Petition for Writ of Certiorari — Margaret Temponeras, Petitioner v. United States

No. ______

In the

Supreme Court of the United States

__________________

MARGARET TEMPONERAS,

Petitioner,

v.

UNITED STATES OF AMERICA,

Respondent.

__________________

On Petition for Writ of Certiorari to the

United States Court of Appeals for the Sixth Circuit

__________________

PETITION FOR WRIT OF CERTIORARI

__________________

ALEXANDRA C. SISKOPOULOS

Counsel of Record

SISKOPOULOS LAW FIRM, LLP

33 West 19th Street, 4th Floor

New York, New York 10011

(646) 942-1798

acs@siskolegal.com

Counsel for Petitioner

March 12, 2021

Becker Gallagher · Cincinnati, OH · Washington, D.C. · 800.890.5001

i

QUESTION PRESENTED

The Controlled Substances Act, 21 U.S.C. § 841, and

its corresponding regulation at 21 C.F.R. § 1306.04 are

hopelessly vague laws that criminalize perfectly

reasonable behavior by medical doctors. The federal

circuits have wild, differing interpretations of how to

apply these vague laws and a circuit split is painfully

obvious here. Unlike a standard medical practice,

prescribing pain medication is an integral part of a

pain management practice making the term “legitimate

medical purpose” inherently vague. Prosecutors have

arbitrarily applied these laws to secure criminal

convictions even though doctors were prescribing

lawful medications pursuant to the standards set forth

by medical boards and pharmaceutical companies.

This Court’s intervention is desperately needed here.

The question presented is:

1. Whether 21 U.S.C. § 841 and 21 C.F.R.

§ 1306.04 are unconstitutionally vague whereas

the term “legitimate medical purpose” does not

provide fair notice of a standard upon which

pain management medical practices can be held

criminally liable.

ii

LIST OF DIRECTLY RELATED PROCEEDINGS

1. United States of America v. Margaret

Temponeras, District Court Case No. 1:15-cr00065- TSB-1, United States District Court for

the Southern District of Ohio (Cincinnati) (final

judgment of conviction entered on February 3,

2020).

2. United States of America v. Margaret

Temponeras, Sixth Circuit Case No. 20-3192,

United States Court of Appeals for the Sixth

Circuit (unpublished decision affirming

judgment of conviction entered on October 16,

2020).

iii

TABLE OF CONTENTS

QUESTION PRESENTED . . . . . . . . . . . . . . . . . . . . i

LIST OF DIRECTLY RELATED

PROCEEDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

TABLE OF AUTHORITIES. . . . . . . . . . . . . . . . . . . . v

PETITION FOR WRIT OF CERTIORARI . . . . . . . . 1

OPINIONS BELOW. . . . . . . . . . . . . . . . . . . . . . . . . . 1

JURISDICTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

RELEVANT CONSTITUTIONAL AND

STATUTORY PROVISIONS . . . . . . . . . . . . . . . . . . . 2

STATEMENT OF THE CASE . . . . . . . . . . . . . . . . . . 3

1. Factual and Procedural History . . . . . . . . . . . 3

2. How the federal question sought to be

reviewed was raised . . . . . . . . . . . . . . . . . . . . 9

REASONS FOR GRANTING THE WRIT. . . . . . . . 10

I. This Court has never provided clarity on the

vague term “legitimate medical practice”

encompassed in 21 U.S.C. § 841 and 21 C.F.R.

