Amicus Curiae Brief — Xiulu Ruan, Petitioner v. United States
Supreme Court briefMay 7, 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,
v.
UNITED STATES OF AMERICA,
Respondent.
---------------------------------♦--------------------------------On Petition For A 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 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
i
TABLE OF CONTENTS
Page
TABLE OF CONTENTS ......................................
i
TABLE OF AUTHORITIES .................................
ii
INTEREST OF AMICI CURIAE .........................
1
SUMMARY OF THE ARGUMENT .....................
1
ARGUMENT ........................................................
4
I.
Statutory Framework, Purpose, and Conflicting Approaches ....................................
4
A. The Statutes and the Regulation ........
4
B. United States v. Moore and Its Aftermath of Clashing Approaches .............
5
C. The Shaky Consensus .........................
8
II.
The Erosion of Standards and the Risks of
Harm .......................................................... 10
III.
Patient Harm is Predictable if the Standard of Care is the Proxy for Criminal Liability ........................................................... 12
IV.
Criminalizing Negligent Prescribing Improperly Intrudes on the States’ Power to
Regulate Medical Practice ......................... 15
CONCLUSION..................................................... 25
APPENDIX – LIST OF SIGNATORIES ............. App. 1
ii
TABLE OF AUTHORITIES
Page
CASES
Barsky v. Bd. of Regents, 347 U.S. 442 (1954) ............16
Bond v. United States, 572 U.S. 844 (2014) ................16
Buckman Co. v. Plaintiffs’ Legal Comm., 531
U.S. 341 (2001) ........................................................23
Cal. Div. of Labor Standards Enforcement v.
Dillingham Constr., N.A., Inc., 519 U.S. 316
(1997) .......................................................................17
Gregory v. Ashcroft, 501 U.S. 452 (1991) .............. 17, 24
Gonzales v. Oregon, 546 U.S. 243 (2006) ............ 5, 6, 19
Hillsborough Cty. v. Automated Med. Labs., Inc.,
471 U.S. 707 (1985) .................................................16
Linder v. United States, 268 U.S. 5 (1925) .................15
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)...............17
New State Ice Co. v. Liebmann, 285 U.S. 262
(1932) .......................................................................24
Oregon v. Ashcroft, 368 F.3d 1118 (2004) ...................22
Pa. Dep’t of Corr. v. Yeskey, 524 U.S. 206 (1998) .........17
Pegram v. Herdrich, 530 U.S. 211 (2000) ...................17
Raygor v. Regents of University of Minnesota,
534 U.S. 533 (2002) .................................................16
Rush Prudential HMO, Inc. v. Moran, 536 U.S.
355 (2002) ................................................................16
iii
TABLE OF AUTHORITIES—Continued
Page
Solid Waste Agency of Northern Cook County v.
United States Corps of Engineers, 531 U.S. 159
(2001) .......................................................................16
United States v. Feingold, 454 F.3d 1001 (9th Cir.
2006) ..........................................................................9
United States. v. Godofsky, 943 F.3d 1011 (6th
Cir. 2019) ...................................................................7
United States v. Hurwitz, 459 F.3d 463 (4th Cir.
2006) ..........................................................................9
United States v. Khan, 989 F.3d 806 (10th Cir.
2021) .................................................................... 7, 11
United States v. Kozminski, 487 U.S. 931 (1988) .......18
United States v. McIver, 470 F.3d 550 (4th Cir.
2006) ..........................................................................9
United States v. Merrill, 513 F.3d 1293 (11th Cir.
2008) ..........................................................................2
United States v. Moore, 423 U.S. 122 (1975) ... 2, 5, 6, 11, 20
United States v. Naum, 832 Fed. App’x 137 (4th
Cir. 2020) (unpublished), petition for cert. pending, 20-4133 (April 22, 2021)...................................11
United States v. Nelson, 383 F.3d 1227 (10th Cir.
2004) .................................................................... 8, 11
United States v. Ruan, 966 F.3d 1101 (11th Cir.
