[00:00:27] Speaker 01: Here are the next argued cases, number 17, 25, 40. [00:00:31] Speaker 01: Oliver against the Secretary of Health and Human Services. [00:00:35] Speaker 02: Good morning, Your Honors. [00:00:37] Speaker 02: May it please the Court, I'm Clifford Shoemaker, representing the petitioner in this case, Hedy Oliver. [00:00:42] Speaker 02: Your Honor, I've been doing vaccine injury litigation for over 40 years. [00:00:47] Speaker 02: And there's one thing that hundreds of experts have agreed with over that period of time. [00:00:53] Speaker 02: And that is that the reason why some children [00:00:55] Speaker 02: react adversely to a vaccination, while the overwhelming majority do not, has got to be due to genetic susceptibility and or the status of the immune system on the time of vaccination. [00:01:09] Speaker 02: Those are the only two reasons that we can have for explaining why some children react and most don't. [00:01:15] Speaker 01: But 40 years ago, the mechanism, the science for confirming genetic susceptibility didn't exist. [00:01:24] Speaker 01: And what's striking about this case is actually being able to genetically determine or verify or predict or whatever it is, the inclination, the susceptibility of this child. [00:01:40] Speaker 02: Yes, Your Honor. [00:01:40] Speaker 02: And that's exactly why this case is important, because medicine, as Your Honor has just pointed out, changes constantly. [00:01:48] Speaker 02: We were not allowed to have a hearing in this case, even though we asked for a hearing. [00:01:52] Speaker 02: This case is a case where the special master decided that this was equitable estoppel. [00:01:57] Speaker 02: She basically looked at other decisions that had been made in this area, pointed them out on a footnote, and said... Wait, wait, wait. [00:02:03] Speaker 03: Show me where in the opinion, cite me to where in the opinion the chief special master applied equitable estoppel. [00:02:10] Speaker 02: She did not apply equitable estoppel. [00:02:11] Speaker 02: Didn't say those words. [00:02:12] Speaker 02: But what I'm saying is, practically speaking, that is what happened. [00:02:16] Speaker 03: It was a matter of... Can you identify any case anywhere, any court, where [00:02:23] Speaker 03: a lower tribunal improperly applied equitable estoppel without mentioning it. [00:02:30] Speaker 02: Without mentioning the words? [00:02:32] Speaker 02: No, not the words. [00:02:33] Speaker 02: Yes, there are cases. [00:02:35] Speaker 02: I'm not sure what they are. [00:02:36] Speaker 02: But in this case, it's very clear. [00:02:38] Speaker 02: Come on, counsel. [00:02:39] Speaker 02: I don't know about the cases. [00:02:40] Speaker 02: I don't know about the cases. [00:02:41] Speaker 03: What I am clear about... But that's one of the cores of your case, the other being Dalbert. [00:02:46] Speaker 02: No, the core of our case is that the special master... You just said it was the core of your case. [00:02:50] Speaker 02: No, the core of our case, Your Honor... I can repeat back from... If I said that, I misspoke. [00:02:57] Speaker 02: The core of the case, Your Honor, is that the special master determined that this child's having an SCL1A mutation was predestination. [00:03:06] Speaker 02: It meant that this child was going to have this reaction regardless, that the vaccines had nothing to do with it. [00:03:13] Speaker 02: There is no way that we can say [00:03:15] Speaker 02: that SCN1A mutations are the sole factor unrelated to vaccinations. [00:03:22] Speaker 02: That cannot be said. [00:03:23] Speaker 02: And for simple reasons, if you look at the fact... Are you abandoning your Dale Bearer argument? [00:03:29] Speaker 02: No, I'm not abandoning anything in the petition in the brief, Your Honor. [00:03:32] Speaker 02: But what I am is I'm trying to get to the heart of it. [00:03:34] Speaker 03: Because it looks to me, as I said, like your core arguments were your estoppel argument, without citation authority, and your [00:03:44] Speaker 03: Delbert argument. [00:03:47] Speaker 03: And again, I'm going to ask you the same question I asked you about Estoppel. [00:03:51] Speaker 03: Where, in the opinion, does the Chief Special Master actually apply Delbert? [00:04:00] Speaker 02: The Chief Special Master, I think, did talk about Delbert. [00:04:02] Speaker 02: He mentioned it. [00:04:03] Speaker 02: Yes, yes. [00:04:04] Speaker 03: But where did the Chief Special Master apply a Delbert analysis? [00:04:08] Speaker 02: Well, I don't think she should and could have, because