# Petition for Writ of Certiorari — Johnston v. United States (No. 08-1380)

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition for Writ of Certiorari
- **Published:** January 1, 2008

## Text

Gt Y rere eg US.
No

"61 380 MAY 4 - 9009 |

In TIPFFICE OF THE CLERK
Supreme Court Of Che Anited States

SHARON JOHNSTON,

Petitioner,

UNITED STATES OF AMERICA,

Respondent.

¢

ON PETITION FOR WRIT OF CERTIORARI
To THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT

co

PETITION FOR WRIT OF CERTIORARI

4

Laura D. Cooper
Counsel of Record
ATTORNEY AT LAW

808 Lariat Drive
Eugene, Oregon 97401
(541) 302-6527

Counsel for Petitioner Dated: May 4, 2009

THE LEX GROUP®C e 1750 K Street N.W. ¢ Suite 475 ¢ Washington, DC 20006
(202) 955-0001 @ (800) 815-3791 @ Fax: (202) 955-0022 ¢www.thelexgroupdc.com

1)

2)

3)

QUESTIONS PRESENTED

In a federal criminal prosecution of a
physician under the Controlled Substances
Act [“CSA”] for several counts of writing
prescriptions “outside the course’. of
professional practice” within the meaning of
21 U.S.C. § 802(21) and 21 CFR § 1306.04(a),
did the failure by the federal criminal trial
court to apply Florida state law as the
controlling constitutional authority for
evaluating whether the physician had a
“legitimate” medical purpose within the
meaning of 21 U.S.C. § 830(b)(3)(A)(ii),

constitute a jurisdictional error?

When a threshold jurisdictional error is
assigned for review in a federal appellate
court, does that appellate court’s failure to
address meaningfully that jurisdictional error
effectively deprive that appellate court of '
jurisdiction to issue a merits decision of any
kind?

Does issuance of a federal Circuit Court
merits decision in the knowing absence of
appellate jurisdiction, or an order to depublish
such a decision constitute evidence of judicial
caprice requiring an exercise of this Supreme
Court’s supervisery power?

4)

Does the Eleventh Circuit’s “invited error”
doctrine effectively vitiate a criminal
defendant's statutory right to a meaningful
appeal when the “error” deemed “invited”
otherwise constitutes reversible “plain error”?

PARTIES

All parties appear in the caption of the case on the
title page.

TABLE OF CONTENTS

Page
QUESTIONS PRESENTED ......0:..s:sccssosossssssevecersoesenes i
III ci Sis cdnsintaiaced Viruses apa vieccaveuetes vemeiniey ji
Pe RE goed nn and cesiicersivansactaccisasaadnrens iv
WM EE FAS UE EI wiscssteevesccaverss sivcscvansesins Vlil
OPINION AND DECISION BELOW.......................... 1
RPMI aos iv ascias cecats buesatunse css uiakceneeccacyend 1
CONSTITUTIONAL, STATUTORY, AND
REGULATORY PROVISIONS. .....00ccccsescscsescrnscrscessees 1
STATEMENT OF THE CASE AND
PERTINENT STATEMENT OF FACTS ................... 2
RE rele ike tiscadevedniusans ach hevoiaaneecsenisnunteonaass 4
PI Sievicsssssecaee caste 4

ISSUE 1: In a federal criminal
prosecution of a physician under
the Controlled Substances Act
[“CSA”] for several counts of
writing prescriptions “outside the
course of professional practice”
within the meaning of 21 U.S.C. §
S071) and 21 CFR. §
1306.04(a), did the failure by the
federal criminal trial court to
apply Florida state law as
the controlling constitutional
authority for evaluating whether
the physician had a “legitimate”
medical purpose within the
meaning of 21 USC. §
830(b)(3)(A) (11), constitute a

PIPEBEICCIONIA! OTTOF? ................000.-0cccccees. 5

ISSUE 2: When a threshold
jurisdictional error is assigned for
review in a federal appellate
court, does that appellate court’s
failure to address meaningfully
that jurisdictional error effectively
deprive that appellate court of
jurisdiction to issue a merits

Gece on Ony Rind: ........................... 23

ISSUE 3: Does issuance of a
federal Circuit Court merits
decision in the knowing absence
of appellate jurisdiction, or an
order to depublish such a decision
constitute evidence of judicial
caprice requiring an exercise of
this Supreme Court's supervisory
cs Mecsas iedusedpbihs palbdnkehsKandnnseees 29

ISSUE 4: Does the Eleventh
Circuit’s “invited error’ doctrine
effectively vitiate a federal
criminal defendant’s statutory
right to a meaningful appeal

when the “error” deemed

‘“Invited’ otherwise constitutes
reversible “plain error”? .....................- 31
I a. censuavosuesbsensecesccosecs Ye tar ery. 35

APPENDIX:

Unpublished Opinion of
The United States Court of Appeals for
The Eleventh Circuit
entered March SO, 2008 ...............ccccccccsceccccsce la

Opinion and Order of
The Honorable John E. Steele
Re: Denying Defendant’s Renewed
Motion for Judgment of Acquittal
ee a 18a

Judgment in a Criminal Case

RRC EE BO, BI ons n vnscncevsesocececssvecceacoces’ 2la
Brees I Fi ici ccessvnntisveisvs hvecacvnsavrncousbaias 30a
ME GE Te BF Gs hE os coco sskccaccikcenecndvencossaxonedaes 3la
1 FILTERS Rae Be a Pe OE ER 38a
Excerpt of 21 U.S.C. § B41 ....:ccsccccccccveccercccess sates 40a
Ba I iad iss iassisccdeadgus ease directa 44a
SO A ia ca si cscuvsnssvsnsuewivenccsbexneebgosnspacenaa’ 00a
rs I Se oon ha cence tuacuuecensncanne brani’ Sla
Be en eI ates ke ish hai andes aadnsiendaaasens 63a

Excerpt of Appellee’s Brief in
The Eleventh Circuit Court of Appeals
Record Number 08-14594-HH

entered October 29, 2008 ..........................06 65a
Court’s Instructions to the Jury

SUES TOE ADT GB, BOG. ove siessccssseevscecssscsscesceeis S14
Indictment

Omtered Avrust BO, FOOT once. sccsccessecescescesscces 93a

Vill
TABLE OF AUTHORITIES
Page(s)
CASES

Arizonans for Official English v. Arizona,
520 U.S. 43, 117 S. Ct. 1055,
ABT Ks Bek: BE Be EAT sis desitsitexitioctevieatcerns 25

Borden v. Paul Revere Life Insurance Co.,
935 F.2d 370 Ciat Cir. 19601).......0...ccccecscecceess. 34

Dept. of Prof. Rey., Board of
Medical Examiners v. Reese,
Case No. 83-0355, 1984 Fla. Div. Adm.
Hear. LEXIS 4691 (May 12, 1984) ................ 13

Ex Parte McCardle,
TF PRE OO CHD vkssicskccesvicestasennresen ee 23

Ford v. Garcia,
289 F.3d 1283 (llth Cir. 2002)..................000 33

Forlaw v. Fitzer,
486 So.24 482 Fla. 1984)..........cccccccccerescscesees 13

Gonzales v. Oregon,
546 U.S. 248, 126S. Ct. 904,
TGS Ls. Be. BA FOS CO) one vcccccccccccccsescece passim

Great Southern Fire Proof Hotel Co. v. Jones,
177 U.S. 449, 20 S. Ct. 690,
44 1. Eid. $8 S68 GP silicic coke 22

LX

Hoover v. Agency for Health Care Administration,
676 So.2d 1380 (Fla. 3d DCA 1996)............... 13

Hormel v. Helvering,
312 U.S. 552, 61S. Ct. 719,
a UE COED cvcsisccnesdccasscssavvserecsssensens 33

Hughey v. United States,
495 U.S. 411, 1108S. Ct. 1979,
108 Li. Ed. 2d 408 (LOGO) ......cccrcccccssccccssecceneees 16

Johnston v. Dept. of Prof. Reg., Board of

Medical Examiners,
456 So.2d 939 (Fla. lst DCA 1984)................ 13

Juidice v. Vail,
430 U.S. 327, 97S. Ct. 1211
Bi, Be, ee Te CAT ID cssccccncvccccccvascesocccsvcsacee 25

Kircher v. Putnam Funds Trust,
547 U.S. 633, 126 S. Ct. 2145,
165 L. Ed. 2d 92 (2006) ......................csceceeeeees 20

Maiz v. Virani,
253 F.3d 641 (11th Cir. 2001) .......0..00000000. 33

Mansfield, C. & L. M. R. Co. v. Swan,
111 U.S. 379, 4S. Ct. 510,
28 L. Ed. 2d 462 (1884) .0.... cc ccccccccce ccc eece eee 24

McBoyle v. United States,
283 U.S. 25, 51S. Ct. 340,
75 L. Ed. 2d 816 (1931) 2.0.0.0... ccccccecceceeceseeeeceeee 8

Mitchell v. Maurer,
293 U.S. 237, 55 S. Ct. 167,
FEE els Bs IE CD cen ovessccsccervsccesvsesestevses 17, 25

Morrison v. Olson,
487 U.S. 654, 108 S. Ct. 2597,
BE Bi, Bete Be CD cvccicnsccccccicsscssescavonvees 16

Mt. Healthy City Bd. of Ed. v. Doyle,
429 U.S. 274, 97S. Ct. 568,
ORME Gf >) 0). 7 yy een 22

New York v. United States,
505 U.S. 144, 112 S. Ct. 2408,
EO Fs, Fes Be Be CRED ocvsndccesccccsccccccevevesnsees 19

O’Neill v. United States,
411 F.Ba TBO (OE Gir. FOGB)......0cccscccsccscesccsees: 33

Osborn v. Haley,
549 U.S. 225, 127 S. Ct. 881,
DGG Da, Bete, BE SEO CAT) ccccccccceseccccscccccnscscenees 21

Pate v. Seaboard R.R., Inc.,
SIS F.2a 1074 CLIth Cir. 1967)..........cccrccccccess 33

Printz v. United States,
521 U.S. 898, 117 S. Ct. 2365,
138 L. Ed. 3d $14 (1997) ..................:. 17, 18, 19

Steel Co. v. Citizens For A Better Environment,
523 U.S. 83, 118 S. Ct. 1003,
140 L. Ed. 2d 210 (1998) .................... 17, 18, 20

xl

United States v. Aguilar,
515 U.S. 593, 115 S. Ct. 2357,
BEE Bas es Be CRO cesses vccscnssssonccscoseses 8, 15-16

United States v. Barrow,
118 F.3d 482 (6th Cir. 1997).......................... 34

United States v. Corrick,
298 U.S. 435, 56S. Ct. 829,
BD Bas Me, BI CED co ccecsccoccovsccecscns: 25, 27, 28

United States v. Fulford,
267 F.S4 1241 Cilth Cir. 2007) .......00.ccccceseoess 34

United States v. Green,
ST2 F.36 748 (GER Cir. BOOD) ......ccsccccrccccscescess 34

United States v. Griffith,
301 F.3d 880 (8th Cir. 2002) ....................0000s 34

United States v. Hopkins,
310 F.3d 143 (4th Cir. 2002) ................cccceceee. 34

United States v. Jernigan,
341 F.3d 1273 (ith Cir. 2003) ................00008. 34

United States v. Jones,
570 F.2d 765 (8th Cir. 1978) ................ccseccess. 13

United States v. Moore,
423 U.S. 122, 96S. Ct. 335,
Ge Bs Be, Te te CTD cv ceccccisceccscscicctsesecsssoacss 10

Xl
United States v. Olano,
507 U.S. 725, 113 S. Ct. 1770,
123 L. Ed. 2d 508 (1993) .................... 16, 32, 33

United States v. Perez,
116 F.3d 840 (9th Cir. 1997).......................... 34

United States v. Ross,
181 F.3d S70 (Lith Cir. 1997) .........ccccscccvecsess 34

United States v. Smith,
459 F.3d 1276 (2006)...cccceccecccsecsesesecsessesseecsees 34

CONSTITUTIONAL PROVISIONS

CF ile MT, CIEE, FF vec tsevccdeccicosessesecccecsnes soveaacaee 12
es Tens sc cubpstesevesarcenocinnssners passim
Se I sn vccsskcccocnuctesnsseeoesencsucnesn passim
ee: IID. Th, cs ccssnnesesueseneveisecsesucses 4, 30, 35
STATUTES

21 U.S.C. § 802......... Saar ee Sek ie ee Cok ee 2
We TI IES codvevcecasevctnassds svevsekencpvsoncecsvevestens 5, 6
aes od. os sccsukegabsvavscoudasvaumesasenodsaseepies 2
EF I aiaiicsinesnsicssicasnacvsesscnvadasssiavcicsavecess 6

21 U.S.C. § BBO MSMA)GS). ...cccrccccccccerssccccsrcccses passim

X11]

5G eS ol 2 | GRO RReRma iene Ry an nn ene Ne Hom N cris ROR ranne 2
ee a ise sos adn chclncpaiancccasipheoucennateacaskeuls 1, 3
OU a es 2, 11, 18, 22
ee hisses sd alsiccnen sdoddaancc tases eespaabeli dead 2
Ie I virdaceciinkwendacsiauiesasnsanness cuiceenaiians 1,3
I Ol aii sicakcriessbancev ennui 3
Be NIN sdenssis nt ansiviveincclannsyncetaicomncaananeees 33
Be ee saiaschasdsossnsasaczivacobninskieieoiacctsaeesciadeareae 34
Be an Be wisi cssececeascvasncivevesncss 9, 11, 14, 17
ee A ins. os nadeucuchesdaoanacacnaueenciioln 1,6
REGULATIONS

ee 1. eee ene 2
21 C.F.R. § 1306.04(a)....ccccceccssesesscsestsseseeeees 5, 6, 7, 23
RULE

ae Ws Bre kinked nar caneds cdicencvserccersectods 32

X1V

OTHER AUTHORITY

Arthurs, Sean, A Foolish Consistency: How
Refusing To Review Ford v. Garcia’s Invited
Error Demonstrates the Eleventh Circuit’s
Prioritization of Procedure Over Justice, 72
0S RAED Bic, BER. Ee Ce wince icteiccacecvesevscoccdusessacde

PETITION FOR A WRIT OF CERTIORARI

The petitioner, DR. SHARON JOHNSTON,
respectfully prays that a writ of certiorari issue to
review the decision of the United States Court of
Appeals for the Eleventh Circuit entered March 30,
2009 on a direct criminal appeal by Dr. Sharon
Johnston following trial and conviction on four
counts of violation of the Controlled Substances Act,
21 U.S.C. § 841(a).