§ 1306.04 resulting in haphazard application of

these laws and a circuit split. Ultimately, this

vague term has allowed the government to

criminalize a practice of medicine that was

accepted and practiced by doctors in the medical

community. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

iv

II. The inherent vagueness of the law is

exacerbated by continuing changes in medical

opinion and conflicting laws. What was deemed

appropriate while Petitioner was practicing

medicine, has now been castigated as

illegitimate by the government by virtue of these

inherently vague provisions . . . . . . . . . . . . . . . . 15

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

APPENDIX

Appendix A Opinion in the United States Court of

Appeals for the Sixth Circuit

(October 16, 2020) . . . . . . . . . . . . . App. 1

Appendix B Judgment in the United States

District Court for the Southern

District of Ohio

(February 3, 2020) . . . . . . . . . . . . App. 5

Appendix C Statutory and Regulatory Provisions

Involved . . . . . . . . . . . . . . . . . . . . App. 15

21 U.S.C. § 841 . . . . . . . . . . . . . . App. 15

21 C.F.R. § 1306.04 . . . . . . . . . . . App. 34

2005 OAC Ann. 4731-21-02 . . . . App. 36

2017 OAC Ann. 4731-21-02 . . . . App. 42

Appendix D Complaint, Ohio v. Purdue Pharma,

L.P., et al. Excerpts. . . . . . . . . . . App. 49

v

TABLE OF AUTHORITIES

CASES

City of Chicago v. Morales,

527 U.S. 41 (1999). . . . . . . . . . . . . . . . . . . . . . . . 13

Connally v. Gen. Constr. Co.,

269 U.S. 385 (1926). . . . . . . . . . . . . . . . . . . . . . . 13

Grayned v. City of Rockford,

408 U.S. 104 (1972). . . . . . . . . . . . . . . . . . . . . . . 13

Johnson v. United States,

576 U.S. 591 (2015). . . . . . . . . . . . . . . . . . . . . . . 13

Kolender v. Lawson,

461 U.S. 352 (1983). . . . . . . . . . . . . . . . . . . . . . . 13

Lanzetta v. New Jersey,

306 U.S. 451 (1939). . . . . . . . . . . . . . . . . . . . . . . 14

Sessions v. Dimaya,

138 S. Ct. 1204 (2018). . . . . . . . . . . . . . . . . . 14, 17

Smith v. Goguen,

415 U.S. 566 (1974). . . . . . . . . . . . . . . . . . . . . . . 13

United States v. Birbragher,

603 F.3d 478 (11th Cir. 2010). . . . . . . . . . . . . . . 12

United States v. Green,

222 F. Supp. 3d (W.D.N.Y. 2016) . . . . . . . . . 10, 24

United States v. Houdersheldt,

No. 3:19-00239, 2020 U.S. Dist. LEXIS 241736

(S.D. W. Va. Dec. 23, 2020). . . . . . . . . . . . . . . . . 15

vi

United States v. Moore,

423 U.S. 122 (1975). . . . . . . . . . . . . . . . . 12, 14, 19

United States v. Reese,

92 U.S. 214 (1875). . . . . . . . . . . . . . . . . . . . . . . . 14

United States v. Volkman,

797 F.3d 377 (6th Cir. 2015). . . . . . . . . . . . . . . . 14

CONSTITUTION AND STATUTES

U.S. Const. amend. V . . . . . . . . . . . . . . . . . . . . . . . . . 2

18 U.S.C. § 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

21 U.S.C. § 841 . . . . . . . . . . . . . . . . . . . . . . . . . passim

21 U.S.C. § 841(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

21 U.S.C. § 841(a)(1) . . . . . . . . . . . . . . . . . . . . 3, 5, 15

21 U.S.C. § 841(b)(1)(C) . . . . . . . . . . . . . . . . . . . . . . . 3

21 U.S.C. § 841(b)(1)(E) . . . . . . . . . . . . . . . . . . . . . . . 3

21 U.S.C. § 841(b)(2) . . . . . . . . . . . . . . . . . . . . . . . . . 3

21 U.S.C. § 846 . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 4, 5

21 U.S.C. § 856(a)(1) . . . . . . . . . . . . . . . . . . . . . . . . . 3

28 U.S.C. §1254(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

OAC Ann. 4731-21-02 (2005) . . . . . . . . . . . . . . . . . . 23

OAC Ann. 4731-21-02 (2017) . . . . . . . . . . . . . . . . . . 23

REGULATIONS

21 C.F.R. § 1306.04 . . . . . . . . . . . . . . . . . . . . . passim

vii

RULES

Sup. Ct. R. 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

OTHER AUTHORITIES

Cato Institute, Overdosing on Regulation - How the

Government Caused the Opioid Epidemic,

https://www.cato.org/policy-analysis/overdosingregulation-how-government-caused-opioidepidemic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

National Law Review, Standards for Use of Opiates

in Treatment of Pain Changes in Ohio,

https://www.natlawreview.com/article/standar

ds-use-opiates-treatment-pain-changes-ohio. . . 24

Ohio Academy of Family Physicians Letter to the

Medical and Pharmacy Boards (October 2018),

https://www.ohioafp.org/wfmu-article/oafpa d d r e s s e s - p r o bl e m s - w i t h- au g u s t - o a r r s compliance-reports/. . . . . . . . . . . . . . . . . . . . . . . . 8

Ohio Marijuana Card, Understanding Pain that is

Chronic, Severe or Intractable,

https://www.ohiomarijuanacard.com/post/unde

rstanding-pain-that-is-chronic-severe-orintractable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Practical Pain Management, Benzodiazepines and

Opioids: Only Trained Pain Practitioners Should

Prescribe,

https://www.practicalpainmanagement.com/tre

atments/pharmacological/benzodiazepinesopioids-only-trained-pain-practitioners-shouldprescribe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

viii

Practical Pain Management, State Pain Laws: A

Case for Intractable Pain Centers Part III,

https://www.practicalpainmanagement.com/res

ources/ethics/state-pain-laws-case-intractablepain-centers-part-iii . . . . . . . . . . . . . . . . . . . . . . 21

Science Direct, Clinical Solutions to Chronic Pain

and the Opiate Epidemic,

https://www.sciencedirect.com/science/article/p

ii/S0091743518303098?via%3Dihub . . . . . . 19, 20

State Medical Board of Ohio Release (November

2017), https://med.ohio.gov/Publications/RecentNews/state-of-ohio-board-of-pharmacymistakenly-sends-oarrs-email . . . . . . . . . . . . . . . 8

1

PETITION FOR WRIT OF CERTIORARI

Petitioner Margaret Temponeras respectfully

petitions for a writ of certiorari to review the decision

and judgment of the United States Court of Appeals for

the Sixth Circuit in this case, or in the alternative,

Petitioner respectfully requests that this Honorable

Court summarily reverse the decision and judgment of

the United States Court of Appeals for the Sixth

Circuit pursuant to Supreme Court Rule 16.

OPINIONS BELOW

The United States Court of Appeals for the Sixth

Circuit issued its unpublished opinion on October 16,

2020 and is reproduced at App.1-4. The opinion of the

United States Court of Appeals for the Sixth Circuit is

available at United States v. Temponeras, 828 F. App’x

320 (6th Cir. 2020). On February 3, 2020, the District

Court entered a criminal judgment of conviction.

App.5-14.

JURISDICTION

The Sixth Circuit issued its opinion on October 16,

2020. On March 19, 2020, this Court extended the

deadline to file any petition for a writ of certiorari due

on or after that date to 150 days. This Court has

jurisdiction under 28 U.S.C. §1254(1).

2

RELEVANT CONSTITUTIONAL AND

STATUTORY PROVISIONS

The Fifth Amendment of the United States

Constitution provides in relevant part:

“No person shall…be deprived of life, liberty, or

property, without due process of law.” U.S. Const.

amend. V.

21 U.S.C. § 841 provides in relevant part:

“Except as authorized by this title, 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.” 21 U.S.C. § 841. The full text of

21 U.S.C. § 841 is reproduced at App.15-33.

21 C.F.R. § 1306.04 provides in relevant part:

A prescription for a controlled substance to be

effective must be issued for a legitimate medical

purpose by an individual practitioner acting in

the usual course of his professional practice.

