[00:00:00] Speaker 03: Our final case this afternoon is number 25, 1409, Nunez v. HHS. Okay, Ms. [00:00:08] Speaker 03: Wilson. [00:00:10] Speaker 01: Good afternoon, Your Honors. May it please the Court. [00:00:14] Speaker 01: I'm Amber Wilson, and I'm here on behalf of Petitioner Appellant Richard Nunez. [00:00:19] Speaker 01: This appeal concerns the legal framework applied to the circumstantial evidence under Alton. It is not a request to reweigh scientific evidence. [00:00:31] Speaker 01: The chief special master was certainly permitted to evaluate petitioner's literature and expert testimony. [00:00:38] Speaker 01: The problem is not simply that the evidence was found insufficient. The problem is why it was deemed insufficient. [00:00:47] Speaker 01: The legal error is the benchmark against which the evidence was evaluated. [00:00:54] Speaker 01: The decision treated categories of circumstantial scientific evidence, case reports, mechanistic studies, known immune pathways, and biological plausibility as if legally insufficient unless the evidence independently established generalized causation. [00:01:12] Speaker 01: That is not merely weighing the evidence. That is a structural transformation of prong one under Alfin. [00:01:21] Speaker 01: Once the chief special master concluded that this case wholly turned on prong one, The individualized causation inquiry contemplated by prongs two and three was effectively displaced by a dispositive generalized causation analysis at prong one. [00:01:44] Speaker 01: The problem was not just the critical review of evidence or that the special master was required to find it more persuasive. [00:01:52] Speaker 01: The issue is the evaluative framework applied to the circumstantial evidence under Alphen. [00:02:02] Speaker 01: While prong one does require a reputable medical theory showing that the vaccine can cause the injury, the issue is that the chief special master transformed prong one from a threshold inquiry on a reputable medical theory into a dispositive generalized causation requirement. [00:02:23] Speaker 01: Under Alphen, can cause refers to whether a petitioner presented a reputable causal theory supported by circumstantial scientific evidence, not whether the science has already established generalized causation at the population level. [00:02:42] Speaker 01: The problem is not that the chief special master just stopped on prong one. That is a legally valid principle. [00:02:51] Speaker 01: The problem is The problem is that his analysis transformed what counts as sufficient support under prong one. [00:03:05] Speaker 01: The analysis effectively treated prong one by asking, has the circumstantial scientific literature established to a probability standard that vaccines can cause the injury alleged in the general population? [00:03:21] Speaker 01: That is not the same as did petitioner's expert present a reputable theory supported by circumstantial scientific evidence. [00:03:32] Speaker 01: If prong one requires generalized scientific proof that the vaccine can cause the disease across the population before circumstantial scientific evidence can materially support causation, then Althin's three-pronged structure has effectively been collapsed into a single generalized causation inquiry. [00:03:53] Speaker 04: I may be confused by your position, but if the expert you had testified... [00:04:05] Speaker 04: testified to a reasonable, reputable medical theory of causation, but the special master is not persuaded by it after hearing all the evidence, including the experts on the other side. Are you saying the special master is supposed to find that Alton Prong 1 is nonetheless satisfied? [00:04:29] Speaker 01: So, Your Honor, the... [00:04:32] Speaker 01: The prong one still requires a reputable medical theory supported by reliable scientific reasoning. [00:04:40] Speaker 01: Boatman and Gamboa still represent limiting principles. But unlike Boatman and Gamboa, this case is not an unsupported theory case. Here, the literature genuinely supported components of petitioner's theory. [00:04:54] Speaker 03: Supported theory isn't sufficient. Boatman says the fact that it's plausible doesn't make it correct. [00:05:04] Speaker 01: Your Honor, you're correct. [00:05:07] Speaker 01: Boatman and Cerrone do not hold that biological plausibility alone can automatically satisfy petitioners' ultimate burden across all three prongs. [00:05:17] Speaker 01: A petitioner's position is that biological plausibility is still a legally relevant component of a reputable medical theory under prong one. which then must be evaluated together with the individualized evidence under prongs two and three. [00:05:34] Speaker 03: I think you've argued this before in other cases and lost, right? [00:05:43] Speaker 01: No, Your Honor, I do not believe that Cerrone or that Boatman hold that biological plausibility is legally sufficient under prong one. And that's the problem here, Your Honor, is that effectively