Experts address research fabrication lawsuit against Duke, note litigation could be lengthy
In a lawsuit brought under the False Claims Act, a former Duke employee says Duke faculty and administrators ignored and hid allegations of scientific misconduct, allegedly resulting in $200 million of funding based on fraudulent data.
Under the “qui tam” provision of the False Claims Act, a private citizen, also known as a whistleblower, can file actions on behalf of the federal government to recover federal funds provided due to fraudulent information. The FCA could hold Duke liable for up to three times the amount of the government’s damages, in addition to other civil penalties. Duke University, Duke University Health System, former professor of medicine William Foster and former clinical research coordinator Erin Potts-Kant are the defendants named on the case.
In March 2013, Potts-Kant was arrested on charges of embezzling more than $14,000 from Duke. Joseph Thomas, the whistleblower in the case against Duke, began working in the pulmonary division in 2012 where Potts-Kant and Foster worked. Thomas claims that the fraudulent research data Potts-Kant produced was knowingly used in writing research grants to the National Institutes of Health, Environmental Protection Agency and the Department of Health and Human Services. According to the lawsuit, the fabricated data led to more than $80 million in grant funding for Duke University and were used as the basis for grant applications by researchers unaffiliated with Duke totaling approximately $120 million.
Michael Schoenfeld, vice president for public affairs and government relations, denied that Duke was negligent in its actions in an email statement to The Chronicle last week. He wrote instead that Duke immediately began a proper investigation and reported the misconduct to the authorities.
This case appears to be one of the largest suits ever brought under the FCA to focus on research misconduct in an academic institution, attorney Joel Androphy of Berg & Androphy told Science. Androphy, who specializes in false claims litigation, also said to Science that this suit against Duke could "open the floodgates" to others like it.
Blowing the whistle
The lawsuit filed by Thomas in November 2015 was originally sealed and thus not available to the public. The documents were unsealed Aug. 8, revealing the lawsuit against Duke and several employees, as first reported by Retraction Watch.
In the interim, the U.S. government reviewed the lawsuit and decided whether they wanted to intervene, explained Shelley Slade, an attorney specializing in False Claims Act litigation at Vogel, Slade and Goldstein, LLP. It eventually decided not to join in on the case, court documents show.
Slade noted that the government intervenes in only approximately 20 percent of False Claims Act cases and that the cases joined by the government tend to be successful 80 to 90 percent of the time.
"The False Claims act applies to 'reckless' conduct,” wrote Reena Dutta, an attorney at Hodgson Russ LLP who helped represent an FCA case against Columbia University, in an email. "In other words, if university officials acted 'in reckless disregard of the truth or falsity of the information' (quoting from the statute), they could be liable for false claims. So, for example, evidence showing that university officials were aware of the fraudulent research and failed to make the required corrective disclosures or continued relying upon the fraudulent research after they learned it was fraudulent may be enough for liability.”
The lawsuit includes five formal counts against the defendants. As a whole, the counts accuse the defendants of knowingly submitting false information to obtain funding, damaging the integrity of the grant award system.
Whenever allegations of fraud are brought to the attention of the government, there is always the possibility that the government will launch a criminal investigation of the allegations, Slade said. If the government elects to do so, it often asks the court handling the civil case to "stay" that matter while the government completes its criminal investigation.
She added that the civil remedies that might be imposed by a court as a direct result of the case would be in the form of damages equal to triple the government's loss from the fraud and penalties of approximately $11,500 per false statement or false claims.
Slade noted, however, that the amount of damages sought by a whistleblower in their complaint in a False Claims Act case ordinarily significantly exceeds the amount eventually recovered.
Dutta explained that the legal proceedings for this lawsuit could be lengthy given the magnitude of the allegations.
“False Claims Act cases are, by their nature, very complex," she wrote. "When so much money is involved, both parties are going to litigate the case zealously, which will make it a more protracted endeavor. Moreover, the case can’t settle without the government’s written consent, and the government may not be agreeable to a settlement without an admission of wrongdoing by the Defendant, which the Defendant may be unwilling to provide, again dragging out the litigation."
Early warning signs
According to the lawsuit, Potts-Kant was hired by the University in 2005 and worked in the lab of William Foster, who is now retired, according Retraction Watch.
The lawsuit states that between 2005 and Potts-Kant’s employment termination in 2013, she co-authored 38 publications with Foster, something the plaintiff contends was “unusual in light of her relative youth and inexperience.”
Thomas also alleges that Foster and other investigators within the pulmonary division received several warnings during Potts-Kant’s time at Duke. Most notable among these were from Dr. Jerry Eu, a primary investigator within the pulmonary division at that time and now program director of the NIH’s lung immunology and fibrosis division.
