AHLA's Speaking of Health Law
AHLA's Speaking of Health Law
Latest Trends in Vaccine, Vaccination, and Immunization Law
Denise M. Hill, Associate Professor, Drake University, speaks with Brian Dean Abramson, author of the second edition of AHLA’s Vaccine, Vaccination, and Immunization Law, about the latest trends in vaccine, vaccination, and immunization law. Specific trends discussed include employer/employee considerations, international and comparative vaccine law, and legal responses to anti-vaccine activism. They also discuss how the law will continue to evolve in light of the pandemic and ongoing developments to monitor.
Watch the conversation here.
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Speaker 2:Welcome everyone. My name is Denise Hill. I'm an associate professor with Drake university in Des Moines, Iowa, and practiced health law with the Woodfield Netty law firm. I'm pleased to have joining with me today, Brian Abramson, who is the author of the vaccine vaccination and immunization law treatise. That's put out a, the American health law association, Brian. Welcome.
Speaker 3:It is such a pleasure to be here with you, Denise.
Speaker 2:Thank you. So how is it that you came to write a treatise on vaccine law in the first place Brian?
Speaker 3:Well, you know, it's, uh, an interesting one of those circumstances of the way fate brings things together. Uh, I was an intellectual property attorney for a number of beers and I really enjoyed the field of law, but not so much the practice of law. So I decided to pursue an LLM at, uh, George Washington university, which is a feeder school for law clerks to the United States court of appeals for the federal circuit. Um, and I was hired for a federal circuit clerkship and I was hired, um, a number of years out from the, from the clerkship, which is what, uh, how things are being done these days. Um, so I decided to take that intervening time, uh, and I knew I understood patent law because that's what I was studying. Uh, but I didn't know a lot about other areas of jurisdiction in the federal circuit. It has this very broad set of interesting niche topics where it has jurisdiction. One of which is appeals from the United States court of federal claims. So I got myself an internship with judge Susan D Braden of the court of federal claims. And the first day that I walked in the door, I got handed a vaccine injury case to work on. Now, most people don't realize this, but if you are injured by one of the childhood vaccine or alleged that you're injured by one of the childhood vaccines in the United States, measles mom, Bella diptheria, tetanus polio, um, you can't Sue initially the manufacturer distributor or administrator of that vaccine. They are immunized by a statute which is designed to protect that industry and ensure that we have supplies of vaccine. And instead, if you, if you assert this injury, you can file a petition with the United States court of federal claims, which has special masters that oversee those claims. They have an adversarial process. You can be represented. Uh, the department of justice will be on the other side, uh, arguing as to whether or not your claim should be granted. And those are appealed to the United States court appeals for the federal circuit. And I immediately found the area of law to be fascinating. You know, the cases are heartbreaking, but, uh, the law has very well developed. There is a long history of it now. So when I finally did start my federal circuit clerkship, I worked on as many of those cases as I could. Um, and typically a law clerk will work on one vaccine injury case over the course of a one year clerkship. Uh, I happen to do a little over or a two year clerkship. And, um, during that time I kind of grabbed all the vaccine injury cases that I could. So I ended up working on about a half dozen of them, and I felt like I really got, uh, a good sense of the scope of that law. Um, and it happened that there was a day when I was working on a vaccine injury injury case, and I was working on a patent for an advance in the development of vaccines at the same time for a case involving such a patent. Um, and in fact, it was a patent on one of the methods of grafting, a part of the harmful organism, a harmful virus onto a non-harmful virus, a, um, which is something that, uh, you know, my clerkship was about 10 years ago. So it's something that's been in use for a while now. Um, but it was very novel at the time. And I had these two cases open at the same time on my computer, and it was like a bolt of lightning, uh, struck me in and said, you know, there's a whole area of law here that is vaccine in law. Uh, not just in terms of the injury claims and, uh, changes to the intellectual property rules. Um, but also of course, to the way vaccines are addressed by, uh, the FDA in the approval process and with the existence of vaccination mandates. And I immediately felt that I could write a treaties on this subject and I would have coverage of all of these areas. I knew the areas right away that I wanted to cover. Um, and from there from, uh, from the end of my clerkship, it took me about five years to convince a publisher to let me write this book. Uh, and there were a lot of concerns that it was too niche of a topic that no one would be interested in vaccine law. No one's talking about vaccine law. Um, you know, that's what I was told, but I persisted and was finally able, uh, to get a contract, write the book. Um, and I put out the first edition in 2018, uh, and that was even before the measles epidemic of 2019, which is, um, now all but forgotten. But vaccine law obviously has become a subject of great interest to a large number of populations. And it's, um, in a way very gratifying for me to see the, that my work has become relevant
Speaker 2:Well. And, and how important that you identified this gap at the time that you did, because there really was an absence of this type of information for practicing attorneys, for practitioners, for anyone that is working in any aspect of vaccination or immunization loss. So, Brian, we're very fortunate that, uh, you happen to have that moment of clarity when both of those documents were open.
