This article about a challenge to a COVID-19 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.
In late February, a lawsuit challenging an employment mandate, that county officers in New Mexico receive a COVID-19 vaccine, was filed in a district federal court. Although there is some uncertainty on whether an Emergency Use Authorization (EUA) vaccine mandate is legal, this lawsuit is not well-founded, and the county’s response very well-argued. Hopefully, the court will reject this claim.
The COVID-19 vaccine mandate case
On 1 February 2021, County Manager Fernando Macias, from the County of Dona Ana, New Mexico, issued a directive requiring first responders in Dona Ana County to receive Covid-19 vaccines to continue being employed by the county. Isaac Legaretta is a correction officer in the county, working for the Dona Ana Detention Center, which includes a jail and detention center.
“[o]n or about February 18, 2021, Plaintiff received a 5 day notice to comply with the mandate to receive the COVID vaccine. Plaintiff has received a ‘coaching and counseling’ write up for not complying with the directive…
Plaintiff is in imminent danger of being terminated from his job for refusing to accept the vaccine.”
The main argument of the plaintiff, through his lawyers, is that it is illegal to require a EUA vaccine. To bolster that, the plaintiff also argues that a COVID-19 vaccine mandate is preempted by the federal EUA. In addition, the plaintiff, through his lawyers, also alleges that the requirement is in violation of his constitutional right to life, liberty, and privacy. This case is different than most challenges to workplace mandates in that the employer is a public employer, the county, which is also limited by the Constitution.
EUA and COVID-19 vaccine mandate
Probably the strongest claim in the case is that it is illegal to mandate a vaccine under a EUA, and even that claim has limited strength. I have addressed this issue in some detail before and concluded that while there is an argument against a EUA mandate, there are also strong counter-arguments and that an employer mandating the vaccine has a decent chance to survive court review.
I think the way the case was set out in this complaint supports my views. While my initial post provided – I hope – a balanced view of the question, in this post I will set it out differently, describing first the plaintiffs’ arguments, and then explaining why I think they are unconvincing. In a case like this, the job of the plaintiffs’ lawyers is to make the strongest case they can; the clear weaknesses here affect, I think, how this should play out.
The plaintiffs set out their case first by referring to 21 U.S.C. §360bbb-3(e)(1(A)(ii) of the Federal Food, Drugs and Cosmetics Act says the legal framework for an EUA. The specific provision is titled “Unapproved product”, and then “required conditions”, and the clause says that the Secretary (of the Department of Health and Human Services) shall “establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed–
…
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Plaintiffs interpret this to mean “that where a medical product is “unapproved” then no one may be mandated to take it.” They emphasize the language stating that the recipient has the option to accept or refuse the product, and allege that the county violated the law because “Defendants did not inform Plaintiff that he had an option to refuse the vaccine. Quite the opposite, he was advised that he would be fired if he did so.”
Plaintiffs also emphasized that the vaccines are “unapproved”, the clinical trials are still underway and it will take about two years, they say, to “collect adequate data to establish if these vaccines are safe and effective enough for the FDA to license.”
The plaintiff alleges much isn’t known about the vaccines, including their effectiveness against “infection, death, and transmission of SARS-CoV-2, the virus that is allegedly the cause of the COVID disease.” The EUA letter states that the vaccines are not approved or licensed.
The complaint also quotes a statement by the FDA that:
FDA believes that the terms and conditions of an EUA issued under section 564 preempt state or local law, both legislative requirements and common-law duties, that impose different or additional requirements on the medical product for which the EUA was issued in the context of the emergency declared under section 564 … In an emergency, it is critical that the conditions that are part of the EUA or an order or waiver issued pursuant to section 564A — those that FDA has determined to be necessary or appropriate to protect the public health—be strictly followed, and that no additional conditions be imposed.” The source of the statement is the FDA guidance about Emergency Use Authorization.
Finally, the complaint cites Dr. Amanda Cohn, Executive Secretary of the Advisory Committee on Immunization Practices, who said in an ACIP meeting:
I just wanted to add that, just wanted to remind everybody, that under an Emergency Use Authorization, an EUA, vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandated.
Plaintiffs argue that since federal law, by their interpretation, prohibits mandates, a contrary state or local mandate cannot stand under the preemption doctrine. For this purpose, federal preemption says that when a constitutional federal law conflicts with local or state laws or rules, the state or local rule must give way.
Because of that, plaintiffs are asking for a declaration that the mandate is invalid and an injunction prohibiting firing the plaintiff.
The problem is that the plaintiff’s interpretation of federal law is not the only one possible. In the respondents’ answer, they are quoting a more recent statement by CDC that goes the other way, and is in tension with the preemption argument. The CDC says, reflecting the current federal government position:
The Food and Drug Administration (FDA) does not mandate vaccination. However, whether a state, local government, or employer, for example, may require or mandate COVID-19 vaccination is a matter of state or other applicable law.
What led to this change, since the complaint is right that as late as August, Dr. Cohn was stating that EUA vaccines cannot be mandated? I don’t know, but this view by the CDC has substantial reasons behind it.
The first point to remember is that if we go back to the law authorizing the EUA, it does not speak to state or local authorities at all, nor does it speak to employers. The law tells the Secretary of Health to provide information to recipients. But as the CDC points out, traditionally it’s not the federal government who mandated vaccines.
