[00:00:00] Speaker 05: And our next case is Curtis versus Jay Inslee, case number 24-1869. [00:00:50] Speaker 03: Good morning, Your Honors. [00:00:51] Speaker 03: May it please the Court. [00:00:52] Speaker 03: My name is David Schech-Snyder. [00:00:54] Speaker 03: I represent the plaintiffs and appellants. [00:00:56] Speaker 03: I have three points to make in the opening. [00:00:58] Speaker 03: Point one is we're here today because the district court did not accept as true plaintiff's allegations that the only drugs available to plaintiffs to comply with the mandates were investigational, granted emergency use authorization status, [00:01:18] Speaker 03: immunized from liability under the prep act and offered exclusively through the federally funded CDC program a program that provides the plaintiffs a property right to learn of the drugs risks benefits and alternatives and To exercise the option to accept or refuse them without pressure or penalty number two [00:01:46] Speaker 03: We're also here because the district court failed to address the fact that defendants who agreed to the terms of the CDC program were preempted from amending the terms of that program. [00:01:58] Speaker 03: The program was built on voluntariness. [00:02:01] Speaker 03: It's a prep act program. [00:02:04] Speaker 03: The defendants are preempted from changing the program to an involuntary one. [00:02:11] Speaker 03: And third, we're here today because the district court would not address the fact that because the government owned these drugs, but needed a distribution arm for them, they delegated the duty to obtain the legally effective informed consent from any potential recipient that the federal government had to, they delegated that to the state. [00:02:34] Speaker 03: And then the state delegated that to peace health because peace health was a signatory to this program. [00:02:41] Speaker 03: These are drugs that are owned by the government. [00:02:44] Speaker 03: There is no possible way for Peace Health to go to Pfizer and say, you know, I'd like some of those drugs to distribute to individuals. [00:02:52] Speaker 03: Can't do it. [00:02:54] Speaker 03: Got to go through the CDC program. [00:02:56] Speaker 03: This is a federal program, federally owned drugs. [00:02:59] Speaker 03: They must go through the state's immunization cooperative agreement. [00:03:03] Speaker 03: So you've got the state involved, and then the state recruits [00:03:08] Speaker 01: Actors to just actually distribute the drugs let me let me ask you this I Take I hear all of that and I read all of those allegations but then I shifted really to what I thought was the legal question and that is under what statute or provision you're making the claim and so I marched through [00:03:36] Speaker 01: multiple statutes and my preliminary conclusion, but I'm open to having you tell me otherwise, that there's no private right of action under virtually all those statutes. [00:03:48] Speaker 01: So what in your view is the best legal foundation for making the claim, leaving aside all of what you said and crediting that as true? [00:04:02] Speaker 03: Well, the best is we're bringing the case under Section 1983. [00:04:05] Speaker 03: And 1983 is not exclusive to federal laws, but it also includes the Constitution. [00:04:13] Speaker 03: So we believe that under the Constitution, our clients have the fundamental right to refuse the injection of investigational emergency use authorization, PREP Act, immunized drugs. [00:04:27] Speaker 01: Well, I mean, obviously, we have to link [00:04:31] Speaker 01: Your claims to in your allegations to individual claims so I take it for the Constitutional claim you would be claiming the 14th amendment. [00:04:42] Speaker 01: That's correct 14th amendment and and tell me there under the 14th amendment What in your view provides a legitimate claim under the 14th amendment because because of the status of these drugs [00:05:01] Speaker 03: our clients have the right to their own bodily autonomy to determine what goes in their body. [00:05:08] Speaker 03: And as a result, they can refuse investigational drugs. [00:05:12] Speaker 04: So it's not an equal protection claim. [00:05:14] Speaker 04: It's a substantive due process claim. [00:05:16] Speaker 03: It's both. [00:05:16] Speaker 03: It's substantive due process when you're talking about bodily autonomy. [00:05:21] Speaker 03: It is equal protection when you have individuals who are similarly situated, [00:05:28] Speaker 03: in this case, healthcare workers within the state of Washington. [00:05:32] Speaker 03: They're similarly situated. [00:05:33] Speaker 03: Then they're told, okay, here's this mandate. [00:05:37] Speaker 03: Well, the only ones that were punished were the ones that exercised their right to refuse and not the people who exercised their right to accept. [00:05:46] Speaker 