[00:00:00] Speaker 01: Ham versus HHS. [00:00:31] Speaker 01: And counselor down in you reserve five minutes of time for rebuttal. [00:01:09] Speaker 02: Good morning, Your Honors. [00:01:10] Speaker 02: My name is Drew Downing. [00:01:12] Speaker 02: I'm here today on behalf of the Petitioner Appellant in connection with a case that's had a very odd route through the appellate process of the vaccine program. [00:01:25] Speaker 02: Um, the case has to do primarily with what the special masters in the vaccine program and the court of federal claims should use as the standard for finding reasonable basis for a claim made in the program. [00:01:40] Speaker 00: You were unable to provide any medical testimony, um, that the symptoms, um, experience were a result of the Gardasil vaccination. [00:01:51] Speaker 02: That gets to the heart of the argument, I think, Your Honor. [00:01:53] Speaker 02: You're right. [00:01:55] Speaker 02: None of the treating doctors said that this particular vaccination was the cause of this young woman's complaints. [00:02:04] Speaker 00: Basically, what you're saying is, well, we should have had time to look. [00:02:07] Speaker 02: No, that's not it, Your Honor. [00:02:08] Speaker 02: I think the problem here is when you look at what evidence is required to be filed with a petition in the first place, you have to file evidence of a covered vaccination. [00:02:20] Speaker 02: You have to show evidence that the symptoms persisted for longer than six months. [00:02:24] Speaker 02: You have to show evidence of injury. [00:02:27] Speaker 02: Evidence of injury consistent with what is being claimed in the petition. [00:02:31] Speaker 02: You have to be able to articulate a rational basis why the two might be connected, but you don't have to prove causation. [00:02:40] Speaker 02: There should not be any requirement for reasonable basis. [00:02:45] Speaker 02: where a petitioner has to show that a treating physician said that the injuries were caused by the vaccination, as this court has held previously. [00:02:54] Speaker 01: That rarely ever happens. [00:02:56] Speaker 01: It could be true that you don't have to prove causation. [00:02:59] Speaker 01: Just putting that to the side, you have to present some evidence of causation. [00:03:04] Speaker 01: It may not be sufficient evidence to prove causation, but there's got to be at least a scintilla of evidence. [00:03:11] Speaker 02: Well, I think where you come out on that, Your Honor, is you have to show, for reasonable basis, you have to show that the claim is feasible. [00:03:21] Speaker 02: Not that there's a likelihood of prevailing. [00:03:25] Speaker 02: Not that, as I said a minute ago, not that the medical chart reflects vaccine causation. [00:03:31] Speaker 02: In vaccine cases, I've been doing this a long time, that almost never happens. [00:03:36] Speaker 02: Sure. [00:03:36] Speaker 04: I mean, that's what discovery, expert testimony, all that stuff is for the actual proof of causation. [00:03:43] Speaker 04: But isn't the real gist of this case is what you have to show in your initial claim before the special master on causation. [00:03:53] Speaker 04: And it seems to me you're arguing that [00:03:56] Speaker 04: lay testimony or attorney argument is sufficient in the first instance. [00:04:03] Speaker 04: And the government is not requiring you to prove it, but is saying you have to have at least, to quote my colleagues, a scintilla of competent medical evidence. [00:04:13] Speaker 04: And what's wrong with that argument? [00:04:15] Speaker 02: Well, I think that what you have to show, again, I don't think in order to just establish reasonable basis for bringing a case in the first place. [00:04:24] Speaker 02: I think what you have to show are all of the items that are required to be filed with the petition in the first place. [00:04:30] Speaker 02: The medical record in this case doesn't exist. [00:04:32] Speaker 04: But why is it a reasonable basis when your only argument about causation is a layperson? [00:04:40] Speaker 00: I think your problem is that you're mixing rule 11, and there's no question. [00:04:47] Speaker 00: Council reasonably thought something with the causation requirement. [00:04:54] Speaker 00: because just because counsel reasonably thinks something isn't enough, I would think. [00:04:59] Speaker 02: Well, and I think you're right. [00:05:01] Speaker 02: I don't think the attorney's argument in and of itself and standing alone wouldn't get you there. [00:05:06] Speaker 04: But all you have here is the parrot, right? [00:05:10] Speaker 04: That's the only evidence you have on causation is [00:05:14] Speaker 04: the parent. [00:05:15] Speaker 02: Well, the evidence in using this specific case as an example, what you have here is you have under oath testimony from the parent in form of affidavit supporting the allegations, supporting the onset, supporting all that. [00:05:28] Speaker 04: Well, sure. [00:05:29] Speaker 04: Look, the parent can certainly confidently testify to their child got a vaccine. [00:05:35] Speaker 04: Their parent can