The responsibility for the proper prescribing and

dispensing of controlled substances is upon the

prescribing practitioner, 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

3

person issuing it, shall be subject to the

penalties provided for violations of the

provisions of law relating to controlled

substances.

21 C.F.R. § 1306.04. The full text of 21 C.F.R.

§ 1306.04 is reproduced at App.34-35.

STATEMENT OF THE CASE

1. Factual and Procedural History

Margaret Temponeras was a medical doctor who

was indicted by the federal government (hereinafter

“government”) in June 2015. Indictment, RE 1, Page

ID # 1. Ms. Temponeras was charged with the

following criminal counts: Count 1 charged a

conspiracy between defendants to distribute and

dispense “diazepam, carisoprodal, hydrocodone,

oxycodone, and alprazolam, not for a legitimate medical

purpose and outside the scope of medical practice, in

violation of 21 U.S.C. §§ 846, 841(a)(1), (b)(1)(C),

(b)(1)(E), and (b)(2)”; Count 2 alleged a death resulted

from the distribution of Oxycodone and other controlled

substances not for a “legitimate medical purpose and

outside the scope of medical practice…in violation of 21

U.S.C. §§ 841(a), (b)(1)(C), and 18 U.S.C. § 2”; Count 3

and Count 4 alleged defendant maintained a premises

for the purposes of distributing controlled substances

“in violation of 21 U.S.C. § 856(a)(1) and 18 U.S.C. § 2.”

Presentence Report (“PSR”), p. 4, ¶¶ 2-5.

Additionally, Ms. Temponeras’ eighty plus year old

father who was also a doctor, John Temponeras, and

pharmacist, Raymond Fankell, were also charged in

this alleged criminal conspiracy. Indictment, RE 1,

4

Page ID # 1-2. John Temponeras and the government

entered into a plea agreement on or about March 15,

2017. PSR, p. 5, ¶ 11. Thereafter, Raymond Fankell

and the government entered into a plea agreement on

or about March 28, 2017. PSR, p. 5, ¶ 12. Margaret

Temponeras forcefully defended herself against these

criminal charges, but ultimately decided to resolve this

criminal matter via a plea agreement filed on April 3,

2017. Plea Agreement, RE 89, Page ID # 658-665.

The plea agreement states that the “Defendant

agrees to plead guilty to Count 1 of the Indictment in

this case, which charges her with Conspiracy to

Distribute a Controlled Substance, in violation of 21

U.S.C. § 841 and 846.” Plea Agreement, RE 89, Page

ID # 658. The plea agreement statement of facts sets

forth that Dr. Temponeras owned and was the

physician at a chronic pain management clinic and that

many patients received similar combinations of

medications. Plea Agreement, RE 89, Page ID # 663.

The plea agreement further states that “Dr.

MARGARET TEMPONERAS increased a prescription

of 2mg Xanax to four pills per day…These controlled

substances, to-wit: the 2mg Xanax pills.

Dr.

MARGARET TEMPONERAS never tapered them down

from November 9, 2009 through May 9, 2011…Patient

C.L. states that he believes that the number of

oxycontin and oxycodone were decreased after he

complained.” Plea Agreement, RE 89, Page ID # 66364. The plea agreement further sets forth that Dr.

Temponeras “was aware of a high probability that such

distributions were occurring…under her directions and

deliberately closed her eyes to what was obvious, over

prescription of the Xanax medicine, in violation of 21

5

U.S.C. § 846 and 841(a)(1).” Plea Agreement, RE 89,

Page ID # 664.

After the plea agreement was entered into, a

Presentence Report (“PSR”) was prepared. The PSR

reflects that Ms. Temponeras has always maintained

that she was following what she believed to be

appropriate medical guidelines. Ms. Temponeras

maintained that “she spent sufficient time with her

patients” and disputed allegations that she did not

discuss alternative treatments with her patients and

ignored the results of urine tests administered to her

patients. PSR, p. 7, ¶ 22; p. 8, ¶ 24. The PSR also

notes that Ms. Temponeras “participated in certain

courses and obtained certifications in pain

management.” PSR, p. 5, ¶ 14. The Report notes

“[l]ike many other doctors, she was being told by

pharmaceutical companies that Oxycontin and other

similar medications were not addictive. She was

encouraged by pharmaceutical representatives to

prescribe as much medication as it took to address a

patient’s pain.” PSR, pp. 5-6, ¶ 14. The PSR also

makes mention of the medical term of “titration”

commenting that “doctors are supposed to follow

titration which means the patients have optimal pain

relief with minimal side effects.” PSR, p. 7, ¶ 21.

The PSR also notes Ms. Temponeras had

established safeguards to ensure that medications were

not misused by patients and “had policies such as

running a patient’s name in OARRS and KASPER

which are systems in Ohio and Kentucky that tracked

controlled substance prescriptions to see if they had

been flagged as abusing controlled substances, and

6

doing random pill counts at the clinic.” PSR, p. 9, ¶ 27.

Ms. Temponeras also “employed security staff … who

would run record checks on patients to determine if

they had been arrested or convicted for drug offenses.”

PSR, p. 9, ¶ 29. Ms. Temponeras’ pain management

clinic “was treating some of the sickest patients in the

area. Those patients were typically referred to her by

other physicians or they were her former patients.”

Sentencing Hearing Transcript, RE 107, Page ID #798.

The Sentencing Guidelines required the PSR to

determine what number of pills fell outside the

acceptable range. The PSR contains an assumption as

to what prescriptions fell outside of a legitimate

medical purpose. PSR, p. 11, ¶ 40. The PSR notes that

only “6-8%” of prescriptions were for non-controlled

substances. PSR, p. 10, ¶ 37. The PSR contains no

information as to whether this was atypical for a pain

management medical practice. The PSR then utilized

the records of 26 patients to make assumptions at to

what prescriptions were deemed inappropriate and

came to a total by explicitly stating that “[i]f it is

assumed that the amount of Oxycodone and Oxycontin

prescriptions given to these patients … were improper

and outside appropriate medical practice, the total

would be ….” PSR, p. 11, ¶ 40. This assumption never

considered that “doctors are supposed to follow

titration which means the patients have optimal pain

relief with minimal side effects.” PSR, p. 7, ¶ 21.