03: See, they're similarly situated. [00:05:47] Speaker 03: They have the same option, but only those who exercise one option. [00:05:55] Speaker 03: were terminated, were penalized. [00:05:58] Speaker 05: Let's start with the substantive process claim. [00:06:01] Speaker 05: Because it's not that the plaintiffs have been told you must take this drug. [00:06:10] Speaker 05: period, it's, you know, in order to continue being an at-will employee at a hospital or anything else. [00:06:18] Speaker 05: And so what is the, where, what's the source of your constitutional authority that says that someone has a liberty interest in being able, you know, not having that forced upon them to have their at-will employment be in jeopardy based on that choice? [00:06:37] Speaker 03: Well, first of all, as with regard to health care workers, they are in possession of a state issued health care license that is a property interest. [00:06:46] Speaker 03: And they're being told in order for you to continue to use this license that you've already been given and have been practicing under, you must now inject an investigational drug, emergency use prep act drug into your body. [00:07:00] Speaker 05: Are they deprived of a license if they don't take a vaccine? [00:07:05] Speaker 03: Yes, because then they can't work in the health care system. [00:07:08] Speaker 01: They lose a job. [00:07:10] Speaker 03: Or any health care job, because the mandate by Governor Inslee applied to all health care workers, not just Peace Health workers. [00:07:19] Speaker 03: Peace Health issued a mandate because the governor issued a mandate. [00:07:24] Speaker 03: So it flows through. [00:07:26] Speaker 03: So in answer to your question, first of all, [00:07:30] Speaker 03: they're being deprived of a property interest if they're not now injected with this drug. [00:07:36] Speaker 03: And secondly, the at-will employment doctrine is preempted by the PREP Act and by the Supremacy Clause. [00:07:44] Speaker 03: In the PREP Act, it says if any state or local [00:07:49] Speaker 03: subdivision uses or continues in effect with a law or legal requirement that conflicts with the rights that are in the FDCA statute and the EUA statute, then it's preempted. [00:08:02] Speaker 04: Let me back up just a little bit. [00:08:05] Speaker 04: So you said that [00:08:09] Speaker 04: It sounded like what you're saying there, you had a procedural due process claim. [00:08:12] Speaker 04: Is that right? [00:08:13] Speaker 04: Correct. [00:08:14] Speaker 04: There's a procedural as well. [00:08:15] Speaker 03: We have substantive procedural. [00:08:17] Speaker 04: You said like it was terminating some, right? [00:08:22] Speaker 03: Yes, they have. [00:08:23] Speaker 03: In order to work in their profession as nurses at P-cell, they must have a state issued license. [00:08:30] Speaker 03: So that's a property right. [00:08:31] Speaker 04: So their refusal to take the vaccine results in the termination of their license? [00:08:38] Speaker 03: It results in them not being able to use their license the way they have been using it. [00:08:44] Speaker 03: That sounds a little different. [00:08:46] Speaker 03: Well, what's the difference if you have a license but can't use it or don't have a license? [00:08:51] Speaker 03: Is there really any difference between those two? [00:08:53] Speaker 03: We say no. [00:08:54] Speaker 03: We say that's a violation and that's a deprivation of the rights they have in that property interest. [00:09:00] Speaker 05: So I'm trying to think about how you get past Jacobson because this executive order applied to, I think, 600,000 different workers. [00:09:09] Speaker 05: So it wasn't just health care workers. [00:09:11] Speaker 05: There were lots of people that needed to take a vaccine in order to continue working and [00:09:18] Speaker 05: in these fields and Jacobson says there's no substantive due process right to say no to a vaccine. [00:09:27] Speaker 05: So what you know and I understand that you're arguing a difference with whether this is a vaccine versus the emergency use drug but at the end of the day the constitutional principles that there's no substantive due process interest so why doesn't Jacobson foreclose your argument there? [00:09:44] Speaker 03: Jacobson does not apply here. [00:09:46] Speaker 03: First of all, Jacobson did not involve an emergency use authorization, PrEP Act immunized investigational drug. [00:09:53] Speaker 03: It did not. [00:09:54] Speaker 03: It was one that was approved. [00:09:56] Speaker 03: So you have that difference. [00:09:58] Speaker 03: There was no EUA statute in 1905. [00:10:01] Speaker 03: There was no PrEP Act in 1905. [00:10:03] Speaker 03: There was no CDC program in 1905. [00:10:05] Speaker 03: It wasn't the situation where Massachusetts owned all of the smallpox vaccine and determined