likely confidently testify to certain symptoms and to the timing. [00:05:43] Speaker 04: can the parent ever confidently testify to actual causation? [00:05:50] Speaker 04: Absent expertise. [00:05:52] Speaker 02: Exactly. [00:05:52] Speaker 02: No, I don't think they can. [00:05:54] Speaker 02: But I also don't think that that is required, again, for establishing a reasonable basis. [00:05:58] Speaker 04: You don't think there's even a centella requirement that there has to be some indication somewhere [00:06:05] Speaker 04: In the record, at the time this case was filed, that the vaccine caused. [00:06:11] Speaker 00: I do not in Iran, at least a doc saying could be. [00:06:17] Speaker 02: No, I don't think that is a requirement for reasonable basis. [00:06:20] Speaker 02: And I'll tell you why. [00:06:22] Speaker 01: What does the word reasonable mean if that's the case? [00:06:26] Speaker 02: There has to be, and I think that there's not much authority on defining this term in the vaccine program. [00:06:33] Speaker 02: But what the court has said previously is you're not looking at the likelihood of success. [00:06:39] Speaker 02: You're looking at the feasibility for bringing the case in the first place. [00:06:42] Speaker 04: But if there's no evidence whatsoever, [00:06:45] Speaker 04: no competent evidence whatsoever on causation, how is it feasible? [00:06:51] Speaker 02: It's feasible for the following reasons. [00:06:53] Speaker 02: So the claim, first of all, satisfies all the jurisdictional requirements. [00:06:58] Speaker 02: And what you have is a medical chart filed on this young woman that completely corroborates her under oath testimony. [00:07:05] Speaker 02: That's what Judge Williams found in Cottingham too. [00:07:08] Speaker 04: She said... It doesn't corroborate the causation. [00:07:11] Speaker 04: It doesn't corroborate the causation at all. [00:07:13] Speaker 02: That's right, it does not. [00:07:14] Speaker 02: But again, that cannot be the test for reasonable basis. [00:07:18] Speaker 02: It simply can't. [00:07:19] Speaker 02: Medical charts rarely [00:07:22] Speaker 02: include that type of evidence on a petitioner. [00:07:25] Speaker 00: That's why you have medical testimony of some sort. [00:07:27] Speaker 02: Well, that's why you have experts. [00:07:29] Speaker 02: Yes. [00:07:30] Speaker 02: And what happens in this case is you have evidence of the vaccination, evidence of the injury claimed. [00:07:37] Speaker 02: You have all of the requirements until we went to retain an expert. [00:07:43] Speaker 04: You seem to be arguing basically that there's a timing test and if they can show that a vaccine was given and certain symptoms came within a certain time of that vaccine, that that's enough to file a claim. [00:07:59] Speaker 00: And I asked you that question at the beginning and you said no. [00:08:02] Speaker 02: No, temporality is important. [00:08:04] Speaker 02: but in and of itself doesn't get you there. [00:08:06] Speaker 04: What does get you there is... But if the parent is not qualified, and let's just assume this parent is not qualified to make any statement about causation, then how do we have anything but timing here? [00:08:20] Speaker 02: So we have a covered vaccine in the program. [00:08:22] Speaker 02: We have specific injuries that are reflected in that vaccination's product monograph during clinical trials and post-marketing experience. [00:08:32] Speaker 02: We cited medical literature supporting the connection between the two simply to show the special master that we had done our due diligence and that these types of things have been reported following this specific vaccination. [00:08:46] Speaker 02: As the special master should have done, we got to the point where it was time to get experts. [00:08:50] Speaker 02: Once an expert wouldn't opine, we dismissed the case. [00:08:54] Speaker 02: That case still has reasonable basis for all of the reasons we said. [00:08:58] Speaker 02: And if this court is looking for medical causation, [00:09:02] Speaker 02: to be reflected in treating doctor's records, that's going to eliminate 95% of the viable cases in the vaccine program. [00:09:10] Speaker 01: Let's say we're not looking for proof of causation. [00:09:13] Speaker 01: We're not, OK? [00:09:15] Speaker 01: Let's say we're not. [00:09:16] Speaker 01: But we are looking for something that links causation. [00:09:20] Speaker 01: What would that be in your case? [00:09:23] Speaker 02: Well, I think you have to look at everything in our case, which is what I'm saying. [00:09:29] Speaker 02: You have the vaccination timing is important. [00:09:33] Speaker 02: It's not the only thing, but timing is important. [00:09:36] Speaker 02: You have the symptoms that manifest that are reflected as following this particular vaccination. [00:09:42] Speaker 02: Now, none of her treating doctors said in her medical chart that they believe the vaccination caused it. [00:09:50] Speaker 02: But you can look at [00:09:52] Speaker 02: all of that evidence to answer one question, not causation, feasibility. [00:09:58] Speaker 