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Indiana University vaccine mandate upheld by Federal court

This article about the Indiana University vaccine mandate was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On June 21, 2021, eight students, represented by attorney James Bopp Jr., filed a complaint challenging the Indiana University vaccine mandate. On July 18, 2021, Judge Damon R. Leichty, from the federal district court for the Northern District of Indiana, appointed to the court by President Donald Trump, rejected the plaintiffs’ request for a preliminary injunction in a lengthy, thoughtful decision that made it clear the plaintiffs’ chances of success on the merits are very low.

The decision is important in setting the standard for reviewing constitutional claims against university mandates, in making it clear that a reasonable university mandate has a good chance to be upheld, but that public health authorities – or universities – do not have carte blanche to impose any requirements they want, but can legitimately act to prevent disease and improve safety. It thoroughly and intelligently addresses the scientific claims of the plaintiffs – and the approach to them. It examines the difference between a general challenge and a challenge based on a fundamental right like freedom of religion.

It does not substantially add to the discussion of whether universities can mandate a vaccine under an Emergency Use Authorization (EUA); though it does address the facts of the EUA, it does not go into the legal arguments about the EUA law that were addressed in a decision against a Texas hospital. Nor does it directly confront the Indiana passport law,  likely because the university changed in mandate in a way that, according to the attorney general, did not clash with it.

Finally, the decision was 101 pages. I cannot summarize all of it in a reasonable-length post, so this has to be a short summary of what I think are the main points. But it’s worth reading. There is a lot of thoughtful, in-depth analysis in it I just don’t have space for. 

Photo by National Cancer Institute on Unsplash

Indiana University vaccine mandate case

To help it respond to the ongoing COVID-19 Pandemic, Indiana University created a Restart Committee that has fifteen members, including experts in public health. Among other things, the committee recommended a vaccine mandate as part of the plan to safely reopen the campus. Following that, the university announced a COVID-19 vaccine mandate for fall 2021 (according to the lawsuit, the requirement was announced in an email on May 21, 2021). 

The Indiana University vaccine mandate offered a religious exemption and a very narrow medical exemption – covering those with allergies to the vaccine, pregnancy, and some immunocompromised individuals, and an exemption for online-only students.

For those who do not vaccinate or get an exemption, the university warned of “strong consequences”, including students seeing “ their class registration canceled, CrimsonCard access terminated, access to IU systems (Canvas, email, etc.) terminated, and will not be allowed to participate in any on-campus activity.” (cited from the complaint). The lawsuit describes this as virtual expulsion, and that’s probably fair. 

Those who are exempt will have to undergo routine testing and wear a mask. The complaint emphasizes that those with previous immunity to COVID-19, or those with medical conditions where their doctor advises not to vaccinate but that do not fit the specific and narrow definition of medical exemption, do not qualify for an exemption. 

The lawsuit includes eight students. Six of them have been granted religious exemptions, but are complaining about the additional requirements applied to them. One did not apply for a religious exemption, even though the complaint claims that she “has a sincerely held religious objection” to the mandate, so did not get one.

The last one openly states that her opposition is not religiously based but is based on her assessment of the risk/benefit situation. She is the one that, the court rightly noted, has actual standing to challenge the vaccine mandate (as opposed to the additional requirements applied to exemptors), since she could argue she did not request an exemption because her reasons were not religious.

It is a somewhat strange set of plaintiffs for the mandate itself since the majority are not subject to it. The court acknowledged this, pointed out that the presence of the one student who did not merit an exemption allowed it to address the vaccine mandate, and also addressed the additional requirements, which all the other plaintiffs were challenging. 

This was the best-written complaint challenging a mandate I have seen so far, and the court’s decision acknowledged that the lawyer did a competent, strong job arguing for the clients. It still ran into problems, including drawing heavily on anti-vaccine misinformation – for example, the plaintiffs’ main expert was Dr. Peter McCullough, who has made incorrect claims about COVID-19 vaccines in recent times.