Speaker 3:Well, it worked out well for me, I'm gonna say
Speaker 2:So. So Brian, now you have gotten to the point and only a few years later, you're already ready to do a second edition. Um, tell us about what's what's happened and what's in this, uh, second edition that, um, is important for people to know about, um, obviously with the pandemic, there's been incredible number of developments, but, uh, but if you can kind of go through some of the specifics that would be really helpful.
Speaker 3:Oh, Absolut. Um, when I first wrote the book, I had five specific areas in mind and they were regulation, intellectual property, um, funding and distribution, vaccine injury, compensation, and vaccination mandates. And I had chapters on, on those. Um, and you know, when you, when you write, uh, a big thing like that, there are always areas where, uh, they end up on sort of the cutting room floor. There are things where you say, I could write more about this topic, but, you know, given the deadlines and given the, the space constraints and so forth that I'm working with, um, I'm going to leave that out for now. And part of, of what I have done with the second edition is to add chapters on additional topics that I didn't really get to discuss with the first edition. Um, I have a chapter on vaccines in employer, employee contexts in the first edition. I think I had a couple paragraphs about that. It was something that was, you know, one of the, the least explored areas of vaccine law. And of course, uh, with the pandemic that has blown up as an area of importance where we have questions of what can employers do, what can be done privately, uh, what can business owners do with respect to customers coming in the door, and then not just in terms of vaccination mandates, but what can you do for incentivizing employees to take vaccines? And are there limitations on that? Uh, what if you wanna have an onsite vaccination clinic, what are your liabilities with respect to that? So that was one big thing that got added. Um, I also added a chapter on international and comparative vaccine law, uh, which Dorty rice, uh, UC Hastings helped me with, uh, it's important because vaccines as, or sorry, um, diseases, as this has been said, don't observe borders. Uh, and we've had, uh, the COVID pandemic and we've seen other, uh, diseases like measles spread around the world. And you need systems in place to ensure that people traveling from country to country aren't diseases. Uh, you need to be aware of what the requirements are when you're traveling to other countries. And the fact that there are international regimes in place that at least advise certain cautions. And then not just in terms of vaccination, mandates, and, and efforts to prevent the spread of infectious diseases. There are also intellectual property regimes in place and regulatory regimes in different countries, um, by which we respect the regulatory determinations that a vaccine is safe and effective that are made in other countries. Um, so all of that of, uh, material is covered in my international chapter, um, as well as profiles of a selected handful of countries of interest. Um, and then the, the third new chapter that I've added is on legal responses to anti-vaccine activism, which of course has also become a huge thing. There's a tremendous amount of misinformation that is distributed about vaccines. There are activities in which people make, um, assertions often poorly based assertions, uh, that they should be entitled to certain kinds of exemptions. We are seeing on historic rise in the amount of, uh, fraud where in people are attempting to falsify vaccination records. Uh, and those are all, you know, very important issues that we're dealing with in society. So I have coverage of the legal framework of those, um, and those are all brand new chapters to the second edition. Uh, but of course the initial chapters that I had written have been greatly expanded, um, there is substantially more content on exemptions and mandates and various scopes in terms of the question of whether the, uh, the United States federal government can mandate vaccination for certain populations. Uh, there is a section that has been added. Now I have a chapter on specific vaccines where I talk about the legal regime for, for example, the measles vaccine or the mums vaccine. And I have added a, a pretty nice section on COVID 19 vaccines, which of course were, uh, just in development, um, and have just been licensed in, uh, a really recent period of time, even though it seems like a long time ago with everything that's gone on in the world. Um, and I have added substantial more information on things that are of particular interest in these times, emergency use authorization and the countermeasures injury compensation program, which is kind of a counterpart to the national vaccine injury compensation program, which is the one that operates through the court of federal claims. The counter measures injury compensation program just applies to vaccines that are approved as a countermeasure to a current public health threat that has been declared, uh, which is the case with the COVID vaccines. There was a public health emergency declared, um, early in 2020. And that is, uh, on paper set to go until November of 2024. And so during that time, the COVID vaccines, which are not under the national vaccine injury compensation program are covered by that program. So, you know, I've put in substantial content on the operations of that program in my vaccine injury chapter, I've added content on the application of workers' compensation for vaccine injuries. Um, so there are, there are a lot of, uh, little changes. I think that add up to, uh, making the book more holistic in terms of coverage of things that, um, are really relevant to the current, uh, circumstances.
