[00:00:00] Speaker 01: That's one nine eight two to twelve versus HHS. [00:00:36] Speaker 01: Mr. Webb please proceed. [00:01:16] Speaker 02: May I please record? [00:01:19] Speaker 02: First, thank you for the opportunity to present our argument today. [00:01:23] Speaker 02: And second, I'm a little hard of hearing. [00:01:27] Speaker 02: So please be patient with me as I try to understand your questions. [00:01:32] Speaker 02: And Judge Chan, in particular, if your hand is not in front of your lips, it helps me understand your questions. [00:01:38] Speaker 02: OK, very good. [00:01:41] Speaker 02: The first question presented in this appeal [00:01:44] Speaker 02: is what this court met in Capizano v. Secretary of Health and Human Services when it said that requiring a claimant to provide epidemiologic studies in order to prove causation impermissibly raises a claimant's burden under the Vaccine Act. [00:02:03] Speaker 02: We believe that Capizano means that a special master impermissibly raises a claimant's burden of proof if the special master concludes that a claimant [00:02:14] Speaker 02: cannot prove causation because he did not produce an epidemiologic study that directly supported a critical part of his theory of causation. [00:02:24] Speaker 01: Do you lose if I conclude that the special master did not require you to present epidemiological evidence, but rather merely found that Dr. Steinman, the Ahmed 1 and Ahmed 2 articles, and Hahn were not [00:02:41] Speaker 01: persuasive that causation had been established in light of the contrary epidemiological studies? [00:02:48] Speaker 01: Is that the end of your case, if that's what I conclude? [00:02:52] Speaker 02: I should lose on that part of my appeal if you found that the special master did not require us to produce epidemiological studies. [00:03:02] Speaker 02: Now, the last part of that question, I'm not 100% sure I understand, if he merely found [00:03:10] Speaker 02: His conclusion was that Dr. Steinman was unpersuasive. [00:03:14] Speaker 02: I guess the very last part of the question depends on what role. [00:03:24] Speaker 02: I go back to the question of whether he did, in fact, require epidemiology. [00:03:29] Speaker 02: In other words, if he found that Dr. Steinman was not persuasive because there was not an epidemiologic study, [00:03:39] Speaker 02: that supported the premise that live virus influenza vaccine can cause narcolepsy. [00:03:52] Speaker 02: We're arguing, I believe, that it was requiring that epidemiology. [00:03:58] Speaker 02: But this comes to the question. [00:04:00] Speaker 02: That's why I started with this question. [00:04:02] Speaker 02: What does it mean to require epidemiology? [00:04:08] Speaker 02: special master believes that require an epidemiology. [00:04:12] Speaker 02: Well, as far as I can tell, he felt that he acknowledges in his opinion that he cannot require epidemiology or that a petitioner can prove a case without an epidemiologic study. [00:04:29] Speaker 02: He says that. [00:04:31] Speaker 02: And then he goes on to weigh the epidemiology [00:04:38] Speaker 02: epidemiologic evidence in a way that I believe required a epidemiologic study to respond to the Duffy article. [00:04:50] Speaker 03: But how else was he to respond to the or consider and weigh the evidence? [00:04:59] Speaker 03: What to do what he did? [00:05:00] Speaker 03: He just looked at the evidence on both sides and came to a conclusion. [00:05:07] Speaker 02: That comes to the list of ways I think he required epidemiologic evidence. [00:05:15] Speaker 02: We believe that if you weigh the absence of an epidemiologic study against the petitioner or against the claimant, you're requiring epidemiologic evidence. [00:05:28] Speaker 01: Well, I don't see that he weighed against you the absence. [00:05:31] Speaker 01: He found Dr. Steinman's claims. [00:05:34] Speaker 01: not to be persuasive in light of limitations in Ahmed 1 and Ahmed 2. [00:05:41] Speaker 01: He said, Dr. Steinman's own article suggested the link between pandemrix and narcolepsy was most likely attributed to how H1N1 antigens and pandemrix were prepared and confirmed that different vaccine formulations would have different risks for narcolepsy. [00:05:58] Speaker 01: And then he also cited the Duffy article, which is the government produced its own [00:06:04] Speaker 01: evidence, which happened to be an epidemiological study that