that it would distribute those drugs. [00:10:15] Speaker 03: The difference is these are federally owned drugs. [00:10:19] Speaker 03: This is government property. [00:10:23] Speaker 03: If you don't believe me, ask Dr. Kirk Moore, who's being prosecuted in Utah right now, and the government is maintaining that these drugs are government property. [00:10:33] Speaker 03: So there's a big difference between Jacobson and this case, and also factually. [00:10:40] Speaker 05: Can you explain it to me? [00:10:41] Speaker 05: What is it about it being a government drug in your view that creates a substantive due process right? [00:10:47] Speaker 05: As opposed to it being a private vaccine that the government says you have to vaccinate for the good of public health. [00:10:53] Speaker 05: Why does that make a difference? [00:10:56] Speaker 03: Because the government under the Constitution owes different duties to individuals than private employers do. [00:11:02] Speaker 03: If there's an FDA licensed drug and it's okay now for private employers to distribute them outside of a governmental program, yes, that's Jacobson. [00:11:14] Speaker 03: What we have here is government property and people being told that they must take government injections of investigational drugs, drugs that are not at the same level of the drug that was at issue in Jacobson. [00:11:30] Speaker 03: So Jacobson does not apply to the facts of this case. [00:11:33] Speaker 05: But you don't dispute that after the vaccine has been approved, the government can require people to take government FDA approved vaccines after the fact, even if they have a conscientious objection to. [00:11:48] Speaker 03: I want to make sure we're talking about the same thing here because one of the arguments is that the license for Comornati [00:11:54] Speaker 03: That was that was issued on August 23rd can somehow apply to the Pfizer BioNTech vaccine. [00:12:00] Speaker 03: That's what we're talking about. [00:12:01] Speaker 05: How about you just answer my question. [00:12:02] Speaker 05: An FDA approved vaccine. [00:12:05] Speaker 05: Forget the emergency use in that context. [00:12:08] Speaker 03: Yes, in that situation, then you would still have to go through the same process that they used in Jacobson. [00:12:14] Speaker 03: And they used the rational basis there. [00:12:17] Speaker 03: We don't believe rational basis is involved here because we're talking about government-owned drugs that are being forced upon people to inject them. [00:12:25] Speaker 03: We believe it's a fundamental right to reject investigation of drugs under the bodily autonomy rule. [00:12:32] Speaker 01: So we think... And it doesn't matter that the investigational drug is clinically identical to the vaccine? [00:12:40] Speaker 03: You see, that's a factual allegation we disagree with. [00:12:44] Speaker 03: And I'll tell you, the Pfizer-BioNTech vaccine [00:12:48] Speaker 03: the EUA drug came in a six dose vial and needed to be diluted. [00:12:54] Speaker 03: Comrinati comes in a single dose vial, does not need to be diluted. [00:12:59] Speaker 03: Those drugs are not the same. [00:13:01] Speaker 03: And in fact, in the record, there's evidence, Pfizer indicated they were not going to manufacture the approved Comrinati drug codes. [00:13:10] Speaker 03: And they said they were going to wait until after their trisucrose formulation was ready. [00:13:15] Speaker 03: That didn't happen until 2023. [00:13:17] Speaker 01: I think in some ways you're jumping ahead because I'm still stuck, maybe improperly, but on what's the claim. [00:13:26] Speaker 01: And so I go through all the statutes, you know, the EUA and this and that and CFR and USC and I don't see any private right of action. [00:13:36] Speaker 01: So then I get to your substantive due process. [00:13:39] Speaker 01: But it seems to me that where we have imposed [00:13:43] Speaker 01: a substantive due process, we've looked at historical examples, cultural norms, et cetera, et cetera, shock the conscience. [00:13:51] Speaker 01: And you haven't really stated a claim under that. [00:13:58] Speaker 01: Is that your, I mean, is your substantive due process under the 14th Amendment your best foundational claim? [00:14:08] Speaker 03: under the 14th Amendment and also under the unconstitutional conditions doctrine, which is also the 14th Amendment. [00:14:14] Speaker 03: So because you can't hinge the exercise of your right upon engaging in that behavior. [00:14:22] Speaker 03: So we believe it's an unconstitutional condition as well. [00:14:26] Speaker 03: We disagree that there's no private right of action under the EUA statute, because there are individually conferred rights. [00:14:32] Speaker 03: It even speaks of individuals must be informed of the option to accept or refuse. [00:14:38] Speaker 05: What about the bar under the FDCA, under