William Facteau and Patrick Fabian v. United States

Petitioners were convicted of introducing into interstate commerce a “misbranded” and “adulterated” medical device. 21 U.S.C. § 331(a). That provision prohibits the distribution of an FDA-cleared device if the manufacturer has an off-label “intended use” for the device—i.e., a use different from the one cleared by FDA. FDA regulations provide that “intended use” is determined by the manufacturer’s “objective intent,” which may be shown by (i) a manufacturer’s “expressions,” such as “advertising matter” or other “oral or written statements”; and (ii) the circumstances surrounding the distribution of the article,” including “circumstances in which the article is, with the knowledge of [the manufacturer], offered and used for a purpose for which it is neither labeled nor advertised.” 21 C.F.R. §§ 201.128, 801.4 (2016 ed.). Because off-label uses are lawful and ubiquitous, such “circumstances” are ubiquitous as well. The “intended use” regulations thus effectively criminalize both truthful, non-misleading speech about off-label uses and “knowledge” of common and lawful “circumstances.” The questions presented are:

1. Whether FDA’s “intended use” regulations violate the First Amendment by requiring manufacturers to refrain from truthful, nonmisleading speech about off-label uses.

2. Whether FDA’s “intended use” regulations violate the Fifth Amendment by encouraging arbitrary enforcement and denying fair notice of what conduct may lead to prosecution.