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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
TOGETHER EMPLOYEES, by Individual
Representatives, ROBERTA LANCIONE,
JOYCE MILLER, MARIA DIFRONZO,
MICHAEL SACCOCCIO, ELIZABETH
BIGGER, NATASHA DICICCO, NICHOLAS
ARNO, and RUBEN ALMEIDA
Plaintiffs,
v.
MASS GENERAL BRIGHAM
INCORPORATED,
Defendant.
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Civil Action No. 1:21-cv-11686
DECLARATION OF DR. DEAN HASHIMOTO
I, Dr. Dean Hashimoto, am above the age of 18 and competent to testify. All the
information in this declaration is based on my personal knowledge.
1.
I am the Chief Medical Officer, Workplace Health and Wellness, at Mass General
Brigham, Incorporated (“MGB”).
2.
I attended medical school at the University of California, San Francisco School
of Medicine. I am board certified in Occupational Medicine, a preventative medicine specialty,
and have graduate degrees in public health. I also have a law degree and teach at Boston College
Law School, where my scholarship focuses on health care policy and public health. I have
substantial experience in developing systematic ways to evaluate medical information, including
the implementation of the impartial medical examiner system in the Massachusetts Department
of Industrial Accidents (DIA) and within the self-insured workers’ compensation insurance
division of the Mass General Brigham. I have been the Chair of the Health Care Services Board
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at the Massachusetts DIA since 1998 and oversee the development and revisions of the state
medical treatment guidelines that are used for utilization review.
3.
I developed and led MGB’s interactive process for determining whether or not to
grant medical exemptions from the vaccine requirement established by MGB’s COVID-19
Vaccination Policy.
A.
MGB Announced Its Vaccination Policy, Requiring That Staff
Be Vaccinated against COVID-19 Unless Approved for a
Religious or Medical Exemption
4.
On or about August 10, 2021, MGB’s President and CEO sent a notice to staff
members explaining its COVID-19 Vaccination Policy (the “Vaccination Policy”). A true and
accurate copy of the President’s communication is at Exhibit 2. The Policy initially indicated
that employees should be fully vaccinated by October 15, 2021, unless they were granted a
religious or medical exemption. (Later MGB revised the Vaccination Policy to require a first
dose of a two-dose series by October 15, 2021, followed by a later second dose). The deadline
for employees to request an exemption was September 3, 2021. See Declaration of Dr. Michael
Klompas filed contemporaneously herewith.
5.
The announcement included a link to forms that employees could use to request a
medical or religious exemption from the Vaccination Policy. The link to the request forms was
also available on MGB’s employee intranet site. Managers were also empowered to help direct
employees to the forms.
B.
MGB Provided a Simple Process for Employees to Request a
Medical Exemption
6.
In order to request a medical exemption, an employee could print a MGB form
and have it completed and signed by their health care provider (HCP). A true and accurate copy
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of the form (as revised following updated CDC guidance regarding pregnancy, described below
in Section G of this declaration) is at Exhibit 7.
7.
There were various boxes that the provider could check to indicate certain
conditions indicated by the Centers for Disease Control (CDC) as potential contraindications for
the COVID-19 vaccine. The MGB COVID-19 Vaccine Policy, which is posted on the MGB
website, describes the medical contraindications and indications for temporary deferral of
COVID-19 vaccination. See Exhibit 8. This MGB policy is based on CDC guidance, as is true
for other COVID-related employee policies such as the return-to-work and testing requirements.
A live link to that guidance can be accessed here: https://www.cdc.gov/vaccines/covid-
19/clinical-considerations/covid-19-vaccines-us.html (last accessed 11/1/2021)
8.
One box indicated: “History of severe or immediate allergic (anaphylactic)
reaction to a previous dose or component of a COVID-19 vaccine.” The form noted that MGB
“encourage[d] consultation with an allergy specialist.” The form asked the HCP to indicate the
name of the vaccine or vaccine component to which the employee had had an anaphylactic
reaction, the date that prior vaccine was received, and a description of the reaction. See Exhibit
7.
9.
Another box indicated: “Temporary exemption due to administration of COVID-
19 monoclonal antibodies,” and asked the HCP to identify the date of the last dose administered.
See Exhibit 7.
10.
Another box indicated: “Temporary exemption due to a history of multisystem
inflammatory syndrome,” and asked the HCP to indicate the date of diagnosis. See Exhibit 7.
