Search:

A summary of presentations from the weekly Summit partner webinars

August 8, 2024 – The latest Summit Summary

ACIP and HRSA May Be in Constitutional Jeopardy – Richard H. Hughes IV, Attorney: Epstein, Becker, and Green; and Legal Developments: Mandates and Misinformation – Dorit R. Reiss

Richard Hughes gave an update on vaccine litigation, and Dorit Reiss gave an update on vaccine mandates and misinformation.

VIEW SLIDES

Watch video recording


Vaccine Litigation Update
Anti-vaccine advocates are using the courts to target hospitals, school systems, medical licensing boards, and pharmaceutical companies with the goal of “exposing” those who they deem to be forcing vaccines on unwilling recipients.

These anti-vaccine advocates are applying the work they have done with anti-vaccine legislation to litigation, a continuation of the use of the court system for COVID-19 vaccine litigation. Based on this trend, there may be additional litigation applied to a broader anti-vaccine agenda.

  • Activists who attend ACIP meetings and others have realized that the courts can be weaponized for misinformation and disinformation. The headlines and media – and not necessarily rulings in their favor – are foundational to the success of the movement.
  • It’s a systematic and thoughtful approach that is based on a model similar to what led to the overturning of Roe v. Wade, which amounted to a chipping away that led to a limitation in the decision in Planned Parenthood v. Casey, and finally, the overturning in Dobbs.
  • Activists use emotional arguments that get the attention of the court and others to make their cases. They take advantage of a Supreme Court focused on the role of regulators and experts and the administrative state.
    • There is interest among some justices to dismantle the administrative state and they are leveraging COVID-19 fatigue and frustration. COVID-19 vaccination rates are declining, and they are taking advantage of the grievances that are leading to that trend.

There is precedent for vaccine mandates.

  • Jacobson v. Massachusetts, decided in 1905, said that compulsory vaccination is a reasonable exercise of the state police power, that the state’s interest in protecting citizens overrides individual interests.
    • This decision also said you have to provide medical exemptions where applicable.
  • Zucht v. King affirmed that vaccination requirements for school entry are constitutional and reasonably related to the state’s interest in preventing the spread of contagious disease within schools.
    • This decision reinforced that if you’re in a non-outbreak scenario, you’re dealing with endemic disease and trying to suppress a threat. (This is important regarding measles, mumps, rubella, polio, etc.)

Now, there are arguments that are allowed to proceed in high courts that argue that vaccination is forced medical treatment.

  • Health Freedom Defense Fund v. Carvalho, in the 9th Circuit, argued that, because vaccines don’t prevent all transmission, they are not vaccines but are medical treatment.
  • Norris v. Stanley filed a petition for certiorari which invited chipping away at Jacobson and Zucht. (The Supreme Court declined to take the case.)

During the pandemic, after almost a century without the court taking up a vaccine case, two cases emerged that involved religious exemptions to the COVID-19 vaccine for healthcare workers.

  • A case in New York did not have strong standing.
  • A case in Maine was a result of regulators at the Health Department desiring an effective requirement without the allowance of medical exemptions. Supreme Court justices who didn’t like this inserted language in their dissenting opinions to counter the spirit of the Jacobson decision and assert that these cases are targeting people based on religion, or subordinating religious interest to secular interest.

This type of assault on vaccines undermines public health authority in a context where there is already a broader assault on public health authority.

Braidwood v. Becerra and ACIP-Recommended Immunizations
Braidwood v. Becerra is a case about preventive services, broadly, and ACIP-recommended immunizations may be at stake. It’s a serious threat that applies to the private market and needs to be understood. Under the Affordable Care Act (ACA), private payers must provide “first-dollar coverage,” with $0 out of pocket, of recommended immunizations on the ACIP schedule. Also, A and B grade U.S. Preventive Services Task Force (USPSTF) services and certain HRSA recommended services – specifically contraceptives – must be covered without cost sharing. This case is really about employers that do not want to provide coverage related to sexually transmitted infections and drug use. They posit that things like the HPV vaccine, the hepatitis B vaccine, screening for drug use, etc. facilitate behavior outside of a marriage between one man and one woman. So, it’s a religious exemption.

