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[Rep. Martin LaLonde (Chair)]: Alright. Welcome back to the House Judiciary Committee this Thursday afternoon. Taking a little bit more testimony on h five forty five. We've kind of had testimony throughout the day, but there's are a couple of issues I wanted to understand a little bit better, and one which we didn't address this morning but would like to address now, and then one that kind of came up a little bit later. The one is negligence versus gross negligence. Why is it or is it not important to have gross negligence as the standard that we have? And the other is how informed consent came up and want to understand a little bit more of how this works into this if it does. So we'll start again with Lauren LaLonde, if you can identify yourself for the record and proceed. Talk about those couple issues.

[Lauren Lehman, General Counsel, Vermont Department of Health]: Great, thank you for the opportunity. It's Lauren Lehman, General Counsel for the Department of Health. And I'll start with the negligence issue. For us, again, the concern is access. And so we want to ensure that providers don't avoid providing vaccines because of concerns about a lengthy and costly tort suit. And so if they are concerned that the negligence standards too low or too risky, as such that they won't provide vaccines, we would be concerned about that. So that's our support for the current standard. If that is what the doctors and providers say that they need to have in order to feel secure providing those vaccines.

[Rep. Martin LaLonde (Chair)]: Can you tell us what the difference between gross negligence and negligence is?

[Lauren Lehman, General Counsel, Vermont Department of Health]: I am not the expert in that, unfortunately. I believe somebody from VMS is here to talk about that. And I thought Katie McLenn also had a chart that she was going to be able to share. Unfortunately, I'm not well versed in the difference. Okay,

[Rep. Martin LaLonde (Chair)]: all right. And if you can address the other issue that I did mention.

[Lauren Lehman, General Counsel, Vermont Department of Health]: Certainly, so informed consent is already a standard of practice in Vermont, and in many states, failure to provide informed consent is considered negligence and medical provider negligence. And so the providers today are subject to medical malpractice liability if they fail to provide an informed consent. They need to provide any treatment alternatives and reasonable foreseeable risks to tell their patients about that that are commonly known by the profession at the time they're providing that treatment. And that's required under 12 VSA nineteen oh nine. It's kind of you have to read it sort of backwards, but that is the malpractice standard in the state already. The department does not support adding a separate informed consent standard for vaccines again, because we'd be concerned about access and making sure people are actually truly getting the information they need when discussing with their providers. They already have to get informed consent before we, before a provider provides any vaccination or treatment. And it would be inconsistent with, we don't have laws that require certain types of informed consent for each treatment, it would not keep pace with the medical technology and knowledge. So we believe vaccinations are similar to that and should have informed consent consistent with the rest of healthcare.

[Rep. Martin LaLonde (Chair)]: Any questions on that from folks?

[Lauren Lehman, General Counsel, Vermont Department of Health]: Ken, go ahead.

[Rep. Kenneth Goslant (Clerk)]: This is this doesn't just have to do with insurance, This is for all coverage. Correct?

[Lauren Lehman, General Counsel, Vermont Department of Health]: I'm sorry. I'm not sure I understand the question.

[Rep. Kenneth Goslant (Clerk)]: Well, I'm not sure I do either.

[Rep. Kevin “Coach” Christie (Ranking Member)]: And I'm not surprised.

[Rep. Kenneth Goslant (Clerk)]: But but this has to do with all vaccinations, whether you have insurance or not.

[Lauren Lehman, General Counsel, Vermont Department of Health]: The informed consent component or the liability protection? Both. Both would be, yes, both would be, regardless of whether you have insurance or not. The vaccines right now are provided for free, and we would continue that practice under age five forty five.

[Rep. Kenneth Goslant (Clerk)]: So if some, so, okay, so now I'm getting to my point. So if somebody wanted a vaccine, is, and the provider didn't have it, couldn't they get it somewhere else or is that illegal?

