Sorrellonia. Speech in aid of pharmaceutical marketing... is a form of expression protected by the... First Amendment.

Transcription

1 Sorrellonia Speech in aid of pharmaceutical marketing... is a form of expression protected by the... First Amendment. Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2659, 2667 (2011). [W]e construe the FDCA as not criminalizing the simple promotion of a drug s off-label use because such a construction would raise First Amendment concerns. United States v. Caronia, No cr (Dec. 3, 2012) (Slip Op. 26). 4

2 Caronia: Procedural History Government investigation began in 2005 Caronia and Gleason audio-recorded on two occasions as they promoted Xyrem for... unapproved indications and unapproved subpopulations Grant jury indictment in 2007 Superseding Information filed by Government in 2008 Ten-day jury trial in October /16/08: Caronia found guilty of conspiracy to introduce misbranded drug into interstate commerce, acquitted of separate conspiracy prong and separate misbranding count; Rule 29 motion resolved in Government s favor United States v. Caronia, 576 F. Supp. 2d 385, 403 (E.D.N.Y. 2008) 5

3 Caronia: The Issue Does the First Amendment preclude prosecution where actus reus = speech? Pretrial motion: Application of misbranding provisions to speech unconstitutionally restricts right to free speech under the First Amendment (also vagueness/overbreadth) Motion denied, but district court (1) found issue unsettled and (2) rejected Government argument that Caronia was being prosecuted for conduct United States v. Caronia, 576 F. Supp. 2d 385, 403 (E.D.N.Y. 2008) 6

4 The Appeal Did the District Court err by not dismissing the charges against the defendant under Section 21 U.S.C. 331(k), misbranding a drug into interstate commerce and conspiracy to do the same, because the statute is unconstitutional? Oral argument December 2, 2010 Rebriefing ordered in view of Sorrell (July 2011) [T]he same First Amendment standards...would apply to... the Federal Government acting, for example, through... FDA[] regulation. (Sorrell Dissent.) Amicus briefs: WLF, MIWG 7

5 Holding 12/3/2012: Divided Second Circuit panel vacates conviction [W]e construe the FDCA as not criminalizing the simple promotion of a drug s off-label use because such a construction would raise First Amendment concerns. Slip Op. at 26. We decline the government s invitation to construe the FDCA s misbranding provisions to criminalize the simple promotion of a drug s off-label use by pharmaceutical manufacturers and their representatives because such a construction and a conviction obtained under the government s application of the FDCA would run afoul of the First Amendment. Slip Op. at 33. 8

6 Central Hudson Analysis STANDARD OF REVIEW Court held prosecution subject to heightened First Amendment review. But court found First Amendment violation even when prosecution judged under the intermediate standard of review applied to commercial speech the Central Hudson test Prosecution flunks both 3rd and 4th prongs of Central Hudson: prohibiting truthful off-label speech does not directly advance government s interests the government s speech regulation is not narrowly drawn to further those interests 9

7 Significance Doctrinal First successful assertion of First Amendment defense in criminal case arising under the FDCA Second appeals court invalidation of FDCA provision on First Amendment grounds Practical Divided court in one judicial circuit Future proceedings could affect holding Narrow scope of decision Premised on government having prosecute[d] Caronia for his speech (Slip Op. at 31.) 10

8 Wisconsin v. Mitchell Government has relied on Wisconsin v. Mitchell, 508 U.S. 476 (1993) in asserting that it is regulating conduct, not speech because speech is introduced as evidence solely to establish intent or motive Mitchell involved speech in traditional mens rea setting to justify enhanced sentence, so case is distinguishable Intended use an element of misbranding under 21 U.S.C. 352(f)(1) does not relate to tort or criminal law intent concepts 11

9 Evidentiary Use of Speech Majority assumed that the First Amendment would not be offended by the evidentiary use of speech 12 Government had argued: Caronia s promotion of Xyrem for off-label use served merely as evidence of intent.... (Slip Op. at 27 (quoting Gov t Br. 52)) Majority reserved question, finding the Government had not, in fact and in this case, offered evidence of Caronia s speech to prove intended use (Slip Op. at 27-28) Footnote 10 assumes that the Government can prove intended use by referring to promotional statements (Slip Op. 32 n.10, Slip Op. at 51) Dissent emphasized First Amendment does not prohibit evidentiary use of speech (speech = motive)

10 Rehearing Future Proceedings Rehearing petition due mid-january Typically disposed of in two to four weeks Infrequently granted by Second Circuit Certiorari 3 February deadline unless rehearing petition filed, in which case 90 days from conclusion ~30 days for Caronia response, 10 days for Government reply, few weeks for Court to rule (longer if summer) Retrial Potential Double Jeopardy/SOL constraints 13

11 Conclusions Caronia represents a significant advance in the First Amendment case law, again affirming that the current FDA regulatory and accompanying enforcement regime presents grave constitutional difficulties For meaningful programmatic reform at FDA to occur, something more is required than the invalidation of a single conviction arising in an unusual posture The government s favored evidence of intent interpretation of the FDCA remains intact Cases prosecuted using subjective intent and other alternative theories do not fit within Caronia s holding For the majority view to realize its potential, the claimsbased theory of intended use must be firmly established 14