Caronia, The Latest

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The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA's suppression of truthful commercial speech concerning off-label uses, and we said so. Not only that, the dissent in Sorrell caught the FDA angle, too. Id. at 2678. Only the dissenters didn’t like it – we did.

It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever. As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer's representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use. Both the other doctor, and the rep, who facilitated the conversation, were prosecuted. Nothing false was said, but the government went ahead anyway, and obtained a conviction.

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Published In: Administrative Agency Updates, Civil Procedure Updates, Constitutional Law Updates, Criminal Law Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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