[00:00:01] Speaker 02: May it please the court, your honors. [00:00:03] Speaker 02: Thank you very much for allowing me the opportunity to come today. [00:00:07] Speaker 02: I represent RD, a minor, who we have asserted was injured by the MMR vaccine. [00:00:12] Speaker 02: I'm not going to go through too much of the facts, as I know you've probably read the briefs, but basically he received the MMR vaccine. [00:00:21] Speaker 02: Within 10 days or so, he developed severe bacterial pneumonia. [00:00:27] Speaker 02: There are not a whole lot of disagreements in this case. [00:00:30] Speaker 02: There are a lot of major issues of agreement. [00:00:32] Speaker 02: The immediate cause of the pneumonia was a bacterial infection. [00:00:37] Speaker 02: Both sides agree, and I think this is critical, that MMR has immunosuppressive effects, including T-cell suppression. [00:00:44] Speaker 02: That's the key issue in this case. [00:00:47] Speaker 02: The respondent conceded that if we suppress or remove a mysis T-cells, that mouse develops pneumococcal infection. [00:00:57] Speaker 02: The third prong, often three, the timing aspect of this case is not in dispute. [00:01:04] Speaker 02: Now I gave a primer on the immune system in my briefs. [00:01:07] Speaker 02: I'll briefly go through it. [00:01:11] Speaker 02: Body consists of the innate system, which has the ability to recognize pathogens and then the adaptive system consisting of T cells and B cells. [00:01:23] Speaker 02: Where we disagree and where we feel [00:01:26] Speaker 02: The legal issue in question is, we feel that T cells play a substantial role in the modulation of pneumococcal colonization and infection. [00:01:36] Speaker 04: How is that a legal issue? [00:01:37] Speaker 04: That's a factual issue, is it not? [00:01:42] Speaker 02: Well, let me rephrase. [00:01:43] Speaker 02: In other words, we believe that the evidence shows that T cells do play that role. [00:01:50] Speaker 04: What the evidence shows is a factual issue. [00:01:54] Speaker 02: Yes, Your Honor. [00:01:54] Speaker 04: You have a position on the facts. [00:01:57] Speaker 04: The government's expert had a different position. [00:01:59] Speaker 04: The special master in the trial court accepted the government's expert's opinion on the facts. [00:02:06] Speaker 04: Isn't that a credibility determination that is virtually unreviewable here? [00:02:11] Speaker 02: Respectfully disagree, your honor, because the question in our minds is the weight of the epidemiological and studies that we set forth. [00:02:24] Speaker 02: shouldn't be shielded by a credibility determination on the experts. [00:02:28] Speaker 02: I believe that's what the respondent is trying to do here. [00:02:31] Speaker 04: They're trying to phrase questions. [00:02:40] Speaker 04: Your side comes in with an expert explaining what the facts show. [00:02:43] Speaker 04: Their side comes in with an expert showing what the facts show. [00:02:47] Speaker 04: And the special master looks at all that evidence and makes a factual determination based on that. [00:02:53] Speaker 04: And generally, that's the role of the special master. [00:02:56] Speaker 04: It's not our job to re-judge that factual determination unless it's completely lacking in support. [00:03:04] Speaker 02: And that's our position. [00:03:05] Speaker 04: It's an implausible... But the problem... [00:03:08] Speaker 04: that the government's expert's opinion is so implausible that it lacks all evidentiary weight. [00:03:18] Speaker 02: In light of the evidence that we presented, Your Honor, respectfully, yes. [00:03:22] Speaker 04: No, it can't be in light of the evidence you presented, because that's asking us to weigh the evidence. [00:03:27] Speaker 04: It has to be that the government's expert is not entitled to any weight whatsoever. [00:03:33] Speaker 04: But isn't the government's expert [00:03:36] Speaker 04: a pediatric immunologist that practices in this field and is qualified to apply on these issues. [00:03:44] Speaker 04: And isn't the problem for you that he just disagrees with your theory of the case? [00:03:51] Speaker 02: He disagreed with our theory of the case. [00:03:53] Speaker 02: He presented no true evidence in support of his position. [00:03:57] Speaker 02: In other words, our point is the Special Master completely abrogated the standards of causation. [00:04:04] Speaker 02: If I come to you and I say, [00:04:07] Speaker 02: You agree that mammals, mice, are in support of our theory, often one, a biologically plausible explanation, meaning that T cells play a critical role. [00:04:18] Speaker 02: And then you start heightening the standard and you say, well, prove it to me in humans. [00:04:23] Speaker 02: Now you've just created another level of certainty. [00:04:28] Speaker 02: I present you human studies that echo the studies of the mice. [00:04:35] Speaker 