Kaplan, Judge Kaplan, even pointed out [00:04:13] Speaker 02: Dow bearer is not even an issue because you can't permit the testimony of the expert. [00:04:20] Speaker 03: If you've admitted the testimony, you're going to pass dow bearer. [00:04:25] Speaker 03: In that case, how is it? [00:04:26] Speaker 03: 17 through 33 of your blue grade seems to say the chief special master misapplied dow bearer. [00:04:33] Speaker 03: Now you're telling me, couldn't have. [00:04:37] Speaker 02: Well, she misapplied it with respect to the often prongs that [00:04:41] Speaker 02: that's Dr. Schaffer testified about. [00:04:43] Speaker 02: He talked about the second-hit theory. [00:04:46] Speaker 03: Where in her opinion did she misapply it? [00:04:53] Speaker 01: Well, let me end this exchange because I think that Daubert does raise an extraordinarily fundamental issue in this case with the march of science. [00:05:10] Speaker 01: what might have been considered inappropriate or unsupported under Dalbert because of the difficulties of verifying the genetic predisposition is now history. [00:05:24] Speaker 01: This infant having experienced this reaction, one of the things that I think the special master mentioned was that even if the fever, the vaccination and the fever [00:05:39] Speaker 01: triggered this epileptic seizure response with a genetic mutation that now can be checked and verified and even a few years ago wasn't available. [00:05:55] Speaker 01: That ends it because the child had this problem and it was bound to come out. [00:06:01] Speaker 01: And this is a very, I think, interesting and curious aspect in terms because a few years ago [00:06:10] Speaker 01: This would certainly have been attributed to the vaccinations because of the way things worked in time, the vaccination immediately followed by fever, immediately followed by the seizure. [00:06:21] Speaker 01: It's very hard to say that there's no relationship, but if that was bound to happen anyway, somewhere in the six month range that this infant is in. [00:06:33] Speaker 02: We are not saying that the genetic risk factor was not there. [00:06:36] Speaker 02: But it was not inevitable. [00:06:38] Speaker 02: It was not destiny that this child was going to have a seizure. [00:06:41] Speaker 02: We don't really know. [00:06:42] Speaker 01: It looks as if maybe it is. [00:06:44] Speaker 02: We know that in 35% of the cases of people that, first of all, SCM1A mutation is simply a genetic finding. [00:06:51] Speaker 02: It doesn't become Dravet syndrome until you have a seizure disorder. [00:06:55] Speaker 02: We know that there are many children and many family members who have an SCM1A mutation and are perfectly normal. [00:07:02] Speaker 02: And that's why Dr. Raymond was wrong when he said it was the missense gene. [00:07:06] Speaker 02: Because when you have families, and for instance, some of the articles talk about extensive families where they all have the same mutation. [00:07:14] Speaker 02: Some of them had severe seizures, some had mild seizures, some had no seizures at all. [00:07:19] Speaker 02: And if you look at the last article that we provided in our reply brief, which should have been allowed in the case if we'd had a hearing, that article perfectly demonstrates that timing is so important. [00:07:32] Speaker 02: If you don't have the first seizure until after 12 months, [00:07:35] Speaker 02: If you don't have any seizures for the first 12 months and you have the SU-1 main mutation, you won't want to have Gervais. [00:07:40] Speaker 02: Zero percent chance. [00:07:42] Speaker 02: If you survive six months, there's a 51 percent chance that you'll have a seizure. [00:07:48] Speaker 03: You're talking about conflicting evidence below. [00:07:56] Speaker 03: Where did you argue that the Chief Special Master erred in relying on the government's evidence? [00:08:03] Speaker 03: or that it was unreliable, as opposed to that your expert was more persuasive. [00:08:10] Speaker 03: I mean, over and over again, you make these arguments, and they're very fascinating reading. [00:08:18] Speaker 03: But there's a counter argument to each one from the other side's experts. [00:08:24] Speaker 02: Well, and the other thing is that while she mentions the newer articles that have come out recently, the one article, of course, that hasn't been considered, and we asked the court to take judicial notice, [00:08:33] Speaker 02: is the one that we mentioned in our reply brief, because that is a very significant article that came out just in 2017, which does point out