For The Defense, December 2011 - DRI Today

Drug anD MeDical Device
“mere beef jerky,” IMS Health Inc. v Ayotte,
550 F.3d 42, 53 (CA1 2008), and the Second
Circuit viewed it as speech akin to a “cookbook,
laboratory result or train schedule,”
the Supreme Court granted certiorari.
The Supreme Court analysis began by
stating that “[s]peech in aid of pharmaceutical
marketing, however, is a form of expression
protected by the Free Speech Clause of
Sorrell… plainly paves the
way for courts to review the
First Amendment implications
of the patchwork regulatory
scheme governing offlabel
communications.
the First Amendment.” 131 S. Ct. at 2659.
The Court found that the law warranted
heightened scrutiny because Vermont
“designed [the law] to impose a specific,
content- based burden on protected expression.”
Id. at 2664. The Court wrote that
“[t]he First Amendment requires heightened
scrutiny whenever the government
creates a ‘regulation of speech because of
disagreement with the message it conveys.’”
Id. Vermont argued, as does the FDA about
manufacturer off- label speech, that heightened
scrutiny was not warranted because
the law was “a mere commercial regulation.”
The Supreme Court disagreed, stating
that (1) the “law does not simply have
an effect on speech, but is impermissibly
directed at certain content and is aimed at
particular speakers,” and (2) distinct from
previous cases that considered limiting access
to using governmental information,
the law in Sorrell “implicated” commercially
available information and restricted
“[a]n individual’s right to speak… when information
he or she possesses is subjected
to ‘restraint on the way in which the information
might be used or disseminated.’”
Id. at 2665 (internal citation omitted). In
addressing the conflict between the First
Circuit and the Second Circuit, the Court
stated that “[f]acts, after all, are the begin-
46 ■ For The Defense ■ December 2011
ning point for much of the speech that is
most essential to advance human knowledge
and to conduct human affairs. There
is thus a strong argument that prescriber-
identifying information is speech for First
Amendment purposes.” Id. at 2667.
According to the Supreme Court,
Those who seek to censor or burden free
expression often assert that disfavored
speech has adverse effects. But the “fear
that people would make bad decisions if
given truthful information cannot justify
content- based burdens on speech.”
The First Amendment directs us to be
especially skeptical of regulations that
seek to keep people in the dark for what
the government perceives to be their
own good. These precepts apply with
full force when the audience, in this
case prescribing physicians, consists of
“sophisticated and experienced consumers.”…That
the State finds expression too
persuasive does not permit it to quiet the
speech or to burden its messengers.
131 S. Ct. 2670.
The Court quoted one Vermont physician:
“We have a saying in medicine, information
is power. And the more you know,
or anyone knows, the better decisions can
be made.” Id. at 2671.
Sorrell is not an off- label case, but it
plainly paves the way for courts to review
the First Amendment implications of the
patchwork regulatory scheme governing
off- label communications. Significantly,
the Second Circuit will review another
First Amendment case, this time squarely
addressing the First Amendment in the
context of off- label marketing.
U.S. v. Caronia, 576 F. Supp.
2d 385 (E.D.N.Y. 2008)
Orphan Medical manufactured and marketed
a sleep- inducing depressant, Zyrem.
A government informant contacted Mr.
Caronia, a sales representative, asking for
information on off- label use and for a presentation
by a medical liaison. Mr. Caronia
arranged the presentation, and the sting
operation resulted in prosecution. Unfortunately
for Mr. Caronia, his employer
admitted to a conspiracy to misbrand and
paid a hefty penalty. In addition, a former
manager testified that he had personally
instructed the medical liaison to misbrand
the product on prior occasions.
In denying Mr. Caronia’s motion to dismiss,
the trial court presciently stated:
Reduced to its essence, Caronia’s argument
is that the government cannot
restrict truthful, non- misleading promotion
by a pharmaceutical manufacturer
(or its employees) to a physician
of the off- label uses of an FDA- approved
drug… squarely, Caronia’s constitutional
attack calls into questions America’s
regulatory regime for the approval
and marketing of prescription drugs.
The court went on to state: “The Constitutional
issues raised in Caronia’s motion are
very much unsettled, not only in the circuit
but nationwide.” The court ruled that “[i]t
is clear to the Court that the promotion of
off- label uses of an FDA- approved prescription
drug is speech not conduct.” The court
found the facts supported three of the four
Central Hudson factors and stated: “With
that the overture ends and the play begins.
Enter on stage the essential question—can
government satisfy the fourth prong of Central
Hudson?” In answering that question,
the Caronia trial court stated that
here, the FDA’s maintaining through the
FDCA’s misbranding provisions some
control over the off- label promotion of
manufacturers does appear essential to
maintaining the integrity of the FDA’s
new drug approval process…this Court
is unable to identify non- speech restrictions
that would likely constrain in any
effective way manufacturers from circumventing
that approval process.
The case was tried to a verdict against
Mr. Caronia, and the jury convicted him
on one count of “conspiracy to introduce
or deliver for introduction into interstate
commerce a drug, Xyrem, that was misbranded.”
The jury imposed a $25 fine and
community service as a sentence.
With the tide rising on the First Amendment,
Mr. Caronia has been joined by amici
that have been battling this issue since the
days when it was “laughed out of court.”
Only now no one is laughing. Caronia is
up before the Second Circuit, and supplemental
briefing was filed in August 2011,
addressing the First Amendment issues
raised by the Supreme Court in Sorrell.
While it is not clear how the Second
Circuit will rule in Caronia, in Sorrell the
Second Circuit found that the Vermont
statute violated the First Amendment, stat-