02: Not only on top of that, I give you [00:04:37] Speaker 02: evidence from the National Institute of Health supporting my theory. [00:04:41] Speaker 04: I give you a company that is actually trying to develop... I get it, but these are all arguments that are directed to the special master about the evidence you're presenting him. [00:04:51] Speaker 04: He rejected it and instead relied on the government's expert who explained, I think with fairly sufficient detail, why he disagreed that this would have caused the specific infection. [00:05:07] Speaker 04: If we accept, let me put it in another way. [00:05:09] Speaker 04: If we accept the government's experts evidence as true, then aren't we just in a weighing situation where you have what you cite as an abundance of evidence on your side. [00:05:24] Speaker 04: They have evidence on the other side. [00:05:27] Speaker 04: How are we as an appellate court designed to agree with you on a factual conclusion [00:05:35] Speaker 04: unless the government's expert is entitled to no weight whatsoever. [00:05:42] Speaker 02: Well, my response to that is, if we look at the case law that's come out on this issue, Andro said credibility determinations are not to evaluate whether an expert witnesses medical theory supported by the weight of the epidemiological evidence. [00:05:59] Speaker 02: Meaning set aside the credibility determinations, and look at the epidemiological evidence. [00:06:05] Speaker 02: Our point is he shielded it. [00:06:07] Speaker 02: He basically said, right along the lines of what you're saying, shielded from appellate review by looking at credibility determinations of the experts without looking at underlying weight of the epidemiological evidence. [00:06:21] Speaker 02: Case after case that has been cited in this court says that's the wrong way to approach it, but that's exactly what he did. [00:06:28] Speaker 04: I don't understand what you're saying. [00:06:31] Speaker 04: He didn't disregard your evidence. [00:06:33] Speaker 04: He weighed it. [00:06:34] Speaker 04: against the government's evidence and determine that the government's evidence was more correct. [00:06:42] Speaker 04: Can you point to me in his decision where he excluded your evidence rather than just found it insufficient? [00:06:53] Speaker 02: I can't point out where he actually excluded the evidence. [00:06:56] Speaker 02: What I can say is that the conclusions that he came to [00:07:02] Speaker 02: based on the weight of the evidence was so implausible. [00:07:05] Speaker 02: It violated the standards of often one. [00:07:08] Speaker 03: Can you explain specifically what was implausible? [00:07:11] Speaker 03: I mean, for example, let's take the human studies. [00:07:14] Speaker 03: Sure. [00:07:14] Speaker 03: Isn't it? [00:07:14] Speaker 03: I understand the special master found those at best to be mixed or inconclusive because that phase two trial didn't really show a connection between T cells and pneumonia. [00:07:30] Speaker 03: And then on the going to the mice studies, [00:07:33] Speaker 03: There's some reference on scientific evidence that tells us we can't automatically take experimental results from mice and extrapolate that to humans. [00:07:48] Speaker 03: And there is some science that suggests that mice respond to pneumonia bacteria differently than humans do. [00:07:56] Speaker 03: So at best, the mice studies, the human studies, [00:08:02] Speaker 03: are muddled and so I don't understand given that the government expert appears to be better qualified here than your expert who is not an immunologist, why aren't we just stuck as a reviewing court to give deference to what seems like a [00:08:28] Speaker 03: a muddled record, not something that I think we could regard as some kind of overwhelming record in your favor that would make any contrary view implausible. [00:08:39] Speaker 03: What is the evidence that the special master relied on to conclude this record isn't conclusive? [00:08:49] Speaker 03: Where did the special master go wrong? [00:08:52] Speaker 02: I thought he went wrong in, number one, [00:08:55] Speaker 02: Taking a company that was trying to develop a T cell based vaccine and demanding that they actually reach statistical significance. [00:09:04] Speaker 02: That to me signals a level of scientific certainty that doesn't belong in the vaccine program. [00:09:11] Speaker 02: And I go back to what Palak said. [00:09:13] Speaker 02: Palak said that when you have a bunch of researchers that are actively investigating an idea and they're trying to develop it, the Vaccine Act requires no more. [00:09:22] Speaker 02: In that particular case, he wanted a vaccine that was serotype-independent that would have eradicated pneumococcus throughout the world. [00:09:30] Speaker 02: I respectfully disagree with the assessment that it's muddled. [00:09:34] Speaker 