the federal drug? [00:14:43] Speaker 03: Well, you look at that. [00:14:44] Speaker 03: You look at 337 and the enforcement, it says, and there was a recent Wilkins decision by the Ninth Circuit. [00:14:51] Speaker 03: And it ignored one word, a very important word, [00:14:54] Speaker 03: in Section 21 U.S.C. [00:14:57] Speaker 03: 337A, and that is, it says, except as provided in subsection B, which talks about states bringing actions in their own name, all such proceedings for the enforcement or to strain violations must be in the name of the United States. [00:15:17] Speaker 03: What does such mean? [00:15:19] Speaker 03: They could have, the Congress could have easily written all proceedings for the enforcement, or in the name of the United States. [00:15:27] Speaker 03: It says all such proceedings. [00:15:29] Speaker 03: Such refers back to something else that refers to the except as provided in subsection B You look at the actions in subsection B. Those are in the name of the state. [00:15:38] Speaker 05: They're under section 341 Those are adulteration of food So what they are still actions in the name of the state neither of those two things Seem to permit an individual raising a claim [00:15:53] Speaker 05: Which is what you guys are. [00:15:54] Speaker 03: But the point is, is that we're not raising a claim under 341, and we're not, none of our claims are part of 331, which are the prohibited acts under the FDCA. [00:16:05] Speaker 03: So if you look at what the government is supposed to be enforcing, those are in section 331, the prohibited acts. [00:16:13] Speaker 03: 360 BBB-3 is mentioned twice. [00:16:16] Speaker 03: None of those are applicable to this case. [00:16:18] Speaker 03: One is the refusal to copy records, and one is for the actual introduction of the [00:16:23] Speaker 03: and delivery of the drugs into interstate commerce, none of which is at issue here. [00:16:30] Speaker 03: So why is there the word such? [00:16:33] Speaker 03: It's because there are other rights that are in the EUA statute that can be enforced by 1983 and should be enforced. [00:16:44] Speaker 01: Give me the most specific language from that statute that you believe creates a private right of action. [00:16:54] Speaker 03: It is, well, as you know, it's a three-step process, but to show in 360 BBB-3E1A2, and it says the appropriate, the secretary shall establish appropriate conditions designed to ensure that individuals to whom the product is administered are informed [00:17:22] Speaker 03: of the option to accept or refuse administration of the product. [00:17:27] Speaker 01: But that doesn't create a private right of action for the individual. [00:17:32] Speaker 03: Not a private right of action. [00:17:33] Speaker 03: It creates a 1983 claim, which are different from a private right of action. [00:17:38] Speaker 01: Well, under 1983, you're going to have a statutory right of action. [00:17:43] Speaker 01: So we look to see if the statute provides a private right of action. [00:17:47] Speaker 01: Or we've already discussed the Constitutionals. [00:17:49] Speaker 01: We've already talked about the 14th Amendment. [00:17:53] Speaker 01: under 1983, you can't have some free standing claim that doesn't, under a statute that doesn't give you a private right of action. [00:18:04] Speaker 03: I respectfully disagree. [00:18:05] Speaker 03: If the statute states a specific cause of action for an individual, they don't need Section 1983. [00:18:13] Speaker 03: They use the statute. [00:18:14] Speaker 03: Look at Title VII. [00:18:15] Speaker 03: That's why you go to the EEOC, and that's the private right of action. [00:18:19] Speaker 03: If there is no private right of action within the statute, like this enforcement scheme, but there are individually conferred rights, as we've just mentioned, [00:18:31] Speaker 03: then that's when you use 1983 to enforce those rights, especially when the government is not enforcing them. [00:18:39] Speaker 01: We have a long line of cases that basically say that there are a whole host of obligations that the government has, but that are not necessarily enforceable by private individuals. [00:18:54] Speaker 01: I mean, there's long history and extensive case law on that. [00:19:01] Speaker 01: Just because the government abdicates doesn't mean there's a private right of action. [00:19:06] Speaker 03: No, but looking at the verbiage of the EUA statute. [00:19:09] Speaker 01: And you would use the word individual as the hook. [00:19:12] Speaker 03: Exactly. [00:19:13] Speaker 03: Look, Talensky tells us to do that. [00:19:14] Speaker 03: The Supreme Court tells us to look for individually conferred rights that are specific to individuals. [00:19:20] Speaker 03: And what could be more individual than someone saying, [00:19:23] Speaker 03: I refuse. [00:19:24] Speaker 03: I exercise