Petition for Writ of Certiorari — Lonnie W. Hubbard, Petitioner v. United States

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Supreme Court. U.S.

FILED

JAN 1 6 2U2U

OFFICE OF THE CLERK

IN THE

SUPREME COURT OF THE UNITED STATES

LONNIE W. HUBBARD

_ — PETITIONER

(Your Name)

vs.

UNITED STATES OF AMERICA

— RESPONDENT(S)

ON PETITION FOR A WRIT OF CERTIORARI TO

UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT

(NAME OF COURT THAT LAST RULED ON MERITS OF YOUR CASE)

PETITION FOR WRIT OF CERTIORARI

LONNIE W. HUBBARD

(Your Name)

FEDERAL CORRECTION INSTITUTION-HAZELTON

P.0. Box 5000

(Address)

BRUCETON MILLS, WV 26525

(City, State, Zip Code)

NO PHONE

(Phone Number)

: J

V^J E-

If*

QUESTION(S) PRESENTED

STATEMENT BEFORE QUESTION

After defendant pharmacist Lonnie W. Hubbard was charged in an indictment by

the U.S. Attorney’s Office for allegedly illegally dispensing controlled

substance prescriptions in violation of 21 C.F.R. § 1306.04(a) & 21 U.S.C.

§ 841(a)(1), defendant pharmacist pled 'not guilty' because he was sure he

obtained legitimate medical purposes before every controlled substance

prescription was filled. After he lost at trial, he asked the Court of

Appeals for the Sixth Circuit, whether there was sufficient evidence to.

convict him to the Counts in the indictment because the essential element

of § 1306.04(a) 'without a legitimate medical purpose' was not satisfied

, by the government's burden of proof. The Court of Appeals ruled defendant

pharmacist's argument frivolous and held "knowingly distributing prescriptions

outside the course of professional practice is a sufficient condition to

convict a defendant under the criminal statutes" and affirmed the District

Court's decision.

QUESTION

WHETHER THE COURT OF APPEALS ERRED BY HOLDING A JURY COULD RATIONALLY

CONCLUDE THAT DEFENDANT PHARMACIST ABDICATED HIS DUTY UNDER §§ 1306.04(a)

& 841(a)(1), DESPITE PHARMACIST'S ARGUMENT THAT THERE WERE 'LEGITIMATE

MEDICAL PURPOSES' FOR THE CONTROLLED SUBSTANCE PRESCRIPTIONS HE FILLED

BECAUSE TRIAL WITNESSES TESTIFIED THAT THEY HAD REAL INJURIES AND MEDICAL

NEEDS REQUIRING MEDICATION BEFORE PHARMACIST FILLED THEIR PRESCRIPTIONS.

LIST OF PARTIES

[ $ All parties appear in the caption of the case on the cover page.

[ ] All parties do not appear in the caption of the case on the cover page. A list of

all parties to the proceeding in the court whose judgment is the subject of this

petition is as follows:

TABLE OF CONTENTS

OPINIONS BELOW

JURISDICTION

CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED

STATEMENT OF THE CASE

REASONS FOR GRANTING THE WRIT

CONCLUSION

INDEX TO APPENDICES

APPENDIX A

The opinion of the United States Court of Appeals for the

Sixth Circuit.

APPENDIX B

A copy of the order denying the 'Petition for Panel Rehearing'.

APPENDIX C

The opinion of the United States District Court for the

Sixth Circuit.

APPENDIX D

The verbatim reading of Federal Statute 21 U.S.C. § 829

because it is too lengthy to cite in 'CONSTITUTIONAL AND

STATUTORY PROVISIONS INVOLVED' page 3.

APPENDIX E

APPENDIX F

iii

TABLE OF AUTHORITIES

CASES

PAGE

12,13,24

Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904 (2006)

United States v. Moore, 423 U.S. 122, 96 S. Ct. 325 (1975)

9,10,12,17,19,23

Yates v. United States, 574 U.S. 528, 135 S. Ct. 1074 (2015)

United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008)

United States v. Birbragher, 576 Fed. Supp. 2d. 1000 (8th Cir. 2010)

United States v. Boettjer, 569 F.2d 1078 (9th Cir. 1978)

United States v. Chaney, 921 F.3d 572 (6th Cir. 2019)

15,16,24

United States v. Collier, 478 F.2d 268 (5th Cir. 1973)

United States v. Darji, 609 Fed. Appx. 320 (6th Cir. 2015)

United States v. Feingold, 454 F.3d 1001 (9th Cir. 2006)/

12,17,18

United States v. Fuchs, 467 F.3d 889 (5th Cir. 2006)

United States v. Kanner, 603 F.3d 530 (8th Cir. 2010)

United States v. Kirk, 584 F.2d 773 (6th Cir. 1978)