significantly what we're talking about. [00:08:42] Speaker 03: In that case... How on earth can we? [00:08:45] Speaker 02: Well, this is the point that Your Honor was making, is that medicine changes. [00:08:50] Speaker 02: It is no longer inevitable that someone who has an SCL1 mutation, a child... We have many children with SCL1 mutations that will never have dravets. [00:08:59] Speaker 02: because they don't have anything to trigger the onset of seizures with the appropriate time frame. [00:09:03] Speaker 01: No, I was saying, yes, it changes, but the change hurts you. [00:09:10] Speaker 01: It does not hurt us. [00:09:11] Speaker 01: This is what the special master really said. [00:09:13] Speaker 01: Now that we know this relationship of this syndrome and these manifestations, they were so close to being inevitable that even if [00:09:27] Speaker 01: It was triggered by the fever or by the vaccination or whatever with a child with this genetic structure. [00:09:36] Speaker 02: This is like saying you have hemophilia. [00:09:38] Speaker 02: I didn't kill you when my car ran into you. [00:09:41] Speaker 02: If I hadn't done that, something else would have done it later. [00:09:44] Speaker 02: That's what exactly we have here. [00:09:47] Speaker 02: We know, for instance, this is a risk factor. [00:09:50] Speaker 02: But we also know that if those children don't have an exposure that triggers a seizure within the first six months, [00:09:57] Speaker 02: then their risk of developing Dravet's reduces to 51%. [00:10:02] Speaker 02: If they don't have something that triggers the first seizure within the year, they never have Dravet's syndrome. [00:10:07] Speaker 02: They go on to become adults who have the same SCN1 mutation and never have a problem. [00:10:12] Speaker 02: Let me back you up, please. [00:10:14] Speaker 02: Yes, sir. [00:10:15] Speaker 03: You asked us to take judicial notice of the 2017 article. [00:10:20] Speaker 03: What authority do you have, legal authority, that says that we can take judicial notice of a scientific article on the foundation? [00:10:28] Speaker 02: As we pointed out in our brief, if we had been granted a hearing, a hearing would have been scheduled the end of 2017. [00:10:34] Speaker 02: By that time, the article would have come out. [00:10:36] Speaker 02: We were denied a hearing. [00:10:40] Speaker 02: I've never had the opportunity to cross-examine these experts on this issue. [00:10:44] Speaker 02: When I talk, please. [00:10:46] Speaker 03: Or when Judge Newman talks. [00:10:50] Speaker 03: what I asked you for what authority you have for us to take judicial notice. [00:10:56] Speaker 03: You're not arguing, you're not answering that question. [00:10:58] Speaker 03: You're saying the hearing should have been held and then they would have done it. [00:11:03] Speaker 03: That doesn't allow us to take judicial notice of something. [00:11:06] Speaker 03: We can look and see what the weather was. [00:11:10] Speaker 03: That's judicial notice. [00:11:13] Speaker 02: If you look at the articles that were actually filed, the Claussen article makes it clear [00:11:17] Speaker 02: that there's something required other than SCN1 amputation in order to provoke trovese. [00:11:22] Speaker 03: You're not answering my question. [00:11:25] Speaker 02: About the judicial notice? [00:11:26] Speaker 03: About the judicial notice. [00:11:26] Speaker 02: The only argument I have on that, Your Honor, is that if we had been granted a hearing, which we were denied, and I was denied the hearing, I didn't have the chance to cross-examine Dr. Raymond, I didn't have the chance to present the evidence of my witness. [00:11:39] Speaker 02: Don't waste your time. [00:11:40] Speaker 03: That's your only argument. [00:11:43] Speaker 02: The Claussen article, for instance, talks about the fact that, and that's one of the articles that the government does rely upon, talks about the fact that when a seizure, and we know that seizures in 35% of the cases where seizures occur in SCLNA, a DPT vaccine occurred within 48 hours before that. [00:12:02] Speaker 02: So we know that DPT vaccines are a substantial trigger for Dravet syndrome. [00:12:07] Speaker 02: That's highly significant. [00:12:09] Speaker 02: That's really high. [00:12:10] Speaker 02: The point we're making is that if this is avoided and all these articles point out that the earlier the onset of Dravet's, the more severe it is and the more likely it is to, they looked at early onset cases and late onset cases. [00:12:25] Speaker 02: And so if we look at