Vermont Legislature SmartTranscripts:

[Senator Nader Hashim (Chair, Senate Judiciary)]: We are live. Alright. Good morning. We are back in senate judiciary. It's February 12. We're gonna spend a little bit on page five forty five. This is a bill that's currently in health and welfare. They asked us to take a look at a narrow section, primarily on page seven regarding civil and administrative immunity. We have Allison here who requested to testify. And if you could just introduce yourself and what the which organization you're from, that would be great. And then I'm happy to hear your thoughts.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Okay. Thank you so much, and thanks

[Allison Despathy (Co-Director, HealthChoice Vermont)]: for finding the time. I know you guys have a class schedule. I appreciate it. I'm Allison Despathy. I am a co director with HealthChoice Vermont. We represent 5,000 Vermonters who really care a lot about ensuring that they can make private informed healthcare decisions here. So I was able to testify to human services in the house and judiciary, and then also able to testify in Senate Health and Welfare. And so thank you for allowing me here because I think really one of the concerns that a lot of people are seeing is very specific to your jurisdiction on this bill. So essentially, just wanna tell a little bit of a story quick. In the nineteen eighties, early nineteen eighties, there was a vaccine. It was diphtheria pertussis tetanus, and it was a live cell vaccine pertussis, and it was causing a lot of neurological damage, seizures, and death. So pharmaceutical manufacturers of the vaccine were being sued and going out of business. One ended up being left, their name was Ladero, they turned into Wyeth, they were bought by Pfizer. But because of that, what ended up happening is president Reagan in 1986 signed the National Childhood Vaccine Injury Act. And what that dude did is instead of making manufacturers of vaccines produce a safer product, they said, we're gonna give you a liability shield. So you are not responsible for the safety of your product. So they gave that to pharmaceutical manufacturers for vaccines that land on the federal schedule, and they also gave it to anyone giving a vaccine. And with that, in order to balance the scales of justice really, is they said, if we're gonna give this liability shield, then how are we gonna provide compensation? We have to have some sort of legal recourse for people who might be injured or killed. So with that, in conjunction, they set up what was called the National Vaccine Injury Compensation Program. They also made it that providers originally had to give a 10 page informed consent benefit risk analysis to anyone who was getting vaccine. So those were the two things that they did because here they are coming in saying we are gonna offer this liability shield. So since 1988, when the compensation program was enacted, they have paid over $5,000,000,000 for vaccine injury and death, and how it relates to Vermont. In my practice, I have a nutrition practice in the Northeast Kingdom in St. Johnsbury, and I work with over 200 people who've been vaccine injured. So I've worked with them through this process, and they come to me from a nutrition standpoint, because most of the time it's parents who are trying to say, my child's been injured, I wanna do anything I can to try to help get my child covered and get them healthy because of what happened with the injury. And I know it's so tough when you start talking about vaccines because they're immediately sort of polarized and politicized because of what's happening to science, and it's very unfortunate. And so one of the things I was wanting to ask is if we were talking about any other product, so pretend we're not even talking about a vaccine because I know that's like an instant trigger to people and people sort of go into their camps on it and what's happening on a federal level, it like causes a lot of chaos and is very triggering. But if we were talking about any other product that the state was gonna potentially offer a liability shield for a provider, what would we be doing? Like, how would we make people aware? How would we say to them specifically that, you cannot sue this provider if you have a reaction to this product. So I just want to put it in that context of would we create our own statewide compensation program the way they did on a federal level? Would we give them legal assistance? What would we do? So I think the reason that this comes up, and I know there's like a lot of history that plays into this. So the reason that this comes up is nobody has a problem with the Department of Health ill in the sense of they want to procure vaccines, they wanna make sure they're affordable, they wanna make sure insurance companies cover it. They're doing their job, no problem. The part where people are struggling is that right now there's a federal vaccine schedule, and all of the vaccines on that schedule provide the liability shield to the pharmaceutical industry and to the administrators, which means if you have an injury or your child dies from that vaccine, you go to the compensation program. You don't go through the tort system. You don't go, you can't sue the pharmaceutical companies, etcetera. For example, just to sort of put it in Vermont perspective, there was a girl, her name was Caitlin Matten. She was from Barton, Vermont, and she went to a wellness check when she was seven years old. And she ended up with a flu zone vaccine that contained mercury at the time and she died. Says on the birth certificate myocarditis because of the vaccine. It took her family, her mom Nicole, who has testified in the state house, 11 to get compensation. And she got the highest amount of compensation from this injury program, which is actually heartbreaking to hear. I mean, it was $250,000 that her mom received for the death of her child from a vaccine. And so essentially where the concern is this bill is if the state if the federal government, the CDC, etcetera, pull a vaccine from the federal schedule, and this for whatever reason it is, say hepatitis B, and this is me just putting in perspective hepatitis B. And I apologize, I know there's like a lot of history and information here. Hepatitis B was the first vaccine approved after pharmaceutical industries received this liability shield. It was the first genetically modified virus in a vaccine. There were five days of safety monitoring done. This is hideous with one hundred and forty seven children under the age 10. When you talk about a product that pharmaceutical companies are liable for the safety of, you're talking about two to nine years of safety monitoring, and it's compared to a placebo. So because vaccines are not, the pharmaceutical manufacturers are not responsible for the safety of their product, no vaccine on the childhood schedule has been compared in a placebo clinical trial. And the reason this is relevant is because it gets to your guys' jurisdiction. So So there's been no placebo controls on any vaccine in the childhood schedule, and they've been studied for three days, five days, or several months of safety monitoring because the pharmaceutical industry is not responsible for the safety of