02: There is no proof that you can't extrapolate the findings of mouse studies to humans. [00:09:39] Speaker 02: Their proof revolved around fungal infections. [00:09:43] Speaker 02: And then how do you juxtapose that with the fact that you have human studies [00:09:49] Speaker 02: that actually echo the very findings of the mouse studies. [00:09:54] Speaker 02: In other words, we're creating a situation where no petitioner can succeed under these standards. [00:10:02] Speaker 02: We have mice studies that prove our case, that they conceded prove our case. [00:10:08] Speaker 02: We have human studies, epidemiological studies, and yet we're denied because he believes one expert over the other. [00:10:17] Speaker 02: In other words, we're critiquing the messenger, not the message. [00:10:21] Speaker 02: And that's a problem. [00:10:23] Speaker 02: In other words, if a special master all he has to do is say, well, I believe this expert, he comes off better than your expert. [00:10:32] Speaker 02: But the government's expert doesn't have any contrary epidemiological evidence. [00:10:38] Speaker 02: Doesn't have any contrary human studies. [00:10:40] Speaker 02: Just simply voices his dissatisfaction and his contrary opinion. [00:10:47] Speaker 02: Whereas we have an expert that perhaps isn't as well-versed. [00:10:50] Speaker 02: I understand that point. [00:10:52] Speaker 02: But he has the epidemiological evidence. [00:10:56] Speaker 02: Then, in a way, appeals here are futile, because it simply comes down to who has the better well-received expert. [00:11:04] Speaker 00: And I think it's difficult because pneumonia is not on the table as a table injury for these vaccines. [00:11:13] Speaker 00: But let me ask you a question that I'm also going to ask the government. [00:11:17] Speaker 00: Because one of the things that struck me was that the special master seemed to take the blanket position that you can't extrapolate from mouse studies to humans. [00:11:30] Speaker 00: And that's what the special master said. [00:11:33] Speaker 00: And I think that's notoriously incorrect. [00:11:38] Speaker 00: I didn't see a challenge on a deliberate basis in terms of the threshold [00:11:47] Speaker 00: of admissibility and the mice studies which were discarded by the special master seemed to be quite significant when in fact this sequence of events with a number of days intervening did not satisfy the vaccine table of injury. [00:12:10] Speaker 00: Where does that take us? [00:12:13] Speaker 02: I'm sorry, Your Honor, I'm not sure I understand your question. [00:12:16] Speaker 00: In terms of the Daubert challenges to... Was there a Daubert challenge to the special master's treatment of the mouse studies? [00:12:25] Speaker 02: I don't recall if we made a formal Daubert challenge on that. [00:12:30] Speaker 02: He treated the mouse studies, he disregarded the mouse studies. [00:12:34] Speaker 00: To say they can't be extrapolated to humans. [00:12:36] Speaker 02: Correct. [00:12:37] Speaker 00: Not that the studies themselves were flawed, but as to how [00:12:43] Speaker 00: powerful an impact, they certainly contributed, did they not, to the conclusion that there was not causation. [00:12:53] Speaker 02: Your Honor, for the mouse studies, the respondent conceded and their expert conceded that if we suppress a mice's T cells, they're prone to pneumococcal infection. [00:13:03] Speaker 02: So from that statement alone, my understanding is he accepted the findings of the mice. [00:13:09] Speaker 02: He just refused to extrapolate them to humans. [00:13:12] Speaker 00: Yes, he said they didn't apply to humans. [00:13:14] Speaker 02: That's correct, Your Honor. [00:13:16] Speaker 04: And our point is... Isn't that what the government's expert also said? [00:13:19] Speaker 04: That these specific studies weren't automatically... could be extrapolated? [00:13:25] Speaker 00: Not automatically. [00:13:26] Speaker 00: It wasn't a stronger statement than that. [00:13:29] Speaker 00: I was given that impression. [00:13:32] Speaker 02: He said mouse immunology is not human immunology. [00:13:35] Speaker 04: Did you make a Daubert challenge to their expert? [00:13:38] Speaker 04: Did you get his report in advance? [00:13:42] Speaker 02: I got his report within days of the hearing, yes, your honor. [00:13:50] Speaker 02: I did not make a formal, dauber challenge to the mouse immunology is not human immunology. [00:13:56] Speaker 02: I attacked it with our human studies. [00:14:00] Speaker 02: I didn't make a formal... Go ahead. [00:14:02] Speaker 04: Well, I'm just curious. [00:14:03] Speaker 04: I mean, it seems to me that for you to prevail, you have to demonstrate that the government's expert's opinion lacks all weight [00:14:12] Speaker 04: If that's the case, then you should have made a Daubert motion to exclude his testimony as not