Author: Morgan Lewis
Published: January 29th 2021
Original Article Link
The following article is courtesy of CGCC
member Morgan Lewis. This following article does not, and is not intended to
constitute legal advice.
As the United States races to deliver safe and effective
coronavirus (COVID-19) vaccines under the Biden administration, employers,
healthcare providers, and many others are assessing what it means for their
industries and organizations. It is difficult to capture the fast-moving
developments around the vaccines and the issues and opportunities they raise in
real time, but here we outline a selection of key legal considerations and
updates as the rollout continues to take shape. They include the status of the
US Food and Drug Administration’s (FDA’s) vaccine products, distribution, key
legal issues at the state level, employer mandates and employee incentives, and
important liability concerns.
CURRENT VACCINES AND FDA APPROVAL
- Under new leadership, FDA will need
to continue to assess new vaccines and new vaccine dosing regimens based
on science and data, but also within the context of evolving public health
realities like vaccine reluctance, demand for access, and geographic
disparities in vaccine implementation resources. - As the demand for prompt access to
vaccines continues to build in the general population, there will be increased
stress on the vaccine supply chain (syringes, wipes, packaging, coolant,
storage) and on vaccine manufacturing capacity, which could prompt
increased federal government intervention. - The science and research and
development around COVID-19 vaccines will continue for many years beyond
the initial contingent of vaccines, with resources directed to efficacy
generally and against new variants, duration of response, second
generation products in different delivery systems, and new and more
cost-effective manufacturing technologies.
VACCINES DISTRIBUTION
- The biggest issue is still that
demand for the vaccinations exceeds supply. - The implementation of phased
distribution recommendations from the Centers for Disease Control and
Prevention’s Advisory Committee on Immunization Practices (ACIP) varies by
jurisdiction, causing disparity among phases and some confusion. - A workforce capacity issue in
administration may arise as the same healthcare organizations that are
caring for COVID-19 patients are being used as vaccination hubs while new
hubs and community centers are being conceived. - States are organizing distribution
of vaccine through differing centralized teams requiring knowledge of each
states’ processes and whether there is also a delegation to local health
departments. - Through an Executive Order (EO)
signed on January 20 the Biden administration intends to direct the
Federal Emergency Management Agency with respect to dollars and personnel
to create 100 community vaccination centers and pharmacy programs for the
public. There is also a directive in the EO to ignite the public health
service corps to expand the workforce to administer the vaccines.
EMPLOYER VACCINE MANDATES – FEDERAL
CONSIDERATIONS
- According to the Equal Employment
Opportunity Commission (EEOC), a mandatory vaccination policy may be
lawful under the Americans with Disabilities Act (ADA) and Title VII,
provided that available reasonable accommodations are made for individuals
with disabilities and those with sincerely held religious beliefs,
practices, or observances; however, depending on the nature of an
employer’s business, a host of practical issues must be considered before
imposing a mandatory vaccine program, such as impact to employee morale
and employee turnover. - Prior to excluding an employee who
cannot receive the vaccine due to his or her disability from the
workplace, the EEOC advises that an employer must demonstrate that the
unvaccinated individual will expose others to the virus at the worksite
and that no reasonable accommodation (absent undue hardship) exists that
would eliminate or reduce the risk of the unvaccinated employee posing a
direct threat. - Employers must engage in the
interactive process to evaluate whether there are any reasonable
accommodations (such as additional protective gear or moving an employee’s
workstation) that would eliminate or reduce the risk of the employee
posing a direct threat. - Mandatory vaccination programs
should be undertaken with caution, given the lack of concrete substantive law
(the EEOC’s guidance is simply guidance), state laws with different
requirements, and the dearth of information regarding the safety of having
some unvaccinated employees in the workforce.
