[00:00:06] Speaker 00: Okay. [00:00:08] Speaker 00: All right, the next case before the court, please. [00:00:11] Speaker 00: The next case before the court is Millick versus Secretary of Health and Human Services. [00:00:16] Speaker 00: This is an appeal from a decision by a special master appointed under the Vaccine Act where the special master denied benefits to the claimants. [00:00:29] Speaker 00: Mr. Krakow, you want four minutes for rebuttal? [00:00:33] Speaker 02: Yes. [00:00:33] Speaker 00: All right. [00:00:34] Speaker 00: You may proceed. [00:00:35] Speaker 02: Thank you, Your Honor. [00:00:36] Speaker 02: Robert Krakow for Petitioners Merrick and Yolanda Millick. [00:00:41] Speaker 02: May it please the Court. [00:00:42] Speaker 02: We're here because 18 years ago [00:00:46] Speaker 02: Arthur Millick received an MMR vaccine. [00:00:49] Speaker 02: Nineteen days later, he began limping. [00:00:52] Speaker 02: Prior to receiving the MMR vaccine, the record shows that he was perfectly healthy. [00:00:58] Speaker 02: There is absolutely nothing in the contemporaneous pediatric record showing otherwise. [00:01:04] Speaker 02: Notwithstanding, yes. [00:01:09] Speaker 00: The Special Master raised this issue and it was a thoughtful one, but is there really, is this one [00:01:16] Speaker 00: disease mechanism that the doctors are referring to, in other words, are the physical and mental components tied together because it's one brain misfiring? [00:01:28] Speaker 02: I don't think the record clarifies that. [00:01:30] Speaker 02: I'm not sure medical science clarifies that. [00:01:33] Speaker 02: What we know is that there was a diagnosis of Arthur Millich of spastic diplegia, a motor disorder. [00:01:40] Speaker 02: Today, he's in a wheelchair. [00:01:42] Speaker 02: He speaks and understands both Polish and English today, and that's in the record. [00:01:48] Speaker 02: What he can't do is take care of himself and walk and do the things people would do. [00:01:54] Speaker 02: There are some not well-defined cognitive problems that he had. [00:02:01] Speaker 02: Those cognitive problems did not appear prior to the MMR vaccine. [00:02:06] Speaker 01: You raise an arbitrary or capricious argument, arguing that the Vaccine Act is unconstitutional, and you cite to Article 3 of the Constitution, but you don't identify which clause of Article 3 [00:02:26] Speaker 01: or which rights in that article guarantee your right to do a no-vote review. [00:02:31] Speaker 01: Give us some help here. [00:02:33] Speaker 02: Sure. [00:02:34] Speaker 02: We're relying in part on a recent Supreme Court case, Stern versus Marshall, which discussed the consideration of claims that were traditionally brought to common law, like a products liability claim or a vaccine injury claim that are now being adjudicated [00:02:54] Speaker 02: through an alternative courts under the Vaccine Act as we have in the Vaccine Injury Compensation Program. [00:03:00] Speaker 02: Under the original understanding of the act, there was an opportunity for a petitioner to reject a judgment in the vaccine court or elect to proceed in a state or federal court under common law or under state statutes. [00:03:23] Speaker 02: That is now gone. [00:03:26] Speaker 02: We submit that a litigant bringing these kinds of claims is entitled to de novo review in an Article III court as he traditionally would be available. [00:03:37] Speaker 00: So you're saying Stern vs. Marshall says that you can't be deprived of the right to an Article III court? [00:03:45] Speaker 02: That's right, that has been limited in a follow-up case 2015 by a case called Wellness International. [00:03:54] Speaker 02: However, [00:03:55] Speaker 02: That involved a case where the parties consented to jurisdiction. [00:03:59] Speaker 02: That has not happened here. [00:04:00] Speaker 02: There was no place then or now for Arthur Millick to bring his claim other than the vaccine injury compensation. [00:04:10] Speaker 02: Did he bring the claim before or after the Supreme Court said that there... Well before. [00:04:14] Speaker 02: He brought the claim in 2001. [00:04:16] Speaker 02: The injury was in 1998. [00:04:18] Speaker 00: So once the Supreme Court, Justice Scalia, I think, issued its decision saying that these claims were largely preempted, then at that point you are already before the vaccine court. [00:04:31] Speaker 02: Yes, and even prior to that, prior to that decision, we would have had the opportunity to reject the judgment in the vaccine court. [00:04:41] Speaker 02: and proceed in a state or federal court, alleging products liability claim, design defect, or other basis. [00:04:52] Speaker 02: Now the only claim we would have. [00:04:54] Speaker 02: So I'm a little confused. [00:04:55] Speaker 03: Yes, sir. [00:04:56] Speaker 03: So prior to this preemption decision, you think the vaccine court system was constitutional, because you could elect to go to state or federal court? [00:05:09] Speaker 02: We would have made the argument then, however, [00:05:12] Speaker 02: The landscape changed when Bruzowitz was decided. [00:05:15] Speaker 02: So it made our argument stronger and more viable. [00:05:22] Speaker 03: Well, let's just assume it was constitutional before Bruzowitz. [00:05:27] Speaker 03: You think that the Supreme Court, when it decided this preemption thing, made the entire system