For the Defense - Vol. 7, Issue 3 - 33

is that it left the medical community teetering a fine line;
administer the medications that their chronic pain patients
needed (many of whom require more than 90 mg MME
of morphine to feel any relief) or face the wrath of the
DOJ. Feeling the looming threat of losing their careers,
many chose to rapidly taper their patient's medication,
which can have devastating physical and psychological
consequences. Some chose to cut their patients off and
dismiss them from their practice outright. The number of
opioid prescriptions written has been declining since 2012,
but the decline escalated further after the 2016 Guideline
was released. Which raises an essential question: If the
number of opioid prescriptions is declining, why does the
number of opioid related deaths continue to skyrocket?
According to the National Center for Drug Abuse
Statistics (NCDAS), more than 96,700 people die from
drug overdoses each year, and opioids are a factor in
approximately 72% of those deaths.21
The national opioid
overdose death rate has increased 255.74% between 2000
and 2019. Pennsylvania alone sees around 4,377 overdose
death per year, 71.98% higher than the national average.
The 2016 Guideline, meant only to serve as a suggestion,
caused a wave of states to enact strict opioid prescription
regulations. The new regulations left doctors with little
choice but to severely restrict the prescriptions they
doled out. Consequently, tens of thousands of chronic
pain patients needed to search for relief elsewhere. The
National Institute of Drug Abuse (NIDA) estimates that
80% of heroin users start out using, and then misusing,
prescription opioids.22
When doctors taper patients off
their prescriptions too quickly, or cut them off altogether,
the withdrawal symptoms can be unbearable. It is possible
to find prescription opioids on the streets, but they are
expensive. Many end up turning to heroin as a cheap
alternative just to feel normal, when all they needed was
a morphine prescription from their doctor that exceeded
the 90 mg MME cut-off.
The 2016 Guidelines were likely well-intentioned, but
the ripple effect is hard to ignore. This is why the revised
2022 Guideline emphasizes that the approach to opioid
prescriptions should be patient-centered and within each
individual doctor's best judgement, rather than following
any rigid standard. In the 2022 draft, the CDC states,
" Though not the intention of the 2016 CDC Guideline,
design and implementation of new laws, regulations, and
policies also drew from its recommendations.... While
some laws, regulations, and policies that were derived
from the 2016 CDC Guideline might have had positive
results from some patients, a central tenent of the
2016 CDC Guideline was that the recommendations are
voluntary and are intended to be flexible to support, not
supplant, individualized, patient-centered care. " 23
With the CDC championing a subjective approach to
opioid prescriptions, and the U.S. Supreme Court holding in
Ruan that the mens rea component to § 841 is a subjective
standard as well, it will be interesting to see if states follow
suit and modify existing rigid legislation. Doing so would
return medical discretion to the practitioners who are
most familiar with their individual patients, provide them
with space to prescribe in a safe and controlled manner
without fear of prosecution, and keep their patients who
suffer from chronic pain from searching for relief in the
dark and dangerous corners of the illicit drug market.
Potential Effect of Commonwealth Prosecutions
Although a major win for the defense in federal
court, Ruan is unlikely to have any near-term effect on
state prosecutions of medical practitioners within the
Commonwealth. That is because, unlike Congress, the
Pennsylvania General Assembly effectively wrote a
" reasonable doctor " standard into the state law.
The Commonwealth's
Controlled
Substance, Drug,
Device and Cosmetic Act ( " Drug Act " ) has language
which mirrors the CSA in that it carves out an exception
for practitioners to prescribe controlled substances " as
authorized. " 24
However, where the federal law requires
general good faith, the state law further demands that
prescriptions are issued " in accordance with the treatment
principles accepted by a responsible segment of the
medical profession. " 25
To convict a practitioner under the Drug Act, the
Commonwealth must prove that no responsible segment
of the medical profession exists which would find the
prescription acceptable. As interpreted by the Superior
Court, the Drug Act requires proof beyond a reasonable
doubt that " all responsible segments of the profession
[must] reject those methods " used by a defendant
prescriber. 26
Yet, the government regularly carries this burden by
presenting an expert doctor who is willing to testify that,
industry-wide, no responsible practitioner would have
prescribed in the allegedly bad-faith way the defendant
had prescribed. In fact, even where the government
presents no expert testimony about the accepted
treatment principles for a particular patient or prescription,
a jury can nonetheless infer from other evidence that a
defendant doctor spurned the practices of all responsible
segments of the profession.27
In any case, a Pennsylvania
jury need not consider the practitioner's subjective intent
in issuing a prescription.
On the heels of Ruan and forthcoming CDC guidance,
one would hope that Pennsylvania lawmakers will
reassess the bar for criminal liability imposed upon
practitioners in the Commonwealth. But, in the short
term, it is also conceivable that we will see an uptick in
prosecutions of medical practitioners suspected of violating
the Drug Act. Ruan has forced the DOJ to reevaluate
an unknowable number of pending investigations into
prescribing practices. Thus, where the Commonwealth
can obtain a conviction upon a mere showing of objective
bad faith, referrals for prosecution might very well flow
back into state courts.
Vol. 7, Issue 3 l For The Defense 33
For the Defense - Vol. 7, Issue 3

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