10,16

United States v. Kohli, 847 F.3d 483 (7th Cir. 2017)

United States v. Lovern, 590 F.3d 1095 (10th Cir. 2009)

United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004)

United States v. Orta-Rosario, 469 Fed. Appx. 140 (4th Cir. 2012)

United States v. Outler, 659 F.2d 1306 (5th Cir. 1981)

10,11

United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978)

797 F.2d 1146 (2nd Cir. 1986)

United States v. Volkman, 797 F.3d 377 (6th Cir. 2015)

13,14,24

United States v. Vamos

United States v. Brickhouse, 2016 U.S. Dist. LEXIS 59821 (E.D. Tenn. 2016)14

United States v. Quinones, 536 Fed. Supp. 2d. 267 (E.D. N.Y. 2008)

OTHER

http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide .htm (2014)

TABLE OF AUTHORITIES ( cont.)

https://www.deadiversion.usdoj.gov/pubs/manuals/index.html (2014)

Pharmacy Practice and the Law, Richard R. Abood, 7th Ed. 2014

PAGE

CODE OF FEDERAL REGULATIONS

21 C.F.R. § 1306.04(a)

9,11,12,13,14,15,16,19,20,21,22,23,24

STATUTES

21 U.S.C. § 801

21 U.S.C. § 802

13,21,22

21 U.S.C. § 812(b)

12,21

21 U.S.C. f 829(c)

12,21

21 U.S.C. § 830(b)(3)(A)(ii)

12,21

21 U.S.C. S 841

9,11,12;i4,15,16,17,20,22,23,24

FEDERAL RULES

Rule 29 Motion

IN THE

SUPREME COURT OF THE UNITED STATES

PETITION FOR WRIT OF CERTIORARI

Petitioner respectfully prays that a writ of certiorari issue to review the judgment below.

OPINIONS BELOW

P] For cases from federal courts:

The opinion of the United States court of appeals appears at Appendix

the petition and ign^tecj

______ States v. Hubbard,

|X] reported at 2019 U.S,._Adp. LEXTS 21311. (Ath rir._?0lQ) or,

[ ] has been designated for publication but is not yet reported; or,

[ ] is unpublished.

The opinion of the United States district court appears at Appendix

the petition and is

United States v. Hubbard,

Bd reported at -2017 U.S.-Dist. LEXIS £2982 (6th 0T§£-2QX9)or,

[ ] has been designated for publication but is not yet reported; or,

[ ] is unpublished.

-A .1

[ ] For cases from state courts:

The opinion of the highest state court to review the merits appears at

Appendix_____ to the petition and is

[ ] reported at

; or,

[ ] has been designated for publication but is not yet reported; or,

[ ] is unpublished.

The opinion of the_

appears at Appendix

court

to the petition and is

[ ] reported at

; or,

[ ] has been designated for publication but is not yet reported; or,

[ ] is unpublished.

JURISDICTION

[X] For cases from federal courts:

The date on which the United States Court of Appeals decided my case

was July 19, 2019

[ ] No petition for rehearing was timely filed in my case.

[X] A timely petition for rehearing was denied by the United States Court of

Appeals on the following date: Novpnibpr 19. 2019

, and a copy of the

order denying rehearing appears at Appendix

[ ] An extension of time to file the petition for a writ of certiorari was granted

to and including _

(date) on

(date)

in Application No.

The jurisdiction of this Court is invoked under 28 U. S. C. § 1254(1).

[ ] For cases from state courts:

The date on which the highest state court decided my case was

A copy of that decision appears at Appendix_______

[ ] A timely petition for rehearing was thereafter denied on the following date:

--------------------------------- , and a copy of the order denying rehearing

appears at Appendix

[ ] An extension of time to file the petition for a writ of certiorari was granted

to and including____

(date) on

(date)in

Application No. __ A

The jurisdiction of this Court is invoked under 28 U. S. C. § 1257(a).

CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED

Federal Statute

21 U.S.C. § 841

§ 841. Prohibited acts A

(a) Unlawful acts. Except as authorized by this title, it shall be unlawful

for any person knowingly or intentionally—

(il) to manufacture, distribute, or dispense, or possess with intent to

manufacture, distribute, or dispense, a controlled substance; or

Code of Federal Regulation

21 C.F.R. § 1306.04

§ 1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued

for a legitimate medical purpose by an individual practioner acting in

the usual course of his professional practice. The responsibility for

the proper prescribing and dispensing of controlled substances is upon

the prescribing practioner, but a corresponding responsibility rests

with the pharmacist who fills the prescription. An order purporting to

be a prescription issued not in the usual course of professional

treatment or in legitimate and authorized research is not a prescription

within the meaning and intent of section 309 of the Act (21 U.S.C. 829)

and the person knowingly filling such a purported prescription, as well

as the person issuing it, shall be subject to the penalties provided

for violations of the provisions of law relating to controlled

substances.

