[00:00:02] Speaker 02: The United States Court of Appeals for the Federal Circuit is now open and in session. [00:00:06] Speaker 02: God save the United States and its honorable court. [00:00:15] Speaker 02: We're ready to proceed, Your Honor. [00:00:16] Speaker 02: Oh, thank you. [00:00:17] Speaker 02: Kathleen Chincaplan, please proceed. [00:00:20] Speaker 00: Thank you, Your Honor. [00:00:21] Speaker 00: My name is Sylvia Chincaplan, and I represent the Petitioners' Appellants. [00:00:26] Speaker 00: This is a sudden infant death case after vaccinations. [00:00:30] Speaker 00: And in this instance, the special master in low court indicated that Dr. Miller's theory was specific in its identification of the necessary brain vulnerability, its identification of stressors that are relevant to an infant's susceptibility to SIDS, including vaccination, the effect of cytokines on the body and the periphery, mechanism for how said cytokines arrive at the brain, and the effect of those cytokines in the part of the brain suffering from the defect. [00:00:59] Speaker 00: She indicated that the theory failed because the increase in cytokine production must directly lead to the failure to arouse and the infant's subsequent death. [00:01:10] Speaker 00: And she further indicated that Dr. Miller did not tie a transportation mechanism to the cytokines produced locally after vaccinations. [00:01:19] Speaker 00: And it remained unclear how or why they would arbitrarily find their way across the blood-brain barrier. [00:01:25] Speaker 00: As this court is well aware, under Alvin, [00:01:27] Speaker 00: No direct evidence is required. [00:01:30] Speaker 00: Direct evidence elevates the petitioner's burden of proof beyond preponderant evidence. [00:01:37] Speaker 00: The petition, however, did provide circumstantial evidence. [00:01:41] Speaker 06: But, Counsel, hasn't this case essentially been decided by this Court, and both Mon case have held that the theory that childhood vaccines can cause SIDS is an unsound [00:01:55] Speaker 06: an unreliable extension of the triple risk model? [00:02:00] Speaker 00: Your Honor, Boatman is not applicable to the situation because there was additional evidence that was presented in this case that was not present in Boatman. [00:02:09] Speaker 00: Specifically, there was an article filed by a respondent which indicated that the immediate effect of immunizations are similar to that of a mild infection. [00:02:20] Speaker 00: And that was present at the appendix of page 459. [00:02:25] Speaker 00: Further, the petitioners in this case had filed an article, Kashiwagi, which is present at Appendix 367, which indicated that cytokines generated after vaccinations are comparable to those cytokines that are generated from patients who are seen on an outpatient basis for mild flu and hospitalized and inpatient basis for moderate flu. [00:02:52] Speaker 00: And what they found was that the severity of the symptoms did not increase the severity of the cytokine production. [00:02:58] Speaker 00: What they did find was that the more vaccinations a person received, the greater the cytokine generation was, but it was not statistically significant. [00:03:09] Speaker 03: But that still doesn't answer the question about cytokines crossing the brain blood barrier, does it? [00:03:18] Speaker 00: I'm sorry, Your Honor. [00:03:21] Speaker 00: There was evidence presented by both parties that cytokines can pass by active or direct means and indirect means. [00:03:31] Speaker 00: And Dr. McCusker, a respondent expert, did not dispute that. [00:03:36] Speaker 00: She, in fact, amplified that testimony. [00:03:39] Speaker 00: She indicated that it could be by active transport, by diffusion, by [00:03:44] Speaker 00: diffusion through the areas where there is no blood-brain barrier. [00:03:51] Speaker 06: Aren't we getting at the fact questions here? [00:03:55] Speaker 06: Cytokines need a normal brain stem to enter the brain, and didn't this child not have a normal brain stem? [00:04:03] Speaker 00: You're right. [00:04:06] Speaker 00: They don't need a normal brain stem to enter the blood-brain barrier, Your Honor. [00:04:10] Speaker 00: What they do is they need a normal brain stem to react normally. [00:04:14] Speaker 00: And that is the crux of the issue here. [00:04:16] Speaker 00: It's the fact that this child did not have a normal brain stem, and because of that, was not able to respond to the cytokines that were generated as a result of the immunizations. [00:04:28] Speaker 03: And the petitioners have presented not only evidence that it can... Well, I'm not sure that answers Judge Laurie's question. [00:04:36] Speaker 