Amicus Curiae Brief — Xiulu Ruan, Petitioner v. United States

Supreme Court briefDec 23, 2021

Ask Donna

What actually matters in this document.

Text

No. 20-1410

================================================================================================================

In The

Supreme Court of the United States

---------------------------------♦--------------------------------DR. XIULU RUAN,

Petitioner,

UNITED STATES OF AMERICA,

Respondent.

---------------------------------♦--------------------------------On Writ Of Certiorari To The

United States Court Of Appeals

For The Eleventh Circuit

---------------------------------♦--------------------------------BRIEF OF AMICI CURIAE

PROFESSORS OF HEALTH LAW AND POLICY

IN SUPPORT OF PETITIONER

---------------------------------♦--------------------------------JENNIFER D. OLIVA

Counsel of Record

Associate Dean for Faculty

Research & Development

Professor of Law

Director, Center for Health

& Pharmaceutical Law

SETON HALL UNIVERSITY SCHOOL OF LAW

One Newark Center

Newark, NJ 07012

973-642-8151

jennifer.oliva@shu.edu

KELLY K. DINEEN

Associate Professor of Law

Director, Health Law Program

CREIGHTON UNIVERSITY SCHOOL OF LAW

2500 California Plaza

Omaha, NE 68178

402-280-2127

kellydineen2@creighton.edu

Counsel for Amici Curiae

================================================================================================================

COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

TABLE OF CONTENTS

Page

INTEREST OF AMICI CURIAE .........................

SUMMARY OF THE ARGUMENT .....................

ARGUMENT ........................................................

Conviction of Practitioners under Section

841(a)(1) Should Require a Knowing Departure from the Terms of Their Authorization .........................................................

A. The Statutory Framework and Elements of the Crime ..............................

B. The Scienter Requirement .................. 11

II.

Eliminating the Mens Rea Requirement

from 841(a)(1) Stifles Innovation, Harms

Patients, and Compromises Practitioners’

Ethical Integrity ........................................ 14

III.

Any Construction of the CSA that Criminalizes Medical Error Improperly Intrudes on the States’ Power to Regulate

the Practice of Medicine ............................ 19

IV.

Under the Eleventh Circuit’s Construction of Section 841(a), the Standard the

Government had to Satisfy to Convict Dr.

Ruan of Felony Distribution was Lower

than the Applicable State Standard for

Civil Malpractice Liability ........................ 30

CONCLUSION..................................................... 34

APPENDIX

LIST OF SIGNATORIES .................................... App. 1

TABLE OF AUTHORITIES

Page

CASES

Barsky v. Bd. of Regents, 347 U.S. 442 (1954) ............19

Buckman Co. v. Plaintiffs’ Legal Comm., 531

U.S. 341 (2001) ........................................................27

Dennis v. United States, 341 U.S. 494 (1951) .............11

Flores-Figueroa v. United States, 556 U.S. 646

(2009) .......................................................................11

Gregory v. Ashcroft, 501 U.S. 452 (1991) .............. 20, 29

Gonzales v. Oregon, 546 U.S. 243 (2006) ...... 1, 9, 13, 23

Hillsborough Cty. v. Automated Med. Labs., Inc.,

471 U.S. 707 (1985) .................................................19

Linder v. United States, 268 U.S. 5 (1925) .................19

Liparota v. United States, 471 U.S. 419 (1985) .... 11, 12

McFadden v. United States, 576 U.S. 186 (2015) ... 6, 8, 11

New State Ice Co. v. Liebmann, 285 U.S. 262

(1932) .......................................................................29

Oregon v. Ashcroft, 368 F.3d 1118 (2004) ...................26

Pa. Dep’t of Corr. v. Yeskey, 524 U.S. 206 (1998) .........21

Pegram v. Herdrich, 530 U.S. 211 (2000) ...................21

Raygor v. Regents of University of Minnesota,

534 U.S. 533 (2002) ........................................... 20, 21

Rehaif v. United States, 139 S. Ct. 2191 (2019) ... 12, 13

Rush Prudential HMO, Inc. v. Moran, 536 U.S.

355 (2002) ................................................................20

iii

TABLE OF AUTHORITIES—Continued

Page

Solid Waste Agency of Northern Cook County v.

United States Corps of Engineers, 531 U.S. 159

(2001) .......................................................................21

Sporhase v. Neb. ex rel. Douglas, 458 U.S. 941

(1982) .......................................................................22

Staples v. United States, 511 U.S. 600 (1994) ...... 11, 12

United States v. Khan, 989 F.3d 806 (10th Cir.

2021) .............................................................. 6, 11, 12

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

2017) ..........................................................................9

United States v. Kozminski, 487 U.S. 931 (1988) .......21

United States v. Lopez, 514 U.S. 549 (1995) ...............29

United States v. Merrill, 513 F.3d 1293 (11th Cir.

2008) ........................................................................31

United States v. Moore, 423 U.S. 122 (1975) ... 8, 9, 13, 24

United States v. Ruan, 966 F.3d 1101 (11th Cir.

2020), cert. granted 17-12653 (Nov. 5, 2021) ...... 9, 10

United States v. Regenerative Sci., LLC, 878

F. Supp. 2d 248 (D.D.C. 2012) .................................27

United States v. Universal C.I.T. Credit Corp.,

344 U.S. 218 (1952) .................................................22

United States v. X–Citement Video, Inc., 513 U.S.

64 (1994) ..................................................................12

TABLE OF AUTHORITIES—Continued

Page

PETITIONS FOR CERTIORARI & AMICI BRIEFS

Brief of Amici Curiae Professors of Health Law

and Policy in Support of Petitioner, Ruan v.

United States, No. 20-1410 (May 7, 2021) ................5

Petition for Cert., Ruan v. United States, docketed, 17-12653 (Apr. 7, 2021) ............................. 30, 32

STATUTES, LEGISLATION & REGULATIONS

21 U.S.C. § 396 ............................................................27

21 U.S.C. §801(1) ..................................................... 2, 24

21 U.S.C. § 802(21) ............................................ 7, 12, 25

21 U.S.C. § 811(b) ........................................................24

21 U.S.C. § 821 ..............................................................7

21 U.S.C. § 822(a) ..........................................................7

21 U.S.C. § 822(b) ..........................................................7

21 U.S.C. § 823(f ) .............................................. 7, 25, 26

21 U.S.C. § 824 ..............................................................8

21 U.S.C. § 823(g) .................................................. 22, 28

21 U.S.C. § 823(g)(2)(H)(i) ..................................... 22, 28

21 U.S.C. § 829 ..............................................................7

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

21 U.S.C. § 871(b) ..........................................................7

21 U.S.C. § 903 ............................................................25

42 U.S.C. § 263a-2(i)(1) ...............................................28

TABLE OF AUTHORITIES—Continued

Page

42 U.S.C. § 290bb-2a ...................................................23

42 U.S.C. § 416 ............................................................28

42 U.S.C. § 1395 ..........................................................28

21 C.F.R. § 1306.04 ................................................. 8, 10

21 C.F.R. § 1306.03 .......................................................7

Ala. Code. § 6-5-542(2) ................................................30

Ala. Code. § 6-5-548(a) ................................................32

Ala. Code. § 6-5-548(c) ................................................32

Ariz. Rev. Stat. Ann. § 12-2604 ...................................33

Narcotic Addict Treatment Act, Pub. L. No. 93281, Stat. (1974) ......................................................24

ADMINISTRATIVE & LEGISLATIVE MATERIALS

H.R. Rep. No. 105-310 (1997) .....................................28

S. Rep. No. 93-192 (1973) ............................................25

S. Rep. No. 106-299 (2000) ..........................................26

OTHER AUTHORITIES

Evan D. Anderson, Jason Sloan, & Leo Beletsky,

Intensive Care for Pain as an Overdose Prevention Tool: Legal Considerations and Policy

Imperatives, 5 U. PA. L. & PUB. AFF. 63

(2019) ................................................................. 16, 23

TABLE OF AUTHORITIES—Continued

Page

Michael C. Barnes, A More Sensible Surge: Ending DOJ’s Indiscriminate Raids of Healthcare

Providers, 8 LEGISLATION AND POL’Y BRIEF 7

(2019) .......................................................................15

Daniel Z. Buchman, Anita Ho, & Daniel S. Goldberg, Investigating Trust, Expertise, and Epistemic Injustice in Chronic Pain, 14 BIOETHICAL

INQUIRY 31 (2017) ......................................................3

John A. Caldwell & J. Lynn Caldwell, Fatigue

in Military Aviation: An Overview of U.S.