Federal Statute

21 U.S.C. § 829

(See Appendix D for verbatim reading of the statute.)

STATEMENT OF THE CASE

In 2015, the United States filed a thirty-eight Count indictment against

Hubbard, a pharmacist, his pharmacy, Rx Discount of Berea, PLLC, his wife

and six others.

The indictment alleged that the defendant conspired to

distribute oxycodone and pseudoephedrine, distributed oxycodone, pseudoephedrine„

and hydrocodone, failed to obtain proper I.D. from persons purchasing

pseudoephedrine, maintained a drug premises, and conspired to commit 'money/

laundering and other fraudulent financial transactions.

Two superseding

indictments were subsequently filed bringing the total number of charges

to seventy-three.

An eight day jury trial was held in February 2017, where

Courits\,7 & 47 were dismissed on motion by the United States.

The jury found

Hubbard guilty on the remaining counts and the district court imposed a

total term of imprisonment of 360 months, followed by three years supervised

release.

The district court also ordered criminal forfeiture of real and

personal property,

Hubbard filcifa motion for a new trial, which was

overruled.

On direct appeal, Hubbard,1,rs counsel filed a motion to withdraw pursuant

to Anders v. California, 386 U.S. 738 (1967) notifying the Court';of a lack of

good-faith issues for appeal,

with a response-brief.

Hubbard responded to counsel's Anders brief

The Court subsequently entered an order granting

counsel's motion to withdraw, appointed new counsel under the CJA and allowed

the filing of supplemental briefs following appointment of new counsel.

Although new.counsel was appointed, he filed a motion to withdraw pursuant

to Anders, stating he had nothing to add to original counsel's brief,

filed another response-brief.

Hubbard

The Court independantly reviewed the record

and briefs, of counsel and Hubbard and allowed counsel to withdraw because

no grounds for appeal could be sustained.

Specifically, Hubbard claimed

STATEMENT OF THE CASE (cent.)

insufficient evidence on the indictment's oxycodone Counts under §§ 1306.04(a)

& 841.

The Court answered, M[t]his Court long ago held the language in §

841(a)(1) and 21 C.F.R. § 1306.04(a) clearly defines the pharmacist's

responsibilities that give rise to conduct that constitutes an unlawful

distribution of a prescription drug ... [kjnowingly distributing prescriptions

outside the course of professional practice is a sufficient condition to

convict a defendant under the criminal statutes relating to controlled

substances."

The Court found frivolous Hubbard's argument that the controlled

substance prescriptions he filled were for legitimate medical purposes

finding "[djespite Hubbard's argument that he filled prescriptions for

customers who testified at trial that they had real injuries and medical

needs that required prescription medication, a jury could rationally

conclude that Hubbard abdicated his duty as a pharmacist to ensure that

each of these prescriptions was for a legitimate medical purpose, even in

light of the witnesses' alleged injuries or conditions.

No arguable issue

could be raised on appeal to challenge the sufficiency of the evidence as

it related to Counts 49 to 59."

Hubbard filed a timely 'Petition for Panel Rehearing' contesting four

aspects of his case.

That motion was denied four months later.

Hubbard

now files this 'Petition for Writ of Certiorari' to the Supreme Court.

REASONS FOR GRANTING THE PETITION

America's 'Opioid Crisis' has expanded the Department of Justice's

prosecution of healthcare practioners under the criminal statutes of the

Controlled Substance Act (CSA), most notably under §§ 1306.04(a) & 841.

The

Supreme Court in United States v. Moore, 423 U.S. 122 (1975) held a

practioner could be charged and convicted under § 841 when a doctor ceases

to be a doctor and becomes a drug pusher.

The Court did not fully elaborate

on what exact essential elements are required for conviction, but did find

practioners were not exempted from criminal liability because of their

status as a registrant.

The Supreme Court not elaborating on what essential elements were

required for conviction ended up causing a federal Circuit split as to what

essential elements are required to prosecute a practioner under §§ 1306.04(a)

& 841.

Today, ten federal Circuits hold a practioner can be held criminally

liable for dispensing controlled substance prescriptions when he dispenses

them either 'outside the usual course of his professional practice' or when

he dispenses them 'without a legitimate medical purpose .

Two federal

Circuits hold a practioner can be held criminally liable for dispensing

controlled substance prescriptions when he dispenses them outside the usual

course of his professional practice' and when he dispenses them 'without a

legitimate medical purpose',

This 'higher showing' for conviction prevents

practioners from being convicted solely on a jury's finding of malpractice,

negligence, incompetence, or that he was foolish or reckless.

Moreover,

several Circuits have ruled the above mentioned phrases can be used

interchangeably.