went against you. [00:06:11] Speaker 01: But, I mean, he's got to weigh all the evidence. [00:06:13] Speaker 01: And he says, okay, well, they've got a study that weighs against you. [00:06:16] Speaker 01: You've got a guy who's got a theory, but his theory is undermined by some of his own articles, as well as limitations in Ahmed 2 and Ahmed 1. [00:06:26] Speaker 01: And then the special master found against you. [00:06:29] Speaker 01: You hadn't successfully proven causation. [00:06:31] Speaker 01: under those circumstances. [00:06:33] Speaker 01: I don't see how that's requiring you to produce an epidemiological study. [00:06:39] Speaker 01: I don't see how you can read the opinion that way. [00:06:42] Speaker 02: Well, let me see if I can read it. [00:06:44] Speaker 02: Obviously, this is a critical question. [00:06:45] Speaker 02: I've thought about it. [00:06:51] Speaker 02: And it's possible that I read this opinion differently than you folks do. [00:06:56] Speaker 02: It seems to me, it's from reading the special master's dependent, that [00:07:01] Speaker 02: Um, had there not been a Duffy article, we would have had a stronger case. [00:07:09] Speaker 01: Well, but that's, had there, had there not been any evidence on the government side, you would have had a stronger case, right? [00:07:15] Speaker 01: I mean, he's weighing a giant pot of evidence. [00:07:19] Speaker 01: So there's evidence against you and evidence in favor of you. [00:07:21] Speaker 01: And he's got to come to a conclusion about it. [00:07:24] Speaker 02: I think that Duffy was a hugely important part of his weighing the evidence. [00:07:31] Speaker 02: And that's inconsistent with Kapusana. [00:07:35] Speaker 01: What does it mean to... Wait, are you suggesting that the special master doesn't have the right to look at epidemiological evidence and give it weight when it is presented? [00:07:46] Speaker 02: No. [00:07:46] Speaker 01: Because that seems to be what you said. [00:07:47] Speaker 02: No, and yes. [00:07:48] Speaker 02: Let me explain that. [00:07:51] Speaker 02: Epidemiologic study, an epidemiologic study that finds a statistically significant association [00:08:01] Speaker 02: between a vaccine and an injury is evidence that there is an association and could be inferred to support causation. [00:08:15] Speaker 02: An epidemiologic study that does not observe a statistically significant association between a vaccine and an injury is not evidence that the vaccine did not cause that injury. [00:08:29] Speaker 02: It's not evidence that there is not an association. [00:08:33] Speaker 02: It's an absence of evidence. [00:08:35] Speaker 01: Hold on. [00:08:35] Speaker 01: Suppose that I did a study and I set out to try to prove that narcolepsy was in fact linked to the flu mist, which is what your causation theory is. [00:08:46] Speaker 01: The flu mist caused your client's narcolepsy. [00:08:49] Speaker 01: So suppose I set out to do a study. [00:08:51] Speaker 01: Now, I'm an honest scientist, right? [00:08:53] Speaker 01: So even though my hope is I'm going to find some sort of correlation in the data between people who get the flu mist and then have narcolepsy, suppose that I find zero incidence and I report it. [00:09:06] Speaker 01: I've done a study of 100,000 people with narcolepsy. [00:09:10] Speaker 01: None of them were given the flu mist. [00:09:11] Speaker 01: I've done a study of 100,000 people who took the flu mist and none of them contracted narcolepsy. [00:09:17] Speaker 01: And so I scientifically report that I'm able to find no correlation between these two. [00:09:23] Speaker 01: Here's all the data I analyzed. [00:09:26] Speaker 01: I did this study over several years. [00:09:28] Speaker 01: I was very careful. [00:09:30] Speaker 01: You're telling me that that can't be evidence that the special master even considers in assessing whether there is a link between the flumist and narcolepsy? [00:09:41] Speaker 02: I'm saying, well, it must be clear here. [00:09:46] Speaker 02: This conversation about why epidemiologic evidence means different things if it finds an association, observes an association, and does not observe an association. [00:10:07] Speaker 01: When a study finds there's no statistically significant increase in narcolepsy by [00:10:12] Speaker 01: virtue of people taking the flu mist, you can undermine the study by challenging the methodology employed, the