those products. They know that if there's an injury or damage that will go to the National Vaccine Compensation Injury Program, and they are not liable. So what we're saying here is hepatitis B, for example, there's been a petition filed. They did FOIA requests to the FDA. This is back in 2017 and 2018. They've done FOIA requests to get the safety monitoring data on hepatitis B as an example. And this is Recumbivac's hepatitis B that I'm talking about. So the four year requests ended up resulting in a 1,200, over 1,200, I think it was twelve sixty four page document that confirmed that hepatitis B was only studied for safety for five days after injection. Because of that, they have petitioned and they said you need to revoke or suspend the use of hepatitis B vaccine. So if, as an example, I'm saying, if they find that this did not go through adequate safety study and that there are concerns around this, and if the federal government pulls the hepatitis B vaccine from the schedule, but the state decides to say, hey, we're gonna stick with hepatitis B given to babies on the first day of life, during the first twenty four hours, then that is no longer if the state chooses to do that different schedule, that is no longer gonna qualify for the national Vaccine Injury Compensation Program. So what you're saying is shouldn't and I'm thinking of, of course, your constituents and patients, and I think of the people in my practice that I work with, shouldn't that person be made aware that this is no longer on the federal schedule, this is no longer gonna be covered under the National Vaccine Injury Compensation Program. So shouldn't there be that information given to the patient? And I think one of the Department of Health people said, well, we don't wanna cause any sort of distrust, we don't wanna like, but there should be a question in the parents' mind. They should be able to seek questions and say, well, why is it off the federal schedule? And why is it on the state schedule? And what does it mean if it's not covered in the National Vaccine Injury Compensation Program? I don't even know what that is. But if their child gets injured or died, they're gonna wanna know what that is. And so I just feel like from a state responsibility standpoint, and I'm thinking of patients in Vermont and your constituents, shouldn't there be a heads up if the state, even as simple as, if the state was going to do a change that differed from the federal schedule, we're gonna keep this vaccine, but now the federal government is saying we're not. Shouldn't the Department of Health at the very least report back to Senate Health and Welfare to say, hey, we've done this shift. We now have a difference in this. So that could be one possible path. And then the other possible paths and representative Berg did testify in human services with the possible amendment. He also testified in Senate health and welfare, I think it was yesterday or the day before, maybe it was Tuesday. And I think he'd be willing to come in, but just to try to say, how do we sort of balance this thing out if if the state is now gonna give the shield to anyone giving a vaccine? Should it be that there's informed consent that has to happen? And we know that informed consent is already in statute, but should there be more substantive informed consent that is given to the patient? Should the patient be made aware that there is a difference in schedules? Should the patient be made aware that this provider is no longer liable for what happens when this product is administered? It seems like there should be a level of transparency that happens with you guys implementing the shield, which is not common. I mean, correct me if I'm wrong, but I don't I think there's maybe one other product that the state does this with, and it's a life or death situation in a drug in a drug situation. I could be wrong, but that's my understanding at this time. So if if the state is gonna offer the shield, how do you protect the patient? Like, do you inform them? I think that's the fundamental question, which obviously lands on your best plate of how do you balance out this equation, really? So that's what we're that's what we're concerned about. And the one thing I would say, American Academy of Pediatrics had emailed the legislators in the house, and they had said, and this is something that they also verbalized in committee, was that providers give what's called a vaccine information statement sheet. And that basically says, you know, you might have a little fever, you might have a headache. And by the way, if you have an injury, contact the vaccine adverse event reporting system, and here's how you do it. The CDC for decades has said that is not informed consent. That's not offering someone informed consent. So a provider can't just say here, boom, I've given you now informed consent. And so I think it's, those are some of the avenues that I just wanted to offer for, where do you go? Do you go to the clinical office space with the provider and the patient and make sure there's honest transparency happening? Like, by the way, there's been a change in the schedules. I think you should be aware this is no longer covered on the compensation program. By the way, I cannot be held liable for anything that happens with this product. Or do you say, hey, Department of Health, I mean, obviously, you guys know how it works, especially in this committee, you guys create law and policy and they execute it. So, you know, should the Department of Health come back to the Senate, health and welfare and say, this is what we're proposing. This is why we are going with a different schedule, and here's our evidence, here's our reasoning, and what do you think about that? Should there be a level of oversight if that was to happen? And I'm kind of just scratching the surface on some of the history, but I needed you guys to try to have at least a little bit of that to see where this question comes up. And really human services, when I testified there, I had like forty minutes and they were all very upset. Understandably, have been including myself for like forty years. Why does pharmaceutical companies have a liability shield on the product? That's the fundamental issue here, right? Like that's really where like, and there is legislation on a federal level where that could be changed and states try to deal with that. States try to say, if you come do advertising for commercials in our state, then you're liable for the product. Like they so there are ways that people are trying to do that, but right now the pharmaceutical company is protected and it basically lands on how do you make sure patients are also protected in their decision. So I think that's kind of the big thing. I did wanna say yesterday, Tuesday, when representative Kurt offered testimony, I and can get you a copy of this, or we could also have him come in potentially is he did have some, besides the amendment he proposed in human services in the house, he did also have a little bit of a different approach for potential language in there, whether it's reporting back or it's something that happens in the office between provider and patient, if that provider is now gonna have a shield on this product. So I can we can get that to you.

