Under an EUA Can Businesses Require Employees to Get Vaccinated?

While corporate media is reporting near unanimity for employer mandates, leading experts in the field remain more circumspect. One such pro vaccine advocate is Dorit Rubinstein Reiss, who is a Professor of Law at UC Hastings College of Law.  Professor Reiss' research focus is legal and policy issues related to vaccines. On May 8, 2020, despite Jacobson's plain language to the contrary (see Gorsuch's concurrence in Roman Catholic Diocese) Professor Reiss (Reiss) wrote: 

"There may be good ethical grounds to mandate a COVID-19 vaccine, as long as the risk is low, and access is readily available. Our jurisprudence suggests that states will face few, if any, legal barriers in doing so, and the past political fights brought on by anti-vaccination groups are likely to be significantly weakened by the unparalleled intensity of the COVID-19 crisis." (Reiss and Caplan, Considerations in mandating a new Covid-19 vaccine in the USA for children and adults, J Law Biosci. 2020 Jan-Jun; 7(1): Isaa025)).

 

Reiss is strident vaccine advocate and was named an "immunization hero" by the pharmaceutical lobby. Reiss has called for examination of whether parents who don't vaccinate their children, including those who obtain legal exemptions, should face legal liability. She was a supporter of California Senate Bill 277, which cut back on exemptions to vaccination requirements for enrollment in California schools and daycare centers. In short, Reiss has a clear pro-vaccine bias, so her reticence (as an "immunization hero") in supporting employer mandates is highly relevant to the debate.   

Central to Reiss' analysis of employer mandates is the text of 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies (relevant sections reproduced at bottom). Specifically, Reiss focuses on the language in (e) (1) (A) (ii) (III):

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed

(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.

 

With respect to this explicit language in the 21 U.S. Code, Reiss writes: 

"On its face, this seems to suggest that as part of the EUA, the Secretary of HHS should require, in the conditions of the EUA, that individuals be told that they can refuse the product – in this case the vaccine. This would imply that mandates are not allowed. This disclosure is a 'required condition' of an EUA, which means the issue needs to be directly addressed in the authorization [which it is not]. In support of this interpretation is the fact that this is how the FDA interprets the act, and agency interpretations are, in some cases, given deference by the courts. 

 

Further supporting that interpretation is the fact that another statutory provision –10 U.S.C. §1107a – allows the President to waive the requirement that people be told that they can accept or refuse the product for members of the armed forces, but only if  '…the President determines, in writing, that complying with such requirement is not in the interests of national security.' The specific waiver implies that for those not in the armed forces, and in other circumstances, the condition cannot be waived, and a mandate cannot be imposed.

 

There are also good policy reasons to suggest that for products approved on an Emergency Use Authorization, where full data from clinical trials is not yet available, a mandate is undesirable. Imposing a mandate when there is still substantial uncertainty about the risk/benefit profile of the product is much trickier than for a licensed product. With more uncertainty, people deserve a choice that is not too onerous, and having to choose between a job – especially in this economy – and a vaccine, or between, for example, flying abroad and a vaccine, may be a very onerous choice." (Reiss, Dorit. "Under an EUA, Can Businesses Require Employees and Customers to Get Vaccinated?" Bill of Health, November 30, 2020) [Bill of Health].

The terminology Reiss employs "onerous choice," is a euphemism in this instance for 'duress."  

 

"Duress is pressure exerted upon a person to coerce that person to perform an act they ordinarily would not perform." Black's Law Dictionary (6th ed.)

Exerting undue pressure against a person to choose between vaccination and employment constitutes coercion and is inconsistent with 21 U.S. Code which provides for the "option to accept or refuse" administration of a unapproved investigational drug. 

In spite of  21 U.S. Code's clear and explicit language, Reiss tempers her argument against employer mandates by offering the following three points: 

"First, the statute requires the Secretary to address the issue – but does not clearly say the Secretary has to allow consequences-free refusal of the product. In fact, because the statute says that the Secretary needs to inform people of the “consequences, if any, of refusing administration of the product,” it suggests that the Secretary has the discretion to allow such consequences – and hence, that the Secretary has discretion to permit mandates (something the Secretary may or may not do)." (Reiss, supra Bill of Health)

In the Code, its seems apparent "consequences" refers to the potential adverse health consequences resulting from a person's vaccination choices and not to a penalty for vaccine refusal.  Thus, the discretion that the Secretary inform people of consequences, does not negate the clear textual option language, but permits the Secretary to convey relevant health information, so that people can govern their own behavior and comprehend the consequences of vaccine refusal.  This is the essence of informed consent.

Reiss in her May 8, 2020 article, "Considerations in mandating a new Covid-19 vaccine in the USA for children and adults," employs Field & Kaplan's term "consequences." To the extent Reiss seeks ideational consistency with Field & Kaplan, her interpretation of the term "consequences" should not encompass a penalty, which would be antithetical to the requisite agency inherent in an option. Thus, in the context of an option, the rule of statutory construction for interpreting the meaning of 'consequences," speaks to providing people with information on health consequences of vaccine refusal, rather than punishing them for exercising autonomy.  

 

"In essence, autonomy recognizes the right of individuals to govern their own behavior. To exercise this right, it is necessary to be free from outside influences and limitations, which are the essential elements of liberty, and to have the ability to comprehend the action to be taken, the alternatives, and the consequences, which are the components of agency." Robert I. Field & Arthur L. Caplan, A Proposed Ethical Framework for Mandates: Competing Values and the Case of HPV. 18 KENNEDY INST. OF ETHICS J. 111, 113–16 (2008).