the decision stopped and stated that it wholly turned on prong one. So it evaluated the circumstantial evidence against the benchmark of generalized causation. [00:06:16] Speaker 01: When under the Act, the ALFIN structure matters because off-table claims often involve incomplete science, uncertain mechanisms, rare injuries, and sparse proof at the general population level. [00:06:31] Speaker 01: If the phrase can cause under ALFIN, it becomes... [00:06:36] Speaker 01: proving the vaccine more likely than not at the general population level, then prong two loses its independent meaning, and the act resembles more of a toxic tort general doctrine. [00:06:50] Speaker 01: Allison allows inferential reasoning. [00:06:52] Speaker 02: You're not saying that the special master cannot ever rely just on prong one and end the analysis. You're just saying that in this case, it was inappropriate to do so. Correct, Your Honor. And you think that in doing so, the special master read more into what was required by prong one. Is there a particular language that you think... supports that? [00:07:21] Speaker 01: Well, I think that the language that the special master used on Apex 18 is very clear that he was looking for a component of the Tdap vaccine to be more likely than not capable of causing the specific biological mechanism. [00:07:41] Speaker 01: And it's not, Your Honor, that there is a that there is not a distinction. There is a distinction here. [00:07:49] Speaker 01: Boatman and Gamboa do support that a special master can reject a case. [00:08:00] Speaker 01: Unsupported theories, however, lacked evidentiary grounding. Scientifically incomplete theories, which is what we have here, remain inferential and unresolved in some respects, but are still anchored in converging scientific and medical evidence. Here, the theory was treated as insufficient not because the science remains incomplete, but because the circumstantial literature failed to support generalized causation. [00:08:27] Speaker 02: It also said other things, too. The special master said other things, too, in that paragraph you're relying on, right? [00:08:39] Speaker 01: Yes, Your Honor, the special master. [00:08:41] Speaker 02: It's too many speculative assumptions and things like that. There's other language, right? It has to be all read in context, right? [00:08:50] Speaker 01: Well, that is correct, Your Honor. It is the totality. But if you look at what the decision did here was the decision actually atomized each of those categories of circumstantial scientific evidence. and then looked at them and decided that because the evidence was incomplete, indirect, or non-definitive, that it could not meet the legal burden. [00:09:17] Speaker 01: But the Vaccine Act expressly contemplates causation claims involving incomplete science and circumstantial scientific evidence. Under all things, circumstantial evidence does not mean unsupported speculation. It means the causal question is answered cumulatively through multiple converging sources of scientific and medical evidence. [00:09:41] Speaker 01: Dole's is actually quite on point here because Dole's reinforced that relevant scientific evidence cannot be functionally sidelined merely because it is indirect or incomplete. But that is exactly what happened here. The problem is not just that the evidence was found insufficient. It is how the conclusions were reached and why. [00:10:04] Speaker 01: Circumstantial evidence retains legal significance under Alton even if no single study or the mechanism can conclusively resolve the causal question. [00:10:17] Speaker 01: Here, both a biologically plausible mechanism and published case reports materially supported expert's theory under Alton. A biological mechanism explains how the injury can occur Case reports then show how the injury occurred in real patients. Together, they provide reliable evidence that the causal theory being proposed is medically sound. [00:10:42] Speaker 01: This, respectfully, is not a case of weak evidence being improperly elevated. This is a case where direct clinical observations were discounted because they did not match perfectly petitioner's facts. [00:10:55] Speaker 01: That is not the same as, did petitioner's expert present a reputable theory supported by circumstantial scientific evidence? [00:11:04] Speaker 04: Can you talk just for a moment about the competing experts? Because the special master did see their testimony and seems to have found the government's experts more credible and persuasive. [00:11:19] Speaker 04: Don't we have to review that deferentially? [00:11:26] Speaker 01: Again, Your Honor, respectfully, the error here is not that the special master reviewed the evidence or that he found it more persuasive. [00:11:38] Speaker 01: The error is the benchmark against which he evaluated the evidence and the framework. So even though he says that he looked at the totality of the evidence, it is the manner and the method with which he looked