03: Are you saying that they can cross the blood-brain barrier even with [00:04:44] Speaker 03: an abnormal brain stem? [00:04:48] Speaker 03: Yes, Your Honor. [00:04:49] Speaker 00: And where's the evidence in the record to that effect? [00:04:55] Speaker 00: There is no direct evidence. [00:04:58] Speaker 00: The indirect circumstantial evidence that exists is that there was testimony by both parties that cytokines can cross the blood-beam barrier. [00:05:09] Speaker 00: And Your Honor, there is one area [00:05:13] Speaker 00: that is not covered by the blood-brain barrier. [00:05:15] Speaker 00: And that's where the brain stem comes down to join the spinal cord. [00:05:20] Speaker 00: So that area is not covered by the blood-brain barrier. [00:05:25] Speaker 00: Therefore, it would be just by diffusion that it could get into the brain compartment and affect our brain. [00:05:32] Speaker 06: You're saying there's no direct evidence. [00:05:36] Speaker 06: Correct. [00:05:37] Speaker 06: And drawing inferences and listening to experts, this is the job of the special master. [00:05:43] Speaker 06: not to this court, isn't that correct? [00:05:46] Speaker 00: That is correct, Your Honor. [00:05:48] Speaker 00: However, the court did not fail to address the entire record. [00:05:55] Speaker 00: She failed to indicate that. [00:05:59] Speaker 00: There was testimony on this, on how cytokines can cross a blood vein barrier. [00:06:07] Speaker 03: Did she have to point to everything in the record to [00:06:11] Speaker 00: uh... to make it clear that she's reviewed it i mean she did say having considered that record at the whole and in its entirety did you not uh... yes that that she did say that uh... however undisputed evidence from both parties that it does cross a blood-brain barrier or it can get into the central nervous system infect the brain and the fact that both parties agreed upon it and she indicated that uh... we have presented uh... that we have presented no evidence [00:06:41] Speaker 00: would suggest that she did not consider the record as a whole. [00:06:47] Speaker 05: Well, Council, are you saying that since Boatman was decided on background of conflicting experts and so on as we have here, that the science is advised and there are [00:07:02] Speaker 05: new kinds of evidence and new evidence and new analysis that would preconceivably distinguish the situation from the time Boatman was deciding or you're saying just that because we're still talking primarily about unknowns that there's, it's hard to distinguish the precedent. [00:07:30] Speaker 00: I am suggesting, Your Honor, and it is in fact true that there is evidence in the current case that was not present in Boatman. [00:07:38] Speaker 00: Specifically in Boatman, one of the reasons that entitlement was denied was because the child did not demonstrate the defect that was present as described in the triple risk model. [00:07:54] Speaker 00: In this instance, the parties both agreed [00:07:58] Speaker 00: that the child had gliosis of the brain stem, which includes the ocular nucleus. [00:08:03] Speaker 00: And they both agreed that that defect represented was in accordance with that described by Dr. Kinney. [00:08:13] Speaker 00: And both parties agreed that the child died of SIDS. [00:08:17] Speaker 05: And... Well, to agree you died of SIDS means to agree that you don't know why the child died. [00:08:25] Speaker 00: Well, we don't have direct evidence, as I said, Your Honor, but we do have circumstantial evidence. [00:08:30] Speaker 00: And the circumstantial evidence was provided not only by testimony, but also by the human research studies that were discussed at hearing, as well as the animal studies that were discussed at hearing. [00:08:42] Speaker 03: But the animal studies, the special master found that the animal studies did not actually show what you claim they did based on expert testimony. [00:08:55] Speaker 03: The special minister has a right to credit that testimony, does she not? [00:09:01] Speaker 00: She doesn't, Your Honor, except for the fact that there was no dispute by the parties, really, that the animal studies then indicated that pro-inflammatory cytokines such as IL-1-beta has an inhibitory effect on the serotonergic system. [00:09:20] Speaker 00: And serotonin is the arousal neurotransmitter. [00:09:24] Speaker 00: So if it has an inhibitory effect, it prevents serotonin from rising and allowing the infant to wake up. [00:09:34] Speaker 00: That was not in dispute. [00:09:37] Speaker 00: What was in dispute was Dr. McCusker contended that the cytokines remain localized and are short-lived. [00:09:46] Speaker 