[Lauren Lehman, General Counsel, Vermont Department of Health]: Absolutely, they could go to another healthcare provider and ask for that, they could get it a lot of them, with certain limitations on ages, etcetera, you can go to pharmacies, you can go to your healthcare provider. So anybody, any healthcare professional who can administer or distribute a vaccine and prescribe a vaccine under their scope of practice, can offer a vaccine in Vermont.

[Rep. Kenneth Goslant (Clerk)]: And just to back up to me, so I'm understanding this, they wouldn't get in trouble for doing that, right? Even though it's not following protocol or whatever the word is that I'm trying to think up for the state of Vermont?

[Lauren Lehman, General Counsel, Vermont Department of Health]: So let me take a step back. So every doctor or healthcare provider needs to follow the standard of care. If they don't follow the standard of care, it could be considered negligence. So if you are a podiatrist, a foot doctor, or say a ear, nose and throat, and somebody is asking for a tetanus shot, and you have no experience and no knowledge of tetanus shots or how to use it, and it's not part of your practice, that could be considered negligence, right? You're acting outside your knowledge, your ability, training, your education. If you're an individual and you go to your primary care physician and say, I want the RSV vaccine, and they say, Oh, we're so sorry, we don't have it in office. Let's change that to the COVID vaccine, and they say, Oh, we don't have it in office, and you decide to go to the pharmacy and get it there later on, that would be absolutely acceptable. Now, then you're talking about these routine vaccines that would be recommended by the commissioner under this. There might be some vaccines that aren't included in the routine recommendations of the Commissioner. Those might be like travel vaccines that aren't commonly given and those aren't currently recommended under the federal schemes often. For those, this bill would not apply to those vaccines that are outside the recommendations of the commissioner. That was a lot. I'm sorry. I tried to parse that in three different ways.

[Rep. Kenneth Goslant (Clerk)]: No, you didn't. This just goes back to me because obviously this is not my field of, I'm gonna say expertise and the room's gonna have fun with this because I have no expertise, but the point of the matter is, what I'm getting at is, just remember years ago, in fact, I think it's still going on, whether you have fluoride or not in the water system, right? Which isn't that a type of vaccine? No. No. Okay.

[Lauren Lehman, General Counsel, Vermont Department of Health]: That's a supplement, that's something, it doesn't cause an immune reaction, etcetera. It is something that's used to, that affects the tooth enamel and prevents cavities. So it's distinct from vaccines. Vaccines are not in the water. They're usually injectable and provided in a medical setting.

[Rep. Kenneth Goslant (Clerk)]: Right, so I kind of get that, but just the kind of the way people think and all this stuff and how they are protective on their rights and all this stuff there. It's like, was kind of using that as an example, if you understand what I'm saying.

[Lauren Lehman, General Counsel, Vermont Department of Health]: I hear what you're saying. And I think there's a distinction in that, if you are dependent on public water and can only, absent having a lot of money to drill your own personal well, have to drink public water, you are forced to consume that fluoride or not forced, but you like you either need to buy bottled water or drink that. And we're fully supportive at this point of certain levels of fluoride in the water. But it's different with vaccines. This bill would not mandate anybody consume vaccines. There would not be a situation where somebody would be forced to get one of these vaccines. There's still absolute autonomy in choosing not to consume that vaccine. And I don't wanna contrast that fully with fluoride, because there's a whole different discussion over there. And I don't want to step in it right now. But I want to do say that there is a huge distinction and that this is an individual choice, an individual with their provider making that choice to have a vaccine.

[Rep. Kenneth Goslant (Clerk)]: I was just using that as an example about how everybody wants to protect their rights or whatever, or have a say in it, and I think it was a big outcry, if I'm not mistaken, in Richmond or something like that a couple of years ago where the guy was putting his stuff in it, putting Yeah. Fluoride

[Lauren Lehman, General Counsel, Vermont Department of Health]: was not putting in it.

[Rep. Kenneth Goslant (Clerk)]: Was not. Okay. Thank

[Lauren Lehman, General Counsel, Vermont Department of Health]: you. Yep.