OPINION AND DECISION BELOW

The decision of the United States Court of
Appeals for the Eleventh Circuit was unpublished,
and a copy of that decision is included in the
Appendix, infra.

JURISDICTION

The Eleventh Circuit affirmed the conviction
on March 30, 2009. The jurisdiction of this Court is
invoked under 28 U.S.C. § 1254.

CONSTITUTIONAL, STATUTORY, AND
REGULATORY PROVISIONS

The Appendix to this Petition for Certiorari
reproduces:

The text of the Florida Patient’s Bill of Rights
and Responsibilities, Fla. Stat. § 381.026.
App. 5la-62a.

* The text of the Tenth Amendment to the
United States Constitution. App. 30a

. Portions of the text of the federal Controlled
Substances Act, including:

O 21 U.S.C. § 802. Definitions. App. 38a-
39a.

° 21 U.S.C. § 829. Prescriptions. App.
40a-43a.

° 21 U.S.C. § 841. Prohibited acts A.
App. 40a-43a.

re) 21 U.S.C. § 843. Prohibited acts C. App
44a-49a.

O 21 U.S.C. § 903. Application of State
law. App. 50a.

O 21 C.F.R. § 1306.04. Purpose of issue of
prescription. 63a-64a.

STATEMENT OF THE CASE AND
PERTINENT STATEMENT OF FACTS

Dr. Sharon Johnston was convicted following
a jury trial in Fort Myers, Florida, of prescribing
controlled substances to three undercover DEA
agents, all of whom came to her posing as patients
claiming to seek relief for chronic pain. Each of the
agents falsely represented to Dr. Johnston that they
had chronic pain, that they had previously been
receiving opioid analgesics for their pain, and that

their pain had been palliated to some extent by these
drugs. In each instance, Dr. Johnston physically
examined the patients, and derived a diagnosis
based upon her training, education, experience,
physical examination, and review of pertinent
medical records. Dr. Johnston also a‘ vised each
undercover agent to obtain an MRI. Nevertheless,
Dr. Johnston was charged with four counts of
violating the Controlled Substances Act, 21 U.S.C. §
841(a) (“CSA”), was convicted by a jury, and is
presently incarcerated. The jury at Dr. Johnston’s
trial was instructed to apply a “national medical
standard” based wholly on expert testimony, and the
law of Florida played no role in her trial in providing
a standard against which to measure the “scope” of
professional practice. Dr. Johnston timely appealed
from a judgment of conviction entered on July 29,
2008, in the United States District Court for the
Middle District of Florida at Fort Myers to the U.S.
Court of Appeals for the Eleventh Circuit under 28
U.S.C. § 1291. Dr. Johnston’s criminal appellate
counsel raised for the first time on appeal to the
United States Court of Appeals for the Eleventh
Circuit a substantial question challenging the
subject matter jurisdiction of the trial court under
the CSA. The Eleventh Circuit affirmed the
conviction in its opinion dated March 30, 2009
wherein the appellate merits decision failed
address meaningfully that threshold jurisdictional
issue on the grounds that the error had been
“invited” by trial counsel, and the panel then
depublished the resulting decision. This tiniely
Petition for a Writ of Certiorari follows under 28
U.S.C. § 1254.

ARGUMENT

Introduction:

Dr. Sharon Johnston comes to this Court
having been convicted of a crime that does not exist,
by a court without jurisdiction to enter a conviction,
and affirmed by a court that did not confirm that it
had jurisdiction to do so and — worse yet — blatantly
attempted to “bury” its decision through
depublication. The fact that the Circuit Court
spilled so much ink explaining the “facts” but
dishonestly “ducked” the fundamental question of
jurisdiction (which challenged the fundamental
“standard” by which those very “facts” could be
measured) -- and then depublished the decision --
should itself sound alarm bells to the supervisory
review court. This entire proceeding has been
indelibly painted with the bright and unmistakable
color of unconstitutional outcome-driven caprice.

The conviction was fundamentally unfair from
the very beginning for lack of any predictable
standard by which fairly to judge the “legitimacy” of
the accused physician’s medical purpose, which also
undermined any determination about what was
within the proper “course of professional practice.”
The proceedings have also been tainted with a
fundamental unraveling of the rule of law through
explicit judicial usurpation of Florida’s Tenth
Amendment retained constitutional sovereignty to
regulate substantive medical practice. This
unraveling was exacerbated by the appellate court’s
use of a deliberately obtuse “invited error”
procedural bar which enforced procedural rigidity at

the expense of fundamental justice, and ultimately
produced a blatantly outcome-driven decision so
intent on affirming an unjust criminal conviction
that the appellate court knowingly overstepped its
own unwaivable appellate jurisdictional boundaries.

Discussion:

ISSUE 1: In a_ federal criminal
prosecution of a physician under the
Controlled Substances Act [“CSA”] for
several counts of writing prescriptions
“outside the course of professional
practice” within the meaning of 21 U.S.C.
§ 802(21) and 21 C.F.R. § 1306.04(a), did
the failure by the federal criminal trial
court to apply Florida state law as the
controlling constitutional authority for
evaluating whether the physician had a
“legitimate” medical purpose within the
meaning of 21 U.S.C. § 830(b)(3)(A)(ii),
constitute a jurisdictional error?

This case began with a criminal indictment! in
a Fort Myers Middle District of Florida U.S. District
Court, of physician Dr. Sharon Johnston, under the
Controlled Substances Act [“CSA”] for several counts
of writing prescriptions “outside the course? of
professional practice” within the meaning of 21
U.S.C. § 802(21). The CSA purports to criminalize
all distribution of controlled substances, and simply

1 See Indictment. App. 93a.

2 The actual Indictment language used is “outside the scgpe of
professional practice.” Id.

excepts prescriptions issued by a physician for a
“legitimate medical purpose” in “the course of
professional practice.” See 21 U.S.C. §§ 802(21),
829(c), 830(b)(3)(A)(ii) and 21 C.F.R. § 1306.04(a).3

Dr. Johnston was a duly-licensed Florida
physician and all of the charged prescriptions were
written during legitimate office visits for undercover
DEA agents who knowingly and falsely represented
to the physician that they had chronic pain.‘ In each
instance, Dr. Johnston physically examined the
patients and derived a diagnosis based upon her
training, education, experience, physical
examination, and review of pertinent medical
records. Dr. Johnston also advised each undercover
agent to obtain an MRI.

‘vhe charged prescriptions could only meet the
CSA violation criteria if they were not deemed issued
“for a legitimate medical purpose by an individual
practitioner acting in the usual course of his
professional practice” within the meaning of 21
U.S.C. §§ 802(21), or 830(b)(8)(A)Qi) and 21 C.F.R. §

3 Every prescription for a controlled substance must “be issued
for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice.” 21
C.F.R. § 1306.04(a). App. 63a-64a.

4 No application of Florida state law could arguably support a
finding of criminality based on these facts. Florida Patient’s
Bill of Rights and Responsibilities, Fla. Stat. § 381.026 (App.
5la) charges the patient with the responsibility to provide
accurate ana truthful information to the physician. Under the
federal approach, the innocent physician is placed in the
position of being an absolute guarantor of patient reports and
revelations. See also note 8, infra.

1306.04(a). Consequently, to be issued in the “usual
course of professional practice” a prescription must
have been issued for a “legitimate medical purpose”
within the meaning of 21 U.S.C. § 830(b)(3)(A)(ii).

The ambiguity of the phrase “legitimate
medical purpose” within § 830(b)(3)(A)(ii) is critical
to an understanding of the nature of the error
committed by the trial court, and arises from a
fundamental dispute about who decides what is
“legitimate” in the context of a medical practice. The
fundamental dispute presented here is centered
upon the unconstitutional nature of a new judicially-
created ‘national medical standard” which
unlawfully usurps the police power expressly
reserved to the states under the Tenth Amendment.

In Gonzales v. Oregon, 546 U.S. 243, 269,
(2006)(“Gonzales”), this Court very clearly observed:

Congress regulates medical practice
insofar as it bars doctors from using
their prescription writing powers as a
means to engage in illicit drug dealing
and trafficking as conventionally
understood. Beyond this, however, the
statute manifests no intent to regulate
the practice of medicine generally. The
silence is understandable, given the
structure and hmitations of federalism,
which allow the States ‘great latitude
under their police powers to legislate as
to the protection of lives, limbs, health,
comfort, and quiet of all persons.’
{Citations omitted.]

In fact, the Court stated that the CSA’s structure
and operation presume and rely upon a functioning
medical profession regulated under the States’ police
powers. Jd. The Gonzales Court recognized that the
term “legitimate medical purpose” — the lack of
which constitutes the statutory crime (see §
830(b)(3)(A)(ii)) — was itself insufficient to describe a
criminal act with the particularity required of
federal criminal law: the phrase “legitimate medical
purpose’ is a generality, susceptible to more precise
definition and open to varying constructions, and
thus ambiguous in the relevant sense.” Gonzalez,
546 U.S. at 257 [emphasis added]. Such ambiguity
necessarily implicates due process notice principles.
“A fair warning should be given to the world in
language that the common world will understand, of
what the law intends to do if a certain line is
passed.” United States v. Aguilar, 515 U.S. 593, 600
(1995) (citing McBoyle v. United States, 283 U.S. 25,
27 (1931)). Given that insufficiently definitive
statutory ambiguity, the word “legitimate” must
refer to something else from which the required
principled specificity can be drawn.

The precise issue in Gonzales was whether an
interpretive rule offered by the Attorney General
would be accorded judicial deference as providing the
required specificity.5 In declining deference, the

5 The interpretive rule declared that physician-assisted suicide
was not a “legitimate medical purpose” and therefore not in
“the course of professional practice” within the meaning of the
CSA. In response, an Oregon physician and others challenged
that rule as a means to stave off threatened federal criminal
prosecutions of Oregon physicians under the CSA. The
Gonzalez Court held that the Attorney General is not
authorized to create substantive medical policy under his

Court noted that the only provision in which
Congress itself has set a general, uniform federal
medical practice standard is contained in 42 U.S.C. §
2990bb2a, in which the treatment of drug addicts is
specified. Gonzales, 546 U.S. at 570-571. Aside from
that single provision, Gonzales unequivocally held
that a state medical practice standard must serve as

the sine qua non of the federal crime because the
Attorney General has no “authority to define
diversion based on [his] view of legitimate medical
practice...” Gonzalez, at 262.

However, despite the clear mandate in
Gonzales to apply a state medical practice standard
to define the otherwise ambiguous CSA criminal
criteria, the judge in this case charged the jury to
apply a “national medical standard’® as_ the

“control,” “registration” and “general powers” provided in the
CSA. Id. at 259-61, 126 S. Ct. at 917-18, 163 L. Ed. 2d at 768-
69. Those powers are so limited because he lacks the expertise
to create medical policy, which authority within the Executive
Branch lies exclusively with the Secretary of Health and
Human Services. Jd. at 293-95, 126 S. Ct. at 936-37, 163 L. Ed.
2d at 790-91.

6 Jury Instructions, Pgs. 9, 10. App. 88a. The term “national
medical standard” does not distinguish between “standard of
care” (which is drawn from tort law and references professional
norms the deviation from which constitute varying degrees of
negligence) and “medical practice rules” (which are the only
bodies of law capable of marking the outer boundaries of the
practice of medicine sufficiently to define in a principled
manner the terrain of a “safe harbor” in which a physician may
operate as a “healer” and enjoy immunity from criminal
charges). ‘Tort standards are only capable of defining “bad
medicine as conventionally understood” whereas state medical
practice rules are capable of defining “drug dealing as
conventionally understood.” The critical error in using a

“medical standard” in place of a “medical practice rule” is that
federal criminal conduct must not constitute medical practice at
all — not just medical practice with which federal officials,
experts, or juries disagree. The conflationary use of a tort
standard here subjected this physician to criminal charges for

what amounted to a medical disagreement which violates the
Tenth Amendment as well as basic due process “fair notice”
principles. In that manner, this “national medical standard”
completely obliterates the distinctions between criminal law,
tort law, strict liability, professional regulation, and
administrative law and the courts effectively rewrite the CSA
to criminalize all DEA controlled substances medical
disagreements, in specific defiance of both Gonzales and United
States v. Moore, 423 U.S. 122, 122 (1975). The tort-crime non-
differentiation is demonstrated here by both the government's
and court’s normative statements about what Dr. Johnston
should have done — in their view -- to be a more careful and
thorough doctor. The newly-created federal DEA “red flags”
“standards” used in this case as a wholesale prosecutorial
invention also provides a startling glimpse into a world in
which DEA officials dictate medical practice standards and “red
flags” effectively vitiate the treatment imperative. This
paradigm changes the fundamental relationship of physicians
to their patients because physicians become judged not by
whether they meet quality of life goals for patients, but rather
by whether they adequately further law enforcement aims. In
effect, it also turns the entire physician-patient relationship
into a criminal profile. Second, physicians are forced to adopt
an adversarial relationship with their patients without
informing them of the change, and patient visits essentially
become a form of interrogation. Under this approach,
physicians are not allowed to simply believe their patients;
instead, it is the physician's job to detect patient deception.
Another radical result of this paradigm is that the goals of
treatment for any condition requiring opioid medications
become indistinguishable from the goals of treatment for
addiction, with the net effect that all such patients are treated
as current or potential drug addicts, who by definition cannot be
trusted, and whose interaction with the medication itself needs
to be closely monitored and minimized. This is precisely what
occurred in this case; the physician was convicted for treating

11

yardstick for Dr. Johnston’s CSA culpability. A
“nationaL_medical standard” in this context is
necessarily completel ely fabricated because Congress
has__not ined _“m s.
Gonzales confirms that apart from 42 U.S.C. §
2990bb2a, only state law is capable of marking that
particular CSA boundary. Any federal “boundary”
offered apart from 42 U.S.C. § 2990bb2a or a state
medical practice law is therefore necessarily a post

hoc federal invention’ which as applied by a federal

her patients’ pain by applying the treatment goals and practice
standards used for addiction by the government’s testifying
expert. In point of fact, she was tried for trusting her patients.
If this approach takes hold throughout the United States, the
physician's function as healer will be _ irretrievably
compromised, and the physician-patient relationship will be
forever supplanted with a police state of medicine. It is no
stretch to imagine federal prosecutions based on these
principles to eventually encompass all medical decision-making
by a physician.

