According to “The History of Vaccines”-an educational resource by the College of Physicians of Philadelphia, the development and growing use of smallpox vaccine in the early 1800’s triggered the establishment of vaccination mandates, especially for children. Over the years, there has been a great debate over whether to vaccinate children or not.
So are there any legal issues behind not vaccinating your child? Or is it the parent or guardian’s legal right to make that decision on their child’s behalf? Today on Lawyer 2 Lawyer, host, attorney Craig Williams is joined by Dorit Rubinstein Reiss, professor of law at UC Hastings College of Law and James Hodge, director of the Center for Public Health Law and Policy at Arizona State University, as they take a look at the legal framework of the anti-vaccination movement, the rights of the child, the rights of the parent, legislation, and the great vaccination debate.
Dorit Rubinstein Reiss is professor of law at UC Hastings College of Law.
James Hodge is professor of public health law and ethics at Arizona State University Sandra Day O’Connor College of Law.
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The Legal Framework of the Anti-Vaccination Movement
James Hodge: Most kids in the United States flat out get vaccinated, period, but against the backdrop of the dynamic perceptions of parents about the risks of vaccines and kids perhaps even seeing it more in line with their own personal health, you do get these controversies that erupt.
Dorit Rubinstein Reiss: From the beginning of vaccination at least. Certainly there were anti-vaccine activists from Jenner and onwards, although they have been less prominent and less influential during the 20th Century, probably until the 1980s and on
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J. Craig Williams: Welcome to Lawyer 2 Lawyer on the Legal Talk Network. I am Craig Williams coming to you from a sunny, but cold Southern California. I write a legal blog called May It Please the Court and have out two books; one is titled ‘How to Get Sued’ and the other one is ‘The Sled’.
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Well, according to the History of Vaccines, which is an educational resource published by the College of Physicians in Philadelphia, the development and growing use of the smallpox vaccine in the early 1800s triggered the establishment of vaccination mandates, especially for children. Over the years however there has been a great debate over whether to vaccinate children or not.
And just recently there was an 18-year-old child from Ohio who after years of not being vaccinated despite his mother’s wishes became vaccinated. So are there legal issues behind not vaccinating your child? Is it the parent or guardian’s legal right to make that decision on the child’s behalf?
And today on Lawyer 2 Lawyer we are going to take a look at the legal framework of the Anti-Vaccination Movement, the rights of a child, the rights of the parent, legislation and the great vaccination debate.
And to help us do that today we have got a great lineup of guests. Here to discuss today’s topic is Dorit Reiss. She is a Professor of Law at UC Hastings College of Law in San Francisco. Her research and activities are focused on legal issues related to vaccines, including exemption laws and tort liability related to non-vaccination. Welcome to the show Dorit.
Dorit Rubinstein Reiss: Thank you for having me.
J. Craig Williams: And our next guest is James Hodge. He is a Professor of Public Health Law and Ethics at Arizona State University Sandra Day O’Connor College of Law. He is also the Director for the Center for Public Health Law and Policy at ASU. Through scholarship teaching and applied projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics and human rights. And welcome to the show James.
James Hodge: Craig, thank you for having me as well.
J. Craig Williams: Well, James, let’s start with you. Can you give our listeners a little bit of the history of vaccinations; I read that they used to be called variolations?
James Hodge: Yeah, so true. Vaccinations go back typically in regards to our US history several hundred years in relation to what and how we were viewing these specific interventions, but they have actually a very ancient history to them. Thousands of years back we may have been using vaccinations in one form or another. But the modern history of it has absolutely implicated some of the most profound law and policy and ethics issues that we can imagine, that still play out well today.
But the practice as far as its potential use in regards to smallpox outbreaks has been most profound and most beneficial for improving the utility and the efficacy of vaccination over many decades.
J. Craig Williams: And Dorit, the Anti-Vaccination Movement pretty much started from the beginning as well, is that right?
Dorit Rubinstein Reiss: From the beginning of vaccination at least. Certainly there were anti-vaccine activists from Jenner and onwards, although they have been less prominent and less influential during the 20th Century, probably until the 1980s and on.
J. Craig Williams: Right. Now, vaccinations are mandated in some states and there are a couple of exceptions.
James, how do the mandates and the exceptions work?