02: Would it be feasible that I, as petitioner's counsel, could go retain an expert in autonomic dysfunction, dysautonomia, this particular type of condition, who would opine? [00:10:08] Speaker 02: It absolutely is feasible based on this record, and that's what you're looking at. [00:10:13] Speaker 02: You cannot look for medical causation in the notes, but clearly [00:10:18] Speaker 02: The special master looked solely for that and so did judge Williams on the unfortunately the third time it went up for review because special master Moran in the in his decision says the key is Causation and then he points out two things. [00:10:37] Speaker 02: We didn't have a treating doctor We didn't have an expert [00:10:42] Speaker 02: And that is not the standard for reasonable basis. [00:10:44] Speaker 00: Why isn't it reasonable, though, to expect counsel to at least talk to a medical professional and get some kind of input? [00:10:54] Speaker 00: Well, I think the reason... I'm not asking for formal expert testimony submission, but why isn't that reasonable? [00:11:05] Speaker 02: Well, I think if you [00:11:09] Speaker 02: If the requirement is, then that petitioner's counsel has to consult with some sort of expert in the field prior. [00:11:21] Speaker 00: Or ask the treating physician and say, do you have any reason to believe that? [00:11:27] Speaker 00: This was causative. [00:11:29] Speaker 02: Well, the second one is easier than the first. [00:11:31] Speaker 02: The second one, as far as the treating physicians go, is they typically will not answer that question. [00:11:35] Speaker 02: Risk management won't let them get involved beyond what their medical chart says. [00:11:42] Speaker 02: It could, in some instances, be reasonable to consult with an expert prior to filing. [00:11:50] Speaker 02: That costs money. [00:11:52] Speaker 02: And frankly, I would only do that in a case where it was clear [00:11:58] Speaker 02: that we were going to be moving on. [00:12:00] Speaker 02: That was going to be my expert. [00:12:02] Speaker 02: To finish answering your question, Your Honor, the only reason I would do that would be to glean specific language for my petition as far as what the theory might have been. [00:12:13] Speaker 04: Isn't that the point of reasonable basis, though, that you have to at least undertake some minimal investigation? [00:12:21] Speaker 04: file a purely speculative case based upon some kind of lay notion that this might have caused this, and then seek to shift the cost to the government for that initial exploration. [00:12:33] Speaker 04: I mean, you reference like 95% of the cases. [00:12:37] Speaker 04: It seems to me that in most of these cases when you file them, you do go on and get expert testimony. [00:12:42] Speaker 04: And then even if it's not sufficient, you ultimately end up getting your attorney's fees because there was a reasonable basis. [00:12:48] Speaker 04: This seems to me to be one of those rare cases where there's no evidence whatsoever linking this vaccine to the child's condition here. [00:12:59] Speaker 02: And I think you raise an important point, Your Honor, because [00:13:04] Speaker 02: I want to contrast this case with this court's pronouncement in Simmons. [00:13:09] Speaker 02: Simmons is sort of what started all of this, as far as the courts being more strictly in their review. [00:13:17] Speaker 02: And the difference in Simmons is that the petitioner's counsel didn't submit anything. [00:13:24] Speaker 02: No affidavit, no medical records reflecting the injury, no proof of vaccination, nothing. [00:13:30] Speaker 02: And this court said, you have to at least submit something. [00:13:34] Speaker 02: You've got to present some reason, some evidence why you think it could be a feasible case. [00:13:42] Speaker 02: And we've done that here. [00:13:44] Speaker 02: Evidence includes the proof of vaccination, the witness statements, the medical chart that reflects the injuries that are being claimed. [00:13:51] Speaker 02: The only missing piece of the puzzle is vaccine causation. [00:13:56] Speaker 02: If that was in this particular record, there'd never be a question about reasonable basis because I'd have the treating physician saying was vaccine related. [00:14:05] Speaker 02: We'd probably go on and start trying to resolve the case. [00:14:08] Speaker 02: I'm running out of time. [00:14:11] Speaker 01: Yes you are. [00:14:12] Speaker 01: That's good. [00:14:13] Speaker 01: I'm going to restore your time because we need to get to the bottom of this. [00:14:18] Speaker 01: Mr. Johnson. [00:14:20] Speaker 03: Yes, good morning, your honor. [00:14:21] Speaker 03: May it please the court. [00:14:23] Speaker 03: Mr. Downing began with what is required to be filed with the petition and I'm going to start there as well because I think it is an appropriate place to start. [00:14:30] Speaker 03: And I believe this is actually where Congress provided a roadmap for what constitutes a reasonable basis for filing a petition, and that's contained in Section 11 of the statute. [00:14:41] Speaker 03: And then this is Section 11C specifically, which sets out the section that's titled Petition Content. [00:14:48] Speaker 03: And this is the section that specifies what is supposed to be included with every petition that's filed in this program. [00:14:56] Speaker 03: And the section begins in paragraph one, except it's provided in paragraph three, and an affidavit and supporting documentation. [00:15:05] Speaker 03: So that is the type of evidence that is supposed to be filed with a petition, both an affidavit and supporting documentation. [00:15:12] Speaker 03: And then there are a number of different elements that Congress has included that are supposed to be petitioners supposed to prove in order to be entitled to compensation. [00:15:21] Speaker 03: I believe Mr. Downing represented that section. [00:15:25] Speaker 03: This does not include proof of causation, but that is actually not correct. [00:15:29] Speaker 03: If the court will look at paragraph small c, large 1, capital C, and then it's sub Roman numeral 2, [00:15:42] Speaker 03: supposed to include supporting documentation that the person sustained or had significantly aggravated any illness, disability, injury, or condition not set forth in the vaccine injury table, but which was caused by a vaccine referred to in subparagraph A. So we all get that this is the petition requires or is required to have a causation element. [00:16:04] Speaker 04: But the argument, and it's not clear to me, [00:16:09] Speaker 04: what is required for a reasonable basis under the attorney's fee statute. [00:16:14] Speaker 03: Correct. [00:16:15] Speaker 03: And I think that is, because the statute doesn't define the term reasonable basis, that is what has caused a lot of confusion with the special masters and with the- And you agree that this is not a 12b6 standard or the like. [00:16:27] Speaker 04: This is a pretty minimal standard to encourage people to participate in this program. [00:16:32] Speaker 03: Correct. [00:16:34] Speaker 03: But I think that what Congress is envisioning and intending is that, [00:16:37] Speaker 03: A petition will include some supporting documentation to address each of the elements that are set forth in Section 11C. [00:16:45] Speaker 01: How do you square your argument with the Simmons case? [00:16:48] Speaker 03: We actually believe Simmons settles the issues that are presented in this appeal. [00:16:53] Speaker 03: Simmons and this court determined or held in Simmons that the reasonable basis analysis is an objective inquiry that pertains to the merits of the claims set forth in the petition. [00:17:04] Speaker 03: And then Simmons, the court, affirmed the Court of Federal Claims determination that that case lacked reasonable basis because there was no evidence presented of an injury caused by vaccination. [00:17:13] Speaker 04: But as your friend points out, there is no evidence presented whatsoever here. [00:17:18] Speaker 04: Yeah, I know. [00:17:20] Speaker 04: We can go a little about that. [00:17:21] Speaker 04: This is not a big point to discuss in Simmons. [00:17:24] Speaker 04: He's got a lot of evidence here. [00:17:26] Speaker 04: Essentially, he's got everything except medical evidence about causation. [00:17:34] Speaker 03: Which is the most critical issue in the case. [00:17:37] Speaker 04: But is it critical for a reasonable basis or for ultimate proof of the claim? [00:17:42] Speaker 04: Sure, what he filed is never going to win in this case. [00:17:44] Speaker 04: But is it a reasonable basis to start a case and then proceed? [00:17:48] Speaker 03: And this is where we differ on what the term feasibility should relate to. [00:17:54] Speaker 03: Mr. Downing, I think, characterized that as, is it feasible to allow the counsel to go on and continue investigating the case? [00:18:02] Speaker 03: Our view of feasibility is that, is it feasible for a special master to fine for petitioner on this record? [00:18:09] Speaker 03: Not has the petitioner satisfied the preponderant standard [00:18:12] Speaker 03: But is there, as you said, a scintilla of evidence addressing each of the essential elements? [00:18:17] Speaker 04: Well, that sounds awful close to a 12b6 standard. [00:18:20] Speaker 04: And I think you would agree that it's not that high, is it? [00:18:24] Speaker 03: I think that there has to be, for the claim to be feasible, there has to be some scintilla of evidence. [00:18:30] Speaker 03: Substitute the word possible for feasible. [00:18:33] Speaker 03: Exactly. [00:18:34] Speaker 03: I mean, possible means that there is something that a special master could rely on. [00:18:39] Speaker 03: It doesn't, and it gets, in the section 11C, I think it gets the petitioner in the door. [00:18:44] Speaker 00: That's what it does. [00:18:45] Speaker 00: Would you accept the presiding judge's use of the word scintilla? [00:18:50] Speaker 03: Yes. [00:18:51] Speaker 03: I mean, I think that that's where the special master has some discretion in determining whether, if evidence is submitted, does it rise to the level of establishing reasonable basis. [00:19:02] Speaker 