There were two sets of arguments under Braidwood:

  • Religious Freedom Restoration Act: These claims are about entitlement to a religious exemption and were narrowed to PrEP for HIV.
  • The administrative and constitutional law argument is where the threat remains to ACIP. These claims assert that ACIP, HRSA, and the USPSTF are acting unconstitutionally under the ACA because they are not Senate-confirmed and are thus, acting without political accountability. The initial judge who heard the case considered this and ruled that the USPSTF is actually acting independently, insulated by statute from political influence; however, the judge also decided that ACIP and HRSA, owing to their appointments and confirmations have political accountability and can remain intact.
    • Based on that distinction, the judge issued a nationwide injunction against the USPSTF and suspended the federal government from enforcing the requirement to cover A and B grade USPSTF services.
    • This case was appealed to the 5th Circuit Court of Appeals where a stay in the case was issued, allowing ACA enforcement to continue, except for the plaintiffs. However, the 5th Circuit said the judge overstepped and ordered the lower court to revisit the case, including taking another look at ACIP and HRSA again.
      • The potential risks in this case are as follows:
        • The judge could say that ACIP and HRSA are unconstitutional.
        • The judge could reissue an injunction, essentially overturning all the requirements for all the body services to be covered, including vaccines.
        • The judge could limit the restriction of requirements to PrEP, but that is a slippery slope regarding religious exemptions.

BACK TO TOP

VIEW SLIDES

Legal Developments: Mandates and Misinformation
Society is splitting into silent silos of information and people are getting their information from sources with anti-vaccine views.

The court said in Jacobson v. Massachusetts that it’s okay to have reasonable limits on individual rights in public health and that the court would defer to policymakers and experts. During the pandemic, that decision had a revival and vaccine mandates survived scrutiny by the courts. However, we have already seen a small number of judges use Jacobson to strike down some mandates. More concerning, there are three Supreme Court justices that have specifically suggested that Jacobson should be overturned.

The most concerning recent development has been the 9th Circuit decision in Health Freedom Defense Fund v. Carvalho, which gave credence to a misleading anti-vaccine claim that the COVID-19 vaccine has no effect on transmission or infection and is essentially a medical treatment and not a vaccine. It not only allowed misinformation to go forward to fact finding, but it also narrows Jacobson, saying if it doesn’t prevent – not just reduce, but prevent – outbreaks in the population, then Jacobson doesn’t apply. This is an issue because a lot of vaccines reduce but do not prevent outbreaks.

Workplace Mandates

There is a difference between workplace mandates and constitutional rights, and public employers must respect constitutional rights. Vaccine mandates have been considered a work safety rule.

  • Employers owe employees a safe workplace and, if vaccine mandates increase safety, that should be reason enough, ethically.
    • The employee can act to make sure employees don’t get sick and to protect employees. Protective equipment protects employees themselves and employers have an interest in a healthy workforce as that affects their financial interest.
    • Going to work already comes with rules: regulating the workplace is inherent in the work agreement.
  • Workers have rights, too, and regulation must include them.
    • The most relevant workplace law here is the Civil Rights Act of 1964 which says that employers with 15+ employees cannot discriminate based on religion. This means that if an employee has a sincere and religious objection to a workplace rule it must be accommodated. (Note that the objection must be based on a sincere religious belief, but the assessment of that sincerity cannot include judgment about the religion itself, such as whether it has a deity, or is outside the mainstream, or seemingly extreme.)
      • More of these cases are being allowed through and it costs a lot of money for employers to keep going through the legal system.
      • For influenza and COVID-19, the accommodations for people who did not want the vaccine were masking and testing.
      • In 2023, the Supreme Court said that employers must give an accommodation unless it is a substantial burden not to; substantial burden has yet to be defined, but it will be about cost to the business, effects on others, etc.
      • The courts are on a trend of tightening protections of religious freedom. The Supreme Court is also tightening those protections and has suggested that with any secular exemptions (e.g., medical exemptions) employers must also offer a religious exemption. There are also cases that, concerningly, allow claims that previously would have been rejected out of hand.
      • Employers stand on solid ground when they offer a secular and a religious exemption.
    • Some additional challenges to mandates include…
      • the Americans With Disabilities Act, which may not be limited to contraindications to the vaccine, but as in the case of anxiety if that is claimed and allowed as a disability;
      • the collective bargaining framework of unions, which may claim that a mandate should have only been imposed after union negotiation;
      • and the argument that vaccines under an emergency use authorization cannot be mandated, which is an open legal question.

A big damper on federal mandates is the possibility of future litigation based on President Biden’s mandates, imposed during the COVID-19 pandemic and some of which have been struck down, setting a precedent for more conservative challenges to limit the administrative state – with vaccines being pulled into the mix.

School Mandates

For the last 100 years, school mandates have been on strong legal ground, with no school mandates being struck down on constitutional grounds. Sometimes the courts wanted religious exemptions and the policymakers didn’t agree. There is now litigation in five states pushing the claim that school mandates must have a religious exemption if there is a medical exemption and, in Mississippi, a judge accepted the claim. (Notably, the Attorney General of Mississippi offered no arguments against the claim, which is unusual and may have swung the decision.) Other cases have not gone the same way, but there is cause for concern, because a lot of states have introduced legislation to limit school mandates.