my option to refuse. [00:19:26] Speaker 05: And then... Let me see if my colleagues have any other questions, and then we'll hear from the other side. [00:19:31] Speaker 05: And I'll give you a little time for rebuttal. [00:19:33] Speaker 05: Thank you, sir. [00:19:40] Speaker 02: Good morning, Your Honors. [00:19:42] Speaker 02: I'm Ian Rogers from Pacifica Law Group on behalf of Apple League Governor Jay Inslee, and I'm splitting my time with Council for Peace, Health, so I'll be taking the first 10 minutes. [00:19:49] Speaker 02: Just watch your time. [00:19:50] Speaker 02: Thank you. [00:19:52] Speaker 02: The court should affirm the dismissal of the employees' claims here for three reasons. [00:19:56] Speaker 02: First, Governor Inslee is entitled to qualified immunity from those claims unless the employees can identify a right that was clearly established at the time of the mandate. [00:20:05] Speaker 02: As both Judge McEwen and Judge Sanchez indicated, they have no such right, the authorities to the contrary. [00:20:12] Speaker 02: So qualified immunity precludes their claims. [00:20:14] Speaker 02: Second, the right that they claim here to refuse vaccination without penalty requires that they establish that the mandate constituted human medical research. [00:20:24] Speaker 02: But the research-related authorities that they cite confirm that it doesn't. [00:20:28] Speaker 02: And in any event, they're not enforceable under Section 1983, so give them no rights here. [00:20:33] Speaker 02: And third, the distinction that they attempt to draw that they place at the heart of their case between FDA approved drugs and EUA approved drugs is irrelevant and self-defeating. [00:20:45] Speaker 02: None of the authorities approving or confirming the validity of vaccines turn on FDA approval. [00:20:51] Speaker 02: Jacobson, in fact, was issued the year before the FDA even existed. [00:20:56] Speaker 02: And the definition of research doesn't turn on FDA approval either. [00:21:00] Speaker 02: And their invocation of the PREP Act is only self-defeating. [00:21:04] Speaker 02: That's an immunity provision. [00:21:05] Speaker 02: It gives them no rights. [00:21:07] Speaker 02: Their constant reference to it only provides an independent basis for dismissal under the PREP Act immunity provision. [00:21:13] Speaker 02: So for those reasons, the court should affirm dismissal. [00:21:16] Speaker 02: First, unqualified immunity again. [00:21:18] Speaker 02: As the court's already recognized, over 100 years of precedent since the United States Supreme Court's 1905 decision in Jacobson affirms the validity of vaccine mandates generally. [00:21:27] Speaker 02: This court has repeatedly affirmed the legality of Washington's mandate specifically. [00:21:32] Speaker 02: And in Johnson v. Cotech, the court addressed the distinction the employees attempt to make here between EUA drugs and FDA-approved drugs and found that even if it was colorable, arguably, it would at best make the mandate debatable and couldn't overcome the presumption of qualified immunity. [00:21:49] Speaker 02: The same is true here. [00:21:51] Speaker 02: The employees attempt to get around that by claiming that Governor Inslee had a ministerial duty to accept their choice not to be vaccinated. [00:21:58] Speaker 02: But even if you take that as true, it was complied with. [00:22:01] Speaker 02: The employees concede that they did successfully refuse vaccination. [00:22:05] Speaker 02: So qualified immunity bars the claims. [00:22:07] Speaker 01: Would you discuss to some degree the due process claim? [00:22:14] Speaker 01: And because the council put a great deal of emphasis on the constitutional [00:22:21] Speaker 01: claim and you could argue that intuitively if you take their characterization of the facts which is like forcing someone to have an injection against their will would shock the conscience and secondly if you had a license a medical license but you can't use it so it's all but tied up in these that that would give you [00:22:47] Speaker 01: a due process claim. [00:22:49] Speaker 01: What is Governor Inslee's or former Governor Inslee's response to that? [00:22:53] Speaker 02: So first a clarification. [00:22:55] Speaker 02: The employees don't allege that they were forced to take the vaccine. [00:22:58] Speaker 02: They specifically allege, I think repeatedly in their complaint, including at paragraph 143, that they did refuse injection and were penalized for that. [00:23:07] Speaker 02: So there's no dispute that that [00:23:10] Speaker 02: That is what happened. [00:23:12] Speaker 02: You know, it's possible a case could arise where there was a forced vaccination and that would present different issues potentially that aren't at issue here, although conceivably that would still be authorized under Jacobson. [00:23:22] Speaker 02: There, the