For this complaint, too, Dr. McCullough – though he seemed to be more careful than in other pronouncements – argued that Indiana has reached herd immunity, and appeared to overstate the vaccine’s risks (and promoted his own protocol for treating COVID-19, which had little evidence behind it.) 

The Court clearly found Dr. McCullough’s claims less credible than the University’s experts on every point.

To get a preliminary injunction, the students would have to show, as the court set out, that without one, they would suffer “irreparable harm”, that there is no adequate remedy in law (for example, if you’re losing money but can later be repaid, a preliminary injunction is less likely to be granted, and whether there is “reasonable likelihood of success on the merits”. Most of the analysis in the decision explained why the students – the plaintiffs – did not have a reasonable likelihood of succeeding on the merits. 

Indiana University vaccine mandate
Photo by Tingey Injury Law Firm on Unsplash

The claims

The complaint contained numerous major claims, not all of which were addressed by the court.

  1. The main constitutional claim of the complaint, and the one addressed in depth by the court, was that the Indiana University vaccine mandate – including the requirement to vaccinate, but also the masking and testing requirements – was unconstitutional because it interfered with liberty without reasonable reasons. In legal terms, this is a substantive due process claim: it claims that the university’s mandate interfered with a protected interest without a good connection between the measure and a legitimate interest.  Under this heading, the complaint argues that the mandate is against CDC’s recommendations, other counties in Indiana and other universities, none of which mandate vaccines (all of which, though, recommend them). 
  2. Another constitutional claim raised by the students is that the mask and testing requirements interfere with their freedom of religion – some alleged religious objections to these measures.
  3. The complaint also argued at length that you cannot mandate a vaccine under an EUA. The decision did address the fact that not all EUAs are the same and pointed out that COVID-19 vaccines underwent extensive testing; but the court did not really address the complaint’s legal argument on this.
  4. The complaint argues the mandate violates informed consent. 
  5. The Complaint argued that the mandate violated Indiana’s new law about vaccine passports. This, again, was not addressed in the decision. In a previous interview, public health law expert Ross Silverman disagreed, and after the university changed its approach, the AG stated that the law did not prohibit mandates and the university’s revised approach did not violate the statute.

Substantive due process:

The Due Process Clause of the Fourteenth Amendment states that “nor shall any State deprive any person of life, liberty, or property without due process of law”. While this appears to speak of process, a longstanding (if controversial) legal tradition sees this as also protecting life, liberty, and property against unjustified interference. Basically, a state seeking to infringe on one of these three needs to meet a certain standard (one of three), and show that the infringement is justified with a good enough interest, and is not beyond the permissible degree.

Most laws affect liberty, but most of them just touch on, say, “regular” liberty, and the standard they’re subject to is rational basis review – which only requires that the state have a legitimate interest and the measure to be rationally connected to that interest. This is a reasonableness standard – is this a reasonable way to achieve a legitimate goal? 

At the other extreme are laws that interfere with fundamental liberties. These laws are subject to strict scrutiny, a very high bar. They can only be upheld if they serve a compelling interest, and are narrowly tailored to achieve those interests – they infringe on the right in question to a minimum degree. 

The first question the court addressed is which standard should apply. The Court addressed what is the right standard in a public health crisis. Its starting point was, correctly, the 1905 case of Jacobson v. Massachusetts, in which the Supreme Court upheld a smallpox vaccine mandate. The court – correctly in my view – read Jacobson as allowing reasonable regulation in public health, even when such regulation interferes with individual rights.

This standard has two aspects: it allows interference in individual liberties in the name of public health, but such interference has to be reasonable. Note that courts have varied in applying Jacobson during the COVID-19 pandemic, with some giving very strong deference to public health – to the extent of ignoring the reasonableness aspect or other rights – and some giving low deference.

The court also – again, correctly in my view – concluded that the Supreme Court’s recent jurisprudence on religious freedom was limited to religious freedom, and did not directly address the cases covered by Jacobson, where the tension is between general individual liberty – rather than a specifically enumerated right in the bill of rights – and public health. 