Military-Approved Pharmacological Countermeasures, 76 AVIATION, SPACE, & ENV’T MED.

C39 (2005) .................................................................3

Centers for Disease Control and Prevention,

National Center for Health Statistics, Drug

Overdose Deaths in the U.S. Top 100,000 Annually (Nov. 17, 2021), https://www.cdc.gov/nchs/

pressroom/nchs_press_releases/2021/20211117.

htm ............................................................................5

Ronald W. Chapman II, Defending Hippocrates:

Representing Physicians in the Wake of the

Opioid Epidemic, 43 CHAMPION 40 (2019) ..............10

Beth D. Darnall, et al. International Stakeholder

Community of Pain Experts and Leaders Call

for an Urgent Action on Forced Opioid Tapering, 20 PAIN MED. 429 (2019) ..................................17

Nabarum Dasgupta et al., Opioid Crisis: No

Easy Fix to its Social and Economic Determinants, 108 AMER. J. PUB. HEALTH 2 (2018) ...............4

vii

TABLE OF AUTHORITIES—Continued

Page

Kelly K. Dineen, Addressing Prescription Opioid

Abuse Concerns in Context: Synchronizing

Policy Solutions to Multiple Complex Health

Problems, 40 L. & PSYCH. REV. 1 (2016) ...................3

Kelly K. Dineen, Definitions Matter: A Taxonomy

of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce Patient Harm,

67 KS. L. REV. 101 (2019) .............................. 4, 14, 17

Kelly K. Dineen & Elizabeth Pendo, Substance

Use Disorder Discrimination and the Cares

Act: Using Disability Law to Inform Part 2

Rulemaking, 52 ARIZ. ST. L.J. 1143 (2020).............16

Kelly K. Dineen & James M. DuBois, Between a

Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While

Avoiding Legal Sanction?, 42 AMER. J.L. &

MED. 1 (2016) ................................................... 4, 6, 14

Fahima Dossa et al., Propofol Versus Midazolam

with or Without Short-Acting Opioids for Sedation in Colonoscopy: A Systematic Review

and Meta-Analysis of Safety, Satisfaction, and

Efficiency Outcomes, 91 GASTROINTESTINAL

ENDOSCOPY 1015 (2020) .............................................2

Deborah Dowell et al., CDC Guideline for Prescribing Opioids for Chronic Pain, 65 MMWR

RECOMM. REP. 1 (2016) ............................................17

viii

TABLE OF AUTHORITIES—Continued

Page

Richard H. Epstein, et al., Intraoperative

Handoffs Among Anesthesia Providers Increase the Incidence of Documentation Errors

for Controlled Drugs, 43 JOINT COMM’N J.

QUALITY & PATIENT SAFETY 392 (2017) .....................2

William N. Eskridge, Jr. & Philip P. Frickey,

Quasi-Constitutional Law: Clear Statement

Rules as Constitutional Lawmaking, 45 VAND.

L. REV. 593 (1992) ...................................................21

Deborah Hellman, Prosecuting Doctors for

Trusting Patients, 16 GEO. MASON L. REV. 701

(2009) .......................................................................13

Diane E. Hoffmann, Treating Pain Verses Reducing Drug Diversion and Abuse: Recalibrating

the Balance in Our Drug Control Laws and

Policies, 1 ST. LOUIS U. J. HEALTH L. & POL’Y

231 (2008) ................................................................10

Sandra H. Johnson, Customary Standards of

Care, 43 HASTINGS CTR. REP. 6 (2013) ....................14

Sandra H. Johnson, Regulating Physician Behavior: Taking Doctors’ “Bad Law” Claims Seriously, 53 ST. LOUIS U. L.J. 973 (2009) ..................15

Amy Lieberman & Corey Davis, Laws Limited

the Prescribing or Dispensing of Opioids, NETWORK FOR PUBLIC HEALTH LAW (May 11, 2021),

https://www.networkforphl.org/resources/lawslimiting-the-prescribing-or-dispensing-of-opioids/

?blm_aid=844744295 ................................................4

TABLE OF AUTHORITIES—Continued

Page

Jai Madhok & Frederick G. Mihm, Rethinking

Sedation During Prolonged Mechanical Ventilation for COVID-19 Respiratory Failure, 131

ANESTHESIA & ANALGESIA 1 (2020) ............................2

John J. Mulrooney, II & Katherine E. Legel, Current Navigation Points in Drug Diversion

Law: Hidden Rocks in Shallow, Murky, DrugInfested Waters, 101 MARQ. L. REV. 333

(2017) .........................................................................8

Kate M. Nicholson & Deborah Hellman, Opioid

Prescribing and the Ethical Duty to Do No

Harm, 46 AMER. J. L. & MED. 297 (2020) .................3

NAT’L ACADEMIES OF SCIENCES, MEDICATIONS FOR

OPIOID USE DISORDER SAVE LIVES (2019) ................16

NAT’L ASS’N OF ATTORNEYS GENERAL, “FIRST, DO

NO HARM”: CRIMINAL PROSECUTIONS OF DOCTORS

FOR DISTRIBUTING CONTROLLED SUBSTANCES

OUTSIDE OF LEGITIMATE MEDICAL NEED (May 4,

2017), https://www.naag.org/attorney-generaljournal/criminal-prosecutions-of-doctors-fordistributing-controlled-substances/ ..........................5

NAT’L CONFERENCE OF STATE LEGISLATURES, MEDICAL LIABILITY/MALPRACTICE MERIT AFFIDAVITS

AND EXPERT WITNESSES (June 24, 2014) .................31

Amelia L. Persico et al., Opioid Taper Practices

Among Clinicians, 14 J. PAIN RES. 3353

(2021) .......................................................................17

TABLE OF AUTHORITIES—Continued

Page

Cara L. Sedney et al., “The DEA Would Come in

And Destroy You”: A Qualitative Study of

Fear And Unintended Consequences Emerging

From Restrictive Opioid Prescribing Policies

In West Virginia (Oct. 25, 2021), https://www.

researchsquare.com/article/rs-991531/v1 ...............15

Christine Vestal, Rapid Opioid Cutoff is Risky

Too, Feds Warn, PEW (May 21, 2019) ......................18

Lynn Webster, Pain and Suicide: The Other Side

of the Opioid Story, 15 PAIN MED. 345 (2014) ........19

Jackie Yenerall & Melinda B. Buntin, Prescriber

Responses to a Pain Clinic Law: Cease or

Modify?, 206 DRUG & ALCOHOL DEP. 107591

(2020) .......................................................................18

PHILLIP ZHANG & PREETI PATEL, PRACTITIONERS

AND PRESCRIPTIVE AUTHORITY (2021), https://

www.ncbi.nlm.nih.gov/books/NBK574557/ ..............2

INTEREST OF AMICI CURIAE1

Amici are professors of health law and policy at

American universities. We have no personal interest in

the outcome of this case. We have a professional interest in reducing morbidity and mortality related to

drugs and ensuring access to appropriate treatment

for patients with pain, addiction, and the many other

conditions for which prescribed controlled substances

are appropriate. Those interests are threatened by

medical practitioners’ understandable fears of criminal sanction created by the weakened, inconsistent,

and unpredictable standards to convict prescribers under Section 841(a)(1) of the Controlled Substances Act

(CSA).

