[00:00:00] Speaker 02: Looks like we're all here. [00:00:02] Speaker 02: We'll turn now to 24-4114 Dressen versus AstraZeneca AB. [00:00:10] Speaker 02: Mr. Anderson, are you ready to proceed? [00:00:12] Speaker 01: I am, Your Honor. [00:00:15] Speaker 01: Good morning, and may it please the Court. [00:00:17] Speaker 01: I'm going to try to reserve three minutes of my time. [00:00:20] Speaker 01: In a declared national emergency, like the COVID pandemic, federal immunity for vaccine manufacturers depends on two things. [00:00:29] Speaker 01: Does the plaintiff assert a loss covered by the statute? [00:00:33] Speaker 01: And two, was that loss allegedly caused by the administration of a vaccine? [00:00:40] Speaker 01: The complaint answers both questions for us. [00:00:43] Speaker 01: Ms. [00:00:43] Speaker 01: Dressen says in paragraph 27 that she suffered, quote, a COVID vaccine injury. [00:00:49] Speaker 01: In paragraphs 168, 169, and 174, she seeks to recover her medical expenses and emotional damages. [00:00:56] Speaker 01: That's her loss. [00:00:57] Speaker 01: That she says she, quote, incurred as a result of the vaccine. [00:01:01] Speaker 01: That's the causation. [00:01:03] Speaker 01: The PREP Act directly addresses this scenario. [00:01:07] Speaker 01: It gives manufacturers immunity from suit and liability under federal and state law for all claims for loss. [00:01:16] Speaker 01: which Congress broadly defined to include the physical, mental, and emotional injuries that Miss Dressing claims here. [00:01:22] Speaker 01: Anytime that loss has a causal relationship to the administration of a vaccine. [00:01:28] Speaker 01: The plain text bars this suit. [00:01:30] Speaker 01: The decision below should be reversed because nothing in the statute carves out contract claims. [00:01:36] Speaker 04: Why did your client bother entering into these contracts in the first place if you're gonna [00:01:44] Speaker 04: you know, fail to honor them and claim immunity. [00:01:47] Speaker 04: I don't quite get it. [00:01:48] Speaker 04: Is that because the PrEP immunity came later? [00:01:50] Speaker 01: So, Your Honor, this is AstraZeneca's global standard-informed consent form, and it's attached to the complaint. [00:01:58] Speaker 01: And you see that this is a required element of clinical vaccine trials all over the world. [00:02:03] Speaker 01: And [00:02:04] Speaker 01: In this case, the Prep Act immunity, Congress just overlaid the conditions for enforcement of any kind of claim. [00:02:14] Speaker 01: So all claims for loss. [00:02:16] Speaker 01: But every single promise that was made in the informed consent form was made subject to the Prep Act. [00:02:21] Speaker 01: That's the choice that Congress made. [00:02:23] Speaker 01: And Ms. [00:02:24] Speaker 01: Dressen was directly informed expressly that the Prep Act may limit her ability to sue or recover. [00:02:31] Speaker 01: And this was not some fine print on page 62 of the appendix here. [00:02:35] Speaker 01: There were three paragraphs that spelled out the limitations that federal law imposes under the conditions of a national emergency right here. [00:02:43] Speaker 01: And so the analytical error below is when Congress said all claims for loss, [00:02:51] Speaker 01: They use that phrase because they meant all claims, right? [00:02:54] Speaker 01: So we need to have a loss in causation. [00:02:56] Speaker 01: Under those circumstances, Congress was agnostic to the legal theory that was applied. [00:03:02] Speaker 04: Well, is her argument that the PREP Act compensation does not fully compensate her for the vaccine injury? [00:03:10] Speaker 04: Is that the underlying controversy between your client and her? [00:03:15] Speaker 01: I think the underlying controversy here is, again, a statutory question of whether contract claims are categorically excluded. [00:03:23] Speaker 04: I'm talking about what the damages theory is. [00:03:26] Speaker 01: Correct. [00:03:27] Speaker 01: And so the damages, we understand that Ms. [00:03:29] Speaker 01: Dressen has sought compensation [00:03:31] Speaker 01: from the exclusive remedial regime that Congress created, the CICP, and that the losses that she sought from the federal compensation program are the exact same losses that she seeks here. [00:03:42] Speaker 01: And she's entitled to seek compensation through the federal program, but what she can't do, because the statute forbids it, is pursue duplicative state law claims for what she calls, what she attributes to the COVID vaccine, right? [00:03:56] Speaker 01: That's precisely the sort of claim that the PREP Act immunizes. [00:04:00] Speaker 02: Now, could your form, are you saying that the protection provided to Zeneca by the act cannot be waived? [00:04:10] Speaker 02: Could it be waived in a form? [00:04:13] Speaker 01: Now, presumably a clear and unmistakable waiver of