Monday, December 03, 2012
Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds
The long wait is over. Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012). By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds. The ruling is unmistakable. There was no question that off-label promotion had occurred. Slip op. at 14-16. The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.
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Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding. Slip op. at 27 (emphasis original). Thus:
The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”
Id.
The majority in Caronia didn't buy the change of tactics. "[T]hat is not what happened in this case." Id. at 28.
Continue reading here
Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds
The long wait is over. Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012). By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds. The ruling is unmistakable. There was no question that off-label promotion had occurred. Slip op. at 14-16. The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.
off
Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding. Slip op. at 27 (emphasis original). Thus:
The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”
Id.
The majority in Caronia didn't buy the change of tactics. "[T]hat is not what happened in this case." Id. at 28.
Continue reading here
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