I think the court’s approach here – under which Jacobson has both aspects, allowing regulation but requiring reasonableness, and Jacobson is limited to public health v. liberty in general, not individual rights – is a very reasonable approach. 

In this case, the court rejected the university’s effort to describe the right affected as just to attend a university, which is not actually protected, and defined it instead as the liberty of a college student to refuse a vaccine during a pandemic. The court pointed out that there is a long jurisprudence protecting individuals’ constitutional right to refuse medical treatment – but that right is not unlimited and within the law.

The court compared this negatively to rights that did receive protection – those rights had a long history of protection in common law or other legal traditions. There is such special protection for the right to refuse a vaccine. And that’s not a coincidence. The court reminded us that individuals’ choices were protected when the choice is refusing lifesaving or other medical treatments that affect themselves, and not others. In contrast, the decision not to vaccinate does affect others, it is a question of public health, and history supports – rather than opposes – the constitutionality of a vaccine mandate such as the one proposed by Indiana University. 

Because the right to refuse a vaccine is simply a “significant” rather than a fundamental liberty, and because there is no fundamental right to a college education or to attend a public university, the court only holds the vaccine mandate to rational basis review. 

The court’s starting point is that Indiana University “has a legitimate interest in promoting the health of its campus communities—students, and not least the faculty and staff who come daily in contact with them.”

The court analyzed in-depth the factual arguments made by students and found them unconvincing. I will keep this discussion short because although important to the case, it has the least legal relevance – it is focused on the argued facts.

The court rejected the students’ argument that the pandemic is “basically over” because it’s against the conclusion of practically all public health authorities – the Secretary of Health and Human Services at the federal level, Indiana’s Department of Health, the CDC, etc. The judge also reminded us that part of the decline in cases is because of the massive vaccination effort. He reminded us of the concerns around the Delta variant, and concluded that Indiana University “reasonably believes the vaccine promotes the safety of not only its students but that of its entire community.” 

The judge points out the thorough, careful process of the university, with an expert committee carefully and repeatedly discussing the evidence. 

Although the fatality rate of COVID is lower for healthy individuals than older ones, lack of vaccine could still lead to death and harms even in the young population of students – and not all students are young and healthy. The university pointed out that over 8,500 faculty and staff are at real risk of complications from COVID. Besides deaths, there are other risks of harm from COVID, and those risks are real and serious. 

The Indiana University community also supports the vaccine mandate policy. Most students have been vaccinated, and elected bodies by the faculties and the students supported the policy. The policy is well within the university’s legal authority, and the legislature can always step in. 

The court gave more weight to Dr. Beeler’s – the university’s expert – testimony on the risks of the vaccine. In essence, he said that the vaccine has been given to millions, the data has been closely monitored, and even rare risks – like anaphylaxis, myocarditis and clots, all rare events – were caught fast.

Other risks do not have evidence beyond a temporal connection, and even the students’ expert – Dr. McCullough – avoided claiming a causal link, using very cautious language to avoid that. Dr. Beele concludes, and other experts agree, that the risks of COVID-19 for young people – the age group the plaintiffs argue is not at risk – are much higher than the risk of the rare harms of the vaccine. The court said it is “not deciding” causation, but there isn’t good evidence against the university’s actions. 

The court concluded that “Indiana University faces still an “objectionable” and “serious threat” to the “academic community” that its vaccination policy seeks reasonably to address for campus health,” so the mandate is constitutional (the case the court is quoting from was omitted). 

The court acknowledges that more information may arise later, but found that the thorough nature of the EUA granting, and the abundant data behind it, all of which were “closely considered” by the university when it adopted the mandate, support the university’s decision. 

The court said:

Today, Indiana University has a rational basis to conclude that the COVID-19 vaccine is safe and efficacious for its students. The vaccine has been used on about 157 million Americans; and data now about eight months later, though it will grow more robust in years to come, is considerable and shows major side effects are rare.

The policy is consistent with CDC’s recommendations and can help the university achieve herd immunity. 