the Claussen articles, we look at Berkovich and McIntosh, all of these articles which we described in our brief point out the fact that if this child had not had this reaction, [00:12:37] Speaker 02: And everybody can agree that seizures were caused by that vaccine. [00:12:41] Speaker 02: The vaccine caused the seizure. [00:12:43] Speaker 02: The same day the child got a vaccination, 1130 that night, the child was seizing. [00:12:48] Speaker 02: No one's going to say that that vaccine wasn't the trigger for that seizure. [00:12:51] Speaker 02: What they're saying, though, is that this was inevitable. [00:12:54] Speaker 02: This child would have had seizures from Javés regardless of whether the child got the vaccine. [00:12:59] Speaker 02: That's not true. [00:13:01] Speaker 02: You cannot say that... I don't think they went that far. [00:13:04] Speaker 01: I think they said that with this propensity. [00:13:08] Speaker 01: This clear genetic propensity, even if the seizure was triggered by the vaccine, it was inevitable. [00:13:19] Speaker 02: No. [00:13:19] Speaker 02: If it's triggered by the vaccine, it's a but for cause. [00:13:22] Speaker 02: But for the vaccine, the seizures would not have started that day. [00:13:25] Speaker 02: You agree with that? [00:13:26] Speaker 02: If you agree with that, then you have to go to the articles. [00:13:28] Speaker 02: And the articles say if the seizures, if you don't have the first thing that provokes a seizure within six months, you reduce to 51%. [00:13:34] Speaker 02: This was six months. [00:13:36] Speaker 02: If that child had got past one year, the article showed that it would have been zero chance of the child developing dravets. [00:13:42] Speaker 02: The family article that you look at, if you look at the family article, the Goldberg Stern article, which is on page 36 of our brief, that article looked at families, an extensive family that took the history and they took the genetics of the whole family. [00:13:57] Speaker 02: They found that some had mild seizures, some had severe seizures, some didn't have any seizures at all. [00:14:02] Speaker 02: Some made it all the way through to adulthood with never having seizures. [00:14:05] Speaker 02: If this child had not had a seizure provoked by vaccine at the time he did, he may not have developed Dravet's. [00:14:12] Speaker 02: He may have made it to 12 months. [00:14:14] Speaker 02: Yes, something could have come along in the six months to 12 months that might have provoked the seizure. [00:14:19] Speaker 02: We don't know that. [00:14:19] Speaker 02: We don't have a crystal ball. [00:14:21] Speaker 02: That's not an alternate cause. [00:14:22] Speaker 02: You can't claim that as an alternate cause. [00:14:24] Speaker 02: If this child would have made it to 12 months without having a seizure, without having something that provoked the seizure, the child would have likely never had Dravet's syndrome, never had any seizure disorder. [00:14:35] Speaker 02: So this is not the sole cause, and it's not unrelated to vaccinations. [00:14:39] Speaker 01: We'll see. [00:14:39] Speaker 01: So let's hear from the secretary. [00:14:42] Speaker 01: We'll ask the same questions. [00:14:45] Speaker 01: Mr. Principato. [00:14:51] Speaker 00: Good morning, and may it please the court. [00:14:53] Speaker 00: My name is Daniel Principato, appearing on behalf of the Secretary of Health and Human Services. [00:14:58] Speaker 00: The issues today are whether the chief special master's decision denying entitlement was arbitrary and capricious, [00:15:03] Speaker 00: and whether her decision to decide this case without an evidentiary hearing was an abuse of her discretion. [00:15:07] Speaker 01: But you know, I don't think that even your side is taking the position that there was a hundred percent chance that there was no relation between the vaccination and the fever and the seizure, all happening within one day. [00:15:24] Speaker 00: That's correct. [00:15:26] Speaker 01: Within hours. [00:15:28] Speaker 01: That's correct. [00:15:29] Speaker 01: Isn't the position [00:15:32] Speaker 01: that you've taken is that this infant was going to have seizures anyway. [00:15:37] Speaker 01: And it does look as if that's quite a complicated position to take on which a lot of information is still being learned. [00:15:47] Speaker 01: So why should this infant be on the short end of that? [00:15:54] Speaker 00: So our position is that the Chief Special Master is finding that the Dravet syndrome was not caused by the vaccine, was not arbitrary and