Dana-Farber Cancer Institute Inc. (Dana-Farber) has agreed to pay $15,000,000 to resolve allegations that, between 2014 and 2024, it violated the False Claims Act by making materially false statements and certifications related to National Institutes of Health (NIH) research grants.
Dana-Farber is a cancer treatment and research center headquartered in Boston, with locations across Massachusetts and New Hampshire. Dana-Farber receives research grant funding from federal government agencies, including NIH.
“NIH has limited resources to support important research being conducted at institutions across the country,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Today’s settlement demonstrates that the Department of Justice will pursue grantees that undermine the integrity of federal funding decisions by failing to use research funds appropriately or by failing to abide by grant awards’ terms and conditions.”
“There is no place in scientific research, particularly cancer research, for fraud, waste and abuse, and my office will continue to investigate institutions, no matter how prestigious, to ensure that research data is not tainted and that taxpayer funds are used appropriately,” said U.S. Attorney Leah B. Foley for the District of Massachusetts. “Patients, and the medical community, rely on the important research conducted by institutions like Dana-Farber. It is critical, to say the least, that all research findings are accurately reported,”
“The alleged falsification of research data and improper use of federal funds represents a serious breach of public trust and threatens the rigorous standards that uphold the credibility of the scientific process,” said Deputy Inspector General for Investigations Christian J. Schrank of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). “Individuals who violate federal grant-making rules not only risk legal consequences but also compromise the stewardship of taxpayer resources. HHS-OIG remains firmly committed to ensuring accountability and safeguarding the integrity of Department programs.”
As part of the settlement, Dana-Farber admitted that its researchers used funds from six NIH grants to conduct research that resulted in 14 publications in scientific journals containing misrepresented and/or duplicated images and data. The publications reused images to represent different experimental conditions; duplicated images to represent different testing conditions, mice, and/or timepoints; or rotated, magnified, or stretched images. Further, Dana-Farber admitted that a supervising researcher failed to exercise sufficient oversight over these researchers, and that Dana-Farber spent funds from those six NIH grants that were unallowable. As part of the settlement, Dana-Farber also admitted that another researcher received four NIH grants after submitting grant applications that discussed a journal article authored by the researcher but did not disclose that certain images and data in that article were misrepresented and/or duplicated. The United States contends that Dana-Farber caused the submission of false claims to NIH by falsely certifying compliance with grant terms and conditions, spending grant funds on unallowable expenses, and obtaining grants through false and misleading statements.
Dana-Farber cooperated with the government in this matter and received credit under the Department’s guidelines for taking disclosure, cooperation, and remediation into account in False Claims Act cases. Among other actions, Dana-Farber summarized voluminous materials relevant to the government’s investigation, voluntarily disclosed additional allegations of research misconduct relevant to the government’s investigation, voluntarily produced materials without a subpoena, sought to resolve this matter expeditiously, accepted responsibility for its conduct, and implemented remedial measures.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Sholto David. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. David will receive $2,625,000 under today’s settlement. The qui tam case is captioned U.S. ex rel. Sholto David v. Dana-Farber Cancer Institute, Inc., No. 2:24-cv-11059-WGY (D. Mass.).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the District of Massachusetts, with assistance from the Department of Health and Human Services Office of Inspector General.
The investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
The matter was handled by Trial Attorney Megan Engel of the Civil Division’s Commercial Litigation Branch (Fraud Section) and Assistant U.S. Attorneys Olivia Benjamin and Brian LaMacchia for the District of Massachusetts.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
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