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 (as we have discussed here and here).
Relators have led the charge in advancing and litigating this theory of liability, with DOJ largely watching from the sidelines. Indeed, in 2019, DOJ moved to dismiss a fraud-on-the-FDA case over the relator’s objections. However, in a recently filed Statement of Interest, DOJ offered a vigorous defense of the theory. In the underlying case, the relator alleged that a blood glucose test manufacturer knowingly distributed defective test strips after discovering and concealing manufacturing deficiencies, and that these test strips were accordingly rendered adulterated or misbranded in violation of the Food, Drug, and Cosmetic Act (“FDCA”). As a result, the complaint alleged that the defendant caused federal healthcare programs “to reimburse dangerous and worthless glucose testing...
Fenland residents have been warned not to risk incorrectly claiming Council Tax Support following two recent prosecutions for false claims. Support and benefits are there to help vulnerable and low...