number of subjects. [00:10:19] Speaker 01: But I don't see how you can say that isn't evidence that the government can present to oppose your theory of causation. [00:10:25] Speaker 01: I don't see how that evidence is irrelevant or deemed improper for the special master to use or rely upon in his decision. [00:10:35] Speaker 02: It's certainly relevant in response to a study that finds that there was an association [00:10:44] Speaker 02: But it isn't real. [00:10:49] Speaker 02: I'm trying to explain this because it's not in the briefs. [00:10:56] Speaker 02: And it's not in the briefs for a reason. [00:10:58] Speaker 02: I think this is a question probably about, it's a scientific question, whether it's appropriate to use epidemiologic evidence as [00:11:13] Speaker 02: evidence that a vaccine did not cause or cannot cause narcolepsy. [00:11:21] Speaker 02: I think that's probably a factual question. [00:11:25] Speaker 01: To be clear, the government never argued nor did the special monster find that it can't prove narcolepsy. [00:11:35] Speaker 01: They simply said you had failed to satisfy your burden of a causation theory in light of all of the evidence. [00:11:42] Speaker 01: I don't believe they used it to disprove any kind of correlation so much as to say, in light of the evidence, you failed to meet your burden. [00:11:54] Speaker 01: Would you like to save your rebuttal time? [00:11:56] Speaker 02: I'm sorry? [00:11:56] Speaker 01: Would you like to save your rebuttal time? [00:11:58] Speaker 01: Yes, I do. [00:11:59] Speaker 01: Yeah, OK. [00:12:01] Speaker 01: Mr. Coleman? [00:12:08] Speaker 04: Thank you, Your Honor. [00:12:08] Speaker 04: May it please the court, Robert Coleman, on behalf of the Respondent Secretary of Health and Human Services. [00:12:13] Speaker 04: As an initial point, I would like to indicate that respondent's position was well summarized by Your Honor Judge Moore, put forward here during the opening argument, and that we second that. [00:12:25] Speaker 04: However, I would just like to draw the court's particular attention to. [00:12:29] Speaker 01: It's always useful to have a judge be seconded by a random attorney, but I don't actually know what you're seconding. [00:12:35] Speaker 01: We had a lot of colloquy over the course of his 14 or 11 minutes or so. [00:12:39] Speaker 01: What is it that I said that you agree with? [00:12:42] Speaker 04: Sure. [00:12:43] Speaker 04: What Respondent agrees with is your summary that is included by the special master on page 28 of his appendix, where he indicates that Petitioner's expert, which is Dr. Steinman, that his theory of the case is undermined by the OMID-1 and OMID-2 studies which were put forward by Petitioner. [00:13:03] Speaker 04: That is that it is not simply the inclusion of the H1N1 virus in every flu vaccine that would give rise to a potential increase in narcolepsy. [00:13:13] Speaker 04: Further, the special master here, although we did consider the epidemiologic evidence that was submitted, particularly the Duffy study, that is permissible under this court's precedent. [00:13:25] Speaker 04: And the special master did go out of his way on page 30 of the appendix to indicate that simply acknowledging an epidemiologic study that shows that there is no particular correlation between a vaccine and injury does not [00:13:41] Speaker 04: completely disprove that connection, but it is simply evidence that should be considered overall. [00:13:51] Speaker 01: What was the evidence that you think is the substantial evidence that supports the special master's fact finding in this instance about a lack of proof of causation? [00:14:00] Speaker 04: The standard of review is simply arbitrary and capricious here, but I believe that [00:14:11] Speaker 01: In respondent's position, there is... What does arbitrary and capricious mean with regard to fact-binding? [00:14:15] Speaker 01: I'm trying to think. [00:14:17] Speaker 04: Well, in this court's precedent, particularly under the Hines decision, the court has found that consideration of the relevant evidence and drawing of plausible inferences and providing a rational basis for his decision would entitle the special master to be affirmed. [00:14:36] Speaker 01: So, then tell me what evidence establishes that his [00:14:39] Speaker 01: fact-finding in this case related to causation is not arbitrary and capricious. [00:14:45] Speaker 04: The