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Sept. 7 — The increased use of the whistle-blower statute in research misconduct cases could significantly shift how universities and principal investigators manage research grants, attorneys told Bloomberg BNA.
The issue was spotlighted when Joseph M. Thomas, a former employee of Duke University's pulmonary division, filed a complaint against the university under the False Claims Act (FCA). Thomas alleged that former colleague Erin N. Potts-Kant, her supervisor and the university had falsified data in research funded by the National Institutes of Health and the Environmental Protection Agency ( United States ex rel. Joseph M. Thomas v. Duke Univ., W.D. Va., No. 4:13-cv-00017, unsealed 8/9/16 ).
The falsifications were made to obtain 60 research grants totaling $200 million in government funding, according to the complaint, filed Nov. 13, 2015, in the U.S. District Court for the Western District of Virginia and unsealed on Aug. 9. Thomas asked that Duke reimburse the U.S. government triple the amount of damages plus civil penalties for each false claim.
The impact on the life sciences research community “could be significant” because of Thomas's use of the FCA in a research misconduct context, F. Lisa Murtha, senior managing director and practice leader for the clinical research and compliance practice of FTI Consulting, Philadelphia, told Bloomberg BNA in a Sept. 6 e-mail.
“If this case moves forward, this could mean that universities and other research organizations will need to be ever more diligent in overseeing/validating research results and training their researchers on the potential harm that can come to them from allegations of scientific misconduct.”
Once Duke is served, it will file an answer to the complaint, Thomas will respond, and Duke will likely move to dismiss. If the court denies the motion, the case would go forward.
Typically, a review of scientific misconduct cases is supervised by the Department of Health and Human Services' Office of Research Integrity (ORI), which levels punishments that can include suspension or exclusion from providing services to any federal health program or agency.
The FCA includes a “qui tam” provision that allows people who aren't affiliated with the government, called “relators,” to file actions on behalf of the government, which entitles them to receive usually about 15 percent to 25 percent of any recovered damages.
Jonathan Phillips, a Washington-based attorney with Gibson Dunn's Food and Drug Administration/health-care practice, told Bloomberg BNA in a Sept. 7 phone interview that the more high-profile uses of the FCA in life sciences-related cases involves sales and marketing functions and business arrangements with providers.
“An FCA case involving research grants is less common, but that doesn't make it any less sobering. Research entities should be concerned because a case like this is a reminder that any time they receive government funds the FCA comes into play, with sanctions that can include damages to be determined by the court, trebled damages and civil penalties of up to $20,000 for each false claim. And if you have a grant application and a series of progress reports, you could conceivably have a dozen false claims, and for multiple grants it adds up fast,” Phillips said.
Murtha said, “The use of the FCA and the imposition of monetary fines and penalties for research misconduct is relatively new. Principal investigators for research grants should take this as an important warning that they will need to begin a process of validation of experiments that are done in their labs by less experienced investigators and post docs. PIs will need to be able to support any and all research data if they intend to rely on those data for applications for federal awards.”
Phillips noted that the government filed a “no decision” notice in the case, which means the government isn't intervening at this time but could do so later. “We see this happening more and more because the courts are giving the government less and less time to investigate the claims. We're also seeing more and more relators pursuing the actions without government intervention. Last year was a record year for recovery for relators in declined cases.”
According to the complaint, Potts-Kant joined Duke's pulmonary division in the Airway Physiology Laboratory of William M. Foster in 2005 when she was 25 years old and later became a clinical research coordinator.
Thomas alleged that sometimes Potts-Kant didn't even run the experiments for the grant research but simply made up data. On other occasions, she ran the experiments but later altered the resulting data to make them conform to the PI's preconceived hypothesis or to increase its statistical significance. She and Foster later co-authored articles in scientific journals based on false, fabricated and fraudulent data, Thomas said.
Duke University didn't foster a research environment that discourages research misconduct, didn't deal forthrightly with possible research misconduct as required by the regulations and made false certifications in its grant applications and progress reports, the complaint said.
Sometime between November 2012 and March 2013, the pulmonary division found that Potts-Kant had submitted false invoices for scientific equipment and supplies totalling $14,000. She was charged with felony embezzlement and convicted.
Thomas wrote that Duke then conducted a review of the Foster Lab data that were reported in grant applications, grant progress reports and publications. The review found that for many of the experiments, raw data didn't exist, and that experiments the reviewers attempted to duplicate not only didn't produce the results that had been reported, but also killed the laboratory mice.
And yet, after these discoveries, Thomas said, Duke submitted a grants progress report based on Potts-Kant data. It also ignored repeated warnings from outside scientists about Foster Lab's research misconduct.
In the complaint, Thomas asserted counts of false and fraudulent claims in grant applications and false records and statements against Duke, Foster and Potts-Kant. It justified the use of an FCA action for a remedy to research misconduct under the NIH's Grants Policy Statement, Part 1, Section 2, “Fraud, Waste and Abuse of NIH Grant Funds,” pages 1 to 47.
Michael Schoenfeld, Duke’s vice president for public affairs and government relations, told Bloomberg BNA in a Sept. 6 e-mail, “After Duke learned that a former employee, Erin Potts-Kant, had been embezzling funds from the university (for which she later was prosecuted and convicted), we also discovered discrepancies in some data that she had been generating in research projects.”
Even though the full scope of Potts-Kant’s actions weren't known at the time, Schoenfeld said, Duke notified several government agencies in June 2013 about the matter and immediately launched a formal scientific misconduct investigation, as required by federal law. “Since then, Duke has provided extensive information to the government regarding the grants in question, and we will continue to cooperate with their investigation. As with all pending litigation, we will decline further comment on the case.”
The complaint was filed by Gentry Locke Rakes & Moore, Roanoke, Va.
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The complaint is at http://src.bna.com/ilN.
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