00: However, her testimony did not acknowledge [00:09:50] Speaker 00: uh... an article the kashiwaki article which she also presented and in kashiwaki the cytokines were found in the petitioners in the patient's bloodstream twenty four to forty eight hours after vaccination uh... and that is certainly not short-lived and once again that was from a blood draw right that was from a blood draw your honor however not necessarily from in the brain [00:10:20] Speaker 00: Well, Your Honor, once in the blood, it will circulate. [00:10:26] Speaker 00: It's inevitable. [00:10:27] Speaker 00: It just happens. [00:10:28] Speaker 00: The heart rate will propel it forward. [00:10:31] Speaker 00: It's only when a person ceases, dies, when blood circulation fails. [00:10:39] Speaker 00: So we know that the cytokines will circulate. [00:10:44] Speaker 00: We know that it will reach the blood-brain barrier. [00:10:47] Speaker 00: and there was no dispute that cytokines can cross the blood pain barrier. [00:10:54] Speaker 00: And the animal studies indicate that pro-inflammatory cytokines, such as IO1 beta, has an inhibitory effect on the serotonergic system, which is a system that we are currently discussing. [00:11:09] Speaker 00: So it's petitioners' opinion that they have met all the outcome prompts. [00:11:15] Speaker 00: And his case can be distinguished by the fact that he had the actual defect, which was not present in the Boatmine case. [00:11:25] Speaker 00: There was. [00:11:29] Speaker 03: This court had previously indicated in Boatmine... I'm trying to understand, how does the fact of the defect relate to the validity of the underlying theory? [00:11:39] Speaker 00: The child with the defect does not respond as a normal brain would. [00:11:45] Speaker 00: And as you indicated, a normal brain is necessary for these cytokines to act in the manner in which it is expected to act. [00:11:54] Speaker 00: So in a child with a defect, it won't respond normally. [00:11:59] Speaker 00: And that is the crux of the entire triple risk model, is that these children have an intrinsic defect which will not allow them to arouse when they're placed under an extrinsic stress. [00:12:13] Speaker 00: And of course, it only occurs during a vulnerable period of life. [00:12:17] Speaker 00: And that currently is believed to be under six months for SIDS, but the peak is between two and four months. [00:12:25] Speaker 00: And this child was four months old when he received his immunizations. [00:12:29] Speaker 00: So his death occurred at the peak of what is now known to be the period of SIDS. [00:12:38] Speaker 00: Further, Your Honor, in your boat mine case, you would indicate that [00:12:43] Speaker 00: And since nobody agreed with or no other physician had indicated that vaccinations could be a cause of SIDS, that theory was unreliable. [00:12:56] Speaker 00: However, novel theories have been heard in this court before and have been found reliable. [00:13:03] Speaker 00: Specifically, ALPIN involved a novel theory. [00:13:07] Speaker 00: It involved a situation where a tetanus vaccine caused a central nervous system demyelinating disorder. [00:13:13] Speaker 00: which had never been found in the past. [00:13:17] Speaker 00: And what this court indicated was that the purpose of the Vaccine Act preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body. [00:13:32] Speaker 00: And the... So there is some evidence here, Your Honor, [00:13:44] Speaker 00: vaccinations are the equivalent of trivial infections. [00:13:51] Speaker 00: And as I indicated earlier, that part of that evidence was provided by the respondent when they submitted the Veneman article, Appendix 459. [00:14:05] Speaker 00: And the Veneman article indicated that the immediate effect of immunizations [00:14:11] Speaker 00: are similar to that of a mild infection. [00:14:15] Speaker 00: A mild infection has been recognized to be an extrinsic factor associated with SIDS. [00:14:22] Speaker 00: And mild infections generate cytokines. [00:14:27] Speaker 00: And that was demonstrated in the Kashiwagi article, which is also not present in the Beaumont decision. [00:14:34] Speaker 05: Council, have you come across any scholarly studies, statistical studies, collections of data as to just the temporal relationship between when the infant is received, the vaccines, and experience of SIDS? [00:14:52] Speaker 00: There are no epidemiological studies that... I'm sorry. [00:14:57] Speaker 00: There were epidemiological studies presented at the hearing, but they all had flaws in them. [00:15:04] Speaker 00: and the flaws were revealed under cross-examination, and even Dr. McCusker, respondent's