special master here considered the epidemiologic evidence that was submitted, but submitted all of the other relevant evidence as well, considered the thorough expert reports that were provided by both sides, those seven total expert reports, and drew plausible inferences there from that meaning that... Did your experts testify that there was [00:15:06] Speaker 01: no correlation, or that no correlation had been identified, or they hadn't seen evidence of a correlation. [00:15:13] Speaker 01: What was the precise nature? [00:15:14] Speaker 01: Because it's hard to prove a negative, right? [00:15:15] Speaker 01: Absolutely. [00:15:16] Speaker 01: So what did your experts actually testify about? [00:15:19] Speaker 04: Our experts indicated in their reports that there was no identified correlation, and that although there does appear to be some correlation in some of the evidence between pandemics, which is not the vaccine at issue here. [00:15:33] Speaker 01: What's the difference between the flu mist and pandemics? [00:15:36] Speaker 04: Pandemrix is a deactivated flu vaccine. [00:15:40] Speaker 01: Here, we're dealing with... That means it's dead? [00:15:42] Speaker 01: Yes, that means it's dead. [00:15:43] Speaker 01: So it's a dead virus versus a live virus. [00:15:46] Speaker 04: Right. [00:15:46] Speaker 04: And here, the Flumis vaccine is a live attenuated virus, so it's weakened. [00:15:51] Speaker 04: So the viral strain is weakened here. [00:15:54] Speaker 04: But there is something... And this is what the OMID 1 and 2 studies seem to indicate, which is that there's something about [00:16:01] Speaker 04: the unique manufacturing process, the deactivation of the virus in that pandemics manufacturing process that appears to give rise to this increased incidence of narcolepsy. [00:16:14] Speaker 01: So the issue here is that- Just out of curiosity, is it permanent or is it temporary? [00:16:19] Speaker 01: The narcolepsy? [00:16:19] Speaker 04: Yeah. [00:16:20] Speaker 04: I'm not sure if it's permanent. [00:16:24] Speaker 04: However, the issue here is that petitioner cannot bridge the gap between [00:16:30] Speaker 04: pandemics and the Flumis vaccine, which is what we're dealing with in this particular instance. [00:16:36] Speaker 03: As I understand Mr. Webb's argument, he's saying that because the special master considered the epidemiologic evidence that was in the record, that in effect places a burden on him to produce a contrary epidemiological study, and that shouldn't be his burden. [00:16:58] Speaker 03: What's wrong with his argument? [00:17:01] Speaker 04: Here, the special master is permitted to consider the epidemiologic evidence, and that's all the special master did here. [00:17:08] Speaker 04: We agree that the special master could not then require petitioner to demonstrate with their own epidemiologic evidence that they're entitled to compensation. [00:17:18] Speaker 03: But if the special master is considering epidemiological evidence submitted by one side, doesn't that sort of place [00:17:26] Speaker 03: a burden on the other side to match or meet that evidence with contrary evidence? [00:17:33] Speaker 04: Perhaps with contrary evidence, but not with epidemiologic evidence. [00:17:36] Speaker 04: And that's the issue here, is that its petitioner should not be required to submit epidemiologic evidence specifically. [00:17:45] Speaker 04: And to that point, on page 32 of the appendix, the special master indicates that [00:17:50] Speaker 04: additional evidence could have been submitted, but he does not identify epidemiologic evidence as something that should be offered to rebut the evidence provided by respondent. [00:18:00] Speaker 04: And again, this really comes down to a burden issue. [00:18:03] Speaker 04: And under the act, it's the petitioner's burden to demonstrate entitlement to compensation. [00:18:09] Speaker 04: And here, the special master found that evidence was simply inadequate to do that. [00:18:15] Speaker 00: In your view, is there something besides [00:18:18] Speaker 00: counter-epidemiologic study that would have been enough for the claimant to satisfy its burden? [00:18:25] Speaker 04: Perhaps. [00:18:26] Speaker 04: And this, I would draw the court's attention back to page 32 of the appendix, where Special Master indicates that a study identifying what antibodies are present in individuals who have been vaccinated with the