On December 18, 2020, we issued an SKO Insider focused on the roll-out of COVID-19 vaccination policies by healthcare employers.[1] Although the practical concerns of non-healthcare employers may vary, the same legal framework applies to other industry employers.
Background
Generally, the legal constraint on the ability of employers to require vaccination as a condition of employment derives from Title I of the Americans with Disabilities Act (ADA), which prohibits medical inquiries or examinations unless “shown to be job-related and consistent with business necessity.”[2] Requesting proof of vaccination or administering a vaccine does not constitute a medical inquiry or examination.[3] It is the prescreening for vaccination that implicates the ADA prohibition against medical inquiries. An employer therefore may avoid running afoul of the ADA by requiring proof of vaccination administered by an independent third party not under contract with the employer — meaning neither the employer nor the employer’s agent obtains the medical information elicited during vaccination prescreening.
In guidance issued on December 16, 2020, the United States Equal Employment Opportunity Commission (“EEOC”) addressed questions related to the applicability of equal employment opportunity (“EEO”) laws to COVID-19 vaccines, specifically clarifying that “[t]he EEO laws do not interfere with or prevent employers from following CDC or other federal, state, and local public health authorities’ guidelines and suggestions.”[4] Similarly, the Occupational Safety and Health Administration (OSHA) has long recognized the permissibility of employers to mandate immunization, stating in a 2009 Standard Interpretation letter that “although OSHA does not specifically require employees to take the vaccines, an employer may do so.”[5]
Set forth below are five basic issues for employers to keep in mind when considering whether and how to implement COVID-19 vaccine policies.
1. Consider conditions imposed by the Food, Drug and Cosmetic Act applicable to products administered under “Emergency Use Authorization” before implementing mandatory COVID-19 vaccination policies.
Currently, the available COVID-19 vaccines are being administered pursuant to Emergency Use Authorizations (“EUA”) by the Food and Drug Administration (“FDA”).[6] EUA allows the use of unapproved medical products during public health emergencies.[7] The Food, Drug and Cosmetic Act (FD&C Act) requires the FDA to assure, with limited exception,[8] that recipients of EUA products are informed of the “option to accept or refuse administration of the product,” as well as the “consequences of refusal” and “alternatives” to the product.[9] There is scant judicial or administrative authority construing this provision. At Section K.4, the guidance issued by the EEOC on December 16, 2020 explicitly discusses the requisite notification to recipients of vaccines administered under an EUA; however, the EEOC does not offer pointed guidance on whether an EUA impacts the permissibility of employers to mandate such vaccines. In 2005, having previously enjoined an involuntary anthrax vaccine program of military personnel by the Department of Defense, the United States District Court for District of Columbia amended its order in Doe v. Rumsfeld to permit administration of the vaccine on a voluntary basis pursuant to an EUA.[10] The Rumsfeld decision did not analyze the EUA provision in any detail, however.
As a bottom line, whether individuals’ right to refuse a vaccine administered under an EUA restricts employers’ ability to exclude such individuals from the workplace without running afoul of the FD&C Act is an unsettled question. In light of this uncertainty, employers who are considering mandating COVID-19 immunization might avoid EUA-related challenges by delaying implementation of such policies until the vaccine(s) receive full FDA approval.
2. For unionized workforces, consider the obligation to engage in collective bargaining.
Employers should be aware that a mandatory vaccination policy is a term of employment likely to be subject to the duty to bargain in good faith. Indeed, courts previously have found that such duty to bargain applied to mandatory vaccination policies even when such term was not expressly referenced in the collective bargaining agreement (CBA). In Virginia Mason Hospital v. Washington State Nurses Ass’n,[11] a hospital unilaterally required nurses to receive flu shots, arguing that the patient care priority, management rights, past practice, and zipper clauses in the CBA justified its unilateral requirement.[12] The union argued that a recognition clause and the CBA’s preamble required the hospital to negotiate with the union before unilaterally requiring the vaccinations.[13] The arbitrator found that the recognition clause trumped the management rights and other clauses, and the Ninth Circuit Court of Appeals affirmed such determination.[14] In United Nurses of Children’s Hosp. v. Rady Children’s Hosp.,[15] the union filed a filed a grievance after the hospital unilaterally implemented a mandatory vaccine policy that had been a subject of discussion between the union and the hospital. The district court granted the union’s motion to compel arbitration to the extent that the union asserted that implementation of the policy is a dispute subject to arbitration.[16]
3. Consider incentives to encourage voluntary participation in an immunization initiative as an alternative to mandating vaccination.