7 The federal prosecutorial practice of relying on experts to
establish a CSA benchmark for a physician prosecution under
this same provision is always post hoc, and is fraught with such
enormous constitutional danger that the practice should be
banned outright. An expert is inevitably given more weight
than a competing defendant’s point of view since the defendant
is considered to have a vested interest in the outcome. An
expert may choose which aspects of state law serve him well (or
do not, as the case may be); as a result, the expert's
pronouncements become a complete substitute for state law, in
express violation of the CSA preemption provision in 21 U.S.C.
§ 903. In essence “state law” becomes whatever the expert says
it is and there is no guarantee that the expert will convey how
well-established such law actually is or is not, or will clearly
enunciate and describe the difference between tort and crime at
all. In essence, an expert cannot be deemed to have standing to
represent or stand for a body of state law or state medical
regulators, and should only be allowed to provide an assistance

12

court to support a rule of decision therefore also
constitutes a judicially-created federal common law.

adjunct thereto, if at all. This problem is particularly acute at
any time that an expert utilizes a “standard” that is materially
objectionable as stated or applied in any way. Such “evidence”
which becomes a governing legal standard of criminal conduct

shifts the burden of proof to the defendant to disprove that
standard, which completely vitiates the Defendant’s Fifth
Amendment right to silence and places the physician in the
unenviable position of having not merely to “correct” the
prosecutor and expert at trial even though at an enormous
evidentiary disadvantage based on perceived bias, but also to
“persuade” in order to prevail in a criminal proceeding, which
effectively reverses the presumption of innocence. Even
with competing testimony, there are no safeguards in place
that can instruct the jury about which of the varying standards
they are “offered” are correct. Because this error implicates
fundamental questions of separation of powers (and is therefore
jurisdictional in nature), this is not a choice a jury should be
empowered to make to begin with. Nevertheless, these are
issues that arise with astonishing regularity in physician
prosecutions under the CSA, and they umformly arise because
rogue experts are used to establish disputable “benchmarks,” as
opposed to explaining unequivocal state law that is objectively
provable. Federal prosecutors should be forbidden from using
expert witnesses to “establish” the existence of a benchmark as
a violation of federalism, and as an impingement on both the
presumption of innocence, and the Fifth Amendment. As a
practical matter, courts adhering to state law should not need
experts to define CSA terms at trial. To enforce Tenth
Amendment limitations, a federal prosecutor should be
required either to defer to a decision by a state medical
regulator or to proceed with a trial without experts by
establishing “drug dealing as conventionally understood.” As a
third alternative, a prosecutor should be required to offer up
state medical practice authority establishing beyond a
reasonable doubt that the physician's conduct lacked a
“legitimate” medical purpose. Absent such limitations, and
given current federal prosecutorial practices, the Attorney
General has essentially appointed itself as a de facto national
medical regulator.

13

Dr. Sharon Johnston was therefore tried and
convicted for prescribing “outside the course of
professional practice,” -- and thus without a
“legitimate medical purpose” within the meaning of
21 U.S.C. § 830(b)(8)(A)Gi) — through a judicially-
created “national medical standard.” In upholding a
conviction on those terms, both the trial and
appellate courts have sanctioned the use of a lay
federal jury as a complete constitutional substitute
for the Florida state medical regulator® as the
deliberative body which effectively defines what
constitutes the “legitimate” practice of medicine in
Florida, in express violation of 21 U.S.C. § 903 and
the Tenth Amendment.

8 Florida state medical practice decisions demonstrate the
irreconcilable nature of the federal criminal conviction here.
See, e.g., Forlaw v. Fitzer, 456 So.2d 432 (Fla. 1984) (per
curiam) (prescribing to an addict without a physical exam not
outside medical practice); Hoover v. Agency for Health Care
Administration, 676 So.2d 1380 (Fla. 3d DCA 1996) (ack of
medical records and high quantities of narcotics were not
sufficient bases for a practice violation, and admonishing
“draconian” standards of pain management); Johnston v. Dept.
of Prof. Reg., Board of Medical Examiners, 456 So.2d 939 (Fla.
Ist DCA 1984) (prescribing thousands Dilaudid tablets to a
single patient during one year medically appropriate); Dept. of
Prof. Reg., Board of Medical Examiners v. Reese, Case No. 83-
0355, 1984 Fla. Div. Adm. Hear. LEXIS 4691 at *9 (May 12,
1984) (“[p]ain control is the most difficult area to quantitate by
virtue of the manner in which patients react to pain
undermedication”); See also, United States v. Jones, 570 F.2d
765 (8th Cir. 1978)(reasoning cited with approval in Forlaw,
456 So.2d at 435) dack of a physical exam and directions to fill
prescription at a certain pharmacy alone insufficient for
criminal conviction).

14

As the Gonzales Court iterated, there is no
Congressionally-authorized “national” medical
practice standard that applies to a physician aside
from 42 U.S.C. § 2990bb2a for the simple reason that
Congress has not created one. Gonzales, 546 U.S. at
570-571. If a “national medical standard” does not
exist to define a federal crime, a federal court cannot
simply create federal common law as a statutory
substitute in violation of Tenth Amendment
principles. What the Department of Justice has
done here is to regulate by prosecution; rather than
announcing a “national medical standard” by way of
an interpretive rule, it has learned the lesson of
Gonzales and now bypasses regulation altogether by
simply applying its idea of “proper” medical practice
through prosecutions in Article III Courts.

That Department of Justice approach was
confirmed by the appellate briefing in this case. The
government argued that the completely new
“national medical standard” jury instruction was not
erroneous, even though none of the cases cited by the
government address the limitation of Gonzales. See
Government Appellate Brief at 27-29. App. 71a.
Instead, the government asserted that Gonzales
holds only that the Department of Justice is
precluded from enforcing the CSA in ways that
conflict with explicit and existing state law (in a sort
of “reverse conflict-preemption” principle). As a
corollary, the federal government asserted it was
also free to “fill in” or authoritatively “interpret”
state law and thereby apply a new _federally-
created standard in doing so. See Government
Appellate Brief at 31. App. 72a. In other words, the
government simply disregards the primary thrust

15

of Gonzales that the Attorney General has no
“authority to define diversion based on [his] view of
legitimate medical practice...” Gonzalez, at 262.

Instead of regulating that authority, now a
prosecutor simply exercises it. By using an “expert”
to “declare” what the government deems “sound
medical policy” at trial, the Attorney General has
accomplished precisely that which Gonzales
expressly struck down. The government’s failure to
adhere to state law here thus commits the same
legal error in fact that was proposed by _ the
interpretive rule in Gonzalez and the instant federal
criminal prosecution which applied a_ federal
common law of medical practice to secure a
conviction under the CSA thus represents the
identical federal encroachment to Florida as the
Gonzales interpretive rule represented to Oregon.
See Gonzales, 546 U.S. at 253-54. Even worse, Dr.
Johnston has now been convicted of the crime of
disobeying that new federal medical policy which the
Department of Justice had no authority to create in
the first place (and never bothered to announce in
advance).

To the extent that the Attorney General lacks
authority to regulate -- meaning he lacks authority
to create new policy, the Attorney General must
necessarily stmilarly lack the authority to prosecute
cases applying those very same new policies because
due process constraints prevent current criminal
prosecutions from introducing new policies for which
defendants have had no prior “notice” that would
allow them to conform their conduct to the
requirements of law. See United States v. Aguilar,

16

515 U.S. at 600. Thus, Department of Justice
prosecutorial authority must necessarily be more
circumscribed than its parallel Congressional grant
of regulatory authority. Cf Morrison v. Olson, 487
U.S. 654 (1988) (Independent Counsel are appointed
to exercise prosecutorial authority but not regulatory
authority). |

Article III Courts must expressly repudiate
the practice of “regulation by prosecution” as
occurred here, and can do so quite effectively by
recognizing the jurisdictional nature of the error
committed.2 The extstence of the error consisting of
the failure to apply state law was unequivocal given
the clear mandate of Gonzales. Unfortunately, the
error was recognized by neither the trial court nor
any of the attorneys (including defense counsel)?!
until representation of the defendant by appellate
counsel had been undertaken fcllowing conviction.
However, this was not an ordinary error subject to
preservation limitations; instead, the Supreme
Court’s own description in Gonzales establishes its

9 The rule of lenity demands resolution of ambiguities in
criminal statutes in favor of the defendant. See Hughey v.
United States, 495 U.S. 411, 422, 110 S. Ct. 1979, 1985-86, 109
L. Ed. 2d 408 (1990)). Thus, even if this Court were not to
deem the Gonzales error to be jurisdictional in nature, if the
law actually applied here was ttself not sufficiently definitive as
to provide ample fair warning of the statutory crime, a federal
conviction could not be sustainable if any reasonable
interpretation of the physician’s conduct supported that
legitimacy.

10 Dr. Johnston’s own trial counsel erroneously agreed to
application of a “national standard,” an error which is “plain”
within the meaning of United States v. Olano, 507 U.S. 728,
732, 113 S. Ct. 1770, 1776, 123 L. Ed. 2d 508 (1993). See infra.

17

jurisdictional nature: a court which fails to adhere
to the state law requirement tramples_upon_the
Tenth _ Amendment’s express reservation of state
sovereignty and thereby exceeds its own authority
granted under the CSA.'1 The statutory authority
granted by Congress under the CSA simply has not
provided Article III Courts the authority to displace
a state’s constitutional reservation of sovereign state
power under the Tenth Amendment to regulate the
practice of medicine any more than the Attorney
General possessed it in Gonzales. Consequently, the
state “reservation” of the right to define “legitimate
medical purpose” within the CSA is a matter of
constitutional authority, and an authorized federal
CSA prosecution involving nonadherence to a
“legitimate medical purpose” apart from the single
federal definition in 42 U.S.C. § 2990bb2a must
necessarily expressly incorporate the law of the
single constitutionally-authorized definitional
source: the state. See Printz v. U.S., 521 U.S. 898,
932 (1997). Moreover, a federal court’s failure
to adhere to state constitutional authority in
defining the scope of “legitimate medical purpose”
removes the prosecution from its Congressional
grant of authority, which creates a defect in the
federal Court's own Article III subject matter
jurisdiction. See Steel Co. v. Citizens For A Better
Environment, 523 U.S. 83, 101 (1998)(“Steel”’); see
also Mitchell v. Maurer, 293 U.S. 237, 244 (1934)
(“Mitchell’)(diversity).

\ See Gonzalez, 546 U.S. at 253-54; see also Printz, 521 U.S. at
932 (1997)(holding federal statute violated state sovereignty
and was “categorically unconstitutional” and not subject to any
balancing analysis).

18

The critical difference between the nature of
this “jurisdictional” question and an ordinary legal
question is described in Steel: the former is based on
constitutional authority and implicates separation of
competing constitutional powers, whereas the latter
does not. As a consequence, the Steel Court noted
that when a legal question importunes jurisdiction,
that

[mJuch more than legal niceties are at
stake here. The _ statutory and
(especially) constitutional elements of
jurisdiction are an essential ingredient

‘ of separation and equilibration of
powers, restraining the courts from
acting at certain times, and even
restraining them from acting
permanently regarding certain subjects.
See United States v. Richardson, 418
U.S. 166, 179 (1974); Schlesinger ov.
Reservists Comm. to Stop the War, 418
U.S. 208, 227 (1974).

Steel, 523 U.S. at 101. Viewed through the prism of
authority and competing constitutional powers, the
Court’s “state law” requirement in Gonzales does not
simply clarify one element of proof to make out a
CSA violation; instead, the Court describes this
requirement clearly in terms of authority and
describes the resulting tension as one which plays
out between separate and distinct competitive federal
and_staie constitutional powers. Moreover, the
Printz Court described at length why federal
encroachments on state sovereignty necessarily

19

demand an inflexible and categorical boundary that
must be demarcated as inviolable:

[m]uch of the Constitution is concerned
with setting forth the form of our
government, and the courts have
traditionally invalidated measures
deviating from that form. The result
may appear ‘formalistic’ in a given case
to partisans of the measure at issue,
because such measures are typically the
product of the era’s perceived necessity.
But the Constitution protects us from
our own best intentions: It divides
power among sovereigns and among
branches of government precisely so
that we may resist the temptation to
concentrate power in one location as an
expedient solution to the crisis of the
day.