In Gonzales v. Oregon, 546 U.S. 243 (2006), the Supreme Court held that

the Attorney General does not have statutory authority to criminalize

ll.

REASONS FOR GRANTING THE PETITION (Cont.)

assisted suicides and that his interpretation was inconsistent with the

statute.

In the Court's dicta, the Court highlights the statutes which

require a 'legitimate medical purpose' in order for a prescription to be

valid supporting the notion that this element is required for dispensing

controlled substances, and the two phrases of § 1306.04(a) Are not

interchangeable.

Federal Courts have repeatedly ruled §§ 1306.04(a) & 841(a)(1) are not

void for vagueness and clear in their proscriptions to practioners.

The Sixth Circuit's holdings on convicting practioners under §§ 1306.04(a)

& 841 seem contrary to its own findings and dicta.

In. one case the Sixth

Circuit holds that 'without a legitimate medical purpose' is a required

element to convict a practioner under § 841(a)(1), but in another case,

the Sixth Circuit holds that 'knowingly distributing prescriptions outside

, ' the course of professional practice [alone] is a sufficient condition to

convict a defendant under the criminal statutes'.

They both cannot be correct.

The DEA's guidance advises pharmacists literally that § 1306.04(a)

requires two elements for the purpose of a prescription:

the prescription be

issued for a legitimate medical purpose by an individual practioner acting in

the usual course of his professional practice.

Clearly here also, the two

phrases are not interchangeable.

Congress intended the literal reading of the text of the regulation and

statutes to include both essential elements 'without a legitimate medical

purpose' and 'outside the usual course of professional practice' in order to

convict practioners.

Congress intended the phrases to have distinct, separate

meanings in the regulation and statutes and are not interchangeable.

The Supreme Court should grant this petition and clarify its holdings

7 .

REASONS FOR GRANTING THE PETITION (Cont.)

and dicta in Moore ending the federal Circuit split by ruling unequivocally

that Congress intended that § 1306.04(a) requires two essential elements to

convict healthcare practioners under § 841, which is a 'higher showing' for

conviction which prevents practioners from being convicted on a finding of

malpractice, negligence, incompetence or otherwise.

Furthermore, the

Supreme Court should find that the two phrases have distinct, separate

meanings in the regulation and statutes and that they may not be used

interchangeably, or be used as a single element such as what the Sixth

Circuit has held.

FEDERAL CIRCUITS ARE SPLIT IN HOW TO DETERMINE WHETHER A FRACITONER

VIOLATED THE CRIMINAL STATUTES UNDER THE CSA.

The Moore Court Allowed Prosecution for Practioners Under § 841, But

Did Not Address the Required Essential Elements for Conviction.

The Supreme Court in United States v. Moore, 423U.S. 122, 139-43, 96

S. Ct. 325, 46 L. Ed. 2d. 333 (1975), held that a registered physician

could be charged and convicted under § 841 of the CSA for drug trafficking.

The precise elements of §§ 1306.04(a) & 841(a)(1) were not specifically

addressed in Moore, but the Court held that (l) a physician registered

under the Act was not per se exempted from prosecution under § 841 merely

because of his status as a registrant, with only the lawful acts of

registrants being exempted, and (2) a registered physician could be

prosecuted under § 841 when his activities fell outside the usual course

of professional practice, and (3) the evidence in the case was sufficient

to establish the defendant’s conduct exceeded the bounds of professional

practice.

Thus, a physician remains criminally liable when he ceases to

dispense controlled substances as a medical professional, and acts as a

"pusher” instead. Moore, 423 U.S. at 138, 143.

This hallmark Supreme Court

case would be interpreted to allow conviction under § 841 for healthcare

practioners such as doctors, pharmacists, dentists, nurse practioners, and

physician assistants who ceased to be medical professionals and instead

became drug pushers.

Ten federal Circuits have interpreted §§ 1306.04(a) &

841, Moore to allow conviction of practioners when they dispense "other than

in good faith ... in the usual course of a professional practice and in

accordance with a standard of medical practice generally recognized and

accepted in the United States." Moore, 423 U.S. at 139.

Those ten Circuits

are the 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th, 11th and D.C. Circuits.

However, two Circuits have held that §§ 1306.04(a) & 841 and the dicta in

Moore, directly and implicitly intended, that a prescription for a controlled

substance must be issued for a 'legitimate medical purpose' AND be dispensed

in the 'usual course of his professional practice'.

Those two Circuits are

the 7th & 9th Circuits.

The Phrases 'Without a Legitimate Medical Purpose' and 'Outside the Usual

bourse of Professional Practice' Have Been Used Interchangeably After

Moore, and the Rtrases Have No Statutory Definitions.