at that That is erroneous under Alton. [00:12:03] Speaker 01: The Vaccine Act was designed because definitive scientific proof often does not exist, because vaccine injuries are understood to be rare, and because mechanisms may remain incomplete. If all of the circumstantial evidence is discounted categorically because it is incomplete, indirect, or not definitive, then only generalized scientific proof can be sufficient. [00:12:28] Speaker 01: That is the problem. It is not simply that petitioner's evidence was found insufficient, but the evidence was evaluated against a benchmark that required a level of scientific conclusiveness that often specifically recognized would often be unavailable in vaccine cases under the Act. [00:12:50] Speaker 01: I'm going to save my time for a rebuttal. Sure. Thank you. [00:13:00] Speaker 03: Ms. Kurosh? [00:13:01] Speaker 00: Yes, good afternoon. Nassim Kurosh for Respondent. May it please the Court. [00:13:06] Speaker 00: Your Honors, there is no reversible error in this case. The Chief Special Master did his job. He applied the correct legal standard. He considered the entire record. He thoughtfully weighed the evidence, and he drew rational inferences. There is no reading under which his findings are wholly implausible. And, of course, on appeal, the standard of review is highly deferential. This court does not reweigh the evidence, second-guess the chief special master's fact-intensive conclusions, or substitute its judgment for that of the chief special master. [00:13:39] Speaker 00: Of course, petitioner is entitled to a different view. But petitioner cannot point to any evidence that the chief disregarded or overlooked, and in fact has not identified any error whatsoever in the chief special master's decision, just his disagreement with the result. But that is not grounds for review. [00:13:57] Speaker 02: The argument is that there is a higher level standard that was applied, right? And so what is your basis for saying, no, the regular standard was applied? [00:14:07] Speaker 00: Well, I don't think Petitioner's argument finds any basis in the decision itself. If we read the decision itself, it's clear that the Chief Special Master correctly articulated the preponderance standard. [00:14:19] Speaker 00: And if I could for a moment, Your Honor, I'll just do a slight detour here to discuss plausibility versus preponderance before I get into the specific factual findings. [00:14:28] Speaker 00: But my friend in argument here mentioned plausibility several times. This Court has articulated on numerous occasions that plausibility is is a lower standard than preponderance, and it is not acceptable, including on Alt and Prong 1 specifically. That goes as far back as Moberly in 2010, Lalonde in 2014, Beaumont in 2019, Kologic in 2024, Cerrone in 2025. So plausibility is lower than preponderance and is not acceptable. This court has articulated that several times, and that's, of course, consistent with the Vaccine Act itself, which sets forth the preponderance standard. [00:15:05] Speaker 00: And actually, on review to the claims court here, the petitioner again argued that plausibility can somehow be grafted onto preponderance, and the claims court rightly rejected that argument. It said that, this is the appendix at 28, grafting plausibility onto preponderance would make little, if any, sense in light of the Federal Circuit's repeated rejection of plausibility as distinct from and impermissibly lower than preponderance. So preponderance is absolutely the standard, Your Honors. [00:15:35] Speaker 00: As the petitioner's assertion that the chief elevated the standard above preponderance, I mean, the petitioner hasn't pointed to any actual indication in the decision that that's the case. And I think if we look at the decision, it's clear that, first of all, the chief specifically said he's not demanding scientific certainty. That's the appendix at page 10. He correctly recited the standard, and there's no indication whatsoever. And to be clear, Your Honor, it's petitioner's burden... to identify anywhere where the chief special master did so to demand scientific certainty, definitive evidence, direct evidence, complete or conclusive proof. [00:16:12] Speaker 00: I mean, these are assertions that petitioner is making. These are arguments that petitioner is making, but there's no basis in the decision for them, and petitioner doesn't point to any specific issue, any specific instance where this might have happened. They're just sort of generalized, conclusory assertions. And I'll note also, I mean, this court said as far back as Hodges in 1993 that when a special master denies a petitioner's claim, that doesn't mean the special master was demanding certainty. It just means the special master determined that the petitioner did not carry the burden as to preponderance. [00:16:45] Speaker 00: And I think that's exactly what happened here. [00:16:47] Speaker 04: Can you just help me? Alt and prompt