Monday, December 3, 2012
Second Circuit On First Amendment Right to Promote Drug for Off-Label Use Without Criminal Consequences
In a sharply divided and long overdue opinion in United States v. Caronia issued today, a panel of the Second Circuit reversed a conviction relying primarily on the Supreme Court's 2011 decision in Sorrell v. IMS Health, Inc.
The conviction, according to the jury verdict, was for "Conspiracy to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a)(2)." However, Judge Denny Chin, writing for the majority, emphasized that Caronia's statements - - - promoting the off-label use of the drug while he was as a pharmaceutical marketer - - - were the basis of the conviction: "Caronia was, in fact, prosecuted and convicted for promoting Xyrem off-label." Thus, because the majority rejected the government's argument that the statements were (merely) evidence of intent, the conviction raised a First Amendment issue. The panel then extensively discussed Sorrell, beginning with an explication of its two-step analysis:
First, the Court considered whether the government regulation restricting speech was content- and speaker-based. The Court held that it was; the regulation was therefore subject to heightened scrutiny and was "presumptively invalid." Second, the Court considered whether the government had shown that the restriction on speech was consistent with the First Amendment under the applicable level of heightened scrutiny. The Court did not decide the level of heightened scrutiny to be applied, that is, strict, intermediate, or some other form of heightened scrutiny.
[citations omitted]. The panel concluded "that the government's construction of the FDCA's misbranding provisions imposes content- and speaker-based restrictions on speech subject to heightened scrutiny," and then that "the government cannot justify a criminal prohibition of off-label promotion even under Central Hudson's less rigorous intermediate test." The majority seems especially troubled that the crime, at least as the court has constructed it, is "speaker-based because it targets one kind of speaker -- pharmaceutical manufacturers -- while allowing others to speak without restriction."
In a vigorous dissent, Judge Debra Ann Livingston stressed that speech acts are often evidence of intent and that "the majority calls into question the very foundations of our century-old system of drug regulation." She provides a literary analogy to refute Caronia's argument that he "merely discussed “a perfectly lawful practice: the use of a lawful drug, Xyrem, for off-label purposes.”
But the fact that a physician or a patient could legally use Xyrem for an off-label purpose is not enough to make out Caronia’s First Amendment claim. There might be no law forbidding the consumption of arsenic. But this would not endow Abby and Martha with a First Amendment right to offer arsenic-laced wine to lonely old bachelors with the intent that they drink it. See Arsenic and Old Lace (Warner Bros. Pictures 1944). And any statements Abby or Martha made suggesting their intent—even if all of the statements were truthful and not misleading—would not be barred from evidence by the First Amendment simply because arsenic might legally be consumed.
While Judge Chin's opinion could - - - taken to its logical conclusion - - - have a dramatic effect, it seems limited to the pharmaceutical arena.