[Rep. Martin LaLonde (Chair)]: Tom? Strange

[Rep. Thomas Burditt (Vice Chair)]: question, but it wouldn't be me if I didn't ask a strange question, I guess. Hypothetically you know, not hypothetically. I like to see my doctor and get his advice, for my vaccines. And, yes, they they may say, well, I don't have that, so I can go somewhere else and get it. Is there anything to prevent me from going out and getting successive ones from different people inside an unrecommended time? And is there anything to prevent that?

[Lauren Lehman, General Counsel, Vermont Department of Health]: Yes. So there's an Vermont immunization registry and providers when they provide you with a vaccine, it's a fully confidential database, enter that into the IMR is what we call it, the immunization registry, so that when you go to your next provider, they look up and say, Oh, you've already had the first dose of this, it's not recommended that you have another one. If that provider doesn't look on the IMR, or if that provider ignores what's in the IMR and provides a vaccine off schedule or a different dose, then that could be considered not following the standard of care and could be gross negligence.

[Rep. Thomas Burditt (Vice Chair)]: That explains a lot,

[Rep. Martin LaLonde (Chair)]: thank you. Great, any other questions? Tom? You right now, and I apologize because I've missed this morning, and I'm pretty sure I I I know the answer, but if if you could just maybe go over real quick the pieces of in this bill that are for us that we're discussing and and just the pieces that we're gonna be voting on. It's specifically, it's section two, it's 18 BSA 1130A, but specifically subsection C, which is an immunity provision for healthcare professionals. It's on page six, six, the bottom of page six. The reason I mentioned the eleven thirty A, generally eleven thirty A lays out the recommendations that if the doctor or professional healthcare provider in C, if they follow those recommendations, then they have the benefit of the immunity unless they're close negligence. Which we've done before for other issues. We have done immunity protection before for healthcare professionals. So what this doesn't do, and then we not ask because it's not in the bill, is about pharmaceutical company, the manufacturer's liability. That's currently preempted by federal law. And if that changes sometime down the road, maybe we'll be having to look at that. But right now that's preempted. Right. And it doesn't look at if there's any kind of liability of the entity doing these recommendations, also not being asked of us. So it's really relatively narrow. And one of the issues that I thought was really the primary issue we needed to look at was the gross negligence versus negligence standard and whether this comports with other immunity provisions that we've looked at before. So, yeah, Zach. Thanks, Gerard. And I guess this is kind of

[Rep. Zachary Harvey (Member)]: a question for you, Lauren, is the thing that I'm hoping to get to the cornerstone of is the need for immunity at all. And I think the question that I have, and I think maybe some others in the room also have questions on this, is if there were a time, and we're already seeing that the Department of Health in Washington under Secretary Kennedy's leadership is already there is this divergent path in terms of what's recommended and what the vaccine schedules look like, both at the federal level and then now at the state level. And the way that I'm interpreting subsection C of section two is that if Vermont doctors continue prescribing and giving vaccines to whoever it might be, whether it's children or adults, that are antithetical to the views of the federal administration, does this, I mean, this is essentially providing that immunity and protection for those doctors if the federal government were looking to intervene at some point. Am I understanding that right? And is immunity really necessary? I guess what does the immunity provision here accomplish in your view?

[Lauren Lehman, General Counsel, Vermont Department of Health]: Certainly, so I think it accomplishes what the VICP is intended to accomplish on the federal level. It ensures access. So again, even one, vaccine injuries and adverse events are very rare, very rare.

[Rep. Kevin “Coach” Christie (Ranking Member)]: But if

[Lauren Lehman, General Counsel, Vermont Department of Health]: a court suit were to come along, it would be costly and lengthy. And so it can be a deterrent to providers, especially those that might be working for larger chains to undertake that risk and that liability. And so they might decide, it's too much risk, we're not going to provide this vaccine. And the downstream effects of that are that individuals can't access that vaccine either. The federal level has been changing, it's changed and it's created some confusion about when something has to be shared decision making about when vaccines are administered, etcetera. There is confusion over access to the COVID vaccine in the fall and the flu vaccine and who could provide it and when. And so, the health department, our goal is scientifically sound evidence based information and guidance to providers and access to for individuals and this liability protection. Know this morning I talked about the system as a whole. This is one component of that to ensure continued access, and it mimics the federal level, and it is a state level protection in case there are situations where we disagree with, our scientific experts disagree with the federal level assessments.