one. [00:16:51] Speaker 00: Yes, Your Honor. [00:16:52] Speaker 04: What exactly is it that you think they have to prove by preponderance? to get to move on to prongs two and three? [00:17:00] Speaker 00: They have to prove, Your Honor, that the vaccine at issue can cause the condition or injury at issue. So prong one, we often refer to as general causation. It's the can-cause prong. In theory, in general, can this vaccine, this specific vaccine, cause this specific disease? [00:17:17] Speaker 03: It's not can, it's whether it does, right? [00:17:23] Speaker 00: Well, it's distinct. I say it's can in general because it's distinct from prong two, which would be, okay, once we've established on prong one that it can, then we ask on prong two, in this specific case, prong two is what we call specific causation. [00:17:35] Speaker 03: Does it in general cause this kind of injury? Not in some hypothetical sense, could it? [00:17:43] Speaker 00: Yes, Your Honor, I think that's what the preponderance standard means. It means not just hypothetically could it, but have you proven more likely than not, meaning greater than 50%, can it cause it? Even if it's rare, can it happen? That's the general causation prong. That's prong one. Prong two is, okay, even assuming it can, let's say you've proven prong one, did it in this particular case, looking at this particular patient, their clinical course, their manifestation, was their condition caused by the vaccine in this case? [00:18:13] Speaker 00: And then prong three sort of takes a piece of both prong one and prong two. It looks at a medically appropriate timeframe. It says, okay, if this vaccine can cause this injury, what's the timeframe in which we expect onset to occur? And then we look at prong two, the particular clinical course in this case, and we say, is that what happened here? So those are the three prongs. They're all distinct. I certainly don't think it's the case, as petitioners suggested, that they can be collapsed into one. And on any prong, if any prong is not met... then petitioner's claim is denied because petitioner's burden is to prove each prong by preponderant evidence. [00:18:47] Speaker 00: And again, this court has said that many times in many cases, including Oliver in 2018. [00:18:53] Speaker 00: I mean, even going back to Alfin, Dobrydnev in 2014, and then Alfin itself in 2005. It's a conjunctive three-prong test proven by preponderance. So a failure to meet any prong results in denial of the claim, and that's what happened here. [00:19:08] Speaker 03: How does attorney's fees work in these cases? [00:19:12] Speaker 00: Your Honor, attorney's fees are decided after an entitlement ruling or a decision, and it has to do with reasonable basis in the case. So we're not there yet. [00:19:21] Speaker 03: If there's good faith and reasonable basis, then typically— Who makes the reasonable basis determination? Excuse me? Who makes the reasonable basis determination? [00:19:28] Speaker 00: The special master, Your Honor. [00:19:30] Speaker 03: Special master. [00:19:30] Speaker 00: Yes, after the merits are decided. [00:19:32] Speaker 03: So the special master is asked to award fees both before the special master and the Court of Federal Claims and on appeal? [00:19:41] Speaker 00: Correct. And actually, I should correct myself, Your Honor, because sometimes there are interim attorney's fees and costs. But typically, they're awarded after the merits. And yes, it does have to do with the appeal as well. The special master decides. [00:19:53] Speaker 03: And so there's a reasonable basis. Is this standard? [00:19:56] Speaker 00: Yes. So reasonable basis and good faith. Reasonable basis being objective and good faith being subjective. And then if those two things are met, they also review the cost themselves for reasonableness. [00:20:08] Speaker 00: So if I could just return for a minute to Judge Stoll's question about the particulars of this case, I want to address Dole's briefly. Petitioner mentioned Dole's, and it's mentioned in his reply brief as well. [00:20:22] Speaker 00: I think that case, which is from this court last year, it's a non-presidential case, it essentially just says that a special master can't be barred from relying on particular evidence. So in that case, there was a claims court judge that essentially directed the special master not to rely on certain literature that he wanted to rely on. And this court said, well, that's not permissible. And I think that's a pretty unremarkable proposition. I don't think it really has any effect on this case. There is a particular discussion in Dole's of statistical significance, but that wasn't an issue in this case. [00:20:56] Speaker 00: There was actually no statistical evidence presented, and the chief special master didn't discuss it. So I think that issue of a special master being barred from relying on evidence didn't occur here, and that case is not really on point. [00:21:10] Speaker 00: I do want to discuss