No. 23-1016

William Facteau and Patrick Fabian v. United States

Lower Court: First Circuit
Docketed: 2024-03-15
Status: Denied
Type: Paid
Amici (1) Experienced Counsel
Tags: arbitrary-enforcement fda-regulations fifth-amendment first-amendment interstate-commerce medical-device off-label-use truthful-speech
Latest Conference: 2024-09-30
Question Presented (from Petition)

1. Whether FDA's "intended use" regulations violate the First Amendment by requiring manufacturers to refrain from truthful, non-misleading 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.

Question Presented (AI Summary)

Whether FDA's intended use' regulations violate the First Amendment and Fifth Amendment

Docket Entries

2024-10-07
Petition DENIED.
2024-07-02
DISTRIBUTED for Conference of 9/30/2024.
2024-07-01
Reply of William Facteau, et al. submitted.
2024-07-01
2024-06-14
Brief of respondent United States in opposition filed.
2024-05-01
Motion to extend the time to file a response is granted and the time is further extended to and including June 14, 2024.
2024-04-30
Motion to extend the time to file a response from May 15, 2024 to June 14, 2024, submitted to The Clerk.
2024-04-15
2024-03-28
Motion to extend the time to file a response is granted and the time is extended to and including May 15, 2024.
2024-03-26
Motion to extend the time to file a response from April 15, 2024 to May 15, 2024, submitted to The Clerk.
2024-03-13

Attorneys

Howard Root
Mark Edward DuValDuVal and Associates, P.A., Amicus
United States
Elizabeth B. Prelogar — Respondent
William Facteau, et al.
Jeffrey S. BucholtzKing & Spalding LLP, Petitioner