capricious. [00:16:07] Speaker 00: So just to back up, it's well understood that vaccines can cause a fever that can lead to a seizure. [00:16:14] Speaker 00: But crucially here, the Chief Special Master concluded that the vaccine did not cause Dravet syndrome and nor did the first seizure cause Dravet syndrome. [00:16:22] Speaker 00: So while a vaccine may cause a seizure, a vaccine is not going to cause an underlying seizure disorder. [00:16:28] Speaker 00: And the chief special master evaluated all of the evidence, appropriately evaluated all of the evidence, and found that petitioners failed to meet their burden, and that the government, in fact, met its burden. [00:16:37] Speaker 01: What if the vaccine just merely triggers this genetic defect to manifest itself, whereas if this hadn't happened and the child got to be older, perhaps it could resist [00:16:53] Speaker 00: Well, there's no evidence that the vaccine can cause the genetic defect. [00:16:58] Speaker 01: No. [00:16:58] Speaker 01: Well, that's the problem, isn't it? [00:17:01] Speaker 01: And as a result, we've certainly seen enough cases where when the well is right, isn't it a table injury if there is a seizure within three days after vaccination? [00:17:18] Speaker 00: Well, this isn't a table case, and I'm not sure which claim you're referring to. [00:17:23] Speaker 00: The question is whether the Chief Special Master was arbitrary and capricious in finding that the initial seizure didn't lead to the Gervais syndrome. [00:17:32] Speaker 03: Let me walk you through a Doe-Bare question, OK? [00:17:37] Speaker 03: In de Bazin versus Secretary of Health and Human Services in 2008, the government made arguments similar to the Oliver's. [00:17:53] Speaker 03: Delbert arguments. [00:17:55] Speaker 03: And we rejected them, saying Delbert was in avocet because the chief special master there didn't, or the special master, didn't exclude any expert evidence under Delbert. [00:18:10] Speaker 03: But in 10 v. secretary, we affirmed the admission of Delbert information to find expert testimony unreliable [00:18:23] Speaker 03: rather than inadmissible. [00:18:25] Speaker 03: So does Dover apply only when testimony is inadmissible or does it apply to determining relative weight according to the testimony? [00:18:38] Speaker 00: Yeah, that's a great question. [00:18:40] Speaker 00: And in the vaccine program, it's been used to weigh credibility of evidence or reliability and persuasiveness of evidence. [00:18:48] Speaker 00: and not necessarily exclude it. [00:18:49] Speaker 00: And I think that this probably due to the fact that the Vaccine Act has lower admission evidentiary standards than regular courts. [00:18:56] Speaker 03: So if you're allowing Daubert to weigh evidence, did the Chief Special Master implicitly conduct a Daubert analysis? [00:19:09] Speaker 00: Well, I think so. [00:19:09] Speaker 00: I think that, yes, she evaluated the persuasiveness of the evidence in light of Daubert, and appropriately so. [00:19:18] Speaker 03: Which is what your opposing counsel should have said. [00:19:20] Speaker 03: That's where I was going. [00:19:21] Speaker 01: You know, if we didn't have the current capability of DNA analysis, and so an infant at six months gets the vaccination, within hours starts to run a high fever. [00:19:39] Speaker 01: Within hours, manifest seizures. [00:19:42] Speaker 01: The relationship cause and effect [00:19:45] Speaker 01: I think is not questioned that this is within the category of vaccine injury. [00:19:52] Speaker 01: What's happened here is that we've now found a complicating factor, a propensity, whatever you want to call it, but a genetic predisposition. [00:20:05] Speaker 01: I don't know if that's the right word, but anyway, a genetic flaw that has these manifestations of these seizures epileptic type [00:20:16] Speaker 01: seizures, but going back only a few years in the history of the vaccine injury legislation, there's no doubt, is there, but that this would have just been routinely included as compensable? [00:20:33] Speaker 00: Well, there is. [00:20:34] Speaker 00: I believe that science progresses. [00:20:36] Speaker 00: There is now. [00:20:37] Speaker 00: The secretary's position is that a vaccine may cause a seizure, but it's not going to cause a seizure disorder. [00:20:43] Speaker 00: And it's not in the record, but even in epilepsy cases, I believe the science is now progressing to question whether that's a result of an underlying disorder that has yet to be identified. [00:20:55] Speaker 00: In this case, we have