Trupp v. Roche Diagnostics Corp.

440 F.Supp.3d 990

Robin TRUPP Ph.D, Plaintiff,

v.ROCHE DIAGNOSTICS CORPORATION, Defendant.

No. 1:18-cv-02587-SEB-DLP

United States District Court, S.D. Indiana, Indianapolis Division.

Signed February 24, 2020

Christopher S. Stake, Kathleen Ann DeLaney, DeLaney & DeLaney LLC, Indianapolis, IN, for Plaintiff.

Hannesson Ignatius Murphy, Kenneth J. Yerkes, Koryn Michelle McHone, Patricia L. Ogden, Barnes & Thornburg, LLP, Indianapolis, IN, for Defendant.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

* * * SEALED * * *

SARAH EVANS BARKER, JUDGE

This cause is before the Court on Defendant Roche Diagnostic Corporation's ("Roche") Motion for Summary Judgment, [Dkt. 72], filed on July 22, 2019, pursuant to Federal Rule of Civil Procedure 56. Plaintiff Robin Trupp, Ph.D, initiated this action on August 8, 2018, [Dkt. 1], alleging that Roche retaliated against her in violation of the False Claims Act, 31 U.S.C. § 3729 et seq. , and the Family Medical Leave Act, 29 U.S.C. § 2601 et seq. For the reasons detailed below, we grant Roche's Motion for Summary Judgment.

Background

I. Dr. Trupp's Employment with Roche

Roche is a global diagnostics company that manufacturers medical devices and immunoassays, which are subject to regulations of the U.S. Food and Drug Administration ("FDA"). [Dkt. 75-13, at 2]. Roche's primary clientele is health care providers, including hospitals. Dr. Trupp was employed by Roche as the Director of Medical and Scientific Affairs ("MSA"), Cardiac from July 2015 until November 30, 2018. [Dkt. 75-13, at 5, 10-11; Dkt. 83-1, at 3, 20]. As the Director of MSA, Cardiac, Dr. Trupp supervised a team of medical and scientific professionals; managed an annual operating budget of [redacted]; provided expertise for product development, and served as a liaison to Roche's Global Clinical and Medical groups. [Dkt. 75-13, at 5; Dkt. 83-1, at 4]. On November 13, 2018, Dr. Trupp was offered the position of Director of Medical Access, which she accepted on November 30, 2018. To date, she remains employed at Roche as the Director of Medical Access. [Dkt. 75-13, at 10-11].

II. The Gen 5 STAT Immunoassay

As Roche describes, an "assay" is a term used "generally to define a blood test run on a patient's blood sample to quantify levels of the substance." [Dkt. 75-13, at 3; Dkt. 83-1, at 5]. For example, the Gen 5 STAT immunoassay—the device which, as will be further discussed hereafter, initially sparked controversy between Roche and Dr. Trupp—measures cardiac troponin¹ and is utilized by health care providers to aid in the diagnosis of heart attacks. [Dkt. 75-13, at 3; Dkt. 83-1, at 5]. The assay is not intended to be used on its own to diagnose a heart attack ; the results should "always be correlated with the patient's medical history, presentation, EKG, and other imaging data." [Dkt. 75-13, at 3].

In January 2017, following seven years of a "rigorous approval process," Roche received clearance from the FDA for the use of the Gen 5 STAT immunoassay on two Roche instruments, the e411 and the e601/602. [Id. ]. The FDA also granted approval for one product insert to be included with the assay for both instruments.² The product insert described the differences in the two instruments, addressing when the instruments perform comparably within an acceptable range of variation.³ [Id. , at 3-4]. Additionally, the product insert outlines the recommended purpose of the assay. [Id. ]. Notwithstanding Roche's recommended use of the assay, the FDA permits medical professionals to use the assay in any manner they deem medically appropriate in the practice of medicine, even if it is inconsistent with the directive as provided in the product insert. [Id. ]. Such use would be considered "off-label." [Id. at 5]. However, Roche is prohibited from promoting the off-label use of its products. [Id. at 22].

III. Facts Giving Rise to Dr. Trupp's Claim for FCA Retaliation

In or around February 2018, one of Dr. Trupp's subordinates, Carmen Wiley, Ph.D, developed concerns that Roche [redacted] Following her review of a Roche document that [redacted] [Dkt. 83-1, at 5-6]. Specifically, she realized that the e411 instrument used at two-step process for the assay, whereas the e601/e602 instrument used a one-step process. [Dkt. 75-13, at 12; Dkt. 83-1, at 6]. In practice, if Roche's customers (i.e., health care providers) were to use the assay in an off-label manner, [redacted] "erroneous clinical decisions could be made" and "there may be an increased risk of missing a heart attack diagnosis." [Dkt. 83-1, at 6-7].

Dr. Wiley thus advocated for [redacted] [Dkt. 75-13, at 12; Dkt. 83-1, at 5]. Although the single product insert supplied with both instruments notified users of [redacted] Dr. Wiley remained concerned that customers "may not pay close attention to" the information as presented. [Dkt. 75-13, at 12; Dkt. 83-1, at 8]. She thus "felt strongly that [Roche] should provide more education and be more transparent with customers." [Dkt. 83-1, at 8]. However, Dr. Wiley asserts that her initial inquiries suggesting the need for increased education were "downplayed." [redacted] [Dkt. 83-1, at 7].