James Hodge: Well, the mandates in relation to the term is something to describe even from the onset. So let’s be sure of a couple of fronts. Vaccines without doubt are required among specific populations, most notably school kids, kids attending daycare and other specific arenas, and that’s tied to the epidemiology of specific conditions as well as the utility of vaccinations at an early age.
But let’s also be clear about one thing, we are talking about mandates in the form of permission to attend school or daycare purposes. Virtually all states allow some exemptions for vaccinations as well. Parents get to decide these. There are exemptions based on religious objections, philosophical objections, some of these are harder than others to obtain, but to be sure nearly all states do have some exemptions of another, plus the primary one, the one that we can never forget, the one that’s constitutionally grounded. No person who is an unfit medical candidate for the purposes of vaccination at any age has to be vaccinated.
It has never been the case, absent Supreme Court — consistent with Supreme Court jurisprudence of this century at least that persons who are unfit candidates medically would have to be vaccinated against their will. Others though, absent a religious, philosophical exemption, typically are going to be vaccinated for multiple conditions well before they attend daycare or school.
J. Craig Williams: What is the objection of anti-vaxxers, I mean what do they believe is occurring to their children when they vaccinate them?
Dorit Rubinstein Reiss: So there are two types of objection. One sort of objection is to vaccines generally and the other is to vaccine mandates, and they draw on different sources. Much of the concern about vaccine draws concerns about side effects and that too has been present since the 19th Century at least. And at the time of the smallpox vaccine it was probably more well-founded than it is today.
So a part of the concern is a fear that if my child is vaccinated, my child will be one of those that suffer a vaccine side effect. And anti-vaccine people think that those side effects are a lot more common than scientists suggest.
Other concerns revolve around vaccine testing. The Anti-Vaccine Movement claims vaccines are not sufficiently tested, which is not true, because vaccines are tested more than other things.
Another set of concerns are on religious objections; for example, about the use of cell lines in vaccines. So vaccine viruses have to be grown in living cells and some of them are grown in cells that are drawn from cells from abortion in the 1960s. Abortion is not related to vaccines, but the cells were drawn from there.
Opposition to vaccine mandates also draws on, in some cases, strong belief in parental autonomy, strong concerns about the role of the state in terms of schools, and an emphasis on a right to education.
J. Craig Williams: Now Dorit, there was a change in California last year where an exemption was removed, how did that occur?
Dorit Rubinstein Reiss: So in 2014, the end of 2014 and the beginning of 2015, California saw a large measles outbreak that spread to, I think, 17 states and Mexico and Canada. We actually got a little Mexican 07:53 measles for the first time in a long time. The outbreak caused an outrage against non-vaccinating parents and the legislature in collaboration with some parents group and a lot of other groups passed the law removing the personal belief exemption to vaccination requirement; that was in 2015, at the end of June 2015, and the law became operative in June 2016.
J. Craig Williams: Well James, there has been some significant opposition to vaccines and it seems to be based on one study. What’s the objection to and what’s the basis of that Lancet study?
James Hodge: Oh yeah, that has been so notorious Craig, so very notorious. And something that Dorit mentioned in regards to the unfounded nature of person’s perceptions about the risks of vaccines. The risks aren’t there, but in a specific study back about 20, 25 years ago, specific date, extends back to then, you saw this particular researcher named Andrew Wakefield, who came out with a series of observations about the potential risks of specific vaccines to the potential onset of autism among kids.
Serious allegation, serious risk, and as rising rates of autism among American kids seemed to correlate with that over the course of a several year period, parents began to become extremely concerned that maybe there was something to this, that this link of specific vaccines, highly recommended by the Centers for Disease Control and Prevention might be tied to rising rates of autism among kids. The correlation seemed interesting, almost definitive to parents.
The study was proven to be fictitious, false in every capacity. It was withdrawn by The Lancet several years later. Andrew Wakefield lost his faculty position and title. In every way, shape, and form the study was completely debunked as a pure fraud.
And yet, persons still believe in the potential for linking vaccines to kids’ autism as a national phenomenon. That has been one of the hardest things to live down is just the myth of the risks of vaccines.