Printz, 521 U.S. 933, quoting New York v. United
States, 505 U.S. 144, 187 (1992). An “inviolable”
boundary is by definition jurisdictional.

By necessary implication, the Gonzales “state
law” requirement clearly outlines a system of
federalism under which federal encroachment is
both inviolable as well as outside the scope of
Congressionally-authorized power, and such an
encroachment functions to the direct detriment of
Tenth Amendment reserved state authority which is
in direct competition with it. By failing to adhere to
the state law constitutional boundary, the
proceeding necessarily takes on other errors of

20

constitutional dimension. For example, by failing to
use state law as the definitional benchmark in this
conviction, the federal court allowed the prosecutor
to charge, prosecute, and convict based on a
noncrime, and_- essentially subjugated the
constitutional authority of a state medical regulator
to a federal lay jury. Any other view of the Gonzales
error would support the exercise of power “beyond
the bounds of authorized judicial action and thus
offend fundamental principles of separation of
powers.” Steel, 523 U.S. at 94.

The jurisdictional nature of this error is also
apparent from other Supreme Court cases discussing
missing predicate “jurisdictional” elements, e.g.,
those things which are necessary to establish the
federal _court’s delegated Congressional authority
under Article IJI. For example, in a removal
juris “iction case, Kircher v. Putnam Funds Trust,
547 U.S. 633, 126 S. Ct. 2145, 165 L. Ed. 2d 92
(2006), the Supreme Court held that remand by a
federal district court for lack of subject matter
jurisdiction after removal was proper for a group of
securities class action cases that fell outside the
defined Congressional scope of a siatute designed to
curtail certain state security class action lawsuits.
The Court reasoned that Congressional intent to
preclude certain cases simply d:d not cover the cases
remanded; because the cases therefore fell outside
the Congressional legislative grant of judicial
authority, the cases were properly treated as beyond
the court’s Article III subject matter jurisdiction.
Similarly, in the instant case, when the federal
criminal prosecutor failed to apply state law, that
prosecution exceeded the scope of Congressional

21

intent under the CSA and ceased to be “authorized”
under Article III.

Moreover, the Attorney General was not given
“unreviewable” authority under the CSA. By way of
comparison, Osborn 'v. Haley, 549 U.S. 225, 127 S.
Ct. 881, 166 L. Ed. 2d 819 (2007)(“Osborn”)
demonstrates the statutory construction that would
have been required to shield the CSA state law error
from its jurisdictional consequences. In Osborn the
Supreme Court described the Attorney General’s
authority under the Westfall Act to certify that a
claim filed in state court against a federal employee
occurred within that employee’s scope of
employment. Following such a certification, the
United States is substituted as a defendant and the
case is removed to federal court. The statute
commands that the Attorney General’s certification
“conclusively” establishes scope of employment for
removal jurisdiction purposes; consequently, the
Court held that even when the facts upon which that
certification is based are later shown to have been in
error, the Court is nevertheless not deprived of
continuing jurisdiction over the matter. A specific
provision attaching statutory conclusiveness to the
certification of the Attorney General “differentiates
certified Westfall cases from the typical case
involving ‘jurisdictional’ facts; but for that statutory
command of conclusiveness, the case [would be]
remanded for want of subject matter jurisdiction.”
Only an express Congressional directive within the
statute that the decision by the Attorney General
could not be reviewed preserved the federal court’s
jurisdiction.

22

By contrast, the jurisdictional proof required
to establish lack of “legitimate medical purpose”
within the meaning of the CSA must be
accomplished with specific reference to state law. No
Congressional “saving” exists in the CSA; in fact,
quite the opposite -- the CSA specifically preserves
the state’s police power in the preemption provision
contained in 21 U.S.C. § 903.12 By analogy, when a
CSA prosecution fails to employ state law to define
whether a_ physician's conduct is outside a
“legitimate medical purpose,” that prosecution fails
to establish necessary jurisdictional facts, and
thereby exceeds the scope of Congressional authority
under the CSA (e.g., it ceases to be “authorized”) so
that the federal district court is deprived of subject
matter jurisdiction under Article ITI.

As with any other federal proceeding, the
revelation to the trial court that jurisdictional “facts”
were missing (here, that the federal prosecutor was
not using state law to evaluate and prosecute the
legitimacy of the medical purpose of the physician)
should have caused it to undertake a sua sponte
evaluation of its own jurisdiction, even if not raised
by the parties. See Mt. Healthy City Bd. of Ed. v.
Doyle, 429 U.S. 274, 278-279 (1977); Great Southern
Fire Proof Hotel Co. v. Jones, 177 U.S. 449, 453
(1900). Further, the necessary action demanded of
the Court upon the revelation that the federal
prosecutor had encroached upon the state's

12 As 21 U.S.C. § 903 clearly demonstrates, it was never the
intent of the Congress to use the CSA to substitute federal lay
juries for state medical boards, nor for federal criminal
prosecutions to regulate the state practice of medicine (whose
public health interest is better served by licensure proceedings
than by forfeiture, bankruptcy, and imprisonment).

23

constitutional authority is unequivocal: “Jurisdiction
is the power to declare the law, and when it ceases to
exist, the only function remaining to the court is that
of announcing the fact and dismissing the cause.”
Id., (quoting Ex Parte McCardle, 7 Wall. 506, 514
(1869)). Thus, the federal court should have
dismissed for lack of jurisdiction when it became
apparent that the prosecutor was not relying on state
law to define the meaning of “legitimate medical
purpose” within the meaning of 21 U.S.C. §
830(b)(3)(A)(ii) and 21 C.F.R. § 1306.04(a).

ISSUE 2: When a threshold jurisdictional
error is assigned for review in a federal
appellate court, does that appellate
court’s failure to address meaningfully
that jurisdictional error’ effectively
deprive that appellate court’ of
jurisdiction to issue a merits decision of
any kind?

The existence of what is hereafter referred to
as a “Gonzales” error — which consists of a court's
jurisdictional failure to apply state law as the
benchmark for determining the “legitimacy” of a
physician’s medical purpose within the meaning of
21 U.S.C. § 830(b)(8)(A)~G1) and 21 C.F.R. §
1306.04(a) -- is unequivocal in this case. The
Eleventh Circuit acknowledged that this precise
issue had been presented by the Appellant as a
jurisdictional issue. See Appellate Decision at 10.
App. lla. Even if the Eleventh Circuit ultimately
disagreed with Appellant’s point of view about
whether the error was jurisdictional in nature, the
appellate court nevertheless had an unwaivable

24

threshold duty to evaluate in some meaningful way
whether Gonzales commands the application of state
law, and if so, whether the failure to apply that state
law was jurisdictional in nature.

The Court’s duty to engage in that threshold
evaluation is longstanding and _ well-established
under the precedent of this very Court:

On every writ of error or appeal, the
first and fundamental question is that
of jurisdiction, first, of this court, and
then of the court from which the record
comes. This question the court is bound
to ask and answer for itself, even when
not otherwise suggested, and without
respect to the relation of the parties to
it. Great Southern Fire Proof Hotel Co.
v. Jones, [177 U.S. 449] 453 [(1900)].
The requirement that jurisdiction be
established as a threshold matter
‘spring[s] from the nature and hmits of
the judicial power of the United States’
and is ‘inflexible and without exception.’

Mansfield, C. & L. M. R. Co. v. Swan, 111 U.S. 379,
382 (1884).

The appellate court could not address the
merits of the appeal without first meaningfully
evaluating that substantial jurisdictional challenge
once it had been raised by the Appellant.}8

'S “(E]very federal appellate court has a special obligation to
‘satisfy itself not only of its own jurisdiction, but also that of the
lower courts in a cause under review,’ even though the parties

25

Unfortunately, the Eleventh Circuit failed to engage
in any serious evaluation of its own jurisdiction,
even though it explicitly acknowledged that the issue
was raised by the Appellant:

We are unpersuaded by Johnston’s
argument that the alleged error in the
jury instructions is jurisdictional. “A
jurisdictional defect is one that ‘strip[s]
the court of its power to act and ma[kes]
its judgment vold.” McCoy v. United
States, 266 F.3d 1245, 1249 (11th Cir.
2001) (citation omitted). An indictment
suffers from a jurisdictional defect
when it charges no crime at all, Le. a
non- offense. United States v. Peter, 310
F.3d 709, 714-15 (11th Cir. 2002) No

are prepared to concede it.” Mitchell, 293 U.S. at 244; see
Juidice v. Vail, 430 U.S. 327, 331-332 (1977)(standing).

The appellants did not raise the question of
jurisdiction at the hearing below. But the lack
of jurisdiction of a federal court touching the
subject-matter of the litigation cannot be
waived by the parties, and the District Court
should, therefore, have declined sua sponte to
proceed in the cause. And if the record discloses
that the lower court was without jurisdiction
this court will notice the defect, although the
parties make no contention concerning it. While
the District Court lacked jurisdiction, we have
jurisdiction on appeal, not of the merits, but
merely for the purpose of correcting the error of
the lower court in entertaining the suit.”

United States v. Corrick, 298 U.S. 435, 440
(1936)(“Corrick”)(footnotes omitted); Arizonans for Official
English v. Arizona, 520 U.S. 43, 73 (1997).

26

such situation exists here because the
district court had jurisdiction pursuant
to a valid indictment charging Johnston
with crimes under the CSA. Because
the alleged error is not jurisdictional,
we conclude that invited error doctrine
precludes review of the jury instruction
that applied a national standard of
care.

Appeal Decision, pages 10-11. App. lla. The
appellate court did not seriously entertain the
question and performed no analysis. In fact, the
indictment itself does not specify in any way what
benchmark is used to define “scope of professional
practice.” Instead, the indictment simply uses an
altered version of ambiguous statutory language and
does not define the term used with reference to
anything. In that respect, the indictment itself
violated the requirement of Gonzales by leaving the
term “ambiguous in the relevant sense,” Gonzalez,
546 U.S. at 257, and therefore charged what
amounts to a noncrime. The appellate court simply
assumed a valid charging instrument without
bothering to look. Nevertheless, even if the
indictment itself were somehow deeiied legally
sufficient, once the prosecution was undertaken and
it became clear that the meaning attached to the
otherwise ambiguous language in that indictment
was being drawn without reference to defining state
law, then the court had a sua sponte duty to evaiuate
its own Article III jurisdiction.

Without meaningfully evaluating the
constitutional requirements of Gonzales and its

27

application in the case before it, the appellate court
simply assumed trial court jurisdiction both attached
and continued throughout the proceeding, and issued
a decision on the merits of the appellate case on that
basis. Unfortunately, in doing so, the Eleventh
Circuit was exercising appellate jurisdiction it never
established. In the face of a substantial appellate
question of trial court jurisdiction, appellate
jurisdiction is itself absent until that question is
meaningfully addressed. See Corrick, 298 U.S. at
440. Thus, in the case at bar, without first having
undertaking a meaningful evaluation of the
threshold jurisdiction issue raised by the Appellant,
no appellate jurisdiction attached to the merits
decision, and the appellate decision was ultra vires.
Regardless whether the balance of the appellate
decision was technically legally correct, the appellate
court’s failure meaningfully to confirm the existence
of its own jurisdiction stripped its federal authority
to enter any judgment except dismissal for lack of
jurisdiction.!4 See Corrick, 298 U.S. at 440.

14 The Eleventh Circuit failed to confirm its own appellate
jurisdiction but nevertheless issued an ultra vires merits
decision denying review of a substantive legal issue based on
invited error. In a system of limited federal judicial power,
there is no logical circumstance in which error of a
jurisdictional nature should ever be deemed “invited.” In the
first place, that doctrine cannot vitiate a court’s sua sponte
obligation to evaluate its own jurisdiction. If meaningful
jurisdiction analysis discloses that jurisdiction is present there
is no reason to deny review of the question based on a
procedural bar because an intellectually honest decision on the
merits will support the same conclusion. However, if that
analysis demonstrates a lack of jurisdiction, a court has no
jurisdiction to judge the merits of the matter ab initio and the
case must he dismissed (not denied on the merits due to a

28

It is therefore evident that compounding
federal subject matter jurisdictional errors have
existed in this case from the Indictment forward.
Dr. Johnston now essentially stands convicted of a
crime_that does not exist, by a court without
jurisdiction to enter a conviction, affirmed by a court
that did not confirm whether it had jurisdiction to
conduct a review; and, worse yet, the appellate court
blatantly attempted to “bury” its decision through
depublication. What is missing is fundamental
justice — Dr. Johnston has never truly had her “day
in court” as measured meaningfully by
constitutionally relevant state authority to define a
crime that is not otherwise “ambiguous in the
relevant sense.” That ambiguity is the central
problem: it allowed the prosecutor and his paid
experts to “fill in” whatever newly-created federal
common law “medical standards” served his post hoc
needs, even though the Attorney General has no
“authority to define diversion based on [his] view of
legitimate medical practice...” Gonzalez, at 262.

purported error of “invited” nature). See Corrick, 298 U.S. at
440.

29

ISSUE 3: Does issuance of a federal
Circuit Court merits decision in the
knowing absence of appellate
jurisdiction, or an order to depublish
such a decision constitute evidence of
judicial caprice requiring an exercise of
this Supreme Court’s supervisory power?

As demonstrated above, the appellate court in
this case “invented” its own appellate jurisdiction in
order to issue a ruling on the merits. In that respect,
the primary knowing judicial error here was
committed by the appellate court, which failed
meaningfully to analyze its own federal jurisdiction
but nevertheless issued an ultra vires decision on the
merits of the appeal.