03: But that's not even the case we have here, because there was no evidence. [00:19:06] Speaker 04: Well, I want to ask you about that. [00:19:07] Speaker 04: But does it always have to be confident medical testimony on causation? [00:19:12] Speaker 03: Again, I think that is where it's up to the discretion of the special master to determine. [00:19:16] Speaker 04: I mean, here's why I'm asking you this. [00:19:18] Speaker 04: Because this is, one, it seems like this is a relatively new vaccine. [00:19:23] Speaker 04: There isn't a lot of scientific proof on this out here that it can just go find an article in the literature referencing this. [00:19:30] Speaker 04: But he did point to, and I admit I overlooked this a bit, he did point to the symptoms or the possible side effects of this. [00:19:42] Speaker 04: Vaccine and apparently it's accompanying literature and pointed out that these side effects match up with, at least in part with the record evidence here. [00:19:52] Speaker 04: Why isn't that. [00:19:53] Speaker 04: Confident evidence. [00:19:54] Speaker 04: that the vaccine might have caused these symptoms. [00:19:57] Speaker 03: I think this, again, goes to what I think the question you were asking about. [00:20:01] Speaker 03: Does an attorney's interpretation of the medical literature? [00:20:05] Speaker 04: No, no, I'm not asking you about the attorney's representation. [00:20:07] Speaker 04: I mean, you're not disputing, I assume, that the product literature accompanying this vaccine. [00:20:13] Speaker 04: And again, I overlooked it. [00:20:13] Speaker 04: So I would have to go back in the record to check and see whether his representations are accurate. [00:20:18] Speaker 04: But most vaccines come with a list of you may have these symptoms. [00:20:25] Speaker 04: Not on everybody, but you may have them. [00:20:27] Speaker 04: It comes with every vaccine, right? [00:20:29] Speaker 04: And so this one has a list of those things, right? [00:20:32] Speaker 03: So those are symptoms, yes. [00:20:33] Speaker 03: Those are listed on the package insert. [00:20:36] Speaker 03: And those are symptoms that have been reported. [00:20:37] Speaker 03: And those are based upon medical evidence, presumably. [00:20:39] Speaker 03: They are based on reports of symptoms that occurred after vaccination. [00:20:43] Speaker 03: They are not necessarily the results of studies looking at whether there is an association. [00:20:48] Speaker 04: Sure, but the company is not going to put those out unless it's at least somewhat [00:20:53] Speaker 04: assured that those are actually going to happen, are they? [00:20:57] Speaker 04: I mean, they're going to be very cautious. [00:20:59] Speaker 03: I think the manufacturers are required to include those on the package insert if they have been reported and post vaccine. [00:21:06] Speaker 01: So part of those symptoms were headaches, fainting, menstrual problems. [00:21:11] Speaker 01: And it seems to me that they set that out. [00:21:14] Speaker 01: At least they made that. [00:21:15] Speaker 03: The problem is the timing of the symptoms based on the facts of this case. [00:21:20] Speaker 01: But that would go to the merits. [00:21:21] Speaker 01: That would go to actually proving causation. [00:21:23] Speaker 01: We're talking about timing. [00:21:25] Speaker 01: But they do have some evidence. [00:21:27] Speaker 01: in the record that the child was suffering from the same symptoms that are noted on the schedule. [00:21:36] Speaker 03: Your Honor, there is evidence that there were headaches by petitioners own sworn affidavit four months post vaccination. [00:21:45] Speaker 03: There were two episodes of fainting eight and 10 months after vaccination. [00:21:48] Speaker 03: There were menstrual problems about a year and a half after vaccination. [00:21:51] Speaker 01: Those match up to the symptoms in the schedule. [00:21:54] Speaker 01: Whether it's enough to prove causation, that's another issue. [00:21:58] Speaker 01: That's not the reasonable basis that we're looking at. [00:22:00] Speaker 03: But no one has said that those symptoms were caused by the vaccine. [00:22:03] Speaker 03: That is the problem. [00:22:05] Speaker 04: So your view is that even taking those symptoms and the accompanying product information is true and sufficiently tied to the vaccine, there still has to be one further step that it's feasible in the specific case to connect the vaccine to [00:22:24] Speaker 04: the symptoms and that there's just no objective medical evidence here. [00:22:29] Speaker 03: Correct. [00:22:29] Speaker 04: There's no objective evidence, as Simmons termed it. [00:22:32] Speaker 03: Absolutely. [00:22:32] Speaker 03: That is exactly our point. [00:22:34] Speaker 01: What's the legal authority for that? [00:22:37] Speaker 03: Simmons. [00:22:38] Speaker 03: That this court said in Simmons that this is an objective inquiry. [00:22:42] Speaker 03: It's not based on [00:22:43] Speaker 03: what possibly could happen. [00:22:45] Speaker 03: And I think that the special master even addressed this below, because