Speaker 2:Excellent. Brian. Um, so, uh, you, and, and the other experts that you've gotten to know through the process of, of vaccines and vaccination becoming more, uh, of a mainstream discussion, um, what, what do you expect will change the I'm presuming there'll be a next edition because there's a lot of development in this area. What are some of the things that you think, um, listeners should be thinking about and, and could expect not only that you'll cover in the book, but that they're going to encounter and practice
Speaker 3:Well. Um, because of the nature of the publishing industry, the book was put together, uh, before the recent Supreme court cases came out on the OSHA and CMS mandates. Um, and that of course will be something not only that will be a subject of coverage for, uh, my next edition or, uh, perhaps a supplement that may come out, uh, at some point in the future. Um, but that will be ground for a lot of further legal developments. There are cases, uh, prior to that, where circuit courts have stayed application of the federal vaccine mandate for federal contractors. Um, they have stayed in one instance, uh, a mandate for military personnel, uh, who have sought religious exemptions and for whom those religious exemptions were denied, uh, and all of those are going to be affected by the Supreme court cases and, and what the court, the Supreme court has said about, uh, vaccination mandates. Through those two cases, we are also very likely going to see, um, a very fertile ground of, and in further efforts to, uh, develop exemption sort of vaccination mandates, uh, religious exemptions, I think are likely to become a particularly contentious area. Um, we are also of course seeing, uh, instances where states are trying to, uh, get in the way of vaccination mandates and place pro a on those mandates. And those aren't necessarily in conflict with federal laws. Um, if you have a federal statute or a federal rule that says you have to have a, a vaccination mandate, but you also have to provide a religious exemption and then the state steps in and tries to very broadly define the parameters of the religious exemption, um, that is going to be something that ends up in the courts and that practitioners are going to have to be aware of. Um, on a more positive note, I think, uh, the success of the RNA vaccines in dealing with COVID 19 is historic. It's a new technology. It's one that is potentially applicable to a lot of other areas. We may see the development of R a vaccines for other diseases that are currently vaccinated as childhood diseases. Uh, we may also see, uh, potentially the development of an HIV vaccine or a vaccine for, uh, Zika virus, or, uh, there's been a lot of research in, in the past couple years for vaccines, for conditions like Alzheimer's and certain kinds of cancers. Um, so I expect that we will see a rush of progress in of the deployment of MRI, a vaccines for COVID 19 in the development of other vaccines. Uh, and of course we don't know what COVID itself is going to do. We're not done with it yet. Um, it's shifted from being pandemic to pandemic, um, which means it's not over. It means it's going to be here for the long two term, and we need to be prepared to deal with it as we deal with influenza with regular measures to prevent it from, uh, killing too many people in the course of the year. Uh, we're probably going to see upwards of a hundred thousand COVID deaths per year, going forward for the rest of our lives, unless there is some really radical change, uh, either in the way people behave or in the technology
Speaker 2:And, and Brian, uh, it it's been very serendipitous for me personally, is another author of, uh, a publication on vaccine mandates to have interacted with yourself. Um, I feel very fortunate that both of us have had the opportunity to interact with, um, experts across areas of vaccination and immunization, uh, in the country. And, and, um, I'm wondering if, um, as we come together for the first national vaccine law conference in, at George Mason law school in, uh, September, do you believe that some of the information that we gain from interacting with other experts and practitioners across the country will help to inform, uh, that next edition of the book?