the particulars also with respect to mechanism. So again, the chief special master did not require any particular type of evidence. And in fact, he specifically said that. Again, this is the appendix at page 10. He specifically said petitioners don't have to provide any particular type or category of evidence, which is correct. That's consistent with this court's case law. [00:21:34] Speaker 00: Petitioners' primary evidence in this case was mechanistic evidence. It was a purported mechanism of vaccine injury. But what the chief special master found was that it was very nonspecific and very unsupported. [00:21:48] Speaker 00: And it was quite thin. I mean, I think this court has said, for instance, in Brokolshan in 2010, this court talked about specificity. It said that because causation is relative to the injury, petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner's case. [00:22:09] Speaker 00: That didn't occur here. Basically, Petitioner's expert sort of generally described some immune system characteristics or processes, but didn't provide any evidence that's specific to the Tdap vaccine and the condition at issue here, which is polymyalgia rheumatica, PMR. And so, for instance, the chief special master talked about this. He said that Dr. F. Timu proposed a mechanism that was based on, quote, an antigen-specific antibody that and genetic susceptibility, but he actually offered no evidence on either of those points, not on an antigen, not on an antibody, and he also offered no evidence on particular genetic susceptibility in this case. [00:22:49] Speaker 00: So he was just kind of throwing out general terms, but not in any way providing detail such that his theory was substantiated and supported. [00:22:57] Speaker 00: And I also want to just briefly address here the point about circumstantial evidence. Petitioner mentioned circumstantial evidence many times, I don't think the chief special master discounted circumstantial evidence. I actually don't think he could. I don't think any special master could. [00:23:13] Speaker 00: This is referred to in our brief, page 19, note 7. But I'll just state briefly, I mean, as to direct versus circumstantial evidence, direct evidence is evidence that is observed with one's own senses, right? [00:23:29] Speaker 00: whereas circumstantial evidence is evidence we infer, having not directly observed. But I think under prong one in a vaccine case, you're almost never going to have direct evidence because it's nearly impossible for a person to observe with their own eyes and ears, their own senses, the microbiological processes that are happening inside the body. So on prong one, on theory, on medical theory, we're almost always going to have circumstantial evidence. That's what special masters are considering day in and day out. And so I don't think there's ever an issue with evidence being circumstantial. [00:24:02] Speaker 00: I think the problem in this case was the quality and quantity of the evidence. It was lacking on both fronts. And that's why the chief special master concluded, this is in the appendix at 18, he said, petitioner's evidence only somewhat allowed for a faint possibility of vaccine causation. So I think that's the issue here. [00:24:25] Speaker 00: And I'll also just address briefly, in addition to the mechanism, the Chief Special Master addressed really the only other thing that Petitioner put forward, which was a couple of medical articles that were essentially case reports. These were the Falsetti and Soriano articles. [00:24:40] Speaker 00: So again, Petitioner sort of quarrels with the Chief Special Master calling these weak evidence. But he was entitled to do that. I mean, that's a part of his intrinsic powers as a fact finder to weigh the evidence. But also it's consistent even with this court's precedence. I mean, if you look at, for instance, Porter in 2011, this court said that case reports provide no meaningful causation analysis. And there are many decisions from the claims court from special masters that recognize the same thing. I think that's well understood, that case reports are some of the weakest form of evidence in medicine and science. [00:25:16] Speaker 00: But he looked at two of the articles in this case, Falsetti and Soriano. He looked specifically at, for instance, admissions that Dr. Eftimio, Petitioner's expert, made about those articles, how they don't present reliable conclusions. [00:25:29] Speaker 00: One of them is a case report involving a flu vaccine and PMR relapse that just sort of refers to another unpublished case report of a Tdap vaccine. So these were all just kind of not on point overall weak evidence, and I think he was very much within his rights to find them as such. That's his province's fact finder. [00:25:48] Speaker 00: So he definitely considered all of the evidence. I will also just say briefly, Petitioner, my friend in argument here, just mentioned general population and population-level data several