[00:00:00] Speaker 00: 15-5072 Moriarty versus HHS. [00:00:05] Speaker 00: Mr. Shoemaker, please proceed. [00:00:07] Speaker 01: Good morning, Your Honor. [00:00:07] Speaker 01: May it please the Court. [00:00:08] Speaker 01: My name is Clifford Shoemaker, and I'm representing Eilise Moriarty, the petitioner appellant in this case, or Father Stephen Moriarty, who's in the Court. [00:00:17] Speaker 01: And I would like to tell you a little bit about Eilise. [00:00:21] Speaker 01: Eilise developed an encephalopathy characterized by seizures, epileptic encephalopathy, [00:00:28] Speaker 01: that started five days after her second MMR vaccination. [00:00:33] Speaker 01: All of those facts are significant. [00:00:35] Speaker 01: Unlike the Cone case, which some of the members of this court have heard before, this case does not involve any issue of timing. [00:00:43] Speaker 01: As a matter of fact, the special master points out that the petitioners met prong three of all of them. [00:00:49] Speaker 01: The timing in this case was totally appropriate for an immune-mediated reaction after her second MMR vaccination. [00:00:57] Speaker 01: That evidence alone is strong evidence that this was an immune-mediated injury. [00:01:02] Speaker 01: There is no evidence in this case presented by anyone that there was any alternate cause. [00:01:08] Speaker 01: Treating doctors in this case even discussed the fact that they felt that the vaccination was the cause. [00:01:14] Speaker 00: Well, did they discuss the fact that they thought the vaccination was the cause? [00:01:18] Speaker 00: Or in three places in three different medical records in the background section, [00:01:22] Speaker 00: Did they discuss that they had been told that the vaccination was the cause? [00:01:27] Speaker 00: I didn't see in those records an independent determination by those doctors in the form of an opinion that there was actual causation, but rather a recognition that someone had told them in the background when they were taking the medical information that it had been caused by. [00:01:42] Speaker 01: That's certainly a possibility. [00:01:44] Speaker 01: There's no evidence in the record that their statements are based on the mother's testimony, other than the fact that one of the statements says that the team [00:01:53] Speaker 01: Now the team is referring to the team of doctors. [00:01:55] Speaker 00: But if you're saying it's possible that what the government says about it being in the background section, that it was reported to them and not an independent opinion, the problem you have in this case is you have a very high hurdle to overcome. [00:02:10] Speaker 00: Because as sympathetic as I might be to this young girl and her family's plight, I don't get to review this case de novo. [00:02:16] Speaker 00: I have to look for substantial evidence and arbitrary capriciousness at the decision below. [00:02:22] Speaker 00: And if you're admitting to me that the evidence could possibly be construed exactly the way the government says it should be and the way the special master already found it, then it's really hard for me on appeal to do anything but affirm that. [00:02:34] Speaker 01: I understand, Your Honor. [00:02:35] Speaker 01: And let me go to an issue that's not a fact issue, the issue of law. [00:02:39] Speaker 01: In this case, the special master dealt with the medical literature by talking about reliability of Dr. Shafir's testimony. [00:02:49] Speaker 01: Incidentally, Dr. Shafrir has testified for the government. [00:02:52] Speaker 01: He's testified as a respondent's witness in cases. [00:02:55] Speaker 01: He's testified for petitioners in cases. [00:02:57] Speaker 01: Dr. Shafrir is clearly more qualified than Dr. McDonald despite what the special master said. [00:03:02] Speaker 01: Dr. McDonald had never treated a case of epileptic encephalopathy. [00:03:06] Speaker 01: Dr. Shafrir has treated several. [00:03:08] Speaker 01: And Dr. Shafrir talked a lot in the, he discussed a lot of the progression of the disease in the case because that was important to his opinion. [00:03:16] Speaker 01: That's this logical sequence of cause and effect. [00:03:19] Speaker 01: It was very important to his opinion because it demonstrated what you would expect to see with an immune-mediated encephalopathy from an MMR vaccination. [00:03:28] Speaker 01: Now the special master not only said that plausible medical theory or possible medical theory is not adequate, he said you'd have to have a probable medical theory. [00:03:38] Speaker 01: Probability is established in these cases by satisfying the three prongs of all. [00:03:42] Speaker 01: It's not each one has to be probable, it's that the [00:03:48] Speaker 01: The medical theory has to be plausible. [00:03:51] Speaker 01: Granted, the government's experts said it was possible and may be plausible possible. [00:03:56] Speaker 01: We're not going to get into that semantics argument, but I think it's at least evidence that supports our case. [00:04:01] Speaker 01: Dr. Shafir testified that there are three ways that the MMR vaccination could have caused this encephalopathy. [00:04:10] Speaker 01: One would be that it awakened a dormant virus. [00:04:14] Speaker 01: Two would be a direct viral invasion. [00:04:16] Speaker 01: And three would be an immune-mediated event, or what we call an autoimmune event. [00:04:21] Speaker 01: Many, if not most, of the cases in the vaccine program involve autoimmunity. [00:04:25] Speaker 01: That is, where the body's immune system becomes misdirected and attacks self instead of the antigens and the vaccine that it's supposed to attack. [00:04:34] Speaker 01: These reactions are very, very rare. [00:04:37] Speaker 01: Fortunately, they're very rare. [00:04:39] Speaker 01: We know that, for instance, measles and mumps and rubella can cause post-vaccinations or post-viral encephalopathy. [00:04:47] Speaker 01: And before we had the MMR vaccine, there were many, many cases of children coming down with encephalopathy after the natural infection. [00:04:54] Speaker 01: We also know that it's very rare, but it can occur after the live MMR vaccination. [00:05:00] Speaker 01: One of the articles that Dr. Shafir cited in his report, the NCES study, demonstrates, and we know that. [00:05:06] Speaker 00: Can I ask you about this? [00:05:08] Speaker 00: Did the special master refuse to look at or disregard [00:05:14] Speaker 00: The studies cited in his report, there's a question in my mind about whether there was, I know there were some reports and some studies attached to his expert report, but then he may not have opined on those reports when he actually gave his testimony, yet it seems to me that the special master was obligated to look at all of the evidence presented. [00:05:34] Speaker 00: And is one of your arguments that the Special Master erred by not taking into account those reports? [00:05:40] Speaker 01: It is, Your Honor, because he opined about those reports in his own report. [00:05:44] Speaker 01: Dr. Shaffir discussed the medical articles and the significance of those articles in his report. [00:05:49] Speaker 01: He not only talked about it in direct examination, but the Special Master also implied that talking about it on cross or on redirect was not as important as talking about it in direct. [00:06:00] Speaker 01: The record as a whole, I'm sorry, Your Honor, [00:06:02] Speaker 03: Let's go back. [00:06:03] Speaker 03: Did you say that you're expert testified in reference to the to the different medical reports that or not medical reports? [00:06:11] Speaker 03: Articles that that are in the record and I cite to you specifically a 1459 And that's this the acuteness of laws is followed by permanent brain injury Did you actually testify as to this particular report? [00:06:27] Speaker 01: It is actual testimony. [00:06:28] Speaker 01: Yes. [00:06:29] Speaker 01: I don't recall, Your Honor, but I know he talked about it in his expert report, which is a part of the record that the Special Master has to consider. [00:06:36] Speaker 01: It's a part of the record as a whole. [00:06:38] Speaker 03: Is this how this report got into the record? [00:06:41] Speaker 01: Yes, Your Honor. [00:06:42] Speaker 01: Okay. [00:06:44] Speaker 01: Dr. Shafrir described, as I already said, the three ways [00:06:50] Speaker 01: The timing in this case is also evidence this is an autoimmune encephalopathy. [00:06:55] Speaker 05: Doesn't LaLande stand for the proposition that the type of literature you're talking about has to refer to the type of injury that the petitioner suffered? [00:07:05] Speaker 01: First of all, Your Honor, there's no requirement that the petitioners file any of it. [00:07:08] Speaker 05: I'm looking at the language in LaLande. [00:07:12] Speaker 05: Yes, Your Honor, I understand. [00:07:13] Speaker 05: One of the arguments against you here is that the literature you've cited in the end, CES study and the other thing, don't home in on or discuss at all the specific type of injury that your client has suffered here. [00:07:31] Speaker 05: Yes, Your Honor, I think that... And if it doesn't describe that, then in the land they said, okay, that literature is ineffective for purposes of often [00:07:41] Speaker 05: So where I'm standing from is that the literature that you feel was incorrectly overlooked here, you haven't made the case. [00:07:54] Speaker 05: In fact, you just admitted that it doesn't address the condition that your client had. [00:08:00] Speaker 05: So in the legal language, it would be harmless error. [00:08:06] Speaker 05: Just to be honest with you, that's my problem is when often prong one, [00:08:11] Speaker 05: You made the argument that the special master had, in essence, changed the law by requiring this degree of specificity. [00:08:19] Speaker 05: But that degree of specificity seems to me to be mandated by our precedent. [00:08:24] Speaker 05: It's mandated by the precedent, and the examiner didn't misstate the law. [00:08:29] Speaker 05: And if he failed to spend enough time looking at that literature, it would be, you haven't shown in your briefs why the error is harmful. [00:08:38] Speaker 01: But the special master was requiring basically pronged two of the Stevens analysis. [00:08:43] Speaker 01: He was requiring medical literature or proof in the scientific community. [00:08:47] Speaker 01: The Alton decision makes clear, if I may answer your question. [00:08:51] Speaker 05: Well, he's rejecting your possible plausible test. [00:08:56] Speaker 05: And that test was rejected in Moberly. [00:08:59] Speaker 05: But it was accepted in Andrade. [00:09:00] Speaker 05: Moberly says possible probable is not the statutory test. [00:09:05] Speaker 01: Well, Your Honor, if you can read Andreu and Moberly