[Rep. Zachary Harvey (Member)]: So I guess in your view, that the Vermont Department of Health has either better resources or more information than the federal government?

[Lauren Lehman, General Counsel, Vermont Department of Health]: I wouldn't say that.

[Rep. Zachary Harvey (Member)]: Or you have a different interpretation of the science?

[Lauren Lehman, General Counsel, Vermont Department of Health]: There are different interpretations of the science.

[Rep. Martin LaLonde (Chair)]: I think

[Rep. Zachary Harvey (Member)]: that's right. And I think that's kind of what I'm getting at is, regardless of who is sitting at 1600 Pennsylvania Avenue, that if there is better science coming from the Department of Health with their vast resources and scientists and doctors that are informing this, I guess my concern is that if they make a determination at the federal level that something is not necessary or worse, it could be dangerous for Vermonters, why should our doctors be protected in giving that vaccine to people when it could cause irrevocable

[Jessa Barnard, Vermont Medical Society]: harm?

[Lauren Lehman, General Counsel, Vermont Department of Health]: I really wish there were a way, honestly, for us to make that evaluation, but a lot of the changes that have been made recently on the federal level, they have not provided the scientific evidence or the studies they've relied on in making those changes. So what's happened is a lot of national groups and a lot of states have then had to turn to local experts directly to the universities who used to staff those exact committees that provided the scientific evidence on the federal level, and get the information directly from the source. And so now we're having to change, you know, avenues from where which we get that information because we're unable to get that information from those places we used to.

[Rep. Zachary Harvey (Member)]: And are those sources as reliable?

[Lauren Lehman, General Counsel, Vermont Department of Health]: They're the same sources as

[Rep. Zachary Harvey (Member)]: have

[Lauren Lehman, General Counsel, Vermont Department of Health]: for been governing the past thirty years, yeah, forty years now.

[Rep. Zachary Harvey (Member)]: Okay, great. Thank you.

[Rep. Kenneth Goslant (Clerk)]: Thanks. Thank

[Lauren Lehman, General Counsel, Vermont Department of Health]: you. Just a follow-up on that piece of it. So it sounds like this is a new kind of territory that you're entering, that before you would the recommendations would come with the science and references and all of that, and that's not the case with this current That is correct. It would typically be studies shared and information shared basing describing why certain changes were being made to the schedule or to the recommendations in the studies would be shared with the public.

[Rep. Martin LaLonde (Chair)]: Thank you very much, Lauren. I appreciate it. I'm gonna, Jess, if you have anything more to add. I think we've covered a lot, but you're welcome to join us if we have a few minutes. If you could identify yourself. Yes, of course.