Mr. Downing made this argument that had he got an expert, it's possible that the expert could have made a causal connection, and that would have established a reasonable basis. [00:22:58] Speaker 03: That's certainly possible, but that is not the type of objective inquiry that this court imagined in Simmons. [00:23:03] Speaker 04: Can you think of any type of evidence that would satisfy this causation requirement without resort to expert [00:23:12] Speaker 04: to like pre-filing investigation with an expert or the doctors? [00:23:16] Speaker 03: Absolutely. [00:23:17] Speaker 03: We see cases all the time where physicians within their records say this is possibly a post-vaccination reaction, draw some kind of connection. [00:23:27] Speaker 03: And, you know, typically we would not make a reasonable basis objection in those types of cases because in our view, there is at least some scintilla of evidence connecting the vaccination and the injury. [00:23:39] Speaker 03: We don't have that here. [00:23:41] Speaker 03: And so that is where this case is different than the other types of cases where you do have some evidence from a treating physician making, even if it doesn't lay out a fulsome theory of causation that would be sufficient to satisfy the often requirements, it at least provides some basis for the petitioner to say there's evidence that would support this case moving forward. [00:24:04] Speaker 03: That's a useful representation by the government. [00:24:10] Speaker 03: So unless the court has further questions. [00:24:13] Speaker 03: No, sir. [00:24:14] Speaker 03: Thank you. [00:24:20] Speaker 01: Mr. Dunn, you have four minutes. [00:24:22] Speaker 00: Mr. Dunn, you have a lot of experience in this area, too. [00:24:25] Speaker 00: Is that your experience that if the treating physician has said in the notes, this could be [00:24:33] Speaker 00: Related that the government will accept that is I think is the general rule. [00:24:38] Speaker 02: Mr. Johnson is right. [00:24:41] Speaker 02: I think that is true. [00:24:42] Speaker 02: If the treating doctors have said possibly caused by vaccination or whatever in their chart. [00:24:49] Speaker 02: We wouldn't be here probably. [00:24:52] Speaker 02: Thank you. [00:24:53] Speaker 02: But as I, as I said, in my initial argument. [00:24:56] Speaker 02: That doesn't happen very often. [00:24:59] Speaker 02: It does happen. [00:25:00] Speaker 02: There are cases where the treating doctors will say that. [00:25:03] Speaker 02: It doesn't happen very often. [00:25:05] Speaker 02: Physicians are loathe to attribute causation to vaccination until... Your friend says they see it. [00:25:12] Speaker 00: It does happen. [00:25:14] Speaker 02: Yeah, it does happen. [00:25:15] Speaker 02: I'm not suggesting that. [00:25:18] Speaker 02: But my point is this, Your Honors. [00:25:21] Speaker 02: I think Simmons did not overrule a more totality of the circumstances type test. [00:25:34] Speaker 02: Yes, there does have to be objective evidence in the record. [00:25:38] Speaker 02: We have that here. [00:25:40] Speaker 02: We have a lot of objective evidence, the affidavits, the vaccination record, the medical records, the product monograph, and so forth. [00:25:48] Speaker 04: And, your honor, I was going to, but there's, again, I mean, I think I tend to agree with you that Simmons. [00:25:56] Speaker 04: I mean, first of all, I can't really overrule an on box decision, but I think it was it was, you know, reading it in context. [00:26:02] Speaker 04: It's talking about, you know. [00:26:05] Speaker 04: whether you can use timing alone and things like that, there still has to be some objective medical evidence, though, to form a reasonable basis. [00:26:13] Speaker 04: And this seems to me, the government may be trying to use this to get a broader principle, but this seems to be to be a very narrow case in which there just is nothing here that supports the causality. [00:26:26] Speaker 04: I agree with you. [00:26:27] Speaker 04: You have everything else. [00:26:29] Speaker 04: But there is nothing that supports linking on these facts the vaccination with these symptoms that have occurred, some of them significantly later than the vaccine. [00:26:39] Speaker 02: They are, Your Honor. [00:26:40] Speaker 02: So what I would look at in that instance, and again, I acknowledge I do not, I don't have a treater here that has linked the two causally. [00:26:50] Speaker 02: Instead, what you have is you have a healthy young woman, pre-vaccination, receives a vaccination, [00:26:57] Speaker 02: manifest certain types of injuries and so forth that are again reflected by the manufacturer. [00:27:04] Speaker 02: And it wasn't just the post-marketing experience. [00:27:06] Speaker 02: Mr. Johnson was talking about that. [00:27:07] Speaker 02: It's the clinical trials. [00:27:08] Speaker 04: We get all the facts here. [00:27:09] Speaker 04: We understand that. [00:27:10] Speaker 04: I guess the question for me is you're asking us to make, at least at this stage, allow you to make an inference based upon the vaccine and