Basically, the plaintiff – and other supporters of the view that the EUA provision prohibits mandates – are asking a court to determine that a provision directed at the Secretary of Health and Human Services overturns an existing legal framework that allows states and localities to impose rules in the public health – and allows employers to set workplace health and safety conditions – by implication, without addressing them directly at all.
Maybe, but that is an extremely big legal change to make by implication. Employers have a decent argument that this provision is not directed at them, and does not change existing state and local law by implication alone.
Further, the provision itself is ambiguous. It mentions the consequences of declining a product, suggesting that there could be such consequences. Especially outside the Secretary’s orbit.
Plaintiff also mentions that the employers did not inform him of the risks or benefits of vaccines, but the statute is fairly clear that such information needs to be given by those administering the vaccine. It is not directed at employers per se, and the plaintiff was not getting the vaccine from his employers directly.
What about the quotes from the FDA and from Dr. Cohn? Could the employee not rely on them? Well, not really.
First, the FDA issued a guidance document. Under our Supreme Court jurisprudence, while the law is not as clear as it could be in this area, agency guidance does not always get a very high level of judicial deference; Dr. Cohn’s comment would likely get even less deference: it was an oral comment by an official that, although entrusted with substantial responsibilities (and, because of her capability, intelligence, and integrity, deserving of much personal respect) is not a legal expert, and not in charge of applying the EUA law (the latter is relevant to assessing the level of deference).
Further, the language quoted from the FDA – the preemption clause – does not directly address mandates. It is part of the “Preemption” section of the guidance document, and that section, the document explains, anticipates conflicts of state law if “if states have existing requirements governing the shipment, holding, dispensing, administration, or labeling of unapproved medical products or approved medical products for unapproved uses.”
That’s not about the mandate. This clause is not a good source for arguing that the FDA is prohibiting mandates. In fact, the word mandate does not appear in the FDA guidance. The closest reference in the document is that the document quotes that “the statute requires that FDA ensure that recipients are informed to the extent practicable given the circumstances… that they have the option to accept or refuse the EUA product and of any consequences of refusing..”[the vaccine].
The only operational conclusion from that is the FDA’s recommendation to include this language in the EUA fact sheet that manufacturers prepare for recipients. Again, this is directed at recipients – and manufacturers – not employers.
In other words, while the plaintiff has a colorable argument that the EUA law prohibits mandates, the county likely has a much stronger argument that there is no such prohibition.
The complaint also seems to me to understate the data behind the vaccines, which draw on clinical trials as large or larger than those used to license vaccines, trials consisting of tens of thousands of people, which found the vaccines very effective and very safe. Experience since, with the vaccines given to tens of millions of people, and supported, for example, by a study with over a million from Israel, supports that.
At this point, EUA COVID-19 vaccines have strong evidence to support their safety and effectiveness.
Plaintiff’s right to due process, life, liberty, and privacy
Because the county is a public employer, it has to respect people’s constitutional rights. Plaintiff argues that:
If the Defendants were to terminate the Plaintiff for refusing to take a vaccine it would be a violation of his due process right to life and liberty under the 14th Amendment and an invasion of the zone of privacy and right to bodily integrity which have been held to emanate from various Bill of Rights amendments, including the first, fourth and fifth as well as the ninth amendment which speaks of essential but unenumerated rights.
The plaintiff’s lawyers even tried to coopt the famous case of Jacobson v. Massachusetts, which upheld a vaccine mandate, by pointing out that it acknowledged that there are limits on the government’s power to limit individual rights for public health. That is true, but Jacobson also approached such limits with some deference to the authorities.
At any rate, a COVID-19 vaccine mandate like this would easily survive the reasonableness requirement embedded in Jacobson. The county is requiring public servants working in certain positions to get a vaccine with extensive safety and effectiveness data behind them.
Plaintiff is a corrections officer, literally working with a captive population in a congregate setting. Plaintiff is not being held down or forcibly vaccinated and does not face criminal charges if he does not vaccinate.
He is told that if he wants to work with a vulnerable population, he needs to get a vaccine. This is an imminently reasonable requirement, in these circumstances. At least arguably, when the state detains people the state owes them to take basic safety precautions and requiring that the correction officers be vaccinated seems a natural step in the right direction – especially since jails have been part of the relatively high rate of Covid-19 seen among incarcerated persons.
I will add that when the government is acting as an employer, those working for it will inevitably be subject to workplace rules. By taking the employment, the employee is accepting some limits on conduct. While constitutional rights do not disappear, there are limits to their application in their employment context – even freedom of speech can be limited in the workplace when the speech is not about a matter of public concern.
In this context, the county, in its response, mentions a federal law prohibiting courts from issuing injunctions “in any case involving or growing out of a labor dispute to prohibit any person or persons participating or interested in such dispute … from doing, whether singly or in concert, any of several acts.” 29 U.S.C. § 104
The county pointed out that:
…(since) Plaintiff’s request is an injunction requiring his employer to maintain an employment relationship with him, the Court lacks jurisdiction to enter such an Order under the Act.
Conclusion
While the plaintiff has some arguments that the EUA law prohibits mandates, it is not a very strong argument, and the county has a strong counter that the EUA law does not prevent them from requiring employees to vaccinate.
Further, this case – a corrections officer seeking to continue to interact with a captive population without taking precautions to reduce the risks of a serious disease – is not a particularly strong one for arguing against a mandate. Hopefully, a court will allow the county to continue acting to protect the public and the people under its care.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also 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.