As an alternative to mandates, employers might consider offering incentives to encourage employees to get the COVID-19 vaccine. Such incentive programs may implicate ADA guidelines because employer-sponsored wellness programs often involve the collection of medical information. An employer may collect medical information as part of an “employee health program,” as long as the employee’s participation in the program is “voluntary”.[17]
In 2016, the EEOC implemented regulations permitting an incentive of up to 30% of the cost of coverage in exchange for an employee’s participation in a wellness program.[18] The AARP challenged the regulations on the ground that the 30% level was too high to give employees a meaningful choice about participating in wellness programs that require the disclosure of ADA-protected information.[19] The district court found that the EEOC had failed to provide its reason for adopting the 30% incentive threshold and remanded the rules to the agency for reconsideration.[20] On January 7, 2021, the EEOC issued a Notice of Proposed Rulemaking that would limit any incentives to a de minimis threshold for wellness programs where employees are required to submit to a medical exam or inquiry; however, the proposed rule was not published in the Federal Register by President Biden’s inauguration. Pursuant to a freeze pending review, the regulatory documents have been withdrawn from the Office of the Federal Register and removed from the EEOC’s website. In a letter sent to the EEOC on February 1, 2021, an organization representing over 40 business groups requested clarification regarding the incentives that employers may offer employees to get the COVID-19 vaccines, stating: “Employer-provided incentives can assist governments in quickly and efficiently distributing vaccines. Legal uncertainty about providing such incentives, however, have many employers concerned over liability and has made them hesitant to act.”[21]
In light of the lack of clear guidance on the subject, employers utilizing such programs should limit incentives to a one-time truly gratuitous benefit, i.e., not unreasonably large such that it could be deemed coercive. Possible options might include a one-time modest monetary bonus or gift card, additional PTO, a “casual” dress day, or similar perk.
4. Consider how to address objections to vaccination on medical or religious grounds.
Medical Exemptions
An employee with a disability under the ADA that prevents him or her from safely taking a vaccination is entitled to reasonable accommodation subject to undue hardship to the employer.[22] Upon being placed on notice of a disability and request for accommodation, the employer should engage in an interactive process to identify a reasonable accommodation (meet with the employee, request information about the conditions and limitations, identify the desired accommodation, and discuss viable alternatives when the requested accommodation is too burdensome).[23]
To qualify for an accommodation, an employee must demonstrate a disability within the meaning of the ADA — mild reactions generally will not qualify.[24] Typical examples of conditions qualifying for exemption include severe allergy to the vaccine or ingredients, weakened immune or a serious reaction to a vaccine in the past. Some conditions not causally linked to physical risk of the vaccination may nevertheless entitle an employee to an accommodation. For example, in Ruggiero v. Mount Nittany Med. Ctr., the United States Court of Appeals for the Third Circuit held that the employee adequately pled a claim for failure to accommodate under the ADA even though she did have any contraindications to the required Tdap vaccine and sought an exemption based on severe anxiety related to a history of food allergies supported by a doctor’s note.[25] Cases like Ruggiero underscore the importance of engaging in the interactive process with an employee who gives notice of an alleged disability and makes a request for accommodation.
In order to exclude the employee from the workplace despite such objection, the employer must demonstrate that an unvaccinated employee would pose a “direct threat” due to a “significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.” The employer would need to consider factors such as the availability and effectiveness of personal protective gear as a substitute. Other factors, such as the degree of community spread at the relevant time and the likelihood that an unvaccinated employee poses a threat to him/herself or others.
Employers also should be prepared to respond to objections to vaccination by pregnant employees who have concerns about a lack of medical evidence related to the safety of the COVID-19 vaccines for pregnant person and fetuses.[26]
Religious Exemptions
An employee who objects to vaccination based upon a sincerely held religious belief, practice or observance must be afforded a reasonable accommodation unless it would pose an undue hardship upon the employer.[27] Although a deeply held general opposition to vaccination based on beliefs regarding efficacy and/or safety does not itself constitute a religious objection,[28] the religious exemption is not necessarily limited to traditional and institutional forms of religion and, in fact, has been applied to strict dietary practice.[29]
5. Consider workers compensation implications.
If employers mandate COVID-19 vaccinations as a condition of employment, severe adverse reactions resulting in injury are likely to be deemed a compensable event under applicable workers compensation laws. Even in circumstances where vaccination has been encouraged or otherwise facilitated by employers, adverse events have been found compensable.[30] Of course, the risks to employees and costs to employers associated with continued spread of the COVID-19 virus likely outweigh the worker’s compensation liability risks associated with encouraging or requiring immunization.
