First Circuit remands case over brain research grant application

Jessica M. Karmasek May 8, 2012, 10:30am

BOSTON (Legal Newsline) - A federal appeals court on Monday vacated a lower court's ruling in a lawsuit brought against two hospitals and various researchers over their grant application to a federal health agency.

The U.S. Court of Appeals for the First Circuit said the U.S. District Court for the District of Massachusetts was wrong in granting summary judgment for defendants Brigham and Women's Hospital, Massachusetts General Hospital, Dr. Marilyn Albert and Dr. Ronald Killiany.

In 2006, plaintiff Dr. Kenneth Jones filed a qui tam action under the federal False Claims Act, or FCA, against the defendants.

Jones claimed that they violated the FCA by including false statements in a grant application that was submitted to the National Institute on Aging, or NIA, for research on Alzheimer's disease, a neurodegenerative illness associated with aging.

The NIA is an institute within the National Institutes of Health, or NIH, which is an agency of the U.S. Department of Health and Human Services.

Jones alleged that statements in the Program Project Grant Application were predicated on "falsified data" and that the defendants knowingly failed to take corrective action or disavow the data.

Jones appealed to the First Circuit, maintaining that "material factual disputes" remain concerning the defendants' conduct.

The federal appeals court sided with Jones, concluding 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," Senior Circuit Judge Kermit V. Lipez wrote for the First Circuit.

"When properly considered, those statements generate genuine issues of material fact concerning some of (Jones') FCA claims."

In particular, the First Circuit said it disagreed that the creation of the data in question was necessarily a matter of scientific judgment.

"The district court relied on 'the undisputed fact that tracing the EC (entorhinal cortex -- one of the first areas of the brain to be affected by Alzheimer's) is highly subjective and thus two scientists who use the same protocol manually to trace the EC may nevertheless obtain different results.' This reliance, however, misses the point that the various results produced in this case were obtained by one scientist purportedly using the same protocol," Lipez wrote.

"Although the decision as to which measurement method to employ was a question of scientific judgment, that is not the issue here."

The First Circuit said the distribution of altered data among and within participant groups raises "the greatest concern."

Of the 103 participants in the final study population, 30 participants' scans were re-traced, it noted.

"We conclude that the distribution of revisions presents a genuine issue of material fact as to whether, as (Dr. Daniel) Teitelbaum put it, Killiany cherry-picked measurements to revise in a non-random fashion 'in order to produce data that would support his hypothesis on the role of EC volume and the prediction of prodromal (Alzheimer's disease),'" Lipez wrote.

The First Circuit remanded the case to the district court.

"If the jury should find that statements in the application are false, they must also determine whether those statements were material and whether the defendants acted knowingly in violating the FCA," Lipez concluded.

From Legal Newsline: Reach Jessica Karmasek by email at

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