either relevant or sufficiently explained or not based upon sufficient evidence or the like. [00:14:25] Speaker 04: But you complain about the special master accepting the government's expert, but if he wasn't challenged, if he was accepted as an expert, then what he says is evidence supporting the decision. [00:14:40] Speaker 04: Is it not? [00:14:43] Speaker 02: Didn't make a formal Daubert challenge. [00:14:45] Speaker 02: I challenged the conclusions of, of him based on his medical literature and, uh, and lack of actual specific reference to pneumococcus. [00:14:57] Speaker 02: I look, I, in my briefs, I explicitly and in arguments, all his literature that he was trying to use was based on fungal infections. [00:15:07] Speaker 02: It's not one mention of pneumococcus in there. [00:15:10] Speaker 02: And it doesn't square with the human studies on Pneumococcus. [00:15:13] Speaker 03: Can you tell me where, in the special master's opinion, the special master said mouse studies are completely and totally irrelevant when it comes to understanding human biology. [00:15:29] Speaker 03: I mean, at age 22, 23, I see the special master saying, well, [00:15:39] Speaker 03: According to the reference on manual of scientific evidence, it's important for someone relying on mice studies to explain what the similarity is in biology between humans and mice. [00:15:54] Speaker 03: And in this particular instance, Dr. Lashkin did not make that kind of comparison, whereas Dr. Romberg, in comparison, explained how mice differ from people and how [00:16:09] Speaker 03: that mice respond to pneumonia bacteria differently from how humans respond to pneumonia bacteria. [00:16:24] Speaker 03: There's some kind of ill 7F gene that one mammal has that the other doesn't. [00:16:34] Speaker 03: Do you understand what I'm talking about here? [00:16:36] Speaker 03: I don't quite see anywhere here [00:16:38] Speaker 03: where the special master is saying, my studies are just off the table. [00:16:44] Speaker 03: Instead, the special master appears to be considering what each expert said and did not say on this question. [00:16:53] Speaker 02: And I think our response to that was that is an impermissible heightening of the burden of the standard of causation. [00:17:01] Speaker 02: Every researcher, just from a common sense standpoint, uses mice in their experiments. [00:17:06] Speaker 02: And even the government conceded that we wouldn't be doing these experiments on mice if we couldn't extrapolate the conclusions to humans. [00:17:17] Speaker 00: He said, without some reliable showing that an extrapolation from mice to people is appropriate, the studies based upon mice are not useful. [00:17:27] Speaker 00: And based on that statement certainly leaves the impression that relies was not placed on the mouse studies. [00:17:36] Speaker 00: which I think supports what you're trying to tell us. [00:17:41] Speaker 00: There are other difficulties, 10 days is perhaps a long time, if in fact it was a consequence of the vaccination. [00:17:55] Speaker 02: Our argument has been from the beginning that raising the standards and taking mammalian studies, mice studies, and saying now we have to prove that it actually relates to humans [00:18:06] Speaker 02: is an expansion of what Congress intended under the Vaccine Act. [00:18:10] Speaker 02: Now, it's completely unrealistic. [00:18:14] Speaker 03: Just a last question. [00:18:15] Speaker 03: This is the second MMR injection that R.D. [00:18:20] Speaker 03: received, right? [00:18:22] Speaker 03: There was an earlier vaccination? [00:18:26] Speaker 03: Yes, Your Honor. [00:18:29] Speaker 03: Back when he was two years old. [00:18:30] Speaker 03: Did he suffer from any kind of rash or negative reaction after the first [00:18:36] Speaker 02: Not within a medically acceptable time frame. [00:18:40] Speaker 02: He had a rash, but when we investigated it, it was too far away from the initial MMR vaccination. [00:18:48] Speaker 02: Now this was when he was two. [00:18:50] Speaker 02: Five years later, he gets the second MMR. [00:18:55] Speaker 00: Okay, let's hear from the government. [00:18:57] Speaker 00: We'll save your rebuttal time. [00:19:06] Speaker 01: Good morning. [00:19:07] Speaker 01: May it please the court. [00:19:08] Speaker 01: I'd like to start with just a correction to something that was just discussed. [00:19:12] Speaker 01: The first MMR vaccine was actually given when RD was one year old and the rash that he allegedly suffered or at the beginning of the case that petitioner said he suffered occurred about one year after that. [00:19:23] Speaker 01: There was absolutely no relationship between the rash that RD purportedly suffered after the MMR vaccine and the initial vaccine. [00:19:32] Speaker 01: Your Honor, the critical question presented in this case was one of immunology, specifically how the