[Jessa Barnard, Vermont Medical Society]: Good afternoon. Thank you for having us back. Jessa Barnard with the Vermont Medical Society. So my colleague Stephanie Winters was here this morning, I think this morning? Yes, this morning, and asked me to help address some of the questions specifically around negligence versus gross negligence. So I can do my best. I know the council, I'm sure could help you with this as well and sort of why, what difference that makes from the provider perspective. So we represent physicians and physician assistants, but obviously there are many providers giving vaccines and it well, a few others in addition to those groups, APRNs, pharmacists. So this is really important for the prescriber and pharmacy community in general. The big difference in our view, and actually I think Lauren just gave a great example of this. So gross negligence involves some sort of knowledge of what you are doing, awareness that you are an indifference to the fact that you may be causing harm to somebody. It's some kind of purposeful behavior. So the example Lauren just gave was looking in the vaccine immunization registry, seeing somebody already received a vaccine and knowing that still giving them a second dose when it wasn't appropriate. The difference with negligence is I think of it in a simple way as a mistake. You didn't realize it was something you shouldn't be doing, or you didn't mean to cause harm. So the other example I was thinking of is my best example I could come up with sort of on the fly here was looking in the registry, not seeing that any other vaccine was given. So you give that dose and what happens if maybe it just hadn't showed up yet in the registry. So it actually, you did give a second dose, but it's because you didn't know you shouldn't have done that. Yes, the patient has to allege an injury before going to, these are all kind of a malpractice or tort standard. But as you all well know, that only gets sort of proven or shown down the road. Any patients or you can often end up filing a lawsuit and still having to go through that process of defending yourself, expending the resources on an attorney. That leads to a lot of not just actual expense, but emotional stress for providers. It really calls into question their professional competence, their decision making, and it leads to, in fact, people sometimes even leaving the profession because they don't want to put themselves through that kind of a situation again. So our intent is to get vaccines to the public in an evidence based way. This protection would provide that reassurance that it won't just be a mistake that lands you in court, even if ultimately you're successful. And if you remove the gross negligence or just had it be negligence, that is the malpractice standard. It would basically be no protection. I don't know the purpose of an immunity provision if only included gross negligence and didn't cover negligent behavior. Basically the mistakes, the unintentional behaviors. I think Lauren did a great job already describing the standard for informed consent. I will just say we've had this conversation around other types of procedures and other bills in this building, and we have consistently said, let's not break out procedure by procedure informed consent. We already have a standard for all procedures in terms of the patient knowing the risks, benefits, alternatives. You have to have that conversation, you have to document it. In fact, for vaccines specifically, we already do actually have an added requirement, which is giving a vaccine information sheet that is a written document, plain language explains the risks, benefits. And so we feel like that is quite sufficiently addressed, both in state statute and with that information sheet that's required to be given by federal law.

[Rep. Martin LaLonde (Chair)]: On that issue, if they don't give informed consent, that kind of falls out of this, that's not part of this immunity statute. The immunity-

[Jessa Barnard, Vermont Medical Society]: I don't think, think, yes, I believe I agree with you and that would be a separate, probably allegation of malpractice or negligence and feeling to give informed consent, not about the vaccine you gave, but just the piece around consent. I believe. I mean, I'm not a tort lawyer, but I think that's a fair interpretation. Separate claim.

[Rep. Martin LaLonde (Chair)]: That's not what this is trying to protect. What this is protecting is following the recommendations essentially.

[Jessa Barnard, Vermont Medical Society]: Right, an allegation of injury from that vaccine, administering that vaccine itself in accordance with the recommendations.

[Rep. Thomas Burditt (Vice Chair)]: Quickly. Mandated vaccines are required by is there anything that's actually mandated? Do I have to

[Jessa Barnard, Vermont Medical Society]: For some purposes, like school entry, there are mandates, but not you as an adult, unless your employer or a school was requiring it. There's not a general requirement for any

[Rep. Martin LaLonde (Chair)]: other vaccines.

[Rep. Thomas Burditt (Vice Chair)]: The federal guideline on those required vaccines in that section changing?

[Jessa Barnard, Vermont Medical Society]: Let me make sure. And actually, Lauren may even be the better one to answer this, but if I'm understanding your question, what we're talking about are basically clinical guidelines, not mandatory vaccines. So even the federal recommendations we're talking about, those are not mandates for anyone to receive those vaccines. Those are really about, we're really talking about clinical best practice for clinicians as well as And then it's linked, and the reason we need this bill, it's linked to things like insurance coverage. What vaccines do insurers have to pay for? There is nothing in the current federal scheme or Vermont about those being requirements. That's a whole separate list of what vaccines may be required for preschool or K through 12.

[Rep. Thomas Burditt (Vice Chair)]: I have to guess. So whatever is required to go to school, for instance, a school age child, is that changing at all?

[Jessa Barnard, Vermont Medical Society]: No? Not in this field. Doesn't address anything about requirements for any vaccine.

