False Claims Act Can Hamper Science With 'Bounty Hunter' Lawsuits

Fraud and misconduct in scientific research have become a problem attracting national and international attention. Although concern over research misconduct was once confined to the scientific community, it has since become the focus of media scrutiny and the obsession of congressional committees. With this growing interest has come increased governmental intervention, particularly where public research funds are involved. Whereas deceitful scientists were once subjected only to the disapproval of their peers, their activities may now invoke serious criminal and civil sanctions. Among these are civil "bounty hunter" provisions of the Federal False Claims Act, which permit private individuals to sue for a share of squandered federal funds. By substituting a financial incentive for the self-policing norms of the scientific community, this statute promises to have a negative impact on the way scientific research is conducted. Research misconduct takes a variety of forms, any of which could potentially trigger legal liability. It is generally considered to be most serious when the actions constitute true scientific fraud--that is, a report of experiments never conducted, observations never performed, calculations never made. Such a fabricated report is rarely limited to imaginary numbers, charts, or graphs. The study usually will not be believed without physical evidence of the experiment. For the fraud to succeed, such evidence must also be fabricated, and must be convincing enough to fool other scientists. Famous examples of such forged evidence include the white mice painted black in 1974 by William Summerlin at Sloan Kettering Institute for Cancer Research in New York (part of Memorial Sloan-Kettering Cancer Center) so as to appear to have accepted skin grafts from black mice, or the fraudulent skull of the British "Piltdown man," an anthropological hoax that was crafted to resemble a prehistoric fossil. Scientific fraud may not always involve blatant fabrication. True data may be generated but then deliberately manipulated so as to support conclusions that are untrue. A dishonest researcher may "trim" his or her data, adjusting the values of her results to make the observations fit a particular hypothesis. Such data manipulation may occur at several stages: The equipment used in an experiment might be tampered with to produce the desired measurements, or the researcher may alter a true observation as it is recorded, or the researcher may "fudge" the desired result during interpretation of the raw data. A related practice is selective reporting of data--that is, publishing actual observations, but deliberately omitting those that do not support the researcher's conclusions. In any of these cases, the results reported will be unreliable and irreproducible. Many scientists have argued that science should police itself against misconduct. Certainly, the scientific validation process of publication, peer review, and experimental reproduction serves as an indirect check on the integrity of scientists: Mistakes that cannot reasonably be attributed to independent scientific error suggest the presence of misconduct. Where the data are found to be falsified or fabricated, no conclusion except willful misconduct is possible. In those instances, informal sanctions such as communal derision or ostracism will be triggered. Scientists who know this should be deterred from misconduct, and those who are not will be discovered and reprimanded. Nonetheless, the primary purpose of these mechanisms is to screen data for errors rather than to ferret out misconduct, and the screening institutions of science may be poorly adapted to detect willful misconduct. Once upon a time, a failure to screen out fabricated research was a problem only for other scientists, whose own research might be hampered by reliance on the falsified data. However, such a screening failure becomes more than an obstacle to furthering research when scientists must account for public funding of research. Taxpayers and elected officials demand stringent screening for falsified data that absorb dollars that could be spent here. Indeed, society may demand screening and corrective mechanisms from outside of science to remedy real or perceived inadequacies in the internal policing of science. Outside policing of misconduct generally follows from oversight of federal research grants. Such grants are subject to a variety of stipulations contained in federal regulations and statutes. When misconduct infringes these guidelines, it passes from a matter to be addressed by the scientific community to a matter dealt with by legal process. No single legal structure governs issues of research misconduct. Oversight mechanisms include the full panoply of legal institutions: Courts, administrative agencies, executive officials, and even private plaintiffs play a role in research oversight. Some misconduct may be policed under the civil False Claims Act, 31 U.S.C. 3729 et seq. The provisions of the act provide for a penalty of $5,000 to $10,000 per violation, plus treble damages for knowing submission of a false claim to a federal agency. "False claims" under the statute encompass any attempt to induce the government to pay out funds. The statute certainly covers claims made with an intent to defraud the government, and has in at least some instances been construed to include claims made in reckless disregard for the truth. Because this is a civil statute, the government need only prove the elements of the offense by a preponderance of the evidence, not beyond a reasonable doubt. This relaxed burden of proof, coupled with stiff penalties, may increasingly make this the government's weapon of choice to censure research misconduct. However, the feature of the civil False Claims Act that is most likely to have the greatest impact on the everyday practice of science may be the so-called qui tam, or bounty-hunter, provisions (31 U.S.C. 3730), which allow private suits to recover money defrauded from the United States. Congress has recently amended these provisions to encourage their use. Under the new