human immune system responds when confronted with pneumococcal bacteria. [00:19:42] Speaker 01: After carefully considering the entire record, the special master determined that Petitioner's proper theory was not grounded in reliable science. [00:19:50] Speaker 01: In reaching this conclusion, the special master relied on well settled immunological principles, medical literature, and the testimony of Dr. Neil Romberg, a well credentialed [00:20:00] Speaker 01: board-certified pediatric immunologist. [00:20:05] Speaker 01: I appreciated your comment and your question, Judge Hughes, because the legal question here is whether or not the special master erred. [00:20:13] Speaker 01: It is not whether or not the T cells play a substantive role in the body's defenses against pneumococcus. [00:20:19] Speaker 01: And I think the special master's decision makes very clear that he considered all of the evidence and properly determined that there is no such connection. [00:20:30] Speaker 00: It does appear that there may very well have been a significant error in the path drawing the conclusion from the events. [00:20:44] Speaker 00: And there certainly is a very unusual sequence of events of this serious consequence just a few days after the vaccination. [00:20:56] Speaker 00: So we know that there are presumptions [00:21:01] Speaker 00: And even though pneumonia is, after that period of time, isn't on the table, which would automatically presume causation, where does one draw the line? [00:21:17] Speaker 01: Well, Your Honor, as you indicate, the pneumonia is not a table injury. [00:21:23] Speaker 01: And the simple fact that the child developed pneumonia a few days after getting the MMR vaccine [00:21:30] Speaker 01: does not legally or scientifically show that there is a causal connection between the two. [00:21:35] Speaker 01: There are millions... No one says it's impossible. [00:21:38] Speaker 00: Is that right? [00:21:39] Speaker 01: We're looking at likelihood? [00:21:41] Speaker 01: Well, this is an off-table case. [00:21:42] Speaker 01: It is petitioner's burden to establish by preponderant evidence that the vaccine can and did contribute to the child's pneumonia. [00:21:51] Speaker 01: There are a million cases of pneumonia that occur every year. [00:21:55] Speaker 01: There has not been even a single case study that shows that even [00:21:59] Speaker 01: suggests that there could be a causal connection. [00:22:02] Speaker 01: So sometimes things happen within temporal proximity to a vaccine or taking of a drug, but that does not demonstrate in any way that there is a causal connection. [00:22:14] Speaker 01: And as I indicated, this is an off-table case. [00:22:18] Speaker 01: It is petitioner's burden, not respondent's burden, to establish a causal relationship. [00:22:26] Speaker 01: It's very important in this case that petitioners did not present the testimony of an immunologist, nor did they file an expert report from an immunologist. [00:22:35] Speaker 01: Petitioners here are trying to overturn about 100 years of well-established immunology, and they didn't present an immunologist to do so, and I think that's telling, because we have a very well-credentialed immunologist, Dr. Neil Romberg, who comes from the Children's Hospital of Philadelphia, a premier institution, and he said, [00:22:56] Speaker 01: The theory, it would be great if it worked, but it doesn't work. [00:23:00] Speaker 01: It does not work in humans, and that is what we are talking about. [00:23:03] Speaker 01: I know you have some concern, Judge Newman, about the mice and the extrapolation of the mice studies. [00:23:10] Speaker 01: I think Dr. Romberg, if you look at the transcript, did a pretty good job explaining why you can't extrapolate regarding this particular bacteria and this particular type of T cell. [00:23:26] Speaker 01: If the human immune system and the mouse's immune system were identical, there would never be a need to do experiments on humans. [00:23:35] Speaker 01: And we all know that, unfortunately, we have to do experiments on humans. [00:23:40] Speaker 01: Dr. Romberg pointed out that cancer was cured 20 years ago in mice. [00:23:44] Speaker 01: It has not, unfortunately, been cured in humans. [00:23:47] Speaker 01: And why is that? [00:23:48] Speaker 01: It's because the immunology is different. [00:23:50] Speaker 01: Mice serve their purpose. [00:23:51] Speaker 01: A lot of the animals that are studied serve their purposes because there are similarities, but there are significant differences, and this happens to be one of them, that you cannot take the particular type of T cell that is suppressed. [00:24:05] Speaker 01: It is not all T cells. [00:24:06] Speaker 01: It is just TH1, one particular type that is suppressed in temporal proximity to MMR and extrapolate that to [00:24:15] Speaker 01: all types of T cells and all