immunity. [00:04:17] Speaker 01: I don't think there's a reason that it couldn't be. [00:04:19] Speaker 01: We certainly don't have that here. [00:04:21] Speaker 01: We have the opposite. [00:04:22] Speaker 02: Well, that has not been litigated, right? [00:04:26] Speaker 02: Correct. [00:04:27] Speaker 02: So we could decide that this is a claim that is covered by the act and remand to the district court to see whether there's been a waiver. [00:04:37] Speaker 02: Could we not? [00:04:38] Speaker 01: Correct, Your Honor. [00:04:39] Speaker 01: That was an alternative theory that was raised below. [00:04:42] Speaker 01: It's an alternative theory for affirmance raised on appeal. [00:04:45] Speaker 01: It was not decided below. [00:04:46] Speaker 01: And I would respectfully submit that the clear and unmistakable standard for waiver can't be met in a circumstance where the immunity itself was clearly disclosed on the same page of that informed consent form. [00:05:01] Speaker 01: But yes, Your Honor, that could be decided below. [00:05:05] Speaker 02: So we don't need to decide whether the form overrides the act. [00:05:10] Speaker 02: We don't need to decide that at this stage of the proceedings. [00:05:16] Speaker 02: The question just is whether the damages she's seeking are [00:05:21] Speaker 02: covered by the by the Prep Act absent waivers. [00:05:24] Speaker 02: Is that right? [00:05:24] Speaker 01: Correct. [00:05:25] Speaker 01: Whether the statute carves out contract claims. [00:05:28] Speaker 01: And that is the question on interlocutory appeal here. [00:05:32] Speaker 04: Mr. Anderson, I do have a question about that. [00:05:36] Speaker 04: Are you finished answering Judge Hart's? [00:05:38] Speaker 04: I do have a question about the collateral order doctrine applied here. [00:05:42] Speaker 04: And our cases are pretty stringent on [00:05:47] Speaker 04: the application of that, in particular when you're looking at litigation between two private parties. [00:05:56] Speaker 04: We almost never agree that those types of disputes, even with an underlying immunity, can be interlocutorily appealed. [00:06:05] Speaker 04: What do you think makes this one special? [00:06:09] Speaker 01: It's Congress's choice of the scope of immunity here. [00:06:13] Speaker 01: It's immunity from suit and liability. [00:06:15] Speaker 01: That's the statutory text. [00:06:17] Speaker 01: And so as every court of appeals to address this question has agreed, that is subject to interlocutory appeal from a motion, from a denial of the motion to dismiss. [00:06:25] Speaker 01: So the Sixth Circuit in Goins, the Eighth Circuit as well, recognizes that that meets the Cohen or Mohawk standards for an interlocutory appeal for sovereign immunity here. [00:06:36] Speaker 01: And they're applying [00:06:37] Speaker 01: familiar doctrines of sovereign immunity, tribal immunity, qualified immunity that make this an appealable final order because the immunity from suit would be forever lost if this case proceeds beyond a motion to dismiss. [00:06:50] Speaker 04: will be it be lost in this case, but you know, it could be the issue could be resolved on a direct appeal. [00:06:57] Speaker 04: I don't necessarily disagree with you. [00:06:58] Speaker 04: I've been on the losing end of these collateral order in the 10th Circuit. [00:07:02] Speaker 04: So I have a lot of sympathy for that. [00:07:05] Speaker 04: But, you know, having been on the losing end, you know, we've we found no collateral order for litigation privilege, for Bivens Actions, False Claims Act. [00:07:16] Speaker 04: You know, we we have for, you know, the case you cited cases in your brief and [00:07:19] Speaker 04: So we've gone kind of both ways. [00:07:22] Speaker 04: But I think you've answered my question. [00:07:23] Speaker 04: It's basically Congress has given you a broad immunity, and you deserve to have that decided. [00:07:30] Speaker 01: That's right, Your Honor. [00:07:31] Speaker 01: And so turning back to the merits, because the question on appeal, again, to Judge Hartz, is this narrow question of whether the statute carves out contract claims categorically. [00:07:41] Speaker 01: And we know it doesn't. [00:07:42] Speaker 01: In fact, Congress knew how to create an exception for contract claims. [00:07:46] Speaker 01: It wrote one in the PLCAA, that's the firearms statute, just two months earlier. [00:07:53] Speaker 01: And it omitted contract claims from the sale or purchase of a product. [00:07:58] Speaker 01: But it omitted that carve out in the PREP Act. [00:08:01] Speaker 01: And that omission was deliberate because legislators were forced to make the difficult policy choice that in an emergency, the national interest is best served [00:08:11] Speaker 01: by the rapid development and deployment of life-saving vaccines without the looming threat of litigation, right? [00:08:17] Speaker 01: It was