To make matters worse, however, the Court
further departed from any meaningful semblance of
the rule of law and transparently attempted to evade
or bury the consequences of its own analytic failure
by depublishing the decision. Depublication of a
decision in which an unwativable jurisdictional issue
was clearly raised and inadequately addressed
provides unmistakable evidence of the existence of a
parallel extra-constitutional body of Circuit law for
which the Court is completely unaccountable and
which is an expression of a form of tyranny by
judicial caprice ~ where Circuit court judges
personally decide without limitation which rules of
law they choose to disregard by simply depublishing
the resulting decisions. This unsupervised assertion
of such unaccountable power will certainly
undermine public faith in the integrity of our legal
system and “prove” to citizens the existence of an

30

outcome-driven “convict at any cost” federal
judiciary. Absent some supervisory limitations on
which decisions a Circuit Court may depublish,
nothing prevents such Courts from evading issues —
even primary questions of jurisdiction — in like
manner as occurred here.

As a result, this entire proceeding now has
been indelibly painted with the bright and
unmistakable color of unconstitutional caprice; the
Eleventh Circuit U.S. Court of Appeals has
depublished a transparently dishonest decision on an
umportant jurisdictional issue in the Circuit. This
conviction was therefore not only fundamentally
unfair for lack of any predictable standard by which
fairly to judge the “legitimacy” of the accused
physician’s medical purpose from the very beginning,
but it was also tainted with a fundamental
unraveling of the rule of iaw through explicit judicial
usurpation of Florida’s Tenth Amendment retained
constitutional sovereignty to regulate substantive
medical practice, and exacerbated with a
deliberately obtuse “invited review” criminal
appellate procedural bar which legitimizes the
exercise of procedural rigidity at the expense of
fundamental justice. This ultimately resulted in a
blatantly outcome driven appellate decision that
discloses such a strong preference for affirming a
criminal conviction that the panel willingly
sidestepped its own unwaivable’ appellate
jurisdiction boundaries to do so.

The appellate court’s first duty should have
been to perform an intellectually honest and
searching analysis of the briefed jurisdictional error.

31

It did not; in fact, it performed no analysis
whatsoever beyond parroting hornbook law about
the function of a criminal indictment, assumed that
the charging instrument was valid, and failed to
consider the consequences of subsequent vitiation of
jurisdictional facts. Had the court performed any
meaningful evaluation of the actual issue presented,
it would have determined that the failure to cite and
adhere to state law as the sole constitutionally-
relevant authority for measuring the “legitimacy” of
the physician’s medical purpose was outside the
Article III congressional grant of authority under the
CSA.

Consequently, both the U.S. District Court
and the U.S. Court of Appeals for the Eleventh
Circuit have so far departed from their own Article
III jurisdiction limitations in this case as well as
bedrock principles of fundamental fairness as to call
for an exercise of the Supreme Court’s supervisory
power. Again, it hears repeating — what is missing
here is fundamental justice.

ISSUE 4: Does the Eleventh Circuit’s
“invited error” doctrine effectively vitiate
a federal criminal defendant’s statutory
right to a meaningful appeal when the
“error” deemed “invited” otherwise
constitutes reversible “plain error”?

Given the court’s sua sponte duty to evaluate
its own jurisdiction, a jurisdictional error can never
be deemed “invited” by a litigant. Nevertheless,
even if this Court does not deem the Gonzales error
to be “jurisdictional” in nature, an honest evaluation

32

of that issue should have revealed the commission of
reversible “plain error.” See United States v. Olano,
507 U.S. 725, 732, 113 S. Ct. 1770, 1776, 123 L. Ed.
2d 508 (1993) (“Olano”) (a federal appellate court can
correct plain errors even when not preserved at
trial). Under the plain error standard, an appellate
court can correct an error not raised at trial, if there
is (1) error, (2) that is plain, and (3) that seriously
affects the fairness, integrity, or public reputation of
judicial proceedings. Jd.

In this case, the law applied by the trial court
to define “legitimate medical purpose” directly
contradicted existing Supreme Court precedent
under Gonzales and was therefore “error” that was
“well-established” at the time of trial. Moreover,
there was no federal “crime” as prosecuted aside
from state law.!5 Thus, there is also no doubt that
the Gonzales error seriously affected the fairness of
the proceeding. Instead, this physician was
convicted in a criminal proceeding in which lines
between tort and crime were completely blurred,
where expert witnesses themselves become
unreliable primary de jure sources of “law’,1® and a
complicated medical judgment was rendered by a lay
jury as a federe! substitute for a state medical
regulator. Even if the appellate court had
determined that the Gonzales error was _ not
jurisdictional, the court should nevertheless have
reversed on the grounds of “plain error.” See Fed. R.
Crim. P. 52(b).

15 See notes 4 and 8, supra.

16 See note 7, supra.

33

Justice Black’s ordering of the rules of justice
as superior to the rules of procedure remains a
central tenet in the federal appellate structure.!7 In
28 U.S.C. § 2106, Congress directed that, when
entering judgment, a court of appeals may affirm,
modify, vacate, set aside or reverse any judgment,
decree, or order of a court lawfully brought before it
for review, and may... direct the entry of such
appropriate judgment, decree, or order, or require
such further proceedings to be had as may be just
under the circumstances.” Congress did not mention
“balance” between procedural mechanisms and the
demands of justice; nor did it state that a just result
may be foregone in the interests of judicial economy.
Instead, Congress delegated to the appellate courts
the responsibility for requiring “further proceedings .
.. as may be just.” Id. See O'Neill v. United States,
411 F.2d 139, 143-44 (3d Cir. 1969).

Unfortunately, the Eleventh Circuit US.
Court of Appeals is unique among the federal Circuit
Courts in that it alone applies an absolute bar in a
criminal case!8 to any error deemed “invited” by trial
counsel even if that error otherwise qualifies as
“plain error” under the Olano standard. See Ford uv.
Garcia. 289 F.3d 1283, 1294 (11th Cir. 2602); United

17 Rules of practice and procedure are devised to promote the
ends of justice, not to defeat them. “Orderly rules of procedure
do not require sacrifice of the rules of fundamental justice.”
Hormel v. Helvering, 312 U.S. 552, 557 (1941).

18 The Eleventh Circuit has left open possibility of applying an
exception, see Maiz v. Virani, 253 F.3d 641, 677 (11th Cir.
2001), but has applied such an exception only in civil cases. See
Pate v. Seaboard R.R., Inc., 819 F.2d 1074, 1083 (llth Cir.
1987) (internal quotations and citation omitted).

34

States v. Fulford, 267 F.3d 1241, 1247 (11th Cir.
2001); United States v. Ross, 131 F.3d 970, 988 (11th
Cir. 1997); see also Arthurs, Sean, A Foolish
Consistency: How Refusing To Review Ford uv.
Garcia’s Invited Error Demonstrates the Eleventh
Circuit’s Prioritization of Procedure Over Justice, 72
U. CIN. L. REV. 1707 (2004). The primary purpose of
the invited error doctrine is to deter defendants from
making “an affirmative, apparently strategic
decision at trial and then complain[ing] on appeal
that the result of that decision constitutes reversible
error.” United States v. Jernigan, 341 F.3d 1273,
1290 (11th Cir. 2003).

Nevertheless, six of the seven circuits that
have addressed this issue have cited the primacy of
their duty to secure justice and thereby refused to
foreclose review of invited errors altogether. See
Borden v. Paul Revere Life Insurance Co., 935 F.2d
370, 375 (1st Cir. 1991); United States v. Hopkins,
310 F.3d 143, 151 (4th Cir. 2002); United States v.
Green, 272 F.3d 748, 754 (5th Cir. 2001); United
States v. Barrow, 118 F.3d 482, 491 (6th Cir. 1997);
United States v. Griffith, 301 F.3d 880, 883 (8th Cir.
2002); United States v. Perez, 116 F.3d 840 (9th Cir.
1997).

However, in the face of plain error, this
unutted error bar serves neither justice nor judicial
economy because the burdens of proof for plain error
and ineffective assistance of counsel “overlap
significantly,” such that, when “the first three
prongs of the plain error standard” are satisfied,
“counsel was incompetent for not having objected.”
United States v. Smith, 459 F.3d 1276, 1303 (2006)

35

(Tjoflat, J., specially concurring). In other words, it
is nonsensical for the appellate court to apply
“invited error” in a case that also constitutes “plain
error” because the very application of “invited error”
in that situation proves that the defendant had
ineffective assistance of trial counsel. Application of
the “invited error’ bar by the appellate court under
these circumstances completely subjugates the
interests of justice to the inflexible demands of a
procedural mechanism by holding the criminal
defendant accountable for a decision made by a
demonstrably ineffective trial counsel on direct
appeal; in reality, this only multiplies the work of
the courts by guaranteeing that they will have to
review this case again on a petition for Habeas
Corpus under 28 U.S.C. § 2255 based on the court’s
own pronouncement of counsel ineffectiveness. Thus,
even if the Circuit Court disagreed about the
jurisdictional nature of the underlying error, it
should have applied an exception to the “invited
error” doctrine in the face of “plain error.”

CONCLUSION

The ultimate question which has been begged
throughout this entire proceeding by the lower
courts is who decides what is a “legitimate” medical
purpose? No honest application of Florida state law
could arguably support a finding of criminality to
sustain this conviction, and for that reason federal
prosecutors likely expressly avoided it!9 and instead
applied a previously nonexistent “national medical
standard” to determine criminality. By treading
upon the State’s Tenth Amendment reservation of

19 See footnotes 4 and 8, supra.

36

rights to regulate substantive medical practice, the
federal court did not exercise a valid Congressional
delegation of Article III jurisdiction upon which to
base a federal criminal conviction. The jurisdiction
of both the U.S. District Court and the Court of
Appeals to enter a judgment of conviction were thus
vitiated and the decisions were both therefore ultra
vires; even worse, the decision of the Eleventh
Circuit U.S. Circuit Court below knowingly evaded
its own primary duty to assess its own jurisdiction.

The Eleventh Circuit has now effectively
replaced the Florida state medical regulator with a
federal lay jury, and having done so it then went to
great lengths to synthesize the “facts” of the case in
such a way as to rationalize its conviction by making
multiple normative judgments about medical care.
The decision begs the ultimate question — how the
appellate Court [and also the jury] could possibly
evaluate medical “facts” in the complete absence of a
jurisdictional “standard” to begin with? For the
sake of individual justice, the basic rule of law in the
United States, and in deference to Constitutional
limitations of federal authority under the Tenth
Amendment which have been wholly disregarded
here, this Petition should be granted.

Respectfully submitted,

/s/ Laura D. Cooper
Laura D. Cooper
Counsel of Record
ATTORNFY AT LAW

808 Lariat Drive
Eugene, Oregon 97401
(541) 302-6527

APPENDIX

la

[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT

No. 08-14594
Non-Argument Calendar

FILED
U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
MARCH 30, 2009
THOMAS K. KAHN
CLERK

D. C. Docket No. 07-00105-CR-FTM-29-DNF
UNITED STATES OF AMERICA,
Plaintiff-Appellee,
versus
SHARON JOHNSTON,

Defendant-Appellant.

Appeal from the United States District Court

for the Middle District of Florida

(March 30, 2009)

2a

Before BLACK, PRYOR and KRAVITCH, Circuit
Judges.

PER CURIAM:

The Controlled Substances Act (“CSA”), 21
U.S.C. § 841, prohibits dispensing controlled
substances, unless prescribed “for a _ legitimate
medical purpose by an individual practitioner acting
in the usual course of his professional practice.” 21
C.F.R. § 1306.04(a). Dr. Sharon Johnston was
convicted for illegally dispensing: Oxycodone (the
generic name for Roxicodone) and Alprazolam (the
generic name for Xanax) (Count 1); Oxycodone
(Count 2); Alprazolam and Methadone (Count 3);
and Oxycodone (Count 4) in violation of 21 U.S.C. §§
841(a)(1) and (b)(1)(C).! She was sentenced to 30
months’ imprisonment on each count, to run
concurrently. She now appeals.

I. Facts

Johnston was an _ osteopathic physician,
specializing in neurology, working in Naples,
Florida. In 2007, a medical malpractice investigator
with the State of Florida Department of Health
received information that Johnston may have been
unlawfully proscribing narcotics. She transmitted
this information to Amber Baginski, a detective with
the Naples Police Department that was assigned to
the Drug Enforcement Administration (“DEA”) as a
task force officer. The DEA instituted an
investigation and sent three undercover detectives

' Roxicodone and Methadone are Schedule II narcotics and
Xanax is a schedule IV narcotic.

3a

into Johnston’s office posing as patients. They were
all instructed not to bring any medical files,
prescription bottles, or “show proof that they had
had any kind of medical exam or had been given any
prescriptions.” On the basis of the evidence gained
from these visits, Johnston was indicted and tried.

The three undercover detectives testified at
trial. The substance of their testimony was as
follows: Mark Schaible, posing as Marcus Damm,
visited Johnston’s office on June 11, 2007.2 Schaible
complained of back pain, told Johnston that he was
injured while exercising at the gym, and that he had
pain radiating down his leg. Schaible told Johnston
that he worked in Daytona, but when Johnston
commented on the long distance her traveled to see
her, Schaible stated that he was staying with his
mother in nearby Fort Myers. Johnston told Schaible
that he had a “herniated disk back there that’s
causing all the pain” and that “[s]Jooner or later” he
would need an MRI, but she did not immediately
recommend that he get one done. Schaible testified
that certain statements that he made to Johnston
were intended to act as “red flags,” including: (1) he
was previously a patient of Dr. Pizarro, who was
under indictment for soliciting sex in exchange for
narcotics; and (2) he had been “bumming”
medications from his friends. Johnston tested
Schaible’s reflexes, had him extend his arms and
touch his fingertips, and checked his blood pressure.
Johnston only looked at Schaible’s back when
discussing his tattoos. She did not otherwise touch

? Schaible recorded his conversation with Johnston and the
tape was played at trial.