11.
Finally, the form permitted the HCP to identify “Other medical reasons,” and
asked the HCP to describe those reasons on the form. The form indicated “Requests with be
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reviewed on a case-by-case basis. Clarification from the requesting employee and/or their
physician may be requested in writing or by phone.”
12.
The form instructed the HCP to submit the form to a dedicated email address.
C.
The Two Clinical Panels Examining Requests for Medical
Exemptions
13.
MGB assembled two clinical panels to review requests for medical exemptions.
14.
The first was an Occupational Health Clinical Panel, comprised of three
occupational health clinical directors of the major MGB hospitals (MGH, Brigham & Women’s
Hospital, Newton-Wellesley Hospital, Salem Hospital) who are nurse practitioners and registered
nurses by training with substantial experience in vaccine administration and disability evaluation
and management.
15.
The second was an Infection Control Panel, comprised of five physicians who are
experts in infection control and disease.
16.
I and others worked to establish standardized processes to ensure that these two
panels worked in sync with each other in examining and making consistent and thoughtful
decisions about employees’ medical exemption requests.
D.
MGB’s Urgent Health and Safety Priorities Provided
Guidance for the Medical Exemption Review Process
17.
Prior to reviewing any exemption requests, the two panels involved in the medical
exemption process were advised of MGB’s urgent health and safety priorities that would guide
the review process. These priorities were developed by senior leadership and health experts at
MGB, a widely renowned healthcare system.
18.
First, the review process needed to be prompt, given the spread of the COVID-19
Delta variant and the need to have most employees vaccinated by the deadlines set out in MGB’s
Vaccination Policy. Second, the review process was to be as rigorous as possible consistent with
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the law, so as to minimize the number of unvaccinated staff at MGB given the risks that
unvaccinated staff presented to MGB’s medically vulnerable patient population, other employees
and visitors and to ensure available staff to respond to the ongoing public health crisis. Third, it
would be an undue hardship for MGB to allow large numbers of employees to remain
unvaccinated while interacting with MGB’s medically vulnerable patient population, other
employees and visitors.
19.
The two panels that assessed requests for medical exemptions were aware that the
pandemic, and particularly the rapid spread of the Delta variant of COVID-19, was a public
health emergency, and that MGB had an urgent responsibility to help patients diagnosed with
COVID-19, as well as to protect its staff, medically vulnerable population and visitors from
infection. We were also aware that as a major healthcare system, the perception of safety was
critical for patients, visitors and the public. Furthermore, universal vaccination of employees is
necessary to preserve the integrity of the entire workforce of our healthcare system that is
dedicated to providing excellent patient care, including those who contribute by remote work.
20.
Under my leadership, the two panels were tasked with implementing a process for
medical exemption requests that would be consistent with those urgent health and safety
priorities. I was aware that the impending fall and winter seasons were particularly concerning
for new waves of COVID-19 infection especially given the Delta variant. Two of the prior waves
of the pandemic spread had occurred during the Fall/Winter time periods.
21.
Understanding all of this context of the pandemic emergency, I took pains to
create a centralized, rigorous, standardized process that would be both efficient and provide
careful, individualized review.
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E.
The Medical Review Panels Were Tasked with Reviewing
What Would Be a High Volume of Requests in an Accelerated
Time Frame, to Meet the Urgent Health and Safety Priorities
22.
The clinical review panels were also advised that exemption requests were to be
reviewed and processed as soon as possible, with the understanding that the employees needed to
receive a vaccine by October 15 under the Vaccination Policy.
23.
This timeline was to ensure that any employee whose exemption was denied
would have adequate time to consider vaccination, and if they decided to vaccinate, to do so
under the schedule laid out in the Vaccination Policy.
F.
MGB’s Interactive Process with Respect to Medical Exemption
Requests
24.
Together with the two medical panels, we developed an interactive process with
respect to medical exemption requests.
25.
When medical exemption requests came in, the Occupational Health Clinical
Panel reviewed the requests and involved Human Resources as appropriate in accommodation
issues. Each medical exemption request was given an individualized, thoughtful, case-by-case
review.
26.
At the beginning of the process, the Occupational Health Clinical Panel discussed
many of the requests with the Infection Control Panel. Over time, as the two panels developed a
synchronized approach to particular conditions based on CDC guidance as described in Exhibit
8, there were instances where the Occupational Health Clinical Panel could make a decision on a
request based on a group decision the two panels had made together as to how to handle
particular categories of requests or issues within requests.