balancing the private rights with public safety. [00:08:21] Speaker 01: But as was alluded to earlier, Congress did not leave participants without a remedy. [00:08:26] Speaker 01: It centralized that recovery in the CICP. [00:08:29] Speaker 01: And so, you know, again, Ms. [00:08:30] Speaker 01: Dressen has sought those claims here. [00:08:32] Speaker 01: And I want to focus on what I believe to be the key analytical error made in the decision below, because the district court found an exception for contract claims in the causation element. [00:08:44] Speaker 01: And respectfully, I believe the court misapplied that causation element. [00:08:49] Speaker 01: The district court asked whether the breach of contract was caused by the administration of a vaccine, rather than asking whether the loss [00:08:58] Speaker 01: was causally related to the administration of a vaccine, which is what the statutory text requires. [00:09:04] Speaker 01: So the district court just asked the wrong question and therefore reached the wrong result. [00:09:08] Speaker 01: Congress was focused on losses, not labels. [00:09:11] Speaker 01: And if a covered loss is causally related to the administration of the vaccine, then all claims, all claims are immunized under the statute. [00:09:20] Speaker 01: And as this court recognized in Allen, all means all. [00:09:24] Speaker 01: As the Supreme Court recognized in Norfolk and Western Railway, [00:09:28] Speaker 01: An exemption from all other law, which was the statutory language in that case, includes contract claims. [00:09:35] Speaker 01: There are no implicit exceptions in Congress. [00:09:38] Speaker 01: And that breadth is a feature of this law. [00:09:41] Speaker 01: It's not a flaw. [00:09:43] Speaker 01: While the uniform rule may seem broad, it's the very breadth that allows the lifesaving countermeasures to exist at all. [00:09:57] Speaker 02: Do we lose you? [00:09:58] Speaker 01: No, I'm still here. [00:09:59] Speaker 01: I won't get the questions. [00:10:01] Speaker 01: I'm happy to. [00:10:03] Speaker 02: You didn't move and I thought maybe there was a transmission problem. [00:10:08] Speaker 03: May I ask a brief question? [00:10:10] Speaker 03: If we do reverse. [00:10:15] Speaker 03: Do we need to go in your prayer on page 37? [00:10:18] Speaker 03: You include a number of things. [00:10:20] Speaker 03: You alluded to some that fit the PrEP Act's definition or illustrations of what constitutes a loss, emotional injury, medical injury and the like. [00:10:35] Speaker 03: But there are some species of recovery like lost income. [00:10:40] Speaker 03: If we do reverse, do we need to go item by item in your prayer? [00:10:44] Speaker 03: and determine which of the specific requests for relief in the complaint are or not proper losses that would fall within the immunity under the PREP Act, or do we just skirt that? [00:11:05] Speaker 01: Your Honor, I don't think that level of parsing is necessary. [00:11:08] Speaker 01: And in fact, that would encourage artful pleading. [00:11:11] Speaker 01: What Congress was focused on is the nature of the loss writ large, not how many different kinds of loss can be articulated. [00:11:19] Speaker 01: And lost income, for instance, could be captured by the business interruption definition of loss, which, of course, Congress defined as all kinds of loss, and it included some specific examples. [00:11:29] Speaker 01: So I don't think that level of parsing is necessary. [00:11:31] Speaker 01: And what it boils down to, respectfully, is that absent the injection, no claim exists at all in this case. [00:11:39] Speaker 01: And so that's, again, that was Congress's focus here, looking at the loss, determine whether it meets a relaxed causation standard between the administration of the vaccine, and that is this case, and therefore immunity applies. [00:11:53] Speaker 03: Thank you. [00:11:55] Speaker 01: There are no further questions. [00:11:56] Speaker 01: I'd like to reserve the remainder of my time. [00:11:59] Speaker 02: Thank you, counsel. [00:12:00] Speaker 01: Thank you. [00:12:05] Speaker 02: Mr. Cunnett? [00:12:08] Speaker 00: May it please the court. [00:12:12] Speaker 00: My name is Michael Connett, and I am an attorney for the appellee Breanne Dressen. [00:12:18] Speaker 00: At its root, AstraZeneca's position is that it has a license to breach its contracts, a license to break its promises, and more fundamentally, a license to lie. [00:12:38] Speaker 00: that the immunity under the PREP Act is so radically broad that it can lie to clinical trial participants like Ms. [00:12:49] Speaker 00: Dressen without incurring any civil liability. [00:12:54] Speaker 00: AstraZeneca's position is that it can induce [00:13:01] Speaker 00: prospective trial participants like Ms. [00:13:03] Speaker 00: Dressen to take an experimental drug by unequivocally promising that if they get