unconstitutional? [00:05:35] Speaker 03: I mean, the Supreme Court was clearly aware of the whole vaccine compensation system, wasn't it? [00:05:39] Speaker 02: The issue of the constitutionality on the grounds that we're arguing was not before the court. [00:05:47] Speaker 03: No, I understand that. [00:05:48] Speaker 03: That wasn't the issue. [00:05:49] Speaker 03: It was a preemption issue. [00:05:49] Speaker 03: But certainly, they were aware of the vaccine court system. [00:05:53] Speaker 03: That's the basis of the preemption. [00:05:54] Speaker 03: Absolutely. [00:05:55] Speaker 03: Do you think the Supreme Court would have intended to buy its decision to render the entire system unconstitutional? [00:06:02] Speaker 02: I don't know whether or not Justice Scalia contemplated that. [00:06:10] Speaker 02: I do know that there was a very well-reasoned dissent by Justice Sotomayor that discussed that it was fundamental to our system of adjudicating civil claims, tort claims in particular, that petitioners have an opportunity. [00:06:28] Speaker 02: The preemption issue was not discussed. [00:06:30] Speaker 02: The preemption issue I'm raising, the de novo review issue that I'm raising, was not presented or discussed there. [00:06:36] Speaker 00: And we've never discussed it in the four years since? [00:06:41] Speaker 00: I couldn't find anything. [00:06:42] Speaker 02: I don't believe. [00:06:43] Speaker 02: Well, there is a claims court decision, because the issue was raised, that discussed that. [00:06:49] Speaker 02: But I don't believe it was raised before the circuit. [00:06:52] Speaker 00: I mean, what about analogous context? [00:06:54] Speaker 00: I mean, there are many instances in which the Supreme Court has said that tort claims are preempted by federal regulatory systems. [00:07:04] Speaker 00: Are in those instances, such as the failure to warn claims, [00:07:07] Speaker 00: with respect to medical devices, etc. [00:07:10] Speaker 00: Are those all on Constituency? [00:07:12] Speaker 02: Well, the statute, we would argue by analogy, yes, but we're not, that's not before the court here. [00:07:18] Speaker 02: The Vaccine Act, in fact, does provide FDA preemption under sections 22 and 23. [00:07:28] Speaker 02: assuming the FDA approved the label. [00:07:32] Speaker 02: But we're talking more about design defect claims and the type of claims that you have here. [00:07:38] Speaker 02: We simply do not see how [00:07:43] Speaker 02: a fact-based, fact-intensive type of claim that is decided by a special master is entitled to the extreme deference that's being accorded when, as in this case, you see interpretations of facts that are just not supportable. [00:08:02] Speaker 02: And in fact, the claims court said they were not supportable. [00:08:05] Speaker 02: The key interpretation by the respondent's expert [00:08:08] Speaker 02: of the pre-vaccine developmental delay, which may or may not be connected to the motor problem. [00:08:16] Speaker 01: Don't go away from your constitutional question yet. [00:08:22] Speaker 01: You make an argument that [00:08:25] Speaker 01: Your client was deprived of common law protections afforded in the state courts for torches and injuries. [00:08:37] Speaker 01: What specific protections in state courts or common law? [00:08:43] Speaker 02: I think the best way to put that, and I appreciate the question, the best way to put that is if [00:08:51] Speaker 02: Arthur Millick went before a state or federal jury with this evidence. [00:08:58] Speaker 01: First of all, we don't... So you're saying right to trial by jury. [00:09:00] Speaker 02: Right to trial by jury, but also right to de novo review. [00:09:04] Speaker 02: An Article III judge reviewing that evidence and determining whether it's sufficient or not, or an appellate court determining that evidence with de novo review would be [00:09:15] Speaker 02: those set of uh... right-wing denovo review of the evidence well article three judge would have the right to do that in an appellate court i mean let's say you went to a federal juror district court had a jury trial on this issue there were fact findings against you you think the appellate court no not with a jury not with a jury verdict so we were deprived of a right to jury were deprived of a right to review of the evidence by a federal district court judge [00:09:45] Speaker 02: I'm not arguing that appellate review would typically be de novo. [00:09:49] Speaker 02: This court, of course, does not have de novo review. [00:09:53] Speaker 02: So there is no de novo review anywhere. [00:09:56] Speaker 02: What we have is a special master's interpretation of the facts. [00:10:00] Speaker 02: And I've briefed that extensively. [00:10:02] Speaker 00: So you're saying it's the Court of Federal Claims that should have had de novo review over the special master's determination. [00:10:08] Speaker 02: Yes. [00:10:09] Speaker 03: Well, how does that help your argument? [00:10:10] Speaker 03: I mean, the Court of Federal Claims isn't an article 3 court either. [00:10:15] Speaker 02: Well, if there was de novo review in the Federal Claims Court, it may cure the film. [00:10:21] Speaker 03: How could that cure your constitutional argument, which is apparently based upon Article 3? [00:10:26] Speaker 03: It seems to me the logic of your argument is you have to have de novo review by Article 3 court, and the only