Judge Chin also acknowledged the possibility that misbranding prosecutions still could be brought if the government relied
on off-label promotion only as evidence of intent to misbrand rather than as a crime itself.
Judge Debra Ann Livingston dissented. She argued the FDA's regulations drive manufacturers to get FDA-approval for all new
uses and that this itself prevents doctors from being duped by manufacturer claims that neither have been FDA reviewed nor
Both judges applied a slippery First Amendment standard that gives judges a good deal of leeway to disagree, not the strict
standard that ensures reporters cannot be gagged even when they have a story wrong or the story is expected to do much harm.
The Supreme Court had used the same slippery standard in Sorrell to invalidate the Vermont law and ducked the broader question of whether the First Amendment requires the strict standard
in all cases.
Caronia presents a case in which bad facts could push the Supreme Court in the FDA's favor if the slippery standard is used. If that
happens, the Court finally may be forced to decide a question that has been long in the making—whether commercial speech warrants
full First Amendment protection. Under strict scrutiny, speech is protected against regulation unless the regulation advances
compelling interests and no other means are available to do so. Even a good deal of false speech is entitled to First Amendment
protection under this standard.
Whether the Supreme Court would take this path is suggested by Justice Anthony Kennedy's opinion for the Sorrell majority. He wrote that 'a 'consumer's concern for the free flow of commercial speech often may be far keener than his concern
for urgent political dialogue'...that reality has great relevance in the fields of medicine and public health, where information
can save lives." He added, "The choice 'between the dangers of suppressing information, and the dangers of its misuse if it
is freely available' is one that the First Amendment makes for us."
In the Caronia case, the government chose not to seek rehearing in the Second Circuit, and it now has through March 4, 2013 to decide whether
to seek Supreme Court review. It would not be surprising if the government chooses to live with the lumps it got from the
Second Circuit. It has a lot more to lose in the Supreme Court.
Thomas R. Julin, Jamie Z. Isani, and Patricia Acosta are lawyers in the Miami office of Hunton & Williams LLP. They designed and litigated the First Amendment challenge to the
law invalidated by Sorrell v. IMS Health Inc.