As Dorit noted, some vaccines pose a risk for some candidates, and as I mentioned, nobody who can prove to be an unfit candidate for vaccine can be required to take the vaccine under federal state mandates, constitutionally well protected. But that is a very, very small portion of the US population, and to be sure studies like what you saw with the Andrew Wakefield example and The Lancet proved to be very damaging in relation to public perception not matching reality.
J. Craig Williams: And how do we weigh parental rights and children’s rights? I mean what about children who say, and there have been a significant number of them who have made the news lately who have stood up and said, I want to be vaccinated, but I am only 14, what’s the law and how does that framework fit together?
James Hodge: So that’s a great question Craig and those are the types of phenomenon that you get out of these divergent views among parents and sometimes kids who are reaching that age of making some of their own medical decisions for themselves. So to that end, you see these controversies arise.
Now, at the point in time when the minor reaches majority, they make their own choice about vaccinations. You can get vaccinated if you so choose. Even prior to reaching the age of majority in some jurisdictions you may see specific medical decisions left to a person with the know-how and capacity to make them even under the age of 18. We can’t list out specifically which states might adhere to that, but I will say obviously kids under the age of 18 make certain decisions about their sexual health and other arenas, vaccination may be included within that.
But it is a fascinating observation that you literally have at times families pitted against each other with one not allowing a kid to get vaccinated and the other — that minor seeking vaccination. It’s not a common phenomenon playing out across the country. Most kids in the United States flat out get vaccinated, period, but against the backdrop of the dynamic perceptions of parents about the risks of vaccines and kids perhaps even seeing it more in line with their own personal health, you do get these controversies that erupt.
J. Craig Williams: Dorit, how does tort liability fit into this? I mean there is obviously a patient zero for the measles outbreak that you were talking about earlier and a lot of children that got sick from it, some that died, how does the patient zero tort liability lie?
Dorit Rubinstein Reiss: So there are two potential tort questions here. The first is can parents of children infected by patient zero through the parents who didn’t vaccinate? One example I like to use is there was a famous case in Germany where an 11-year-old who had a fever and a runny nose was brought to the doctor. It was before 12:45, so he didn’t know he had measles and infected six people in the waiting room, three of them babies too young to vaccinate, and two of the babies later died from measles, from measles complication. So can the parents of the babies sue the parents of the unvaccinated child?
There you have at least two potential questions, maybe three. First, is there a duty to vaccinate? Normally we don’t have a duty to act, but you can make an argument that the decision not to vaccinate is not your usual non-action. You are not sitting and watching something happen, you are not a bystander. Parents who don’t vaccinate usually actively decide not to vaccinate their child and have to sometimes push back against family members and doctors. It’s a much more deliberate active act than usual non-action.
Also, we do have exceptions to the rules of there is no duty to act and there is arguably a room for an exception here.
Finally, maybe it’s a place where state legislature can create the duty. So duty is an issue for third parties. Similarly, in some cases causation will be an issue. That’s a case-by-case question.
For measles we usually know who started the outbreak and can track it pretty well. For pertussis, for example, we usually don’t, because pertussis can be asymptomatic. So that’s going to be a much harder causation case.
Finally, money might be an issue. If you are suing another family, do they have money to cover a big tort award?
The second kind of case is the case of a child, like you describe, the child, let’s say, 14:21 contracts measles because their parents didn’t vaccinate them. Can that child sue the parents? And there the legal case itself would be much easier. They is duty of the parents to the child, but you may have a problem with parental immunity. In many states parents are still immune from tort liability when they make medical decisions for their child; in a minority of states they are not.
So California and Pennsylvania are examples where parental immunity doesn’t apply in the same way. The parent is held to a Reasonable and Prudent Parent Standard and their children may be able to sue their parents, although in practice that’s probably going to be extremely rare. You would have to have a breakdown in the family or something. Children usually, probably won’t look to sue their parents, maybe unless they are colluding to get insurance.
J. Craig Williams: So now you have got me wondering Dorit, what happened in the German case where the two babies died?
Dorit Rubinstein Reiss: The parents didn’t sue. The parents were — there was never a tort case there. I am using it because it’s such a stark case where the decision not to vaccinate hurt others who couldn’t vaccinate — who couldn’t protect themselves, and had such horrible consequences, but there was never a tort case.