Speaker 3:It absolutely will. Um, one of the things that I have sought to do, and really that I have had the opportunity to do, um, because of the book is to connect with other people who have expertise in other areas of vaccine law. Um, of course, when writing the book, I sought out people who had expertise in particular areas and, uh, was able to get, uh, J Thomas of Georgetown university law school, uh, to write the patent chapters of the book and, uh, Peter Sapphire of cov, BU Covington, BU who also, uh, teaches food and drug law at George Washington university to, um, co-author with me, the chapter on vaccine regulation. And then most recently, uh, I think I'd mentioned before, uh, dere rub and Stein rice, um, contributed to my international chapter. And she also co-authored the chapter on responses to anti-vaccine activism. Um, and then of course, I, I got to meet you Denise Hill Drake university. And, uh, you've become a, a great friend and there are many other people who I never would've, uh, come across in my life if I hadn't gone into this field and gone into this venture. Um, and one thing that I am, uh, very, very dedicatedly trying to do is to connect people who have interests in different areas of vaccine law and, you know, bring them together. That's, that's why we're having the conference this fall. We're bringing people together in one room. Um, I, and in a way, I think, you know, the book itself brings people together in that way, because it, it introduces all these different areas of vaccine law and the fact that there are so many different places where, uh, the law in a particular area has been, um, bent towards this public policy interest in having a fully vaccinated population.
Speaker 2:Well, and, and it's so interesting that you shared that, you know, you had to work so hard to find someone to understand how significant vaccination and, and the legal issues associated with it are. Uh, my guess is that, uh, this important issue will no longer need you to work so hard to, to get the attention of those who, who publish and, and work in this area that, uh, the world now understands how complex and important these issues are. So we're very grateful to you for all the efforts that, that you and your counterparts have put into, um, the first edition and, and second edition of your book and, and what's to come in the future. And, and it's been an absolute pleasure with you, and I'm grateful to have you with us today,
Speaker 3:Denise, thank you so much. Um, it is always a pleasure, uh, to speak with you, especially about vaccine law, you know, uh, Denise and I kind of describe ourselves as vaccine law nerds. And when we have a conversation, we start talking about things, um, it can just go kind of on and on without end. Um, cause there are so many things going on in vaccine law. It is, uh, certainly a field that continues to develop. And it's kind of surprising at the time that I wrote my initial treaties. Um, it was kind of locked in as a field. It was a field where, uh, you kind of felt like, okay, it's mature in everything that's going to happen. That's going to be surprising to you has already happened. Um, but of course those predictions never come true. And there were massive changes that occurred, um, almost immediately after the, the first book came out. Uh, and you know, certainly we're now in a situation where we're expecting those to continue. Um, you know, and we've, we've talked about the fact that there are some states that are even trying to roll back childhood vaccination mandates, and that would be something with, um, potentially profound public health effects. Uh, and you know, on, on the one hand, uh, we speak to, well, maybe this isn't necessarily good policy, uh, and on the other hand, we're documenters of what is going on and how the courts, uh, address these things and how policy makers have address these things. And, you know, we, we, we play an important role in, in both of those directions.
Speaker 2:Well, and both of us as, as, uh, professors, uh, teaching in this area and other areas of health law and cetera. Um, you know, if any, as students are listening to this, um, I'd really encourage you as the next generation of, uh, potential vaccine law and immunization law experts to, to really think about this area, because now that we've had a global pandemic, we've had expensive experience dealing with some of these issues that had been, we thought settled for a hundred years, there's a host of, of new issues that are ready to be explored and, and to, so, um, we certainly encourage, uh, any young attorney or any attorney at all, or a practitioner. We worked with mark easterly, who is a, uh, Houston Methodist, um, the first, uh, first health system in the nation to implement a vaccine mandate policy. And the complexities that came along with defending that in the state of Texas, uh, where the governor had a very different approach, uh, to vaccine mandates in, in a very highly charged political, um, environment. And, um, and so your book and, and these issues for practitioners and, and attorneys and students alike, I think has, uh, massive importa. So I'm just so grateful for your time today. Brian, anything else you wanna add?
Speaker 3:I just wanna thank you so much, uh, for taking the time to interview me on this. Um, and I would, I would also say the Denise's book, um, which focuses on the healthcare aspects of vaccination mandates is also an excellent piece. Um, and, uh, I hope everyone has the opportunity to really get an understanding of vaccine law and the importance that it plays, because it really does cut across so many other areas of law and introduces an understanding of, um, administrative law and intellectual property law. Uh, there are constitutional law issues. There are tort law issues, uh, and you know, that's, it's something that just endlessly fascinates me and I hope other people come to find it as interesting as I have for the past decade.
Speaker 2:All right. Thank you for your time, Brian. You have a great afternoon.
Speaker 3:Thank you, Denise. You as well.
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