side by side and justify those decisions being on the same level. [00:09:11] Speaker 05: Well, I mean, my problem is I've got to faithfully apply the precedent as it exists. [00:09:17] Speaker 01: Which is Andreu? [00:09:19] Speaker 05: Well, I've got Moberly's on the books. [00:09:21] Speaker 01: It's on the books, Andreu's on the books, and Alton's on the books. [00:09:25] Speaker 01: Alton says that medical literature is not required. [00:09:28] Speaker 01: Alton also points out that Congress intended that we be allowed to use circumstantial evidence and inference. [00:09:35] Speaker 01: What the court is requiring in this case is what I, growing up in Iowa, used to refer to as a case on all fours. [00:09:41] Speaker 05: That is, a case that's identical to the petitioner. [00:09:44] Speaker 05: Moberly precedes comes before Andrea, right? [00:09:48] Speaker 01: Moberly comes after Andrea. [00:09:53] Speaker 01: I don't know if that makes any difference. [00:09:54] Speaker 01: I think if you look at Alf and Andrea together, and look at Pollock, and look at Cone, and look at the cases that are coming down today, [00:10:02] Speaker 01: We're looking at a situation where he clearly applied the wrong law. [00:10:06] Speaker 01: He clearly tried to impose a probable requirement on medical theory, which is not the requirement. [00:10:12] Speaker 01: That's putting the Stevens prongs back into the requirement. [00:10:16] Speaker 03: Is his reference in use of the word probable with respect to the Althorn test, to a plausible theory? [00:10:27] Speaker 03: Is it in reference to that or to the standard of proof that's required overall in a vaccine case? [00:10:34] Speaker 01: Well, he's applying it to the prong one, in my opinion. [00:10:38] Speaker 01: And what I'm saying is that the whole, all three of these things make up probability. [00:10:43] Speaker 01: You shouldn't apply probability to the single prong one. [00:10:47] Speaker 01: That is not required. [00:10:48] Speaker 01: It's required to show a plausible medical theory. [00:10:51] Speaker 01: Dr. Shafrir did that. [00:10:53] Speaker 01: There is no evidence of anything else. [00:10:56] Speaker 01: The respondent says, well, these doctors that talked about it in the medical records were remote from the event. [00:11:01] Speaker 01: That's true, because there had been no other alternate cause found. [00:11:05] Speaker 01: And very often, when all alternate causes are rolled out. [00:11:08] Speaker 05: Well, no alternate cause found, there wasn't any adjudication of that issue, right? [00:11:13] Speaker 01: Of alternate cause? [00:11:14] Speaker 01: The government presented no evidence of an alternate cause. [00:11:19] Speaker 01: That's their burden of proof, not mine, to prove that there wasn't any. [00:11:21] Speaker 01: And there was nothing in the record [00:11:23] Speaker 01: There's nothing from the respondents in the way of proof. [00:11:25] Speaker 01: Their expert didn't talk about an alternate cause. [00:11:28] Speaker 01: There's no evidence of an alternate cause in this case. [00:11:31] Speaker 01: We're talking about a logical medical theory. [00:11:34] Speaker 05: Why is the issue of any importance? [00:11:37] Speaker 01: It's important because, Your Honor, you're saying that we have to have medical literature that identifies identically everything in this case. [00:11:45] Speaker 01: That's not true. [00:11:47] Speaker 01: That's never been required. [00:11:48] Speaker 01: It should never be required. [00:11:50] Speaker 01: To require us to have a medical article [00:11:53] Speaker 01: that fits every single aspect of the case is illogical. [00:11:56] Speaker 01: We're allowed to use circumstantial evidence. [00:11:59] Speaker 01: We're allowed to infer from other articles and from other evidence in the literature. [00:12:03] Speaker 01: That's always been allowed and should not be denied. [00:12:05] Speaker 01: The petitioner in these cases, or we can't win any cases. [00:12:09] Speaker 01: If we had to have a medical article in every case that showed identical reactions, most of the cases in this program would not win, period. [00:12:19] Speaker 01: I'd like to reserve the rest. [00:12:21] Speaker 05: Well, at that standard of proof, [00:12:23] Speaker 01: Excuse me. [00:12:23] Speaker 05: I have to overrule La Long? [00:12:26] Speaker 01: I think you have to rule in this case. [00:12:28] Speaker 01: I think you have to rule in the facts in this case. [00:12:30] Speaker 05: Sir, we were bound by precedent. [00:12:32] Speaker 05: We were supposed to try to line these cases up so that they tend to make sense one against the other. [00:12:38] Speaker 01: Well, they're not lined up. [00:12:39] Speaker 01: If you line up Moberly and Andreu, they're not lined up. [00:12:42] Speaker 01: I'm sorry. [00:12:44] Speaker 05: Well, I'm talking about Lalonde now, where the language says that the literature in Lalonde that was being used to satisfy Alton Prone 1 failed both with regard to the timing of a two-phase event and the type of injury that Lalonde alleges. [00:13:03] Speaker 05: So in other words, what you're saying is that... I'm just reading from the text of an opinion that binds me. [00:13:08] Speaker 01: I understand. [00:13:09] Speaker 01: So what you're saying is that if we don't submit any medical literature, which is not required under Alton, [00:13:14] Speaker 01: then we're better off than if we submit medical literature, which we think supports it through inference and circumstance, even though it's not directly on point. [00:13:23] Speaker 01: If you found an article directly on point for every one of these cases. [00:13:26] Speaker 05: Well, it's not so much directly on point. [00:13:28] Speaker 05: I don't read LeLond to say that, to say that there's some indication in the reference that you're talking to that the condition the client has is possible, is within the range of reactions that might occur. [00:13:44] Speaker 01: So the special master conceded that by saying that the timing fit. [00:13:48] Speaker 01: How can the timing fit if it's not appropriate? [00:13:51] Speaker 01: How can you have a medical theory, how can you say the temporal relationship is appropriate for this type of reaction, but the medical theory isn't there? [00:13:59] Speaker 01: How can you say that? [00:14:00] Speaker 01: The medical theory of causation, we know that MMR vaccines can cause encephalopathy. [00:14:05] Speaker 01: That's a given. [00:14:06] Speaker 01: We know it. [00:14:07] Speaker 01: We know that the MMR vaccine can cause encephalopathy characterized by epilepsy, by seizures. [00:14:12] Speaker 01: The question in this case was, [00:14:14] Speaker 01: They were saying, well, there wasn't testing done to prove that it was autoimmune in nature. [00:14:17] Speaker 05: How do we know the second point that you just made? [00:14:20] Speaker 01: Because epileptic seizures are a part of encephalopathy. [00:14:24] Speaker 01: If you look at the NCES study, if you look at the study referenced, all these studies, seizures are just a symptom of encephalopathy. [00:14:32] Speaker 01: That's all they are. [00:14:34] Speaker 01: As a matter of fact, this child's seizures were cured at Johns Hopkins, were stopped with a ketogenic diet. [00:14:39] Speaker 00: OK, Mr. Shoemaker, you're well into your rebuttal time. [00:14:42] Speaker 00: Thank you. [00:14:42] Speaker 00: I think we should hear from the government. [00:14:46] Speaker 00: How do I say your name, counsel? [00:14:48] Speaker 02: Glenn McLeod. [00:14:49] Speaker 00: Mr. McLeod, please proceed. [00:14:59] Speaker 02: May it please the court. [00:15:00] Speaker 02: My name is Glenn McLeod, and I represent the appellee in this case. [00:15:06] Speaker 02: This is a straightforward case concerning vaccine precedent. [00:15:12] Speaker 02: Elise's case involves whether or not she suffered. [00:15:15] Speaker 02: an autoimmune brain damage secondary to her second measles bumps and rubella or MMR vaccination in January of 2001. [00:15:24] Speaker 02: The special master in this case inherited the case from another special master who conducted the actual trial. [00:15:30] Speaker 02: The special master who inherited the case gave the opportunity to the petitioners to have a second hearing which was declined by petitioner and the respondent [00:15:40] Speaker 02: So the special master reviewed the entire record of the testimony and the medical literature and the opinions, both written and oral. [00:15:48] Speaker 02: And based upon his evaluation, the totality of the evidence concluded that the petitioner had not presented a persuasive, reliable medical theory linking the MMR vaccination. [00:15:59] Speaker 00: It is helpful to have you explain the procedural history. [00:16:02] Speaker 00: Thank you for doing that. [00:16:03] Speaker 00: I have a question about it that is brought to mind by what you just said. [00:16:07] Speaker 00: One of the things this special master [00:16:10] Speaker 00: made quite clearly was a credibility determination as between the two experts. [00:16:14] Speaker 00: But according to the history that you just related, is it true that he did not actually firsthand dismiss the testimony of either experts, but rather only had the same written record that I have in front of me, because he was not, in fact, the special master who heard these two experts testify? [00:16:29] Speaker 02: Two points in response to this question are, first of all, you are correct. [00:16:33] Speaker 02: The special master in this case did not observe the experts testifying live in a testimony. [00:16:39] Speaker 02: However, and that's why I point out, he did give that opportunity to the parties, but he did have the transcript of testimony. [00:16:45] Speaker 00: The same thing I have, right? [00:16:46] Speaker 02: The same thing you have, the curriculum vitae of both experts, the testimony of their experience. [00:16:51] Speaker 00: So what was his determination of credibility based on? [00:16:55] Speaker 00: Ask between these two experts. [00:16:56] Speaker 00: Tell me what is the substantial evidence that supports, because this is unusual. [00:17:01] Speaker 00: Usually I have to give so much deference to these credibility determinations, because maybe as the guy sat there, he was flinching or had a tic [00:17:08] Speaker 00: Every time he said a certain word that made you think he wasn't telling the truth or something, you just don't know. [00:17:12] Speaker 00: You're not physically present watching the person in the courtroom. [00:17:17] Speaker 00: And so you really just can't replace your judgment for that of the special master's judgment. [00:17:22] Speaker 00: But here he wasn't physically present watching the people in the courtroom. [00:17:25] Speaker 00: So actually I can, right? [00:17:26] Speaker 00: I can step right into issues because I can read the written record exactly as he can read the written record. [00:17:32] Speaker 00: Although this isn't one of those situations where we usually give. [00:17:35] Speaker 00: the same level of deference, because we weren't physically present, and he may have witnessed things that we can't step into his shoes and see. [00:17:43] Speaker 02: Although with all due respect, Your Honor, his decision in this case was not based on the property. [00:17:46] Speaker 02: That was not the crux of his decision. [00:17:48] Speaker 00: But he did make a credibility determination, did he not? [00:17:50] Speaker 02: He weighed the opinions of the two separate experts in conjunction with the facts of the case. [00:17:55] Speaker 02: And that's very important as far as [00:17:59] Speaker 02: the opinion that provided by Dr. Shafrir in the case, that the petitioner suffered, that the child suffered a specific kind of brain injury. [00:18:06] Speaker 02: And that is very relevant. [00:18:08] Speaker 02: An autoimmune-mediated encephalopathy or brain injury. [00:18:11] Speaker 02: And so the question is, do the facts of this case support that theory? [00:18:15] Speaker 02: Even if you assume Dr. Shafrir's theory is plausible or reliable, whatever position, let's assume that that theory satisfied Prong-1 of all. [00:18:25] Speaker 02: The key of this case is whether the logical sequence of cause and effect [00:18:28] Speaker 02: based on the facts of the record evidence, not so much credibility of the opinions of the experts, but whether the logical sequence of cause and effect matches, reliably, persuasively, with Dr. Schifrin's. [00:18:40] Speaker 03: Wouldn't that determination, in part, depend on the determination made for prong one? [00:18:47] Speaker 03: And if you got prong one wrong, then wouldn't that taint your determination for prong two? [00:18:54] Speaker 02: Not necessarily, Your Honor, because I'm saying if you assume that the petitioner had a persuasive medical theory, that medical theory was tied to a very specific injury, autoimmune mediated injury. [00:19:06] Speaker 03: Well, you heard me refer earlier to this particular report. [00:19:10] Speaker 03: Are you familiar with it? [00:19:12] Speaker 02: Which report, Your Honor? [00:19:13] Speaker 03: It's on A1459. [00:19:15] Speaker 03: Yes, sir. [00:19:19] Speaker 03: Are you familiar with that report? [00:19:20] Speaker 03: I am. [00:19:20] Speaker 03: OK. [00:19:21] Speaker 03: Now, did the Special Master refer to this report at all in his decision? [00:19:26] Speaker 02: No, Your Honor. [00:19:27] Speaker 02: It was not referenced specifically. [00:19:28] Speaker 03: Okay, so we don't know if he considered this report or not. [00:19:32] Speaker 03: Wouldn't that be correct? [00:19:34] Speaker 02: There's nothing in the record that says he didn't respond to it. [00:19:36] Speaker 03: Okay, so I want you to look at the conclusion down here at right underneath the abstract, which is the first three paragraphs of the report. [00:19:50] Speaker 03: And do you see, therefore, the report specifically refers to the causal relationship between measles vaccine and the type of injury that we're dealing with here? [00:20:01] Speaker 02: Actually, Your Honor, it doesn't say that. [00:20:03] Speaker 02: What it says is the type of injury we're dealing here is autoimmune-mediated encephalopathy. [00:20:09] Speaker 02: I assume you're referring to the conclusion that says this clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist [00:20:19] Speaker 02: as a rare complication of measles immunization. [00:20:23] Speaker 02: The government's expert in this case, when asked about whether measles vaccine can cause encephalopathy, said it is a possibility, which is consistent with this. [00:20:31] Speaker 02: But the crux of this case matches the type of injury alleged, well not the type of injury, but the approach that this court dealt with in the Hibbard case. [00:20:40] Speaker 02: Hibbard was cited by the special master in his decision, and that is [00:20:44] Speaker 02: that if you assume the accuracy of the petitioner's medical theory, it must fit the facts of the case. [00:20:50] Speaker 02: And yet in this case, there is absolutely no credible evidence of an autoimmune-mediated process in this child. [00:20:58] Speaker 02: That is, pronged to. [00:20:59] Speaker 02: So she's never been diagnosed with that condition? [00:21:03] Speaker 02: Not only has she not been diagnosed with an autoimmune-mediated encephalopathy. [00:21:08] Speaker 02: And to be clear on that, the theory that Dr. Shafir posited was that the MMR produced [00:21:13] Speaker 02: normal immune reaction that somehow led to the attack of her brain that manifested in seizures. [00:21:23] Speaker 02: So she suffered an acute brain injury as a result of an autoimmune... But we're still dealing with encephalopathy, right? [00:21:30] Speaker 02: Yes, Your Honor, but we're dealing with a specific kind of encephalopathy. [00:21:33] Speaker 02: And as the Special Master said in his opinion on page 23 and 24, he delineates very clearly that [00:21:42] Speaker 02: The second element to establish by preponderant evidence is a logical sequence of cause and effect showing that the MMR vaccine did in fact cause Elisa's autoimmune epileptic