The Sixth Circuit, and others, have endorsed a broad approach to determine

what conduct falls "outside the accepted bounds of professional practice" so

as to constitute a CSA violation utilizing a case-by-case approach.

See

United States v. Kirk, 584 F.2d 773, 784 (6th Cir. 1978) holding "there is

no difference in the meanings of the statutory phrase, 'In the usual course

of professional practice' and the regulations' phrase, 'legitimate medical

purpose.'"

See also^United States v. Outler, 659 F.2d 1306, 1308-09 (5th

Cir. 1981) apparently using the phrases "without a legitimate medical reason"

and "beyond the course of professional practice" interchangeably by the

Court.

Moreover, there are no statutory definitions of 'legitimate medical

purpose' or 'outside the usual course of professional practice' but caselaw

provides that "[t]he term 'professional practice' refers to generally

accepted medical practice." United States v. Vamos

797 F.2d 1146, 1151

(2nd Cir. 1986).

Several Circuits Hold that a Practioner has Unlawfully Dispensed a

Controlled Substance if he Dispenses the Substance Either 'Outside the

Usual Course of Professional Practice' OR if he Dispenses it 'Without a

Legitimate Medical Purpose'.

In United States v. Nelson, 383 F.3d 1227, 1231-33 (10th Cir. 2004) the

Court held that a practioner has unlawfully distributed a controlled substance

if she prescribes the substance either 'outside the usual course of medical

practice' or 'without a legitimate medical purpose' based on the wordings of

§ 1306.04 and Moore, 423 U.S. at 122, 124 ("Registered physicians can be

prosecuted under § 841 when their activities fall outside the usual course

of professional practice.")

The Court also found the converse of § 1306.04(a)

true that conversely then, "a practioner would be unauthorized to dispense a

controlled substance if he acts without a legitimate medical purpose or

outside the usual course of professional practice." Id. at 1233.

In United

States v. Fuchs, 467 F.3d 889, 899 (5th Cir. 2006), a defendant pharmacist

challenged his convictions for dispensing controlled substances not in the

usual course of professional practice, in violation of § 841(a)(1), based

on the ground that "the government was required to prove not only that he

dispensed controlled substances outside the usual course of professional

practice but also that he did so without a legitimate medical purpose."

Fuchs at 899.

Both his indictment and jury instructions did not mention

'legitimate medical purpose', and under plain error review the Court did

not find the instruction problematic, recognizing that Circuit's previous

caselaw listed as a single element that the dispensing be done "other than

for a

legitimate medical purpose and in the usual course of his professional

practice" (quoting United States v. Rosen, 582 F.2d 1032, 1033 (5th Cir.

1978).

The Fuchs Court further recognized that the phrases 'without a

legitimate medical reason' and 'beyond the course of professional practice'

can be used interchangeably relying on Outler, holding there is no clearly

established law the indictment and jury instructions must reference

'legitimate medical purpose'. Id. at 900-01.

This is a 'lower showing' of

Circuit interpretation of § 1306.04(a) and Moore to convict a practioner

under § 841.

Two Circuits Hold that a Practioner has Unlawfully Distributed a Controlled

Substance if he Dispenses the Substance' ’Outside the Usual Course of

Professional Practice* AND if he Dispenses it ’Without a Legitimate Medical

Purpose’.

The Seventh Circuit holds, "[t]o convict a prescribing physician under

§ 841(a) of the [CSA], the government must prove that the physician knowingly

prescribed a controlled substance outside the usual course of professional

practice and [the physician prescribed it] without a legitimate medical

purpose • • • •

In other words, the evidence must show that the physician not

only intentionally distributed drugs, but that he 'intentionally' act[ed] as

a pusher rather than a medical professional." United States v. Kohli, 847

F.3d 483, 489-90 (7th Cir. 2017).

"In every case, the critical inquiry is

whether the relevant prescriptions were made for a valid medical purpose

and within the usual course of professional practice." Id. 491.

The Ninth

Circuit adds a third essential element; (3) "that the practioner acted

with intent to distribute the drugs and with intent to distribute them

outside the course of professional practice." United States v. Feingold,

454 F.3d 1001, 1008 (9th Cir. 2006).

This is a 'higher showing' of

Circuit interpretation of § 1306.04(a) and Moore to convict a practioner

under § 841.

The Dicta in Gonzales by the Supreme Court Suggest 'Medical Use' and

'Medical Purpose' are Essential Elements Enacted by Congress in §

1306.04(a) and the Statutes Required for a Prescription to be Valid.

In Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904, 163 L. Ed. 2d. 748

(2006), the Supreme Court held that the Attorney General does not have

statutory authority to criminalize assisted suicides and that his

interpretation was inconsistent with the statute.