The students have shown no better basis for challenging the other requirements. There is no fundamental constitutional right not to wear a mask or not be tested. These measures are reasonable because masks and testing are rationally related to promoting the health and safety of students, by preventing or reducing transmission. These measures are not particularly intrusive or burdensome, just an inconvenience. And students have been living with mask mandates for over a year. 

Freedom of religion

The students argue that the mask and testing requirements violate their religion. The court pointed out that the Supreme Court has, previously, held that “general regulations that have the effect of incidentally burdening religious practices in general and neutral ways need only be rationally supported by the state.” The leading case for that is Employment Division v. Smith.

On this specific point, the court is right now on reasonable grounds, but the Supreme Court has signaled that it is tightening freedom of religion. That said, in the most recent decision on this, Fulton v. City of Philadelphia, the Supreme Court did not overturn Smith.

The plaintiffs may try to raise this religious freedom argument higher, but they will run into some issues. First, as the decision pointed out, since all the students have worn masks in the past, and most have been tested, their claim that these measures violate their religious beliefs may be suspect. Second, these requirements are accompanying a religious exemption; they are there to protect the freedom of religion of students with religious objections to the vaccine and may be seen as supporting religious freedom, not against it. Third, the only argument that appears in the case that the masks and testing violate religion suggests that the risk is that students with masks will be targeted for their religion. As the court points out since there are also medical exemptions, observers won’t know the reason for the mask – and the court said they expect the university can address specific circumstances where a mask does, in fact, interfere with learning. 

Informed consent

The court pointed out that the EUA statute creates requirements for informed consent, but:

…the informed consent requirement under the EUA statute only applies to medical providers. The university isn’t directly administering the vaccine to its students; instead, it is requiring students to obtain the vaccine from a medical provider and to attest that they have been vaccinated, save for certain exemptions. The students will be informed of the risks and benefits of the vaccine and of the option to accept or refuse the vaccine by their medical providers. See id. The university isn’t forcing the students to undergo injections. The situation here is a far cry from past blunders in medical ethics like the Tuskegee Study.

The court acknowledged that the Indiana University vaccine mandate is giving the students a difficult choice, but the “hard choice doesn’t amount to coercion.” The students are choosing among options, and are told of the risks and benefits and options to refuse. 

Irreparable harm?

The court found that a vaccine mandate for a semester, or a delay in college or graduate education, isn’t irreparable harm. Nor is having to wear a mask for a semester, or being tested. It may be inconvenient, but it’s not irreparable harm. 

The university’s interest is the stronger one, especially since students are not forced to take the vaccine – they can skip a semester or transfer elsewhere, to colleges in Indiana that have not mandated vaccines. 

The court ended us by reminding us that it is not declaring vaccines are absolutely safe and effective, just that the university is:

..reasonably pursuing a legitimate aim of public health for its students, faculty, and staff. 

This university policy isn’t forced vaccination. …. The choice isn’t so coercive as to constitute irreparable constitutional harm.

Where is this now?

At this point, the students have not been given a preliminary injunction. They have the choice of continuing to litigate on the merits with Indiana University vaccine mandate policy in place – most of them have exemptions, so can attend while masking and testing, but two do not. The court made it clear it sees their case as weak, but their (capable) lawyer would have a chance to change that during the case.

Alternatively, the students can appeal the decision on the preliminary injunction to the Circuit Court of Appeals and then, potentially, to the Supreme Court. Or, as other anti-vaccine litigants have done, they may choose to withdraw the claim (I doubt they will do that, but it is one of the options). 

We will see. This is a strong decision on the constitutional issues, though, and can influence other courts looking at the case. 

12 August 2021 Update

Justice Amy Coney Barrett rejected the request of students challenging Indiana University’s Mandate to put the mandate on hold while the case is being heard. Justice Barrett gave no reasoning for the decision. 

Constitutional law expert Prof. Steve Vladeck said: 

An in-chambers denial without even requesting a response — let alone referring it to the full Court — is a pretty strong sign that #SCOTUS is in no hurry to block university vaccination mandates, especially those, like Indiana’s, with appropriate medical and religious exemptions.

Dorit Rubinstein Reiss

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