Misinformation

There are several cases currently addressing the government’s efforts to use social media to fight misinformation on the grounds that it violates the First Amendment. The Supreme Court recently rejected a case but said that plaintiffs have to show that the government targeted them personally, which opens the door for these kinds of arguments.

In another case regarding an FDA tweet on doctors prescribing veterinary Ivermectin for COVID-19 infection, the court found that the FDA does not have the authority to make recommendations, even though the FDA could point to a specific clause that arguably gives it that authority. It’s a legally flawed decision but was never overturned because the FDA settled and agreed to remove the tweet.

The courts have shown that they are willing to make it harder for the government to combat misinformation.

QUESTIONS & ANSWERS

Q: Is it possible that we could reach a state where we could lose school entry mandates? I mean, there’s so much talk about it. I know you’ve tried to provide a picture, but in your experience, because this is going to be a state-by-state issue, right? What are the chances? Will we get to a situation where we have certain states where it’s all gone, and other states that have completely removed school entry requirements and other states that have just remained.
Dorit Reiss (UCLawSF): I think the chances of a complete removal of school entry requirements are low, but what we can see is more and more states opening exemptions and the courts requiring states that have removed or tightened exemptions to go back on them, and allow more exemptions. So, I think it’ll be more of a chipping away. If a state completely removes school mandates, it’s going to be very rare, but you can undermine the school mandate by giving a wild, wide, open exemption very easily. And I forgot to say about what can you do. Your voices are needed. And to echo what Richard said, if some of you are willing to educate judges, there are trainings for judges, and hearing from experienced experts on the facts might help.

Q: How are members of congress and their staff members receiving advocacy around this? Do they welcome it? (And, it is not just members of Congress, but the judicial offices are probably really important targets for the education, as well.)
Richard Hughes (Epstein Becker Green): I do think it is a different issue than what we’re commonly accustomed to in the policy, the legislative, the regulatory arena. I think many people on this call and many advocates are accustomed to making the pro vaccine arguments. This really is different. The courts are a different animal entirely, and there are things that can be done to address the misinformation in the courts. One of them is to file amicus briefs. And that’s a great opportunity to clarify science to make persuasive arguments. And I think that those can be effective in certain courts. But there are other things that I’ve thought of. If folks are interested in having further conversations around junk science in the courts, generally that there is a problem with junk science in the courts, there are actual approaches that could be taken, like what are the standards of evidentiary review in the courts, that we could think about.
Dorit Reiss (UCLawSF): So, the Congressional issue is something that other types of advocates, such as Vaccinate Your Family and the Summit are probably more on top of than we are. I know that you interact with congressional staff quite a bit, and maybe some of you can talk to that, but to echo what Richard said we really need to insert a lot of this earlier. A lot of law schools have public health classes already, but the law is one thing. People are isolated unless we fight this on several levels, including in the media. Someone who hears in the media again and again that COVID vaccines don’t prevent transmission, or that childhood vaccines cause autism…and when you get to the court, and they’re now the judge, it’s a little late to address this. So, first of all, we need to fight the educational battle. Second, as Richard said, we need to work on coming in early. Richard is correct that we need to think about the procedural framework. But I really think that, although it adds to the burden, I know immunization coalitions and immunization groups are already doing, if you could get in at the step where you educate state legislatures, attorney generals, judges. That’s where you need to catch them. I mean before it ever gets to a case, is where you need to talk to them. The anti-vaccine groups are not wrong in doing a lot of presentations in front of legislators. I don’t think they’ve captured the judge-training market yet, so maybe that’s a place.
L.J Tan (Immunize): I think that’s a great idea. I wonder if AVAC is on the phone? Hope you’re sharing this with AVAC? If not, I think we’re going to bring it up. This judicial education seems like an important piece that’s missing.