the product literature [00:27:21] Speaker 04: And but there's no real proof of timing or whether this is in sufficient time. [00:27:26] Speaker 04: You want that to be enough. [00:27:28] Speaker 04: The government wants you to do at least some initial work to provide at least a possibility, a possible explanation from any qualified medical profession on that. [00:27:38] Speaker 04: And that, I mean, they do point to the statute and it does suggest that that's [00:27:43] Speaker 04: what's required in the petition. [00:27:44] Speaker 04: And so if the petition requires all of those elements, then why don't you have to have at least some kind of possibility in the petition on all of those elements to establish a reasonable basis? [00:27:57] Speaker 02: And I don't disagree with that. [00:28:00] Speaker 02: I think you have to show objectively at the time. [00:28:04] Speaker 02: And I think we're speaking about different things whenever they talk about causation. [00:28:12] Speaker 02: Um, from the petitioner standpoint, what we have is the vaccination medical records documenting the harm. [00:28:20] Speaker 02: The harm began post vaccination. [00:28:23] Speaker 02: Now the missing piece of the puzzle is medical testimony, whether it be from a treater or from an expert. [00:28:29] Speaker 02: Um, and I think that, not just testimony, but reflected in the record. [00:28:35] Speaker 04: I mean, you don't have anything. [00:28:38] Speaker 04: The show that it was caused by the vaccine, which is the language of the statute from from a right from the treaters. [00:28:46] Speaker 04: There is no none of that is is in there and let's just assume that the lay person testimony of the mother is just not sufficient. [00:28:53] Speaker 04: I think that that. [00:28:54] Speaker 04: You know, we can argue about that, but that would be, I think, a fair assumption that you just can't have parents without any training saying this vaccine caused these events sometimes later. [00:29:04] Speaker 04: So, again, once we get to that point, aren't you just asking for, I'm sorry, I'm taking you over time, an inference? [00:29:11] Speaker 02: Well, I think at that point, like I said earlier, if we had [00:29:17] Speaker 02: causation reflected in the medical chart, we probably wouldn't be having a reasonable basis discussion. [00:29:24] Speaker 04: I get it, but if you don't have causation reflected, then why isn't it appropriate under these statutes and the reasonable basis statute? [00:29:31] Speaker 04: to require you to get at least some opinion, and it may not be formal like, and I understand it's money, but before you file the complaint. [00:29:40] Speaker 02: Well, I think a perfect example of that, Your Honor, is, and I may pronounce it incorrectly, it's in both sides briefs, I think the Pereira case. [00:29:49] Speaker 02: That case is very similar to this one in the sense that the case proceeded along, the court ordered counsel to get an expert, and counsel didn't get a very good one. [00:30:01] Speaker 02: The expert's opinion wasn't grounded in fact. [00:30:05] Speaker 02: It wasn't based on the records. [00:30:07] Speaker 02: It was just wholly speculative. [00:30:09] Speaker 02: The court there had a status conference with them and said, that's not going to be sufficient. [00:30:14] Speaker 02: But if you proceed forward, and I'm not convinced, you're going to not have reasonable basis. [00:30:19] Speaker 02: And that's exactly what happened. [00:30:21] Speaker 02: The court found they had reasonable basis up to that point. [00:30:24] Speaker 04: But at least there they had that expert opinion that was possible, even if it was after the fact determined to be wholly unreliable. [00:30:33] Speaker 04: There was something there. [00:30:35] Speaker 04: There's just nothing here. [00:30:36] Speaker 02: That expert opinion was so unreliable that the court found that the reasonable basis was lost the instant that that opinion hit the lawyer's desk. [00:30:45] Speaker 04: But without it, there would have been no reasonable basis whatsoever. [00:30:49] Speaker 02: But the court awarded fees. [00:30:50] Speaker 04: Look, here's my problem. [00:30:53] Speaker 04: And maybe you're not doing this, but it seems to me that you're arguing for some variation of a knowledge timing test that just doesn't appear to be in the statute. [00:31:02] Speaker 04: And Congress knows how to enact these kind of knowledge timing tests. [00:31:05] Speaker 04: They do it all the kind of time for other programs. [00:31:08] Speaker 04: They do it in veterans benefits, where if you were in Vietnam and you have a list of [00:31:14] Speaker 04: Diseases you don't have to prove compensation they do it in the whistleblower context if you make a disclosure within a certain amount of time causation is Presumed and I just don't see how we read that into the statute when it's not there. [00:31:28] Speaker 02: Let me and I know I'm over so let me Describe where I think that to answer your question this plays out. [00:31:36] Speaker 02: I think special masters clearly have discretion and [00:31:41] Speaker 