---------------------------------♦---------------------------------

SUMMARY OF THE ARGUMENT

Prescribing controlled substances for the benefit

of patients is an everyday and essential practice for

physicians and other authorized prescribing practitioners.2 Gonzales v. Oregon, 546 U.S. 243, 254 (2006)

Rule 37 statement: The parties were notified and consented

to the filing of this brief more than 10 days before its filing. See

Sup. Ct. R. 37.2(a). No party’s counsel authored any of this brief;

amicus alone funded its preparation and submission. See Sup. Ct.

R. 37.6.

Although these cases involve physicians, other practitioners—such as advance practice registered nurses and physician assistants—have prescribing authority under state law and are

authorized to prescribe under the Controlled Substances Act to

the extent of their state’s permissions and in compliance with the

Drug Enforcement Agency’s requirements of authorization. See

(explaining that the inability to prescribe controlled

substances would constitute a “severe restriction on

medical practice”). Despite dominant public narratives

about the harms of prescribed controlled substances,

these compounds are neither harmful nor useful absent context. In fact, they are essential to modern medicine;3 a reality acknowledged by Congress in the

initial sentences of the CSA. 21 U.S.C. § 801(1) (many

of the controlled substances under the statute’s purview “have a useful and legitimate medical purpose

and are necessary to maintain the health and general

welfare of the American people”). Indeed, prescribed

controlled substances are a critical component of appropriate, ethical, and evidence-based care for patients with a range medical needs and conditions

beyond pain and opioid use disorder, from treating patients with severe COVID-19 respiratory failure, Jai

Madhok & Frederick G. Mihm, Rethinking Sedation

During Prolonged Mechanical Ventilation for COVID19 Respiratory Failure, 131 ANESTHESIA & ANALGESIA 1

generally, PHILLIP ZHANG & PREETI PATEL, PRACTITIONERS AND

PRESCRIPTIVE AUTHORITY (2021), https://www.ncbi.nlm.nih.gov/

books/NBK574557/.

For example, every person who has had general surgery or

a procedure with sedation (e.g., colonscopy) has received prescribed controlled substances. See generally, Richard H. Epstein,

et al., Intraoperative Handoffs Among Anesthesia Providers Increase the Incidence of Documentation Errors for Controlled

Drugs, 43 JOINT COMM’N J. QUALITY & PATIENT SAFETY 392

(2017); Fahima Dossa et al., Propofol Versus Midazolam with or

Without Short-Acting Opioids for Sedation in Colonoscopy: A Systematic Review and Meta-Analysis of Safety, Satisfaction, and

Efficiency Outcomes, 91 GASTROINTESTINAL ENDOSCOPY 1015

(2020).

(2020), to regulating wakefulness for pilots. John A.

Caldwell & J. Lynn Caldwell, Fatigue in Military Aviation: An Overview of U.S. Military-Approved Pharmacological Countermeasures, 76 AVIATION, SPACE, &

ENV’T MED. C39 (2005).

Like all medications, prescribed controlled substances also carry the potential for harm, including the

risk that those drugs may be diverted for use by others

without medical supervision. Practitioners have professional legal and ethical duties to carefully weigh the

potential benefits and harms to their patients, and to

prescribe controlled substances in a way that reduces

the likelihood of diversion. See Kate M. Nicholson &

Deborah Hellman, Opioid Prescribing and the Ethical

Duty to Do No Harm, AMER. J. L. & MED. 297 (2020);

Kelly K. Dineen, Addressing Prescription Opioid Abuse

Concerns in Context: Synchronizing Policy Solutions

to Multiple Complex Health Problems, 40 L. & PSYCH.

REV. 1, 35 (2016). These prescribing decisions are

fraught with peril,4 including legal peril, in ways that

prescribing other potentially harmful drugs are not—

especially considering the responses to the drug overdose crises in the United States.5 Over the last decade,

Daniel Z. Buchman, Anita Ho, & Daniel S. Goldberg, Investigating Trust, Expertise, and Epistemic Injustice in Chronic

Pain, 14 BIOETHICAL INQUIRY 31 (2017).

The “opioid crisis” is an inaccurate description of the drug

use related morbidity and mortality crisis in the U.S., which is a

pressing and complex problem with social, cultural, medical, and

legal causes. Abundant evidence supports the conclusion that neither prescription opioids nor any class of prescription controlled

substances were the only or even a primary driver of overdose

legal and institutional actors have implemented

blunt, reactive policies with the singular goal of reducing controlled substances prescriptions. See, e.g.,

Amy Lieberman & Corey Davis, Laws Limited the Prescribing or Dispensing of Opioids, NETWORK FOR PUBLIC

HEALTH LAW (May 11, 2021), https://www.networkforphl.

org/resources/laws-limiting-the-prescribing-or-dispensingof-opioids/?blm_aid=844744295. As prescribing rates

have plummeted during the last decade, the harms to

patients in need of care and safe access to medication

have significantly increased. Kelly K. Dineen, Definitions Matter: A Taxonomy of Inappropriate Prescribing

to Shape Effective Opioid Policy and Reduce Patient

Harm, 67 KS. L. REV. 101 (2019); Nicholson & Hellman.

CSA Section 841(a)(1) prosecutions carry a significant possibility of federal imprisonment—the most

severe of the many legal and quasi-legal remedies

available to address problematic prescribing. Kelly K.

Dineen & James M. DuBois, Between a Rock and a

Hard Place: Can Physicians Prescribe Opioids to Treat

Pain Adequately While Avoiding Legal Sanction?,

42 AMER. J.L. & MED. 1 (2016). Until recently, Section 841(a)’s scienter requirement, which demands a

knowing departure from the usual course of professional practice, constrained such prosecutions. But

the CSA has been weaponized against practitioners in

reaction to the overdose crisis. Federal practitioner

deaths. See, e.g., Nabarum Dasgupta et al., Opioid Crisis: No Easy

Fix to its Social and Economic Determinants, 108 AMER. J. PUB.

HEALTH 2 (2018).

investigations and prosecutions have increased while

the standards for conviction under Section 841(a)(1)

have steadily eroded. See, e.g., NAT’L ASS’N OF ATTORNEYS GENERAL, “FIRST, DO NO HARM”: CRIMINAL PROSECUTIONS OF DOCTORS FOR DISTRIBUTING CONTROLLED

SUBSTANCES OUTSIDE OF LEGITIMATE MEDICAL NEED

(May 4, 2017), https://www.naag.org/attorney-generaljournal/criminal-prosecutions-of-doctors-for-distributingcontrolled-substances/.

Prosecutorial and judicial statutory reconstruction to more easily convict practitioners is not the

cure for drug related morbidity and mortality. See

Centers for Disease Control and Prevention, National

Center for Health Statistics, Drug Overdose Deaths

in the U.S. Top 100,000 Annually (Nov. 17, 2021),

https://www.cdc.gov/nchs/pressroom/nchs_press_releases/

2021/20211117.htm (reporting an almost 30% increase

in and record high number of overdose deaths between

April 2020 and 2021). As we previously explained, and

as the petitioners have described in the consolidated

cases here, the Tenth and Eleventh Circuits have effectively eliminated Section 841(a)(1)’s mens rea requirements as applied to prescribers. Brief of Amici Curiae

Professors of Health Law and Policy in Support of Petitioner, Ruan v. United States, No. 20-1410 (May 7,

2021). While the government must prove intentional

or knowing distribution of controlled substances for

non-prescribers under Tenth and Eleventh Circuit

precedent, the government may convict an authorized

prescriber of felony distribution without proof that

they had any knowledge of “all the facts that make

[their] conduct illegal.” McFadden v. United States, 576

U.S. 186, 194–95 (2015). Practitioners can face decades

in prison for nothing more than deviations from accepted medical standards, including mistaken, foolish,

negligent, and reckless prescribing (good faith medical

error). See Dineen & DuBois at 21.