Article 3 court in the chain of this compensation system [00:10:35] Speaker 02: So I agree with that and revising my prior statement and I think our position to be consistent would be claims court should have de novo review but we should have an opportunity in a real sense to go before a district court which we don't have at all now. [00:10:51] Speaker 02: we don't have an opportunity to go before a district court under any standard. [00:10:54] Speaker 03: I mean, that's what is breathtaking in the scope of your argument. [00:10:58] Speaker 03: If we accepted your constitutional argument, it would render almost any scheme in which the federal government enacted some kind of remedial system in non-honorable three courts and had preemption unconstitutional. [00:11:15] Speaker 03: We've had these kind of remedial schemes around for decades, if not more years. [00:11:21] Speaker 03: Don't you think the Supreme Court would have found that by now? [00:11:24] Speaker 02: I think in Stern versus Marshall, they did to a large extent find that. [00:11:31] Speaker 02: I don't think the argument has been made with respect to the Vaccine Act since the Supreme Court took away any meaningful avenue to an Article III court or a common law court. [00:11:45] Speaker 02: But I also would like to emphasize that even if the constitutional argument was not [00:11:53] Speaker 02: accepted by the court that this record under even an arbitrary capricious or abusive discretion review does not pass muster. [00:12:05] Speaker 00: All right, let's turn to that, and I'll give you a few extra minutes so that we can do that. [00:12:09] Speaker 00: Thank you. [00:12:10] Speaker 00: You opened with a pretty broad statement that said there was no evidence of any problem at all before the vaccine. [00:12:20] Speaker 00: Now, I can see to you that there's very little in the record of evidence of any motor problems before the vaccine. [00:12:27] Speaker 00: But the special master said that your claim [00:12:31] Speaker 00: as well as all your experts, treated the developmental delay and the motor problems as one disease mechanism. [00:12:41] Speaker 00: How do you get around that? [00:12:42] Speaker 02: In fact, the first pediatric neurologist who saw Arthur Millick on March 3rd, 1998, after he started limping on February 19th, 1998, said he saw two distinct problems. [00:12:59] Speaker 02: He did not associate the two with each other. [00:13:02] Speaker 02: He said, and this is a key [00:13:04] Speaker 00: Yeah, I agree with that. [00:13:05] Speaker 00: That's a pretty clear statement, that he said one was long-standing, one was acute or brand new. [00:13:10] Speaker 00: And there's a couple other places where some of the doctors that saw him divided the two. [00:13:17] Speaker 00: The problem is that you filed a claim, and your experts didn't divide the two. [00:13:23] Speaker 00: Your experts treated them as evidence of one disease mechanism. [00:13:28] Speaker 02: Well, the expert didn't. [00:13:30] Speaker 02: First thing a petitioner's expert did is [00:13:35] Speaker 02: articulate why there's nothing in the record to show pre-vaccine developmental delay in any form. [00:13:43] Speaker 02: So that's the first thing. [00:13:44] Speaker 02: The second thing is he gave, he felt the appropriate diagnosis, an appropriate way to look at author's condition was spastic diplegia, which is primarily, which is a motor problem. [00:13:55] Speaker 02: I think the issue of whether [00:14:00] Speaker 02: language problem relates to that is something that was injected in the case by the respondents expert because he read into the record in a very strange way which the claims court criticized very severely said it was poorly supported and not supported by the record of a pre-vaccine language delay. [00:14:22] Speaker 02: So that's how that got injected into the case. [00:14:24] Speaker 02: Our claim [00:14:25] Speaker 00: Well, if the court found that it wasn't supported by the record, then you still have the second point, which is you've got to have something that indicates that the MMR was a trigger, right? [00:14:39] Speaker 00: Yes. [00:14:40] Speaker 00: Encephalitis? [00:14:41] Speaker 02: Yes, well, Prom 1 often is not an issue here. [00:14:45] Speaker 02: The court said we have a reliable medical theory. [00:14:50] Speaker 02: So the issue is the logical sequence of cause and effect and the temporal proximity. [00:14:56] Speaker 02: And it's probably the temporal issue that probably causes the most [00:15:00] Speaker 02: concern, and the court said that it was, we didn't show that it was proximate. [00:15:07] Speaker 02: However, the literature, and I cited this in the Ward case, it's at the appendix page 916, 8916, actually shows that it is a higher incidence of developmental problems from the MMR, adverse events from the MMR, [00:15:27] Speaker 02: 15 to 35 days out. [00:15:29] Speaker 02: So it is possible for it to happen. [00:15:30] Speaker 02: The question, it's most likely within 5 to 11 days, but it's not unlikely or it's possible after that. [00:15:37] Speaker 02: So I would argue based on this court's analysis of that kind of issue in Palick, [00:15:44] Speaker 02: that we've met that temporality issue. [00:15:46] Speaker 02: There's nothing else in the record that explains it. [00:15:49] Speaker 02: The respondent talks about a sore throat. [00:15:51] Speaker 02: There's no verification that there's a sore throat. [00:15:54] Speaker 02: There's no explanation how a sore throat would cause this devastating injury. [00:15:58] Speaker 02: There is an explanation of how the MMR would cause that kind of devastating injury. [00:16:02] Speaker 02: And while we're talking about that, aside from a strained interpretation of the contemporaneous pediatric record pre-vaccination, [00:16:11] Speaker 02: What the respondent points to are two post vaccination reviews. [00:16:17] Speaker 02: One is Dr. Maytel, this idea of long standing, but he himself clarified that and said he can't say when that happened. [00:16:25] Speaker 02: It was just there. [00:16:27] Speaker 02: And the court dismissed that as being litigation-driven when we have a paid expert for the respondent who's not being characterized as litigation-driven. [00:16:37] Speaker 02: Dr. Matel has been a treating doctor for 18 years. [00:16:42] Speaker 02: The second thing that the Special Master pointed to, and also the claims court, is a psychological evaluation more than six months after the injury by a psychologist named Alan Auska. [00:16:59] Speaker 02: The court, the special master read into that a finding that there was pre vaccination developmental delay when there's nothing that can be gleaned from that analysis except that there is developmental delay at the time of the evaluation. [00:17:17] Speaker 02: So I would submit there's nothing in the record that credibly supports the special master's findings, or for that matter, the claims court. [00:17:26] Speaker 00: Well, that Dr. Malanowska's finding, I mean, purported to be at nine months and four years of age, right? [00:17:34] Speaker 00: At four years and nine months of age, right? [00:17:36] Speaker 02: four years and nine months. [00:17:38] Speaker 02: That's when she did her evaluation. [00:17:40] Speaker 02: So that was seven months after the vaccination. [00:17:44] Speaker 00: And you're saying you don't see anything in Dr. Malinowska's findings that indicate that those two functioning problems pre-existed the MMR? [00:17:56] Speaker 02: No, because you cannot, [00:18:01] Speaker 02: retrospectively say that Dr. Malinaska could not say that when that started or that it started before the MMR. [00:18:09] Speaker 02: All she can say is that there is a developmental delay at that time and maybe he was functioning six months behind or whatever, but she doesn't say when that happened. [00:18:17] Speaker 02: That's the time of her evaluation. [00:18:20] Speaker 00: I would respectfully submit... Well, she's looking back at the three-year report and the two-year report, right? [00:18:25] Speaker 02: I don't believe so, because if you look back at the three-year and two-year report, there's nothing there to support a conclusion. [00:18:30] Speaker 02: She's looking at [00:18:31] Speaker 02: Arthur Millick at four years and nine months and making determination how far behind he was. [00:18:37] Speaker 02: She cannot say that he was behind at the age of four years. [00:18:41] Speaker 02: As a matter of fact, the pediatric record on the day of vaccination said Arthur Millick was doing well, speaking well. [00:18:48] Speaker 02: Three months before, there's also a pediatric review saying he was doing well. [00:18:52] Speaker 02: The respondent simply says, oh, pediatricians get it wrong all the time. [00:18:56] Speaker 02: I don't think that's a fair inference you can draw from the record. [00:18:59] Speaker 02: Simply said, the pediatricians are wrong, I'm right. [00:19:01] Speaker 02: Even Dr. Matal says, I can't say when that started. [00:19:06] Speaker 02: I know it's here now and also he doesn't necessarily connect the two. [00:19:10] Speaker 02: So how does that relate to the primary problem Arthur Millick had and has is the motor problem. [00:19:17] Speaker 00: So is your best argument that these are two different diseases that perhaps he was [00:19:25] Speaker 00: Developing slowly on a cognitive level but that the motor skill issue was not a problem or was not identified at all before? [00:19:34] Speaker 00: Or is your best argument that there was no evidence of either problem? [00:19:40] Speaker 02: I think the second argument is our argument. [00:19:44] Speaker 02: I don't think medical science or the treating doctors or anyone else can say whether these two things were separate or not or whether the language problem that appeared later was a result of the motor problem. [00:19:56] Speaker 02: That has not been clarified. [00:19:58] Speaker 02: I'm not respectfully sure it can be clarified, and we didn't attempt to do that. [00:20:03] Speaker 02: I don't think that's something that doctors can do within the limits. [00:20:08] Speaker 02: There was extensive testing of alternative causes, and none of the doctors at the Institute for Basic Research in New York [00:20:17] Speaker 02: found that anything prior, they never referred to anything prior to the vaccination and they primarily looked at a motor problem. [00:20:24] Speaker 02: So our argument is that there was no problem pre-vaccination that is supportable in the record. [00:20:32] Speaker 02: or otherwise. [00:20:33] Speaker 02: It just didn't exist. [00:20:34] Speaker 02: And it was read into the record. [00:20:36] Speaker 02: It was invented. [00:20:37] Speaker 02: It was created by the respondent's expert. [00:20:41] Speaker 02: Of course, the special master of first is superior credentials. [00:20:45] Speaker 02: You can't decide these issues just based on credentials alone. [00:20:49] Speaker 02: We had a competent neurologist. [00:20:51] Speaker 02: He sees nothing in the evidentiary record. [00:20:54] Speaker 02: It's not there. [00:20:55] Speaker 00: Well, credentials do go to the question of credibility, and we have said special masters have the right to make credibility determinations. [00:21:01] Speaker 02: And here we have someone who has presumed, I'll concede superior credentials, who reads a record in such a way that even the claims court says it's unsupportable, not worthy of support, not worthy. [00:21:15] Speaker 02: And those are the two key pediatric records he interprets. [00:21:19] Speaker 02: At 15 months, he says, because there was no, I think the respondent argues, doesn't have the word assessment, that it's not a developmental assessment. [00:21:27] Speaker 02: Because three to six words were checked, they're not some other things. [00:21:31] Speaker 02: That somehow shows a developmental delay. [00:21:33] Speaker 02: It doesn't. [00:21:34] Speaker 02: It simply does not support it. [00:21:36] Speaker 02: So you can't bring in an expert with superior credentials who reads into a record [00:21:43] Speaker 02: something that's there by the force that he's arguing by the force of his credentials. [00:21:48] Speaker 02: I think the phrase, I don't speak Latin, but would be ipsy dixit. [00:21:51] Speaker 02: He just said it. [00:21:53] Speaker 02: That doesn't make it so. [00:21:54] Speaker 02: It's not in the record. [00:21:55] Speaker 02: And that would be the heart of our arbitrary and capricious argument, which is, of course, separate from the constitutional argument, and I believe, respectfully, has a great deal of force in this case. [00:22:06] Speaker 00: OK. [00:22:06] Speaker 00: I'll give you four minutes for the rebuttal. [00:22:08] Speaker 00: Thank you. [00:22:08] Speaker 00: If the government needs an additional four, we'll allow that. [00:22:17] Speaker 00: Let's start with the standard of review issue. [00:22:20] Speaker 00: I mean, we do have a situation in which there is a huge amount of power invested in these special masters, most of whom do not have medical backgrounds. [00:22:30] Speaker 00: And they're making medical determinations. [00:22:34] Speaker 00: Shouldn't there be some mechanism for a full review of those factual determinations? [00:22:39] Speaker 04: I don't believe so. [00:22:40] Speaker 04: I believe it was the intent of Congress in creating this particular forum to bring these vaccine cases to enable these special masters to work exclusively on these particular cases and to develop an expertise in dealing with them routinely. [00:22:56] Speaker 04: and seeing these cases and dealing with, if not the same issue, time and again, similar issues, similar causation issues. [00:23:06] Speaker 04: And I believe this court has recognized that that expertise is worthy of deference, great deference particularly, in a case like this where only factual and credibility issues have been raised on appeal. [00:23:20] Speaker 04: That's why I believe the chief judge below correctly applied the arbitrary and capricious standard [00:23:26] Speaker 04: and affirmed the decision of the special master, because the special master, according to this case law, clearly considered the relevant facts, drew plausible inferences, and provided a rational basis to justify his decision. [00:23:40] Speaker 00: Do you agree that before Bruchowitz it was understood that there was the ability to resort to an Article III court if you wanted to reject the judgment of the special master or even to avoid filing with the vaccine court? [00:23:54] Speaker 04: Yeah, I believe there's been that opportunity, and I believe that Brucewitz does not foreclose petitioners from all possible avenues of bringing an Article III claim, but... But pretty much. [00:24:09] Speaker 04: A design defect claim is precluded, it seems, by the Brucewitz Court, although referring to the Stern and Marshall Court, it's unclear. [00:24:19] Speaker 04: I don't think it has been fleshed out whether those design defect claims are really the stuff of litigation brought before the courts of Westminster in 1789 so that it would constitute a common law claim that can [00:24:33] Speaker 04: be removed from the judicial cognizance. [00:24:36] Speaker 04: So I don't believe that in petitioners briefing that issue is fully laid out, an issue that this court is recognizing has great gravity. [00:24:47] Speaker 04: It would implicate not only just the vaccine program, but also other similar programs that have been in place for years and years. [00:24:55] Speaker 04: So the implications of that argument [00:24:58] Speaker 04: are great, and simply on the bare bones arguments put forth in the briefing here, I don't think that that kind of decision can be undertaken lightly. [00:25:10] Speaker 00: All right, well let's, assuming we've got to review this for arbitrary and capricious, there's a couple problems I had with the special master's determinations [00:25:20] Speaker 00: Like for one, calling Dr. McTaw's position litigation-driven, even though he wasn't being paid for it, and yet not considering the fact that the government's expert was, in fact, a paid expert, who by definition is coming up with a litigation-driven result. [00:25:42] Speaker 00: Why is one person's expert litigation-driven despite not being hired for the litigation, and the other one's not? [00:25:48] Speaker 04: First and foremost, I would indicate that in reviewing a case on arbitrary and capricious grounds, we're simply looking for any rational basis provided by the special master to justify his decision. [00:26:03] Speaker 04: And this special master issued a 38-page thorough decision in which he provided numerous justifications. [00:26:08] Speaker 04: So, Dr. May tells [00:26:10] Speaker 04: points made in his letter and in his initial report are just a part of that justification. [00:26:17] Speaker 04: There are other distinct justifications that satisfy the arbitrary and capricious standard. [00:26:23] Speaker 04: But to get to your point, to get to your point. [00:26:27] Speaker 04: I believe that what he was referring to as far as litigation driven is that Dr. Maytel's alleged clarification letter was issued some 16 years after his initial consultation that he was referring to in this clarification letter. [00:26:45] Speaker 04: That amount of time simply weighs against the credibility of that statement. [00:26:50] Speaker 00: Further, the statement- You think a doctor can't remember one of the saddest cases that he's had to ever experience? [00:26:59] Speaker 04: I think that he absolutely can remember it. [00:27:00] Speaker 00: He wants to see healthy children. [00:27:01] Speaker 00: This was not a healthy child. [00:27:03] Speaker 04: Absolutely. [00:27:03] Speaker 04: However, if you take the definition offered by Dr. Matel in this clarification letter, that longstanding simply means that it existed pre-examination. [00:27:13] Speaker 04: then firstly, that does not contradict Dr. Korman, respondents expert's theory of the case. [00:27:19] Speaker 04: He simply says, I don't know when the symptoms started, not the symptoms only started after the vaccine. [00:27:26] Speaker 04: He's just saying, I don't know. [00:27:27] Speaker 04: Therefore, the other records can stand on their own. [00:27:32] Speaker 04: But additionally, if you take that definition of long standing to mean simply existing prior to examination, then the acute symptoms of limping that he noticed or noted [00:27:43] Speaker 04: would also be long-standing symptoms of limping because those existed pre-examination as well. [00:27:49] Speaker 04: So it renders, that definition renders the record illegible, incoherent. [00:27:56] Speaker 00: That's a point that was made by the special master and is another point that weighs against... How do you respond to the Court of Federal Claims view that there was really no support for this notion that these problems existed before the NMR? [00:28:12] Speaker 04: I think that one of the distinct points made by the Chief Judge was that very point, but I think that that weighs against petitioners' claim, because Respondent is not primarily relying on those pre-vaccination records. [00:28:26] Speaker 04: Those pre-vaccination records are very short, very vague, and do not demonstrate that any developmental assessment was thoroughly undertaken. [00:28:37] Speaker 04: That is the point that the chief judge made, in fact. [00:28:40] Speaker 04: There was one small, rather ancillary point that Dr. Corman was relying on in those pre-vaccination records. [00:28:49] Speaker 04: But that's what petitioners' whole case hinges on. [00:28:52] Speaker 04: And the chief judge said, we can't use those records. [00:28:54] Speaker 00: The whole thing we're looking at here is who had the burden of proof. [00:28:59] Speaker 00: So in other words, the question that we have is, should the burden have shifted to the government to disprove? [00:29:07] Speaker 00: And if in fact... [00:29:10] Speaker 00: As you can see, perhaps, that the chief judge was right, that there was no evidence that it pre-existed the MMR. [00:29:18] Speaker 00: Why shouldn't the burden have shifted to the government to disprove the connection between the MMR and the illness? [00:29:26] Speaker 04: The special master and the chief judge neither found that the burden had shifted, because the initial burden is on the petitioners to demonstrate by preponderance of the evidence that the MMR vaccine caused AM's condition. [00:29:40] Speaker 04: The petitioners did not meet that burden. [00:29:42] Speaker 04: Without meeting that burden, the burden never shifts in the first place to the respondent. [00:29:46] Speaker 04: That burden is there as a matter of law. [00:29:48] Speaker 04: Yes. [00:29:49] Speaker 04: And so long as that has not been satisfied, there's no burden shifting. [00:29:54] Speaker 04: Neither judge below found that there was any burden shifting. [00:29:56] Speaker 00: But the other problem I have with the special master's conclusion, and this I see all the time, the special masters say, well, you know, [00:30:05] Speaker 00: This is not a good diagnosis, because it was partially based on the fact that nobody could figure out what caused this. [00:30:12] Speaker 00: Isn't that what differential diagnosis is all about? [00:30:16] Speaker 00: That you go in, and one of the first things you do is see, OK, you've got these conditions. [00:30:21] Speaker 00: Let's see if we can figure out what caused it. [00:30:23] Speaker 00: And if you can't, then if you've got a mechanism