Despite acknowledging that the dosage of the

medication must provide optimal pain relief with

minimal side effects, the PSR did not determine which

amounts were in excess, but rather assumed every pill

dispensed was inappropriate.

7

Thereafter, a sentencing hearing was held to

determine Ms. Temponeras’ sentence. The plea

agreement had established an agreed upon sentencing

range of thirty-six months to eight-four months. Plea

Agreement, RE 89, Page ID # 659. At the Sentencing

Hearing, the government acknowledged the Ohio

Medical Board had failed Ms. Temponeras. Sentencing

Hearing Transcript, RE 107, Page ID # 780-781.

Despite this acknowledgement, the government argued

that Ms. Temponeras was essentially running a pill

mill with no legitimate medical purpose.

The

government argued that red flags made her aware that

her prescription practices were excessive and brought

in last-minute exhibits at the sentencing hearing to

establish this argument. The government argued these

exhibits clearly showed that Ms. Temponeras was

warned and on notice. The exhibits provided by the

government, however, clearly note that even though a

letter from a pharmacy may alert a doctor to an issue

with a prescription, the letter does not usurp the

doctor’s professional medical judgment explicitly

stating “[w]hile this information is not intended to

replace your clinical judgment, we hope you find it

helpful in planning the best course of therapy for your

patients.” Sixth Cir. Apx 24. The government argued

that OARRS reports indicated that Ms. Temponeras’

prescriptions were excessive. Again, these reports are

considered an aid to doctors to ensure that patients are

not obtaining prescriptions from multiple sources.

These OARRS reports found in Exhibit 4 clearly

forewarn that this may not be accurate information.

Sixth Cir. Apx 36-37. Indeed, public information reveals

that OARRS reports have been plagued with

8

inaccuracies, inconsistencies and material falsehoods.1, 2

These OARRS reports are not intended to usurp a

doctor’s medical opinion.

At the conclusion of the sentencing hearing,

Margaret Temponeras was sentenced to 84 months in

a federal prison – the maximum sentence under the

terms of the plea agreement. Dkt 11/12/2019 Minute

Entry, Sixth Cir. Apx 15-16; Plea Agreement, RE 89,

Page ID # 659. The criminal judgment was entered on

February 3, 2020. App.5-14. A timely appeal was filed

1

In November 2017, the State Medical Board of Ohio issued the

following release:

Please be advised that the State of Ohio Board of

Pharmacy sent out emails this morning to approximately

7,000 prescribers indicating failure to comply with laws

requiring the use of the Ohio Automated Rx Reporting

System (OARRS).

The emails were erroneously

distributed without the knowledge of the State Medical

Board of Ohio, Ohio Board of Nursing or the Ohio State

Dental Board and may contain inaccurate information. If

you received this morning’s email, please disregard it. You

do not need to take any further action at this time. The

Pharmacy Board apologizes for this mistake and any

concerns it may have caused.

See, https://med.ohio.gov/Publications/Recent-News/state-of-ohioboard-of-pharmacy-mistakenly-sends-oarrs-email

2

In October 2018, the Ohio Academy of Family Physicians wrote

a letter to the Medical and Pharmacy Boards regarding the

inaccuracies in the OARRS Reports such as “missing codes,” “tying

a physician to the wrong medical license number,” and even an

instance of “a physician received a non-compliance report for

August when the physician was not even practicing medicine.” See,

https://www.ohioafp.org/wfmu-article/oafp-addresses-problemswith-august-oarrs-compliance-reports/

9

on February 14, 2020. Notice of Appeal, RE 111, Page

ID # 853-854.

Thereafter, Petitioner pursued an appeal in the

United States Court of Appeals for the Sixth Circuit.

On appeal, Ms. Temponeras argued that the in the

context of a pain management medical practice, 21

U.S.C. § 841 and 21 C.F.R. §1306.04 are

unconstitutionally vague.

The Sixth Circuit affirmed the judgment of the

District Court on October 16, 2020. App.1-4.

2. How the federal question sought to be

reviewed was raised.

On direct appeal to the United States Court of

Appeals for the Sixth Circuit, the Petitioner argued

that in the context of a pain management medical

practice, 21 U.S.C. § 841 and 21 C.F.R. § 1306.04 are

unconstitutionally vague because 21 U.S.C. § 841 and

21 C.F.R. § 1306.04 do not provide fair notice of a

standard upon which pain management medical

practices can be held criminally liable. Unlike a

standard medical practice, prescribing pain medication

is an integral part of a pain management practice

making the term “legitimate medical purpose”

inherently vague.

10

REASONS FOR GRANTING THE WRIT

The Sixth Circuit’s decision is the ideal vehicle to

address whether the Controlled Substances Act, 21

U.S.C. § 841, and 21 C.F.R. § 1306.04 are

unconstitutionally vague as applied to pain

management medical practices. These laws do not

provide fair notice of a standard upon which doctors

who have pain management medical practices can be

held criminally liable. The inherent nature of a pain

management medical practice is to treat pain for which

all other medical remedies have failed. As such, the

long-term treatment of patients through controlled

substances is an inherent part of the medical practice.

“Congress enacted the Comprehensive Drug Abuse

Prevention and Control Act of 1970 (‘the Act’)

in response to President Nixon’s declared ‘war on

drugs.’” United States v. Green, 222 F. Supp. 3d 267,

271 (W.D.N.Y. 2016)(citation omitted). The problem

with this statute which has been in effect for

approximately fifty years is that it does not reflect the

modern medical practice of pain management and it

fails to take into account the ever-changing medical

standards regarding prescribing practices.