expert, admitted that there were flaws in the epidemiology. [00:15:18] Speaker 00: So there is no epidemiology specifically on point, and part of the problem is that for a decent epidemiological study, one has to have an unvaccinated population. [00:15:31] Speaker 00: And there is no unvaccinated population to compare to. [00:15:34] Speaker 00: I, apparently my time is up, your honor. [00:15:38] Speaker 00: If you would like me to answer any other questions, I would be pleased to do so. [00:15:42] Speaker 05: Well, we'll save you rebuttal time. [00:15:44] Speaker 05: Let's hear from the other side. [00:15:46] Speaker 00: Thank you. [00:15:47] Speaker 05: Okay. [00:15:48] Speaker 05: Thank you. [00:15:50] Speaker 04: All right. [00:15:50] Speaker 04: Move lots. [00:15:52] Speaker 04: Yes. [00:15:53] Speaker 04: Good morning, your honors. [00:15:54] Speaker 04: And may it please the court. [00:15:57] Speaker 04: JJ's loss is a tragic loss. [00:15:59] Speaker 04: for this family, but there is no reliable scientific evidence that childhood vaccines can cause sudden infant death syndrome or SIDS. [00:16:09] Speaker 05: I'm thinking about the history of the table injuries, which are in circumstances where it is indeed difficult to tie scientifically the injury to the vaccine. [00:16:28] Speaker 05: But the circumstances are such that it's at least as likely as not. [00:16:35] Speaker 05: And isn't that the principle of the table injury? [00:16:39] Speaker 05: Why shouldn't SIDS also, if the infant experiences SIDS within, let's say, 24, 48 hours, and I think one of the experts put this timeframe on it, that it's at least as likely as not that the vaccine contributed. [00:16:59] Speaker 05: Isn't that how this science seems to be evolving? [00:17:05] Speaker 04: No, it's not, Your Honor. [00:17:08] Speaker 04: First of all, [00:17:09] Speaker 04: There's no evidence in this case and in the volume of literature regarding sudden infant deaths that ties vaccination with SIDS. [00:17:19] Speaker 04: And comparing this off-table case to an on-table case is, with respect, an opposite. [00:17:27] Speaker 04: I mean, relying on legislative intent to decrease petitioners' burden of proof in a non-table case [00:17:34] Speaker 04: would, in the words of this court, conflate the burden of proof imposed for the off-table injuries with lenient presumptions applicable to table injuries, which is impermissible. [00:17:45] Speaker 04: As you... Well, I said impermissible. [00:17:48] Speaker 05: I'm trying to understand the public policy. [00:17:52] Speaker 05: And if we have just a massive public response of avoiding vaccine administration, [00:18:00] Speaker 05: during the first four months because that's the period of maximum SIDS events. [00:18:09] Speaker 05: That's contrary to the public policy as well, is it not? [00:18:15] Speaker 04: I'm not sure I understand your question. [00:18:18] Speaker 05: I understand your... I'm really trying to understand. [00:18:21] Speaker 05: We have these markedly [00:18:24] Speaker 05: circumstantial connections of events and we don't have as yet clear scientific correlation. [00:18:37] Speaker 05: Although, at least I ask counsel, the science seems to be evolving. [00:18:44] Speaker 05: We may get to a point [00:18:45] Speaker 05: where there is a measure of connection between the infant dying within a day or within hours, as we saw in Boatman, our administration of the vaccine. [00:18:59] Speaker 05: trying to get it right, trying to figure out how to apply the public purpose of not discouraging vaccinations because of a very small number. [00:19:15] Speaker 05: And as I recall, when the Vaccine Act was enacted, it was accepted that a very small percentage, six in my mind, one-half of 1% of infants or people [00:19:30] Speaker 05: do have an adverse genetic predisposition, and that's unknown, and that's why there's an adverse vaccine response. [00:19:42] Speaker 05: Whether then you need to prove direct causation or accept it on the table is the next step. [00:19:49] Speaker 05: But the first step is that when there is, let's call it a genetic flaw, and the recipient of the vaccine [00:19:59] Speaker 05: But that's why there's an adverse response, not that the vaccine is defective. [00:20:05] Speaker 05: So trying to put that together with the occasional case that we see on SIDS, which is not a table injury, is, [00:20:16] Speaker 05: really what's troubling me about these cases. [00:20:20] Speaker 05: So is the, as far as you know, is the government, is HHS trying to study and to understand the causes of SIDS? [00:20:32] Speaker 04: Yes, the medical personnel at HHS follow these