"Second, while agencies do get deference to interpretation in some circumstances, in this case, the discretion to set the conditions is given to the Secretary, not the FDA, so there may be questions on whether the FDA’s position here deserves deference. Further, the interpretation by FDA is embodied in a guidance document – not a formal rule. In administrative law terms, this is an interpretive rule. And such interpretive rules do not automatically get Chevron deference. The jurisprudence on when they do or do not get Chevron deference is very unclear – that is the line of cases not so fondly named 'The Mead Mess' by scholars." (Reiss, supra Bill of Health).

While admittedly the "Mead Mess" is confusing, resort to Chevron deference is inapplicable to 21 U.S. Code § 360bbb–3,  since the Code specifically, unambiguously and clearly on its face, gives people the option to accept or refuse administration of the product. 

"If Chevron applies, a court asks at step one whether Congress directly addressed the precise issue before the court, using traditional tools of statutory construction. If the statute is clear on its face, the court must effectuate Congress’s stated intent. However, if the court concludes instead that a statute is silent or ambiguous with respect to the specific issue, the court proceeds to Chevron’s second step. At step two, courts defer to an agency’s reasonable interpretation of the statute." (Chevron Deference: A Primer, Valerie C. Brannon Legislative Attorney Jared P. Cole Legislative Attorney, Congressional Research Service,  September 19, 2017).

'Third, following the FDA’s interpretation means the statute – in passing, and without saying it directly – would require the Secretary to prohibit private business across the United States from setting employment conditions or safety conditions. That’s not impossible – the federal government has the power to approve these products, fully or through an EUA, and the power to limit use is part of that approval – but it is also not obvious, because it is a large imposition on private business that may not always be justified. A discretionary grant of authority is just as reasonable." (Reiss, supra Bill of Health)

 

Under the federal Occupational Safety and Health Act (OSHA) and many states’ laws, employers are obligated to provide a workplace free from serious recognized hazards. To comply with that requirement, employers have the right to establish legitimate health and safety standards, policies, and requirements so long as they are job-related and consistent with business necessity.

 

In spite of these hypothetical employer rights, private businesses follow health and safety regs and rarely if ever establish them. Even in those unique instances where employers might wish to exceed health and safety codes, they must proceed with extreme caution, so as not to run afoul of existing regulations. One such example is a business wishing to improve indoor air quality (IAQ) for the safety and health of its workers.  Because IAQ is dependent on insulation materials, and business owners had a hypothetical choice as to which material to specify, the fiberglass industry exerted pressure on the EPA to utilize its regulatory power to compel businesses to use fiberglass. This push to fiberglass has no basis in safety or effectiveness, but was the direct result of industry pressure on the EPA to force the use of fiberglass, while ignoring the performance data demonstrating fiberglass doesn't work. Furthermore, scientific studies indicating the dangers of fiberglass (glass wool) in air ducts were also buried in Congressional committees by lobbyists; and safer alternatives were barred by EPA regulations, authored by industry. Unfortunately, this example is not atypical, as large industry has become expert at manipulating regulatory authority, to impose their products on private entities regardless of the safety data.  In short, as a consequence of EPA regulatory capture, workers are exposed to unnecessary hazards and employers are unable to abate the danger. Given this reality- that powerful industries are able to impose hazards for profit (see Pfizer's rap sheet), the argument that private employers should have the right to establish vaccine mandates, is a strawman which opens the door to externally imposed mandates by industry. https://www.corp-research.org/pfizer

Even if 21 U.S. Code's "option to refuse" is inapplicable, another impediment to a business mandated covid vaccine, is courts in a number of jurisdictions have held workers can only be required to receive vaccinations (such as rubella or flu vaccines), so long as the requirement is job-related and consistent with business necessity. lawworldview.com/a-guide-for-employers-considering-a-mandatory-flu-vaccination-policy-us/

Because there is little to no statistical data mRNA covid vaccines prevent transmissibility, the argument a vaccine is necessary to protect employees or those who come in contact with employees from contagion is without merit. According to Eric Topol, MD, founder and director of the Scripps Research Translational Institute, the data on mRNA vaccines as a prophylactic against transmission is inconclusive (CIDRAP December 15, 2020).

 

Additionally, there is little if any evidence mRNA vaccines protect against severe disease which means vaccination serves only to mitigate mild covid symptoms such as fever, chills and cough. More problematic is the manufacturer's data which indicates that many who receive the vaccine will suffer moderate to severe side effects. Balancing the certainty of these side effects against a recovery rate in excess of 99%, the question becomes - is it consistent with business necessity to inject healthy employees with a drug of limited effectiveness which has been subjected to no long term safety testing? Also, in balancing the risk/benefit profile it should be noted that those who are most impacted by severe disease are not in the workforce. Per the National Center for Health Statistics updated December 23, 2020, 80% of Covid mortality occurs in those 65 plus; the majority of whom are 75 years plus and suffer multiple comorbidities.

 

Given the vaccine offers little to no protection against covid transmissibility, rather than forcing those least susceptible to assume the disproportionate risk of mandatory vaccination, would it not be more judicious (narrowly tailored) for those most vulnerable to protect themselves by adhering to the Faucian fundamentals - mask wearing, social distancing, avoiding large crowds, practicing good hygiene, and not to go indoors with people they are not sheltering with (especially bars). (Q & A with Anthony Fauci, MD, American Medical Association August 4, 2020). 

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21 U.S. Code § 360bbb–3 -

(e)Conditions of authorization

(1)Unapproved product

(A)Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i)Appropriate conditions designed to ensure that health care professionals administering the product are informed—(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III)

of the alternatives to the product that are available, and of their benefits and risks.

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—(I)

that the Secretary has authorized the emergency use of the product;

(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.

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