that could have been the cause, that that's where a professional would normally look. [00:30:34] Speaker 04: Yes, in general I agree with that, but the evidence presented here demonstrates that there's no clear evidence that the MMR vaccine played a role at all. [00:30:47] Speaker 04: So there were differential diagnoses, but those diagnoses, those doctors did not actually get into what was the cause. [00:30:56] Speaker 04: They were looking at the diagnosis of the problem. [00:30:59] Speaker 00: Well, all they can get into is a most likely cause. [00:31:02] Speaker 00: I mean, there's lots of illnesses out there. [00:31:04] Speaker 00: We don't know what caused them. [00:31:05] Speaker 04: They are, particularly an infection that the AM suffered here, which was closer temporally in relation to the onset of limping than the vaccine. [00:31:15] Speaker 04: And the vaccine, the MMR vaccine, is attenuated for the purpose that it won't get into the central nervous system. [00:31:21] Speaker 04: So therefore, it typically does not cause any problems. [00:31:24] Speaker 00: But there is an established connection between the MMR [00:31:26] Speaker 00: vaccine and these motor problems? [00:31:30] Speaker 04: It is possible, although the Rantala article that was submitted by petitioners showed that there is actually no causation there. [00:31:37] Speaker 04: And the special master did find the L-th and PROM-1 was satisfied, but basically because Dr. Korman said, I think it is possible that there could be, in some circumstance, the MMR vaccine causing a neurological problem. [00:31:51] Speaker 04: But L-th and PROM-1 really shouldn't be satisfied if [00:31:55] Speaker 04: The only theory is that there's a possibility. [00:31:59] Speaker 04: But in any event, the infection was also a potential cause here as well. [00:32:05] Speaker 04: And the burden is really on the petitioner here to prove by preponderance of the evidence that it is the MMR vaccine. [00:32:13] Speaker 04: And that just simply hasn't been the case. [00:32:15] Speaker 04: The reason why that's not the case is because that's just not borne out by the evidence. [00:32:20] Speaker 00: Because there's a seven-day gap or something between when you think it should have been kicked in and when it did? [00:32:28] Speaker 04: No, because of a litany of other support. [00:32:31] Speaker 04: Dr. Maytel's conclusion that this was long-standing because of Dr. Mullinauska's evaluation in which she determined that AM's [00:32:41] Speaker 04: skills in numerous developmental categories are significantly delayed, yet the parents did not know any cognitive regression. [00:32:50] Speaker 04: Therefore, you couldn't have Dr. Malinowska's findings without a delay predating the vaccine, without the MRI findings. [00:32:59] Speaker 00: So a parent with a first child should know exactly how [00:33:05] Speaker 00: much they can speak at age four and not realize that maybe they're really only at a three-year-old level. [00:33:10] Speaker 04: Not exactly, but I don't think that's what was asked by the doctors either. [00:33:12] Speaker 04: These doctors who routinely treat patients, three different doctors noted, both before and after Dr. Malanowska's examination, that the parents [00:33:23] Speaker 04: expressly noted that they did not notice any cognitive regression. [00:33:27] Speaker 04: The cognitive regression that would be necessary here in order to, if AM was normal on the day of vaccine, but only 10 months later he had regressed to the two and a half year level in certain developmental categories, there would be a significant cognitive regression. [00:33:44] Speaker 04: And certainly parents who, at this point, or at that point in the process, their ears had perked up to a potential problem here with their child, they certainly would have noticed some kind of regression. [00:33:56] Speaker 00: But that's assuming that they would have understood where he was supposed to be. [00:34:00] Speaker 00: I mean, every child is different, right? [00:34:02] Speaker 04: True. [00:34:02] Speaker 04: That's very true. [00:34:03] Speaker 00: I had two children. [00:34:04] Speaker 00: One was speaking 400-word vocabulary at 14 months, but didn't walk till she was two. [00:34:10] Speaker 00: And the other did the opposite, walked at seven and didn't talk till they were two. [00:34:13] Speaker 04: But here we're talking about regression. [00:34:15] Speaker 04: So being at a certain point and then going backward. [00:34:18] Speaker 04: So it's not just developing at a different rate. [00:34:21] Speaker 04: It's going backward. [00:34:22] Speaker 04: That's why regression is used. [00:34:23] Speaker 04: But again, I will remind you that that's just one of the justifications offered by the special master here. [00:34:29] Speaker 04: He had a 38-page opinion that was very thorough, that considered all the relevant facts, drew plausible inferences, and provided a rational basis. [00:34:38] Speaker 04: And therefore, the chief judge below found she had to affirm. [00:34:41] Speaker 04: And that's why respondent here requests that this court both affirm the special master and the chief judge below. [00:34:50] Speaker 04: Okay. [00:34:52] Speaker 02: Thank you. [00:35:01] Speaker 02: Just a few follow-up points, I'd be happy to answer any additional questions. [00:35:05] Speaker 02: First of all, Prong wants an initiative