For

instance, medical marijuana clinics have recently been

established to treat those afflicted with chronic pain

even though the federal government classifies

marijuana as a drug with no legitimate medical

purpose. This makes the term “legitimate medical

purpose” inherently vague in the context of pain

management.

Currently, medical doctors who have never had any

criminal record are being swept up in a political push

11

to punish someone for the opioid epidemic that has

plagued this country. These vague terms are being

used by federal prosecutors to round up and prosecute

doctors who were prescribing opioids at a time when

the medical profession was advising doctors that their

prescribing practices were appropriate, legitimate, and

lifesaving. This national roundup is based upon the

number of pills doctors prescribed to patients without

regard to the medical standards at the time the pills

were prescribed. These doctors have had their careers

ruined and have been banished to long prison

sentences based upon a prosecutor’s interpretation of

what a legitimate medical practice entails rather than

what the medical profession believed at the time.

Prosecutors have failed to remember that

pharmaceutical companies touted these drugs as

critical treatment to combat chronic pain, and medical

boards throughout this country echoed this sentiment.

I. This Court has never provided clarity on the

vague term “legitimate medical practice”

encompassed in 21 U.S.C. § 841 and 21 C.F.R.

§ 1306.04 resulting in haphazard application of

these laws and a circuit split. Ultimately, this

vague term has allowed the government to

criminalize a practice of medicine that was

accepted and practiced by doctors in the

medical community.

The Controlled Substances Act, 21 U.S.C. § 841,

states “[e]xcept as authorized by this title, 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

12

controlled substance.” 21 U.S.C. § 841. The statute

provides an exception for medical professionals to

dispense these controlled substances if they are

registered. United States v. Birbragher, 603 F.3d 478

(11th Cir. 2010).

While medical professionals are permitted to

dispense controlled substances, in 1975, this Court

established that a medical professional can be

prosecuted “under 21 U.S.C. § 841 when their activities

fall outside the usual course of professional practice.”

United States v. Moore, 423 U.S. 122, 124 (1975). With

regard to the prosecution of doctors, the statute is read

in conjunction with 21 C.F.R. § 1306.04 which provides

that “[a] prescription for a controlled substance to be

effective 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. In United States v. Moore, 423 U.S. 122

(1975), this Court never addressed what constituted a

legitimate medical purpose because the Court noted

“[i]n the case of methadone treatment the limits of

approved practice are particularly clear,” the defendant

admitted he was not authorized to conduct a

methadone maintenance clinic and had previously

agreed to abide by “certain medical procedures in

future methadone programs” which he admittedly

failed to follow. Id. at 144-45. As such, what

constituted a “legitimate medical purpose” and “outside

the scope” were never put at issue and thus, never

decided by this Court.

In the context of a pain management medical

practice, 21 U.S.C. § 841 and 21 C.F.R. § 1306.04

13

simply do not clearly define its prohibitions and does

not give “ordinary people fair notice of the conduct it

punishes, or so standardless that it invites arbitrary

enforcement.” Johnson v. United States, 576 U.S. 591,

595 (2015); Grayned v. City of Rockford, 408 U.S. 104,

108 (1972). Due process principles advise that a penal

statute is void for vagueness if it does not clearly define

its prohibitions. Grayned v. City of Rockford, 408 U.S.

104, 108 (1972). The Fifth Amendment provides that

“[n]o person shall ... be deprived of life, liberty, or

property, without due process of law.” Johnson v.

United States, 576 U.S. 591, 595 (2015). United States

Supreme Court cases clearly “establish that the

Government violates this guarantee by taking away

someone’s life, liberty, or property under a criminal law

so vague that it fails to give ordinary people fair notice

of the conduct it punishes, or so standardless that it

invites arbitrary enforcement.”

Id.; Kolender v.

Lawson, 461 U.S. 352, 357 (1983).

The law provides that “a statute which either

forbids or requires the doing of an act in terms so vague

that men of common intelligence must necessarily

guess at its meaning and differ as to its application,

violates the first essential of due process.” Connally v.

Gen. Constr. Co., 269 U.S. 385, 391 (1926). As such, it

is essential that a criminal statute make clear what

conduct is prohibited so that an ordinary citizen can

“conform his or her conduct to the law.” City of Chicago

v. Morales, 527 U.S. 41, 58 (1999). Criminal statutes

must also “establish minimal guidelines to govern law

enforcement.” Smith v. Goguen, 415 U.S. 566, 574

(1974). This Court has held “[n]o one may be required

at peril of life, liberty or property to speculate as to the

14

meaning of penal statutes.” Lanzetta v. New Jersey, 306

U.S. 451, 453 (1939).

This Court has stated “it would certainly be

dangerous if the legislature could set a net large

enough to catch all possible offenders and leave it to

the courts to step inside and say who could be

rightfully detained, and who should be set at large.”

United States v. Reese, 92 U.S. 214, 221 (1875).

Unfortunately, these laws as applied to pain

management medical practices casts such a net.

Moreover, the vagueness of these terms is only

compounded by the Sixth Circuit precedent which

provides that “[t]here are no specific guidelines

concerning what is required to support a conclusion

that an accused acted outside the usual course of

professional practice.” United States v. Volkman, 797

F.3d 377, 388 (6th Cir. 2015). The Sixth Circuit has

explicitly stated that “we have endorsed a broad

approach to determining what conduct falls outside the

accepted bounds of professional practice so as to

constitute a CSA violation, eschewing a preestablished

list of prohibited acts in favor of a case-by-case

approach.” Id. at 386. This acknowledgment by the

Sixth Circuit is an admission that this is a vague

statute. This Court has noted “[v]ague laws invite

arbitrary power…they can invite the exercise of

arbitrary power all the same – by leaving the people in

the dark about what the law demands and allowing

prosecutors and courts to make it up.” Sessions v.

