United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON DEFENDANT’S MOTION FOR
ALLISON D. BURROUGHS, U.S. DISTRICT JUDGE.
employment discrimination suit, Plaintiff Susan Katz alleges
that her former employer, Defendant Organogenesis, Inc.
(“Organogenesis”), discriminated against her in
violation of federal and state law and terminated her based
on her disabilities and her use of Family and Medical Leave
Act (“FMLA”) leave. [ECF No. 1-1
(“Complaint” or “Compl.”)]. Currently
pending before the Court is Organogenesis’ motion for
summary judgment. [ECF No. 28]. For the reasons set forth
below, summary judgment is GRANTED in favor of
following facts are either uncontroverted pursuant to Federal
Rule of Civil Procedure 56 and Local Rule 56.1 or stated in
the light most favorable to Ms. Katz, the
is a pharmaceutical manufacturer that is subject to oversight
by the Food & Drug Administration (“FDA”) and
must comply with the FDA’s Current Good Manufacturing
Practice regulations. [ECF No. 30 (“SOF”) ¶
2]. Organogenesis works to comply with these regulations by
ensuring that preventive maintenance tasks on its equipment
are carried out in a timely manner and according to standard
operating procedures (“SOPs”). [SOF ¶ 3].
Preventative maintenance and calibration tasks are tracked
using a computerized maintenance management system
(“CMMS”). [SOF ¶¶ 5–6]. Staff
must complete a written analysis of any error, referred to as
“deviations, ” such as a missed preventative
maintenance task. [SOF ¶ 9]. If more than two related
deviations occur, the standard practice is to initiate a
“CAPA” (a “corrective action preventive
action” or “corrective and preventive
action”) to analyze the root cause. [SOF ¶ 10].
Katz was hired by Organogenesis in 2001 as a Facilities
Coordinator to help administer the CMMS for preventive
maintenance, which was known as “MP2.” [SOF
¶¶ 11– 12]. On March 13, 2006, Ms. Katz was
promoted to Senior Facilities Coordinator, but her
responsibilities largely stayed the same. [SOF ¶¶
13–14]. Ms. Katz took medical leave for a surgical
procedure from September 27 to October 11, 2011, which did
not adversely affect her employment. [SOF ¶¶
30–31]. Ms. Katz’s work with the MP2 system
resulted in positive job performance evaluations from her
then-supervisors and a promotion in 2012 to Supervisor of
Facilities Planning. [SOF ¶¶ 15–17, 31; ECF
No. 32-1 at 9]. As Supervisor of Facilities Planning, Ms.
Katz worked with the quality assurance department on audits,
internal deviations, CAPAs, and SOPs. [SOF ¶ 18]. Her
direct supervisor was the Facilities Manager, who was Mike
Bukoff at the time of the promotion. [SOF ¶ 22]. Ms.
Katz also supervised three direct reports: Brenda Lehan, a
facilities coordinator; George Severance, a document
specialist; and Marie Manning, a facilities associate. [SOF
¶¶ 19–21; ECF No. 32-1 at 14–15].
2012 and early 2013, Organogenesis moved from the MP2 CMMS to
a system called Regulatory Asset Manager (“RAM”).
[SOF ¶ 23]. The RAM system was intended to replace both
MP2, which tracked preventative maintenance management, and
Calman, which tracked calibration management. [SOF ¶
24]. The data from both systems was migrated into the RAM
system. [SOF ¶ 24]. Ms. Katz was part of a team of
approximately ten people that transitioned preventative
maintenance management from MP2 to the RAM system. [SOF
¶ 27; ECF No. 35-1 at 5].
or 2014, Ms. Katz began suffering from myofascial pain
syndrome, a tightening of muscles that causes headaches,
fatigue, and pain. [SOF ¶ 32]. She took medical leave in
May 2015 for three weeks for sinus surgery and used FMLA
leave. [SOF ¶¶ 34–35]. This leave did not
adversely affect her employment. [SOF ¶ 36].
the beginning of 2015, a CAPA known as CAPA 15-007-DR
(“the CAPA”) was opened to address numerous
problems with the RAM system. [SOF ¶ 37]. Ms. Katz was
involved with writing the CAPA and signed off on the action
plan as the team leader. [SOF ¶¶ 38, 40; ECF No.