In the Court's dicta,

the Court noted "[t]he CSA allows prescription of drugs only if they have

a 'currently accepted medical use', 21 U.S.C. § 812(b); requires a 'medical

purpose' for dispensing the least controlled substance of those schedules,

§ 829(c); and, in its reporting provision, defines a 'valid prescription'

as one 'issued for a legitimate medical purpose', § 830(b)(3)(A)(ii).

Similarly, physicians are considered to be acting as practioners under the

statutes if they dispense controlled substances 'in the course of professional

practice', § 802(21).

The regulation uses the terms 'legitimate medical

purpose' and 'course of professional practice"'. Gonzales, 546 U.S. at 257.

The Court's dicta acknowleged § 1306.04(a)'s requirements that all

prescriptions for Schedule II drugs be used "for a legitimate medical

purpose by an individual practioner acting in the usual course of his

professional practice." Gonzales, 546 U.S. at 256.

The Court's dicta fully

support the notion that 'legitimate medical purpose' is required for

dispensing controlled substance prescriptions, that the phrases 'outside

the usual course of professional practice' and 'without a legitimate

medical purpose' are not interchangeable concerning, at least, statutory

intent and rulemaking authority, and that the phrases have

separate,

distinct meanings within the regulation and statutes.

Post-Gonzales, the Sixth Circuit joined the Fifth, Tenth & Eighth

Circuits Holding that Knowingly Distributing Prescriptions Outside the

Course of Professional Practice is a Sufficient Condition to Convict a

Defendant Under the Criminal Statutes.

In United States v. Volkman, 797 F.3d 377, 386 (6th Cir. 2015), Volkman,

a medical doctor, challenged the denial of a proposed jury instruction seeking

to have the verbatim language of Gonzales included.

The Sixth Circuit held

Gonzales provided "no guidance" and was "out-of-context" relating to criminal

law joining the Tenth Circuit in United States v. Lovern, 590 F.3d 1095 (10th

Cir. 2009), leaving the question of what constitutes "the usual course of

professional practice for a jury to sort out." The Eighth Circuit adopted

and expanded upon the Tenth Circuit in United States v. Kanner, 603 F.3d 530

(8th Cir. 2010), adding that "Gonzales did not supplant the standards for

violations of the CSA." Kanner at 535.

"Rather, post-Gonzales, knowingly

distributing prescriptions outside the course of professional practice is a

sufficient condition to convict a defendant under the criminal statutes

relating to controlled substances." (quoting United States v. Armstrong,

550 F.3d 382, 397 (5th Cir. 2008)). Volkman at 386.

The Sixth Circuit held

Volkman's proposed jury instruction would have narrowed the scope of the

jury's inquiry to a question of whether Volkman engaged in 'conventional*

drug dealing, inconsistent with the Sixth Circuit's endorsement of the

broad approach of finding what conduct falls outside the accepted bounds of

professional practice so as to constitute a GSA violation. Id. at 386.

TIE THE STATUTE § 841 & THE REGULATION § 1306.04(a) ARE NOT VOID FOR VAGUENESS

AS APPLIED TO HEALTHCARE PRACTIONERS. CONGRESSIONAL INTENT CAN BE

INFERRED BY THE REGULATION THAT 'LEGITIMATE MEDICAL PURPOSE' IS A

REQUIRED ELEMENT FOR CONVICTION UNDER § 841.

Federal Courts Have Rejected Void For Vagueness Challenges that §§

1306.04(a) & 841 are Vague as Applied to Healthcare Practioners.

Nearly every Circuit has considered void for vagueness challenges

relating to §§ 1306.04(a) & 841. See United States v. Collier, 478 F.2d 268,

270 (5th Cir. 1973)(rejecting "contention ... § 841(a)(1), as applied to

physicians, is unconstitutionally vague."), see United States v. Darji, 609

Fed. Appx. 320, 334 (6th Cir. 2015)("this Court has rejected the claim that

§ 841 and § 1306.04 are void for vagueness."), see United States v. OrtaRosario, 469 Fed. Appx. 140, 143 (4th Cir. 2012)(rejecting argument of

medical doctor that the CSA is impermissibly vague as applied to him because

"there is no statutory definition of 'legitimate medical purpose' or 'usual

course of professional practice'"), see United States v. Brickhouse, 2016

U.S. Dist. LEXIS 59821, 2016 WL 2654359, at 4 (E.D. Tenn. Mar, 30, 2016)

("The Court disagrees that § 841(a)(1) and the regulation at § 1306.04

leave medical practioners rudderless and adrift in the murky waters of

criminal liability."), see United States v. Quinones, 536 Fed. Supp. 2d.

267, 275 (E.D. N.Y. 2008)(rejecting vagueness argument because phrase

"within the usual scope of professional practice" has an "objective meaning

that prevents arbitrary prosecution and conviction:

Neither the government

nor the jury is free to impose its own subjective views about what is and

is not appropriate; rather, the government is obliged to prove, and the

jury constrained to determine, what the medical profession would generally

do in the circumstances."), and see United States v. Birbragher, 576 Fed.