2020), petition for cert. pending, 17-12653
(April 7, 2021) ..........................................................10
United States v. Regenerative Sci., LLC, 878
F. Supp. 2d 248 (D.D.C. 2012) .................................23
iv
TABLE OF AUTHORITIES—Continued
Page
United States v. Rosenberg, 585 F.3d 355 (7th
Cir. 2009) ...................................................................9
United States v. Sabean, 885 F.3d 27 (1st Cir.
2018) ..........................................................................9
United States v. Schneider, 704 F.3d 1287 (10th
Cir. 2013) ...................................................................3
United States v. Varma, 691 F.2d 460 (10th Cir.
1982) ........................................................................11
United States v. Vamos, 797 F.2d 1146 (2d Cir.
1986) ..........................................................................9
United States v. Volkman, 797 F.3d 377 (6th Cir.
2015) ..........................................................................9
United States v. Universal C.I.T. Credit Corp.,
344 U.S. 218 (1952) .................................................18
PETITIONS FOR WRIT OF CERTIORARI
Petition for Cert., Dixon v. United States, 184936, cert. denied (June 22, 2020) ............................7
Petition for Cert., Faithful v. United States, 1820671, cert. denied (Mar. 29, 2021) ...........................7
Petition for Cert., Naum v. United States, docketed, 20-4133 (Apr. 22, 2021) ............................... 7, 10
Petition for Cert., Ruan v. United States, docketed, 17-12653 (Apr. 7, 2021) ............................... 7, 10
v
TABLE OF AUTHORITIES—Continued
Page
STATUTES, LEGISLATION & REGULATIONS
21 U.S.C. § 396 ............................................................23
21 U.S.C. § 802(21) .................................................. 4, 22
21 U.S.C. § 811(b) ........................................................20
21 U.S.C. § 821 ..............................................................4
21 U.S.C. § 822(a) ..........................................................4
21 U.S.C. § 822(b) ..........................................................4
21 U.S.C. § 823(f ) .................................................... 4, 22
21 U.S.C. § 823(g) ........................................................21
21 U.S.C. § 829 ..............................................................4
21 U.S.C. § 841(a) ................................................ passim
21 U.S.C. § 871(b) ..........................................................4
21 U.S.C. § 903 ...................................................... 21, 22
42 U.S.C. § 290bb-2a ...................................................19
42 U.S.C. § 416 ............................................................24
21 C.F.R. § 1306.03 .......................................................4
21 C.F.R. § 1306.04 ......................................... 4, 5, 8, 11
ADMINISTRATIVE & LEGISLATIVE MATERIALS
36 Fed. Reg. 7776 (1971) ...............................................5
S. Rep. No. 93-192 (1973) ...................................... 20, 21
S. Rep. No. 106-299 (2000) ..........................................22
vi
TABLE OF AUTHORITIES—Continued
Page
OTHER AUTHORITIES
Evan D. Anderson et al., Intensive Care for Pain
as an Overdose Prevention Tool: Legal Considerations and Policy Imperatives, 5 U. PA.
L. & PUB. AFF. 63 (2019) ................................... 13, 19
Michael C. Barnes et al., Demanding Better: A
Case for Increased Funding and Involvement
of State Medical Boards in Response to America’s Drug Abuse Crisis, 106 J. MED. REG. 3
(2020) .......................................................................13
Ronald W. Chapman II, Defending Hippocrates:
Representing Physicians in the Wake of the
Opioid Epidemic, 43 CHAMPION 40 (2019) ................8
Nabarum Dasgupta et al., Opioid Crisis: No
Easy Fix to its Social and Economic Determinants, 108 AMER. J. PUB. HEALTH 2 (2018) ...............1
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) ..................................12, 14
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).............13
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) ............................................... 3, 4, 9, 10
vii
TABLE OF AUTHORITIES—Continued
Page
William N. Eskridge, Jr. & Philip P. Frickey,
Quasi-Constitutional Law: Clear Statement
Rules as Constitutional Lawmaking, 45 VAND.
