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Elliott-Lewis v. Abbott Laboratories, Inc.

United States District Court, D. Massachusetts

November 6, 2019





         Plaintiff Ebonia Elliott-Lewis brings this civil action pro se against her former employer, Defendant Abbott Laboratories, Inc. (“Abbott”). She claims Abbott terminated her in retaliation for raising internal concerns about the company's off-label marketing and pre-approval promotion of its products. She alleges retaliation under the False Claims Act (“FCA”) and wrongful termination in violation of public policy. Both parties have moved for summary judgment on the two claims.

         After hearing, the Court ALLOWS Abbott's motion for summary judgment (Docket No. 159) and DENIES Plaintiff's motion for summary judgment (Docket No. 164).


         The following facts are undisputed except where otherwise stated.

         I. Hiring and Expense Reporting Investigation

         Plaintiff joined Abbott Vascular, a division of Abbott, in 2010 as a medical science manager (“MSM”) assigned to the northeastern United States. As an MSM, Plaintiff engaged with healthcare professionals and customers, provided them with medical and scientific data and information, and facilitated opportunities for clinical research. The MSM position did not involve sales responsibilities. Abbott instructed its MSMs that they could proactively engage healthcare professionals and customers in discussions about on-label clinic data updates and safety and efficacy information. With certain restrictions, MSMs could also respond to bona fide unsolicited requests from healthcare professionals and customers for off-label information.

         Plaintiff was supervised directly by Colleen Baird, the national manager for medical science/medical affairs, and indirectly by Dr. Krishna Sudhir, a divisional vice president, and Dr. Charles Simonton, the chief medical officer. Plaintiff received positive feedback, as well as cash bonuses, for multiple projects she undertook during her employment at Abbott.

         In the summer of 2012, Abbott's Office of Ethics and Compliance (“OEC”) investigated Plaintiff for suspicious expense reporting. Plaintiff admitted to rounding her expenses to even numbers, which she believed was consistent with the direction she received from Abbott. During the investigation, she told the OEC that she believed someone reported her to retaliate for a transition in leadership within her department. The OEC found that Plaintiff had violated Abbott's Code of Business Conduct and issued a written warning. The warning noted that Plaintiff's “professionalism was not maintained throughout the investigational process” and that she “took on an argumentative tone, in both the interview and follow up e-mails, bordering on disrespectful.” Dkt. No. 161-2 at 2.

         II. Plaintiff's Internal Complaints

         Throughout 2012 and 2013, Plaintiff raised concerns about what she perceived to be three legal and ethical violations by her colleagues. First, in late October 2012, Plaintiff spoke with Dr. Sudhir about the relationship between Dr. Simonton and an outside physician. Plaintiff told Dr. Sudhir that Dr. Simonton was being very “aggressive” and “pushy” and that the physician was uncomfortable with their interactions. Elliott-Lewis Dep. 19:10-20:7. Plaintiff believed Dr. Simonton “seemed to be offering things in exchange for trying to get [the physician] to change his research conclusions[.]” Id. at 131:4- 24. In the email exchange that prompted Plaintiff's concern, Dr. Simonton critiques the physician's research findings and then suggests the physician may want to collaborate further with Abbott's clinical team to analyze data held by Abbott.

         Second, in 2013, Plaintiff expressed concerns to Baird about a presentation Baird was developing regarding a new product called Absorb, a coronary stent. Because Absorb was not FDA-approved at the time, Plaintiff was concerned the presentation would have a promotional tone and include statements about the product's safety and efficacy. Plaintiff explained that company policy did not permit pre-approval promotion. It is unclear from the record whether anyone at Abbott ever delivered this presentation.

         Third, Plaintiff spoke to Regina Deible, a new MSM hire who had previously worked at Johns Hopkins University, about a presentation she made about Absorb at a continuing medical education (“CME”) conference in Las Vegas in October 2013. Plaintiff expressed concern that Deible's presentation suggested she was still affiliated with Johns Hopkins with no financial relationships to disclose and that the presentation included pre-approval promotional content. Plaintiff believed Deible's presentation also violated Abbott's policies because Abbott was sponsoring the conference and MSMs were not supposed to give presentations or distribute printed materials at CME events sponsored by the company.