encephalopathy. [00:21:53] Speaker 02: A logical presentation from petitioners would entail first showing that Elisa's response to the MMR vaccine was consistent with the theory, and her response is not consistent with this theory. [00:22:06] Speaker 02: Why was it not consistent with the theory? [00:22:08] Speaker 02: The special master articulates the basis. [00:22:11] Speaker 02: For example, if you had an autoimmune-mediated reaction, you would expect to see the following things. [00:22:16] Speaker 02: Objective evidence of, this is on page 24 of his opinion, coming from Dr. McDonald, objective evidence of an autoimmune encephalopathy may include brain swelling and MRI. [00:22:26] Speaker 02: The brain in this case was normal except for inflammatory changes in the sinuses, which both experts indicated was not related to brain injury. [00:22:36] Speaker 02: Lateral and focal neurologic damage, elevated white cells, changes in gamma globulin levels. [00:22:40] Speaker 02: None of these are evidenced in this case. [00:22:47] Speaker 02: And then finally, an autoimmune process that affects the brain is likely to be visible on MRI. [00:22:52] Speaker 02: And the MRI would be grossly abnormal. [00:22:54] Speaker 02: EEG would show total disorganization. [00:22:57] Speaker 02: And seizures stemming from an autoimmune process would not be sporadic. [00:23:01] Speaker 02: Elisa's seizures were sporadic in the beginning. [00:23:03] Speaker 02: Her EEG was not consistent. [00:23:05] Speaker 02: with that clinical presentation. [00:23:09] Speaker 02: The special master also pointed to the treating physician. [00:23:11] Speaker 02: They did not treat her for an autoimmune-mediated condition, leading credence to the conclusion that she had not in fact suffered it. [00:23:19] Speaker 02: Circumstantial evidence, mind you, not dispositive, but circumstantial evidence. [00:23:24] Speaker 00: And what about the, I'm probably saying it wrong, but the ketogenic diet? [00:23:29] Speaker 00: Is that tied to an autoimmune process? [00:23:32] Speaker 00: Isn't that tied to [00:23:33] Speaker 00: At least the literature that I read suggested that that diet can be tried in many different kinds of seizure disorders, certainly to see improvement, but one of them was autoimmune, wasn't it? [00:23:45] Speaker 02: What I saw in the record, Your Honor, was that the ketogenic diet, which is a very high-fat diet that is used to replace glucose with ketones. [00:23:54] Speaker 00: It's a four-to-one fat. [00:23:55] Speaker 00: I did some research on it because I wasn't sure what it was, so I went a little extra record on you. [00:24:00] Speaker 00: just to understand what it was, because I didn't know what it was you were talking, what it was they were talking about, and I was curious. [00:24:05] Speaker 02: So yeah, I learned a little bit about it. [00:24:07] Speaker 02: And I think Mrs. Moriarty may have testified that it was like a 90 percent, for Johns Hopkins, where she went, it was like a 90 percent fat diet. [00:24:16] Speaker 02: But to answer your question, Dr. McDonald talked about it as being evidence of a metabolic disorder, because it treats, it goes to the metabolism, metabolizing of [00:24:27] Speaker 02: of energy, of glucose, or in this case ketone bodies. [00:24:31] Speaker 02: And so he indicated that that was actually circumstantial evidence of a metabolic underpinning for the seizure disorder. [00:24:38] Speaker 00: And didn't the neurologist say her EEG was consistent with the diagnosis of epilepsy? [00:24:44] Speaker 02: That is correct. [00:24:45] Speaker 00: And wouldn't that go against the passage that you just read about, the autoimmune stuff? [00:24:50] Speaker 02: I don't believe so, Your Honor. [00:24:51] Speaker 02: Epilepsy is a generalized condition. [00:24:54] Speaker 02: There are many different causes for epilepsy. [00:24:57] Speaker 00: Not all epilepsy has even uncontrolled seizures obviously So I guess I guess that I'm not particularly following you because I see I do see a lot of evidence that goes both ways Which in a case where I have to give a lot of deference of course favors and appellee But I guess I'm not I'm not completely understanding some of these distinctions you draw and why is it important to me? [00:25:19] Speaker 00: why it's important to me is because I [00:25:21] Speaker 00: Unlike your response to Joe Trano's question when he asked about 1459 and the relevance of that medical literature, depending on some of these facts, and I don't think it is clear to me how the special master weighed them, but what does seem clear to me is that he expressly disregarded that evidence that Joe Trano cited to you, because on page A19, he expressly says that there were studies attached [00:25:50] Speaker 00: to the expert's report, but that he doesn't have to read these because when an expert does not explain the relevance of the article, a special master is not required to interpret it. [00:26:02] Speaker 00: And so it seems to me that he didn't just not talk about the studies that were attached to the end of the expert's report. [00:26:11] Speaker 00: I read his opinion as indicating that he is, in fact, not even going to use them [00:26:16] Speaker 02: Well, all due respect, Your Honor, when I read that paragraph, it seems to the appellee that what he's saying is when an expert lists medical literature, and this clearly doesn't indicate that