:04:00] Speaker 03: or Boatman stray from that prior precedent, then they're not controlling. [00:04:07] Speaker 03: But I think there's a way to resolve them. [00:04:09] Speaker 03: And I think that we cited a case from the lower court, a court of federal claim that's called J, from Judge Holt, that actually does says this. [00:04:16] Speaker 03: And Cottonstead, which we also cited, which is an unpublished decision, also says there's no, Boatman doesn't, you know, whoa, whoa, whoa, you guys are off on the wrong track. [00:04:25] Speaker 03: Boatman, Moberly, these cases don't actually depart from a plausibility standard. [00:04:29] Speaker 03: you're misreading us, the problem is that that problem, that misreading is happening all the time in lots of cases. [00:04:35] Speaker 03: And so we really, you know, it would be nice to have sort of some way to reconcile all these cases that otherwise seem to be in conflict. [00:04:43] Speaker 03: And even in some of the briefing on this issue, you know, things will talk about, well, then Moe really did this as if it could change prior precedent. [00:04:51] Speaker 03: But he can't. [00:04:51] Speaker 04: Can I just ask, the statute? [00:04:53] Speaker 04: says that causation has to be proved by a preponderance. [00:04:57] Speaker 04: Is that right? [00:04:58] Speaker 03: It says that the standard of proof for proving facts, the sufficient amount of facts to prove each element, not causation, each element, whether it was given in the United States, whether it was six months of symptoms, all the elements of 11C, which are the premonitory elements, everything has to be proved with preponderance of evidence, which is similar for every more civil case. [00:05:17] Speaker 04: Including causation. [00:05:18] Speaker 03: Including the elements of causation. [00:05:22] Speaker 04: Right, no, I think it's even harder for you if it has to be caused. [00:05:26] Speaker 04: Let's assume it's causation as a whole. [00:05:30] Speaker 04: And you understand, I think, or you characterize sort of often pronged one as general causation. [00:05:38] Speaker 04: And then two and three is different elements of specific causation. [00:05:42] Speaker 04: That is what happened for the particular plaintiff. [00:05:45] Speaker 04: But assume that you had 100% certainty [00:05:51] Speaker 04: about the timing of the vaccine in relation to the injury that occurs. [00:05:57] Speaker 04: A hundred percent certainty about the plaintiff's symptoms. [00:06:02] Speaker 04: So put aside any dispute about medical records versus personal testimony. [00:06:08] Speaker 04: But all you had on the general theory, which is to say the general proposition that under some specified conditions, this type of vaccine [00:06:19] Speaker 04: is the cause of this kind of injury is, say, a 30% probability. [00:06:27] Speaker 04: How do you get more than 50% probability of causation? [00:06:31] Speaker 03: And I'm glad you phrase it that way, Your Honor, because the problem is not that this injury is caused by it. [00:06:37] Speaker 03: It is caused as the problem. [00:06:39] Speaker 03: That's not the burden. [00:06:40] Speaker 03: biologic plausibility. [00:06:42] Speaker 03: So again, it's helpful to kind of work. [00:06:45] Speaker 04: This is why I started with the statute. [00:06:47] Speaker 04: Yeah. [00:06:47] Speaker 04: Assume, as I think is true, that causation of the vaccination, the particular administration of the vaccine, of the injury has to be shown by preponderance. [00:07:01] Speaker 04: It's a basic element of the case. [00:07:04] Speaker 03: Actual causation needs the facts supporting the proof of actual causation [00:07:09] Speaker 03: need to be proved in terms of the evidence, the fact being true or untrue. [00:07:15] Speaker 03: What is involved in proving actual causation is from the common law, and it's but for causation and proximate causation. [00:07:23] Speaker 03: And then how that's interpreted in the medical context is in general causation and specific causation, meaning can it, did it. [00:07:30] Speaker 