Flumis vaccine could, for instance, be relevant. [00:18:40] Speaker 04: And that's something that was identified in the AMIC 1 and 2 studies as well as something that would further the scientific understanding of this particular issue as well. [00:18:48] Speaker 04: So that's just an example of something that could theoretically have been used. [00:18:53] Speaker 04: But the primary issue, again, is that the special master did not require that epidemiologic evidence to come from the other side. [00:19:01] Speaker 03: If we all agree that there's no requirement that the claimants submit epidemiological evidence, is there anything that prohibits the special master from considering epidemiological evidence? [00:19:17] Speaker 04: No, there is not. [00:19:19] Speaker 04: And particularly in this court's precedent, the court has indicated that epidemiologic evidence may be considered. [00:19:27] Speaker 04: And that's something that can be weighed by the special master. [00:19:29] Speaker 04: And the weighing of the factual evidence by the special master is not something that this court would typically second guess. [00:19:37] Speaker 04: So that really is within the purview, particularly, of the special master. [00:19:43] Speaker 01: Well, and don't we, well, [00:19:46] Speaker 01: We have several cases saying epidemiological studies are probative and relevant to causation. [00:19:51] Speaker 01: But are any of those cases, like Lampe and those, were any of those epidemiological studies presented by the government as opposed to epidemiological studies presented by the petitioner? [00:20:02] Speaker 04: I don't believe so. [00:20:04] Speaker 04: But I believe that the issue is the same. [00:20:09] Speaker 04: regardless of who submits the evidence. [00:20:12] Speaker 04: Once the evidence is before the special master, the special master is to weigh that evidence and determine what its probative value is. [00:20:19] Speaker 04: And that's something solely within the purview of the special master. [00:20:22] Speaker 04: But in the grant decision, which is one of the decisions regarding the use of epidemiologic evidence, this court indicated that that type of evidence is particularly relevant in an instance, such as this instance, [00:20:38] Speaker 04: where there is no direct evidence of actual causation. [00:20:42] Speaker 04: In such an instance, an epidemiologic study could be particularly informative. [00:20:46] Speaker 04: And here, the special master did consider it and weighed it as probative evidence, but considered it in the grand total of all the other evidence as well. [00:21:01] Speaker 01: It does seem like the special master [00:21:05] Speaker 01: Sure did talk about the Duffy article for an awfully long time. [00:21:09] Speaker 01: It seems to have carried a lot of weight in the decision, at least as demonstrated by the number of pages spent on it in the causation analysis. [00:21:20] Speaker 01: I mean, should we be concerned that a study that didn't show a correlation is being given such weight and [00:21:34] Speaker 01: And maybe we can be concerned, but it doesn't rise to the level of arbitrary and capriciousness, even if we are. [00:21:38] Speaker 01: I don't know. [00:21:39] Speaker 01: But I mean, what are your thoughts about the amount of weight this special master seemed to have given this study? [00:21:50] Speaker 04: It was certainly considered, and I do agree. [00:21:52] Speaker 04: It's difficult to identify exactly how much weight is given to the particular study here. [00:21:59] Speaker 01: Well, he said second. [00:22:01] Speaker 01: As the respondent pointed out, the Duffy epidemiological study stood as very strong evidence for budding an association. [00:22:07] Speaker 01: Seems like he gave it a lot of weight. [00:22:09] Speaker 04: He does. [00:22:10] Speaker 04: And I would direct the court back to the Grant decision that indicates that in an instance where there is a lack of direct evidence regarding actual causation, that an epidemiologic study is to be given particular weight. [00:22:23] Speaker 04: So I don't believe that he is. [00:22:25] Speaker 01: And is there maybe something even unique here [00:22:28] Speaker 01: because the petitioner is relying on evidence of a correlation that is found in something not the same but somewhat related. [00:22:37] Speaker 01: So is this a case where this epidemiological evidence is even more relevant