injured, AstraZeneca will cover their costs. [00:13:15] Speaker 00: And when trusting members of the public act on this promise and get injured, AstraZeneca can simply turn around and say, sorry, we don't owe you a single solitary cent. [00:13:30] Speaker 02: Now, how is that argument different from your waiver argument? [00:13:35] Speaker 02: Is it essentially the same as the waiver argument? [00:13:40] Speaker 02: Because apparently if there weren't this form, you would say that they're protected. [00:13:47] Speaker 02: But because of the form, they're not protected, which sounds like a waiver argument to me. [00:13:53] Speaker 00: Your Honor, that's a good question. [00:13:55] Speaker 00: I think ultimately it's two pathways to get to the same result. [00:13:58] Speaker 00: Either the Prep Act, as we argue, does not include and does not cover contractual violations at all. [00:14:05] Speaker 00: Or if it does, then AstraZeneca waived that right by knowingly extinguishing a right that it had by making the promise to pay Miss Dressen's costs if she gets injured. [00:14:23] Speaker 00: So I think it's two pathways to the same end. [00:14:27] Speaker 02: But let me explore your argument for the primary pathway you seem to be taking, which is that the PREP Act doesn't cover contracts, breach of contract. [00:14:43] Speaker 02: As I understand it, your argument rests in large part on the list of things that, of losses that are not covered. [00:14:57] Speaker 02: Under the prep act that are that there's immunity for and you have death, physical, mental, emotional injury, and so on. [00:15:06] Speaker 02: And you say, these are tort. [00:15:09] Speaker 02: Losses. [00:15:11] Speaker 02: And that's that. [00:15:13] Speaker 02: supports the position that contract losses are not covered. [00:15:18] Speaker 02: Am I getting that close to right? [00:15:20] Speaker 00: That is part of it, Your Honor. [00:15:22] Speaker 00: It's one piece of the puzzle. [00:15:24] Speaker 00: We look to the words of the statute to understand what all claims means. [00:15:29] Speaker 00: And when looking to the words of the statute, we see that it is laced [00:15:34] Speaker 00: with tort-based language, both in terms of tort-based mental states, willfulness, recklessness, negligence, tort-based damages like death, physical injury, emotional injury, as well as tort-based conduct. [00:15:51] Speaker 00: If you look at A to B, when we're talking about the scope of immunity, the statute provides a classic laundry list of the type of conduct that you see in product liability tort cases. [00:16:02] Speaker 00: So our argument is first look, you know, you, you, you understand what a word means by the company. [00:16:10] Speaker 00: It keeps NASA tier associates. [00:16:14] Speaker 00: And in this statute, it is laced with tort based language, but that's not all your honor. [00:16:20] Speaker 00: You look to because clearly the statute does not speak to contracts one way or the other, you either have to read in contracts or read out our position is the far more reasonable construction is to read contracts out and one of the ways you get there. [00:16:40] Speaker 00: Is you look to the history of the act you look to the purpose underlying the act and as we note in our papers the history here is you had a tidal wave of tort claims and tort liability against pharmaceutical companies for vaccines. [00:16:59] Speaker 00: Congress was very sensitive to that. [00:17:01] Speaker 00: They wanted to ensure that vaccine companies did not have crippling tort litigation. [00:17:08] Speaker 00: And so they implemented the Prep Act to address tort liability. [00:17:12] Speaker 00: But there was never any such thing as contract liability for pharmaceutical companies with respect to vaccines. [00:17:19] Speaker 00: There's not a single solitary mention in the congressional record about needing to protect vaccine companies from contracts. [00:17:28] Speaker 00: So we would argue, Your Honor, that the words of the statute, this tort-based framework, aligns with the history that gave rise to the Act, as well as Congress's purpose in enacting the Act. [00:17:43] Speaker 02: And... I didn't mean to interrupt you. [00:17:46] Speaker 00: I thought you had concluded, but... I would just add one other point, and one other way you get to this result, Your Honor, is, which I think is a very important piece here, is the absurdity doctrine. [00:17:58] Speaker 00: I think it is unthinkable that Congress could have intended for pharmaceutical companies like AstraZeneca to be able to lie through their teeth. [00:18:11] Speaker 00: to clinical trial participants, promise them that they will cover their costs if they get injured, and then turn around and say, no, we don't have to pay you because Congress gave us a license to lie. [00:18:24] Speaker 00: It's absurd and bizarre to think that Congress would have done