before this Court, even though the respondent appears to suggest that Petitions didn't meet it. [00:35:15] Speaker 02: The burden should have shifted. [00:35:17] Speaker 02: We, our position is, we clearly had preponderant evidence showing, meeting the three prongs of alternate. [00:35:23] Speaker 02: It should have shifted. [00:35:24] Speaker 02: And that's when the consideration of sore throat, et cetera, should have been evaluated. [00:35:29] Speaker 02: And there is clearly insufficient evidence. [00:35:32] Speaker 02: And we believe Respondent has a higher burden at that point to prove that that's the sole cause. [00:35:37] Speaker 02: We met our burden to show that the vaccine was a substantial cause. [00:35:42] Speaker 00: But that's the best you could hope for from us as a remand with the burden being shifted, correct, for reconsideration of the evidence? [00:35:50] Speaker 02: we certainly would uh... welcome the court's uh... consideration of that issue and then we proceed based on that i mean putting aside the constitution well we would of course hope for more but obviously that uh... outcome would certainly be consistent with our view of the evidence and uh... we would then proceed from there and believe we could proof prove our case uh... based on that kind of [00:36:14] Speaker 02: With respect to Dr. Maytown, reference to 16 years later, we're talking about treating doctors. [00:36:22] Speaker 02: So we're talking about three pre-vaccination treating doctors who found no developmental problem. [00:36:28] Speaker 02: But retrospectively, many years later, an expert comes in and says they don't know what they're doing. [00:36:33] Speaker 02: And there was a developmental problem, but there's nothing there. [00:36:36] Speaker 02: And in fact, the claims court agreed with that. [00:36:39] Speaker 00: And then we're talking about... Doesn't just a few words at age two seem a little odd? [00:36:45] Speaker 02: Well, it was three to six words at 15 months. [00:36:47] Speaker 02: In fact, as I cited in the brief, the chief special master in another case cited Nelson's pediatrics for the proposition that four to six words would be sufficient at 15 months. [00:36:59] Speaker 02: So clearly it meets the definitions. [00:37:01] Speaker 02: There's no [00:37:03] Speaker 02: support for the inference that the response expert drew, and that was accepted by the special master. [00:37:10] Speaker 02: Whether it's not enough, you know, there are other issues that we raised that we can't answer. [00:37:15] Speaker 02: The dual language issue, Polish being spoken solely at home, that could have entered into that. [00:37:21] Speaker 02: We can't resolve those issues. [00:37:23] Speaker 02: But what we do know, and this goes to the issue of regression, is that there was [00:37:28] Speaker 02: a post-vaccine onset for the first time of limping, which was a motor problem. [00:37:34] Speaker 02: And we also know that that got progressively worse after that to the point where Arthur Millick is in a wheelchair and today ambulates only with help in a wheelchair and can't do basic self-care tasks. [00:37:49] Speaker 02: So to say there's no regression and to focus on language and say that explains the issue, it doesn't. [00:37:54] Speaker 02: We have to be reminded by [00:37:56] Speaker 02: the teaching of this court and often that medical science has not fully explained how vaccines affect the human body. [00:38:05] Speaker 02: That's why we do have a lower burden of proof for petitioners, notwithstanding the review standard of arbitrary and capricious. [00:38:14] Speaker 02: Petitioners strongly urge the court to consider that we've met that burden and that all, no matter how many pages a special master wrote, no matter how much [00:38:26] Speaker 02: and with all due respect to the special master I have absolute respect for all of them but no matter how tortured the analysis that cannot replace the evidence which is the contemporaneous pediatric record that's what we must rely on and here it was disregarded here it was we took retrospective analysis we took post [00:38:49] Speaker 02: on-set six months post-onset analyses by a psychologist. [00:38:55] Speaker 02: The other treating doctors, all pediatric neurologists, didn't view it that way. [00:38:58] Speaker 02: In fact, one of them said to the special master that he believed it was more likely than not, it was more than 50%, that the MMR vaccine caused this problem. [00:39:10] Speaker 02: That all was disregarded. [00:39:11] Speaker 02: The treating doctors were disregarded and deference was paid. [00:39:15] Speaker 02: And I would submit primarily relying on credentials alone. [00:39:19] Speaker 02: And I also would say that the individual with those credentials invented a retrospective analysis that's just not there. [00:39:28] Speaker 02: And we, based on that, respectfully ask the court to remand this case for further considerations in light of a finding that the petitioners have met their burden. [00:39:39] Speaker 02: And I'd be happy to answer any additional questions. [00:39:41] Speaker 02: Thank you. [00:39:42] Speaker 02: Thank you. [00:39:44] Speaker 00: All right, the last case is one that will be submitted and that the court will determine on the brief. [00:39:49] Speaker 00: That's Everyday MD LLC versus Facebook Inc. [00:39:53] Speaker 00: And with that, the cases will be submitted.