4a

his back, perform any other tests, or recommend an
X-ray.

Schaible informed Johnston he was taking
four to five Roxicodone tablets per day. Johnston
replied, “I don’t know how much youre getting, or
where you're getting it from. Which is fine.” Schaible
also told Johnston that he was taking two to three 1-
milligram tablets of Xanax per day, which Johnston
noted was a lot. Johnston commented that Schaible’s
blood pressure was low, attributing this to the fact
that he was probably “nice and mellow” from the
Roxicodone and Xanax. Schaible also commented, “I
always kind of wondered why you can go into a store
and buy a gallon of vodka and a carton of cigarettes,
you can have a good time, but you can’t take a pain
pill.” Schaible paid cash for the cost of his visit and
left Johnston’s office with prescriptions for 150 15-
milligram tablets of Roxicodone and 90 1-milligram
tablets of Xanax.

Schaible had a_ follow-up appointment
scheduled for July 9, but “to throw up another red
flag” he called three weeks after his first
appointment, claiming that he ran out of his
medication, even though the prescription should
have lasted longer. The appointment was moved to
July 5. At this visit, Schaible complained that his
pain was too high, that the Roxicodone was not
working, and that he had been receiving 40-
milligram Methadone wafers from his friend.
Johnston acknowledged that Methadone is “pretty
powerful stuff’ and “real hard core,” and that moving
from 15 to 40-milligrams is “quite a jump.” Schaible
explained that he took Methadone as often as six
times per day, but that he only bought twenty pills

5a

off of his friend because “he needs to make some
money too.” Johnston did not examine Schaible at all
during the visit and wrote him a prescription for 150
40-milligram Methadone wafers and refilled his
Xanax prescription.

Amber Baginski, who posed as Amber
Needles, was the second patient in the investigation.
She testified that on June 27, 2007, she arrived at
Johnston’s office and noticed that several patients in
the waiting room appeared to be high. Baginski was
taken to an examination room, where she met
Johnston. She told Johnston that she had been a
patient of Dr. Pizarro and that, due to general back
pain, she had been taking 15-milligram Roxicodone
tablets.4 Johnston asked whether Baginski had
fallen or been in an accident, and when Baginski
said no, Johnston responded that most patients tell
her the pain resulted from one of these incidents.
Johnston checked Baginski’s_ reflexes, blood
pressure, and had her touch her fingertips, but did
not examine Baginski’s back or perform any other
tests. As Baginski held out her hands, Johnston
asked, “Doesn’t the pain radiate down your legs?”
Baginski believed Johnston was “telling me what I
needed to say in order to obtain the pain
medication.” When Baginski confirmed th at the pain
radiated, Johnston gave her a prescriptio.: for 90 15-
milligram tablets of Roxicodone. According to

> Baginski carried a recorder, but the device malfunctioned and
therefore no tapes were presented at trial.

* Johnston did not request any of medical records, but did
recommend that she get an MRI. Even though Baginski had
insurance, she declined, stating that it was too expensive.
Johnston did not inquire further.

6a

Baginski, the entire examination lasted less than
five minutes.

Donald McDougall, who posed as Donald
Nieczticz, was the final patient in the investigation.
On July 10, 2007, he visited Johnston’s office, where
he explained to Johnston that he had experienced
pain in the past, but was not currently suffering any
pain.® Johnston asked if McDougall had an MRI and
he told her that although he had, it did not reveal
anything. McDougall told Johnston that he had a
doctor near his home in the Florida Keys and that he
was currently taking 20-milligram Oxycontin
tablets, to which Johnston replied, “you can’t take
that. You’re overmedicated.” Nonetheless, Johnston
did not follow-up about the distance McDougall
traveled to see her, the name of his regular
physician, or when he last had his prescription filled.
As with the other patients, Johnston tested
McDougall’s reflexes, checked his blood pressure,
and had him hold out his arms and touch his
fingertips, but did no further examinations.
McDougall testified that most of the fifteen-minute
examination was spent discussing fishing and real
estate. At the close of the visit, Johnston prescribed
90 30-milligram tablets of Roxicodone, 90 100-
milligram Neurontin, and 60 pills of Flexeril.®

Johnston’s office manager testified that
Johnston used pre-printed examination forms to
save time; Johnston would then cross out whatever

> As with Baginski, the recording device malfunctioned and
therefore no tapes were presented at trial.

® Neurontin and Flexeril are prescription pain killers and
muscle relaxers, but are not covered by the CSA.

7a

information was incorrect after she examined the
patient. About 99 percent of Johnston’s pain
management patients received controlled substance
prescriptions.

The government called two expert witnesses:
Dr. Richard Hood and Dr. Sherri Pinsley. Hood
testified as to the high strength of the drugs
prescribed by Johnston and their many potentially
dangerous and deadly side effects, especially when
taken together or with alcohol. He testified that a
doctor should not increase from a low dose of
Roxicodone to a high dose of Methadone based solely
on a patients’ claims that Methadone is more
effective for him than Roxicodone. Instead, a doctor
could confirm what drugs a patient was using by
urinalysis, obtaining medical records, or obtaining
past prescription bottles. Hood also explained that a
patient illegally buying prescription drugs is a “red
flag . . . [for] diversion and addiction.” Finally, Hood
testified that normally if a patient complains of back
pain, a doctor should palpate the back to see if it
elicits muscle spasms or tenderness.

Pinsley testified that in her pain management
practice, an initial patient visit would include a
head-to-toe examination, including range of motion
exercises and palpating the vertebras of the spine.
Pinsley testified that she would only treat a patient
after obtaining the patient’s medical records and, if
the patient had not undergone any tests, she would
require an MRI or x-ray be conducted.’ Pinsley said

’ Pinsley testified that she would sometimes give prescriptions
that were of limited quantity and dosage until she could obtain
the records or get tests done.

8a

that controlled substances are always her iast resort
and, before prescribing controlled substances, she
requires patients to take a toxicology test so that she
can confirm whether they are taking any medication.
She testified that Johnston’s patient files were
sparse, that her exams were limited, and that she
was concerned that Johnston prompted patients to
give certain answers about pain. She noted that she
was troubled by the red flags raised by the
undercover agents, including traveling a_ long
distance to see Johnston, lack of previous medical
records or tests, buying medications illegally, and
requesting more medications too quickly. In her
opinion, Johnston prescribed stronger medications
than appropriate and acted outside the scope of
professional practice.

Johnston’s case included testimony by her
own expert, Dr. Thomas Romano. Romano was of the
opinion that Johnston’s conduct was professional
and consistent with standards of professional care in
the United States. Romano explained that there is
no objective test for pain and that a doctor has to
listen to a patient’s report of pain and rely on her
own judgment in determining whether the patient is
reliable. Romano acknowledged that some of the
statements made by the detectives could be red flags,
but noted that there could be legitimate explanations
for each that would not have prevented a doctor from
treating a patient. Romano opined that Johnston
acted in good faith in prescribing the medications to
thc three patients.

The jury ultimately convicted Johnston of all
charges. Johnston appeals to this court, arguing that
the district court erred by: (1) applying a national,

9a

rather than state-specific, standard of care; (2)
admitting prejudicial “red flags” evidence and
permitting the government’s experts to testify to
legal conclusions based on the red flags; and (3)
denying Johnston’s motion for acquittal on the
ground that the government did not prove that
Johnston acted with the requisite mens rea.

II. Discussion

A. National standard of care

A doctor may not be convicted under the CSA
for issuing prescriptions to patients unless the doctor
failed to act in good faith and for a legitimate
medical purpose. United States v. Merrill, 513 F.3d
1293, 1301-02 (llth Cir. 2008). Johnston
acknowledges this standard, but argues that the
district court erred by instructing the jury that it
should apply a national standard of care in
determining whether Johnston failed to act in
furtherance of a _ legitimate medical purpose.
Specifically, Johnston takes issue with the district
courts instruction that, “a physicians mere
subjective personal belief that she is meeting a
person’s medical needs by prescribing a controlled
substance is not sufficient to show good faith if the
physician acts outside the accepted standard of
medical practice in the United States” (emphasis
added). Johnston argues that under Gonzales _ v.
Oregon, 546 U.S. 243 (2006), state medical
standards should be used to determine whether a
doctor acted in conformance with accepted medical
standards for the purposes of the CSA. Johnston
argues that by failing to instruct the jury that
Florida’s standard of care governs, the district court

10a

committed reversible error. Moreover, Johnston
argues that this error is jurisdictional and therefore
should be review de novo.

Where a party properly objects to the jury
instructions, we review the legal correctness of a
district court’s jury instruction de novo and issues of
phrasing for abuse of discretion. United States v.
Prather, 205 F.3d 1265, 1270 (llth Cir. 2000).
Ordinarily, if the complaining party fails to object,
we review for plain error. United States v. Schlei,
122 F.3d 944, 973 (11th Cir. 1997). A party waives
the ability to contest the propriety of the
instructions, however, if the party invites the error
by requesting the substance of the instructions that
she later seeks to challenge on appeal. United States
v. Stone, 139 F.3d 822, 838 (11th Cir. 1998). “Where
invited error exists, it precludes a court from
invoking the plain error rule and reversing.” United
States v. Silvestri, 309 F.3d 1311, 1327 (11th Cir.
2005) (citation omitted).

In this case, not only did Johnston fail to
object to the district court’s imposition of a national
standard of care, but she invited the alleged error by
requesting that the court charge the jury that in
order to convict they must find that she “acted
outside the course/scope of professional practice, not
in accordance with a standard of medical practice
generally recognized and acted in the United States”

(emphasis added). Furthermore, Johnston’s proposed
jury instructions included charging the jury on the
section of the Florida Admunistrative Code that
addresses the state’s standards for the use of
controlled substances for the treatment of pain, but

lla

Johnston affirmatively withdrew this instruction at
the charge conference.®

We are also unpersuaded by Johnston's
argument that the alleged error in the jury
instructions is jurisdictional. “A jurisdictional defect
is one that ‘strip[s] the court of its power to act and
ma|[kes] its judgment void.” McCoy v. United States,
266 F.3d 1245, 1249 (llth Cir. 2001) (citation
omitted). An indictment suffers from a jurisdictional
defect when it charges no crime at all, i.e. a non-
offense. United States v. Peter, 310 F.3d 709, 714-15
(llth Cir. 2002) No such situation exists here
because the district court had jurisdiction pursuant
to a valid indictment charging Johnston with crimes
under the CSA. Because the alleged error is not
jurisdictional, we conclude that invited error
doctrine precludes review of the jury instruction that
applied a national standard of care.

B. Red flags evidence

Johnston argues that the district court erred
by permitting the witnesses to testify about “red
flag” profiling evidence and that admitting such
evidence prejudiced the jury. Johnston alleges that
“red flags” is a government-created standard for
identifying drug abuse that has not been accepted by
the medical community, and therefore is not relevant
to the medical standard of care.? Additionally,

* At trial, Johnston’s attorney also questioned Romano about
his opinion as to whether Johnston's treatment “was consistent
with accepted professional standards of care in the United
States.”

® Johnston did not raise this argument before the district court
and submits it for the first time in her brief. She argues that

12a

eohnston contends that the testimony about red
flags was inadmissible under Daubert!® and the
Federal Rules of Evidence because the government
failed to establish that the testimony was reliable or
relevant: Finally, Johnston argues that the district
court improperly permitted experts to use the red
flag testimony to reach legal, rather than medical,
conclusions.

Johnston did not object to the admissibility of
red flag testimony or the experts’ conclusions that
they reached based on the red flags. Where a party
fails to raise an evidentiary objection, we review only
for plain error. United States v. Turner, 474 F.3d
1265, 1275 (11th Cir. 2007). To demonstrate plain
error, Johnston “must show that: (1) an error
occurred; (2) the error was plain; (3) it affected [her]
substantial rights; and (4) it seriously affected the
fairness of the judicial proceedings.” United States v.
Gresham, 325 F.3d 1262, 1265 (11th Cir. 2003). An
error is not plain unless it is contrary to precedent
directly resolving a legal issue. United States v.
Lejarde-Rada, 319 F.3d 1288, 1291 (11th Cir. 2003).

We conclude that Johnston has failed to show
that the district court committed plain error by
admitting the testimony. The Supreme Court has
held that an officer does not have reasonable
suspicion that someone is engaged in criminal
conduct solely on the basis that he fits a profile. Reid

the term “red flags” originated from a 1999 U.S. Drug
Enforcement Administration publication entitled “Don’t be
Scammed by a Drug Abuser.”

'° Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993) (discussing use of expert testimony that has been
determined to be reliable and relevant).

13a

v. Georgia, 448 U.S. 438, 440 (1980) (per curiam)
(discussing “the so-called ‘drug courier profile”). This
court does not permit the admission of evidence
indicating that a defendant fit a particular criminal
profile because such evidence is “inherently
prejudicial because of the potential [it has] for
including innocent citizens.” United States _v.
Hernandez-Cuartas, 717 F.2d 552, 555 (11th Cir.
1983). The instant case, however, is distinguishable.
First, the red flag statements were used to create a
profile about the patient, not Johnston. These
statements were intended to give Johnston reason to
believe that Schaible was an addict or was selling his
medications. The red flags were introduced to show
that Johnston failed to meet the required standard
of care in dealing with her patients; not to show that
Johnston somehow fit a specific criminal profile.
Second, unlike in Reid, Johnston was not identified
as a suspect because she fit a certain criminal
profile. Instead, she was already a suspect prior to
Schaible’s red flag statements. There was therefore
no danger that an innocent person would be swept
up in the investigation simply because she fit a
certain profile.