03: And whether it does, whether we do not have to prove. [00:07:34] Speaker 03: that the vaccine does cause this injury. [00:07:36] Speaker 03: That's what the special master said we had to do, and that's incorrect from the sports precedent. [00:07:41] Speaker 03: We have to prove [00:07:42] Speaker 03: Because that's not ultimately what we're trying to prove. [00:07:44] Speaker 03: This court has said that's what science says. [00:07:46] Speaker 04: So you don't think that a general causation requirement, assuming that preponderance applies to that, I'm talking as a logical matter, put aside our precedent for now, requires that there be some identified conditions [00:08:06] Speaker 04: under which it is more likely than not that if the injury occurs, the vaccine was the cause of it. [00:08:14] Speaker 03: We have a situation where that occurs. [00:08:16] Speaker 03: That's called the table injuries. [00:08:17] Speaker 03: So where that proof is available, where there is proof available that the vaccine has been established to cause this type of injury, then it's administratively added to this table. [00:08:28] Speaker 03: And then those injuries, the causation is presumed. [00:08:32] Speaker 03: We're talking about the outlier cases where this injury has never been understood before to be related to a vaccine, or there's not enough proof. [00:08:40] Speaker 03: And the IOM has said, we don't have enough proof here to make it determined one way or another as a general matter. [00:08:45] Speaker 03: So then we're looking at, and this is in Capizano, we're not looking at it as a general matter. [00:08:50] Speaker 03: We're looking at it for this specific [00:08:52] Speaker 03: petitioner. [00:08:53] Speaker 03: The problem is we still have to figure out, well, OK, for this particular petitioner, could this have happened? [00:08:58] Speaker 03: Is this plausible from a biological standpoint, which is what we say, biological plausibility, that this could happen? [00:09:07] Speaker 03: OK, well, then let's see if that's actually what happened here. [00:09:09] Speaker 03: in the individual case. [00:09:11] Speaker 03: But to the extent that we are not proving as a general matter. [00:09:14] Speaker 03: And furthermore, if there was proof that, and this is in the expert report. [00:09:18] Speaker 03: The experts talked about this in the appendix. [00:09:20] Speaker 03: And I can draw the page if need be. [00:09:22] Speaker 03: But the experts said, if there was proof that a vaccine caused an injury to this extent, it would be pulled. [00:09:27] Speaker 03: And this has happened historically, where a certain vaccine is pulled. [00:09:30] Speaker 03: It would be what? [00:09:31] Speaker 03: It would be pulled. [00:09:32] Speaker 03: It would be taken off the market. [00:09:33] Speaker 03: So we're dealing with every single one of these cases that's in an actual causation context. [00:09:39] Speaker 03: There is never sufficient proof to prove as a general matter that the vaccine does cause this injury. [00:09:45] Speaker 03: It's never there. [00:09:46] Speaker 03: So now the question is, OK, well, what do we do now? [00:09:48] Speaker 03: And this court in Alton and Pafford and all these places, you read the very end of 1281 of Alton, it says, [00:09:57] Speaker 03: dismissing the Stevens test, which it was getting rid of because it required additional criteria, they said proving a medically plausible theory. [00:10:08] Speaker 04: Sounds like Stevens was the one that required something [00:10:14] Speaker 04: in the nature of certain kinds of medical evidence. [00:10:18] Speaker 04: And Alfven said, no, we're not limited to that kind of proof. [00:10:24] Speaker 04: Any other kind of proof will do. [00:10:26] Speaker 04: But the question is what you have to prove. [00:10:29] Speaker 03: Correct. [00:10:29] Speaker 03: And see, I'm going in very rebuttal time, so I'll try to be brief, because I do want to touch on the other issues. [00:10:34] Speaker 03: Alfven, Stevens tried to basically use Daubert criteria, like