Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Katz v. Organogenesis, Inc.

United States District Court, D. Massachusetts

September 20, 2019

SUSAN KATZ, Plaintiff,
v.
ORGANOGENESIS, INC., Defendant.

          MEMORANDUM AND ORDER ON DEFENDANT’S MOTION FOR SUMMARY JUDGMENT

          ALLISON D. BURROUGHS, U.S. DISTRICT JUDGE.

         In this 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 Organogenesis.

         I. BACKGROUND

         A. Factual Background

         The 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 non-movant.[1]

         Organogenesis 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].

         Ms. 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].

         Between 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].

         In 2013 or 2014, Ms. Katz began suffering from myofascial pain syndrome, a tightening of muscles that causes headaches, fatigue, and pain. [SOF ¶ 32].[2] 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].

         Near 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 ¶ 41].

         In 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 ¶¶ 45, 60].

         Ms. Katz sought, but did not receive, FMLA leave for her absence from work between October 2015 and January 2016. [SOF ¶¶ 50–55].[3] 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].

         On 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].

         Between 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].

         During 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].

         At the 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 ¶¶ 93].

         On 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 ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.