We further conclude that the experts’
testimony about the red flags was properly admitted
pursuant to Fed. R. Evid. (“Rule”) 702. Under Rule
702, “filf scientific, technical, or other specialized
knowledge will assist the trier of fact to understand
the evidence or to determine a fact in issue, a
witness qualified as an expert ... may testify thereto
in the form of an opinion or otherwise.” Fed. R. Evid.
702. In Daubert, the Supreme Court established a
two-part test under Rule 702 for the admissibility of
expert testimony: a trial judge must determine

14a

“whether the expert is proposing to testify to (1)
scientific knowledge that (2) will assist the trier of
fact to understand or determine a fact in issue.” 509
U.S. at 592. Some factors that should be considered
in exercising this gate-keeping function include “(1)
whether the expert’s theory can be and has been
tested; (2) whether the theory has been subjected to
peer review and publication; (3) the known or
potential rate of error of the particular scientific
technique; and (4) whether the technique is
generally accepted in the scientific community.”
United States v. Douglas, 489 F.3d 1117, 1124-25
(11th Cir. 2007). “The same criteria that are used to
assess the reliability of a scientific opinion may be
used to evaluate the reliability of non-scientific,
experience-based testimony.” United States v.
Frazier, 387 F.3d 1244, 1262 (llth Cir. 2004) (en
banc) (quoting Kumho Tire Co., Ltd. v. Carmichael,
526 U.S. 137, 152 (1999).

Johnston does not challenge the qualifications
of the experts, but rather argues that “red flags” are
not generally accepted scientific evidence of
drugdealing and addiction. We note, however, that
neither the government nor witnesses treated “red
flags” as a term of art. The witnesses’ testimony
treated “red flags” as synonymous with “warning
signs.” The doctors testified that in light of the
strange statements made by Johnston’s patients,
had they confronted similar statements in their own
practices, they would have sought further
information from the patients before prescribing
narcotics. They did not treat “red flags” as a medical
standard and therefore Johnston’s argument that
this evidence is inadmissible under Daubert fails.

15a

We also reject Johnston’s argument that the
experts improperly testified to legal conclusions.
Although experts may not testify to legal
conclusions, “testimony in the form of an opinion or
inference otherwise admissible is not objectionable
because it embraces an ultimate issue to be decided
by the trier of fact.” Fed. R. Evid. 704(a). Pinsley
testified as to the appropriate standard of care in the
medical field and gave her opinion that the
prescriptions “were written without any legitimate
medical purpose.” Criminal knowledge and intent
are issues of fact, not law. See United States v.
Greenfield, 554 F.2d 179, 183 (5th Cir. 1977)!
(“(Djefendant strenuously asserted that the
prescriptions . . . were for a legitimate medical
purpose and within the course of his professional
practice. Necessarily, the issue of criminal intent or
guilty knowledge was a factual issue for the jury to
resolve.”). Pinsley’s testimony was _ therefore
appropriate. In fact, Johnston questioned her own
expert about whether he believed Johnston “acted in
good faith in prescribing the substances” and
“entered into . . . a_ legitimate’ therapeutic
physician/patient relationship” with each undercover
officer.

We therefore conclude that the district court
did not plainly err by admitting the red flag evidence
and permitting the experts to give opinions based in
part on such evidence.

"In Bonner v. City of Prichard, 661 F.2d 1206, 1207 (11th Cir.

1981) (en banc), this court held that all decisions handed down
by the former Fifth Circuit before the close of business on
September 30, 1981, are binding precedent in the Eleventh
Circuit.

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C. Mens rea

Johnston finally argues that the government
did not establish that she acted with bad intent. She
contends that the government’s only evidence of
mens rea came from her failure to react to the
detectives’ red flags.

We review the denial of a motion for judgment
of acquittal based on sufficiency of the evidence de
novo, drawing all inferences in the government’s
favor. United States v. Bowman, 302 F.3d 1228,
1237 (11th Cir. 2002).!2 To convict under 21 U.S.C. §
841, the government must prove that the physician
knowingly or intentionally dispensed controlled
substances and that she did so other than for a
legitimate medical purpose and in the usual course
of her professional practice. United States v. Rosen,
582 F.2d 1032, 1033 (5th Cir. 1978). Knowledge can
be proven through “inferences based upon
surrounding circumstances.” United States v. Vera,
701 F.2d 1349, 1358 (11th Cir. 1983); see also United
States v. Woodard, 531 F.3d 1352, 1360 (2008)
(explaining that the elements can be shown by direct
or circumstantial evidence). The credibility of a
witness is for the jury to determine. United States v.
Parrado, 911 F.2d 1567, 1571 (11th Cir. 1990).

" The government argues that Johnston did not preserve this
issue for appeal. We disagree. Johnston moved for a judgment
of acquittal at the close of the government's case and at the
close of the evidence, arguing that “the evidence is insufficient
as a matter of law.” Although general motions such as this are
typically disfavored, we nonetheless conclude that because
intent is an essential element of the crime, the issue of mens
rea was adequately preserved for appeal.

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We conclude that there was _ sufficient
evidence from which the jury could adduce that
Johnston dispensed the medication for reasons other
than legitimate medical purposes. The jury heard
several suspicious statements that Schaible made to
Johnston, including that he was illegally purchasing
medication off of friends, that he ran out of
medication earlier than he should have, and
insinuations that he might also be selling his
medication. The jury also heard Baginski’s testimony
that she believed that Johnston was prompting her
with what to say in order to obtain pain medication.
The government's experts testified that Johnston’s
notes were very sparse, that her examinations were
unreasonably brief, that she should have physically
examined patients, conducted medical tests, and
obtained medical records, and that she gave
unreasonably strong prescriptions to the patients.
Pinsley expressed her opinion that the prescriptions
were written outside the scope of medical practice
and for no legitimate medical purpose. The jury also
heard Johnston’s expert’s contrary opinion, but was
free to choose among reasonable constructions of the
evidence. See United States v. Alvarez-Sanchez, 774
F.2d 1036, 1039 (11th Cir. 1985). The district court
therefore did not err in denying the motion for a
judgment of acquittal.

III. Conclusion

For the reasons stated, the convictions are
hereby affirmed.

AFFIRMED.

18a

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
FORT MYERS DIVISION

UNITED STATES OF AMERICA
VS. 2:07-cr-105-FtM-29DNF

SHARON JOHNSTON

OPINION AND ORDER

This matter comes before the Court on
Defendant's Renewed Motion for Judgment of
Acquittal, or in the Alternative, Motion for New
Trial (Doc. #76) filed on April 4, 2008. the
government filed a Response (Doc. #78) on April 11,
2008.

Defendant renews her motion for judgment of
acquittal under FED. R. CRIM. P. 29(c), arguing
that there is insufficient evidence to sustain the
verdicts. Contrary to defendant’s arguments, the
Court finds the jury verdicts to be neither capricious
or irrational. The Court finds that there was ample
evidence from which a reasonable jury could find
defendant's guilt beyond a _ reasonable doubt.
Accordingly, defendants Renewed Motion for
Judgment of Acquittal is denied.

Defendant requests a new trial pursuant to
FED. R. CRIM. P. 33 on the ground that the interest
of justice requires a new trial. In deciding a motion
for new trial, the trial court is allowed to weigh the
evidence and determine credibility for itself. The
Court paid close attention to the testimony of all the

19a

witnesses in this interesting case. As in virtually
every case, the government's evidence was not
without defects and was ably challenged by defense
counsel. The Court’s evaluation of the weight to be
given the various witnesses simply does not coincide
with that suggested by defendant. The Court found
the witnesses credible, and found the testimony
justified the verdicts reached by the jury. While the
evidence was disputed, in the Court’s view the jury
verdicts are fully supported by credible evidence.

The Court also rejects defendant’s arguments
that it erred in allowing testimony that a search
warrant was executed, or in allowing certain cross
examination of defendant's expert Dr. Thomas
Romano, or in refusing a cautionary instruction
concerning certain evidence. The admission of
evidence is within the sound discretion of the trial
court, and the Court upon reflection finds no
evidentiary error.

The Court also finds that the evidence of
defendant’s guilt is not insufficient as a matter of
law, and is not contrary to the greater weight of the
evidence. Further, the Court finds that the guilty
verdicts are not contrary to the law or the evidence.
Finally, the court finds that its jury instructions
were proper and adequately covered the pertinent
issues.

Accordingly, it is now

ORDERED:

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Defendant’s Renewed Motion for Judgment of
Acquittal, or in the Alternative, Motion for New

Trial (Doc. #76) is DENIED.

DONE AND ORDERED at Fort Myers,
Florida, this 16th day of April, 2008.

/s/ John E. Steele
JOHN E. STEELE
United States District Judge

Copies:
AUSA Molloy
Counsel of Record

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UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
FT. MYERS DIVISION

UNITED STATES OF AMERICA

-VS-

SHARON JOHNSTON

Case Number: 2:07-cr-105-FtM-29DNF
USM Number: 34400-018

Joel Hirschhorn, Retained
Keith Pierro, Revained
550 Biltmore Way

Coral Gables, FL 33134
JUDGMENT IN A CRIMINAL CASE

The defendant was found guilty on Count One,
Two, Three & Four of the Indictment.
Accordingly, the Court has adjudicated
that the defendant is guilty of the
following offense(s):

Date

Title & Nature of a Count
Section Offense Peseta d Number(s)
Illegally

21 U.S.C.8§ Dispensing
841(a)(1), Oxycodone & June 11,

841(b)(1)(C) Alprazolam 2007 Cne

22a

21 U.S.C.§§ Illegally
841(a)(1), Dispensing June 27,
841(b)(1)(C) Oxycodone 2067 Two

Illegally
21 U.S.C.§§ Dispensing
841(a)(1), Alprazolam &
841(b)(1)(C) Methadone July 5, 2007 Three

21 U.S.C.§§ Illegally
841(a)(1), Dispensing July 10,
841(b)(1)(C) Oxycodone 2007 Four

The defendant is sentenced as provided in the
following pages of this judgment. The sentence is
imposed pursuant to the Sentencing Reform Act of
1984, as modified by United States v. Booker, 125 S.
Ct. 738 (2005).

IT IS ORDERED that the defendant shall notify
the United States attorney for this district within 30
days of any change of name, residence, or mailing
address until all fines, restitution, costs and special
assessments imposed by this judgment are fully
paid. If ordered to pay restitution, the defendant
shall notify the court and United States attorney of
any material change in the defendant’s economic
circumstances.

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Date of Imposition of Sentence:
July 29, 2008

/s/ John E. Steele

John E. Steele

United states district judge

July 29, 2008

IMPRISONMENT

The defendant is hereby committed to the
custody of the United States Bureau of Prisons to be
imprisoned for a total term of 30 Months as to each
count, to be served concurrently.

The Court recommends to the Bureau of
Prisons:

1. Incarceration in a facility close to
home (Naples, Florida). The defendant is
remanded to the custody of the United States
Marshal.

RETURN
I have executed this judgment as follows:
Defendant delivered on to

at , with a
certified copy of this judgment.

UNITED STATES MARSHAL

24a

By:

Deputy U.S. Marshal
SUPERVISED RELEASE

Upon release from imprisonment, the
defendant shall be on supervised release for a term
of Three (3) Years as to each count, to run
concurrently.

The defendant shall report to the probation
office in the district to which the defendant is
released within 72 hours of release from custody of
the Bureau of Prisons.

The defendant shall not commit another
federal, state or local crime. The defendant shall not
illegally possess a controlled substance. For offenses
committed on or after September 13, 1994:

The defendant shall refrain from any unlawful
use of a controlled substance. The defendant shall
submit to one drug test within 15 days of release
from imprisonment and at least two periodic drug
tests thereafter.

The defendant shall not possess a firearm,
destructive device, or any other dangerous weapon.

If this judgment imposes a fine or a
restitution obligation, it shall be a condition of
supervision that the defendant pay any such fine or
restitution that remains unpaid’ at_ the
commencement of the term of supervision in
accordance with the Schedule of Payments set forth

25a

in the Criminal Monetary Penalties sheet of this
judgment.

The defendant shall comply with the standard
conditions that have been adopted by this court (set
forth below). The defendant shall also comply with
the additional conditions on the attached page.

STANDARD CONDITIONS OF SUPERVISION

1. The defendant shall not leave the judicial
district without the permission of the court or
probation officer;

2. The defendant shall report to the probation
officer and shall submit a truthful and complete
written report within the first five days of each
month;

x. The defendant shall answer truthfully all
inquiries by the probation officer and follow the
instructions of the probation officer;

4. The defendant shall support his or her
dependents and meet other family responsibilities;

S. The defendant shall work regularly at a lawful
occupation, unless excused by the probation officer
for schooling, training, or other acceptable reasons;

6. The defendant shall notify the probation
officer at least ten (10) days prior to any change
in residence or employment;

26a

‘. The defendant shall refrain from excessive use
of alcohol and shall not purchase, possess, use,
distribute, or administer any controlled substance or
any paraphernalia related to any _ controlled
substances, except as prescribed by a physician;

8. The defendant shall not frequent places where
controlled substances are ulegally sold, used,
distributed, or administered;

9. The defendant shall not associate with any
persons engaged in criminal activity and shall not
associate with any person convicted of a felony,
unless granted permission to do so by the probation
officer;

10. The defendant shall permit a probation officer
to visit him or her at any time at home or elsewhere
and shall permit confiscation of any contraband
observed in plain view by the probation officer;

11. The defendant shall notify the probation
officer within seventy-two (72) hours of being
arrested or questioned by a law enforcement officer;

12. The defendant shall not enter into any
agreement to act as an informer or a special agent of
a law enforcement agency without the permission of
the court;

13. As directed by the probation officer, the
defendant shall notify third parties of risks that may
be occasioned by the defendant’s criminal record or
personal history or characteristics, and shall permit
the probation officer to make such notifications and

27a

to confirm the defendant's compliance with such
notification requirement.