testability, [00:10:43] Speaker 03: publication theories. [00:10:45] Speaker 03: Was this particular theory proven in an article somewhere? [00:10:48] Speaker 03: And usually it's not. [00:10:49] Speaker 03: And so they said, you can't require that as proof of plausibility. [00:10:55] Speaker 03: But aside from that, proof of biological plausibility with elimination and then the specific causation factors. [00:11:02] Speaker 03: Temporal association and elimination of other factors is all we've ever required. [00:11:07] Speaker 03: That's what we required. [00:11:08] Speaker 03: That's what the circuit said in [00:11:10] Speaker 03: 2005, reaffirmed in Sharp, reaffirmed in these other places. [00:11:16] Speaker 03: I don't want to belabor that if your honors are satisfied with that. [00:11:19] Speaker 03: I would like to actually just address the other two points briefly. [00:11:23] Speaker 02: Okay. [00:11:24] Speaker 02: Briefly? [00:11:26] Speaker 03: Very briefly. [00:11:27] Speaker 03: The issue-proclusion issue is one that is [00:11:35] Speaker 03: are very big concerns because of what it specifically did. [00:11:39] Speaker 03: In this issue of preclusion, the special master said, in another case, I've decided as a factual conclusion that this evidence isn't relevant in this context. [00:11:53] Speaker 03: That wasn't challenged in this case. [00:11:54] Speaker 03: Respondent didn't raise it. [00:11:55] Speaker 03: Respondent's expert didn't raise it. [00:11:57] Speaker 03: No one challenged it. [00:11:58] Speaker 03: In fact, the respondent's expert in their report, and I can pull the appendix page, the respondent's expert said in their report, [00:12:04] Speaker 03: this person had GBS, and then this diagnosis changed to CIDP when they had a relapse. [00:12:11] Speaker 03: So no one disputed bringing up the relevance of GBS literature into a CIDP case. [00:12:18] Speaker 03: So the situations are similar. [00:12:21] Speaker 03: And the special master said, no, you can't do that. [00:12:22] Speaker 03: I already decided in these other cases that that doesn't work, and you can't do that in this case. [00:12:26] Speaker 03: And then going back to your honor's point about the statute itself, the statutory language defines the record [00:12:33] Speaker 03: defines the record of what the special master can assess in an individual case. [00:12:38] Speaker 03: And it's a record of this case, not some other case. [00:12:41] Speaker 03: And given the fact that these proceedings are closed, it's something that the petitioner, this petitioner, didn't have access to is the record in some other case. [00:12:53] Speaker 03: So anyways, with that, I will try to preserve the remainder of rebuttal. [00:12:56] Speaker 03: Your honor, do you have any questions on this? [00:12:58] Speaker 02: No. [00:12:58] Speaker 02: Thank you, Mr. Kalanowski. [00:13:01] Speaker 02: Ms. [00:13:01] Speaker 02: Kourosh, am I saying it right? [00:13:03] Speaker 01: Yes. [00:13:04] Speaker 01: Thank you, Your Honor. [00:13:05] Speaker 01: Good morning, and may it please the court. [00:13:08] Speaker 01: Your Honors, there is no reversible error in this case. [00:13:10] Speaker 01: The Chief Special Master applied the correct legal standard. [00:13:13] Speaker 01: He considered the entire record. [00:13:15] Speaker 01: He thoughtfully weighed the evidence. [00:13:17] Speaker 01: He drew reasonable inferences. [00:13:19] Speaker 01: And he provided reasoned and supported explanations for his findings. [00:13:22] Speaker 01: So essentially, he did his job. [00:13:24] Speaker 01: And on appeal, the standard is highly differential. [00:13:27] Speaker 01: This court doesn't reweigh the evidence or second-guess the fact-finders' fact-intensive conclusions. [00:13:33] Speaker 01: Of course, reasonable people can differ. [00:13:34] Speaker 01: And petitioner is entitled to a different view. [00:13:37] Speaker 01: But the Chief Special Master's decision was not arbitrary and capricious. [00:13:41] Speaker 01: It was not an abuse of discretion. [00:13:42] Speaker 01: And it was