types of animals, humans and mice, being equated in some fashion. [00:24:26] Speaker 01: Physicians also indicate that the special master improperly raised their burden of proof. [00:24:31] Speaker 01: As we just discussed, this is an off-table case. [00:24:34] Speaker 01: It is their burden to establish, not ours. [00:24:37] Speaker 01: The theory proposed by Dr. Lokshin was not just speculative. [00:24:41] Speaker 01: It is unsupported by what is known about human immunology. [00:24:44] Speaker 01: And it is unsupported by medical literature. [00:24:47] Speaker 01: And in fact, this theory has been tested. [00:24:49] Speaker 01: This is a rarity in our program. [00:24:51] Speaker 01: We actually have a test that was done bringing that theory into play. [00:24:55] Speaker 01: And that was the vaccine. [00:24:58] Speaker 01: And the vaccine failed. [00:24:59] Speaker 01: They stopped the study because it didn't work. [00:25:03] Speaker 01: So I think when you look at Daubert and the scientific reliability that Daubert is trying to bring out, you have that here. [00:25:13] Speaker 01: It failed. [00:25:24] Speaker 01: I'd just like to briefly discuss Altenprong 2, to the extent you have concerns about Altenprong 1, and there being error there. [00:25:32] Speaker 01: As you know, Altenprong 2 requires that petitioners show a logical sequence of cause and effect between the vaccine and the injury. [00:25:40] Speaker 01: And they must show that the vaccine was not only the but for cause of the injury, but a substantial factor in bringing it about. [00:25:46] Speaker 01: Dr. Lokshin, on two occasions, when asked, [00:25:49] Speaker 01: whether or not the vaccine was a substantial factor in the development of RD's pneumonia said he didn't know. [00:25:55] Speaker 01: And I can give you those sites. [00:25:57] Speaker 01: That's appendix at 718 and the appendix at 686. [00:26:01] Speaker 01: There's no treating physician support for petitioner's claim. [00:26:04] Speaker 01: There is no challenge re-challenge. [00:26:07] Speaker 01: The simple fact is that RD encountered an antigen that he had not before, and he was unable to combat it. [00:26:14] Speaker 01: It was sad. [00:26:15] Speaker 01: We're very happy to hear that he has pretty much recovered. [00:26:19] Speaker 01: But the vaccine did not have anything to do with it other than the fact that it was given in temporal proximity to his development of this condition. [00:26:34] Speaker 01: The special master's decision clearly demonstrates that he thoroughly evaluated the entire record and considered all of the relevant evidence and his conclusion that petitioners did not meet their burden of demonstrating the preponderant evidence the prima facie case is rational, reasonable, and amply supported by the record. [00:26:49] Speaker 01: The special master's determination must be afforded substantial deference, and we respectfully request that this court affirm the well-reasoned decisions of the special master in the Court of Federal Claims. [00:27:00] Speaker 00: Thank you. [00:27:02] Speaker 00: Thank you, Ms. [00:27:03] Speaker 00: Perelman. [00:27:10] Speaker 00: Mr. Bezelos. [00:27:12] Speaker 02: Yes, Your Honor. [00:27:12] Speaker 02: I just want to touch on a couple of comments. [00:27:16] Speaker 02: We actually do have a case study. [00:27:18] Speaker 02: epidemiological evidence of increased human invasive pneumococcal disease in children post MMR. [00:27:26] Speaker 02: And I did refer that to my brief where they found that the relative incidence of pneumonia post MMR in the first 30 days was threefold the increase. [00:27:39] Speaker 02: And again, I don't believe the special master took that into account. [00:27:42] Speaker 02: In the two months post MMR, we had a sixfold increase in [00:27:48] Speaker 02: invasive pneumococcal disease post-MMR. [00:27:51] Speaker 02: So I disagree. [00:27:53] Speaker 02: This idea that, and I brought it up in my evidence, and this is what I'm talking about, raising the level of proof to a level of certainty. [00:28:12] Speaker 02: We have a vaccine company putting in millions of dollars into a T cell-based vaccine. [00:28:18] Speaker 02: Now we have respondent arguing, well, you didn't achieve it. [00:28:22] Speaker 02: If you achieve a T cell based vaccine that is serotype independent, you would win the Nobel Prize. [00:28:29] Speaker 02: Because now you don't have to have pneumococcal vaccines that depend on any combination of the 90 or so serotypes that are out there. [00:28:41] Speaker 02: The whole point of bringing up this research was to show that we are actively working on a T cell based vaccine. [00:28:48] Speaker 02: and to show support for our theory. [00:28:51] Speaker 02: Just because we haven't come up with the proper cocktail to actually be able to manipulate T cells doesn't mean that we haven't proven ALTN1. [00:29:01] Speaker 