J. Craig Williams: Thank you. Well, before we move on to our next segment, we are going to take a quick break to hear a message from our sponsor. We will be right back.
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J. Craig Williams: And welcome back to Lawyer 2 Lawyer. I am Craig Williams and we are joined by Dorit Reiss. She is a Professor of Law at UC Hastings College of Law, and James Hodge; he is the Director of the Center for Public Health Law and Policy at Arizona State University.
And before the break we were talking about the relationship of parents and child and the decisions not to vaccinate or vaccinate and whether there is tort liability.
James, what happens when the state declares an emergency, as in Washington and California happened recently, where there have been outbreaks and the state says vaccinate? As a matter of fact, I think coming up here on the 20th is the cutoff for vaccinations for school.
James Hodge: Yes, Craig. What and how you perceive the situation in relation to these emergency statuses regarding outbreaks really becomes very interesting. And so these outbreaks occur in regards to vaccine-preventable conditions like measles, mumps, in other arenas, solely because we have not reached what we call herd immunity within specific populations. That is enough persons got vaccinated because they are required to under school vaccination requirements or otherwise. As a result sufficient numbers of kids or others may be able to contract measles and as a result spread it throughout the community. These are totally preventable, but they can get out of hand fast.
You saw at Disneyland in California several years ago a measles outbreak that emanated from a single kid showing up at the park and then hundreds of cases across multiple states arose from there.
Now in Washington State and in Oregon and other jurisdictions you are seeing measles related outbreaks, totally preventable, leading some jurisdictions however to have to go so far as to declare either localized or state-based emergencies.
Now, what happens under those circumstances are really quite profound. These are public health emergency events authorizing government to do some more things that it might not do otherwise in a non-emergency type of scenario.
So now we are not playing around. If you have a kid unvaccinated who is attempting to go to school against the backdrop of a measles outbreak, authorities in that specific jurisdiction can tell your kid he is not coming to school, we are not going to allow it. This is totally legitimate, totally lawful. You don’t even need the emergency declaration to make that clear. That’s always been a penalty for a parent who might choose a religious or philosophical exemption. If an outbreak occurs, your kid cannot come to school because he or she may be impacted directly at school, potentially leading to liability event, but more to the case we just don’t want the disease spreading throughout the population.
But then you also have another intervention during these emergency environments that I think becomes equally profound and that is the sheer fact that we are going to work hard to get those kids vaccinated. The push from an educational perspective, from a sort of vaccine drive perspective in those jurisdictions is profound. You are starting to see a lot more parents bypass their traditional easy to get religious or philosophical exemptions they may have relied on for years and go ahead and get their kids vaccinated, recognizing and understanding either their public duty to do so or the sheer fact they don’t want to have their kids kept out of school for what may go on for weeks on end until a measles outbreak is free and clear.
That’s the profound nature of these emergency declarations. It really can result in the type of intervention that from a public health perspective can be advantageous.
J. Craig Williams: All right. Now Dorit, I have read about the Vaccine Court and the National Vaccine Injury Compensation Program. Can you explain that to our listeners?
Dorit Rubinstein Reiss: Certainly. So there have been efforts to legislate a 19:44 solution for vaccine injuries for several decades in the US before the Vaccine Court. They didn’t work.
In the 1980s there was a concern about diphtheria pertussis and tetanus vaccine, in part fueled by TV shows that suggested that it caused severe harm, a TV show that was probably not well-founded. There was an increase in the number of lawsuits and manufacturers started leaving the markets. In response, Congress worried that the vaccine supply will decline and children will be at risk managed to hammer out a compromised legislation. Compromise meaning nobody was completely happy with it.
Involved in the legislation were medical organizations, pharmaceutical companies and anti-vaccine organization. The legislation had two purposes. One, to secure the vaccine supplied by protecting manufacturers from liability; two, to help people who have the vaccine harms be compensated quicker and easier.
It did a number of things, but for your question, it created a no-fault compensation program that gives people who go through it a number of breaks. It does not require showing fault; you don’t have to show a design defect or negligence.
It relaxes the standard of causation. In some cases if you claim what’s under the so-called table of injuries, you can have a presumption of causation, causation is presumed, but if you are claiming a non-table injury, the standard is less than in civil court, the Althen standard. It basically says that a plausible theory backed by a credible expert is enough without having scientific data that shows a causal connection.
It also has lax rules in the rules of evidence. Experts are not held to the Daubert standard and more things are allowed even in regular court, and it covers fees and expenses for plaintiffs even if they lose as long as the case was reasonable.
On the other hand, it provides manufacturers with liability protections. For most kind of claims, they are not absolute. You have to go through Vaccine Court and then you can go through regular court.
So for example, there is a case in San Jose right now about the HPV vaccine that went to Vaccine Court and is now in regular court for design defect. The Supreme Court ruled in 2007 there was total preemption, which means that design defects cannot be brought in state courts at all.
So it’s a compromise. It provides a lot of breaks for people with vaccine injuries. It has a very low bar for compensation, although it does have some problems. For example, a very short statute of limitations; three years with no tolling for children, and I know three years is not unusual, but no tolling for children is unusual.
And on one hand, it provides breaks for plaintiffs, petitioners; on the other hand, it does protect manufacturers for liability. I would add that the rate of compensation in the program even with all these breaks is about 1 per million doses of vaccine, and most of that is in settlement. So it’s a very low rate of compensation kind of supporting what the science shows that serious problems in vaccines are very rare.
J. Craig Williams: Now, is this court a federal court and you just invoke jurisdiction like you would invoke admiralty jurisdiction or is it a particular venue and a particular location?
Dorit Rubinstein Reiss: It’s a particular venue. It’s an administrative program under the Court of Federal Claims in Washington and it has I think eight special masters, which are lawyers appointed by the judges of the Court of Federal Claims, which is a congressional court, not an Article 3 court. So it’s an administrative agency in a specific location with judges appointed by the Court of Federal Claims.
J. Craig Williams: Thank you. And James, what are the extent of vaccines that are available, and I just harken back to my experience in the Coastguard where I was going to have international duty and I recall getting assigned to a particular line and being there in my skivvies and walking down the line and getting shots in both arms, in several places and my legs and buttocks and the rest of it. So I have a vaccine list that’s an arm’s length long. What are the vaccines that are out there these days?
James Hodge: Well, you are a regular pincushion there Craig, I must admit, and to be sure, members of the military can be vaccinated for whatever the military tells them to be vaccinated for. They give up the opportunity to object as a result of their service in regards to serving in the military. To be sure there are vaccines that are used in the military setting that are quite distinct than anything we would use in regards to the public setting.
It’s a great question about how many different vaccinatable conditions there are for which either children or adults or members of the military or prisoners or others might be subjected to. What is good to note is that CDC, the Centers for Disease Control and Prevention in Atlanta, working through its Advisory Committee on Immunization Practices or ACIP works very hard to actually ascertain the types of approved vaccines that are available.
FDA, obviously Food and Drug Administration provides specific guidance on approved vaccines, and then CDC works very hard to make sure that those vaccines are tabled appropriately for either pediatric use, adult use, at specific ages such that particular populations are getting the fullest benefit of vaccines at the right point in time.
Now, one way to actually really try to drill down on this is to recognize the types of vaccines that CDC recommends for the purposes of kids prior to the age of three or so are all proven safe, they are proven efficacious, they are designed to do exactly what we want, keep these diseases at bay nationally, period.
And the types of conditions for which an adult may later prove to be vaccinated or approved to be vaccinated for might include conditions for which they may be at special risk.
So one neat and quick example to that, obviously the military, they might be vaccinated for anthrax exposures because of the potential to have to deal with that in regards to their service, and healthcare workers might be required to be vaccinated on an annual basis for everything from annual flu to tuberculosis, depending on their specific setting.
So vaccines pervade all populations across the US. Obviously the kids’ vaccines provoke a lot of the issues because of parental issues and concerns we have discussed.
J. Craig Williams: The typical kids’ ones are whooping cough or pertussis, measles, mumps, rubella, chickenpox is that about it?
James Hodge: Yeah, that’s a good series of examples. And Dorit, there are others to note as well.