Supp. 2d. 1000, 1013 (8th Cir. 2010)("courts have held the language

'legitimate medical purpose' and 'usual course of his professional practice'

is not unconstitutionally vague as applied to physicians.")

These federal

Courts have repeatedly found that practioners CAN be convicted under §§

1306.04(a) & 841 when they meet certain criteria required for conviction

and the Courts have found Congress was clear and unambiguous when it enacted

the regulation and statute in the CSA to combat drug abuse in 1971.

The Sixth Circuit's Holdings on Convicting Practioners under §§ 1306.04(a)

& 841 Seem Contrary to its Own Findings and Dicta.

The Sixth Circuit has long held that "in order to obtain a conviction

under 21 U.S.C. § 841(a)(1) against a licensed physician • • • , the government

must show: '(1) That defendant distributed a controlled substance, (2) That

he acted intentionally or knowingly; and (3) That defendant prescribed the

drug without a legitimate medical purpose AND [he prescribed it] outside

the course of professional practice.'" United States v. Chaney, 921 F.3d 572,

589 (6th Cir. 2019) (emphasis added).

In Chaney, that Court noted at 591

in its dicta, "as the word purpose implies, [the Court] look[s] at a

provider's reason for issuing the prescription when determining whether it

was issued for a legitimate medical purpose ... likewise, a doctor who acts

in good faith and with all due care but nevertheless issues a prescription to

a patient who was merely faking symptoms is nevertheless acting with a

legitimate medical purpose."

The Court holds in Chaney that there are three

essential elements for conviction under §§ 1306.04 & 841 for a physician with

the third element being a two-part requirement that he prescribed a controlled

substance 'without a legitimate medical purpose' AND ' he prescribed it

'outside the course of professional practice', which was why the Court was

looking at the provider's reason he prescribed the prescription.

However,

conversely, in this instant case and in Volkman, those Courts held that

"knowingly distributing prescriptions

outside the course of professional

practice [alone] is a sufficient condition to convict a defendant under the

criminal statutes related to controlled substances." Volkman at 386.

These

later holdings by-pass the requirement of finding 'without a legitimate

medical

purpose' as an element of conviction under §§ 1306.04(a) & 841.

Which holding and dicta are binding?

They both cannot be correct.

The

later holdings are contrary to the first holding and is contrary to the

holding of Kirk at 784, that the phrases 'in the usual course of professional

practice' and 'legitimate medical purpose' can be used interchangeably because

clearly the phrases have different meanings:

legitimate medical purpose is the_

provider's reason he prescribed the prescription, and course of professional

practice refers to generally accepted medical practice.

The Sixth Circuit,

and apparently other Circuits, have not fathomed a scenario where a practioner

dispensed controlled substance prescriptions for a 'legitimate medical

purpose' in good faith, but may have dispensed those prescriptions 'outside

his usual course of professional practice', which would equate to a civil

malpractice or negligent or incompetent or foolish or reckless type of

practioner unfortunately, held criminally liable under a 'lower showing' of

most Circuit's caselaw.

The Feingold Court Held that a Jury Instruction is Improper if it Allows

a Jury to Convict a Licensed Practioner Under § 841 Solely on a Finding

he Committed Negligence, was Incompetent, Foolish or Reckless.

In United States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006), the

Court determined that focusing too heavily on an "outside the scope of

professional practice" viewpoint could lead to a mere malpractice standard

for conviction and that even intentional malpractice would be inconsistent

with Moore's description of a physician violating § 841 as one acting as a

drug 'pusher' rather than physician.

The Court asserted Moore required that

a doctor's actions must completely betray any semblance of 'legitimate

medical treatment', and thus criminal liability required a 'higher showing'

that "the practioner intentionally has distributed controlled substances for

no legitimate medical purpose and [has distributed them] outside the usual

course of [his] professional practice." Id. at 1010.

the question:

The Court openly pondered

Can a defendant who intentionally exceeds a generally recognized

'standard of medical practice' still be engaged in the 'usual course of

professional practice', such that he be found not guilty under criminal

liability?

The threats are that practioners could be prosecuted and perhaps

convicted as criminals whenever the U.S. Attorneys disapprove of their

courses of treatment, or even when they step outside the bounds of

convention medical protocols or general medical practice.

A violation of

the standard of care alone is insufficient to support a criminal conviction

of a practioner under § 841.

Only after assessing the standards to which

medical practioners generally hold themselves, is it possible to evaluate

whether a practioner's conduct has deviated so far from "the usual course

of [his] professional practice", that his actions become criminal, (quoting

Moore, 423 U.S. at 124). Feingold at 1010-11.