02: ALTN1 is a biologically plausible theory of causation that is reasonably persuasive and probable. [00:29:13] Speaker 02: The fact that we actually have companies working on a human T cell based vaccine [00:29:18] Speaker 02: tells us all we need to know. [00:29:20] Speaker 02: Do we need them to actually succeed? [00:29:22] Speaker 02: I think not. [00:29:29] Speaker 02: I'd like to talk about Alpha and Prong 2, because here's the ultimate problem here. [00:29:35] Speaker 02: We went through great lengths to show the legal cause and effect of the vaccination. [00:29:42] Speaker 02: And what we found is we have a young man who has [00:29:46] Speaker 02: multiple levels of low antibodies to many stereotypes, but he doesn't get sick. [00:29:53] Speaker 02: That directly contradicts the government's theory that low levels of antibodies is what caused his sickness. [00:30:02] Speaker 02: He has never developed pneumonia other than for T-cell suppression of the MMR. [00:30:10] Speaker 02: I want to go back to you, Judge Hughes, and what you had said. [00:30:15] Speaker 02: There's multiple case law that sort of discusses this dichotomy between how we view experts and the underlying medical evidence. [00:30:26] Speaker 02: Now, the burden of proof under both Andro and Capizzano said that can be sufficient even without conclusive medical literature, epidemiological studies, or acceptance in the scientific community. [00:30:39] Speaker 02: But we presented all that. [00:30:41] Speaker 02: We may not have had the best messenger for it. [00:30:44] Speaker 02: But we had epidemiological studies. [00:30:47] Speaker 02: We had conclusive medical literature. [00:30:50] Speaker 02: Andrew said, credibility determinations are not to evaluate whether an expert witnesses medical theory is supported by the weight of epidemiological evidence. [00:31:05] Speaker 02: Perhaps it was a tactical error on my part to bring in someone who was not board certified in immunology. [00:31:11] Speaker 02: And I acknowledge that, but this expert [00:31:13] Speaker 02: did have experience in treating pediatric pneumococcal patients. [00:31:19] Speaker 02: He was qualified by the special master to discuss immunological concepts. [00:31:25] Speaker 02: The government has seized on the fact that he's not a board certified immunologist. [00:31:29] Speaker 02: And what they want you to do is sort of set aside the underlying theories and literature that he presented. [00:31:37] Speaker 02: That should stand on its own, regardless of the messenger that presents it. [00:31:42] Speaker 02: Otherwise, as I said, [00:31:43] Speaker 02: The appeals here are futile. [00:31:45] Speaker 02: It just becomes a subjective belief on which expert sounds better or is more credible. [00:31:51] Speaker 00: So your argument, what's needed, we needn't go any farther, and I don't think the government did, than more likely than not, more likely than not there was causation and their position is more likely than not there was not. [00:32:09] Speaker 00: But at what stage and setting aside [00:32:12] Speaker 00: The question that is extremely difficult is to how deeply this court is authorized to weigh the facts. [00:32:23] Speaker 00: Is your position that there should be another review on the more likely and not basis, an issue that I think we may very well not be authorized to decide on this appeal? [00:32:40] Speaker 02: I certainly understand the concern. [00:32:43] Speaker 02: But I would say let's look at the Campbell case. [00:32:46] Speaker 02: The Campbell case said that it was error as a matter of logic to find the medical literature weighs against causation if the articles reasonably stand for the proposition that the vaccine can cause the particular injury. [00:33:00] Speaker 02: And that's part of what I'm arguing today is that it is an error as a matter of logic to take 23 mice and human studies with funding from the National Institute of Health with proof that a vaccine company [00:33:12] Speaker 02: is using the theory and then say that it cannot stand for the proposition that the MMR vaccine caused suppression of the T cells, which led to the pneumonia. [00:33:23] Speaker 02: I mean, I certainly am not asking you to try to reweight everything. [00:33:29] Speaker 02: But I am saying, as a matter of logic and as a matter of what the standards of causation are, it is error. [00:33:41] Speaker 02: said it is an error to apply a standard of scientific certainty to medical literature and epidemiological evidence. [00:33:50] Speaker 02: And that's where I go back to that company that was developing a vaccine based on the very premise that we were arguing today in Alton 1. [00:33:58] Speaker 02: He wanted the vaccine to succeed. [00:34:02] Speaker 02: That boosts it to a level of scientific certainty. [00:34:06] Speaker 02: And I certainly think that trying to