United States Ex Rel. Jones v. Brigham & Women's Hospital
678 F.3d 72
1st Cir.2012Background
- Relator filed FCA qui tam against BWH, MGH, Albert, and Killiany alleging NIH grant application relied on falsified MRI data regarding entorhinal cortex (EC) measurements.
- Project focused on early AD detection; data collection involved blinded raters outlining EC on MRI scans and calculating volumes.
- Jones raised concerns about pre-1998 data revisions by Killiany, prompting Moss’s review and Albert’s handling of the data; relator contends revisions biased results.
- Application for the 2002–2007 NIH funding cycle described results and blinded methodologies but did not disclose two data sets or alleged misconduct.
- District court granted summary judgment for defendants; the First Circuit vacated, finding genuine issues of material fact remained, particularly concerning data manipulation, reliability, blinding, and the application’s materiality and knowledge elements.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Falsity: data manipulation created false statements in the application | Jones asserts Killiany cherry-picked data to produce significance | Defendants contend scientific judgments can vary; data revisions were part of learning curve | Genuine issues of material fact exist regarding falsity. |
| Materiality: whether misrepresented data would influence NIH review | Relator argues manipulated data and unreliable metrics would affect funding | NIH reviewers focus on reliability and blinded methods; some evidence suggests non-materiality | Materiality issue unresolved; questions remain for trial. |
| Knowledge: whether defendants knowingly submitted false data | Jones contends intentional manipulation and concealment of data | District court erred in excluding testimony; no clear proof of knowledge | Genuine issues of material fact as to knowledge. |
| Blinding and reliability: whether Killiany was blinded and whether re-measurements violated protocol | Relator’s Teitelbaum report and Relator’s Table show non-random, unblinded revisions | Experts dispute, arguing revisions could be for accuracy within protocol | Issue of Killiany’s blinding and data integrity raises material facts. |
| PHS compliance claim: failure to investigate/report misconduct as false certification | Alleges independent FCA claim based on failure to comply with §50.103 | Claim not pled properly and pre-award conduct not captured by separate certification | district court did not address properly; §50.103 claim not properly pled; largely upheld on that theory. |
Key Cases Cited
- Hutcheson v. Amgen, Inc., 652 F.3d 103 (1st Cir. 2011) (broad view of falsity; materiality and scienter required)
- Loughren v. Unum Grp., 613 F.3d 300 (1st Cir. 2010) (materiality and scienter requirements applied to FCA)
- Hutcheson and Brown v. Blackstone Medical, Inc., 647 F.3d 377 (1st Cir. 2011) (refined framework for FCA falsity and certification)
- Sci. Applications Intl. Corp., 626 F.3d 1257 (D.C. Cir. 2010) (broad view of falsity; limits on liability by materiality/knowledge)
- Crowe v. Marchand, 506 F.3d 13 (1st Cir. 2007) (abuse-of-discretion review for evidentiary rulings at summary judgment)