Duke University will pay $112.5 million to the federal government to settle a whistleblower lawsuit alleging researchers falsified data to obtain more than $200 million in federal grant funding, according to the Department of Justice.
In the lawsuit, former Duke lab analyst Joseph Thomas alleged a research technician improperly falsified and fabricated data from 2006 to 2013 to obtain research funding from the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA), the DOJ said.
Thomas filed the suit under the False Claims Act which allows people not affiliated with the government to file actions against persons and companies that defraud the government. Under the terms of the settlement, Thomas will receive $33.7 million of the $112.5 million for serving as the whistleblower, the DOJ said. The rest will be paid to the U.S. government.
Duke discovered the possible research misconduct in 2013 after a research technician was fired for embezzling money from the university, according to a Duke University press release. The payment to the government includes both reimbursement for grants received as a result of the falsified and fabricated data and associated penalties.
“We expect Duke researchers to adhere always to the highest standards of integrity, and virtually all of them do that with great dedication,” said President Vincent E. Price in a statement. “When individuals fail to uphold those standards, and those who are aware of possible wrongdoing fail to report it, as happened in this case, we must accept responsibility, acknowledge that our processes for identifying and preventing misconduct did not work, and take steps to improve.”
In March 2013, researcher and biologist Erin Potts-Kant was arrested on charges of embezzlement and later pled guilty to siphoning more than $25,000 from the Duke University Health System, according to Science.
“Duke officials took a closer look at her work and didn't like what they saw. Fifteen of her papers, mostly dealing with pulmonary biology, have now been retracted, with many notices citing "unreliable" data. Several others have been modified with either partial retractions, expressions of concern, or corrections,” Science reported back in 2016.
The lawsuit and sizable settlement underscore the need for a robust compliance program for research grants, Matt Fisher, a partner with Boston-based law firm Mirick O’Connell and chair of the firm’s health law group, told FierceHealthcare.
“While the underlying facts may be extreme, the situation does offer a good reminder that no area of operation where government money could be coming in should be able to operate without some form of regular compliance review. Arguably, if activities had been subjected to more thorough review and assessment, the issue could have been detected and remedied more quickly,” he said.
“This settlement sends a strong message that fraud and dishonesty will not be tolerated in the research funding process,” EPA Acting Region 4 Administrator Mary S. Walker said in a statement. “We will continue to take appropriate legal measures to ensure a fiscally sound system that protects grant funds.”
The lawsuit was filed under seal in federal court in 2014—after the research technician was discovered to have embezzled federal grant funds that had been awarded to the university, but before Duke understood the extent of her research misconduct, university officials said
“Duke reported this to the appropriate agencies and repaid the embezzled funds along with all grant-funded compensation and benefits that had been paid to the technician. The technician eventually pled guilty to two counts of forgery and paid restitution to Duke,” according to the university statement.
In September 2016, Science reported that a U.S. district court unsealed the whistleblower lawsuit filed by Thomas, a former colleague of Potts-Kant.
“It accuses the researcher, her former supervisor, and the university of including fraudulent data in applications and reports involving more than 60 grants worth some $200 million,” Science reported.
Duke officials said the university launched a formal scientific misconduct investigation of the technician’s experiments. Those experiments involved measuring the lung function of laboratory mice using highly specialized equipment and were not connected to human subject or clinical research.
Following a detailed, three-year review of more than 50 potentially compromised research grants, Duke concluded that the technician had falsified or fabricated data that had been included in grant and payment requests submitted to the NIH and other agencies over the period of her employment, the university said. Duke also retracted scientific publications that relied on the data.
In response to the settlement, Duke said it will immediately implement a series of key steps to improve the quality and integrity of research conducted on campus, including the establishing a new, integrated leadership structure for research to provide clear and consistent policy guidance, oversight and accountability for all research at Duke University and Duke Health, and the appointment of a new advisory panel on research integrity and excellence.