times. [00:26:02] Speaker 00: Just to be clear, there were no epidemiological studies presented in this case, so I don't think that's actually an issue here. But this court, again, has found on several occasions, including Grant in 2011, Andreu in 2009, that epidemiological evidence is relevant, and where it exists, it certainly can be probative on prong one. But there wasn't any at issue here, so I don't think that that's really salient to our inquiry. [00:26:31] Speaker 00: On the point about the evidence being stronger than it was in Boatman, Petitioner makes this argument in his brief as well, and it's addressed in the government's brief. This is pages 19 to 20 at note 8. [00:26:44] Speaker 00: Petitioner's burden is not just to present evidence that is better than the evidence that was rejected in another case. Petitioner has to present evidence that is preponderant in this case, and the Chief Special Master found that that didn't occur. [00:26:58] Speaker 00: And sort of on a related note, Petitioner contended in his brief, and I think maybe not as explicitly an argument, but said that the preponderance standard is an impossible burden. So this is addressed in the government's brief, pages 15 to 16 at note 5. [00:27:15] Speaker 00: I think that's demonstrably untrue. The petitioners have prevailed in countless cases before special masters, so it's certainly not an impossible burden. It's very possible, and many petitioners do it. It just didn't occur here. [00:27:28] Speaker 00: And lastly, Your Honors, I just want to address the points about Alton prongs 2 and 3. [00:27:33] Speaker 00: Petitioner argued in his brief that this court should go ahead and make some fact findings, some findings of fact on Alton 2 and 3, and find in favor of petitioner grant entitlement to petitioner. [00:27:45] Speaker 00: This is addressed in the government's brief. This is pages 29 to 30, but that wouldn't be appropriate here. Appellate fact finding is generally ill-advised, and I think that If this court were to find that prongs two and three do need to be decided, then remand is the appropriate remedy. But I don't think that's necessary because, again, the chief special master did his job, and there's no error here, and there's nothing to review. So, again, we would ask that the court affirm. [00:28:08] Speaker 03: Thank you. [00:28:09] Speaker 00: Thank you. [00:28:10] Speaker 03: Ms. Wilson. [00:28:15] Speaker 01: Thank you, Your Honors. [00:28:17] Speaker 01: I do understand the respondent's position is that the special master has correctly articulated the preponderance standard. [00:28:29] Speaker 01: The issue in this case is not the standard. It's the evaluative framework that was applied. [00:28:37] Speaker 01: Petitioners are not saying that you can collapse all of the prongs. [00:28:42] Speaker 03: What we are saying is that... Where is their language in the special master's opinion suggesting that he applied the wrong standard? [00:28:50] Speaker 01: Um... [00:28:51] Speaker 01: The petitioner is not arguing, Your Honor, that the special master especially articulated that he was requiring scientific certainty. The concern is that the circumstantial evidence was repeatedly treated as insufficient. And so the framework that applied here functionally treated all of the evidence as if it needed to independently resolve remaining scientific uncertainty. [00:29:13] Speaker 02: Again, though, but where in the opinion are you gathering that? As you say, this is not about weighing the evidence together. It's not about the conclusion that was reached. It's about the methodology that was used. So there should be something you should be able to point to. [00:29:30] Speaker 01: Well, correct. I mean, I think that the largest or clearest indication of the framework error is that the analysis never really progressed beyond generalized causation. And also, the language that the special master uses, more likely than not, can cause is asking for him to prove that the disease can generally be caused at the population level. And that is the problem here, Your Honor. [00:30:00] Speaker 01: This case is distinguished. [00:30:01] Speaker 02: Why isn't that not, I mean, can cause, is the test, and more likely than not, is the burden of proof? So why isn't that just putting the burden of proof in front of the test? [00:30:16] Speaker 01: Yes, Your Honor, I do understand that those are the semantics there. The problem is that the vaccine program is, and under Alton, the focus is really on individualized causation. So when prong one becomes prove the vaccine more likely than not at the general level, then we've lost the independent meaning of the individualized circumstantial evidence. And so that in and of itself has transformed prong one from, Did the petitioner's expert present a reputable theory supported by circumstantial evidence into did the petitioner's expert prove generalized causation in the scientific literature? [00:31:03] Speaker 03: Thank you. Thank you.