Dimaya, 138 S. Ct. 1204, 1223-24 (2018). It has been

noted that “although Moore affirmed that practitioners

can be prosecuted under Section 841…[the] startling

facts and the limited questions presented to the Court

15

have left lower courts to interpret the appropriate

boundaries for practitioner liability. Understandably,

this has led to uncertainty and a circuit split.” United

States v. Houdersheldt, No. 3:19-00239, 2020 U.S. Dist.

LEXIS 241736, at *17-18 (S.D. W. Va. Dec. 23, 2020).

The First, Seventh and Ninth Circuits have held that

criminal liability only attaches if a “defendant

deliberately acted without a legitimate medical purpose

or outside the bounds of medical practice.” Id. The

Tenth Circuit held that “nothing in the statutory

language at 21 U.S.C. § 841(a)(1), the regulatory

language at 21 C.F.R. § 1306.04, or any case law []

requires the physician to ‘knowingly” act without a

legitimate medical purpose or outside the usual course

of professional practice.” Id. at *19. Simply put, the

application of these laws is a legal mess.

II. The inherent vagueness of the law is

exacerbated by continuing changes in medical

opinion and conflicting laws. What was

deemed appropriate while Petitioner was

practicing medicine, has now been castigated

as illegitimate by the government by virtue of

these inherently vague provisions.

Throughout her time practicing pain management,

the Medical Board of Ohio saw no issue with Ms.

Temponeras’ prescription practices.

Defendant’s

Sentencing Memorandum, RE 106, Page ID # 721.

“The Medical Board is responsible for, among other

tasks, conducting random patient and record reviews.

From 2005 through 2011, Ms. Temponeras and her

clinic received positive feedback from the Medical

Board.” Id. (emphasis added). “Not once did the

16

Medical Board indicate that she should lower the

amount of controlled substances she prescribed or alter

her treatment protocols.” Id. “The Medical Board even

cleared Ms. Temponeras after several complaints were

made about her clinic, telling her each time that she

was operating it appropriately and in full compliance

with the law.” Id. (emphasis added). In fact, “[o]ne

year before her clinic was shut down, Ms. Temponeras

also applied for a three-year DEA license. The DEA

inspected her practice, indicated there were no

problems, and granted her the license.” Id.

At the sentencing hearing, the government took the

positive feedback Ms. Temponeras received from the

Medical Board and touted it as no excuse for Ms.

Temponeras’ prescription practices. Instead, the

government stated that the Medical Board admitted

under oath that they failed in their duties and used

this to sidestep the fact that the Medical Board at the

time she was practicing found Ms. Temponeras’

prescribing practices legitimate and therefore lawful.

Sentencing Hearing Transcript, RE 107, Page ID # 780781.

The government’s argument that the Ohio Medical

Board failed Ms. Temponeras highlights the inherent

vagueness of the laws at issue. These amorphous

provisions are now being used to prosecute doctors for

a change in medical and public opinion regarding the

prescription of opioids. What the Medical Board

deemed appropriate while Ms. Temponeras was

practicing, has now been castigated as inappropriate.

Ms. Temponeras could have no knowledge at the time

she was practicing medicine that the legitimacy of her

17

practice would be retroactively deemed illegitimate.

The danger of this amorphous statute is that “[a] vague

law impermissibly delegates basic policy matters to

policemen, judges, and juries for resolution on an ad

hoc and subjective basis.” Sessions v. Dimaya, 138

S. Ct. 1204, 1228 (2018)(citation omitted).

The ambiguity as to what falls outside the scope of

a legitimate medical practice becomes evident in the

PSR and the sentencing hearing. The PSR notes that

Ms. Temponeras “participated in certain courses and

obtained certifications in pain management.” PSR,

p. 5, ¶ 14. The PSR notes “[l]ike many other doctors,

she was being told by pharmaceutical companies that

Oxycontin and other similar medications were not

addictive. She was encouraged by pharmaceutical

representatives to prescribe as much medication as it

took to address a patient’s pain.” PSR, pp. 5-6, ¶ 14.

The PSR references the medical term “titration”

commenting that “doctors are supposed to follow

titration which means the patients have optimal pain

relief with minimal side effects.” PSR, p. 7, ¶ 21.

After recognizing that legitimate medical practice

requires a doctor to prescribe dosages that give

patients “optimum pain relief with minimum side

effects,” the PSR contains assumptions which

completely ignore this medical standard. The PSR

required the probation officer to determine what pills

were prescribed outside of a legitimate medical

practice. The inherent ambiguity in the statute

resulted in an absurd calculation relied upon in Ms.

Temponeras’ sentencing. In the PSR, the probation

officer notes that only “6 to 8%” of prescriptions were

18

for non-controlled substances but contains no

information if this percentage is uncommon for a pain

management medical practice. PSR, p. 10, ¶ 37. The

PSR then utilized the records of 26 patients to make

assumptions at to what prescriptions were deemed

inappropriate. In calculating the drug totals, the PSR

explicitly states “[i]f it is assumed that the amount of

Oxycodone and Oxycontin prescriptions given to these

patients … were improper and outside appropriate

medical practice, the total would be ….” PSR, p. 11,

¶ 40. Given the inherently vague provisions of the

statutes, the PSR assumed every pill dispensed was

illegitimate.

Ms. Temponeras’ clinic was not a general doctor’s

office. It was solely for the treatment of people in

chronic pain. Ms. Temponeras’ pain management clinic

“was treating some of the sickest patients in the area.

Those patients were typically referred to her by other

physicians or were her former patients.” Sentencing

Hearing Transcript, RE 107, Page ID #798.

Of course, Ms. Temponeras would distribute more

pills than the average family practitioner. This is

because pain management focuses on patients who

suffer from debilitating, chronic pain. Unfortunately,

there are people who suffer from unforeseen car

accidents, sporting injuries, military combat injuries

and freak occurrences that lead to chronic pain.

