Second Circuit Leaves Open Novel Legal Theory that Flawed AI is a “Worthless Service”
In a decision issued last week, the Second Circuit was faced with the novel legal theory that use of flawed artificial intelligence systems can constitute a “worthless service” for purposes of FCA liability. See Doe v. eviCore Healthcare MSI, LLC, No. 22-530-CV, 2023 WL 2249577 (2d Cir. Feb. 28, 2023). The Second Circuit affirmed the district court’s dismissal for failure to satisfy the heightened Rule 9(b) pleading standard but did not reach the merits, leaving open the question of whether such a theory is viable under the FCA.
Court Rejects “Tenuous” Connection Between FDCA Regulatory Violations and Claims for Payment
Recently, a district court in the Southern District of Florida dismissed with prejudice a qui tam complaint premised on the alleged sale of products adulterated and misbranded under the Food Drug and Cosmetic Act (“FDCA”). United States ex rel. Crocano v. Trividia Health Inc., No. 22-CV-60160-RAR (S.D. Fla. July 18, 2022). In so doing, the court declined to embrace the arguments asserted in a Statement of Interest filed by DOJ and reiterated that “the False Claims Act is not the proper avenue for holding [companies] accountable” for violations of the FDCA, because “the FDA’s use of its regulatory enforcement powers may be exercised fully to ensure further compliance.”
National Nursing Home Initiative Picks Up Steam Under the FCA
In March 2020, DOJ implemented the National Nursing Home Initiative (“the Initiative”) to coordinate and enhance civil and criminal efforts to pursue nursing homes that allegedly provide substandard care to their residents. DOJ noted in its announcement of the Initiative that it had already begun investigating approximately 30 nursing facilities in nine states. However, since that announcement, DOJ’s FCA activity as part of this project has been limited. But earlier this week, DOJ announced the filing of one of its first FCA complaints resulting from an investigation launched as part of the Initiative. This case also comes in the wake of the White House’s announcement earlier this year of new initiatives by CMS to enhance the quality of care at nursing homes. In light of both DOJ and White House priorities in this space, this complaint could reflect DOJ’s intention to step up its use of the FCA to police quality of care at nursing homes. (more…)
DOJ Defends Viability of Fraud-on-the-FDA Theory in Statement of Interest
Over the past decade, relators have attempted to expand the long-established “fraudulent inducement” theory of liability into a novel “fraud-on-the-FDA” theory. The fraudulent inducement theory posits that when a defendant’s fraudulent conduct induces a government entity to enter into a contract with the defendant, the claims for payment submitted under that contract are false. However, the fraud-on-the-FDA theory stretches this causal chain by contending that fraudulent conduct directed at FDA can render false the claims for payment submitted to an entirely different government entity, such as CMS. Courts have been divided as to the viability of this theory. (more…)