When Biosafety Meets the Federal False Claims Act

Abstract

A recent lawsuit potentially paves the way for whistleblowers to apply the federal False Claims Act and its vast civil remedies against research institutions for allegedly failing to adhere to federal standards for the performance of biological research in a research setting. Despite the absence of any injury alleged, if the plaintiffs prevail in a lawsuit filed on behalf of the United States, they may recover a portion of the total recovery due to the government under provisions that incentivize whistleblowers to bring such claims to combat fraud, waste, and abuse against government programs. Typically applied against health care entities for Medicare fraud and against defense contractors with procurement contracts, the application of the False Claims Act and its whistleblower provisions have become more prevalent in federally funded research over the past 2 decades. Here, 2 former biosafety officers of a major research institution claim that their former employer and others violated the False Claims Act when routinely failing to comply with the National Institutes of Health guidelines and continued to apply for federal grants with knowledge that it was not compliant. In a field that has historically relied on internal oversight, this case marks yet another potential legal cause of action that may arise.