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Bacewicz v. Molecular Neuroimaging, LLC

United States District Court, D. Connecticut

September 23, 2019

MEREDITH BACEWICZ, Plaintiff,
v.
MOLECULAR NEUROIMAGING, LLC, Defendants.

          RULING ON DEFENDANT’S MOTION TO DISMISS

          Michael P. Shea, U.S.D.J.

         The Plaintiff, Meredith Bacewicz (“Bacewicz”), filed this action against her former employer, Molecular Neuroimaging LLC (“MNI”), claiming MNI terminated her in retaliation for reporting fraudulent conduct by MNI and efforts to stop MNI from continuing such conduct. Bacewicz alleges (1) retaliation in violation of the False Claims Act under 31 U.S.C. § 3730(h); (2) retaliation in violation of Conn. Gen. Stat. § 31-51m; and (3) retaliation in violation of Conn. Gen. Stat. § 31-51q. MNI moves to dismiss all counts for failure to state a claim under Federal Rules of Civil Procedure 12(b)(6). For the reasons discussed below, the motion to dismiss is DENIED.

         I. Background

         The following facts are drawn from the second amended complaint (ECF No. 46) and are accepted as true for the purpose of deciding MNI’s motion to dismiss.

         Plaintiff Meredith Bacewicz worked for MNI as an Image Processing Associate from April 18, 2016 to October 24, 2016. (ECF No. 46 at ¶ 9.) Bacewicz holds an M.S. in neuroscience and had experience working in clinical research prior to her employment at MNI. (Id.) Defendant MNI is a division of inviCRO LLC, a “neuroimaging company specializing in large scale brain imaging clinical research and drug development for neurodegenerative and neuropsychiatric disorders.” (Id. at ¶ 10.) MNI’s principal place of business is in New Haven, CT and its co-founders, Doctors Ken Marek and John Seibyl, currently manage MNI. (Id.)

         MNI provides services related to clinical research studies and drug development and is typically responsible for “receiving and/or performing human brain scans, processing those scans, and reporting the resultant statistical data.” (Id. at ¶¶ 31-32.) MNI conducts both independent research and collaborates with global pharmaceutical and biotech companies. (Id. at ¶ 33.) Bacewicz contends that many of these companies contract with U.S. government agencies such as the National Institute of Health (“NIH”). (Id.) Bacewicz asserts that through work with such companies MNI receives “funds from both public and private sources.” (Id.)

         Bacewicz began working at MNI on April 18, 2016. (Id. at ¶ 9.) Bacewicz worked in the Imaging Services group, and her direct supervisor was the Assistant Director of Image Processing and Analysis, Heather Ovens (“Ovens”). (Id. at ¶ 34.) Bacewicz’s job responsibilities included “analyzing, interpreting and processing MRI, PET and CT scans of the brain relevant to a No. of clinical studies researching Alzheimer’s disease.” (Id. at ¶ 36.) In August 2016, eight Image Processing Associates, including Bacewicz, worked under Ovens. (Id. at ¶ 37.) One of these associates was Kyle LoPresto (“LoPresto”) the “SPECT Processing Manager, and a Sr. SPECT Processing Associate.” (Id.) Bacewicz processed about ten to forty scans per day and estimated that each scan cost between $250 to $500, but the price of such scans varied significantly. (Id. at ¶ 38.)

         Bacewicz began training in spring 2016. (Id. at ¶ 39.) As part of her training, Bacewicz reviewed “Standard Operating Protocols and Working Instruction Documents” but alleges that the documents were often ignored or inaccurate. (Id.) Bacewicz claims she was “instructed to cross off and add steps, and sometimes ignore pertinent documents altogether.” (Id.) When she asked if she should take notes on the changes so the documents could be updated, she was told not to bother. (Id.) During her second week of training, Bacewicz was called into Ovens’ office. (Id. at ¶ 40.) Ovens discussed Bacewicz’s “questioning [of] changes made to MNI protocols and working documents and pointing out the discrepancies with Sponsor protocols.” (Id.) Bacewicz was told she was “‘undermining people’s authority’” and that she was “too new to ask such questions.” (Id.) Ovens informed Bacewicz that “asking such questions was unprofessional and ‘not part of the culture [at MNI].’” (Id.) Bacewicz states that she “maintained her stance on the documents but agreed to be more tactful in her questioning.” (Id.) Bacewicz also claims that MNI was “emphatic that employees should not put anything in writing related to complaints or observed errors.” (Id. at ¶ 41.) She was told that if she had a complaint, she should “bring it to the appropriate person. Don’t put it in email because the FDA can read that.” (Id.) In June 2016, Bacewicz was cleared to begin processing images. (Id. at ¶ 42.) At her ninety-day review, Bacewicz received high praise and her only area of development appeared to be expanding her knowledge of processes and increasing the No. of studies she was working on. (Id. at ¶ 86.)

         Bacewicz claims that MNI committed multiple forms of research misconduct including: failure to follow sponsor protocols, failure to implement and follow standardization practices, changing specific brain scan imaging processing steps, data manipulation and fabrication, and enrolling subjects with exclusionary conditions. (Id. ¶¶ 66-74.) Bacewicz contends that this misconduct rendered results useless and that if the study sponsor knew of the misconduct, it would not have paid MNI for the results. (Id. at ¶ 77.) Bacewicz reported these concerns to peers, LoPresto, Ovens, and the Director of Human Resources. (Id. at ¶¶ 39, 53, 61, 69, 102, 105, 120.) MNI dismissed Bacewicz’s concerns, telling her “that’s how it’s done here, ” “that’s Eli Lilly’s problem, ” “that’s how all businesses operate in Connecticut, ” and “that’s not our concern.” (Id. at ¶ 91.) When MNI did not address her concerns, Bacewicz avoided working on the impacted scans whenever practicable. (Id. at ¶ 89.)

         Bacewicz provides examples from three studies to illustrate MNI’s misconduct. The A4 Study began in 2013 and was sponsored by the National Institute on Aging (an NIH institute), Eli Lilly and Company (“Lilly”), and several philanthropic organizations. (Id. at ¶ 45.) MNI was contracted to perform image processing analysis and determine whether potential participants were eligible for enrollment in the study. (Id. at ¶ 46.) The study specifically dictated that “linear warping” was to be used when performing the “brain normalization” step during image processing. (Id.) “Warping” is an image processing step where images are altered (“warped”) to fit a standard template brain. (Id.) This normalization step serves multiple purposes in clinical studies including standardizing scans to allow researchers to identify commonalities and differences between subjects and groups, allowing results to be reported in a standard coordinate system, accounting for individual differences in brain size and shape, and ensuring that a given region in a subject’s brain corresponds to the same region in another subject’s brain. (Id.) Once a warping procedure has been chosen, it must remain consistent throughout the study so that the results are valid. (Id.) The normalized results, produced using the chosen warping procedure, are used to generate statistical data called standardized uptake values (“SUVs”) for each image. (Id. at ¶ 47.) SUVs are then used to determine eligibility for the study and are a “key ongoing measurement of drug effectiveness.” (Id.)

         In 2014, MNI changed the study protocol from linear warping to nonlinear warping without informing the study sponsor. (Id. at ¶ 48.) Bacewicz and others were initially instructed “verbally and through work instruction documents to use nonlinear warping as standard practice and to use linear warping only if nonlinear normalization failed.” (Id.) Because of this change, ineligible subjects were enrolled and “ongoing data collected from enrolled subjects was fatally compromised.” (Id. at ¶ 49.) According to Bacewicz, this resulted in the data being rendered “worthless” because a second unaccounted for variable was introduced and it was now impossible to determine which variable-the drug or the warping-was responsible for the results. (Id.)

         In June 2016, Lilly became aware of MNI’s failure to follow protocol. (Id. at ¶ 50.) Lilly directed MNI to reanalyze every scan in accordance with the original warping protocol. (Id. at ¶ 51.) Lilly wanted MNI to show that “only a small percentage of subjects were wrongfully enrolled as a result of the switch.” (Id.) During a meeting, Ovens emphasized that MNI’s “financial future was at risk if they could not make that showing.” (Id.) Ovens also sent an email to staff further stating that as a result of the failure to follow protocol MNI could “potentially lose critical contracts with Lilly” and that the founder had deemed the incident “the worst thing that has happened in the history of MNI.” (Id. at ¶ 97.) MNI did not, however, reanalyze each scan correctly. According to Bacewicz, MNI began using “various data manipulation tactics” to show that subjects were correctly deemed eligible and to “make it seem not as bad.” (Id. at ¶ 52.) MNI aimed to show that fewer than 5% of subjects were wrongfully enrolled. (Id. at ¶ 98.)

         MNI utilized a No. of data manipulation tactics. MNI used “masked linear warping” which changes the SUVs generated. (Id. at ¶ 53.) Bacewicz asked LoPresto about the technique and he told her that “it didn’t affect their values as much as we’d hoped.” (Id.) Bacewicz also asked Ovens “whether Lilly knew about the effect of masks, ” but received no answer. (Id.)

         MNI changed other parameters until it achieved the desired eligibility status. (Id.) Bacewicz claims that contracts and other documents she reviewed state that that MNI would use standardized parameters, but that staff was encouraged to change these parameters as they saw fit to improve the “look” of the scan and “sometimes with the express intention of affecting subject eligibility status during the reanalysis.” (Id.)

         Instead of the “mode used for individual processing, ” MNI used “batch mode” analysis to re-analyze multiple scans at once, which generated different SUVs. (Id.) Bacewicz raised the issue that batch mode generates different SUVs and affects eligibility with LoPresto but was told the discrepancy was a “rounding error” and “it’s not a big difference.” (Id.) Ovens informed Bacewicz that the batch mode process was validated, but Bacewicz noted that she never received working instruction documents or protocols confirming the validation. (Id.)

         MNI used different parameters than what was required in the study when analyzing data. (Id.) The original Working Instruction Document dictated that MNI use linear parameters saved as “NLW_Off” (nonlinear warping off). (Id.) However, MNI changed the parameters to “NLW_On” without permission in 2014, which caused Lilly to order the reanalysis. (Id.) Instead of returning to “NLW_Off, ” MNI instructed Bacewicz and others to use other files in place of “NLW_Off” including a second version of “NLW_Off” that was saved in a different server location. (Id.) When Bacewicz compared the results of the identically named “NLW_Off” files, she found that they generated different data. (Id.) The second version of “NLW_Off” was created after the order to reanalyze and had been modified several times. (Id.) Bacewicz claims this was likely an attempt to reach the desired eligibility status. (Id.)

         MNI also submitted data under false subject IDs. If other methods did not produce the desired result, MNI would sometimes “substitute data acquired from another subject.” (Id.) MNI changed file names and audit trails were altered. (Id.) Bacewicz believes that ineligible participants were enrolled in the study because MNI signed off on the scans as “expected.” (Id. at ¶ 54.) These ineligible participants allegedly possessed brain abnormalities in structure and blood flow that would have been identifiable in brain scans performed by MNI. (Id.) Bacewicz contends that MNI exposed subjects to unnecessary potential harm by deeming them eligible for the study. (Id.) She also alleges that the data manipulations and fabricated scan data was an effort to conceal the No. of wrongfully enrolled subjects so MNI could save time and money and could cover up its failure to follow sponsor protocols. (Id. at ¶ 73.)

         The LZAX study began in 2010 and required the exclusion of “subjects with confounding neurological conditions.” (Id. at ¶ 57.) Bacewicz observed that MNI listed a patient who was missing a significant portion of brain matter as “expected, ” leading to his enrollment in the study. (Id. at ¶ 59.) MNI’s Managing Director, Dr. John Siebyl, allegedly agreed that the subject “likely does not meet study criteria.” (Id.) Bacewicz emailed LoPresto to discuss the subject’s scan and was told to discuss the issue in his office, which Bacewicz contends was to conceal the error from sponsors and government officials. (Id. at ¶ 61.) In October 2016, Bacewicz noticed the subject was still enrolled in the study and contact LoPresto again, but to her knowledge the subject still has not been removed. (Id. at ¶ 120.) Bacewicz asserts that MNI was financially motivated to enroll rather than exclude subjects because in some instances, payment was impacted by the No. of enrolled subjects, and in ongoing studies, more subjects meant more future billable scans. (Id. at ¶ 75.)

         The AC Immune clinical trial was sponsored by NIH, AC Immune, and private organizations. (Id. at ¶ 62.) During the course of the study, a likely technical issue caused regions of the brain to be cut off in images of two subjects. (Id. at ΒΆ 63.) Because the scans were incomplete, both subjects should have been deemed ...


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