For the Defense - Vol. 7, Issue 3 - 31

But how was a fact finder to determine whether a
prescriber had crossed over the good-faith line? And who
drew the line in the first place? On these questions, the
parties diverged.
The government's argument was twofold, though each
argument centered on its burden of proof of a defendant's
culpable mental state. The government first argued that
the mens rea component of the statute, " knowingly and
intelligently " , was an exception to, not an element of,
the offense. As an affirmative defense, the prosecution
asserted it was relieved from carrying this burden at trial.
Second, the government suggested that a grammatical
reading of the statute showed that " knowingly or
intentionally " did not modify " except as authorized. "
According to the government, Congress intended for the
mens rea component to attach to only the words following
" knowingly or intentionally. " Besides, the " reasonable
physician " standard had endured for decades. The DOJ
had won innumerable convictions on that standard and
had never been overturned.
The Eleventh Circuit in Ruan and Tenth in Kahn agreed
with the prosecutors. According to the Circuits, the
evaluation of whether a physician " acts in the usual course
of his professional practice [is] based on an objective
standard, not a subjective standard.' " 5
It is proper, said
the Circuits, for a trial court to define good faith on the
practices of what a " reasonable physician should believe
to be proper medical practice. " 6
The appellants countered that a jury instruction
fashioned around an objective standard of accepted
medical practices was against the plain language of the
CSA. Doctors Ruan and Kahn insisted that they believed
they were prescribing in good faith and, unless the
government proved otherwise, it could not prevail under
the statute of specific intent. To convict, the government
had to prove that the doctors deliberately prescribed
in bad faith. That is, that they intentionally issued
prescriptions to their patients that they knew were not
for legitimate medical purposes.
In a resounding win for the defense, the U.S. Supreme
Court rejected the holdings of the lower courts and
arguments put forth by the DOJ. Once a defendant
produces evidence of authorization, the government bears
the burden of proving a prescription was unauthorized.
And, to meet that burden, the U.S. Supreme Court held
that the CSA requires proof of intent. Testimony about
" reasonableness " among a segment of the relevant
medical community will not suffice. Post-Ruan, the
government must prove a subjective disregard for good
faith medical practices if it is to convict a practitioner of
unlawful prescribing under 21 U.S.C.S. § 841.
Writing for the majority, Justice Breyer reminded that
criminal statutes, with few exceptions, are designed
to punish " vicious will " and address the " duty of [an]
individual to choose between good and evil. " 7
Even
where a criminal statute is silent on scienter, the Court
has repeatedly " read into " those statutes a mens rea of
'knowing and intelligent' conduct upon " a longstanding
presumption...that
Congress intends
to
require...a
culpable mental state. " 8
But, here, where it included a general scienter provision
proscribing willful conduct by a medical practitioner,
Congress's objective was unambiguous. To accept the
DOJ's position and apply the mens rea element to only
the words that follow " knowingly and intentionally "
makes little sense. In that scenario, the only intentional
act that the government need prove is the issuance of a
prescription by a practitioner-an act which occurs billions
of times annually. As a society, we " expect...doctors to
prescribe medications to their patients, " and rarely " view
such dispensations as inherently illegitimate. " 9
Thus, only
by applying the scienter requirement to " authorization "
would the statute, and Congress's intent, make sense.
The CSA was designed to penalize practitioners who
intentionally break the law by flouting the authorization
to prescribe controlled substances in good faith. Here,
application of the mens rea component to " except
as authorized " " plays the critical role in separating a
defendant's wrongful from innocent conduct. " 10
Finally, the Court pointed to a similar case of statutory
interpretation where the government proposed a
" reasonableness " standard. In Elonis v. United States, the
statute at issue criminalized threatening communication
but contained no defined scienter component.11
Absent an
explicit scienter component, the government suggested
it need only prove whether " a reasonable person would
find the communications threatening. " In that instance,
and with the CSA here, the Supreme Court said that
imposing criminal liability based upon what a reasonable
person would think, " regardless of what the defendant
thinks-reduces culpability on the all-important element
of the crime to negligence. " 12
But in Ruan it was even clearer. The CSA wasn't lacking
a scienter component. Congress put it right there in
black and white, and it comported with longstanding
notions of criminal justice. So, in a context where medical
practitioners were subject to criminal prosecution for
potentially good-faith medical decisions, the U.S. Supreme
Court showed no hesitation to eschew the " reasonable
doctor " standard for good.
The CDC Endorses Individualized Patient Care
The Court's decision in Ruan seems to be aligned, at
least facially, with the Centers for Disease Control and
Prevention's (CDC) efforts to rebrand their 2016 Guideline
for Prescribing Opioids for Chronic Pain. On February 10,
2022, the CDC published a draft of its proposed Clinical
Practice Guideline for Prescribing Opioids.13
It was meant
to serve as a revision of the 2016 Guideline, encouraging
doctors to take an individualized patient-centered
approach to issuing opioid prescriptions, rather than
following rigid standards.
Vol. 7, Issue 3 l For The Defense 31
For the Defense - Vol. 7, Issue 3

Table of Contents for the Digital Edition of For the Defense - Vol. 7, Issue 3