[Rep. Martin LaLonde (Chair)]: Any other questions?

[Rep. Kevin “Coach” Christie (Ranking Member)]: Yeah, just one. I don't know if it's for you or not, Jess. Is there any pushback at all in Vermont from any health care providers on the new guidelines or different guide, not necessarily new,

[Rep. Martin LaLonde (Chair)]: but different guidelines like what the Fed has We

[Jessa Barnard, Vermont Medical Society]: have some press statements on our website in that regard. Yes. There's a lot of concern about that they are not evidence based and can lead to resurgence of diseases we thought we would That guidelines.

[Rep. Kevin “Coach” Christie (Ranking Member)]: No, no, I'm talking about

[Jessa Barnard, Vermont Medical Society]: This approach? Oh, this bill?

[Rep. Kevin “Coach” Christie (Ranking Member)]: This approach is there pushback from the healthcare industry?

[Jessa Barnard, Vermont Medical Society]: No, there's a lot of support for it because it actually is looking for input. I you've I know folks represent

[Rep. Kevin “Coach” Christie (Ranking Member)]: the healthcare industry, but

[Jessa Barnard, Vermont Medical Society]: No, I think I will say to be fair, the one the only question I have heard raised is, well, what happened? We have great faith in our current administration and health department here in Vermont. Those people could be changing too, but we could always deal with that if we came to that or and they now have to have input from this advisory council, which involves a lot of clinicians in the state. So, we think that process will work well, even with different people in different seats in our governor's administration here.

[Rep. Kevin “Coach” Christie (Ranking Member)]: Well, the healthcare people in the state of Vermont certainly can make a more informed choice than I can, for starters. They have just a little bit more education as far as this stuff goes. As far as the immunity goes, again, we've talked about that we have granted immunity to healthcare personnel in the past, regardless of the issue behind it. I think this is third time I've worked on something like this, at least three. And whether I agree with the issues or not, personally, I think it's important to protect our healthcare workers. And the big reason is we have a shortage. And every time we lose one, I mean, less healthcare, potential healthcare, good healthcare for Vermont. And I'm not a big immunization guy, I was telling Stephanie earlier, but these are recommendations. Nothing mandatory. There's nothing changing around that. You know, Tom brought up the schools. Nothing gonna change there, and I don't think we could change anything as far as employment bumps, there's nothing we can do about it. So I really don't have an issue with the bill.

[Rep. Zachary Harvey (Member)]: Great, I appreciate it.

[Jessa Barnard, Vermont Medical Society]: Thank thanks for your time.

[Lauren Lehman, General Counsel, Vermont Department of Health]: Thank you for your time.

[Rep. Martin LaLonde (Chair)]: We'll be voting on this one tomorrow morning immediately after the floor has dropped home. After the floor, right after the floor hopefully, we have a few witnesses. Not gonna specifically look at a bill, but it's the family of the individual who was killed in a, it was a mental health crisis, and and things certainly went awry with law enforcement. Although the jury is out as far as exactly what happened and if it was at stake or if there was a problem with it, but we just wanna hear from the family of the victims of what they went through in that scenario. So that'll be right after the floor. I think if you saw, I did have ACLU scheduled for after that, but I've postponed that since we're gonna be working on the voter intimidation bill for a while. So we'll probably have them come in at the next audition. Is there an open case on that? An open case or a bill? No, as far as the No. Don't think there's a no. There's not a case. Not at all. It's just it's just that the the bill's gonna be revised. So I No. The the

[Jessa Barnard, Vermont Medical Society]: pardon me.

[Rep. Martin LaLonde (Chair)]: Shoot. The brother case. There's a the the idea is pretty general. And we're we're gonna talk about your bill h one seventy one when we actually get to that bill, which has to do with timing of Yeah. Yeah. Yeah. So that yeah. I've already talked to Oliver about that. But no, just it went through my mind because we've avoided some some work if there's been an open case. Right, right, and I think that might be what the wound is now as well. We're gonna hear from the family though, because they're in town from California now, but let them tell their story.