Additionally, there are other people who develop

chronic conditions simply because this is the cards that

life has given them or perhaps, they practice an

occupation that is particularly taxing on the body. For

instance, it is not uncommon for a person to suffer from

19

a spinal injury in their early thirties. In another

instance, a coal miner’s body may be afflicted with

more chronic pain ailments than the average person.

Pain management practices were started to attend to

the needs of these particular people. These laws,

drafted so many decades ago, are simply void for

vagueness in their application to a pain management

practice – a medical practice which often requires the

prescription of pain alleviating drugs.

At the time Moore was decided in 1975, the medical

community and the public at large believed that opioids

were inherently dangerous. This widely held belief

took a drastic swing in the 1990s. During the 1990s,

there was a tremendous change in public opinion as

well as medical opinion regarding the efficacy and

legitimacy of opioid prescriptions. Opinions began to

shift from the belief that prescription of opioids caused

addiction to the opinion that the underprescription of

opioids was a contributing factor to the illicit drug

epidemic.3 The rationale became that people were

seeking illicit narcotics because doctors were not

adequately addressing patients’ pain.4 At the time,

articles were published linking the inability to obtain

prescriptions for intractable pain as a reason why

3

See, Science Direct, Clinical Solutions to Chronic Pain and the

Opiate Epidemic,

https://www.sciencedirect.com/science/article/pii/S009174351830

3098?via%3Dihub

4

Id.

20

individuals were seeking illicit drugs.5 A change in

medical and public opinion took place.

The medical community was urged to treat pain as

a “Fifth Vital Sign” and doctors were being admonished

for not adequately treating patients’ pain.6 The concept

of pseudoaddiction became accepted by the medical

community and was advanced by independent medical

societies.7 Pseudoaddiction was the belief that patients

with pain will exhibit drug seeking behaviors if their

pain is not adequately treated by their doctor.8 Doctors

were advised that addiction was rare in patients under

medical supervision and drug seeking behavior was

simply a doctor failing to adequately prescribe pain

medication.9 Medical journals detailed that pain and

anxiety were inextricably linked and doctors should

treat both issues concurrently.10 Doctors were advised

that opioids, such as Oxycontin, and anxiety

medication, such as Xanax, should be used together to

effectively treat pain.

5

Id.

6

Id.

7

Id.

8

Id.

9

Id.

10

See, Practical Pain Management, Benzodiazepines and Opioids:

Only Trained Pain Practitioners Should Prescribe,

https://www.practicalpainmanagement.com/treatments/pharmac

ological/benzodiazepines-opioids-only-trained-pain-practitionersshould-prescribe

21

This change in medical consensus led to the passage

of Intractable Pain Laws. California was the first state

to pass intractable pain laws with the reasoning that

doctors were not adequately treating patients’ pain

because doctors feared criminal prosecution if they

prescribed opioids.11 Other states began to follow

California’s lead and began passing their own

intractable pain laws.12 These laws were intended to

allow doctors to prescribe opioids in amounts that were

previously thought to be improper with the new

medical guidance that underprescribing was the real

issue and not overprescribing.13 The State of Ohio’s

intractable pain law, pursuant to which Ms.

Temponeras practiced, explicitly allowed for the use of

prescription drugs “on a protracted basis or when

managing intractable pain with prescription drugs in

amounts or combinations that may not be appropriate

when treating other medical conditions.” App.36; OAC

Ann. 4731-21-02 (2005). Oxycontin was touted as a

safe and effective opioid. At the time, it was believed

that the slow-release nature of the medication made it

11

See, Practical Pain Management, State Pain Laws: A Case for

Intractable Pain Centers Part III,

https://www.practicalpainmanagement.com/resources/ethics/statepain-laws-case-intractable-pain-centers-part-iii

12

Id.

13

Id.

22

a safe medication for treating intractable pain.14 The

FDA approved dosing instructions on these opioids

clearly set forth doctors should increase dosages as

tolerance for a drug increases. Additionally, the

American Pain Society and other industry leaders

promoted the concepts of pain as the “5th Vital Sign”

and pseudoaddiction. Medical journals propounded

these concepts as well. Medical societies also hosted

medical education seminars and issued treatment

guidelines throughout the late 1990s until mid-2010s.

Unbeknownst to doctors at the time, was that the

medical boards and the medical community at large

were defrauded by the pharmaceutical companies.

App.52-53, ¶ 88-89. Specifically, the Attorney General

of Ohio set forth that pharmaceutical companies

engaged in a “deceptive marketing campaign [which]

deprived Ohio patients and their doctors of the ability

to make informed medical decisions and, instead,

caused important, sometimes life-or-death decisions to

be made based not on science, but on hype.” App.50,

¶14. The Attorney General of Ohio set forth that these

pharmaceutical companies “controlled the distribution

of these messages in scientific publications, treatment

guidelines, CMEs, and medical conferences and

seminars.” App.51, ¶ 45. The Attorney General of

Ohio also set forth that the American Academy of Pain

Management and the American Pain Society issued

guidelines that were a “particularly effective channel of

14

See, Cato Institute, Overdosing on Regulation - How the

Government Caused the Opioid Epidemic,

https://www.cato.org/policy-analysis/overdosing-regulation-howgovernment-caused-opioid-epidemic

23

deception and have influenced not only treating

physicians, but also the body of scientific evidence on

opioids; the Guidelines have been cited 732 times in

academic literature, were disseminated in Ohio during

the relevant time period, are still available online, and

were reprinted in the Journal of Pain.” App.51-52,

¶ 84. In the early 2010s, newspaper articles began to

expose that pharmaceutical companies had engaged in

a pervasive campaign to promote prescription of their

opioid products. Doctors and patients relied on this

information. In the mid-2010s, this new information

caused the medical community’s attitude to shift again.