In October of 2011, the Department of Health and Human Services issued a notice that it had found a postdoctoral scholar under Eu who had engaged in the falsification of data for grant funding. The lawsuit alleges that around 2010 and 2011, Eu alerted Foster and another primary investigator, Dr. John Hollingsworth, who is listed as an adjunct associate professor in the department of medicine, that he also suspected Potts-Kant of fabricating data. According to Thomas’s testimony in the document, Eu later gave Potts-Kant instructions with experiments without telling her how the resulting data might look, a “blinded” test the lawsuit claims confirmed his suspicions. However, these concerns were apparently ignored.
Hollingsworth, Foster and Eu could not be reached for comment.
In another example, an investigator from Johns Hopkins University who met Potts-Kant during a poster presentation was suspicious that her data was fabricated. As a precaution, he allegedly approached Foster, who defended Potts-Kant without checking her original lab data.
An investigation begins
In the timeline presented by the lawsuit, Duke University placed Potts-Kant on leave in early March of 2013 for embezzlement charges and soon began a review of the Foster Lab data that had been reported in grant applications, reports and publications.” By this time, Thomas said in his testimony, Duke was fully aware of the allegations of research misconduct.
"Senior managers at Duke University and/or DUHS had actual and specific knowledge of research misconduct involving Potts-Kant and the Foster Lab from at least March 2013,” the document states.
The documentation of the lawsuit further claims that Foster was given a leadership role in the review committee, a finding that Thomas presents in his suit as a conflict of interest.
In speaking to other investigators in the pulmonary division who contributed to the review effort, the lawsuit claims, Thomas found out that almost all of Potts-Kant’s data was misleading.
Among the problems cited is the lack of data provided for many of Potts-Kant’s experiments, including some conducted under the supervision of Foster and Hollingsworth.
Barbara Theriot, a researcher in the pulmonary division whose duties were similar to those of Potts–Kant, and others also allegedly repeated many of Potts-Kant’s experiments, finding results that were entirely inconsistent with those published by her.
The review led to corrections and retractions of previous research. According to Thomas’ testimony, however, the review team significantly delayed this process. Furthermore, Thomas claims that Duke’s Office of Research Administration pushed the authors into correcting their publications rather than entirely retracting them.
"On or about May 7, 2013, Duke’s Office of Research Administration told the pulmonary division that if the trends reported in the publications held up that no retraction would have to be issued and that the Office of Research Administration did not want the issue to 'snowball.'"
Several of the publications Potts-Kant co-authored are still available online without any notice of correction or retraction.
Around April or May 2013, the lawsuit claims, Duke officials circulated a “script” to its investigators for how to inform co-authors outside of Duke of the situation. According to Thomas, the script misleadingly stated that Potts-Kant was involved in an employment situation and did not convey accusations of research misconduct.
Thomas’ claims include a statement which alleges that Dr. Monica Kraft—the Division Chief of the pulmonary division at the time—took steps to avoid broadening actionable evidence, including requesting that pulmonary division researchers avoid creating a "papertrail" in discussing the issue.
Kraft, who is no longer employed by Duke, could not be reached for comment.
Although publication retractions and corrections were issued, the lawsuit claims that Duke University and its associates did not properly address all aspects of Potts-Kant’s misconduct and fraud—it claims that Duke investigators knowingly used falsified data in the submission of a research grant.
The grant in question—referred to as the SP-A Grant in the lawsuit—was funded by the NIH from 2009 to 2014, with Potts-Kant and Foster using some of the money for their work. According to Thomas’ testimony, Duke University submitted an annual grant update in June of 2013 “that included research reports based on experiments performed by Potts-Kant and the Foster Lab.”
In addition to the update, investigators at Duke submitted a grant renewal request in the fall of 2013 which asked for extra funding for five years. Although the renewal did not include Potts-Kant’s faulty data, Thomas alleges that Foster and others at DUHS submitted "recalculated” data to avoid disclosing the unreliability of their previous submissions.
Thomas added in his testimony that the newly calculated data was submitted for the grant despite being inconsistent with data that Theriot had produced when attempting to repeat experiments.
Prior misconduct cases
The lawsuit alludes to previous instances in which Duke investigators were charged with academic misconduct.
Along with a description of the misconduct perpetuated by Dr. Eu’s postdoctorate scholar, the document mentions Dr. Anil Potti, a former cancer researcher at Duke charged in 2010 with falsifying clinical data and using falsified data to enroll new patients in clinical trails.
According to the complaints presented in the lawsuit, the attention behind the so-called Potti scandal should have made Duke more cautious.
"Duke University’s and DUHS’ failure to prevent or detect the Foster Lab research fraud demonstrates a systemic failure by Duke University to foster an environment conducive to responsible research,” the lawsuit reads.