the special master didn't consider it, it's trying to understand the relevance of the article to the theory proposed by the expert, a special master is not required to interpret what is the specific relevance. [00:26:42] Speaker 02: For example, [00:26:43] Speaker 02: in that particular article is very general and is based upon claims in the vaccine adverse event reporting system. [00:26:58] Speaker 02: But Dr. Shafir himself did not explain in any detail the relevance of it. [00:27:02] Speaker 02: And the special master is simply requiring the petitioner, if they provide literature, [00:27:07] Speaker 02: if they provide. [00:27:08] Speaker 05: So what would happen if the Wable article at 1459 at the point where Judge Raina drew your attention to the conclusion, remember that? [00:27:17] Speaker 02: Yes, Your Honor. [00:27:17] Speaker 05: Page 1459. [00:27:19] Speaker 05: If it said that clustering suggests a causal relation between measles vaccine and encephalopathy, including autoimmune mediated encephalopathy. [00:27:28] Speaker 05: Let's assume that it said that. [00:27:30] Speaker 02: Very good. [00:27:31] Speaker 05: And the special master had ignored or had not paid any attention [00:27:36] Speaker 05: in his opinion to that article. [00:27:38] Speaker 05: Wouldn't that be a reversible error? [00:27:41] Speaker 02: If the article's relevance to the facts and circumstances of the case rise to the level that a special master ignores totally. [00:27:53] Speaker 05: Given the way this opinion was written. [00:27:55] Speaker 05: The reason why I'm asking the question is because what I'm trying to get you to tell me is whether or not, as was in Lalonde, [00:28:03] Speaker 05: Literature can be overlooked or ignored or deemed to be irrelevant unless the literature actually refers to the type of condition that the petitioner is alleged to have. [00:28:18] Speaker 02: Yes, Your Honor. [00:28:19] Speaker 05: And that's the way you read the law? [00:28:20] Speaker 02: I do, Your Honor. [00:28:21] Speaker 02: It's a question of relevance and weight to be given to the medical literature that's used to support an opinion. [00:28:29] Speaker 05: You have a case other than the law to support that proposition? [00:28:34] Speaker 02: So specificity. [00:28:36] Speaker 05: What I'm trying to get at is there's a real debate going on in this courtroom right now between your adversary and yourself about the degree of specificity that has to exist in the prior art, as we call it, in the patent room, in the literature. [00:28:51] Speaker 05: When you're trying to look to the literature to see whether or not there is a theory of causation that passes muster under pronged one of all things. [00:29:01] Speaker 05: And I hear you to be saying that literature [00:29:04] Speaker 05: doesn't qualify unless it refers specifically to the condition that the petitioner thinks they have. [00:29:16] Speaker 02: It's a question of weight. [00:29:18] Speaker 02: The weight to be given to the relevance and persuasiveness of the medical literature. [00:29:21] Speaker 02: If the medical literature has, let's assume for the sake of argument, your point, that the medical literature specifically talks about the injury at issue, then that's very relevant. [00:29:31] Speaker 02: And if a special master completely ignores that [00:29:33] Speaker 02: element of evidence, that would be a question for the court to determine whether that was error. [00:29:39] Speaker 02: However, it's a question of weighing the literature and its relevance to the theory propounded. [00:29:48] Speaker 02: If the medical literature has only tangential relevance, it doesn't mean the special master ignores it. [00:29:55] Speaker 05: Don't you think the special master ought to tell us in his or her opinion [00:30:00] Speaker 05: I've looked at all the evidence, and this evidence is only tangentially interesting, or it's irrelevant. [00:30:06] Speaker 05: Irrelevant, tangential, more interesting, very interesting. [00:30:11] Speaker 05: Your Honor, I see my time is up. [00:30:12] Speaker 05: As far as I'm concerned, you can answer the question. [00:30:15] Speaker 02: Thank you, Your Honor. [00:30:17] Speaker 02: It would be helpful if a special master did so, but it's not required, in his opinion, to go through every piece of evidence that was presented. [00:30:25] Speaker 02: We cited the Murphy case in our brief for that proposition on page 17. [00:30:30] Speaker 02: that a special master need not discuss every piece of evidence in the record, so long as his decision makes clear that he fully considered a party's position and arguments on point. [00:30:38] Speaker 02: And he did that in this case. [00:30:41] Speaker 05: Can I just ask one other quick question? [00:30:45] Speaker 05: Sure. [00:30:45] Speaker 05: I'm now concerned with the ideology of this particular case. [00:30:51] Speaker 05: You've got one special master who conducts a hearing. [00:30:56] Speaker 02: Yes, Your Honor. [00:30:56] Speaker 05: And that special master presumably has looked at all the literature and done all the preparation for the hearing the way we prepare for our hearings, right? [00:31:04] Speaker 02: Yes, Your Honor. [00:31:06] Speaker 05: And then you've got another special master comes in. [00:31:09] Speaker 05: And the special master that comes in makes a credibility call, which is suspect, in a way. [00:31:16] Speaker 