[Senator Nader Hashim (Chair, Senate Judiciary)]: Oh, we we do have that language.

[Allison Despathy (Co-Director, HealthChoice Vermont)]: Okay. Good. Okay. Great. Okay. Good.

[Senator Nader Hashim (Chair, Senate Judiciary)]: Committee, any questions? Well, thank you.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Yeah. Thank you for letting

[Allison Despathy (Co-Director, HealthChoice Vermont)]: me take the time. I just wanted to make sure people knew sort of what was going on. And I know that vaccines, like I said, are very politicized and it's like a tough word to talk about. But I would just say if we go back to any product, if we were to do that, what would the action be we would take for the person taking getting the product? So I appreciate the time. Yeah. Okay. Thank you.

[Senator Nader Hashim (Chair, Senate Judiciary)]: So we we're ahead of schedule, which is great. We also have the Department of Health here, and I feel like it's fair that we hear from the Department of Health as well for fifteen minutes or so, however much time you need. Is fifteen minutes alright? Yes. Okay. Great. Yeah. So please feel free to join us and

[Allison Despathy (Co-Director, HealthChoice Vermont)]: Thank you so much.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Appreciate the opportunity. My name is Lauren Lehman. I'm the general counsel of

[Allison Despathy (Co-Director, HealthChoice Vermont)]: the Department of Health. And