provisions, those who report offenses may receive up to 30 percent of funds recovered by suit or settlement. The new provisions also provide for recovery of treble damages, as well as reasonable attorneys' fees and costs. The amended statute also greatly expands the range of potential private plaintiffs, called "relators" under the statute. With a few exceptions, virtually any private person who is an "original source" of information about the false claim can bring an action. The "original source" requirement means that the relator must have independent knowledge about the fraud; suits may not be brought on the basis of information already publicly available. Courts have interpreted this provision to allow suits by government employees when their original information was obtained in the course of their duties. In a scientific setting, this means that a broad range of laboratory personnel--technicians, secretaries, graduate students, postdocs, university administrators, and even administrators from federal agencies such as the National Institutes of Health or the National Science Foundation--are potential relators. In fact, relators who plan or participate in the fraud they report may recover some bounty unless convicted of a criminal violation. The suit is kept under seal for 60 days after it is filed; during this time, the Department of Justice (DOJ) has the opportunity to decide if it wishes to join the action. DOJ may choose to intervene and prosecute the suit itself. If DOJ declines to intervene, the relator may proceed with the suit independently. DOJ may also choose to intervene at a later date, move to dismiss the suit, or settle the suit, subject to court approval. Intervention by the government limits the relator's recovery to between 15 percent and 25 percent of the funds recovered, depending on the relator's contribution to the recovery. The relator may still recover reasonable costs and attorneys' fees. This system provides more-than-adequate incentive to prompt the reporting of false claims, and may even create somewhat perverse reporting incentives. First, the treble damages provision may induce relators to "let the meter run," racking up higher damages over time rather than reporting the fraud promptly. Similarly, the breadth of the standing provisions may deter reporting of fraud to the institution or oversight agency--an employee who reported fraud to his or her superior would merely be giving away valuable information that the superior might use as the basis for his or her own qui tam suit. Additionally, the most likely relators are disgruntled employees, and frequently those in danger of termination or already fired. The qui tam mechanism readily lends itself to retaliatory lawsuits for termination, whether or not the suit is well-founded. To date, qui tam suits under the False Claims Act have been primarily associated with defense contracting, and not with federal research grants. However, some research-related suits are beginning to emerge. In one recent qui tam misconduct suit against the University of California, San Diego, and the University of Utah, a laboratory manager alleged fabrication of immunological data. In another qui tam suit filed against the University of Baltimore, an epidemiological researcher alleged plagiarism of her data. The former suit settled for $1.6 million; the latter resulted in a jury verdict for nearly the same amount. The publicity surrounding such suits virtually guarantees that more "private attorneys general" will step forward to file suits as they become aware of the bounty provisions. Current research practices may even lend themselves to such claims. For example, because of the stiff competition for federal grant money, applicants may ensure the success of their proposals by doing much of the proposed research in advance. The money is then used to pay for the research for the next "proposal," rather than for work for which it was ostensibly granted. Such "leapfrogging" of funds may constitute a false claim under the statute, even though all the work proposed was completed, and the work is scientifically valid. Although many researchers have done this for some time, they may now be liable under the bounty-hunter provisions. Thus, federally funded researchers must remember that any false statement to a federal agency--not merely classic scientific fraud--can trigger the provisions of the statute. This may have unforeseen implications for the practice of science. For example, by deputizing everyone within a laboratory or research group to report misconduct, the qui tam provisions of the False Claims act shift scientific integrity and "whistleblowing" from an internally motivated professional duty to an externally motivated pecuniary opportunity. Any disgruntled member of a research group--the unhappy postdoc, the underpaid lab technician, the overlooked grad student--is a potential relator. This would undoubtedly affect the atmosphere, collegiality, and working environment of research laboratories. As a consequence of the qui tam legal mechanism, scientists who accept federal funds for research must become scrupulously correct in the statements made to the funding agency. The stakes under the False Claims Act are far too high to indulge in "ballpark" figures, creative bookkeeping, or disdain for bureaucratic paperwork. Additionally, laboratory heads and senior researchers will need to pay careful attention to the level of satisfaction among their junior colleagues, employees, and subordinates: Minor slights, snubs, and personality conflicts now hold the potential for expensive legal conflict, as well. Thus, the federal "bounty" for information regarding false claims will likely assist in deterring research misconduct, but may also result in overdeterrence by diverting the attention of scientists from conducting research to protecting themselves against suit. Dan L. Burk is an assistant professor at Seton Hall University School of Law. (The Scientist, Vol:9, #17, pg.12 , September 4, 1995) (Copyright © The Scientist, Inc.)

False Claims Act Can Hamper Science With 'Bounty Hunter' Lawsuits

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