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[1] Considerations for Healthcare Employers Weighing the Roll-Out of Covid-19 Vaccination Policies (December 18, 2020).
[2] 42 USCS § 12112(d)(4)(A).
[3] What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, Sections K.1, K3. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws | U.S. Equal Employment Opportunity Commission (eeoc.gov).
[4] Id.
[5] U.S. Occupational Safety & Health Administration, Standard Interpretation (November 9, 2009), OSHA’s position on mandatory flu shots for employees. | Occupational Safety and Health Administration.
[6] The FDA issued an EUA for the Pfizer-BioNTech COVID-19 Vaccine on December 11, 2020. The Moderna COVID-19 Vaccine received an EUA on December 18, 2020. Johnson & Johnson announced submission of an application for EUA for its Janssen COVID-19 Vaccine on February 4, 2021.
[7] Emergency Use Authorization for Vaccines Explained | FDA.
[8] The President may waive the condition designed to ensure that individuals are informed of the option to accept or refuse administration of a product upon a determination in writing that compliance is not in the interests of national security. 10 USCS § 1107a(a).
[9] 21 USCS § 360bbb-3(e)(1)(A)(ii).
[10] Doe v. Rumsfeld, 2005 U.S. Dist. LEXIS 5573, *2-3 (D. D.C. April 6, 2005).
[11] 511 F.3d 908 (9th Cir. 2007) (distinguished by Totes Isotoner Corp. v. Int’l Chem. Workers Union Council/UFCW Local 664C, 532 F.3d 405, 418 (6th Cir. 2008) (wherein the underlying dispute involved changes to health care benefits)).
[12] Id. at 913-14.
[13] Id. at 915.
[14] Id. at 917.
[15] 2010 U.S. Dist. LEXIS 150090.
[16] Id. at *10-11.
[17] 42 USCS § 12112(d)(4)(B).
[18] Regulations Under the Americans with Disabilities Act, 81 Fed. Reg. 31,126 (May 17, 2016); Regulations Under the Genetic Information Nondiscrimination Act, 81 Fed. Reg. 31,143 (May 17, 2016).
[19] AARP v. United States EEOC, 267 F. Supp. 3d 14, 28 (D. D.C. 2017).
[20] Id. at 39.
[21] February 1, 2021 Letter to Charlotte A. Burrows, Chair, EEOC.
[22] Pandemic Preparedness, supra, Section III.B, Question No. 13.
[23] 29 C.F.R. § 1630.2(o)(3).
[24] E.g., Norman v. NYU Langone Health Sys., 2020 U.S. Dist. LEXIS 180990 (S.D.N.Y. September 30, 2020).
[25] Ruggiero v. Mount Nittany Med. Ctr., 736 Fed. Appx. 35, *40-41 (3rd Cir. June 5, 2018).
[26] What You Should Know, supra, Sections J & K.
[27] Pandemic Preparedness, supra, Section III.B, Question No. 13 (referencing Equal Employment Opportunity Comm’n, EEOC Compliance Manual Section 12: Religious Discrimination 56-65 (2008);
[28] Fallon v. Mercy Catholic Med. Ctr., 200 F. Supp. 3d 553, 563 (E.D. Pa. 2016).
[29] Chenzira v. Cincinnati Children’s Hosp. Med. Ctr., 2012 U.S. Dist. LEXIS 182139, *10 (S.D. Ohio December 27, 2012).
[30] Kai-Ling Fu v. UNC Chapel Hill, 655 S.E.2d 907, 911 (N.C. App. 2008); E.I. Dupont de Nemours & Co. v. Faupel, 859 A.2d 1042, 1053-1054 (Del. Sup. Ct. 2004); Monette v. Manatee Memorial Hosp., 579 So. 2d 195, 197 (Fla. App. 1991). But see Rosen v. Walgreen Co., 2015 Ohio App. LEXIS 5147 (Ohio App. December 22, 2016) (adverse reaction to inoculation voluntarily received at employer’s place of business deemed not compensable).