On February 16, 2018, Dr. Wiley reported her concerns to Dr Trupp. [Dkt. 83-1, at 8]. Finding that a "vast majority" of Roche customers were using the assay off-label, Dr. Trupp came to share Dr. Wiley's concerns. [Id. ] Thus, the pair felt compelled to report this issue to their higher-ups at Roche, but because Roche had undertaken such an arduous process to gain FDA approval for the assay, Dr. Wiley and Dr. Trupp feared Roche would retaliate against them for raising any issues with the product, and specifically, [redacted] [Id. at 9]. On March 27, 2018, purportedly fearing retaliation, Dr. Trupp and Dr. Wiley sought advice from Roche's Vice President for Law and Ethics Compliance, Steve Oldham, about their concerns. [Id. ] Mr. Oldham assured Dr. Trupp and Dr. Wiley that they were acting appropriately, vowing to protect them against any retaliation. [Id. ]

That same day, following their receipt of Mr. Oldham's assurances, Dr. Trupp and Dr. Wiley conferred with Dr. Alan Wright, Roche's Chief Medical Officer. [Id. at 9]. Per Dr. Wright's directive, Dr. Trupp and Dr. Wiley organized a larger group meeting to discuss the issue. [Dkt. 75-13, at 12; Dkt. 83-1, at 9-10]. The meeting included members from the sales, marketing, and MSA departments. No regulatory affairs staff people were included; Dr. Wright had determined, with Dr. Trupp's concurrence, that because the matter did not invoke regulatory concerns but rather post-clearance customer education issues, regulatory affairs staff members did not need to be invited. [Dkt. 75-13, at 12; Dkt. 83-1, and 9-10]. At the time of the March 22, 2018, meeting, neither Dr. Trupp nor Dr. Wiley expressed concerns that Roche had misrepresented the functionality of its product to the FDA, nor did either share any concerns that Roche or its customers were participating in any kind of fraudulent conduct. [Dkt. 75-13, at 13].

In the months following the March 2018 meeting, Roche directed its Global Core Team to coordinate with personnel in Regulatory Affairs and Marketing to address Dr. Trupp and Dr. Wiley's concerns. [Dkt. 75-13, at 12]. Following the Global Core Team's evaluation of the matter, Roche concluded that the issues raised by Dr. Wiley and Dr. Trupp did not affect its customers' clinical decision making, and established a process by which customer inquiries could be addressed if and when they were received. [Dkt. 75-13, at 14].

According to Dr. Trupp, her upward reporting of the issue resulted in an array of negative reactions to her at Roche, confirming her fears that retaliation would likely ensue as a consequence of her speaking up. [Dkt. 83-1, at 11-13]. Specific acts of retaliation against her, as identified by Dr. Trupp, included "being excluded from calls, not invited to meetings, being ignored, and being yelled at." [Id. at 12]. Dr. Trupp also believes that her supervisor, Dr. Christopher Bird, embarked on an internal campaign against her. [Id. at 13]. For example, on May 1, 2018, Dr. Bird told Dr. Wright, "We have to fire Robin this week," and requested that Roche employees report any complaints about Dr. Trupp directly to him. Id. In April 2018, Roche began investigating Dr. Trupp's complaints of retaliation and finished its investigation in or around June 2018, finding that no retaliation had occurred but acknowledging that certain employees had "behave[d] badly." [Dkt. 75-13, at 16].

IV. Facts Giving Rise to Ms. Trupp's Claim for FMLA Retaliation

In July 2018, Dr. Trupp sought and received approval to take FMLA leave. [Dkt. 75-13, at 8-9; Dkt. 83-1, at 16]. She received her full salary for the duration of her leave, which was extended several times. [Dkt. 75-13, at 9].

Dr. Trupp was released to work with no restrictions on August 13, 2018. [Dkt. 83-1, at 17]. She returned to work that day and resumed her role as Director of Medical and Scientific Affairs. [Id. ] However, Dr. Trupp contends that when she returned her job had "changed." She was excluded from MSA leadership meetings, and Dr. Bird canceled her flight to attend a conference, directing her to "sit and catch up on emails." [Id. ] Additionally, Dr. Bird was reportedly scouting out potential candidates to replace Dr. Trupp. Indeed, while Dr. Trupp was on FMLA leave, Dr. Bird inquired of a Roche employee whether she would be interested in Dr. Trupp's position. The employee declined an interest. [Dkt. 83-1, at 16-17].

On August 31, 2018, Dr. Trupp was placed on administrative leave, which according to Roche, was a consequence of her performance deficiencies. [Dkt. 75-13, at 10, Dkt. 83-1, at 17-18].⁴ Her salary and benefits were uninterrupted during the period of administrative leave. [Dkt. 75-13, at 10]. Roche's internal personnel policies provide for administrative leave, but there are few details of that policy delineated. And, while Roche employs a...