02: They have discretion on a case-by-case basis to decide whether or not reasonable basis exists. [00:31:47] Speaker 02: That's well settled. [00:31:49] Speaker 02: The problem with how Special Master Moran handled this is he looked solely for causation. [00:31:54] Speaker 02: He looked at whether or not the treating doctors connected it and whether or not there was expert testimony. [00:32:00] Speaker 02: Instead of the first time it went up to Judge Williams in Cottingham, too, she said, [00:32:08] Speaker 02: look, you need to look at the whole thing. [00:32:10] Speaker 02: Now Simmons was still an issue in that opinion, and that's sort of what created some more appeals. [00:32:15] Speaker 02: But she looked at that from a medical record requirement. [00:32:21] Speaker 02: Did the medical chart corroborate the allegations being made? [00:32:25] Speaker 02: Did they corroborate the injuries being claimed to be due to the vaccination? [00:32:29] Speaker 02: Certainly, the only missing piece is causation. [00:32:32] Speaker 02: But again, you don't need that for reasonable basis. [00:32:36] Speaker 02: that cannot possibly be the standard to evaluate a case at the outset as far as whether a treating doctor says or thinks it might be vaccine related. [00:32:47] Speaker 01: Given the history of this case, even if we were to agree with you, assuming that we agree with you, what would happen? [00:32:54] Speaker 01: We would remand so that the special master can look at the case again and not with the causation lenses, [00:33:03] Speaker 01: And the special master will make a reasonable basis determination, which we would review under what, substantial evidence? [00:33:12] Speaker 01: I mean, where does that leave you? [00:33:15] Speaker 01: In fact, where does that leave you with respect to the fees? [00:33:19] Speaker 02: I think the first part of your question is you're right. [00:33:24] Speaker 02: I think from the appellant and petitioner's standpoint, that is what should happen. [00:33:30] Speaker 02: Remember, the procedural history here is when Judge Williams saw it for the first time. [00:33:35] Speaker 02: She remanded it back to the special master for that exact reason. [00:33:39] Speaker 02: And at that point in time, the special master looked at the case and said, well, if that's what I'm supposed to do, I think the affidavits satisfy reasonable basis all by themselves. [00:33:49] Speaker 02: And he awarded fees. [00:33:51] Speaker 02: Respondent took that up. [00:33:54] Speaker 02: Special Master made some errors about Simmons and stuff in that opinion. [00:33:58] Speaker 02: And that triggered another reversal and a remand back. [00:34:02] Speaker 02: And then he flipped and denied fees. [00:34:04] Speaker 02: It's been the same record the whole time. [00:34:06] Speaker 02: I almost think that that level of a procedural disaster that we've had in this case reflects that there's a question here about whether or not this case has reasonable basis. [00:34:18] Speaker 02: You're absolutely right, Your Honor. [00:34:20] Speaker 02: I do think that's what should happen. [00:34:22] Speaker 02: It should be remanded back to the special master to look at the evidence as a whole. [00:34:26] Speaker 01: Wouldn't this all depend upon how we were reviewing Simmons or what we think Simmons means versus what the special master thinks? [00:34:35] Speaker 02: Yes. [00:34:36] Speaker 02: I think the vaccine program participants on both sides need some clarification there. [00:34:43] Speaker 01: I should have asked you, Your Honor, too. [00:34:44] Speaker 01: But does Simmons mention causation anywhere in it? [00:34:50] Speaker 02: Not when it talks about the evidence that's required. [00:34:55] Speaker 02: Instead, if I remember correctly, Simmons says, as I mentioned earlier, there must be some evidence. [00:35:02] Speaker 02: There must be some objective evidence. [00:35:03] Speaker 02: And I think the way Simmons phrases it is evidence of injury. [00:35:08] Speaker 02: I don't believe Simmons says anything about requiring causation evidence. [00:35:17] Speaker 02: I think partly what has taken us down this path over the last two or three years is one camp wants to look at it. [00:35:27] Speaker 02: It's purely causation. [00:35:29] Speaker 02: If you don't have causation, you don't have reasonable basis. [00:35:32] Speaker 02: And the other camp, the petitioner side, [00:35:34] Speaker 02: looking at it as the special master should be able to look at everything, the novelty of the vaccine, the medical records, the complaints, the product monograph. [00:35:45] Speaker 02: All of that is evidence that is filed in this case that supports the feasibility of the case going forward in the first place. [00:35:51] Speaker 01: OK. [00:35:52] Speaker 01: We thank you for your arguments, and we thank all the parties for their arguments this morning. [00:35:56] Speaker 01: This court now stands in recess. [00:35:59] Speaker 04: All rise. [00:36:01] Speaker 04: The honorable court is adjourned until tomorrow morning at 10 o'clock. [00:36:04] Speaker 04: Hang on.