because it's rebutting something asserted by a correlation being asserted by the petitioner for a different drug? [00:22:51] Speaker 04: That's correct. [00:22:52] Speaker 04: I do agree with that. [00:22:53] Speaker 04: And that's something that the special minister addresses [00:22:56] Speaker 04: page 32 of the appendix as well. [00:23:00] Speaker 01: OK, do you have anything further? [00:23:01] Speaker 04: No, I don't. [00:23:02] Speaker 04: Thank you very much. [00:23:03] Speaker 01: Thank you, Mr. Coleman. [00:23:04] Speaker 01: Mr. Webb has his rebuttal time. [00:23:06] Speaker 02: I wanted to first say that the special master acknowledged that a single epidemiologic study can easily miss an association that really is there. [00:23:27] Speaker 02: And that's exactly why Caposano said we can't require epidemiologic evidence, is that epidemiologic evidence, you really can't expect to find epidemiologic evidence in support of many rare injuries. [00:23:46] Speaker 02: And that principle applies equally to the, well, you can't give this kind of almost conclusive weight to the single study [00:23:57] Speaker 02: that, in fact, studied the question of whether live virus vaccines can cause narcolepsy. [00:24:05] Speaker 02: There was only one study. [00:24:07] Speaker 02: It studied only 175,000 persons who received the vaccine. [00:24:14] Speaker 02: When the Monclociere study showed that the background rate of the, I think I got my words mixed up, showed that you needed [00:24:27] Speaker 02: many more subjects to adequately test the hypothesis that the flu vaccine causes narcolepsy, which leads me to the second aspect of my appeal. [00:24:45] Speaker 02: And that's the question of whether it was an abuse of discretion not to hold a hearing in this case, given that this was a new scientific field. [00:24:57] Speaker 02: was a complex scientific theory. [00:24:59] Speaker 02: And it was put forward by a expert who had, in fact, published on this question. [00:25:07] Speaker 02: And one of the critical points in the special master's decision was that he felt that, somehow, the detail is expert opinion, Dr. Steinman's opinion, in this case, [00:25:26] Speaker 02: was somehow inconsistent with the opinions put forth by the authors of the Ahmed II article, which Dr. Steinman was one of them. [00:25:36] Speaker 02: And in the context of a new theory, a complex theory, and a theory put forth by a true expert that could answer questions about whether there's inconsistency between his articles and [00:25:55] Speaker 02: his opinion in the case, it seems inappropriate not to have a hearing. [00:26:03] Speaker 02: Now, the special masters are overwhelmed with cases, it's true. [00:26:07] Speaker 02: But that doesn't explain not giving the petitioners or giving the detioli his day in court when it's apparent from the special master's decision that he did in fact have questions that could have [00:26:25] Speaker 02: It could have been answered by Dr. Steinman. [00:26:29] Speaker 02: In other words, the record in this case was underdeveloped, given the novelness, novelty, and the complexity of the case. [00:26:42] Speaker 02: And so it is the extreme case. [00:26:44] Speaker 02: It is the rare case in which the special master abuses his discretion if he doesn't provide an opportunity for hearing. [00:26:53] Speaker 02: Now, I can understand [00:26:55] Speaker 02: Everyone was reluctant to second-guess the special master on the decision of whether or not to have a hearing, because he clearly does have that power, though it is circumscribed. [00:27:08] Speaker 02: In this case, it was a mistake. [00:27:11] Speaker 02: I guess the question is, how clear a mistake? [00:27:16] Speaker 02: The standard for review on abuse of discretion is hard to measure. [00:27:21] Speaker 02: The real question is whether [00:27:23] Speaker 02: The language I think is most apropos here is whether there was a clear error of judgment. [00:27:29] Speaker 02: Was it the kind of mistake, the kind of action? [00:27:33] Speaker 02: There was clearly a mistake, and I think it was. [00:27:37] Speaker 02: And so I think under the circumstances, you should remand the case to the Special Master for holding evidence during hearing. [00:27:44] Speaker 01: Thank you. [00:27:44] Speaker 01: Thank you, Mr. Webb. [00:27:45] Speaker 01: I thank both counsel for their argument. [00:27:48] Speaker 01: The case is taken under