that. [00:18:29] Speaker 04: Doesn't the informed consent form have a disclaimer about potential congressional prep immunity? [00:18:39] Speaker 04: Why doesn't that put your client on fair notice that there might be an immunity problem down the road? [00:18:45] Speaker 00: I don't think it does, Your Honor, for several reasons. [00:18:48] Speaker 00: First off, the contract is very clear, unequivocally so, that AstraZeneca will pay the costs of a research injury. [00:19:00] Speaker 00: That language is unequivocal. [00:19:02] Speaker 00: By contrast, several paragraphs later, [00:19:06] Speaker 00: There is language that doesn't mention the Prep Act, never discloses what, you know, that there is a Prep Act or how to find it. [00:19:15] Speaker 00: It talks about a federal order or federal rule. [00:19:18] Speaker 00: But more importantly, Your Honor, is it never says there's a, there's a federal statute that prevents you from ever recovering costs from us. [00:19:32] Speaker 00: unless we commit willful misconduct. [00:19:35] Speaker 00: Instead, it speaks in very ambiguous and equivocal terms as there is a federal order that may limit your right to sue. [00:19:48] Speaker 00: May limit. [00:19:49] Speaker 00: It doesn't say will limit. [00:19:51] Speaker 00: It doesn't take the position that AstraZeneca takes here that there's complete immunity and they don't have to pay a cent. [00:19:58] Speaker 00: It doesn't speak with that. [00:20:00] Speaker 02: But they're saying may because [00:20:02] Speaker 02: This is a global consent form and sometimes the vaccines or whatever drug they're administering is covered by the PREP Act and sometimes it's not. [00:20:13] Speaker 02: So isn't that what the mayor is referring to? [00:20:16] Speaker 02: There may be a statute that limits liability. [00:20:21] Speaker 00: I don't think you can consider that. [00:20:24] Speaker 00: Because I think that goes beyond like if you look at parole evidence rule, we need to look to the four corners of the page, whether or not and there's no evidence in the record to indicate that AstraZeneca why they drafted the contract that way and whether they have the same language in other countries. [00:20:40] Speaker 00: I think you need to look at the contract as written between a sophisticated party like AstraZeneca and an unsophisticated trial participant. [00:20:48] Speaker 00: and ask, what does the plain meaning of that contract states? [00:20:52] Speaker 00: What does the plain meaning say? [00:20:54] Speaker 00: It says, clearly and unequivocally, we will pay your costs. [00:20:59] Speaker 00: And then later it says, there may be a federal statute that may limit your right to sue. [00:21:05] Speaker 00: How does an ordinary lay person interpret that? [00:21:08] Speaker 00: They look at it and they see a clear promise, a clear promise to get their costs recovered if they should get injured. [00:21:16] Speaker 00: And the other stuff is kind of, what does it mean? [00:21:20] Speaker 00: I don't know. [00:21:20] Speaker 00: I mean, what does that language even mean? [00:21:24] Speaker 02: I think we get your point there. [00:21:26] Speaker 02: Let me ask you though, what were you seeking to recover in your lawsuit? [00:21:32] Speaker 00: We are seeking your honor to cover the full extent of damages that can be recovered under the law of contracts. [00:21:41] Speaker 00: both general damages. [00:21:43] Speaker 02: Well, I want to know specifically, because I gather from from what opposing counsel recited a few minutes ago from the complaint, you want the the the pay for her medical expenses and recovery, emotional losses and so on, things that are listed as losses under the Prep Act. [00:22:08] Speaker 02: So why does that language, if what you're seeking through a contract claim are losses that are specifically listed in the PREP Act, how can you say that the fact that that language is used in the PREP Act shows it's limited to tort claims and not contract claims? [00:22:31] Speaker 00: So I'll start by saying that we are [00:22:34] Speaker 00: The damages that we seek in this case do happen to be partially coextensive with the damages that you see in tort cases and what's the difference? [00:22:45] Speaker 02: What? [00:22:45] Speaker 02: What? [00:22:46] Speaker 02: What? [00:22:47] Speaker 02: Well, I don't know. [00:22:48] Speaker 02: Extensive is there. [00:22:49] Speaker 02: Can you name something that wouldn't be covered in the tort pain? [00:22:52] Speaker 00: Yes, Your Honor, I think that you'll see a difference in what you can recover for emotional damages in a contract action. [00:22:59] Speaker 00: There are more limitations on what you can recover, as well as different hurdles that you have to overcome to recover emotional damages under control in Utah, which we have briefed below. [00:23:11] Speaker 00: And also, there's limitations on things like punitive