The text and history of the CSA and this Court’s

relevant precedent all support the conclusion that Section 841(a)(1) was designed to punish practitioners

who engage in intentional or knowing illicit drug distribution by using their authorization to prescribe as

a subterfuge for diverting drugs. The statute was

not intended to remedy poor or even harmful medical

decision-making. The Tenth and Eleventh Circuits’ constructive rewriting of the CSA as applied to practitioners harms patients with legitimate medical need for

controlled substances, forces practitioners to act unethically to protect themselves from legal sanction at

the expense of the well-being of the patient, imperils

the evolution of patient care, and implicates significant

federalism concerns. We respectfully request that this

Court clarify the scienter requirements of Section

841(a)(1) and reject the legal exceptionalism embraced by several federal circuits that have determined to apply good faith to the actus rea rather than

the mens rea requirements of the statute. See, e.g.,

United States v. Khan, 989 F.3d 806 (10th Cir. 2021).

The CSA’s reach should only extend to practitioners

who knowingly or intentionally (i.e., not with subjective good faith) depart from their controlled substances

authorization to prescribe outside the usual course of

professional practice, and thereby transform legitimate prescribing into unlawful distribution. This is the

most coherent interpretation of the line between otherwise lawful activity (prescribing as authorized) and

criminal distribution under Section 841(a)(1).

---------------------------------♦---------------------------------

ARGUMENT

Conviction of Practitioners under Section

841(a)(1) Should Require a Knowing Departure from the Terms of Their Authorization

A. The Statutory Framework and Elements

of the Crime

The Controlled Substances Act (CSA) makes it unlawful, “except as authorized . . . for any person [to]

knowingly or intentionally . . . distribute . . . a controlled substance.” 21 U.S.C. § 841(a)(1) (emphasis

added). Authorization is attended by certification requirements (such as state practitioner licensure and

a valid, DEA-issued certificate of registration (COR)

permitting prescribing),6 as well as practice requirements, including a mandate that authorized practitioners may only distribute controlled substances

“in the course of professional practice,” 21 U.S.C.

§ 802(21), by issuing valid prescriptions, id. § 829, defined as those “issued for a legitimate medical purpose

21 U.S.C. §§ 822(a) & 823(f ); 21 C.F.R. § 1306.03. Authorization also requires conformity with other provisions of the CSA,

id. § 822(b), and with regulations issued by the Attorney General.

See id. §§ 821 & 871(b).

by an individual practitioner acting in the usual course

of his professional practice.” 21 C.F.R. § 1306.04(a) (emphases added). The administrative penalties for failure to comply with the authorization requirements

include suspension and permanent revocation of the

COR. 21 U.S.C. § 824; John J. Mulrooney II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in Shallow, Murky, DrugInfested Waters, 101 MARQ. L. REV. 333, 389 (2017).7

Criminal prosecution under Section 841(a)(1), of

course, carries far more serious penalties. To convict

a non-practitioner defendant, the government must

prove that the defendant (1) intentionally or knowingly (2) distributed (3) a controlled substance. Id.;

McFadden at 188-89 (the government is required to

“establish that the defendant knew he was dealing

with a controlled substance” as one of the facts the defendant must know to constitute a crime) (emphasis

added).

In United States v. Moore, this Court did not address the requirements the government must satisfy to

convict a practitioner under Section 841(a)(1) because

the defendant conceded a knowing departure from the

usual course of professional practice at trial. 423 U.S.

122 (1975). The Court reached the narrower conclusion

that the federal government’s issuance of a COR was

not sufficient to shield practitioners from prosecution

Section 824 also includes a few subsections with mens rea

requirements, see § 824(a)(12)(b); § 824(c)(2)(A), making it even

more unlikely that the felony provision at Section 841(a)(1) would

not include the same or a higher scienter requirement.

when their prescription(s) fall outside “legitimate

channels,” such that they are acting “outside the

bounds of professional practice” and prescribing not

“for legitimate purposes, but primarily for the profits

to be derived therefrom.” Id. at 131-135.8 This Court

has not yet considered “the extent to which the CSA

regulates medical practice beyond prohibiting a doctor

from acting as a drug pusher instead of a physician.”

Gonzales, 546 U.S. at 269 (internal quotations omitted).

Since Moore, the federal circuit courts have inconsistently defined the elements of the crime in prescriber prosecutions. Compare, e.g., United States v.

Ruan, 966 F.3d 1101, 1136 (11th Cir. 2020) (“[i]n the

medical context, drug distribution in violation of

§ 841(a)(1) requires proof that either 1) the prescription was not for a ‘legitimate medical purpose’ or 2) the

prescription was not made in the ‘usual course of professional practice’ ”); with United States v. Kohli, 847

F.3d 483, 486 (7th Cir. 2017) (the government must

prove that the defendant (1) knowingly caused to be

dispensed the controlled substance alleged; (2) did so

by intentionally prescribing the controlled substance

outside the usual course of professional medical practice, and not for a legitimate medical purpose; and

(3) knew that the substance was some kind of a controlled substance).

Moore was decided when the only unilateral federal mechanism to stop a practitioner from prescribing was Section 841

prosecution. The CSA was later amended to allow the DEA to

deny, suspend, or revoke a COR if continued registration would

be inconsistent with the public interest.

Even with differences as to Section 841(a)(1)’s specific elements, there had been some consensus that the

government must prove that the defendant knowingly

departed from “usual course of professional practice,”

or, at a minimum, acted without a “legitimate medical

purpose,” which serves as a proxy of sorts for the practitioner’s knowing departure from the usual course of

professional practice.9 See, e.g., Ronald W. Chapman II,

Defending Hippocrates: Representing Physicians in the

Wake of the Opioid Epidemic, 43 CHAMPION 40 (2019).

The Tenth and Eleventh Circuits, however, have eviscerated that tenuous consensus by eliminating the scienter requirement altogether and, thus, permitting

conviction for prescriptions not written in the usual

course of professional practice. Ruan at 1136; Khan at

825 (the government must prove “that a practitionerdefendant either: (1) subjectively knew a prescription

was issued not for a legitimate medical purpose; or

(2) issued a prescription that was objectively not in

the usual course of professional practice”) (emphasis

added). By writing the mens rea out of the statute, a

good faith medical prescribing error is criminalized,

which conflates civil and criminal liability. See, e.g.,

Diane E. Hoffmann, Treating Pain Verses Reducing

Drug Diversion and Abuse: Recalibrating the Balance

in Our Drug Control Laws and Policies, 1 ST. LOUIS

U. J. HEALTH L. & POL’Y 231 (2008).

The regulation at 21 C.F.R. § 1306.04(a) might be understood as providing context to Section 841(a)(1) by using “legitimate medical purpose” as a short-hand for subjective good faith

to treat a patient in the “course of professional practice.”

B. The Scienter Requirement

“The existence of a mens rea is the rule of, rather

than the exception to, the principles of Anglo-American

criminal jurisprudence,” Dennis v. United States, 341

U.S. 494 (1951), and there is a strong presumption in

favor of reading in a mens rea requirement, even when

not statutorily defined. Staples v. United States, 511

U.S. 600 (1994). Congress explicitly included a minimum scienter requirement of knowledge in the text

of Section 841(a)(1). Interpreting the statute consistent with “ordinary English usage,” Flores-Figueroa

v. United States, 556 U.S. 646, 652 (2009), the government must prove three material elements under Section 841(a)(1) beyond a reasonable doubt: that the

defendant (1) knowingly (2) distributed (3) a controlled

substance. McFadden at 188-189.