05: Because we don't quite know what he means by credibility, because he clearly couldn't have observed the witnesses. [00:31:23] Speaker 05: So you couple that, what I'll call, [00:31:26] Speaker 05: questionable credibility calling, which is adverse to the petitioner. [00:31:32] Speaker 05: How much weight, you say. [00:31:34] Speaker 05: And then you've got an opinion of the second special master calling into question the extent to which the second person looked at the literature. [00:31:45] Speaker 05: And couldn't a reasonable person put those two things together and say, I'll have a good feeling about the final decision here? [00:31:54] Speaker 05: Maybe this ought to go back, and the special master ought to understand that he ought to get the thumb off the scale if it's there for credibility, or at least explain more what the credibility call is, because he's taking one doctor out who actually has, I suppose, more experience than the other. [00:32:12] Speaker 05: And secondly, talk to us about the literature. [00:32:17] Speaker 05: Why wouldn't that be a just result, given what I call the shaping of how this case happened? [00:32:24] Speaker 02: Because the special master did more than just make credibility findings and talk about isolated piece of the evidence. [00:32:30] Speaker 02: I think we have to look at the totality of the approach. [00:32:32] Speaker 05: How do I know how much the credibility call weighed in the mind of this second special master? [00:32:39] Speaker 05: How do I know that it only mattered a little bit, the way you're telling me, as opposed to it mattered a great deal? [00:32:46] Speaker 02: Well, certainly if this court finds that the special master did not draw plausible inferences from the evidence or [00:32:52] Speaker 02: We're not talking about that. [00:32:54] Speaker 05: I'm just talking about the shape of the case, how it happened. [00:32:58] Speaker 02: Well, Judge Wheeler in the court below and the government feels that Special Master in this case did a fine job in examining the evidence and weighing the total of the evidence. [00:33:10] Speaker 02: We don't see that there's an error in his approach to it based on his opinion and prior precedents of this court. [00:33:18] Speaker 00: Thank you, counsel. [00:33:19] Speaker 00: Thank you, Your Honor. [00:33:20] Speaker 00: Two minutes of rebuttal time, please, for Mr. Schumacher. [00:33:26] Speaker 01: Judge Plevenger, if you would look at that article you were just talking about, and you read from the conclusion, and you wanted to know if that was an autoimmune encephalopathy, would it be different? [00:33:35] Speaker 01: Go over to the right-hand column of that article. [00:33:37] Speaker 01: The top of it talks about what I talked about. [00:33:40] Speaker 04: The right-hand column on the same page? [00:33:41] Speaker 01: On the same page. [00:33:42] Speaker 04: And how far down? [00:33:43] Speaker 01: And down to two sentences up above the bottom paragraph. [00:33:49] Speaker 01: says the cause of this acute monophasic encephalopathy that occurs in the absence of a detectable virus in the brain is obscure, but may be suggestive in autoimmune encephalopathy. [00:33:59] Speaker 01: And it goes on to say case reports and reviews suggest that similar neurological complications can lessen. [00:34:04] Speaker 05: What about autoimmune mediated encephalopathy? [00:34:06] Speaker 05: Is that different? [00:34:07] Speaker 01: No, autoimmune is autoimmune. [00:34:09] Speaker 01: The reason we know this is autoimmune, your honor, is because vaccines are designed to create an immune reaction. [00:34:17] Speaker 01: In most cases, that's a good reaction. [00:34:20] Speaker 01: In a few very rare misdirected cases, the immune system becomes misdirected and attacks self. [00:34:27] Speaker 01: That's what we mean by immune-mediated or autoimmune. [00:34:30] Speaker 01: We know that's how these cases occur. [00:34:34] Speaker 01: We know that cephalopathy following MMR vaccine is probably autoimmune. [00:34:38] Speaker 01: This article discusses exactly what Dr. Shafir said. [00:34:41] Speaker 01: The theories of how this happens are dormant virus, virus infecting the brain, [00:34:47] Speaker 01: But the most likely one is this autoimmune, which is described right in this article. [00:34:52] Speaker 01: We know it from the timing. [00:34:54] Speaker 01: Even the special master in this case recognized that five days was a little soon for a typical MMR encephalopathy. [00:35:02] Speaker 01: But he pointed out correctly that this was the second MMR vaccine, so you would expect to see the reaction quicker. [00:35:09] Speaker 01: Because when you get the first vaccine, you have a reaction within a certain period of time. [00:35:14] Speaker 01: When you get the second vaccine, you have a booster response, which is quicker. [00:35:18] Speaker 01: So that's why he said the five days was an appropriate temporal relationship. [00:35:22] Speaker 01: He based the appropriate temporal relationship on autoimmunity, principles of autoimmunity. [00:35:29] Speaker 01: Tests were not done to prove that. [00:35:32] Speaker 01: We can't blame Eilis for the doctors not performing the exact medical tests that would have confirmed, and we wouldn't be here today. [00:35:40] Speaker 01: The fact those tests weren't done doesn't mean that the evidence doesn't point to it completely.