cases very closely and they follow the mechanistic and epidemiologic studies very closely as well. [00:20:46] Speaker 04: interesting and significant, however, your honor, that even though the risk of SIDS is highest in the two to four month period, and that is the exact period when they are receiving, and since they're receiving their two month and their four month vaccines, that despite all those studies, there is no correlation, no causative correlation between vaccines and sudden incidence. [00:21:14] Speaker 04: What we have here [00:21:15] Speaker 06: Counsel, isn't it also part of your answer that it is not within the purview of this court to administer the table and to add new relationships and diseases and causes to the table? [00:21:35] Speaker 04: That's correct, Your Honor. [00:21:36] Speaker 04: That is a function of HHS to add injuries, which in fact they have in the past. [00:21:42] Speaker 04: taking them away as well. [00:21:44] Speaker 03: Council, what is your response to your friend on the other side who says that this case is different from Boatman because there is, in fact, or there's an admitted presence of an abnormal brainstem? [00:22:02] Speaker 03: Does that make a difference? [00:22:04] Speaker 04: It makes a difference, but it weakens their case. [00:22:07] Speaker 04: As Dr. McCusker explained, [00:22:10] Speaker 04: A cytokine is a messenger molecule. [00:22:13] Speaker 04: There are different cytokines, and each one has a different function and a different set of cells that are responsive to it and a different timing of release during an immune response. [00:22:23] Speaker 04: So a cytokine has to bind to the proper receptor for that cell to receive the message and be able to act. [00:22:31] Speaker 04: As this applies to Dr. Miller's theory, if there's no receptor or if the receptor in the recipient cell is not working, [00:22:39] Speaker 04: then the message from the cytokine is not received. [00:22:44] Speaker 04: So she further explained that the upregulation of a specific cytokine can only affect the brain if the corresponding signal transducer is also upregulated and neuronal transmission occurs. [00:23:02] Speaker 04: With this, she was able to effectively rebut Dr. Miller's theory by explaining the cytokines could not suppress the respiratory response in a brain with a defective 5-HP system because the brain stem's receptors are incapable of responding to the cytokines. [00:23:21] Speaker 04: And that is the principle, one of the principle foundation of Dr. Miller's theory here. [00:23:29] Speaker 03: It's a little confusing just because in Bowman we said one of the problems with the theory there was that it was a normal brainstem. [00:23:37] Speaker 03: And here we're saying that now the problem with the theory is that it's an abnormal brainstem. [00:23:43] Speaker 04: Well, one of the problems with the boat arm case below was that there was an assumption of abnormal brainstem based on statistical information. [00:23:59] Speaker 04: And there wasn't any direct information in the case for a fact finder to make that finding. [00:24:07] Speaker 04: That departs from this case. [00:24:10] Speaker 04: So in Boatman, the court never had to address the second issue present here, was that even if there were a brain stem defect, does it play a role in supporting [00:24:27] Speaker 04: Dr. Miller's self-described theory here. [00:24:31] Speaker 04: So you're correct that Boatman didn't directly address this, but the court did address the reliability of Dr. Miller's theory. [00:24:44] Speaker 04: And in that regard, I want to touch briefly upon the assertion that there is new evidence in this case that wasn't in Boatman that should somehow undermine [00:24:57] Speaker 04: the testimony regarding side accounting app regulation in this case. [00:25:04] Speaker 04: As I understand it, Kashiwagi, as an article, was in the appendix in Boatmine. [00:25:11] Speaker 04: But as it reflects this case, it was discussed in a special master's decision at pages 52 and 53. [00:25:20] Speaker 04: That study, as one of the panel noted, [00:25:26] Speaker 04: the researchers were measuring serum cytokines in peripheral blood monocular cells after stimulation with vaccine components as well as serum samples from vaccine recipients within and without several illness. [00:25:44] Speaker 04: Dr. McCusker persuasively testified at the hearing that what this article shows is that cytokines [00:25:53] Speaker 04: It shows an upregulation of cytokines in the peripheral system. [00:25:58] Speaker 04: And that's akin to what may happen in the lymph nodes next to the side of vaccination. [00:26:04] Speaker 04: But it doesn't tell you what's happening in the central nervous system in the brain. [00:26:09] Speaker 04: And that's the focus of Dr. Miller's theory here. [00:26:14] Speaker 04: Second, as to the Venom in article, I respectfully agree with, disagree with my friend. [00:26:22] Speaker 04: It was discussed in the hearing at appendix 37 and 38. [00:26:27] Speaker 04: And it does not provide support for Dr. Miller's comparison, analogy between a mild infection and immunization. [00:26:40] Speaker 04: First of all, the Veneman article doesn't even deal with cytokines and infection or vaccination. [00:26:49] Speaker 04: The term cytokine isn't there at all. [00:26:52] Speaker 04: Venomin was meta-analysis of other case-controlled studies that found, and they determined in that study that, a reanalysis, that vaccination was associated with actually reducing the risk of SIDS, and they called it a healthy vaccine effect. [00:27:13] Speaker 04: However, later in time, Cooner, another author, article that was discussed at pages 38 and 39 [00:27:22] Speaker 04: of the decision reanalyze the venomous data. [00:27:29] Speaker 04: And while they found that there was no association between vaccination and SIDS, they disagreed with the author's conclusion that there was a protective effect. [00:27:42] Speaker 03: We have said repeatedly that a petitioner need not establish a specific biological pathway to prove causation. [00:27:52] Speaker 03: Are you saying that that rule doesn't really apply where there has been so much study of a particular condition like SIDS? [00:28:05] Speaker 04: No, I guess at its foundation what I'm saying is in this case, Dr. Miller himself proffered a very specific theory of causation that depended upon cytokines induced by vaccination. [00:28:19] Speaker 04: entering a very specific part of the brain and damaging the arousal mechanism of an infant with a defective 5-HT system. [00:28:30] Speaker 04: In evaluating that theory, the Special Master's observation that the increased cytokine levels in that theory must directly lead to failure to arouse and death. [00:28:42] Speaker 04: It's simply an indication that Dr. Miller has to support [00:28:47] Speaker 04: the reliability of his own theory. [00:28:53] Speaker 05: Well isn't it fair to say that he's really within progress of science and the advances of science and knowing that he's presenting an opinion on the history of Beltman which says whatever it is you don't even have [00:29:11] Speaker 05: I'll call it a prima facie case of connection despite the temporal relationship, that he's looking at advances in science to try and understand what happens. [00:29:24] Speaker 05: I don't know how often SIDS occur in the infant population, but if it could be better understood, [00:29:36] Speaker 05: to be a much larger benefit than the question of relationship to vaccines. [00:29:46] Speaker 05: That is really trying to focus on what may be different between the state of the science at the time of Boatman and where we are now. [00:29:56] Speaker 04: There's absolutely no difference in the state of science between the Boatman case and this. [00:30:06] Speaker 04: There was no new evidence presented. [00:30:09] Speaker 04: The only difference, of course, in this case, is the evidence of a brain cell defect in JJ. [00:30:17] Speaker 04: And that...the evidence of that defect actually undermined the proposed theory by Dr. Miller. [00:30:26] Speaker 04: I mean, ultimately... Well, how does it undermine it? [00:30:31] Speaker 04: because his theory fails because it cannot work as articulated, and it wasn't consistent, it is not consistent, with what is known about cytokine expression. [00:30:42] Speaker 04: I mean, even with respect to the Kasewagi article that counsel was referring to in her discussion with you, Dr. Miller conceded at the hearing that he could not apply a direct comparison of the findings of that case [00:31:00] Speaker 04: because the authors didn't detect IL-1 beta in the serotonin in any significant quad disease. [00:31:07] Speaker 04: And his theory is that IL-1 beta, when it's introduced in a brain with a damaged medulla, can suppress the arousal system. [00:31:15] Speaker 04: So the theory here is just it's not supported at all. [00:31:20] Speaker 04: In addition, the special master found that [00:31:24] Speaker 04: irrespective of the unreliability of this theory, there was no facts, no specific facts in JJ's case that ties the theory to causing his SIDS under APHIN PROM Q. I recognize that I am out of time. [00:31:40] Speaker 04: I would be happy to respond to any additional questions that Panama has. [00:31:46] Speaker 05: Any more