[Lauren Lehman (General Counsel, Vermont Department of Health)]: I really appreciate the opportunity to testify. You know, I'd like to take a step back about where the BICP Allison just provided a background on that. And it was created for access purposes. We as a country decided public health wise that public health recommends access to vaccines and to protect against multiple diseases of childhood and adulthood. And so in an interest, we need people, need manufacturers to manufacture them and we, the country needed providers to provide them. In the early days, there were significant tort lawsuits that were lengthy and costly. And so a lot of manufacturers and providers were saying we're not gonna provide this access. So to insulate the providers and manufacturers, the federal government caps liability, cap damages you could receive in a civil court to a thousand dollars. If you wanted anything above a thousand dollars, you need to petition the federal government into this vaccine injury compensation program. Still a lengthy process, but there's a separate court within the within the federal claims court and a separate panel, and they review those claims as a vaccine injury table, etcetera, etc. To move through the causation process faster. But as you heard from Allison,

[Allison Despathy (Co-Director, HealthChoice Vermont)]: it can still take eleven years.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: It can still take on average one to three years to go through that process. Vaccines are added to that for coverage in the vaccine injury compensation program by the CDC recommending it, but also by Congress adopting a excise tax to pay into this fund. And then from the fund, people are reimbursed. So it removes vaccine liability from the tort system and caps what individuals can get for compensation for injury.

[Senator Nader Hashim (Chair, Senate Judiciary)]: I do have a question If about a vaccine is taken off the schedule, can a per and somebody sustains an injury as a result of that vaccine and it's not on the schedule, can they is that torch shield

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: removed from the pharmaceutical company?

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Yes. If it's not on the schedule and there are some because what's covered by VICP or VICP is what they call it, injury comp vaccine injury compensation. If it's not covered by that, which, you know, dengue fever, for example, isn't covered by that, then they you can go through the tort system to seek compensation. And it would be similarly challenging to go through a legal system. Your but your damages could be much higher, and it wouldn't be taxpayer based.

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: So if

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: I am understanding

[Allison Despathy (Co-Director, HealthChoice Vermont)]: if Vermont moves forward with, say, this

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: is the Vermont schedule and some of those things are no longer on the federal schedule, someone may

[Lauren Lehman (General Counsel, Vermont Department of Health)]: not be eligible to go through the victim injury compensation program, but they can now sue the pharmaceutical company. Yes. Okay. And I wanna point out that the provision in h five forty five you're sitting at is very narrow. Right? It is health care providers more healthcare providers for injuries to somebody caused by a vaccine administered in accordance with the commissioner's recommendation. So the commissioner's recommendations under this bill will be made in consultation with a committee that's composed of experts in the field, doctors, researchers, etcetera. If a provider is giving a product that if based on those scientifically sound evidence based recommendations, and the person is injured from that product, it's administered in the correct way, at the correct age, and the correct dosage, this is saying that that health care provider shouldn't be liable for using that product. We can't provide and we don't provide and it does not provide a liability shield for the pharmaceutical manufacturer. And if it also doesn't provide a shield, should the health care provider be grossly negligent, be reckless, go off the schedule, ignore allergy signs, etcetera. So there's it's a narrow liability provision, and it's intended again to protect access. We want people to be able to access at pharmacies, at their doctor's office, the vaccines that are scientifically sound, evidence based, intended to protect. And 95% of Vermonters are accessing these vaccines, want access to these vaccines. And I will also say vaccine injuries incredibly rare. One in a million results in compensation. One in a million vaccines distributed that results in compensation from the vaccine injury compensation program. So over the life of it's, know, out of 80,000,000 or 80,000,000,000 doses of vaccines distributed over the last ten years, one in a million has resulted in a

[Senator Nader Hashim (Chair, Senate Judiciary)]: vaccine

[Lauren Lehman (General Counsel, Vermont Department of Health)]: compensation. So it's so rare. There's still an avenue recourse for the patient. We're trying to protect access by allowing providers that narrow liability shield which is consistent with the naloxone one as well as the gender affirming care and reproductive healthcare liability protection. There's also one more thought. Informed consent. So 12 BSA nineteen oh nine already requires informed consent, right? It for all foreseeable risks, a doctor is a health care provider is liable under medical malpractice law for not disclosing the foreseeable risks of a medication. They aren't in other spaces required to disclose reliability avenues. If you get a prescription for antibiotics for strep, nobody is saying to you, if you have anaphylaxis, here's the name of a med malware that you can pursue a medical malpractice attorney that you choose for sue. So to have to disclose your liability options when it comes to a vaccine administration, it's unnecessarily alarming, makes it sound like there's more risk than there is. And it's outside kind of the scope of the practice of the physician with the patient.