Q: Could HHS remedy the constitutional challenges to ACIP and HRSA vaccine recommendations through revised ‘ratification’ processes, to prevent a nationwide ruling against enforcing vaccine coverage mandates? And, if deemed constitutional, could these changes then nullify the Braidwood v. Becerra ruling (and any future lawsuits challenging the constitutionality of the ACIP- and HRSA-related preventive services mandates)?
Richard Hughes (Epstein Becker Green): Yes, you know anytime there’s a judicial decision saying that this law, or the way the law is enforced, does not comply with the Constitution, you can go back and correct course by changing the law or changing the way it’s enforced. And so, it is possible and it has to be done very thoughtfully. I’ll just point out, the thing that I said around the DHHS Secretary’s attempt to retroactively ratify recommendations, the 5th Circuit really caught on to that, and said, “Hold on a second.” Well, the plaintiffs first said, “Hold on a second. That is not. He did not go back and review the evidence and really think about all these recommendations. He, just with the stroke of a pen, did this.” So, I can guarantee you the other side will always find an argument, that’s true of any legal proceeding, to say that still doesn’t comply. I do think that we should think carefully about the administrative reforms, because I don’t think you want to go to Congress for this but thinking about really thoughtful administrative reforms. I think that the way that ACIP and CDC operate from a ratification standpoint is pretty good, but we might strengthen some of the procedures. I think, HRSA is pretty good, but we might strengthen some of the procedures. The USPSTF, unless the Supreme Court or the lower court decided to sever this part of the statute that says they’re independent, we’re not going to see a fix there.
Dorit Reiss (UCLawSF): I want to add something. It’s a little technical, but both ACIP and the USPSTF are in essence advisory committees. The reason this hasn’t come up previously is that generally advisory committees don’t have statutory authority. So, when advisory committees don’t have the decision making power, there’s not a constitutional question. The issue comes up when they’re making the decision, because they’re not “appointed” under their appointment clause. So, there are two things about it: first, as painful as it is, we may end up with having to politicize these processes in order to isolate them from being struck down. In other words, if the final decision is – and that’s what saved ACIP and the HRSA in the lower courts – if the final decision is in the hands of a political actorthe claim goes away but that has the cost of putting the final decision in the hands of a political actor. But right now, where the constitutional law is, we probably are risking a lot more by isolating expert decision than by subjecting them to politics.

Q: Did Richard say that the whole HRSA agency could be found unconstitutional? What would happen to all HRSA programs, like FQHCs?
Richard Hughes (Epstein Becker Green): This is why sometimes I struggle to explain Braidwood, because we try to shorthand things and make it understandable. And it sometimes means that it gets confusing in the process. So, I’ll explain: what we’re really talking about is the role the bodies have under the ACA. We’re not talking about the bodies themselves, right? HRSA is an agency. But to Dorit’s point, ACIP and the USPSTF are advisory bodies. So their existence is not in question at all. So sometimes we’ll slip up when we’re simplifying and say, “overturn ACIP or overturn the USPSTF or overturn HRSA.” What we really mean is the role under the ACA, and that’s all we mean.

Q: The ADA was key in protecting immunocompromised individuals from prohibition of masking requirements in schools. Could the ADA continue to stand in favor of vaccine mandates or could it be susceptible to religious exemptions? This seems illogical, but logic is not paramount to the antivaccine movement.
Dorit Reiss (UCLawSF): That’s a great question. And so, the ADA has been used successfully to prevent states from prohibiting schools from acquiring masks, and I think it could be used. Similarly, for example, to require that schools provide immune-compromised children a safe environment, but that doesn’t necessarily mean they’ll be used to prop up the mandate or prevent religious exemption. So, it’s worth a try, and you’ll need the right plaintiff, someone who’s immune-compromised and at high risk. So the ADA would require an accommodation, but there are other ways to accommodate besides enforcing a strong mandate; for example, making sure that these children go to a high-vaccination coverage rate school or a high-vaccination coverage rate class, and not all those solutions will be comfortable to the parents or the children. So, I think it’s worth litigating. It won’t be simple.

Q: Is there any data that shows the impact of higher vaccine exemptions rates in more permissive states, versus less, and compares to/or finds any relationship with VPD rates? Data like this might make it easier to make arguments against permitting easy vaccine exemptions.
Dorit Reiss (UCLawSF) The resource I usually use for exemptions is the IAC’s own collection of studies, kept updated: https://www.immunize.org/wp-content/uploads/catg.d/p2069.pdf it’s the best I’ve seen.

Q: There is great effort to demonize vaccine experts and vaccine providers and to state that they have a conflict of interest with vaccine makers and vaccine scientists. How can this be addressed?
Dorit Reiss (UCLawSF) There are several answers to the conflicts of interest issue, including:

  • A. Anti-vaccine groups trying to call them out tend, themselves, to make a lot of money off misinformation. Here is one report. https://counterhate.com/research/pandemic-profiteers/
  • B. Any one source should be treated with caution; but the information about vaccines comes from all around the world, from multiple groups, large teams of sciences, and many governments. To assume it’s all tainted by conflicts of interests requires believing in an impractical global conspiracy.

BACK TO TOP

Announcements
  • N/A

BACK TO TOP

Search: