United States ex rel. Jones v. Brigham & Women's Hosp.

• Decision Date: 07 May 2012
• Docket Number: No. 10–2301.,10–2301.
• Citation: 82 Fed.R.Serv.3d 662,678 F.3d 72
• Parties: UNITED STATES, ex rel. Kenneth James JONES, Plaintiff, Appellant, Priscilla Pitt Jones and Kenneth James Jones, Plaintiffs, v. BRIGHAM AND WOMEN'S HOSPITAL, et al., Defendants, Appellees, Harvard Medical School, et al., Defendants.
• Court: U.S. Court of Appeals — First Circuit

678 F.3d 72

82 Fed.R.Serv.3d 662

UNITED STATES, ex rel. Kenneth James JONES, Plaintiff, Appellant,Priscilla Pitt Jones and Kenneth James Jones, Plaintiffs,

v. BRIGHAM AND WOMEN'S HOSPITAL, et al., Defendants, Appellees,Harvard Medical School, et al., Defendants.

No. 10–2301.

United States Court of Appeals, First Circuit.

Heard Sept. 15, 2011.

Decided May 7, 2012.

Jeremy L. Friedman, with whom William D. Hughes, Michael D. Kohn, Hughes & Nunn LLP, Kohn, Kohn & Colapinto, LLP, and Law Office of Jeremy L. Friedman, were on brief, for appellant.

Alan D. Rose, with whom Lisa A. Tenerowicz, and Rose, Chinitz & Rose, were on brief, for appellees.

Before LIPEZ, RIPPLE ^*, and HOWARD, Circuit Judges.

LIPEZ, Circuit Judge.

This case requires us to address claims filed pursuant to the False Claims Act, 31 U.S.C. § 3729 (the “FCA”), alleging that the defendants submitted an application to the National Institute on Aging (“NIA”) for research on Alzheimer's disease (“AD”) which relied on falsified data. The district court granted summary judgment for the defendants. We vacate that ruling.

I.

In 2006, Dr. Kenneth Jones (“Jones” or “Relator”) filed a qui tam action under the FCA against defendants Brigham and Women's Hospital (“BWH”), Massachusetts General Hospital (“MGH”), Dr. Marilyn Albert, and Dr. Ronald Killiany (collectively, the “Defendants”). Jones claimed that the Defendants violated the FCA by including false statements in a grant application that was submitted to the NIA, an institute within the National Institutes of Health (“NIH”). The NIH is an agency of the United States Department of Health and Human Services. Jones alleged that statements in the Program Project Grant Application (the “Application”) were predicated on falsified data and that the Defendants, knowing of this falsity, failed to take corrective action or disavow the data. After the parties filed cross-motions for summary judgment, the district court granted judgment for the Defendants.

Jones timely appeals, maintaining that material factual disputes remain concerning the Defendants' conduct. He asserts that the record supports a conclusion that the Defendants violated the FCA by (1) “knowingly submitting an application for a grant to the [NIH] that was based on falsified and fraudulently manipulated study data and false statements of blinded, reliable methodologies,” and (2) receiving NIH funds while knowingly in violation of regulations that require applicant institutions to investigate and report allegations of scientific misconduct.¹

After careful review of the record, we conclude that the district court abused its discretion by excluding or failing to consider certain expert testimony. It then committed an error of law by failing to consider statements of the parties and experts in a manner required by the summary judgment standard. When properly considered, those statements generate genuine issues of material fact concerning some of Relator's FCA claims. We begin our explanation of these conclusions by describing the research project in question, Relator's concerns, and the NIH grant application process. We then recount in some detail the contents of the parties' expert reports. In Part II, we consider the district court's failure to examine Dr. Daniel Teitelbaum's expert report in its entirety, its improper evaluation of portions of other expert reports, and Relator's other claims.

A. The Research Project

The alleged false claims were submitted to the NIA in conjunction with a Program Project Grant (“PPG”) proposal focused on AD, a neurodegenerative illness associated with aging. Dr. Marilyn Albert acted as the Principal Investigator (the “PI”) on the PPG and oversaw the work of both Killiany and Jones.² The individual Defendants and Relator were part of a larger project team working to identify early physical manifestations of AD in certain regions of the brain and differentiate those characteristics from changes related to normal aging. Successfully doing so would enable health care providers to predict who will develop AD years before the individual displays diagnosable symptoms, thereby permitting early intervention. The NIH began funding this research in 1980 under a grant entitled “Age-related changes of cognition in health and disease” (the “Grant”), and continued to fund the project through 2007.