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: Senator Mose.

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: You may know the answer to this. When the vaccine schedule that currently used was developed, did that rely solely on US research or did that look at sort of global research? I'm not sure.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: I'll have to look into that. My guess is it is global because when you marshal so my very narrow knowledge of the drug application approval process of FDA approval, you're gonna marshal all your resources to get that drug approved, the study was done in The US or outside The US.

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: That was sort of my guess as well. But I'd I'd love to know. And and certainly, I think that broad brush because I know everything in Europe specifically doesn't provide liability shields and does have a, in fact,

[Allison Despathy (Co-Director, HealthChoice Vermont)]: in many instances, much of

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: a fear approval process. So if we're looking at those studies too, think we're getting a really broad look at that safety and efficacy. So thank you. We'll also

[Lauren Lehman (General Counsel, Vermont Department of Health)]: be looking at recommendations from national organizations. So not just on the state level and what are, but we're looking at the American Academy of Pediatrics, American Academy of Family Practitioners, etcetera. So there's gonna be a wide breadth of knowledge brought there. And there'll be transparency as there used to be about what we're relying on and what that process for the recommended schedule would be. Hopefully, it'll align with the federal government. Right now, nothing's changed with the injury compensation program, but things have changed with the schedule and things are not going according to the process that was previously used. We haven't seen studies, we haven't seen science. And so this was really trying to emulate that system at the state level and to kind of insulate us from the things that we don't understand or don't have that transparency to them.

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: That makes a lot sense. Awesome. Thank you.

[Senator Nader Hashim (Chair, Senate Judiciary)]: Thank you. Anybody else have questions, comments?

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: Just a quick one. Yes. Thank you. So I don't have the bill right here. Pardon me. So who is protected in this bill? Is it just those who administer the immunization shots? It doesn't include, like, a a commissioner of health or anybody else, just those individuals who administer the immunizations?

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Yes. So the commissioner of health is somewhat protected under sovereign state sovereignty. I believe Katie's McLennan spoke to it the other day about what the standards are. There's some state sovereignty protections that you have to show that his recommendation was reckless without due diligence, etcetera. So he the department is protected by that. But this liability protection would just be health care providers who administer in accordance with that state recommendation.

[Senator Nader Hashim (Chair, Senate Judiciary)]: Intentional, I believe, intentional misconduct is also the other prong of getting through sovereign immunity. Yeah. Just to answer your question there. So thank you for your testimony and for being here.

[Lauren Lehman (General Counsel, Vermont Department of Health)]: Thank you for the time. Yeah.

[Senator Nader Hashim (Chair, Senate Judiciary)]: So again, our jurisdiction on this is essentially page seven, lines one through seven. I know a lot of conversation about informed consent and also reporting back to the health and welfare committee. Those aren't really questions for us, but rather it is if a healthcare professional who prescribes, dispenses or administers an immunization can be immune unless they are cursely negligent, reckless, or engage in intentional misconduct. Based on everything I've heard, I don't have any proposed changes to the section that we have jurisdiction on. Committee, do you have any comments or suggestions that you'd like to see? Or are you fine with the language as a truth? I'm fine. The language is is

[Senator Tanya Vyhovsky (Member, Senate Judiciary)]: fine as written. When we have more time in a future space, I I might be interested in looking at some of the advertising. Like, it it is a little shocking to me that pharmaceutical companies have this liability. And if there's something to be done to address that at the state level, I'd love to look into that, but not for the purposes of this bill.

[Senator Nader Hashim (Chair, Senate Judiciary)]: So I'll let Senator Lyons know. I think they're doing markup on Friday and it's probably you know, I don't know when they're rolling it out, but either way, that wraps up. Well, I

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: might just say that the area that we're doing the drive by is well, lines one through seven, don't have any problem with that. I need to see the the whole bill. It takes time to meet the whole bill over here, but I'm we're also pregnant. That's how I hope

[Allison Despathy (Co-Director, HealthChoice Vermont)]: Mhmm.

[Senator Robert Norris (Vice Chair, Senate Judiciary)]: Or against. Section, we're I'm

[Senator Nader Hashim (Chair, Senate Judiciary)]: fine with that. Oh, Great. Okay. So we've got 10 until we get back to one ninety three. We'll have