These material elements are the same whether

the defendant is a practitioner or a layperson. In the

case of a practitioner, however, because prescribing is

an authorized activity, the government must meet the

distribution requirement by proving a practitioner

acted outside their authorization. Thus, in practitioner cases, the government must prove that the defendant (1) knowingly (2) acted without authorization

(and, thus, unlawfully distributed) (3) a controlled substance. The word knowingly applies to the verb(s)

(here, distribute) and the object of the verb(s) (here,

controlled substance) in the statute. McFadden at 191;

Liparota v. United States, 471 U.S. 419 (1985). The

second element (acted without authorization) can only

be met if the defendant acted outside the course of

professional practice, 21 U.S.C. § 802 (21), and did so

knowingly. See, e.g., United States v. X–Citement Video,

Inc., 513 U.S. 64, 79 (1994) (Stephens, J., concurring)

(“courts ordinarily read a phrase in a criminal statute

that introduces the elements of a crime with the word

“knowingly” as applied to each element”).

The Tenth and Eleventh Circuits’ elimination of

the knowledge requirement for the actus rea of distribution (prescribing outside the scope of authorization in the case of practitioners) creates a two-tiered

system in which prosecutors are only required to

prove knowledge of distribution when prosecuting laypersons. The assertion that the government may succeed against practitioners by either proving that they

“(1) subjectively knew a prescription was issued not for

a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice,” as the Tenth Circuit held in Kahn

is a perversion of the criminal statute. Such a reading,

in fact, severs the mens rea (subjective knowledge)

from the actus rea (objective departure from the usual

course of practice) and permits conviction if either is

proven instead of reading them together.

Construing the CSA to permit the criminalization

of carelessness or negligence also conflicts with this

Court’s long history of interpreting criminal statutes

to include a mens rea requirement for each element to

avoid criminalizing apparently innocent conduct. See

Staples at 610; Liparata at 426 (requiring knowledge

that the possession of food stamps was unauthorized);

Rehaif v. United States,139 S. Ct. 2191, 2196 (2019)

(“The cases in which we have emphasized scienter’s

importance in separating wrongful from innocent acts

are legion”). Because practitioners frequently prescribe controlled substances knowingly under their authorization, the scienter requirement is critical in

separating accidental or negligent conduct from knowing distribution. Without knowledge of the departure

from authorized prescribing, a practitioner “may well

lack the intent needed to make his behavior wrongful.”

Rehaif at 2197.

Finally, the nature and purpose of the CSA also

supports the conclusion that Congress only intended to

criminalize drug trafficking as traditionally understood, that is, to prosecute practitioners who use their

status as a subterfuge to engage in drug dealing for

personal gain. In Moore, this Court carefully examined the CSA’s legislative history and concluded that

Section 841 only applied to transactions that fell outside legitimate distribution chains and that criminality turned on the nature of the transaction. Moore at

132-138; see also Gonzales at 250. The defendant’s

knowledge that she is prescribing outside of her authorization is central to the nature of the transaction.

As such, the government must prove the practitioner

acted intentionally or knowingly (i.e., other than in

good faith) to secure a conviction. Any other construction, including the spurious objective good faith standard, is just another road to criminalizing prescribing

without the requisite mens rea showing. See, e.g., Deborah Hellman, Prosecuting Doctors for Trusting Patients, 16 GEO. MASON L. REV. 701 (2009).

II.

Eliminating the Mens Rea Requirement

from 841(a)(1) Stifles Innovation, Harms

Patients, and Compromises Practitioners’

Ethical Integrity

In the absence of a mens rea requirement, the national standards of practice used in Section 841(a)(1)

prosecutions to determine the usual course of professional practice is a dangerous precedent for criminal

liability. Standard of care inquiries in civil matters

evaluate the reasonableness of practitioner treatment

decisions and measure prevailing customs, with tolerance for “respectable minority” approaches, including

innovative medical practices. Sandra H. Johnson,

Customary Standards of Care, 43 HASTINGS CTR. REP.

6, 9-10 (2013). In civil matters, liability does not implicate more than reputational and pecuniary interests.

On the other hand, using one component of a civil

standard to determine criminal liability will further

fuel practitioners’ reasonable fears of the kinds of legal

scrutiny that can end not only practitioners’ careers

but deprive them of basic liberties. Dineen & DuBois.

In self-interest, practitioners are incentivized to avoid

innovation and the care of patients with unique or

complex needs. Instead of comporting with the ethical

duties to maximize their patients’ well-being, practitioners over-comply with perceived legal norms to

avoid any possible legal entanglement at those patients’ expense. Id.; Dineen, Definitions Matter.

The fear of criminal scrutiny, including the deterrent effect of investigations alone, motivates practitioners to avoid prescribing controlled substances as

well as the care of the patients who might benefit

from them. Sandra H. Johnson, Regulating Physician

Behavior: Taking Doctors’ “Bad Law” Claims Seriously, 53 ST. LOUIS U. L.J. 973 (2009); see also Cara

L. Sedney et al., “The DEA Would Come In And Destroy You”: A Qualitative Study of Fear And Unintended Consequences Emerging From Restrictive

Opioid Prescribing Policies In West Virginia (Oct. 25,

2021), https://www.researchsquare.com/article/rs-991531/

v1 (conducting qualitative interviews with prescribers

who repeatedly identified the fear of the DEA as motivating patient avoidance). According to Michael

Barnes,

DOJ raids and searches . . . interrupt the delivery of health care, put patients’ lives at

risk, and unjustly destroy careers and livelihoods. They also create confusion and fear

among professionals serving or considering

serving similar patient populations. A reluctance to practice and prescribe controlled

medications when medically necessary is especially troublesome given rising rates of suicide, the availability of increasingly lethal

black-market alternatives, and in the case of

OUD, the federal objective of increasing, rather than decreasing, prescribing.

Michael C. Barnes, A More Sensible Surge: Ending

DOJ’s Indiscriminate Raids of Healthcare Providers, 8

LEG. & POLICY BRIEF 7, 21 (2019).

Fear of scrutiny also contributes to the avoidance

of patients with opioid addiction, for whom prescribed

controlled substances are both the gold standard of

medical care and drastically under-utilized. NAT’L

ACADEMIES OF SCIENCES, MEDICATIONS FOR OPIOID USE

DISORDER SAVE LIVES (2019). As the National Academies of Sciences explained, “the DEA’s approach can be

‘threatening,’ and some . . . providers feel that they are

unfairly scrutinized . . . [and] recent aggressive enforcement strategies[,] . . . including increases in raiding, auditing, and launching criminal investigations

. . . perpetuate the fear of such surveillance.” Id. at 120121. It is ironic that practitioner prosecutions under

Section 841(a)(1) may further drive avoidance of patients with addiction given that an express purpose of

the CSA was to increase access to addiction care, an

area devastated by decades of Harrison Narcotic Act

enforcement against prescribers, which created a century long separation of addiction care from medicine

and pushed people with substance use disorders from

doctors to drug dealers. See, e.g., Evan D. Anderson, Jason Sloan, & Leo Beletsky, Intensive Care for Pain as

an Overdose Prevention Tool: Legal Considerations and

Policy Imperatives, 5 U. PA. L. & PUB. AFF. 63, 98

(2019). Even today, most people with addiction face

stigma, discrimination, and a lack access to evidencebased care. Kelly K. Dineen & Elizabeth Pendo, Substance Use Disorder Discrimination and the Cares Act:

Using Disability Law to Inform Part 2 Rulemaking, 52

ARIZ. ST. L.J. 1143 (2020).