not contrary to the law. [00:13:46] Speaker 01: So it must stand. [00:13:47] Speaker 01: Now, if I could just address first the legal question that petitioner raised. [00:13:53] Speaker 01: Your Honor, preponderance has been the standard of proof since the inception of the program. [00:13:58] Speaker 01: It's in the Act, as Judge Taranto pointed out. [00:14:01] Speaker 01: It's Section 13 of the Vaccine Act. [00:14:03] Speaker 01: It says preponderance. [00:14:04] Speaker 01: And virtually every circuit case since 1991 has said preponderance. [00:14:09] Speaker 01: And I would direct the Court to page 12 of Respondent's Brief that enumerates these cases. [00:14:14] Speaker 01: Now, in 2005, Alton created this three-pronged framework for [00:14:18] Speaker 01: causation and fact cases that more specifically spells out exactly what petitioners need to show. [00:14:23] Speaker 01: But again, Alton says that they have to show those prongs by a preponderance of evidence. [00:14:28] Speaker 01: And every case since then has affirmed that. [00:14:32] Speaker 01: Now, there are a handful of cases that more particularly specify that that applies to theory in particular, meaning that to the extent that petitioners or the special masters have misunderstood and thought that something less than preponderance applies to prong one, which is theory, this court [00:14:48] Speaker 01: has explicitly stated in Dobrydnev in 2014, in Oliver and Olson, which were in 2018, in Boatman, which was in 2019, and, of course, in Moberly and Brokalshen, which petitioner referenced in 2010. [00:15:02] Speaker 01: This court has specifically said that preponderance applies to the theory prong, which is the first prong. [00:15:08] Speaker 04: So there really is no question. [00:15:10] Speaker 04: Can you state what proposition [00:15:13] Speaker 04: for prong one needs to be proved by a preponderance of the evidence? [00:15:21] Speaker 04: It can't be that by a preponderance of the evidence, there exists a theory out there that causally connects things. [00:15:29] Speaker 01: Yes, Your Honor. [00:15:30] Speaker 01: Prong one is that a particular vaccine can cause a particular injury. [00:15:34] Speaker 01: It's often called general causation. [00:15:37] Speaker 01: So meaning a petitioner would have to prove by preponderant evidence that [00:15:41] Speaker 01: A particular vaccine can cause a particular injury. [00:15:44] Speaker 01: Prong two is often called specific causation. [00:15:46] Speaker 01: Did it cause in this case? [00:15:48] Speaker 01: So prong one is can cause, prong two is did it cause. [00:15:50] Speaker 01: So then you would look at the petitioner's particular course, their clinical course, their findings, the things their doctor said. [00:15:56] Speaker 04: And how do you connect the word can to preponderance? [00:16:01] Speaker 04: Well, Your Honor, that- Does it mean that there are conditions under which it is more likely than not that if this injury is present, the cause is the vaccine? [00:16:15] Speaker 01: I think it's up to the special masters to determine that, Your Honor. [00:16:18] Speaker 01: They are special. [00:16:21] Speaker 04: Is that the question? [00:16:23] Speaker 01: The question being, can a vaccine cause- No. [00:16:26] Speaker 04: My formulation did not use the word can. [00:16:32] Speaker 04: I'm trying to understand what it means to say by a preponderance of the evidence that the vaccine can cause it. [00:16:43] Speaker 04: Does that or does that not mean that under certain conditions, it is more likely than not that when the injury appears, the cause was the vaccine. [00:16:56] Speaker 04: The word can covers too much territory. [00:17:00] Speaker 04: I want to translate into something that is more understandable, at least to me. [00:17:07] Speaker 04: Do you mean certain medical conditions? [00:17:10] Speaker 04: No, no. [00:17:11] Speaker 04: Conditions for the proposition. [00:17:13] Speaker 04: that if the injury occurs under the following conditions, that the vaccine preceded the injury by less than 30 