L. REV. 593 (1992) ...................................................17
Deborah Hellman, Prosecuting Physicians for
Trusting Patients, 16 GEO. MASON L. REV. 3
(2009) .......................................................................19
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) ....................12
Sandra H. Johnson, Regulating Physician Behavior: Taking Doctors’ “Bad Law” Claims Seriously, 53 ST. LOUIS U. L.J. 973 (2009) ..................12
Julia MacDonald, “Do No Harm or Injustice to
Them”: Indicting and Convicting Physicians
for Controlled Substance Distribution in the
Age of the Opioid Crisis, 72 ME. L. REV. 197
(2020) .........................................................................7
John J. Mulrooney, II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law:
Hidden Rocks in Shallow, Murky, Drug-Infested
Waters, 101 MARQ. L. REV. 333 (2017) ......................8
Nat’l Academies of Sciences, Medications for
Opioid Use Disorder Save Lives (2019) ............ 13, 14
viii
TABLE OF AUTHORITIES—Continued
Page
Nat’l Conference of State Legislatures, Medical
Liability/Malpractice Merit Affidavits and Expert Witnesses (June 24, 2014) ..................................2
Jennifer D. Oliva & Valena E. Beety, Discovering Forensic Fraud, 112 NW. U. L. REV. 121
(2017) .........................................................................2
Christine Vestal, Rapid Opioid Cutoff is Risky
Too, Feds Warn, PEW (May 21, 2019) ......................14
Jackie Yenerall & Melinda B. Buntin, Prescriber
Responses to a Pain Clinic Law: Cease or
Modify?, 206 DRUG AND ALCOHOL DEP. 107591,
1–4 (2020) ................................................................15
1
INTEREST OF AMICI CURIAE1
Amici are professors of health law and policy at
United States 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 and addiction. Those interests
are threatened by the increasingly weakened and
varying standards to convict prescribing practitioners
under the Controlled Substances Act (CSA).
---------------------------------♦---------------------------------
SUMMARY OF THE ARGUMENT
Controlled substances hold a special place at the
intersection of medicine, law, and society. No decisions
are as fraught with peril in medicine than whether,
how, how much, and for how long to prescribe controlled substances, especially during an opioid crisis.2
These decisions implicate not just the benefits and
risks to the patients to whom drugs are prescribed, but
also the risks to third parties who use diverted drugs
1
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.
2
We use this term for conciseness, not accuracy. Significant
evidence indicates that prescription opioids alone are neither the
lone nor primary driver of what are now several overlapping overdose crises. Nabarum Dasgupta et al., Opioid Crisis: No Easy
Fix to its Social and Economic Determinants, 108 AMER. J. PUB.
HEALTH 2 (2018).
2
without medical supervision. The later consideration is
as far as Congress intended federal law enforcement to
reach into the regulation of medical practice, an area
that falls squarely within the States’ police powers.
The Eleventh, Fourth, and Tenth Circuits have
recently construed the CSA in a manner that permits
the government to convict a prescriber of a felony for
nothing more than deviations from accepted medical
standards, including behavior akin to mere negligence.3 These circuits have criminalized prescribing
negligence by (1) permitting convictions when prescriptions deviate from accepted medical practices
without considering whether the practitioner acted
without a legitimate medical purpose (also referred
to as “beyond the bounds of medical practice”),4 and
3
These are not exactly deviations from the standard of care
in the malpractice sense. Arguably, defendants have fewer protections in CSA cases. The CSA requires no harm. The discovery
processes and expert witness practices also vary between malpractice and CSA proceedings, in part because of the significant,
pertinent differences between the rules of civil and criminal procedure, see, e.g., Jennifer D. Oliva & Valena E. Beety, Discovering
Forensic Fraud, 112 NW. U. L. REV. 121 (2017) and, in part because of the national standard of acceptable practice for CSA
cases. See, e.g., United States v. Merrill, 513 F.3d 1293 (11th Cir.