penalty at issue was much stiffer as the Third Circuit recognized in the CHCIV Rutgers case. [00:23:28] Speaker 02: It wasn't just loss of employment. [00:23:29] Speaker 02: The individual was actually fined and imprisoned as a result of not being vaccinated. [00:23:35] Speaker 02: So the state's rights here are quite strong. [00:23:38] Speaker 02: Regarding the right to medical license, I think as you recognize Judge Pai, it's different to suspend the use of a medical license or to deprive somebody of at-will employment that involves a medical license than to sort of strike the license. [00:23:53] Speaker 02: And they've cited no authority to suggest that this sort of temporary inability to work in the medical field constitutes a due process right. [00:24:02] Speaker 02: And in fact, in the Ditman v. California case, which I believe is cited in co-counsel's brief, the court recognized that Supreme Court authority generally recognizing an interest in employment in a certain field distinguishes cases where there's a complete prohibition on employment and a sort of temporary inability to work. [00:24:20] Speaker 02: There's no allegation here nor could there be that there was anything other than a temporary inability to use their medical license, the vaccine mandates no longer in place. [00:24:29] Speaker 02: So they've not identified any protected property interest that would lead to a substantive due process claim. [00:24:36] Speaker 01: I think the other point that council made is that the use of the word individual and individuals being apprised of certain rights, I think that was in the EUA statute perhaps, [00:24:48] Speaker 01: that that somehow is transformed into a private right of action. [00:24:53] Speaker 01: What's the government's position on that? [00:24:55] Speaker 02: So the authority is expressly to the contrary. [00:24:58] Speaker 02: In fact, the Supreme Court just recently affirmed that statutes, in order to give a private right of action or an action enforceable under Section 1983, there needs to be explicit rights conferring language. [00:25:09] Speaker 02: So that was the Medina v. Planned Parenthood case. [00:25:12] Speaker 02: The statute at issue there provided arguably much more of a right than the one here does. [00:25:18] Speaker 02: It provided that Medicaid plans must provide that individuals eligible for medical assistance can obtain assistance from any qualified provider. [00:25:26] Speaker 02: So it specifically speaks to, you know, arguably rights held by these individuals. [00:25:30] Speaker 02: The statute here is far more attenuated, as you recognize, Judge McHugh, and it provides that the HHS secretary has to establish conditions [00:25:38] Speaker 02: that would ensure people are informed of the right to refuse vaccination. [00:25:42] Speaker 02: And moreover, as the Third Circuit recognized in the CHDIV Rutgers case, it contemplates that there can be consequences for that refusal. [00:25:49] Speaker 02: It says they not only need to be informed of the right to refuse, they need to be informed of any consequences for the refusal. [00:25:56] Speaker 05: So it doesn't... And how are people informed of the right to refuse here? [00:25:59] Speaker 02: The proclamation itself provided for options to seek an exemption or turn down the vaccine. [00:26:10] Speaker 02: There's no allegation here that anybody was deprived of knowledge that they had an option to refuse the vaccine. [00:26:15] Speaker 05: And again... Would the proclamation be fairly understood to say that if you refused and you didn't apply, you know, qualify for an exemption that you would lose your job? [00:26:25] Speaker 02: Yes. [00:26:27] Speaker 02: That's true. [00:26:28] Speaker 02: But again, nothing in the statutes or regulations that the employee site preclude the state from doing that. [00:26:33] Speaker 02: That's consistent with over 100 years of precedent upholding these type of vaccine mandates as a legal exercise of the state's power. [00:26:41] Speaker 02: And lastly, I just want to confirm or reiterate that this distinction between EUA drugs and FDA drugs is completely irrelevant. [00:26:50] Speaker 02: The employees have argued that the court's opinion below rested on, you know, rejecting their factual assertions that the drugs were different. [00:26:59] Speaker 02: But the court actually, although it did include that in the background section, its legal analysis didn't turn on that at all. [00:27:05] Speaker 02: It turned on the absence of any enforceable right, as you noted, Judge McKeown. [00:27:11] Speaker 02: and the existence of Governor Ellensley's qualified immunity. [00:27:15] Speaker 02: So, again, the definition of research that they rely on doesn't turn on the question of FDA approval. [00:27:24] Speaker 02: It says, it's defined broadly as, and this is from 45 CFR 46.102 subsection