         III. 2013 Performance Review

         In December 2013, Plaintiff's supervisors discussed laying her off as part of a reduction in force. They acknowledged she was “coming up to speed and has real talents for the team that are different than the others” but also observed that she “struggle[s] in clinical/cath lab settings” and wondered if she was “the right fit.” Dkt. No. 161, Ex. 8 at 2. On January 11, 2014, Dr. Sudhir determined that Plaintiff should only get 75% of her achievable performance bonus for 2013, the only employee in the group to get less than 100%.

         Baird solicited feedback from Plaintiff's other supervisors in January 2014 in connection with her 2013 performance review. Plaintiff received positive feedback for certain projects she undertook during the previous year. However, Dr. Simonton questioned her “relationship-building capabilities, ” which he believed to be a “core skill” for the job. Dr. Sudhir noted “the strong perception [at headquarters] that she may not be the right person for this role, from points of view of both personality as well as educational background and interests” and that she might be “a better fit for a career in device development rather than medical affairs.” Dkt. No. 161-2 at 17. In her summary, Baird wrote that the “feedback received has been mixed, and growth areas were identified.” Id. at 21. While she praised Plaintiff's work ethic and knowledge, she noted that Plaintiff was sometimes “confrontational, insular and inflexible” and might “work[] better as an individual contributor, rather than truly as a team player.” Id.

         Baird planned to discuss the performance review with Plaintiff during a prescheduled trip together on February 12, 2014. However, because Baird was still finishing the review, the two did not have their formal evaluation meeting that day. Baird did express to Plaintiff some of her concerns about her performance. Plaintiff told Baird that she believed she received negative feedback because Dr. Simonton wanted Deible, the new hire from Johns Hopkins, to have her job due to her better social relationships with physicians. Although she did not say this to Baird, Plaintiff believed that her supervisors wanted someone who could more easily speak with doctors about off-label marketing and pre-approval promotion. Plaintiff told Baird that, if social relationships were so important for the job, she should not have been hired in the first place and asked to be laid off to allow her to escape her noncompetition agreement and find another job. According to Baird, Plaintiff “became combative and confrontational, ” “told [Baird] she did not think she was a good fit” for the job, and “asked to be laid off.” Dkt. No. 161-1 at 3-4.

         IV. Compliance Report and Investigation

         The day after Baird and Plaintiff's meeting, on February 13, 2014, Plaintiff filed a compliance report with the OEC, saying she had been “harassed” by Dr. Simonton, Dr. Sudhir, and Baird starting with the expense reporting investigation in June 2012. She stated in her report that she thought her managers were assigning projects within her territory to Deible and excluding her from trainings. Plaintiff believed her supervisors were trying to push her out because she refused to participate in unlawful marketing, namely pre-approval promotion of Absorb and off-label promotion of Xience, another coronary stent, but could not recall whether she mentioned this in her report. Her report also included her concerns about the relationship between Dr. Simonton and the outside physician and included an email exchange between the two as supporting evidence.

         The OEC opened an investigation and assigned James Curcio, an employee relations manager within the human resources department (“HR”), to communicate with Plaintiff about her harassment claim. Curcio and Plaintiff met for the first time on February 24. Curcio and Plaintiff exchanged numerous communications over the next few weeks about Plaintiff's allegations that her supervisors were harassing and trying to replace her. After Baird sent Plaintiff her final performance evaluation on February 27, for example, Plaintiff told Curcio that she thought the evaluation's “tone ha[d] been altered to be especially negative in response to [her] retaliation/harassment complaint.” Elliott-Lewis Dep. 93:4-18. Curcio arranged a call with Plaintiff, Baird, and Dr. Sudhir to discuss her performance evaluation and expectations going forward. After the call, Plaintiff expressed frustration with the way Baird and Dr. Sudhir were managing her workload and the duties within her territory.

         On March 2, Plaintiff emailed Curcio about what she called “key events surrounding Abbott Vascular's evolving tolerance for noncompliance in the form of medical device off-label promotion (reference Code of Federal Regulations under 21CFR812.7) and pre-approval promotion (reference Code of Federal Regulations under 21CFR801.4).”[1] Dkt. No. 161-3 at 46. Plaintiff explained that Dr. Simonton encouraged her and other MSMs to “proactively discuss off-label topics” with physicians to increase revenue for the division. Id. at 47. She also expressed concern that no one had reached out to her about these allegations. Id.

         On March 4, Curcio told Plaintiff that Abbott had assigned Peter Schutzel to investigate her allegations of regulatory violations. Over the next few weeks, Plaintiff emailed Curcio and Schutzel about these allegations, including that she believed Deible's presentation at the CME conference violated company policy.

         V. Leave of ...

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