2008). Most states reject a purely national standard and require
experts in the same or similar specialty and community. Roughly
half require an affidavit of merit from a qualified expert before
filing a case. Nat’l Conference of State Legislatures, Medical Liability/Malpractice Merit Affidavits and Expert Witnesses (June 24,
2014) (cataloging standards for affidavits of merit and expert witnesses).
4
Some courts have also added or substituted “beyond the
bounds of medical practice,” a phrase from United States v. Moore,
423 U.S. 122, 140 (1975), for “without a legitimate purpose.”
3
(2) constructively refusing to extend to practitioners
a good faith defense. These approaches criminalize
mistaken or negligent prescribing for which there are
already myriad civil, administrative, and even lesser
criminal remedies. See 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, 21
(2016). The constructive rewriting of the CSA as applied to practitioners runs afoul of the text and purpose
of the CSA, conflicts with this Court’s controlling case
law, imperils the evolution of medicine and patient
care, and implicates significant federalism concerns.
We respectfully request that this Court clarify that the
CSA’s reach only extends to practitioners who prescribe knowingly or intentionally (i.e., not in good
faith) without a medical purpose outside the usual
course of professional practice. The questions implicated by the instant petition and those in United States
v. Naum, No. 20-1480, are what the government must
prove to convict a prescribing practitioner under CSA
Section 841(a)(1). Consequently, this Court should
consolidate the instant petition and Naum and grant
certiorari in both cases.
---------------------------------♦---------------------------------
United States v. Schneider, 704 F.3d 1287, 1295–96 (10th Cir.
2013).
4
ARGUMENT
I.
Statutory Framework, Purpose, and Conflicting Approaches
A. The Statutes and the Regulation
The Controlled Substances Act (CSA) makes it unlawful, “except as authorized by this subchapter . . . for
any person [to] knowingly or intentionally . . . distribute, or dispense . . . a controlled substance.” 21 U.S.C.
§ 841(a)(1). Practitioners are among those “authorized
by this chapter” to dispense a controlled substance
once they have received (1) state licensure to practice
medicine, or another profession with prescriptive authority, and (2) a certificate of registration (COR) from
the Attorney General, acting through the Drug Enforcement Administration (DEA). Id. §§ 822(a) & 823(f);
21 C.F.R. § 1306.03. Once licensed (by the state)5 and
registered (by the DEA), practitioners are permitted to
distribute, dispense, [and] conduct research with . . . a
controlled substance in the course of professional practice,” 21 U.S.C. § 802(21) (emphasis added) and in
“conformity with the other provisions of this title.” Id.
§ 822(b). Those provisions include the requirements of
valid prescriptions, id. § 829, and specific grants of authority to the Attorney General to promulgate and enforce regulations. Id. §§ 821 & 871(b). The Attorney
General promulgated 21 C.F.R. § 1306.04, the central
regulation with which practitioners must conform,
5
Some states require additional authorization by DEA equivalent state agencies in addition to licensure and a COR is conditioned on the prior satisfaction of both conditions. See Dineen &
DuBois at n.163.
5
without comment from practitioners in 1971. 36 Fed.
Reg. 7776 (1971). Section 1306.04 explains that an
effective, and, therefore, lawful prescription is one
“issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a) (emphasis
added).6 In summary, a licensed practitioner with a
valid COR who issues a prescription for a legitimate
medical purpose in the usual course of professional
practice is “authorized” and not unlawfully prescribing
under CSA Section 841(a)(1). This reading comports
with United States v. Moore, which this Court decided
almost 50 years ago. 423 U.S. 122 (1975).
B. United States v. Moore and Its Aftermath of Clashing Approaches
In Moore, this Court held that prescribing practitioners fall within the reach of CSA Section 841 when
their prescription(s) fall outside “legitimate channels,”
such that they are acting “outside the bounds of professional practice” and prescribing not “for legitimate
6
In Gonzales v. Oregon, this Court read the language at 21
U.S.C. § 830(b)(3)(A)(ii), added in 2000 and defining a valid prescription as one “issued for a legitimate medical purpose by an
individual practitioner . . . acting in the usual course of the
practitioner’s professional practice,” to conclude that 21 C.F.R.