L, [00:27:32] Speaker 02: defines research as a systematic investigation designed to contribute to generalized knowledge. [00:27:36] Speaker 02: Now that doesn't apply for the reasons outlined in our brief. [00:27:39] Speaker 02: You know, their theory here is that there was certain public health reporting that was required that the regulation specifically exempts from the definition of research. [00:27:47] Speaker 02: But the important thing to recognize now is that the definition of research doesn't turn on FDA approval. [00:27:56] Speaker 02: So they're trying to cabin their argument to say that this is research because it involves an EUA drug. [00:28:00] Speaker 02: But if their argument's accepted here, it would apply to any vaccine mandate for any FDA approved drug in which this type of public health reporting was at issue and could conceivably overturn, again, over 100 years of precedent affirming the legality of these vaccines. [00:28:17] Speaker 02: of these vaccine mandates. [00:28:21] Speaker 02: And finally, as discussed, the EUA statute doesn't give them any right to refuse without penalty. [00:28:27] Speaker 02: The PREP Act also doesn't give them any right to refuse vaccine without penalty. [00:28:32] Speaker 02: The only source of that right is the definition of research that they can't meet. [00:28:35] Speaker 02: and their invocation of the PrEP Act only provides an independent basis for dismissal by bringing their claims under the immunity provision. [00:28:42] Speaker 05: What about counsel's argument that the bar under Section 337A would not bar a claim here under the Emergency Use Authorization Act? [00:28:56] Speaker 02: Well, I don't have the statute in front of me. [00:28:59] Speaker 02: They did not raise that argument in either their opening brief or their reply, so I've not had a chance to consider it. [00:29:03] Speaker 02: But that's contrary to this court's authority, which has twice held in the Johnson v. Cotec case most recently. [00:29:12] Speaker 02: that there is no private right of action under the EUA statute. [00:29:16] Speaker 02: And again, even if you put that aside, the EUA statute doesn't apply. [00:29:21] Speaker 02: As the court recognized, it requires this HHS secretary to establish conditions. [00:29:25] Speaker 02: It doesn't place any limitations on Governor Inslee. [00:29:28] Speaker 02: And even the conditions that the HHS secretary is required to establish don't preclude or don't require an opportunity to refuse vaccination without penalty. [00:29:38] Speaker 02: They contemplate that the penalties simply just have to be disclosed. [00:29:42] Speaker 02: And that was done here. [00:29:44] Speaker 02: So unless your honors have additional questions, we'd ask the court to affirm the dismissal. [00:30:00] Speaker 00: Good morning, Your Honors, and may it please the Court. [00:30:02] Speaker 00: I'm Whitney Brown for the Peace Health Appellees. [00:30:05] Speaker 00: The first question this Court needs to decide is whether the plaintiffs are entitled to bring their claims against the Peace Health Appellees under Section 1983 in the first place. [00:30:14] Speaker 00: Answering that question requires determining whether Peace Health was acting under color of law. [00:30:19] Speaker 00: And under this Court's precedence, that question requires first determining the specific conduct of which the plaintiffs complain. [00:30:26] Speaker 00: This is an important question because, as this court has recognized, an entity may be a state actor for some purposes, but not for others. [00:30:33] Speaker 00: Here, the specific conduct of which the plaintiffs complain is that Peace Health, a private employer, terminated their employment because they declined to comply with Peace Health's mandatory vaccination policy. [00:30:44] Speaker 00: They do not allege as my friend was just saying that they received a vaccine from peace health and that in Administering the vaccine peace health declined to seek their informed consent or otherwise violated their federal constitutional or statutory rights They can't because the entire basis of their complaint is that they were terminated because they refused to be vaccinated So the question here is whether peace health was a state actor When it terminated plaintiff's employment for failure to adhere to its vaccination policy and as our brief explains your honors [00:31:14] Speaker 00: All four of the tests this court applies categorically indicate that Peace Health was acting as a private employer, not as a state actor. [00:31:23] Speaker 00: Plaintiffs in their briefing and here today have entirely failed to engage with either the predicate question, in other words, correctly identifying the specific conduct of which they complain, or the four legal tests that govern this court's analysis. [00:31:36] Speaker 00: Without that showing, they cannot