days. [00:17:26] Speaker 04: The symptom is this. [00:17:28] Speaker 04: The symptom lasts for this long. [00:17:31] Speaker 04: The patient doesn't have other conditions. [00:17:37] Speaker 04: Sorry for doubly using the word. [00:17:39] Speaker 04: that under those circumstances, it is more likely than not that the cause of these conditions was the vaccine. [00:17:48] Speaker 01: No, Your Honor. [00:17:48] Speaker 01: I don't think there are any particular conditions or circumstances that can be specified. [00:17:53] Speaker 04: How do you know what to look for when you get to prongs two and three? [00:17:56] Speaker 04: Aren't you looking for those conditions? [00:17:59] Speaker 01: So, prong one has to do with theory in general. [00:18:02] Speaker 01: Prong two would have to do with whether the theory manifests in that particular case as [00:18:08] Speaker 01: with respect to that particular petitioner. [00:18:10] Speaker 01: You look at their clinical course. [00:18:11] Speaker 01: Do they match what the theory has put forward? [00:18:14] Speaker 01: And then prong three, which is a medically acceptable temporal relationship, actually takes a piece of both. [00:18:19] Speaker 01: It looks at what the theory predicts and predicts the time. [00:18:21] Speaker 04: So let me just put it a different way. [00:18:23] Speaker 04: I'm not sure why plausibility isn't a perfectly sensible English language word for the word can. [00:18:31] Speaker 01: Because, Your Honor, plausibility is less than preponderance. [00:18:34] Speaker 01: Plausibility. [00:18:35] Speaker 04: But you said what has to be preponderant is that it can cause. [00:18:38] Speaker 01: Yes, Your Honor. [00:18:39] Speaker 01: But preponderance is the quantum of proof. [00:18:41] Speaker 01: More likely than not, more probable than not, legally probable. [00:18:44] Speaker 01: That's the language this court has used in many cases, Lalonde, Moberly, Alton, even going back to Knudsen. [00:18:50] Speaker 01: Probable, more probable than not, more likely than not. [00:18:53] Speaker 01: As you said, greater than 50%. [00:18:55] Speaker 01: That's what preponderance is. [00:18:57] Speaker 02: You mean more likely than not that it can cause, i.e., that there might cause, like that it has happened in the past, that there has been a causal link once, even if it's only once out of 100,000 cases. [00:19:12] Speaker 02: You think that that meets the proponents of the evidence standard? [00:19:15] Speaker 01: It would depend on the evidence in that case, Your Honor, because the special masters are supposed to look at the particular mix of evidence put forward. [00:19:22] Speaker 01: And as you discussed with Petitioner's Council, there's no particular [00:19:26] Speaker 01: type of evidence that can be required, a particular category of evidence that can be required. [00:19:30] Speaker 01: The special master can't say you must put forward epidemiological evidence, or you must put forward mechanistic evidence, or you must put forward case reports. [00:19:38] Speaker 01: There's no particular category that's required. [00:19:40] Speaker 01: The special master looks at the total mix of evidence and determines whether a petitioner has preponderantly met his burden. [00:19:47] Speaker 01: Prong one being can cause medical theory, prong two being logical sequence of cause and effect did cause in this case, prong three being temporal relationship. [00:19:55] Speaker 02: I'll be honest, I'm sort of a little bit surprised at the argument. [00:20:04] Speaker 02: What is the gray area between biologically plausible and can cause? [00:20:09] Speaker 02: Biologically plausible means this may well be the cause, right? [00:20:13] Speaker 02: Plausible. [00:20:14] Speaker 02: This might be the reason. [00:20:15] Speaker 02: And that feels like can. [00:20:17] Speaker 02: That feels like it meets the word can. [00:20:19] Speaker 01: I think, Your Honor, because many things are possible or even [00:20:23] Speaker 01: plausible, but they're not probable. [00:20:25] Speaker 01: And this court has