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