damages. [00:23:16] Speaker 04: How can you have a breach of contract here without a vaccine injury? [00:23:23] Speaker 00: Your honor, you can't. [00:23:25] Speaker 00: And the reason you can't is that AstraZeneca drafted this contract. [00:23:30] Speaker 00: And when they drafted this contract, they made the condition precedent of their obligation to pay [00:23:38] Speaker 00: of vaccine injury. [00:23:39] Speaker 00: So our claim follows the terms of their contract. [00:23:44] Speaker 00: Their contract says if the condition precedent, namely vaccine injury occurs, we will pay the costs. [00:23:53] Speaker 00: So our claim [00:23:55] Speaker 00: our claim seeks to recover the general damages of the breach. [00:23:59] Speaker 00: The general damages of the breach follows the promise. [00:24:02] Speaker 04: The promise is- But the condition of precedent isn't satisfied without the vaccine causing a vaccine injury. [00:24:11] Speaker 00: Correct. [00:24:12] Speaker 00: And so, but this goes to the- Right. [00:24:16] Speaker 04: So there's no breach if there's no contract injury. [00:24:18] Speaker 00: There's no breach without a vaccine injury. [00:24:22] Speaker 00: Correct, Your Honor. [00:24:24] Speaker 00: And our position, our argument is that, I mean, when we look to the scope of immunity under a statute, we look to its purpose. [00:24:35] Speaker 00: The purpose of the PREP Act, as both parties agree, is to promote the rapid development of countermeasures, including vaccines. [00:24:44] Speaker 00: A critical component of that are clinical trials. [00:24:49] Speaker 00: and clinical trials require public participation, which requires public trust. [00:24:58] Speaker 00: And if you allow pharmaceutical companies to lie, to straight up lie to trial participants by saying, we're gonna cover your costs if you get injured, and then turn around and say, sorry, we don't have to pay you, we're not gonna pay you, that will erode [00:25:16] Speaker 00: perhaps irreparably so, the trust that is essential to public participation in clinical trials. [00:25:25] Speaker 00: You go ahead. [00:25:27] Speaker 02: Touch back, Rick. [00:25:29] Speaker 02: No, let's move on. [00:25:31] Speaker 02: I think we understand the point being made, so go ahead. [00:25:33] Speaker 02: Touch back, Rick. [00:25:35] Speaker 03: My question to you, Mr. Connett, is I understand that none of us had a role in writing the PrEP Act. [00:25:43] Speaker 03: The first thing that you said, I want to push back on that, that we start with the purpose. [00:25:50] Speaker 03: I don't think that's true. [00:25:51] Speaker 03: We start with the words of the statute. [00:25:54] Speaker 03: And I think that, and you can tell me if I misunderstood your last answer to Judge Timberlake's question, but at least in paragraph 37 of the complaint, you have included medical expenses, emotional injury, [00:26:08] Speaker 03: illustrations, as Judge Hart's mentioned, that are examples explicitly of losses that are enumerated in the Prep Act. [00:26:16] Speaker 03: So then the question is, does the loss arise out of the use of a vaccine? [00:26:23] Speaker 03: You argued in response to Judge Tempovich that, well, it's not a cause, it's a condition precedent. [00:26:29] Speaker 03: But to follow up on Judge Tempovich's question, isn't that answer fatal to your whole argument based on the terminology of the statute? [00:26:39] Speaker 03: You have a loss, at least for some of the species of recovery that you included in paragraph 37 in the prayer, and you cannot have a loss without that condition precedent. [00:26:54] Speaker 03: That's what a condition precedent is. [00:26:57] Speaker 03: And if the use of a vaccine is a condition precedent, why isn't that combination a very simple paragraph to reverse [00:27:08] Speaker 03: based on the argument that we have a loss and we have a conditioned precedent that arises out of the use of the vaccine. [00:27:18] Speaker 00: I'll start by saying, I agree that you don't need to look to congressional purpose or legislative history if you have a statute that's clear on its face and plain on its face. [00:27:29] Speaker 00: But literalism does not equal good textualism. [00:27:33] Speaker 00: And so I think AstraZeneca's position is, well, the word all means all, and you can ignore the context in which this word is placed in the statute as well as the congressional purpose. [00:27:47] Speaker 00: Our position is that there's ambiguity in this statute. [00:27:51] Speaker 00: It definitely does not ever mention contracts. [00:27:54] Speaker 00: So the court has to read contracts in or has to read contracts out. [00:27:59] Speaker 00: And so when you have some ambiguity, it's really critical that you look to the purpose and then ask yourself which construction of this statute is going to best further congressional purpose. [00:28:14] Speaker 00: Is it the