EMPLOYER VACCINES MANDATES – STATE AND
LOCAL CONSIDERATIONS
- Long before the COVID-19 pandemic
occurred, varying state laws have addressed whether vaccines can be
mandated and, in a parallel fashion, registries can be used by public
health officials to see the coverage of vaccinations in each state. - The issues of religious or
conscientious exemption differ among the states and in some cases, the
conscientious exemptions can create such a hole that anyone can object to
receiving a vaccination. - A broad federal regulation was
published under the Trump administration to protect statutory conscience
rights in healthcare that extends to vaccination. It has been temporarily
restrained in two courts but would have to be rescinded in some form or
fashion to be removed from the federal overlay in addition to state laws. - So far, three states have proposed
laws regarding mandates: New York, New Jersey, and Tennessee.
EMPLOYER VACCINES INCENTIVES
- The legal issues surrounding what
employers can do to incentivize employee vaccinations are complicated, and
guidance from the EEOC is sorely needed. - For now, the safest approach for
employers who wish to provide vaccines on site or by a vendor and
incentivize vaccination is to provide only modest incentives, such as a
water bottle or a gift card of modest value. - If an employer wishes to provide
higher incentives, there is less legal risk if the vaccine is provided by
an unaffiliated third party, such as a local public health agency or
pharmacy. - With vaccine incentives in
particular, consider careful messaging to employees to mitigate ER
complaints and confusion. - Consistency is key, but
differentiation in incentives is permitted where it is based on bona fide
business reasons, such as offering incentives just to employees with
public/customer contact.
WAGE AND HOUR CONCERNS
- An employer that provides an
incentive which is not tied to hours worked does not need to include the
value of the incentive in the employee’s regular rate calculation. - If the decision to get vaccinated
is truly voluntary, employers do not need to provide pay for the time an
employee spends getting vaccinated (though many will to encourage
vaccination). - Whether a vaccine is mandatory,
incentivized, or purely voluntary, employers can ask for proof of
vaccination. However, questions about why an employee was not vaccinated
can only be asked where they are job-related and consistent with business
necessity. - Employers with a mandatory vaccine
requirement for new hires can refuse employment for those who have not
received a vaccine. But they need to provide accommodations to those who
did not get vaccinated due to disability or religious needs. - State and local guidance generally
is not premised on vaccinations and does not sunset for vaccinated
employees, especially given the possibility of transmission for vaccinated
workers. - Potential liability exists if
employers rely only on vaccines to prevent the spread of COVID-19 and
remove other workplace safety measures.
LIABILITY PROTECTIONS FOR EMPLOYERS
- Two bodies of statuary law provide
potential routes for liability protection for employers from claims by
employees relating to vaccination: workers’ compensation coverage and the
Public Readiness and Emergency Preparedness (PREP) Act. - Workers’ compensation coverage is
dependent on state law and whether vaccination is mandated by the
employer. If the vaccine is mandated by employers, employees’ liability
claims would be compensable under workers’ compensation in most states. - The vaccines that are available now
are under emergency use authorization (EUA) and the workers’ compensation
bar may not apply if it is determined that use of a vaccine that was under
an EUA constituted gross negligence or reckless conduct. - The PREP Act, which the US
Department of Health and Human Services declared would apply to the
COVID-19 pandemic, is the federal statue for pandemics and potentially
provides very broad protection from liability for covered countermeasures
such as a COVID-19 vaccine. If it applies, the PREP Act provides immunity
from liability for claims of personal injury or monetary loss. - A detailed analysis of four factors
must be done to determine if the PREP Act will provide protection: Is it a
covered countermeasure? Does it fit within the definition of a recommended
activity? Are you within the definition of a covered person? Do you fit
within the limitations on distribution for the PREP Act? - With respect to private employer
vaccination programs, a closed point of dispensing (POD) COVID-19
vaccination program operated and administered by an employer for employees
can be structured in a way that will provide the benefit of PREP Act
liability protection.
These insights and more were shared during Morgan Lewis’ “COVID-19
Vaccines: Legal Considerations in Light of Latest Developments” webinar
on January 21, 2021. Visit the
Navigating the NEXT page for more COVID-19 news and thought leadership.
For any questions regarding this resource,
kindly contact David Fendig (david.fendig@morganlewis.com)