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Jones ex rel. United States v. Massachusetts Gen. Hosp.

United States Court of Appeals, First Circuit

March 16, 2015

KENNETH JAMES JONES, ex rel. United States of America, Plaintiff, Appellant PRISCILLA PITT JONES, Ed.D., ex rel. United States of America; UNITED STATES, ex rel. Kenneth James Jones
v.
MASSACHUSETTS GENERAL HOSPITAL; MARILYN ALBERT, Ph.D.; RONALD J. KILLIANY, Ph.D.; BRIGHAM & WOMEN'S HOSPITAL, Defendants, Appellees. HARVARD MEDICAL SCHOOL; HARVARD UNIVERSITY; MARIE F. KIJEWSKI, Sc.D., Defendants

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APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS. Hon. William G. Young, U.S. District Judge.

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

Alan D. Rose, with whom Brian D. Lipkin and Rose, Chinitz & Rose were on brief, for appellees.

Before Howard, Lipez and Thompson, Circuit Judges.

OPINION

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HOWARD, Circuit Judge.

Relator Kenneth Jones alleges that defendants Dr. Ronald Killiany and Dr. Marilyn Albert knowingly made false statements when submitting a grant application to the National Institute on Aging (" NIA" ) and knowingly falsified certain scientific data underlying the application. Those false statements, Jones contends, influenced the NIA's decision to award over $12 million in federal funds to Massachusetts General Hospital and Brigham and Women's Hospital. In 2006 Jones filed a qui tam action pursuant to the False Claims Act, 31 U.S.C. § 3729 (the " FCA" ), and in a previous appeal we vacated the district court's entry of summary judgment in favor of the defendants. United States ex. rel. Jones v. Brigham & Women's Hosp., 678 F.3d 72 (1st Cir. 2012) (" Jones I" ). The case proceeded to trial, and a jury found for the defendants. Jones appealed again and now argues that the district court erred in denying his motions for judgment as a matter of law and for a new trial. Finding no reason to upset the jury's considered verdict, however, we affirm the judgment below.

I. Background

A. Factual Background

In our previous decision we set forth the basic facts underlying Jones's FCA claim. See Jones I, 678 F.3d at 75-79. We repeat only those facts necessary to understand the claims that Jones asserts in this latest appeal.

On October 2, 2001, the defendants submitted a Program Project Grant (" PPG" ) application to the NIA.[1] The grant application consisted of several distinct projects proposed by researchers at Massachusetts General Hospital and Brigham and Women's Hospital, organized around a common goal: to identify physical characteristics or mental capacities that could accurately predict the onset of Alzheimer's disease in patients. Jones maintains that the application contained materially false claims that induced the NIA to award the grant.

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Dr. Marilyn Albert, one of the defendants, served as the Principal Investigator of the PPG. In that role, Albert was responsible for overseeing all research under the grant, coordinating the work of the various projects, and ensuring compliance with all NIH requirements. Albert also signed the application submitted to the NIA. Four " Cores" provided specific types of research or administrative support to the projects. As pertinent to this case, relator Jones led " Core B," the Data Management and Statistical Core of the PPG. As the leader of that core, Jones assessed, compiled, and analyzed the data produced by the various projects.

Jones's FCA claim focuses on a single project under the PPG umbrella: " Project 3." That project, led by defendant Dr. Killiany, a neuroanatomist, sought to identify and measure certain regions of interest in the brain. The study's goal was to determine whether any physical characteristics of those regions could be used to appreciably predict whether a person with mild memory problems would go on to develop Alzheimer's disease. Jones asserts that, leading up to the 2001 application, Killiany intentionally manipulated data that formed the cornerstone of the Project 3 proposal. That data involved the entorhinal cortex (" EC" ), a small structure in the brain that serves as a pathway into the hippocampus and may also play an independent role in a person's memory.

To track changes in the EC and its relationship to Alzheimer's disease, at the outset of the study each participant was placed into one of two categories based on that participant's clinical dementia rating. Participants labeled as " normal" showed normal, healthy cognition, while those labeled as " questionable" presented mild memory problems. Over the course of the study, if a " questionable" participant's cognitive difficulties progressed to the point that she developed probable Alzheimer's disease, that participant was placed into yet a third category and reclassified as a " converter."