said so particularly. [00:20:27] Speaker 01: For instance, in Beaumont, this court said, we have consistently reiterated that a plausible or possible causal theory does not satisfy the standard. [00:20:36] Speaker 01: In Moverly, proof of a plausible or possible causal link between the vaccine and the injury is not the standard. [00:20:42] Speaker 01: In Brokawshan, [00:20:43] Speaker 01: The question is whether petitioners provide a proof by a preponderance of the evidence of a medical theory. [00:20:48] Speaker 01: So I think plausible, and Petitioner recognizes this in his brief, in his reply rather, pages 7 through 12 of his reply. [00:20:55] Speaker 01: He has an extended discussion regarding how plausibility is actually less than preponderance. [00:20:59] Speaker 01: It is less than probability. [00:21:01] Speaker 01: And he discusses Igbal and Twombly, the Supreme Court precedents that talk about pleading standards. [00:21:05] Speaker 01: So I think it's a lower standard of proof. [00:21:08] Speaker 01: And that's why the Chief Special Master is- Forget what he's arguing. [00:21:11] Speaker 02: I guess I'm just trying to understand what you're arguing. [00:21:16] Speaker 02: So preponderance of the evidence, there has to be a preponderance of the evidence that it can cause this, meaning it happened once. [00:21:26] Speaker 02: That's the part I'm continuing to struggle with. [00:21:29] Speaker 02: It means that there's evidence. [00:21:31] Speaker 01: It means that there's medical or scientific evidence, whether it's epidemiological, mechanistic, whatnot, that shows a causal link between this vaccination and this injury. [00:21:41] Speaker 01: Now, even if they prevail on prong one, they might still lose on prong two, because it could be that in this particular petitioner's case, there are other factors that show that even that theory wouldn't apply here. [00:21:51] Speaker 01: So each prong has to be met by independent evidence. [00:21:55] Speaker 01: So prong one, yes, could be met as a general matter based on existing epidemiological or mechanistic or whatever other kind of evidence. [00:22:02] Speaker 01: But that doesn't necessarily mean that the petitioner in this case satisfies that theory under prong two or under prong three, which is temporal relationship. [00:22:09] Speaker 00: OK, but going back to the language of plausibility, to the extent it's present in the case law, I recognize that in certain instances, it looks like it's just a repetition of what's been presented in the papers. [00:22:22] Speaker 00: But what cases specifically do you think have actually dissected that and brought forth its meaning and what was really intended and how this was supposed to be implied? [00:22:31] Speaker 01: None, Your Honor. [00:22:32] Speaker 01: None, Your Honor. [00:22:33] Speaker 01: Every time that this court actually grapples with the standard of proof and looks at what the act requires, it says preponderant evidence. [00:22:41] Speaker 01: And sometimes, as I mentioned, it defines it as probable or more likely than not. [00:22:45] Speaker 01: The handful of times where the word plausible is used, it's mentioned in passing. [00:22:49] Speaker 01: There's sort of these passing references to the word that don't really [00:22:52] Speaker 01: implicated in any meaningful way. [00:22:54] Speaker 01: And that includes Pafford, Walther, Rickett, Paluck, and Sharp, which Petitioner cites in his reply brief. [00:23:01] Speaker 01: In all of those cases, there's no real. [00:23:03] Speaker 01: What about the Andrew case? [00:23:05] Speaker 01: So Andreu is the case that maybe arguably comes the closest to sounding like it's endorsing plausibility. [00:23:11] Speaker 01: But even then, it doesn't really address medical theory in any meaningful way, because that case turned on prong two, which was logical sequence of cause and effect, meaning specific causation. [00:23:20] Speaker 01: And it dealt specifically with the treating physician's testimony in that case. [00:23:25] Speaker 01: They were discussing that particular