construction that will allow pharmaceutical companies to lie through their teeth, the clinical trial? [00:28:22] Speaker 02: I think you've made that point very well several times, and your time has expired. [00:28:27] Speaker 02: I judge back, I have some more questions, but I think you don't need to go any further on that point. [00:28:33] Speaker 04: I do have a follow-up question. [00:28:37] Speaker 04: I'm just looking at the PREP Act and going back to the statute. [00:28:40] Speaker 04: And we've been talking most about part A, which is the definition of a loss, which includes mostly tort-like damages. [00:28:50] Speaker 04: But part B is scope. [00:28:52] Speaker 04: And in the scope paragraph, it says the immunity applies to any claim of loss that arises out of clinical trials. [00:29:02] Speaker 04: And so it looks like Congress was envisioning harms or losses coming out of clinical trials. [00:29:10] Speaker 04: How would you square that with your argument? [00:29:13] Speaker 00: I think that's clear. [00:29:14] Speaker 00: I think Congress absolutely envisioned things like people getting injured by a vaccine during a clinical trial, and Congress did not want those people to sue the company for that injury, right? [00:29:27] Speaker 00: But the legal injury there, Your Honor, is the injury itself. [00:29:31] Speaker 00: Here, the legal injury is not the vaccine injury. [00:29:35] Speaker 00: The legal injury here is that AstraZeneca breached its contractual obligation. [00:29:41] Speaker 00: That is the legal injury for which we seek relief. [00:29:44] Speaker 00: I do not think, Your Honor, that Congress ever once contemplated the scenario that is here where a company seeks to escape its contractual promise. [00:29:57] Speaker 00: And so that would be my response. [00:30:00] Speaker 00: And lastly, I would note that as the court noted earlier, even if the court were to construe the Prep Act as encompassing contractual violations, [00:30:13] Speaker 00: This case is not right for dismissal because we have two separate pathways for overcoming that through both waiver and estoppel. [00:30:23] Speaker 00: And as AstraZeneca has conceded in its brief, these are issues that do require factual development. [00:30:30] Speaker 00: One is a pure issue of fact, mostly an issue of fact, and the other is a mixed question of fact and law. [00:30:36] Speaker 02: So I would- Yeah, that's understood. [00:30:39] Speaker 02: That's not a dispute. [00:30:43] Speaker 02: Did you have another question, Judge Baccarat? [00:30:45] Speaker 02: Oh, no. [00:30:46] Speaker 02: Okay. [00:30:47] Speaker 02: Because I have a follow up question. [00:30:50] Speaker 02: It wasn't that long ago, during my life as a lawyer, that there was a lot of controversy [00:31:02] Speaker 02: or difference of opinion regarding malpractice cases and to what extent it was a contractual claim or a tort claim. [00:31:10] Speaker 02: If you got a bad result from surgery, was that breach of contract or was that tort? [00:31:18] Speaker 02: Things like that. [00:31:19] Speaker 02: Are you saying that if a state decides to recast [00:31:25] Speaker 02: it's more recent cases that have generally treated these issues as tort claims and called them contract claims that then the suits under those contract claims would not be covered by the Protect Act, that it's just a matter of nomenclature, [00:31:46] Speaker 00: I don't think so, your honor. [00:31:48] Speaker 00: Well, we sort of addressed this down below where AstraZeneca was trying to characterize this case as a breach of warranty kind of case that you see within or an implied warranty case that you see within product liability, which are sometimes called contract actions. [00:32:06] Speaker 00: At the end of the day, those actions have their fundamental roots in tort and [00:32:13] Speaker 00: And so you can't just this is not just a matter of semantics. [00:32:16] Speaker 02: You can't just you're saying you're saying breach of warranty is really fundamentally based on tort law. [00:32:23] Speaker 02: Is that what you're saying? [00:32:24] Speaker 00: Yes. [00:32:24] Speaker 00: In the product liability context. [00:32:26] Speaker 02: Well, why can't we say your contract claim is fundamentally based on tort law? [00:32:32] Speaker 02: Because how do you decide whether it's fundamentally based on tort law or not? [00:32:37] Speaker 00: Well, Utah law provides guidance on just that issue. [00:32:41] Speaker 00: Is there a written promise, the breach of which gives you a cause of action? [00:32:49] Speaker 00: And so in here, that's what we have. [00:32:51] Speaker 00: We have a written instrument with a promise that was broken. [00:32:56] Speaker 00: And that is a very distinct [00:32:59] Speaker 00: cause of action from implying some type of warranty that then becomes termed a contract. [00:33:09] Speaker 00: I think that type of cause