Dorit Rubinstein Reiss: Yeah, there are a number of others; hepatitis B and hepatitis A are on the schedule; Hib disease, which is an infection that used to cause expensive hospitalizations and about 1,000 deaths a year; Prevnar, which covers pneumococcal disease.
How detailed do you want this?
J. Craig Williams: Well, no, just the general ones, because I was — I am curious to find out whether something like a tetanus shot is considered to be a vaccine?
Dorit Rubinstein Reiss: Yes, a tetanus shot is considered to be a vaccine. I think there is about 16 diseases that we vaccinate children against these days and they do include tetanus, they include influenza of course, which is an annual vaccine and has its own issues, but we have about 16 diseases that children get vaccinated against.
J. Craig Williams: And vaccines are not just given to children; you mentioned the flu vaccine, the H1N1, H1N2 and so forth, those annual vaccines are given to the general population. And I believe that there are other ones like shingles and so forth that are available.
Dorit Rubinstein Reiss: That’s exactly right. There is a number of vaccines that are recommended for adults such as the tetanus booster, if you haven’t had one. It’s still 10 years I think, although they might change it, because there is recent data that tetanus lasts longer. Elderly adults have a few other recommendations; as you mentioned shingles, pneumococcal vaccines and of course influenza every year.
J. Craig Williams: Right. Well, James, I am going to ask one of those — one last kind of vaccine question before we wrap up because we have just about reached the end of our program where it’s time to give you folks the opportunity to sum up and give your contact information.
But James, as you do that, I will turn it over to you first. I was born in the late 50s I will admit, but I have on my shoulder or the back of my arm a rather sizable scar from, I am told a vaccine, where did that come from?
James Hodge: Yeah, that’s the smallpox vaccine that would have very likely been administered to you at that age. So we were able globally to eradicate smallpox as a scourge that had affected populations for thousands of years back in the mid 1970s. And then to be sure along the way in doing that which was a tremendous effort to actually literally rid the world of the natural causes of smallpox. Smallpox vaccine began to of course be phased out because it posed no more a risk to others.
Sometimes it’s come back into the fold, as I was mentioning, the military may be vaccinated against smallpox just because of the potential bioterrorism threat that it presents. But to be sure, that’s what you experienced and there are sort of vestiges of the past for persons of certain age who have undergone vaccines, like perhaps you have and others along the way.
Let’s not fail to recognize from a legal and policy perspective exactly what vaccines represent. They are very likely the single greatest advancement in public health science over the last century, to obviate millions of cases of preventable deaths. As a result of vaccines we all live much healthier lives and it almost entirely eradicated certain conditions that would still scourge us today.
So to that end, from a law policy perspective, that’s why the law so heavily reflects and favors vaccination policies that are geared towards participation without compulsion, and to that end, you see consistently school vaccination policies that reflect those particular ends.
J. Craig Williams: And how can our listeners reach out to you James, if they would like to discuss this with you further?
James Hodge: Great, I look forward to it. You can reach me anytime at the following lowercase email address, [email protected].
J. Craig Williams: Great. And Dorit, I will turn it over to you to wrap up and give your contact information along with your final thoughts.
Dorit Rubinstein Reiss: My final thought is James already highlighted the benefits of vaccine. I want to point out that we have one of the safest vaccine supplies we have ever had. 30:24 of vaccine today are lower than they were in the 70s or 60s, even though we have more vaccines. 30:30 are extraordinary rare. Vaccines are thoroughly tested. And part of the reason that the law is so differential to states when they put vaccine mandates in place is not only the importance, as James pointed out, but also the fact that they are extremely safe.
My contact information, people can reach me at my phone number, it’s 415-565-4844, or through email at [email protected].
J. Craig Williams: Wonderful. Well, thank you Dorit. And I would like to thank both of our guests, James Hodge, the Director of Center for Public Health Law and Policy at Arizona State University and Dorit Rubinstein Reiss, she is the Professor of Law at UC Hastings College of Law.
That brings us to the end of our show. If you liked what you heard today, please rate us in Apple Podcasts. You can also visit us at legaltalknetwork.com, where you can leave a comment on today’s show and sign up for our newsletter.
I am Craig Williams. Thank you for listening. Join us next time for another great legal topic.
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