Focused policy efforts to curb all prescribing in

response to the overdose crises has further turned

practitioners away from patients in need. Dineen,

Definitions Matter at 1001-1011 (describing the serious harms and deaths from suicide and the shift to

illicit drugs after prescribers abandoned patients, abruptly stopped prescribing, or rapidly tapered patients’

opioids out of fear of legal scrutiny). One of the most

influential was the CDC Guideline for Prescribing

Opioids for Chronic Pain. Deborah Dowell et al., 65

MMWR RECOMM. REP. 1 (2016). These recommendations and others were accorded the force of legal

mandates and entities from insurance companies to

provider groups, adjusted recommended prescribing

parameters further downward to ensure compliance.

Dineen, Definitions Matter. Practitioners followed

suit, many of whom abandoned their ethical duties to

patients and made medical decisions out of selfprotection rather than in their patients’ best interests,

including by abruptly discontinuing and involuntarily

tapering patients from opioids. Id.; Beth D. Darnall et

al., International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced

Opioid Tapering, 20 PAIN MED. 429 (2019); Amelia L.

Persico et al., Opioid Taper Practices Among Clinicians, 14 J. PAIN RES. 3353, 3357 (2021) (“we found that

motivation for tapering opioids was strongly influenced by CDC guidelines and insurance regulations

rather than medical reasons or patient specific factors”)

(emphasis added).

Patients suffered needlessly and even died. This

situation was so dire that both the Food and Drug Administration (FDA) and the Centers for Disease Control

and Prevention issued warnings about unwarranted

discontinuations and resulting suicides. Christine Vestal, Rapid Opioid Cutoff is Risky Too, Feds Warn, PEW

(May 21, 2019) https://www.pewtrusts.org/en/researchand-analysis/blogs/stateline/2019/05/21/rapid-opioidcutoff-is-risky-too-feds-warn. Today, many practitioners categorically refuse to treat patients with chronic

pain, while others simply stopped medically indicated

prescribing. Jackie Yenerall & Melinda B. Buntin,

Prescriber Responses to a Pain Clinic Law: Cease or

Modify?, 206 DRUG & ALCOHOL DEP. 107591 (2020) (After state law changes, 24% of prescribers stopped prescribing altogether, without regard for patient needs).

Dr. Lynn Webster explained the ethical dilemma

and the harms that can result from the legal pressure

to reduce even helpful medications. Reflecting on his

patient Jack, who died by suicide after Webster decreased Jack’s daily medication dose out of fear of legal

scrutiny, Webster said,

I had to ask myself if my concern for my freedom and licensure had led to this tragedy.

This was a moral dilemma . . . I could have

continued to prescribe a high dose of opioids,

but if he had died . . . the medical examiner

might have said the death was an unintentional overdose . . . [he] might have even intentionally overdosed and no one would know.

Deaths from opioids have become red flags for

investigations. By contrast, Jack’s death by

suicide was not widely recognized by anyone

beyond his family and me. I was tormented by

the thought that he might have died because

I was unable to help him.

Lynn Webster, Pain and Suicide: The Other Side of the

Opioid Story, 15 PAIN MED. 345 (2014).

Patients with pain, addiction, or both desperately

need appropriate care and treatment. If practitioners

are held strictly liable under Section 841(a)(1), patient

abandonment will become ever more common as practitioners act to avoid scrutiny. Progress in medical care

in these areas can only recover if the regulation of medical practice is returned to the province of the states

except in narrow circumstances.

III. Any Construction of the CSA that Criminalizes Medical Error Improperly Intrudes

on the States’ Power to Regulate the Practice of Medicine

Any construction of Section 841(a)(1) that permits

the federal government to criminalize good faith medical errors raises alarming federalism implications.

The states that have primary authority to regulate

the practice of medicine under their reserved Tenth

Amendment police powers. See, e.g., Linder v. United

States, 268 U.S. 5, 18 (1925) (“[D]irect control of medical practice in the states is beyond the power of the

federal government.”); Barsky v. Bd. of Regents, 347

U.S. 442, 449 (1954) (“The state’s [broad power to establish and enforce standards of conduct within its

borders relative to health] extends naturally to the

regulation of all professions concerned with health.”);

Hillsborough Cty. v. Automated Med. Labs., Inc., 471

U.S. 707, 719 (1985) (The regulation of health and

safety is “primarily, and historically, a matter of local

concern[.]”); Rush Prudential HMO, Inc. v. Moran, 536

U.S. 355, 387 (2002) (espousing that establishing

“standards of reasonable medical care” is a “quintessentially state-law” function).

The preservation of a proper balance between federal and state powers is central to our constitutional

design and the protection of fundamental liberties. As

this Court has explained:

This federalist structure of joint sovereigns

preserves to the people numerous advantages.

It assures a decentralized government that

will be more sensitive to the diverse needs of

a heterogenous society; it increases opportunity for citizen involvement in democratic

processes; it allows for more innovation and

experimentation in government; and it makes

government more responsive. . . . Just as the

separation and independence of the coordinate branches of the Federal Government

serve to prevent the accumulation of excessive

power in any one branch, a healthy balance of

power between the States and the Federal

Government will reduce the risk of tyranny

and abuse from either front.

Gregory v. Ashcroft, 501 U.S. 452, 458 (1991).

Consequently, the federal-state balance of power

cannot be dramatically reconstrued by either judicial

supposition or a federal law enforcement agency’s interpretation of a statute that runs afoul of its plain

text. Raygor v. Regents of University of Minnesota, 534

U.S. 533, 543 (2002) (“When Congress intends to alter

the usual constitutional balance between the States

and the Federal Government, it must make its intention to do so unmistakably clear in the language of the

statute.”). The federal government has no right to interfere with a state’s authority to regulate medical

practice without “a clear indication that Congress intended that result.” Solid Waste Agency of Northern

Cook County v. United States Corps of Engineers, 531

U.S. 159, 172 (2001); Pegram v. Herdrich, 530 U.S. 211,

237 (2000) (“[I]n the field of health care, a subject of

traditional state regulation, there is no . . . preemption

without clear manifestation of congressional purpose.”).

In cases involving “Congressional regulation of

core state functions,” the clear statement canon has

been characterized as a “super-strong rule” of statutory

construction that carries weightier force than ordinary preemption. William N. Eskridge, Jr. & Philip P.

Frickey, Quasi-Constitutional Law: Clear Statement

Rules as Constitutional Lawmaking, 45 Vand. L. Rev.

593, 623-24 (1992); see also Pa. Dep’t of Corr. v. Yeskey,

524 U.S. 206, 208–09 (1998) (“[A]bsent an unmistakably clear expression of intent . . . we will interpret a

statute to preserve rather than destroy the States’ substantial sovereign powers.”) (quotation marks and citations omitted).

The rule of lenity, a “time-honored interpretive

guideline,” also applies when Courts construe an ambiguous criminal statute. United States v. Kozminski,

487 U.S. 931, 952 (1988). Under the rule, when

choosing between two constructions of a crime, the

statute shall be construed in favor of the defendant.

United States v. Universal C.I.T. Credit Corp., 344 U.S.

218, 221-22 (1952) (“We should not derive criminal outlawry from some ambiguous implication”). The relevant provision of the CSA at issue here, however, is

unambiguous.

CSA Section 841(a)(1) cannot be interpreted as

criminalizing good faith medical mistakes under pertinent precedent because the statute lacks any suggestion that Congress intended to delegate to the

Department of Justice (DOJ) breathtaking authority

over the practice of medicine. Instead, Congress explicitly left to the states the authority to regulate the

medical professions. See 21 U.S.C. § 823(g)(2)(H)(i)

(“Nothing in such regulations or practice guidelines

may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are

provided.”). This Court has long recognized that the

state’s protection of “the health of its citizens . . . is at

the core of its police power,” Sporhase v. Neb. ex rel.

