The Second Circuit agreed with Caronia and became the first court in the nation to hold that truthful and non-misleading off-label promotional speech is constitutionally protected under the First Amendment and, as a corollary, that off-label promotional speech would not constitute a criminal offense unless the speech was false or misleading.

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Resolution of this issue is important because commercial speech receives a lesser degree of constitutional protection than many other forms of expression, and because governments may entirely prohibit commercial speech that is false or misleading.

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In England, on the other hand, the burden is in exactly the opposite direction: the offending speech is presumed to be false, and it is up to the defendant to prove that it is in fact true.

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Justice Samuel Alito wrote the dissent, on behalf of Justices Antonin Scalia and Clarence Thomas, arguing that by striking down the law the court was shielding lies and breaking from precedents that regarded false statements as not protected by free-speech rights.

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As for the US Department of Justice, the ruling clearly noted that free speech rights do not extend to instances where information is false and misleading.

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