of action, you can't escape the prep act through that kind of semantics. [00:33:19] Speaker 00: But where you have a company that is expressly promising something in an enforceable written contract, that is a distinct [00:33:29] Speaker 00: cause of action. [00:33:31] Speaker 00: And I think it's important to note that this is not something that has caused any issues with litigation in the past. [00:33:39] Speaker 00: This is not something that's gonna open the floodgates of litigation. [00:33:42] Speaker 00: This is entirely within the control of pharmaceutical companies like AstraZeneca to simply not make promises if they're not prepared to keep them. [00:33:51] Speaker 00: Then there's no further liability. [00:33:55] Speaker 02: Okay. [00:33:55] Speaker 02: I think [00:33:56] Speaker 02: In terms of exhaustion, I think we've exhausted your arguments at this point. [00:34:01] Speaker 02: Mr. Anderson has reserved some rebuttal time, so we'll hear from him. [00:34:05] Speaker 02: Thank you. [00:34:07] Speaker 01: Thank you, Your Honors. [00:34:08] Speaker 01: I want to address three points in rebuttal. [00:34:11] Speaker 01: First is the comment that the statutory text does not include an express invocation of contracts either way. [00:34:19] Speaker 01: It also doesn't include an express inclusion of statutory claims, but those are immune, as we saw in the red case. [00:34:26] Speaker 01: It also doesn't say federal constitutional claims are included, but as the Ninth Circuit found in Manny, they are. [00:34:32] Speaker 01: All claims means all claims. [00:34:34] Speaker 01: Congress was not interested in legal labels. [00:34:37] Speaker 01: It wanted to see if there was a loss, as broadly defined by the statute. [00:34:41] Speaker 01: And if so, and it was caused by the administration of a vaccine, all claims that could be brought for that kind of loss are immunized. [00:34:50] Speaker 01: The second is the idea of the unequivocal promise. [00:34:53] Speaker 01: First of all, I want to read from what the informed consent form says. [00:34:57] Speaker 01: But before I do that, nothing in an informed consent form can change the statutory meaning of the PREP Act. [00:35:04] Speaker 01: That is an independent question, as Judge Hartz has reminded us a few times. [00:35:09] Speaker 01: But here's what the contract says. [00:35:11] Speaker 01: You may be prevented from making claims for injuries that have a causal relationship with the use of the investigational product in this study. [00:35:20] Speaker 01: And it goes on to say, including, but not limited to claims for debt. [00:35:24] Speaker 01: It essentially replicates the text of the Prep Act without naming it by name. [00:35:29] Speaker 04: What page of the consent form did you read from? [00:35:32] Speaker 01: I'm reading from page 62 of the appendix. [00:35:35] Speaker 01: That may be the easiest way to find it, Your Honor. [00:35:41] Speaker 01: Lastly, the absurdity canon. [00:35:44] Speaker 01: All means all, and interpreting it that way is not absurd. [00:35:48] Speaker 01: This was a deliberate if difficult policy choice by Congress. [00:35:54] Speaker 01: Reading the text faithfully is not just good textualism. [00:35:59] Speaker 01: It shows respect for Congress's constitutional role in setting national emergency policy. [00:36:06] Speaker 01: It recognizes that Congress used broad language throughout. [00:36:10] Speaker 01: Any claim, all claims. [00:36:13] Speaker 01: Loss means any loss. [00:36:15] Speaker 01: using a causation standard that is as broad as we get in legislative text, arising out of, relating to, caused by. [00:36:22] Speaker 01: It faithfully honors the careful balance that Congress struck. [00:36:28] Speaker 01: It was faced with a national emergency in 2005, recognizing that our industries were not equipped and were deterred from being able to prepare our country for the rapid development and deployment of lifesaving vaccines in the event of a crisis. [00:36:45] Speaker 01: honoring the balance that they struck, broad as it may be, directing injuries that are caused thereby to the federal compensation scheme is not absurd. [00:36:55] Speaker 01: Respectfully, this is a heartland case for immunity. [00:36:59] Speaker 01: The factual predicate of this case, in Ms. [00:37:02] Speaker 01: Dressen's own words, are the personal neurological harm from the vaccine. [00:37:08] Speaker 01: That is precisely the circumstance that the text and purpose of Congress sought to immunize. [00:37:14] Speaker 01: We respectfully ask this court to reverse the judgment below. [00:37:19] Speaker 02: Thank you, counsel. [00:37:21] Speaker 02: Thank you both. [00:37:22] Speaker 02: Cases submitted. [00:37:23] Speaker 02: No more questions, I gather. [00:37:26] Speaker 02: I should have checked. [00:37:27] Speaker 00: No. [00:37:28] Speaker 02: Cases submitted and counsel are excused.