the specific identification of the underlying disorder, the SCN1A gene mutation. [00:21:02] Speaker 00: And so to establish a causation, in fact, claim under Alton, practitioners must show, in brief, a reliable medical theory showing that the vaccine can cause the condition. [00:21:13] Speaker 00: a logical sequence of cause and effect that the vaccine did cause the condition and approximate temporal relationship between the vaccination and the alleged condition. [00:21:22] Speaker 00: But even where the petitioner has stated a prima facie case under Alton, compensation must be denied where the government has shown by preponderance of the evidence that the condition was caused by factors unrelated to the administration of the vaccine. [00:21:34] Speaker 00: And so in this case, the chief special master found the petitioners failed to meet their burden under Alton. [00:21:38] Speaker 00: And even if they did, the secretary showed met his burden because [00:21:42] Speaker 00: show that EO's condition was caused by factors unrelated to the vaccination, the SCI-M1A gene mutation. [00:21:48] Speaker 00: This court will review a special master's factual findings with a highly deferential, arbitrary, and capricious standard. [00:21:54] Speaker 00: Accordingly, this court will uphold a special master's decision so long as she is considered the relevant evidence, drew plausible inferences, and articulated a rational basis for her decision. [00:22:04] Speaker 00: Appellant's counsel today has attempted to reweigh much of the evidence. [00:22:08] Speaker 00: The question isn't whether this court would [00:22:11] Speaker 00: fine in favor of EO or appellants today. [00:22:15] Speaker 00: The question is whether the chief special master's decision is arbitrary and capricious in denying entitlement. [00:22:25] Speaker 00: So moving to our second point, the Vaccine Act explicitly authorizes the special master to decide a claim without an evidentiary hearing. [00:22:33] Speaker 00: Similar entitlement claims have been filed in the past. [00:22:36] Speaker 00: At least 15 have been considered by special masters, five have reached this court, and compensation has been awarded in zero. [00:22:41] Speaker 00: The Chief Special Master herself has decided three of these cases. [00:22:44] Speaker 00: Farrow versus HHS, Mathis versus HHS, and McCarran versus HHS. [00:22:49] Speaker 00: But nevertheless, petitioners were given a full and fair opportunity to litigate their claim. [00:22:53] Speaker 00: Petitioners were given an opportunity to file seven expert reports and over 80 scientific articles. [00:22:58] Speaker 00: The Special Master was within her discretion to determine a petitioner's claim based on the fact that the record was fully developed in light of the well-established background law. [00:23:06] Speaker 00: And moreover, petitioners were not stopped from litigating their case. [00:23:09] Speaker 00: Simply, no estoppel doctrine was applied here. [00:23:12] Speaker 00: In sum, the Chief Special Master's well-reasoned decision should be affirmed. [00:23:16] Speaker 00: Unless this Court has any further questions, the Government will rest once briefed. [00:23:31] Speaker 02: Thank you. [00:23:31] Speaker 02: I'd like to make the point that SCN1A mutation is not a single mutation. [00:23:36] Speaker 02: And there are many, many mutations in the sodium channel genes. [00:23:40] Speaker 02: If you look at the actual findings in this particular case, what the lab says is, since this type of sequence variants are similar to those observed in disease-associated mutations and benign polymorphisms, the nature of this variation precludes clear interpretation. [00:23:55] Speaker 02: Therefore, it is not possible to conclude with any reasonable degree of clinical certainty at this time whether or not this variant is associated with a phenotype in question. [00:24:03] Speaker 01: I saw that. [00:24:05] Speaker 01: But to my mind, I focus on the at this time. [00:24:08] Speaker 02: You have to understand what I'm trying to say, and that is I agree with you wholeheartedly that medicine has changed. [00:24:19] Speaker 02: And remember what I said at the beginning is we've known forever that the reason why some kids react adversely to a vaccine while most do not has got to be due to genetic susceptibility. [00:24:29] Speaker 02: And now that we've discovered one, we've discovered, okay, this is a genetic susceptibility you have. [00:24:35] Speaker 02: Now they're trying to say that's a sole factor unrelated to the vaccination. [00:24:38] Speaker 