Douglas, 458 U.S. 941, 956 (1982), and has expressly

rejected the notion that the CSA grants either DOJ or

DEA the broad authority to regulate the practice of

medicine:

[t]he [CSA] and our case law amply support

the conclusion that 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 limitations of federalism,

which allow the [s]tates “[ ]great latitude under their police powers to legislate as to the

protection of the lives, limbs, health, comfort,

and quiet of all persons.[ ]”

Gonzales, 546 U.S. at 269-70 (emphases added).

Not only does Congress know how to explicitly delegate the authority to regulate controlled substance

prescribing to a federal agency, it has done so in one—

and only one—narrow category: opioid use disorder

(OUD) treatment. Id. at 271 (holding that 42 U.S.C.

§ 290bb-2a is the only arena in which Congress has set

federal medical standards and “indicates that when

Congress wants to regulate medical practice in the

given scheme, it does so by explicit language in the

statute”); see also Anderson et al. at 98 (“Despite the

longstanding norm of federal noninterference in medicine, . . . the federal government can regulate medical

practice if it makes its intention to do so clear and unambiguous.”). And even then, Congress expressly delegated the authority to set federal medical standards

regarding OUD treatment to the Department of

Health and Human Services (HHS) and not a federal

law enforcement agency. 42 U.S.C. § 290bb-2a (“The

Secretary of Health and Human Services, after consultation with the Attorney General . . . shall determine

the appropriate methods of professional practice in the

medical treatment of the narcotic addiction. . . .”).

Federal law enforcement agencies are unqualified

to determine whether drugs “have a useful and legitimate medical purpose and are necessary to maintain

the health and general welfare of the American people.” 21 U.S.C. § 801(1). Congress, therefore, did not

even leave it to DEA to perform one of its core CSA

functions—the scheduling of controlled substances—

without health care agency oversight and evaluation.

See id. § 811(b) (“The Attorney General shall, before initiating proceedings . . . [to schedule or reschedule a

drug] . . . request from the [HHS] Secretary a scientific

and medical evaluation, . . . The recommendations of

the Secretary to the Attorney General shall be binding

. . . as to such scientific and medical matters.”).

Furthermore, this Court has expressly held that

DOJ cannot criminally prosecute OUD prescribers under CSA Section 841(a)(1) unless they sell “drugs, not

for legitimate purposes but ‘primarily for the profits

to be derived therefrom’ ” and are acting outside the

usual course of professional practice such that their behavior is akin to that of a “large-scale [drug] pusher,

not as a physician.” Moore at 345. Congress’s refusal to

permit a federal agency to regulate the practice of medicine beyond illegal trafficking is further evidenced

by the Narcotic Addict Treatment Act (1974) (NATA),

which amended the CSA to permit HHS to regulate

OUD treatment. NATA’s legislative history demonstrates that the Senate Judiciary Committee carefully

weighed the states’ long-standing authority to regulate

“the general practice of medicine” against “the specialized circumstances within the purview of the bill [e.g.,

OUD treatment], which entail inordinate risks of diversion and unethical profiteering.” S. Rep. No. 93-192,

at 13 (1973). The Committee report further explains

that the purpose of the NATA amendments was to “reaffirm the commitment Congress made to the nation

when it passed the [CSA] by . . . facilitating the prosecution of those who engage in the criminal distribution of legitimate narcotic drugs for profit.” Id. at 15.

In sum, the CSA permits the federal prosecution of

prescribers who operate as drug traffickers as traditionally understood and, thereby, knowingly or intentionally engage in prescribing conduct that exceeds

the bounds of professional practice. Congress never

intended to delegate to law enforcement the authority to regulate the practice of medicine by criminalizing good faith medical mistakes. See 21 U.S.C.

§ 903.

The CSA also depends on state law to determine

which medical professionals constitute “practitioners”

acting “in the course of professional practice” and are,

therefore, presumptively eligible for federal controlled

substance registration. 21 U.S.C. § 823(f ) provides that

“[t]he Attorney General shall register practitioners . . .

to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he

practices”) (emphasis added); id. § 802(21) (defining

“practitioner” to include “a physician . . . licensed . . .

by the United States or the jurisdiction in which he

practices . . . to . . . dispense . . . a controlled substance

in the course of professional practice”) (emphasis

added). The CSA further mandates that DOJ defer to

state medical licensing authorities before denying, suspending, or revoking a state-licensed prescriber’s registration. Id. § 823(f )(1) (explaining that the Attorney

General may deny, suspend, or revoke a state-licensed

prescriber’s registration if doing so is in “the public

interest” and that the first of the five factors that the

Attorney General must consider in making such a determination is “[t]he recommendation of the appropriate State licensing board or professional disciplinary

authority”). In a 1998 letter to the House Judiciary

Committee Chairman, Attorney General Janet Reno

explained that the CSA was not “intended to displace

the states as the primary regulators of the medical profession or to override a state’s determination as to

what constitutes legitimate medical practice.” Oregon

v. Ashcroft, 368 F.3d 1118, 1123 (2004).

Consistent with Congress’s long-standing policy

of leaving the regulation of medical practice to the

states was its refusal to enact the Pain Relief Promotion Act (PRPA), which would have made illicit the controlled substances used in physician-assisted suicide

and, thus, delegated to the DEA the authority to regulate medicine. Pointing to the DEA’s lack of requisite

medical and scientific expertise, Congress rejected PRPA.

S. Rep. No. 106-299, at 61 (2000) (“[T]his poorly written, poorly thought-out statute would wreak havoc on

States’ traditional police authority to regulate their

own doctors—an authority they have enjoyed for more

than 200 years. . . . In our view, the DEA is not qualified to handle investigations into allegation [sic] of the

misuse of pain management drugs.”) (emphasis added).

Congress has refused to extend the right to interfere with the states’ regulation of medical practice

even to those federal agencies with significant scientific and medical expertise. The Food Drug and Cosmetics Act (FDCA) expressly provides that it should

not “be construed to limit or interfere with the authority of a health care practitioner to prescribe or

administer any legally marketed device . . . within a

legitimate health care practitioner-patient relationship.” 21 U.S.C. § 396; see also United States v. Regenerative Sci., LLC, 878 F. Supp. 2d 248, 255 (D.D.C.

2012). This express limitation of the FDCA is of significant practical import. If the FDCA pre-empted the

regulation of medical practice, prescribers would be

stripped of their traditional right to prescribe Food and

Drug Administration (FDA) approved drugs “off-label,”

that is, for non-approved uses to benefit their patients.

This Court has expressly endorsed the off-label practice of medicine. Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341, 350 (2001) (off-label use is an “accepted and necessary corollary of the FDA’s mission to

regulate in this area without directly interfering with

the practice of medicine”). The United States Congress

has taken precisely the same view:

In general, the FDA has no authority to regulate how physicians prescribe approved drugs

in the context of their medical practice.

Physicians prescribing off-label uses of approved drugs is not within the jurisdiction of

the FDA.

H.R. Rep. No. 105-310, at 60 (1997).

The Social Security Amendments of 1954 also

make clear federal non-interference with the states’

health-related police powers, providing that “[n]othing

in this title shall be construed as authorizing the Commissioner of Social Security . . . to interfere in any way

with the practice of medicine. . . .” 42 U.S.C. § 416. The

federal Medicare statute, the Fertility Success Rate

and Certification Act of 1992, and the Drug Addiction

Treatment Act of 2000 each included similar expansive

and express prohibitions on federal interference with

the practice of medicine. 42 U.S.C. § 1395 (“Nothing in

[the Medicare statute] shall be construed to authorize

any Federal officer or employee to exercise any supervision or control over the practice of medicine.”); 42

U.S.C. § 263a-2(i)(1) (“[HHS] may not establish any

regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine”); 21 U.S.C. § 823(g)(2)(H)(i) (“Nothing

in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the

manner in which medical services are provided.”).