petitioner's presentation. [00:23:30] Speaker 01: Andreu doesn't, again, doesn't meaningfully grapple with the standard of proof or articulate anything less than preponderance probability. [00:23:38] Speaker 01: And it couldn't, because this court has, as I say, since 1991 in every case, including often articulated preponderance. [00:23:49] Speaker 01: Now, if I could just turn briefly to the question of issue preclusion. [00:23:53] Speaker 04: That didn't. [00:23:54] Speaker 04: I'm kind of interested in this. [00:23:56] Speaker 04: Not because of issue preclusion. [00:23:58] Speaker 04: I don't think there's an issue preclusion going on here. [00:24:00] Speaker 04: But there is this very interesting and at least question raising. [00:24:05] Speaker 04: I'm not suggesting an answer. [00:24:07] Speaker 04: Question raising practice of use in case number 12 [00:24:16] Speaker 04: of things from cases number 1 through 11, and in which at least some of the record [00:24:31] Speaker 04: in cases one through 11 is sealed from outsiders. [00:24:38] Speaker 04: How does kind of normal notice opportunity to meet fairness work out when in case number 12, the plaintiff is faced with the special master looking at cases one through 11? [00:24:58] Speaker 04: I have some ideas, but I'm interested in your ideas. [00:25:01] Speaker 01: So I think, Your Honor, for instance, in this case, the Chief Special Master, when he discussed the past case law regarding GBS and CIDP cases, he cited [00:25:11] Speaker 01: those cases for the medical theory analysis, which really turned on publicly available medical literature. [00:25:18] Speaker 01: And that literature is often very specifically cited in the cases. [00:25:22] Speaker 01: So it's easy to find. [00:25:23] Speaker 01: Experts can find it. [00:25:24] Speaker 01: They can read it. [00:25:25] Speaker 01: They can review it. [00:25:25] Speaker 01: They can comment. [00:25:26] Speaker 04: Indeed, special masters are supposed to write comprehensive opinions, and they cite all of this public stuff, just not the personal, private stuff. [00:25:35] Speaker 01: Exactly, Your Honor. [00:25:37] Speaker 01: As mentioned in our brief, this is page 25, note 9. [00:25:40] Speaker 01: The special masters do have inquisitorial powers in the program. [00:25:43] Speaker 01: They're directed to become specialists with acquired knowledge. [00:25:46] Speaker 01: So just mentioning past cases and what their analysis of, for instance, publicly available medical literature is doesn't amount to issue preclusion. [00:25:54] Speaker 04: And in fact, in this case, forget about issue preclusion. [00:25:58] Speaker 04: Really, forget about issue preclusion. [00:26:01] Speaker 04: The question is whether there's some notice and fairness problem [00:26:06] Speaker 04: with the adjudicator relying on material from other cases, much of which is secret. [00:26:13] Speaker 01: I don't think so, Your Honor, partly for the reasons I stated, but partly also because the Chief Special Master specifically said in this case that he was relying on evidence in this case. [00:26:22] Speaker 01: He talked about the evidence that petitioners expert Dr. Shake put forward and respondents expert Dr. Vartanian put forward. [00:26:29] Speaker 04: But you think it's proper, and if memory serves maybe incorrectly, you certainly [00:26:35] Speaker 04: government certainly has argued when it gets, when it's gotten the 12th case of the same basic theory, oh, you've rejected that before, as if that was, what, precedent? [00:26:49] Speaker 04: It's not precedent. [00:26:50] Speaker 04: It's a factual question. [00:26:51] Speaker 01: That's correct, Your Honor. [00:26:52] Speaker 01: It's not precedent. [00:26:53] Speaker 01: It's not controlling in any way. [00:26:54] Speaker 04: Right. [00:26:54] Speaker 04: So how does that become a factual question when the records in those cases are not available to the plaintiff? [00:27:02] Speaker 04: You've already given one answer, which is that on [00:27:05] Speaker 04: on the general causation question, what's