35-3 at 20 (noting that writing the CAPA was a
“combined effort” of several employees)]. The
CAPA concerned preventive maintenance records that were not
correctly entered into the RAM system. [SOF ¶ 39]. The
action plan for the CAPA included six tasks, five of which
listed either Ms. Katz alone or Ms. Katz and a subordinate or
subordinates as those responsible for its completion. [SOF
August or September of 2015, Mr. Bukoff and Cheryl McManamin,
who supervised Mr. Carmichael, the Calibration Manager,
recommended promoting Mr. Carmichael to supervise the
preventive maintenance program. [SOF ¶ 43]. Shortly
thereafter, from October 2015 to January 2016, Ms. Katz took
medical leave due to her myofascial pain. [SOF ¶¶
Katz sought, but did not receive, FMLA leave for her absence
from work between October 2015 and January 2016. [SOF
¶¶ 50–55]. Instead, Organogenesis approved a
personal leave of absence, originally covering the dates
October 20, 2015 to January 6, 2016. [SOF ¶ 55]. Ms.
Katz returned to work on January 12, 2016. [SOF ¶ 60].
While Ms. Katz was on medical leave, Mr. Carmichael was put
in charge of the CAPA. [SOF ¶ 46].
January 13 and 14, 2016, an outside group, CAI Consulting,
conducted a mock inspection of Organogenesis’
facilities maintenance and engineering functions in
preparation for an upcoming audit. [SOF ¶ 61]. On
January 18, 2016, CAI Consulting issued their report, which
identified several issues with the preventative maintenance
program. [SOF ¶ 62]; see [SOF ¶¶
63–66]. On February 9, 2016, an Organogenesis internal
audit identified 14 issues with calibration and preventive
maintenance records, ten of which were assigned to Ms. Katz
for the completion of “confirmation, root cause,
immediate action, risk assessment and action plan.”
[SOF ¶ 74]. Following the internal audit, Mr. Bukoff was
fired on February 22, 2016. [SOF ¶ 78]. A lead
technician named Rocco Digirolamo was also fired that day.
[SOF ¶ 79]. Mr. Bukoff was told that his termination was
based at least in part on his failure to address issues
identified in the recent audit. [SOF ¶ 80]. Dave
Bartorelli became Interim Facilities Manager and Ms.
Katz’s supervisor. [SOF ¶ 81].
February 2016 and May 2016, Ms. Katz suffered from
Bell’s Palsy, which causes facial paralysis and pain
and made it difficult for Ms. Katz to use a computer or read.
[SOF ¶ 83]. She was approved for FMLA leave from
February 23, 2016 to March 8, 2016, and briefly returned to
work. [SOF ¶¶ 84–85].
her brief return to work in early March, Ms. Katz met with
Bill Moran and Ms. Lehan and sent Mr. Moran a spreadsheet
describing progress on the CAPA. [SOF ¶¶ 94, 96].
The parties dispute whether the RAM system was discussed when
Ms. Katz met with Mr. Moran and how Mr. Moran treated Ms.
Katz relative to Ms. Lehan. [SOF ¶¶ 94–95;
ECF No. 35-2 ¶¶ 13–14, 17].
time, Mr. Moran was working for Organogenesis in La Jolla, CA
and had applied to be the director of facilities at the
company’s Canton facility. [SOF ¶¶ 89, 90].
As part of the application and hiring process, Mr. Moran had
received the CAI Consulting report, which led him to believe
that the people responsible for the RAM system were not doing
their jobs properly. [SOF ¶¶ 91–92]. He also
visited the Canton facility at least twice. [SOF ¶¶
March 11, 2016, Ms. Katz received her 2015 performance
evaluation. [SOF ¶ 86]. Mr. Bukoff, who had completed
the evaluation prior to his termination, gave Ms. Katz a
2.5/5 for the objective of “[a]ssist in managing a 100%
completion of all PM’s.” [SOF ¶ 86]. Mr.
Bukoff noted that “overdue PMs were a result of
disconnects between MP2, RAM, SOPs and quality systems”
and that “[a]cceleration of the implementation of
corrective actions is needed to ensure risk is
mitigated.” [SOF ¶ 86]. Other employees involved
with the CAPA were similarly penalized in their reviews. [ECF
No. 35-3 at 22–23]. Because the Bell’s Palsy was
still impacting ...