Duke Settles Doctored Data Lawsuit for $112.5 Million

Ivan Oransky

Disclosures

March 25, 2019

In one of the largest-ever such agreements with an academic institution, Duke University, in Durham, North Carolina, has settled a whistleblower lawsuit alleging that lung researchers there used fake data in National Institutes of Health (NIH) grant applications.

The settlement, for a case brought under the False Claims Act (FCA), is for $112.5 million, according to attorneys for the whistleblower who brought the case. The act allows for whistleblowers to receive substantial payouts. Under the terms of the settlement, Joseph Thomas, a former biologist who worked in the department where the data were faked, will receive 30% of the $112.5 million. The rest will be paid to the US government.

Duke University, Durham, NC

"I am glad that the legal system has helped to return research funding to the United States government and shine a light on the importance of research integrity," Thomas told Medscape Medical News. He said he is "hopeful that this case bodes well for the future of scientific research."

William Foster, who ran the lab where the data were faked, studied the effects of pollutants on the lungs of mouse models. Thomas alleged that Duke had won some 50 grants from the NIH, the Environmental Protection Agency, and other government agencies "that were directly premised on and/or arose from...research misconduct and fraud" totaling $89 million. He also claimed in the lawsuit that other institutions won $121 million in grants based at least in part on the shoddy data.

Thomas was represented by his brother, John Thomas, formerly of Gentry Locke, in Roanoke, Virginia, and now of Healy Hafemann Magee & Thomas. "When Joe approached me 6 years ago, he knew that he would face significant hardship for doing the right thing — and he did it anyway," John Thomas told Medscape Medical News. "Due to Joe's courage, the United States taxpayers have been compensated for their significant loss and falsified research was identified and addressed."

"This is a difficult moment for Duke," university officials wrote in an email to faculty, staff, and employees today obtained by Medscape Medical News. "This case demonstrates the devastating impact of research fraud and reinforces the need for all of us to have a focused commitment on promoting research integrity and accountability."

Embezzlement Charges, Then Scrutiny

The story begins in March 2013, when lab technician Erin Potts-Kant was arrested on charges that she embezzled more than $25,000 from Duke through purchases at Amazon, Target, and elsewhere. She was eventually convicted. In the meantime, Duke began scrutinizing the work she had done in the lab. Those investigations have led to the retraction of 17 scientific articles so far.

In 2016, Thomas sued Duke, Potts-Kant, and Michael Foster, the director of the lab in which Potts-Kant worked. He alleged that she had at various times either fudged data to obtain a desired result or simply failed to run experiments at all. Duke, Thomas said, knew that some of the data submitted in grant applications had been faked.

"It's a Lot of Money"

Although FCA settlements with corporations for kickbacks and other offenses have reached into the hundreds of millions of dollars, this case is one of the largest such settlements with a university, according to Joel Androphy, of Berg & Androphy in Houston, Texas, who specializes in FCA cases. "It's a lot of money, but it's not enough," Androphy told Medscape Medical News.

In 2017, Brigham and Women's Hospital, in Boston, Massachusetts, and Partners HealthCare agreed to pay the government $10 million to settle allegations that three stem cell scientists at Brigham and Women's "knew or should have known that their laboratory promulgated and relied upon manipulated and falsified information." And in 2016, Columbia University, in New York City, settled a case involving overbilling grant funds for $9.5 million.

This was not Duke's first research scandal in recent years. In 2015, after a prolonged investigation, the US Office of Research Integrity found that Anil Potti, MD, once a cancer researcher at the university, "engaged in research misconduct" in work supported by federal grants. In that case, too, a whistleblower — a medical student — had warned Duke but had been effectively silenced. Duke and Potti have settled at least a dozen malpractice lawsuits brought by patients who participated in trials related to the work.

A year ago, the NIH told Duke its grants would be subject to stricter oversight because of how the university had mishandled "several misconduct cases."

"If you're a private institution, if you get caught, it's going to cost you a lot of money. But realistically, most of the time, you don't get caught," Androphy said. "The system needs to make it such that if you do it one time and you do it wrong, you pay a substantial penalty. If you do it a second time, it's game over."

"The fact that fraud of this magnitude could occur at an institution as well regarded as Duke University illustrates the work that remains to be done on behalf of research integrity across the country," John Thomas said. "It is incumbent upon research institutions to ensure they are being faithful stewards of taxpayer dollars, and it is equally incumbent upon researchers to police their own and report fraud when they see it."

Ivan Oransky, MD, is Medscape vice president for editorial and cofounder of Retraction Watch.

Follow Ivan Oransky on Twitter: @ivanoransky.

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