Congress’s long-standing and express prohibition

on federal interference with state authority to regulate the medical professions is grounded in the uncontroversial notion that it is the states that are the

laboratories of inventive “social and economic experiments” in our dual sovereignty system of government.

New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932)

(Brandeis, J., dissenting) (“It is one of the happy incidents of the federal system that a single courageous

State may, if its citizens choose, serve as a laboratory;

and try novel social and economic experiments without

risk to the rest of the country.”). Permitting state heterogeneity in medical practice bolsters medical innovation and benefits public health. Gregory, 501 U.S. at

458 (explaining that the very purpose of the clear

statement rule is to preserve a “federalist structure of

joint sovereigns . . . that will be more sensitive to the

diverse needs of a heterogeneous society” and that “increases opportunity for citizen involvement in democratic processes; [and] allows for more innovation and

experimentation in government”). Medical innovation

is necessarily wrought from medical practitioners’ discretion to deploy their specialized training and expertise to pioneer new treatment approaches that may

improve patients’ well-being. This is likely why there

is not a single federal statute that indicates that Congress intended to permit a federal law enforcement

agency to criminalize good faith yet mistaken attempts

to revolutionize medical practice. United States v.

Lopez, 514 U.S. 549, 583 (1995) (Kennedy, J., concurring) (cautioning against “foreclos[ing] the States from

experimenting in an area to which States lay claim by

right of history and expertise”).

IV. Under the Eleventh Circuit’s Construction

of Section 841(a), the Standard the Government had to Satisfy to Convict Dr. Ruan of

Felony Distribution was Lower than the

Applicable State Standard for Civil Malpractice Liability

In closing, it is worth noting that the petitioner’s

characterization of the Eleventh Circuit’s construction

of Section 841(a)(1) as “invit[ing] juries to convict doctors of drug dealing based on nothing worse than simple malpractice” is overly generous. Ruan Pet. 3. In

fact, it is far easier for the government to convict a

practitioner for felony criminal distribution under the

CSA in the absence of a scienter requirement than it is

for plaintiffs to succeed in civil malpractice actions

based on the exact same prescribing conduct for at

least two reasons.

First, plaintiffs in state civil malpractice actions

are required to prove that they were harmed due to

their prescriber’s negligence. See, e.g., Ala. Code. § 6-5542(2) (“A breach of the standard of care is the failure

by a health care provider to comply with the standard

of care, which failure proximately causes personal injury or wrongful death. This definition applies to all

actions for injuries or damages or wrongful death

whether in contract or tort and whether based on intentional or unintentional conduct.”). Under Section

841(a)(1), by contrast, the government does not have to

prove that the prescriber’s conduct harmed even a single patient. In fact, the government can convict a prescriber for felony distribution under the CSA even

where it is undisputed that the prescriber’s conduct

improved or enhanced a patient’s health outcomes.

Second, proving a departure from the “usual

course of professional practice” in a Section 841(a)(1)

prosecution is far easier than proving a departure from

the standard of care in a state malpractice action because CSA cases revolve around the national standard

of practice and lack any standards of expertise about

the same or similar specialty, training, or resources.

See, e.g., United States v. Merrill, 513 F.3d 1293 (11th

Cir. 2008). In fact, the experts that testify on departures from the usual course of professional practice in

CSA cases would not be allowed to testify at all in a

most state malpractice actions.10

The majority of the government’s experts on which

the jury relied to determine whether Dr. Ruan’s prescribing practices fell outside the “usual course of his

professional practice” are unqualified to testify in civil

malpractice actions in the State of Alabama, where Dr.

Ruan practiced, due to their lack of expertise and experience in Dr. Ruan’s practice specialty. The Alabama

Medical Liability Act mandates that, “[i]n any action

for injury or damages . . . against a health care provider for breach of the standard of care, the plaintiff

shall have the burden of proving by substantial

Although not the case in Alabama, roughly half of the

states also require an affidavit of merit from a qualified expert

that there are reasonable grounds to believe the defendant was

negligent. NAT’L CONFERENCE OF STATE LEGISLATURES, MEDICAL LIABILITY/MALPRACTICE MERIT AFFIDAVITS AND EXPERT WITNESSES

(Aug. 11, 2021) (cataloging standards for affidavits of merit and

expert witnesses).

evidence that the health care provider failed to exercise such reasonable care, skill, and diligence as other

similarly situated health care providers in the same

general line of practice ordinarily have and exercise in

a like case.” Ala. Code. § 6-5-548(a) (emphasis added).

When a malpractice action is brought against a boardcertified specialist, admissible expert testimony is limited to state-licensed practitioners who, among other

things, are “trained and experienced in the same specialty,” “certified by an appropriate American board in

the same specialty,” and have “practiced in th[at] specialty during the year preceding the date that the alleged breach of the standard of care occurred.” Ala.

Code. § 6-5-548(c). Any Alabama plaintiff that brought

a civil malpractice action against Dr. Ruan, a “boardcertified interventional pain specialist,” for the prescribing conduct at issue in the instant case would

have been limited to experts that satisfied these criteria. Ruan Pet. 5.

At least two of the government’s three experts

who provided crucial testimony at Dr. Ruan’s criminal trial, however, do not come remotely close to

satisfying these requirements. Dr. Greenburg, for instance, not only admitted under oath that he is not

board-certified in pain management and, therefore,

could not have been qualified as an expert in a medical

malpractice case against Dr. Ruan in Alabama (where

he is not licensed to practice medicine), he conceded

that his lack of such certification and expertise also

would have disqualified him from testifying against

board-certified pain management practitioners in

medical malpractice actions in his home state of Arizona (where he is licensed to practice medicine). Tr.

889; 902-903; see also Ariz. Rev. Stat. Ann. § 12-2604

(providing that where a party offers expert testimony

against a board-certified practitioner, said expert must

be board-certified in the same specialty).

The government also provided expert testimony

from Dr. Aultman, a Mississippi licensed hospitalist

(e.g., a practice specialty that treats only acutely ill

hospitalized patients rather than outpatients with persistent pain or opioid use disorder). Tr. 4439-4445. Dr.

Aultman testified that she has never had: (1) any formal training in pain management; (2) any board-certification in pain management; or (3) any residency or

fellowship in pain management. Tr. 4441. Consequently, neither Drs. Greenburg nor Aultman would

have been qualified to testify as experts in a malpractice case against Dr. Ruan in Alabama. As a result, a

medical malpractice plaintiff is always required to

prove more elements (causation and damages) and often mandated to proffer substantially more qualified

expert witnesses to succeed on a civil malpractice

claim than the government needs to prove to secure a

felony criminal conviction for the exact same prescribing conduct under the Eleventh Circuit’s current construction of Section 841(a).

---------------------------------♦---------------------------------

CONCLUSION

For the foregoing reasons, this Court should reverse the judgments of the courts of appeal.

Respectfully Submitted,

JENNIFER D. OLIVA

Counsel of Record

Associate Dean for Faculty

Research & Development

Professor of Law

Director, Center for Health

& Pharmaceutical Law

SETON HALL UNIVERSITY SCHOOL OF LAW

One Newark Center

Newark, NJ 07012

973-642-8151

jennifer.oliva@shu.edu

KELLY K. DINEEN

Associate Professor of Law

Director, Health Law Program

CREIGHTON UNIVERSITY SCHOOL OF LAW

2500 California Plaza

Omaha, NE 68178

402-280-2127

kellydineen2@creighton.edu

Counsel for Amici Curiae

December 23, 2021

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.