The proposed PPG consisted of four “Projects,” long-term research studies focused on related issues, and four “Cores,” each of which provided various types of support to the Projects. Killiany, a neuroanatomist, would head “Project 3,” and utilize MRI to explore regions of interest (“ROIs”), including the EC, in the brain. Project 3 was a continuation of a study already in progress, the preliminary results of which were published in a 2000 paper authored by Killiany, Albert, and Dr. Mark Moss. During the study, Killiany and another researcher (“rater”), Dr. Teresa Gomez–Isla, developed and agreed to a protocol by which to locate and outline the EC and other ROIs on MRI scans. According to the Application, raters were blinded, meaning they were unaware of participants' cognitive groupings.³ Raters were provided with participants' identification numbers and sometimes their names. Participant identification numbers were assigned consecutively upon participants' entry into the study; thus the numbers did not communicate information to the raters about participants' cognitive statuses. Using a trackball mouse and “Neuroview” software, the raters manually outlined a number of brain structures, including the EC, on 103 participants' MRI scans. ⁴ Based on the raters' outlines, the software calculated the volume of the traced EC, and those calculations were later sent to Dr. Mary Hyde, the Data Manager and Programmer for “Core B,” the Data Management and Statistical Core.⁵ Thereafter, members of Core B, supervised by Jones, conducted statistical analyses of the data to determine whether changes in the volume of the EC could help predict which cognitively healthy people would develop AD in the future.

Between 1995 and 1999, Killiany modified his outlining process. In his deposition, Killiany testified that as he worked through participants' scans, he encountered a number of “anatomical anomalies.” When he encountered such anomalies, he went back and reviewed earlier outlines to ensure that those tracings properly considered the anatomical issue. If, upon reviewing an outline, he felt that it should be revised, he re-traced the EC boundary, the software recalculated the volumetric data, and he eventually sent the new data to Hyde.

B. Relator's Concerns About the Study Data

As noted, the relator in this case, Jones, headed Core B. In that role, he supervised data management, assessed project progress, analyzed project data, and developed new analytic frameworks. In March 2001, Jones met with Albert and Dr. Keith Johnson, the leader of Project 2. Jones and Johnson alerted Albert that they had concerns about the data that Killiany produced prior to 1998, which had been used to demonstrate a statistically significant relationship between the volume of the EC and conversion to AD. Jones noted that there was more than one data set for a number of study participants and expressed concern regarding the quantitative differences between those sets. Killiany had re-measured the scans of 30 participants—thirteen in the normal group, twelve in the questionable group, and five in the converter group.⁶ Jones had particular concerns about 23 of those re-measurements. Jones told Albert that the alterations were substantial and that, according to his analysis, the alterations were responsible for the apparent statistical significance. Jones asked Albert to look into the issue. ⁷

In response, Albert asked Dr. Mark Moss, a noted neuroanatomist who had been involved with the PPG since its inception, to examine for accuracy the 23 re-measurements about which Jones and Johnson expressed concern. Moss reviewed the scans in question and hand wrote notes expressing his opinion of the accuracy of each scan. He concluded that with one exception, Killiany's second set of measurements more accurately outlined the EC. At Albert's request, Moss gave his notes to Killiany. Later, Killiany created a typewritten document ostensibly containing Moss's notes,⁸ and sent the document to Jones and Johnson. Albert also received the typed notes and was satisfied with Moss's conclusion that the re-measurements were more accurate than the initial ones. Jones was unsatisfied with Moss's assessment and asked that the scans in question be re-measured. Albert refused. In her deposition, Albert stated that she believed that an additional set of measurements would confuse instead of answer the question of which data set was more accurate, so she did not have the scans re-measured. Jones continued to work with data generated from Killiany's tracings until July 30, 2001, when he told Albert that he would no longer work with Killiany's data without “neutralizing” it. After that, Jones did not work with any MRI data generated from Killiany's tracings.

C. The NIH Grant Application Process

To secure funding from the NIH for age-related research, institutions must submit applications to the Center for Scientific Review and the NIH. The applications are then forwarded to the NIA, where they first undergo a peer review process conducted by a panel of independent experts in the relevant field. The panel considers a number of factors, including the quality and originality of the science proposed, the quality of the investigators, and the quality of the facilities in which the research will take place. Based on these considerations, the Scientific Review Administrator prepares a statement (the “Pink Sheets”) summarizing the strengths and weaknesses of a proposal. If the project is recommended for further consideration, the National Advisory Council on Aging will review the application, focusing...