02: Impossible. [00:24:40] Speaker 02: It cannot be the sole factor unrelated to a vaccination. [00:24:43] Speaker 02: First of all, an SCL mutation is not an underlying disease. [00:24:48] Speaker 02: It's not an underlying seizure disorder. [00:24:51] Speaker 02: It's simply a genetic finding period. [00:24:55] Speaker 02: And you don't have Dravet syndrome until you have seizure disorder. [00:24:59] Speaker 02: And the seizure disorder is triggered by something. [00:25:02] Speaker 03: Is the baby had not had [00:25:06] Speaker 03: vaccination. [00:25:07] Speaker 02: The baby might very well be alive and sitting here in this courtroom today, normal, with no problems, no dervay or anything. [00:25:13] Speaker 02: If that child had made it to 12 months with nothing to trigger it, we can't speculate. [00:25:20] Speaker 02: We don't have a crystal ball to say that something might not have happened at nine months. [00:25:24] Speaker 02: Council? [00:25:25] Speaker 02: Yes. [00:25:26] Speaker 01: Let's hear from Judge Wallach. [00:25:28] Speaker 03: If the baby had not had a vaccination, could the disease still have occurred? [00:25:35] Speaker 02: It could have, it could not have, either way. [00:25:38] Speaker 02: We don't have a crystal ball. [00:25:39] Speaker 02: It's like saying, I had a case one time where the expert on the other side, I said, he agreed that the vaccination probably triggered the seizure. [00:25:47] Speaker 02: He says, but it didn't have to be that. [00:25:48] Speaker 02: It could have been something else. [00:25:49] Speaker 02: It could have been an infection. [00:25:50] Speaker 02: It could have been a divorce of the parents. [00:25:52] Speaker 02: And I said, but those things didn't happen. [00:25:55] Speaker 02: What happened in this case was the vaccine. [00:25:58] Speaker 02: So yes, are there other potential triggers of seizures and Dravet syndrome? [00:26:01] Speaker 02: Probably, because only 35% [00:26:04] Speaker 02: appear to be due to the vaccine, that's a huge percentage, incidentally. [00:26:08] Speaker 02: That's like a relative risk of 17, as we pointed out in our brief. [00:26:12] Speaker 02: The relative risk that if you have Dravet is that you had a vaccination within 48 hours before that is over 17. [00:26:19] Speaker 02: We normally think of relative risks in this program as being above 2. [00:26:22] Speaker 02: 17 is huge. [00:26:24] Speaker 02: So we know that the DPT vaccination is a huge factor in triggering Dravet syndrome. [00:26:31] Speaker 02: It's not the only one. [00:26:32] Speaker 02: Could the child, if the child didn't get these vaccines and didn't have that seizure, that day of the vaccines, could something else have happened at nine months, another vaccination, for instance, that might have triggered it? [00:26:42] Speaker 02: Yes. [00:26:43] Speaker 02: Could the child have gotten to 12 months and never had dravees the rest of his life? [00:26:47] Speaker 02: Yes. [00:26:48] Speaker 02: And that's all pure speculation. [00:26:50] Speaker 02: That's not an alternate cause. [00:26:52] Speaker 02: This was clearly related to the vaccination. [00:26:55] Speaker 02: It was not the sole cause. [00:26:56] Speaker 02: The two things together are the cause. [00:26:59] Speaker 02: You have a genetic risk factor, a susceptibility [00:27:02] Speaker 02: The vaccine trigger is the onset of the seizure disorder. [00:27:05] Speaker 02: The two of them work together to cause it. [00:27:07] Speaker 02: We've known that forever. [00:27:08] Speaker 02: Now we're starting to identify some of the specific genes involved. [00:27:12] Speaker 02: And maybe someday, God willing, we'll be able to look at a child's profile and say, you shouldn't get this, that, or the other thing. [00:27:18] Speaker 02: That would be wonderful. [00:27:20] Speaker 02: Mr. Schimp, I'm sorry. [00:27:22] Speaker 01: We have another question. [00:27:23] Speaker 03: I don't have a question. [00:27:24] Speaker 03: I have a comment. [00:27:27] Speaker 03: We have to stick to the law in these cases. [00:27:30] Speaker 03: But they are so, in the true sense of the word, pathetic. [00:27:33] Speaker 03: There's so much pathos involved in every one of these. [00:27:37] Speaker 03: And I know you... I get invested. [00:27:38] Speaker 03: I'm sorry, Your Honor. [00:27:39] Speaker 03: But I understand. [00:27:40] Speaker 03: I just wanted to say that. [00:27:42] Speaker 03: Sorry. [00:27:43] Speaker 03: Can't help it. [00:27:45] Speaker 01: Thank you, sir. [00:27:45] Speaker 01: Your case is taken under submission.