Duke is close to settling a court case about its handling of falsified data that the lawsuit alleges is tied to $200 million in federal research grants.
The suit, which was filed against Duke in 2015 by former lab analyst Joseph Thomas, claims that Duke used falsified data to obtain research grants and covered up the fraud. Per court documents filed recently, a settlement is awaiting approval by the Department of Justice. According to Science Mag, the terms of the settlement would be expected to become public Dec. 7.
Michael Schoenfeld, vice president for public affairs and government relations, declined to comment on the case in an email to The Chronicle last week.
The lawsuit stems from fraud allegedly committed by former Duke researcher Erin Potts-Kant, who worked in the Pulmonary, Allergy and Critical Care department of Duke Health. Potts-Kant has had more than a dozen papers retracted since news broke of the allegedly faked data. She was arrested in 2013 for embezzling money from Duke.
Potts-Kant admitted to altering some of the data, but maintained that the experiments were actually run. According to Duke's filings, Potts-Kant told the Ad Hoc Investigation Committee, which investigated her research following her arrest, that she had “fabricated and/or falsified [data] that were included in various publications and grant applications..."
The case was filed by Joseph Thomas—another former Duke employee—under the False Claims Act, which allows a "whistleblower" to bring a case when the federal government is allegedly being defrauded. Under the law, Duke could be forced to pay as much as $600 million.
In his suit, Thomas alleges that Potts-Kant manipulated data that she collected when studying the lung function of mice. Based on that data and pursuant research articles, she was then able to secure additional research funding from the federal government, according to the suit. These allegations bring more than 60 federal grants—totaling approximately $200 million from agencies like the National Institutes of Health and Environmental Protection Agency—into question.
Potts-Kant is not the only one accused of questionable conduct in the suit. Supervisors William Foster, former professor of medicine, and Monica Kraft, former division chief of the Pulmonary division, are accused of ignoring warnings of misconduct and being negligent in their supervision.
To date, Potts-Kant has had 16 papers retracted, according to the website Retraction Watch. Foster has been involved in 13 retractions.
In April 2017, U.S. District Court Judge Catherine Eagles rejected Duke's motion to dismiss the lawsuit. That June, the University admitted that falsified data “potentially affected” funding applications.
“We are pleased that the parties have reached a settlement," attorneys for the plaintiff told Science Mag.
The terms of the settlement may not be limited to financial penalties, Joel Androphy, a lawyer who specializes in FCA cases, told Science Mag, and they could also include additional oversight on funding.
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In March, The Chronicle reported that the National Institutes of Health was placing new regulations on the University's research in the wake of Duke's high-profile misconduct cases. The new guidelines, which took effect April 1, require researchers who are applying for more than $250,000 to submit a detailed budget of their expected costs, and researchers must seek the NIH's approval to extend grant budget periods or carry unused funds into the next budget period.
“NIH reports that these new requirements are a result of its concerns about Duke’s management of several research misconduct cases and grant management issues that date back to 2010, some of which have been widely reported like the Anil Potti case,” stated a memo announcing the change to faculty and staff from Provost Sally Kornbluth, Chancellor for Health Affairs A. Eugene Washington, Mary Klotman, dean of the School of Medicine, and Marion Broome, dean of the School of Nursing.
Duke recently created a new position to oversee scientific integrity. The role—"vice dean and associate vice provost for scientific integrity"—will work with people throughout Duke to "provide a consistent University vision for scientific integrity standards and expectations and will drive efforts to ensure the advancement of scientific integrity across Duke University and the School of Medicine."
When asked if the new position was related to the ongoing litigation, Schoenfeld said it was part of an ongoing effort related to integrity.
"The appointment of the new vice dean/associate vice provost is part of Duke’s ongoing effort—that started several years ago—to ensure that faculty and staff at Duke have the training, support and direction to ensure that all research conducted on campus is held to the highest standards of integrity," he wrote in an email.