prevail. [00:31:39] Speaker 00: If the court has any specific questions, I'm happy to answer them. [00:31:42] Speaker 00: Otherwise, we would ask that the court affirm. [00:31:46] Speaker 05: No questions. [00:31:47] Speaker 00: Thank you, your honor. [00:31:52] Speaker 05: Thank you. [00:31:52] Speaker 05: Council will give you a few minutes. [00:31:53] Speaker 05: We'll give you three minutes. [00:32:00] Speaker 03: With regard to consequences, it's only the HHS secretary that can establish consequences. [00:32:08] Speaker 03: Governor Inslee offered no authority for how he can assign consequences. [00:32:16] Speaker 03: to someone's option to refuse. [00:32:21] Speaker 03: There's no authority for Governor Inslee to issue consequences. [00:32:25] Speaker 03: The EUA statute itself says that it is the HHS secretary that establishes the consequences. [00:32:33] Speaker 03: And what did he establish? [00:32:34] Speaker 03: It's in the August 23, 2021 EUA letter. [00:32:38] Speaker 03: And it says, [00:32:40] Speaker 03: The only, if you refuse, the only consequence you will have is you will be told that there will be no change to your medical standard of care. [00:32:50] Speaker 03: Those are the consequences. [00:32:52] Speaker 03: So what authority does Governor Inslee have to assign new consequences above and beyond what the HHS secretary assigned? [00:33:02] Speaker 03: He has none. [00:33:03] Speaker 03: He has brought nothing before this court to provide that authority. [00:33:09] Speaker 05: I mean, he's the head of a state government over state employees. [00:33:14] Speaker 05: Why doesn't that confer authority as to, in his view, what is important for public health and other reasons for the state? [00:33:22] Speaker 03: and if he wanted to say everybody needs to have an FDA licensed flu shot that the ones that are actually FDA licensed that's a different case than where we are now because it comes back to this fact the only drugs available to the plaintiffs to comply with these mandates [00:33:41] Speaker 03: were EUA, PrEP Act, available only through the CDC program, federal government-owned. [00:33:49] Speaker 03: That is completely different than an FDA-licensed drug. [00:33:53] Speaker 03: And to answer P-cell's question about, well, how are we a state actor? [00:33:56] Speaker 03: You agreed in the CDC program that you would be the one to distribute these drugs on behalf of the federal government through the state's program, and that you would comply with the EUA statute, the PrEP Act, and all of the rules of the CDC program. [00:34:12] Speaker 03: If you can't engage in that conduct as a private entity, and they couldn't, they can't bring you any authority where they could go to Pfizer and say, I would like to buy that drug, the Pfizer BioNTech vaccine under EUA and distribute it. [00:34:27] Speaker 03: They couldn't do it. [00:34:28] Speaker 03: And if they did do it, it'd be illegal. [00:34:32] Speaker 03: So the only way they can be involved in this program is to be operating under color of law. [00:34:39] Speaker 03: because they couldn't do it any other way. [00:34:40] Speaker 03: And if they have those responsibilities, but then they try to attach a penalty or a consequence for refusing, again, Peace Health does not have that authority. [00:34:51] Speaker 03: That's not in the EUA statute. [00:34:53] Speaker 03: The Secretary has the authority. [00:34:56] Speaker 03: So how are they acting under color of law? [00:35:00] Speaker 03: They agreed to do so in the CDC program. [00:35:02] Speaker 03: Guess what? [00:35:03] Speaker 03: They couldn't charge anybody for the services that they were providing. [00:35:07] Speaker 03: What private entity does that? [00:35:10] Speaker 03: No. [00:35:10] Speaker 03: That shows that their actions with regard to these drugs is under color of law. [00:35:16] Speaker 03: So when they're interacting with anyone regarding these drugs, whether it's an employee or not, they can't just take off the hat of the CDC program when they're talking to their employees. [00:35:26] Speaker 03: because their employees have the same rights as everyone else. [00:35:29] Speaker 05: You want to summarize? [00:35:30] Speaker 05: Yes. [00:35:30] Speaker 05: Wrap up counsel? [00:35:34] Speaker 03: You know, the Ninth Circuit is where America looks for leadership on issues of bodily autonomy, whether it's my body, my choice, and the woman's right to choose, whether it's gender-affirming care, or whether now it's the right to refuse an investigational EUA prep act drug. [00:35:54] Speaker 03: This is where America looks. [00:35:55] Speaker 03: for leadership on these issues and that's why we ask you to reverse the trial court. [00:36:00] Speaker 05: Thank you counsel. [00:36:01] Speaker 05: Thank you all for your helpful arguments. [00:36:03] Speaker 05: The matter will stand submitted.