This societal pivot away from prescription opioids

was palpable. Ohio’s intractable pain law which

provided that Ms. Temponeras could prescribe opioids

“on a protracted basis or when managing intractable

pain with prescription drugs in amounts or

combinations that may not be appropriate when

treating other medical conditions” was eventually

repealed in 2018 – well after the indictment of Ms.

Temponeras. App.36; OAC Ann. 4731-21-02 (2005).

Before the statute’s repeal, however, this provision of

the intractable pain law remained in the statute until

it was removed in 2017 – long after Ms. Temponeras

ceased practicing medicine. App.42; OAC Ann. 473121-02 (2017). A National Law Review article noted

that “[o]n December 23, 2018, new State Medical Board

of Ohio regulations became effective which marked

another change in the legal standards governing

provider use of opiates for treatment of pain. Notably,

these new regulations also serve to rescind and replace

Ohio’s previously long-standing ‘Chronic Pain Rules,’

also known as the ‘Intractable Pain Rules,’ which were

24

first adopted as a component of the earlier ‘5th Vital

Sign’ era which preceded the current opioid epidemic.

In this respect, these new rules eliminate the last

remaining regulatory vestige of that prior era.”15

The climate at the time Ms. Temponeras opened her

pain management medical practice is akin to the

medical marijuana industry today. The current opinion

about marijuana has changed significantly over time.

The pendulum of opinion has swayed significantly from

the 1980s classroom lectures that you should “just say

no” because marijuana is a “gateway drug” with

absolutely no legitimate medical purpose. Today,

medical marijuana is considered a legitimate medical

industry by most state governments and has been

touted in the medical community as an effective

remedy for almost every ailment including chronic

pain, anxiety, autoimmune disorders and infectious

diseases.16

Incredibly, despite state laws allowing for the

distribution of medical marijuana, marijuana is still

classified as a Schedule I drug defined as having “no

legitimate medical purpose” under federal law. United

States v. Green, 222 F. Supp. 3d 267, 271-72 (W.D.N.Y.

15

See, National Law Review, Standards for Use of Opiates in

Treatment of Pain Changes in Ohio,

https://www.natlawreview.com/article/standards-use-opiatestreatment-pain-changes-ohio

16

See, Ohio Marijuana Card, Understanding Pain that is Chronic,

Severe or Intractable,

https://www.ohiomarijuanacard.com/post/understanding-pain-thatis-chronic-severe-or-intractable

25

2016). Ten years from now, doctors and clinicians who

are now relying on state’s medical marijuana laws may

likely be subjected to the same criminal prosecutions as

pain management doctors now face. Indeed, the

government can utilize even stronger arguments

against the medical marijuana industry citing that the

federal law does not recognize any legitimate medical

purpose for the dispensation of marijuana. Unlike

medical marijuana, opioids have always been classified

as having a legitimate medical use as is noted by its

classification as a Schedule II drug.

To avoid engaging in a criminal act, a person must

be aware of the prohibited conduct as defined by the

law. The Sixth Circuit readily acknowledges that its

approach to these laws is not to define any proscribed

conduct. As such, a medical practitioner does not have

any notice of what conduct is considered outside the

legitimate bounds of practice. This is not a standard,

but rather a hit or miss proposition. Ultimately, a case

is not prosecuted on whether a criminal law is violated,

but rather if a doctor is within the crosshairs of a

federal prosecutor. These are inherently vague laws

which give prosecutors way too much power in

determining whether a crime is committed. Without

specific guidelines, a prosecutor determines whether a

doctor has engaged in criminal conduct inviting the

arbitrary exercise of power which is exactly what the

law prohibits. These vague laws are inherently

dangerous and again cede too much power to an

unelected federal prosecutor. For instance, a patient

may be borderline diabetic and seek the advice of

several doctors to treat this ailment. Doctor A may

immediately argue that aggressive medication is

26

needed, but in contrast Doctor B may advocate for a

change in diet and a daily exercise routine. Do we now

live in an environment where we criminalize an

alternative form of treatment?

Chronic pain has been treated by doctors in

accordance with the standards set forth by the medical

community. Medical standards fluctuate throughout

time based upon new studies and discoveries. Often,

there arises a medical debate as to appropriate medical

standards and practices.17 Medical doctors practice in

this atmosphere and must make professional

judgments as to courses of treatment based upon the

information available to them. Doctors should not be

prosecuted under amorphous legal standards that are

impossible to clearly define and ultimately impossible

to defend against. The government knows the actual

culprit here. Many pharmaceutical companies deceived

the public and the medical community regarding their

product. As such, these vague statutes are providing a

platform to pursue and punish the wrong people.

Doctors are placed in the unenviable position of facing

decades in prison and/or a ten-week trial which is

financially crippling. Let us be frank, this is why most

doctors prosecuted under these statutes take a plea of

guilty. Unless this Court intervenes, the government

can arbitrarily prosecute doctors even though these

medical professionals followed the standards set forth

17

These medical differences of opinion can be readily seen in the

open debates as to the use of hydroxychloroquine for the treatment

of Covid-19 just this past year. Numerous doctors said the

treatment could save lives. Others deemed the usage of the drug

dangerous.

27

by the medical community and pursuant to the

direction of pharmaceutical companies.

This Court’s intervention is also needed whereby

there is an existing circuit split as to how to apply

these very vague, dangerous laws. Currently, this is

not a legal standard but a non-legal crapshoot. These

vague laws may soon ensnare the purveyors of medical

marijuana dispensaries which may face federal

criminal prosecution because the winds of public and/or

medical opinion have changed regarding the use of

medical marijuana. The passage of time has made the

terms “legitimate medical practice” and “outside the

scope” too amorphous and they are clearly vague. This

Court’s intervention here is desperately needed.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

Alexandra C. Siskopoulos

Counsel of Record

Siskopoulos Law Firm, LLP

33 West 19th Street, 4th Floor

New York, New York 10011

(646) 942-1798

acs@siskolegal.com

Counsel for Petitioner

March 12, 2021