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27.
The two panels used a layered, nuanced approach to reviewing the requests. The
panels met as often needed to discuss and process the requests, sometimes in scheduled regular
meetings and sometimes more frequently to respond in a timely way to increased volume.
28.
Under my direction, the Occupational Health Clinical Panel also consulted as
needed with various world-renowned specialists at MGB, including specialists in Obstetrics,
Allergy, and Neurology.
29.
The panels followed the CDC guidance regarding medical contraindications to
vaccination, which evolved over time as new data and studies emerged. A live link to that
guidance can be accessed here: https://www.cdc.gov/vaccines/covid-19/clinical-
considerations/covid-19-vaccines-us.html The medical contraindications to the vaccine are few
and well-defined by the CDC guidance. As a result, our panel could generally make decisions
based upon the original submission by the medical providers.
30.
Where we had questions for the employee or his or her HCP, we would reach out
to the employee or the HCP for more information. For example, the information provided was
too vague, or the nature or severity of the condition was unclear, we would solicit more
information in order to evaluate the request.
31.
As another example, if an employee had submitted a request based on allergies
from a non-allergist HCP, and the information was insufficient to enable a proper evaluation of
the request, we encouraged the employee to see an allergist. In those cases, we offered that the
employee could choose to see a MGB provider, or that the employee could consult his or her
own provider. On a case by case basis, we permitted brief extensions of time for an employee to
seek an additional medical consult where warranted.
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32.
The employee or his or her medical provider could provide more information at a
dedicated Occupational Health e-mail mailbox.
33.
Although we had set a deadline for submission of medical exemption requests, we
continued to review requests that were submitted after the deadline.
G.
When the CDC Changed its Guidance on Pregnancy Based on
New Data, MGB Adapted Its Process to Reflect the New
Guidance
34.
During our medical request review process, the CDC changed its guidance, and
announced an urgent health advisory to increase COVID-19 vaccination among people who were
pregnant, recently pregnant (including those who are lactating), who were currently trying to
become pregnant, or who might become pregnant in the future to prevent serious illness, deaths,
and adverse pregnancy outcomes.
35.
Hospital leadership, including me, consulted with MGB Obstetrics Chiefs about
the change in CDC guidance, and together we decided that we would not grant exemptions based
on pregnancy alone. (Pregnant employees could still seek exemptions based on other medical
conditions that went beyond the fact of pregnancy). In those cases where an exemption had been
approved solely based on pregnancy, we contacted the employee to let them know of the change.
We also consulted with Human Resources and developed other temporary accommodations
where feasible on a case by case basis, such as additional parental leave, given that the policy
had changed based on the new guidance.
H.
The Panels Made Thoughtful Considered Decisions as to Each
Request
36.
Ultimately, one or both panels made thoughtful, considered decisions on each
request.
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37.
The panels also factored into their decision-making MGB’s workforce and public
health considerations with allowing a large number of exemptions, because to do so would
impose an undue hardship given the risks that unvaccinated staff pose to MGB’s medically
vulnerable patient population, employees and visitors.
I.
Communication of the Decision to Accept or Deny Request for
Medical Exemption
38.
As decisions were made, each employee who had requested an exemption
received by e-mail a written decision either approving or denying the request. Each employee
who received a denial was informed that the medical information provided did not demonstrate a
sufficient medical reason or contraindication to support an exemption. Furthermore, the
employee was informed that we would reassess the request if additional medical documentation
was submitted for consideration. If the employee had any additional questions or concerns, or
would like to submit further information for consideration, the employee was asked to contact
the Occupational Health Services through an electronic link to the email mailbox.
39.
Decisions regarding requests were made on a rolling basis to allow denied
applicants as much time as possible to be vaccinated prior to the October 15 deadline.
Allowances were made to ensure sufficient time including giving temporary exemptions for
those consulting their doctors for more information.
J.
Some Employees Reached Out to the Committee About Denial
of Their Requests
40.
Due to MGB’s urgent timeline to achieve its health and safety priorities, MGB
determined that they could not provide an appeal process for every employee whose requests
were denied. MGB also determined that an appeal process would likely result in duplication,
with the Committee having to review substantially the same material submitted in the first round
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of the process. Instead, we invited the employee to submit additional questions or information to
the Committee.
41.
