Rising Importance Of Sub-Regulatory Guidance In False Claims Act Cases

• Published date: 27 August 2021
• Law Firm: Foley & Lardner
• Author: Ms Pamela Johnston, Lori Rubin, Matthew D. Krueger and Lisa M. Noller

On July 1, 2021, United States Attorney General Merrick Garland rescinded the Brand Memorandum and the Sessions Memorandum, which directed Department of Justice (DOJ) attorneys to refrain from using agency guidance to bring enforcement cases such as False Claims Act cases (Garland Memorandum). These prior memoranda, their accompanying regulations, and the relevant Justice Manual provisions narrowed the utility for DOJ attorneys of agency manuals, memoranda, and other forms of agency sub-regulatory guidance. The Biden administration has rolled back earlier directives from the prior administration as 'overly restrictive.' Accordingly, various prior protections found in former DOJ memoranda and DOJ regulations have been revoked. Interestingly, these actions by the Attorney General were not posted on the Attorney's General press release page and have yet to receive much attention by the defense bar. Regardless, they merit a close review by companies and their counsel to see how they may impact pending False Claims Act investigations and cases.

In the Garland Memorandum, Attorney General Garland acknowledged that under current law, DOJ cannot seek to enforce violations of non-promulgated agency guidance. In the Garland Memorandum, he recited that in the enforcement context, 'an...