ADDITIONAL CONDITIONS OF
SUPERVISED RELEASE

The defendant shall also comply with the

following additional conditions of supervised release:

1.

The defendant shall participate as directed in
a substance abuse program (outpatient and/or
inpatient) and follow the Probation Officer’s
instructions regarding the implementation of
this Court directive. Further, the defendant
shall be required to contribute to the costs of
services not to exceed an amount determined
reasonable by the Probation Office’s Sliding
Scale for Substance Abuse Treatment
Services. During and upon the completion of
this program, the defendant is directed to
submit to random drug testing.

The defendant shall participate in a mental
health treatment program (outpatient and/or
inpatient) and shall follow the probation
officer’s instructions regarding the
implementation of this court directive.
Further, the defendant shall be required to
contribute to the costs of these services not to
exceed an amount determined reasonable by
the Probation Office’s Sliding Scale for Mental
Health Treatment Services.

Having been convicted of a qualifying felony
offense, the defendant shall cooperate with the

28a

probation office in the collection of DNA, if not
already collected by the Bureau of Prisons.

4. The mandatory drug testing requirements of
the Violent Crime Control Act are imposed.
The Court orders the defendant to submit to
random drug testing not to exceed 104 tests
per year.AO 245B (Rev. 3/01) Judgment in a
Criminal Case

CRIMINAL MONETARY PENALTIES

The defendant shall pay the following total
criminal monetary penalties in accordance with the
schedule of payments set forth in the Schedule of
Payments.

Total ; Total
Assessment Total Fine Restitution
$400.00 (Due
Immediately) Waived N/A

The defendant shall pay interest on any fine
or restitution of more than $2,500, unless the fine or
restitution is paid in full before the fifteenth day
after the date of the judgment, pursuant to 18 U.S.C.
§ 3612(f). All of the payment options on the Schedule
of Payments may be subject to penalties for
delinquency and default, pursuant to 18 U.S.C. §
3612(g).

The mandatory drug testing requirements of
the Violent Crime Control Act are imposed. Based on
the Court’s determination that additional drug

29a

urinalysis is necessary, the Court authorizes random
drug testing not to exceed 104 tests per year.

*Findings for the total amount of losses are required
under Chapters 109A, 110, 110A, and 113A of Title
18, United States Code, for offenses committed on or
after September 13, 1994 but before April 23, 1996.

30a

Amendment X. Reserved Powers

AMENDMENTS - BILL OF RIGHTS

The powers not delegated to the United States
by the Constitution, nor prohibited by it to the
States, are reserved to the States respectively, or to
the people.

3la

21 USC § 802

Title 21 - FOOD AND DRUGS

Chapter 13 - DRUG ABUSE PREVENTION AND
CONTROL

As used in this subchapter:

(1) The term “addict” means any individual
who habitually uses any narcotic drug so as to
endanger the public morals, health, safety, or
welfare, or who is so far addicted to the use of
narcotic drugs as to have lost the power of self-
control with reference to his addiction.

(2) The term “administer” refers to the direct
application of a controlled substance to the body of a
patient or research subject by -

(A) a practitioner (or, in his presence, by his
authorized agent), or

(B) the patient or research subject at the
direction and in the presence of the practitioner,

whether such application be by injection,
inhalation, ingestion, or any other means.

(3) The term “agent” means an authorized
person who acts on behalf of or at the direction of a
manufacturer, distributor, or dispenser; except that
such term does not include a common or contract
carrier, public warehouseman, or employee of the
carrier or warehouseman, when acting in the usual
and lawful course of the carrier’s or warehouseman’s

business.

32a

(4) The term “Drug Enforcement
Administration” means the Drug Enforcement
Administration in the Department of Justice.

(5) The term “control” means to add a drug or
other substance, or immediate precursor, to a
schedule under part B of this subchapter, whether
by transfer from another schedule or otherwise.

(6) The term “controlled substance” means a
drug or other substance, or immediate precursor,
included in schedule I, II, III, IV, or V of part B of
this subchapter. The term does not include distilled
spirits, wine, malt beverages, or tobacco, as those
terms are defined or used in subtitle E of the
Internal Revenue Code of 1986.

(7) The term “counterfeit substance” means a
controlled substance which, or the container or
labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark,
imprint, number, or device, or any likeness thereof,
of a manufacturer, distributor, or dispenser other
than the person or persons who ins fact
manufactured, distributed, or dispensed such
substance and which thereby falsely purports or is
represented to be the product of, or to have been
distributed by, such other manufacturer, distributor,
or dispenser.

(8) The terms “deliver” or “delivery” mean the
actual, constructive, or attempted transfer of a
controlled substance or a listed chemical, whether or
not there exists an agency relationship.

(9) The term “depressant or stimulant
substance” means -

33a

(A) a drug which contains any quantity of
barbituric acid or any of the salts of barbituric acid;
or

(B) a drug which contains any quantity of (1)
amphetamine or any of its optical isomers; (ii) any
salt of amphetamine or any salt of an optical isomer
of amphetamine; or (ii) any substance which the
Attorney General, after investigation, has found to
be, and by regulation designated as, habit forming
because of its stimulant effect on the central nervous
system; or

(C) lysergic acid diethylamide; or

(D) any drug which contains any quantity ofa
substance which the Attorney General, after
investigation, has found to have, and by regulation
designated as having, a potential for abuse because
of its depressant or stimulant effect on the central
nervous system or its hallucinogenic effect.

(10) The term “dispense” means to deliver a
controlled substance to an ultimate user or research
subject by, or pursuant to the lawful order of, a
practitioner, including the _ prescribing and
administering of a controlled substance and the
packaging, labeling or compounding necessary to
prepare the substance for such delivery. The term
“dispenser” means a practitioner who so delivers a
controlled substance to an ultimate user or research
subject.

(11) The term “distribute” means to deliver
(other than by administering or dispensing) a
controlled substance or a listed chemical. The term

34a

“distributor” means a person who so delivers a
controlled substance or a listed chemical.

(12) The term “drug” has the meaning given
that term by section 321(g)(1) of this title.

(13) The term “felony” means any Federal or
State offense classified by applicable Federal or
State law as a felony.

(14) The term “isomer” means the optical
isomer, except as used in schedule I(c) and schedule
II(a)(4). As used in schedule I(c), the term “isomer”
means any optical, positional, or geometric isomer.
As used in schedule II(a)(4), the term “isomer”
means any optical or geometric isomer.

(15) The term “manufacture” means the
production, preparation, propagation, compounding,
or processing of a drug or other substance, either
directly or indirectly or by extraction from
substances of natural origin, or independently by
means of chemical synthesis or by a combination of
extraction and chemical synthesis, and includes any
packaging or repackaging of such substance or
labeling or relabeling of its container; except that
such term does not include the preparation,
compounding, packaging, or labeling of a drug or
other substance in conformity with applicable State
or local law by a practitioner as an incident to his
administration or dispensing of such drug or
substance in the course cf his professional practice.
The term “manufacturer” means a person who
manufactures a drug or other substance.

35a

(16) The term “marihuana” means all parts of
the plant Cannabis sativa L., whether growing or
not; the seeds thereof; the resin extracted from any
part of such plant; and every compound,
manufacture, salt, derivative, mixture, or
preparation of such plant, its seeds or resin. Such
term does not include the mature stalks of such
plant, fiber produced from such stalks, oil or cake
made from the seeds of such plant, any other
compound, manufacture, salt, derivative, mixture, or
preparation of such mature stalks (except the resin
extracted therefrom), fiber, oil, or cake, or the
sterilized seed of such plant which is incapable of
germination.

(17) The term “narcotic drug” means any of
the following whether produced directly or indirectly
by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by
a combination of extraction and chemical synthesis:

(A) Opium, opiates, derivatives of opium and
opiates, including their isomers, esters, ethers, salts,
and salts of isomers, esters, and ethers, whenever
the existence of such isomers, esters, ethers, anu
salts is possible within the specific chemical
designation. Such term does not include the
isoquinoline alkaloids of opium.

(B) Poppy straw and concentrate of poppy
straw.

(C) Coca leaves, except coca leaves and
extracts of coca leaves from which cocaine, ecgonine,
and derivatives of ecgonine or their salts have been
removed.

36a

(D) Cocaine, its salts, optical and geometric
isomers, and salts of isomers.

(E) Ecgonine, its derivatives, their salts,
isomers, and salts of isomers.

(F) Any compound, mixture, or preparation
which contains any quantity of any of the substances
referred to in subparagraphs (A) through (E).

(18) The term “opiate” means any drug or
other substance having “%.1 addiction-forming or
addiction-sustaining liability similar to morphine or
being capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability.

(19) The term “opium poppy” means the plant
of the species Papaver somniferum L., except the
seed thereof.

(20) The term “poppy straw” means all parts,
except the seeds, of the opium poppy, after mowing.

(21) The term “practitioner” means a
physician, dentist, veterinarian, scientific
investigator, pharmacy, hospital, or other person
licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he
practices or does research, to distribute, dispense,
conduct research with respect to, administer, or use
in teaching or chemical analysis, a controlled
substance in the course of professional practice or
research.

(22) The term “production” includes the
manufacture, planting, cultivation, growing, or
harvesting of a controlled substance.

37a

(23) The term “immediate precursor” means a
substance -

(A) which the Attorney General has found to
be and by regulation designated as being the
principal compound used, or produced primarily for
use, in the manufacture of a controlled substance;

(B) which is an immediate chemical
intermediary used or likely to be used in the
manufacture of such controlled substance; and

(C) the control of which is necessary to
prevent, curtail, or limit the manufacture of such
controlled substance.

(24) The term “Secretary”, unless the context
otherwise indicates, means the Secretary of Health
and Human Services.

(25) The term “serious bodily injury” means
bodily injury which involves -

(A) a substantial risk of death;
(B) protracted and obvious disfigurement; or

(C) protracted ioss or impairment of the
function of a bodily member, organ, or mental
faculty.

(26) The term “State” means a State of the
United States, the District of Columbia, and any
commonwealth, territory, or possession of the United
States.

38a

21 USC § 829

Title 21 - FOOD AND DRUGS

Chapter 13 - DRUG ABUSE PREVENTION AND
CONTROL

SUBCHAPTER I - CONTROL AND
ENFORCEMENT

Part C - Registration of Manufacturers,
Distributors, and Dispensers of Controlled
Substances

(a) Schedule IT substances

Except when dispensed directly by a
practitioner, other than a pharmacist, to an ultimate
user, no controlled substance in schedule II, which is
a prescription drug as determined under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.],
may be dispensed without the written prescription of
a practitioner, except that in emergency situations,
as prescribed by the Secretary by reguation after
consultation with the Attorney General, such drug
may be dispensed upon oral prescription in
accordance with section 503(b) of that Ac: [21 U.S.C.
353(b)]. Prescriptions shall be retained in conformity
with the requirements of section 827 of tiis title. No
prescription for a controlled substance inschedule II
may be refilled.

(b) Schedule III and IV substances

Except when dispensed direcdly by a
practitioner, other than a pharmacist, toin ultimate
user, no controlled substance in schedub III or IV,
which is a prescription drug as determned under

39a

the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.], may be dispensed without a written or
oral prescription in conformity with section 503(b) of
that Act [21 U.S.C. 353(b)]. Such prescriptions may
not be filled or refilled more than six months after
the date thereof or be refilled more than five times
after the date of the prescription unless renewed by
the practitioner.

(c) Schedule V substances

No controlled substance in schedule V which
is a drug may be distributed or dispensed other than
for a medical purpose.

(d) Non-prescription drugs with abuse
potential

Whenever it appears to the Attorney General
that a drug not considered to be a prescription drug
under the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.] should be so considered because
of its abuse potential, he shall so advise the
Secretary and furnish to him all available data
relevant thereto.

(Pub. L. 91-513, title II, Sec. 309, Oct. 27,
1970, 84 Stat. 1260.)

21 USC § 841

Title 21 - FOOD AND DRUGS

Chapter 13 - DRUG ABUSE PREVENTION AND
CONTROL

(a) Unlawful acts

Except as authorized by this subchapter, it
shall be unlawful for any person knowingly or
intentionally -

(1) to manufacture, distribute, or dispense, or
possess with intent to manufacture, distribute, or
dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess
with intent to distribute or dispense, a counterfeit
substance.

(b) Penalties

Except as otherwise provided in section 849,
859, 860, or 861 of this title, any person who violates
subsection (a) of this section shall be sentenced as
follows:

(1)(A) In the case of a violation of subsection
(a) of this section involving -

(i) 1 kilogram or more of a mixture or
substance containing a detectable amount of heroin;

(ui) 5 kilograms or more of a mixture or
substance containing a detectable amount of -

(I) coca leaves, except coca leaves and extracts
of coca leaves from which cocaine, ecgonine, and

4la

derivatives of ecgonine or their salts have been
removed;

(II) cocaine, its salts, optical and geometric
isomers, and salts of isomers;

(III) ecgonine, its derivatives, their salts,
isomers, and salts of isomers; or

(IV) any compound, mixture, or preparation
which contains any quantity of any of the substances
referred to in subclaus

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_0498%3A1. Public record. Not legal advice.