relied on is material that will be available. [00:27:11] Speaker 04: What else? [00:27:12] Speaker 01: Well, I think to the extent that what is discussed in those cases is public. [00:27:18] Speaker 01: For instance, it may be that the petitioner's medical records in their entirety are not available. [00:27:23] Speaker 01: But to the extent that the special master summarizes those medical records and the relevant issues that bear on their analysis, yes, all of that is available in these detailed decisions. [00:27:32] Speaker 01: all of the citations to the medical literature, all of that, petitioners can look at that in future cases the same way that the government can. [00:27:39] Speaker 02: OK, thank you. [00:27:40] Speaker 02: Mr. Kalanowski? [00:27:43] Speaker 01: I'm sorry, Your Honor. [00:27:44] Speaker 01: Did you want me to address any of the other issues that petitioner raised? [00:27:47] Speaker 01: No. [00:27:47] Speaker 01: Thank you. [00:27:53] Speaker 03: Thank you, Your Honor. [00:27:55] Speaker 03: I'll try to keep brief. [00:27:56] Speaker 03: I appreciate we're almost done here. [00:28:00] Speaker 03: I want to just circle back to something we already talked about, which is what needs to be proved with preponderance. [00:28:05] Speaker 03: The theory itself. [00:28:06] Speaker 03: that by this biological mechanism, the vaccine causes this injury, or simply preponderant proof that the theory that has been propounded is biologically plausible. [00:28:19] Speaker 03: And to Chief Judge Moore's point, that by that formulation, it can cause. [00:28:25] Speaker 03: And I want to reemphasize that respondents' position is that it's actually a petitioner's job to prove the theory, to prove [00:28:32] Speaker 03: the theory correct, something that can't be done scientifically. [00:28:36] Speaker 03: In this particular injury, there is not scientific proof of that level for any cause. [00:28:43] Speaker 03: And they're expecting us to prove it for a vaccine. [00:28:45] Speaker 03: Respondent says in their brief that we must demonstrate the theory by the promise of the evidence, not some aspect of theory, not even that the theory can cause this. [00:28:54] Speaker 03: And I guess we all agree that this Ken cause does cause rubric, right, that she mentioned. [00:29:01] Speaker 03: We all agree on that point. [00:29:02] Speaker 03: And her formulation, I appreciate that it's not something that this court deals on a daily basis. [00:29:07] Speaker 03: But that is how we, that's our socket trade. [00:29:10] Speaker 03: We prove that the theory of the mechanism by which we propose this vaccine causes injury, and then we show that that's what's going on here. [00:29:18] Speaker 03: And then the timing response. [00:29:20] Speaker 03: And that's exactly those three things. [00:29:22] Speaker 03: What I just said, like I say, 1281, the undeveloped. [00:29:25] Speaker 03: And it says, this is all that's required. [00:29:27] Speaker 03: And it uses biologic plausibility there, just as it does in Pafford, just as it does in Walther. [00:29:32] Speaker 03: And going back and forward. [00:29:34] Speaker 03: And I think with that, I won't address the rest of our. [00:29:38] Speaker 03: We also had a specific causation issue in this case. [00:29:42] Speaker 03: But given the time involved, and I appreciate the work, [00:29:45] Speaker 03: We definitely got overtime. [00:29:46] Speaker 03: I'm grateful for the time. [00:29:48] Speaker 03: And I do sincerely, and I apologize if I sound overly passionate about it. [00:29:53] Speaker 03: We just don't get a lot of time up with you guys. [00:29:55] Speaker 03: So we really, really would appreciate it. [00:29:59] Speaker 03: I think I speak for response, counsel. [00:30:00] Speaker 03: We really would appreciate some clarification on this, because it comes up in every case. [00:30:05] Speaker 03: And so I'm grateful for the time. [00:30:07] Speaker 03: Thank you. [00:30:08] Speaker 02: Thank both counsel for their argument. [00:30:09] Speaker 02: This case is taken under submission.