A Magnetic Resonance Imaging (" MRI" ) scan was taken of each participant, and those scans were used to measure the size of each participant's EC. By all accounts, the EC is a difficult structure to measure; it is generally only about one cubic centimeter in volume, and its boundaries are difficult to discern on an MRI scan. In 1997, Killiany and another researcher, Dr. Teresa Gomez-Isla, developed a " protocol" to predictably locate and outline the EC. They focused on identifying the boundaries between the EC and surrounding regions of the brain and employed what they both would describe at trial as a " conservative" approach to measuring the EC. Killiany and Gomez-Isla (functioning as " raters" ) then employed this approach for the scans of a group of twenty-five participants. The raters manually traced the EC on MRI scans of each participant using a trackball mouse and software called " Neuroview." Importantly, both raters were allegedly " blinded," meaning that they were not informed of a participant's cognitive categorization as " normal" or " questionable."

Members of Core B, the statistical core, then conducted a " reliability study," comparing Killiany's and Gomez-Isla's twenty-five tracings to determine whether two raters could, in practice, consistently implement the protocol and reach similar results. The comparison yielded an inter-rater reliability measure, or Pearson coefficient, of 0.96, representing a very close match and indicating that two raters could predictably trace the EC and obtain consistent measurements.

Following the reliability study, Gomez-Isla's role in the study concluded. Killiany pressed on and measured the EC of other

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participants in the study. Over the course of the study, Killiany measured the EC of approximately 103 total participants. As he completed his measurements, he would periodically send his calculations to Dr. Mary Hyde, the Data Manager for the statistical core. As he progressed, however, Killiany identified several " anatomical anomalies" in the brains of certain participants. He also testified that implementing the protocol presented a learning curve. As he encountered anomalies and learned more about the EC, he reviewed his prior measurements. When a prior measurement seemed inaccurate, Killiany " would remeasure the area and reapply the operational definition, based on [an] increasing amount of information about measuring the structure on MRI." When Killiany remeasured a participant's EC, he sent a separate file with the new measurement to Hyde rather than overwriting his original measurements. This practice resulted in duplicate tracings of the same MRI scan for some participants. In four instances, Killiany remeasured scans that had been compared with Gomez-Isla's measurements in the reliability study.

Based on Killiany's second set of measurements, the study concluded that the volume of a subject's EC could predict with 93% certainty whether a previously " questionable" participant with mild memory problems would become a " converter" and eventually develop Alzheimer's disease. This finding was presented in a 2000 article in the Annals of Neurology on which Killiany, Albert, and Jones--among others--were listed as co-authors. That article also reported the inter-rater reliability rating of 0.96.

In early 2001, Dr. Keith Johnson from Brigham & Women's Hospital, who led a separate project under the proposed PPG grant, first noticed the existence of two sets of EC measurements for some participants. Johnson brought this discrepancy to Jones's attention by e-mail on February 7, 2001. Jones investigated the matter and became concerned about the efficacy of Killiany's data. Jones raised those concerns in a March 2001 meeting with Albert and informed her that a statistically significant relationship between the volume of a participant's EC and her clinical dementia rating only existed when Killiany's second set of measurements were used. By contrast, if Killiany's original measurements were substituted, the relationship disappeared. Without Killiany's remeasurements, no statistically significant relationship was apparent from the data. Given this discrepancy, Jones requested that Albert review the matter.

Albert asked Dr. Mark Moss, a neuroanatomist, to review twenty-three specific measurements about which Jones had particular concerns. Moss reviewed each of those scans and, with one exception, concluded that Killiany's second set of measurements more accurately outlined the EC for each participant. Unsatisfied with Moss's conclusion, Jones requested that the scans be remeasured by an independent evaluator. Albert refused this request.

Albert and MGH submitted the application to the NIA on October 2, 2001. The application described the preliminary results of several of the Alzheimer's disease studies, including Killiany's study of the EC. It reported the study's finding that the volume of the entorhinal cortex could predict--with 93% accuracy--whether a " questionable" participant would go on to develop Alzheimer's disease. Furthermore, in describing the methods undertaken to produce those results, the application stated that all operators were " blinded to the groupings of ...


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