extrapolate my studies to humans [00:34:10] Speaker 02: is now going well beyond. [00:34:13] Speaker 02: Just for a moment, think about the implications it would have on the vaccine program. [00:34:18] Speaker 02: Now, every petitioner would have to bring in a biologist to take animal studies and extrapolate them to humans. [00:34:25] Speaker 02: I would have to figure out a way. [00:34:27] Speaker 02: How do I do it? [00:34:28] Speaker 02: Because in overwhelming majority of cases, we don't have human studies. [00:34:33] Speaker 02: It just doesn't happen. [00:34:34] Speaker 00: But the overwhelming majority of cases are table injuries. [00:34:39] Speaker 00: And the real problem is when these lines were drawn, how do we penetrate the fact that there was not the statutory presumption? [00:34:54] Speaker 02: It is not a table injury. [00:34:56] Speaker 02: I don't know though that the standards become heightened, whether it's a table injury or an off-table injury. [00:35:01] Speaker 04: I'm really confused by what you say, standards being heightened. [00:35:04] Speaker 04: Your evidence was presented. [00:35:06] Speaker 04: You think it provided a plausible case. [00:35:09] Speaker 04: Are you saying once you provide a plausible case, the government isn't allowed to rebut that at all? [00:35:15] Speaker 04: I mean, what happened is you presented a bunch of studies that showed what they showed. [00:35:19] Speaker 04: The government came in with its evidence and said it shows something else. [00:35:24] Speaker 04: And under the regular standard of proof, the special master says, I make my factual findings based upon the government's evidence. [00:35:31] Speaker 04: That's not a heightened standard. [00:35:33] Speaker 04: That's just disagreeing with your evidence. [00:35:37] Speaker 04: I mean, there are instances in various aspects of the law where if a plaintiff or a petitioner makes a prima facie case, then the government either can't respond or has to overcome that response by a higher standard of evidence. [00:35:55] Speaker 04: But that's not the case here, right? [00:35:57] Speaker 04: It is both sides present their factual case and the special master makes a factual conclusion. [00:36:06] Speaker 02: Well, I don't think the burden never shifted in this case. [00:36:09] Speaker 04: The burden has to shift. [00:36:11] Speaker 04: I mean, the burden is for you to provide a factual basis for this theory. [00:36:17] Speaker 04: And you presented evidence that said, here's our basis. [00:36:21] Speaker 04: The government presented rebuttal evidence that said, no, that factual theory is incorrect. [00:36:27] Speaker 02: I would respectfully disagree that they provided any evidence. [00:36:31] Speaker 02: They put their expert on the stand. [00:36:34] Speaker 04: But that's evidence. [00:36:36] Speaker 04: Isn't it? [00:36:38] Speaker 04: Well, unless you've got the guy excluded, then it's evidence. [00:36:42] Speaker 04: He gets up there and testifies, this is what I know based upon my experience, my review of the literature, my review of your evidence, and here are my conclusions. [00:36:58] Speaker 02: Well, I believe that it was error to rule against us because I believe that the medical articles [00:37:05] Speaker 02: reasonably stand for the proposition that the vaccine caused the injury. [00:37:09] Speaker 02: I don't think any lay person looking at the conclusions of these articles would come away with any other conclusion. [00:37:15] Speaker 04: How can lay persons actually read these articles and come away with any conclusion when we're not experienced or have any kind of knowledge in this specific type of immunology? [00:37:26] Speaker 04: That's what expert witnesses are for is to explain this evidence to us. [00:37:33] Speaker 02: It is complex immunology to a certain extent, but the conclusions are fairly straightforward in the articles. [00:37:39] Speaker 04: I highlight... If they're fairly straightforward, then you would assume that the government's board-certified immunologist, who has expertise in this area, would come to the same conclusion as you. [00:37:51] Speaker 04: But he did not. [00:37:54] Speaker 02: He's an expert for the government. [00:37:55] Speaker 02: He's there to attack our conclusions. [00:38:01] Speaker 04: And again, if he wasn't credible or reliable or had no expertise to provide an opinion, you should have moved to have him excluded. [00:38:11] Speaker 04: Absent that, the fact that he's an expert for the government doesn't detract from his overall weight of his testimony. [00:38:22] Speaker 04: I have your argument. [00:38:23] Speaker 04: I mean, I don't think we need to debate this point anymore. [00:38:26] Speaker 00: We will give it careful thought. [00:38:30] Speaker 00: Thank you both. [00:38:31] Speaker 00: The case is taken under submission. [00:38:33] Speaker 04: Appreciate it.