questions from the panel? [00:31:49] Speaker 05: No, thank you. [00:31:52] Speaker 05: Okay, all right. [00:31:53] Speaker 05: Thank you, Ms. [00:31:54] Speaker 05: Watts. [00:31:55] Speaker 05: Thank you. [00:31:57] Speaker 05: Okay, Ms. [00:31:58] Speaker 05: Jean-Captain, you have your rebuttal time. [00:32:00] Speaker 00: Thank you, Your Honor. [00:32:02] Speaker 00: So, two points, Your Honor. [00:32:05] Speaker 00: There is more evidence in this case than was reflected in the Boatman decision. [00:32:10] Speaker 00: Boatman decision did not reference Kashiwagi, and it also did not reference the statement by Veneman that vaccinations are analogous to [00:32:21] Speaker 00: and that was the premise upon which Dr. Miller's testimony preceded. [00:32:29] Speaker 00: His testimony was supported by human studies in his patients that indicated elevated cytokine levels found in the ocular nucleus or the mandala of the brain. [00:32:39] Speaker 00: And the effect of that was demonstrated by the animal studies, which demonstrated that it shows an inhibitory effect on the serotonergic system. [00:32:50] Speaker 00: Obviously, we cannot have human data here because that would involve human experimentation. [00:32:56] Speaker 00: And we'll have to involve human experimentation in a child who we know has SIDS because this doesn't occur in a normal child. [00:33:03] Speaker 03: What's your answer, though, to counsel's point that where you have an abnormal brain stem, the cytokine can't react with it? [00:33:13] Speaker 00: Well, that is just in opposite to the triple risk theory. [00:33:18] Speaker 00: The triple risk theory envisions that a child has a defect, not that a child doesn't have a defect. [00:33:25] Speaker 00: And it's because of this defect during a vulnerable period of life [00:33:29] Speaker 00: and the interaction with an environmental trigger that leads to the untimely death. [00:33:37] Speaker 00: So Dr. McCusker essentially was misstating the theory. [00:33:42] Speaker 00: And one final point that I would like to make, Your Honor, is when the polio vaccine came on the market many, many years ago, it was a miracle. [00:33:52] Speaker 00: And over the years, there were fewer and fewer cases of polio. [00:33:57] Speaker 00: And what happened was they started noticing that the people who were counting for these infants were coming down with polio, which is known as vaccine-associated paralytic polio. [00:34:10] Speaker 00: And because of this, and there was no more than 10 cases a year, but because of this, HHS switched over to the inactivated form of polio vaccine, and there's been no further cases since. [00:34:23] Speaker 00: Petitioner will concede that this is a rare reaction, but this is the second case that this court has heard within a period of months. [00:34:32] Speaker 00: And this is not the only two cases, there are multiple cases. [00:34:36] Speaker 00: If nothing else, hopefully this decision by the court would indicate that further study is needed by HHS in this matter, and perhaps [00:34:46] Speaker 00: a changing schedule would be best, because there's nothing sacred to this vaccine schedule. [00:34:51] Speaker 00: Vaccine schedules are different throughout the world. [00:34:54] Speaker 00: So as Judge Newman pointed out... Well, is SIDS on any vaccine schedule? [00:35:01] Speaker 03: Pardon me? [00:35:02] Speaker 03: Is SIDS on any vaccine schedule anywhere? [00:35:07] Speaker 00: Well, when I speak about the vaccine schedule, Your Honor, I'm referring to when the vaccines are administered. [00:35:13] Speaker 00: And they're administered in the United States at the highest risk period, whereas in other parts of the world, the vaccine schedule itself differs. [00:35:25] Speaker 00: So there's nothing sacred about the schedule itself. [00:35:29] Speaker 00: I know that my time is up, and I would be pleased to answer any questions the panel has. [00:35:34] Speaker 00: But it is petitioners and the appellants believe that they have met the health and prongs. [00:35:42] Speaker 00: and they respectfully request that this court reverse the denial and entitlement. [00:35:46] Speaker 05: Thank you. [00:35:47] Speaker 05: Any more questions for counsel? [00:35:50] Speaker 03: No further questions. [00:35:52] Speaker 05: Dermali? [00:35:54] Speaker 03: No, thank you. [00:35:55] Speaker 05: Okay, thank you. [00:35:56] Speaker 05: Thank you both. [00:35:57] Speaker 05: Well argued. [00:35:58] Speaker 05: The case is taken under submission. [00:36:00] Speaker 05: That concludes our argued cases for this morning. [00:36:08] Speaker 02: The honorable court is adjourned until tomorrow morning at 10 a.m.