Courts must be careful not to allow a jury to conflate the high standard

of criminal liability with a lower standard of civil malpractice or

negligence by concentrating on a practioner's 'usual course of professional

practice' alone, permitting a jury to convict a practioner simply upon a

finding that he was negligent, was incompetent, was foolish or reckless.

There must be a finding of intent, which requires the jury to find the

practioner intentionally violated the standard of care and a finding the

practioner dispensed prescriptions 'without a legitimate medical purpose',

because if not, intentional malpractice or negligence or recklessness would

impermissibly meet the standard of criminal liability.

The Feingold Court

held that an instruction is improper if it allows a jury to convict a

licensed practioner under § 841 solely on a finding that he committed

malpractice, negligence, or was incompetent.

The Court quoted United States

v. Boettjer, 569 F.2d 1078, 1081 (9th Cir. 1978), noting that the standards

for liability "itself imports considerations of medical legitimacy and

accepted medical standards", and that evidence regarding the applicable

standard of care is "not offered to establish malpractice, but rather to

support the absence of any legitimate medical purpose in [the practioner's]

prescription of controlled substances." Id. at 1082.

The DEA Publishes a Guide to Help Pharmacists Ensure that the Controlled

Substance Prescriptions they Fill are Being Filled for a 'Legitimate

Medical Purpose'.

The DEA, a law enforcement agency and part of the Department of Justice,

publishes a guide, titled 'A Pharmacist's Guide to Prescription Fraud', to

help pharmacists ensure that controlled substance prescriptions are being

issued for a 'legitimate medical purpose'.

The guide is found at http://www.

deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm (2014) and also found in

Appendix D of the '2010 Pharmacist's Manual' also published online at https:

//www.deadiversion.usdoj.gov/pubs/manuals/index.html (2014).

The DEA advises

pharmacists that § 1306.04(a) requires a prescription to be issued for a

legitimate medical purpose by an individual practioner acting in the usual

course of his professional practice.

That means that dentists should not

write constrolled substance prescriptions for chronic back pain because it

is outside of the dentist's usual course of professional practice to issue

such a prescription where he could not have addressed the patient's true

medical need because that is not his specialty.

based solely on the regulation § 1306.04.

This is a literal advisement

This guidance, however, focuses

solely on the prescriber's 'usual course of professional practice' and rarely

on the pharmacist's 'usual course of professional practice' when filling

controlled substance prescriptions presumably because most often as long as

a pharmacist dispenses medication within his pharmacy, he is dispensing —.—

within his 'usual course of professional practice'.

DEA guidance therefore

focuses on the legitimate medical purpose rule, where the objective is to

prevent the diversion of medications to the illicit market without impeding

Richard R. Abood, Pharmacy Practice and

the legitimate use of medications.

the Law, 7th Edition 2014, pgs. 238-39, (Jones & Bartlett Learning).

DEA

guidance is in direct conflict with caselaw in several federal Districts

when prosecuting pharmacists where the government can solely look at the

pharmacist's usual course of professional practice to determine if the

prescriptions dispensed were illegally dispensed under a 'lower showing'

for conviction because 'legitimate medical purpose' is not a required

finding to convict under their interpretations of § 1306.04(a) and Moore.

It is clear also that the DEA does not interchange the phrases

'legitimate medical purpose' and 'usual course of professional practice'

The DEA is not misinforming or

in its admonitions to pharmacists.

mischaracterizing § 1306.04 to pharmacists, but believes like the Seventh

& Ninth Circuits believes and interprets § 1306.04(a) as a two-part

Those two

required element for conviction under § 841 for practioners.

required elements for conviction are 'without a legitimate medical purpose'

The DEA's advise

AND 'outside the usual course of professional practice',

is the literal reading of the regulation and related statutes and for

pharmacists

to exercise their clinical judgment on whether to fill a

controlled substance prescription without impeding the legitimate use of

medications.

Congressional Intent Can be Inferred by Reading the Regulation and

Related Criminal Statutes.

Congress enacted the CSA in 1971 to combat drug abuse.

The inquiry for

statutory interpretation must begin with the text of the regulation and

related statutes of the CSA, noting, headings although "not commanding",

"they supply clues" about Congressional intent. Yates v. United States,

574 U.S. 528, 135 S. Ct. 1074, 1083, 191 L. Ed. 2d, 64 (2015).

U.S.C. § 801.

Congressional findings and declarations:

Under 21

controlled

substances, "The Congress makes the following findings and declarations:

(1)

Many of the drugs included within this title have a useful and

legitimate medical purpose and are necessary to maintain the health and

general welfare of the American people." (emphasis added).

Congress

realized that illegal import, manufacture, distribution, possession and

improper use of controlled substances have a detrimental effect on the

American people when used without a legitimate medical purpose.