Some employees who were displeased with the denial of their requests wrote to
the Occupational Health mailbox to express their disappointment with the decision or seeking to
provide additional information. The panels reviewed those additional communications to
determine if they contained any new medical information sufficient to support the exemption.
42.
However, because the surge in cases from the Delta variant in the summer and fall
of 2021 was (and is) stressing the health care system and this was an emergency, MGB’s ability
to engage in this interactive process on these issues was not limitless.
K.
Decisions on Individual Plaintiffs’ Requests for Exemptions
Maria DiFronzo
43.
On or about August 11, 2021, DiFronzo submitted a medical exemption request
form stating that she was pregnant and indicating that her estimated delivery date is March 4,
2022. A true and accurate copy of the DiFronzo Medical Exemption Request is at Exhibit 9.
44.
On or about August 24, 2021, MGB sent her a denial. A true and accurate copy
of the DiFronzo Medical Exemption Denial is at Exhibit 10. Her denial email referenced the
CDC guidance on pregnancy.
Roberta Lancione
45.
On or about September 2, 2021, Lancione submitted a medical exemption request
form stating that she previously experienced an angioedema following receipt of the influenza
vaccine and that she was currently being treated for chronic lymphocytic leukemia with
Venetoclax. A true and accurate copy of the Lancione Medical Exemption Request is at Exhibit
11.
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46.
On or about September 9, 2021, MGB sent her a denial. A true and accurate copy
of the Lancione Medical Exemption Denial is at Exhibit 12. Neither of her conditions were
included in the CDC contraindications and she did not submit any additional information in
response to the denial letter.
Joyce Miller
47.
On or about August 17, 2021, Miller submitted the attached medical exemption
request form stating that she would experience “severe mental anguish / anxiety (if required to
get experimental vaccine.” [sic]. A true and accurate copy of the Miller Medical Exemption
Request is at Exhibit 13.
48.
All medical exemption requests based upon mental health concerns were
reviewed by Occupation Health Panel and were either reviewed by or based on guidance from
the Infection Control Panel.
49.
On or about September 9, 2021, MGB sent her a denial. A true and accurate copy
of the Miller Medical Exemption Denial is at Exhibit 14.
Michael Saccoccio
50.
On or about August 19, 2021, Saccoccio submitted the attached medical
exemption form stating that the reasons for his request were: “Anxiety, PTSD.” A true and
accurate copy of the Saccoccio Medical Exemption Request is at Exhibit 15.
51.
On or about September 9, 2021, MGB sent him a denial. A true and accurate
copy of the Saccoccio Medical Exemption Denial is at Exhibit 16. He was advised that the
medical information that he provided did not demonstrate a sufficient medical reason or
contraindication to receiving the vaccine.
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52.
Saccoccio supplemented his submission on or about September 13, 2021 with
information from his medical provider and ask that MGB reconsider its denial. A true and
accurate copy of the Saccoccio Supplemental Documentation is at Exhibit 17.
53.
Saccoccio supplemented his reconsideration request further on or about
September 17, 2021 with additional information from his medical provider. A true and accurate
copy of the Saccoccio Additional Supplemental Documentation is at Exhibit 18.
54.
On or about September 24, 2021, MGB confirmed its denial of Saccoccio’s
request, having taken the supplemental submissions into account. A true and accurate copy of
the Confirmation of Saccoccio Medical Exemption Denial is at Exhibit 19. His request was
reviewed by the Occupation Health Panel and the Infection Control Panel, and both panels
recommended that his request be denied.
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L.
Any Unvaccinated Employee Can Return to Work Upon Vaccination
55.
Any of the named Plaintiffs in this matter—or any MGB employee currently on
unpaid leave due to non-compliance with the MGB Vaccination Policy—is eligible to return to
work as soon as he or she is compliant with the Vaccination Policy.
I declare under penalty of perjury that the foregoing is true and correct to the best of my
knowledge and belief. Executed this 30 day of October, 2021.
Dr. Dean Hashimoto
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CERTIFICATE OF SERVICE
I hereby certify that on November 1, 2021, a copy of the foregoing document was filed
electronically through the Court’s electronic filing system (“ECF system”) and that counsel for
Plaintiffs is a registered user of the ECF system. Notice of this filing will be sent by operation of
the Court’s ECF system to all parties indicated on the electronic filing receipt. Parties may
access this filing through the Court’s ECF system.
/s/ Katherine A. Perrelli
Katherine A. Perrelli
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