§ 1306.04 was a parroting regulation. 546 U.S. 243, 257 (2006). In
dissent, Justice Scalia explained that Section 1306.04 “gives
added content to the text of the statute [§ 829],” id. at 279 (Scalia,
J., dissenting), such that a legitimate medical purpose is implicit in the requirements for an effective prescription. Id. (citing
Moore, 423 U.S. at 136 n.13).
6
purposes, but primarily for the profits to be derived
therefrom.”7 Id. at 131–35. The question presented and
underlying egregious behavior of the practitioner in
Moore allowed the Court to avoid addressing exactly
what the government is required to prove to convict
practitioners under the CSA beyond establishing that
they acted “outside the course of professional practice.”
The Court did admit, however, that the CSA failed to
“unambiguously spell[ ] out” such requirements. Id. at
140. The Moore Court did not address the availability
and nature of the good faith defense, although it did
not take issue with the district court’s jury instructions
that included a good faith charge.8 Thirty-one years
later, this Court explained that it had never considered
“the extent to which the CSA regulates medical practice beyond prohibiting a doctor from acting as a drug
pusher instead of a physician,” a statement that remains true today. Gonzales v. Oregon, 546 U.S. 243, 269
(2006) (internal quotes omitted).
In the five decades since Moore, the federal
courts have taken divergent, conflicting, and, frankly,
7
At the time of Moore, the DEA lacked the authority to revoke or suspend a practitioner’s COR and thus, absent the reach
of 841(a)(1), could not stop a practitioner from prescribing unless
the state took action first. See Gonzales, 546 U.S. at 258 (explaining the addition of the 1984 amendments).
8
“The judge instructed the jury it had to find beyond a reasonable doubt that a physician, who knowingly or intentionally,
did dispense or distribute methadone by prescription, did so other
than in good faith for detoxification in the usual course of a professional practice and in accordance with a standard of medical
practice generally recognized and accepted in the United States.”
Moore, 423 U.S. at 139 (emphases added).
7
confusing approaches to Section 841(a)’s rudimentary
requirements. An alarming number of circuit splits
have developed regarding Section 841(a), including:
(1) whether the government must prove a practitioner
departed from a legitimate medical purpose, Petition
for Cert., Naum v. United States, docketed, 20-4133
(Apr. 22, 2021); (2) the availability and form of the good
faith defense, Petition for Cert., Ruan v. United States,
docketed, 17-12653 (Apr. 7, 2021); (3) whether legitimate medical purpose is an element that must be included in the indictment, see Julia MacDonald, “Do No
Harm or Injustice to Them”: Indicting and Convicting
Physicians for Controlled Substance Distribution in
the Age of the Opioid Crisis, 72 ME. L. REV. 197, 213–
16 (2020); (4) the relationship between good faith and
mens rea, United States v. Khan, 989 F.3d 806, 812
(10th Cir. 2021) (concluding that objective good faith
does not negate mens rea but simply explains the
course of professional practice); but see, e.g., United
States. v. Godofsky, 943 F.3d 1011, 1021 (6th Cir.
2019) (“Reasonable [good faith] conduct or beliefs, if
proven, would necessarily prevent the jury from finding that [defendant] had a knowing or intentional
mens rea”); (5) whether the jury must be instructed
on mens rea, Petition for Cert., Dixon v. United States,
18-4936, cert. denied (June 22, 2020); and (6) whether
a prescriber may be convicted of dispensing, distributing, or both, Petition for Cert., Faithful v. United
States, 18-20671, cert. denied (Mar. 29, 2021).
8
C. The Shaky Consensus
Despite these concerning circuit splits, there were
points of general but fragile agreement until recently.
First, the government had to prove that the practitioners knowingly or intentionally acted without a legitimate purpose outside the usual course of professional
practice to secure a conviction under the CSA. See
Ronald W. Chapman II, Defending Hippocrates: Representing Physicians in the Wake of the Opioid Epidemic,
43 CHAMPION 40 (2019). The legitimate medical purpose showing creates a boundary between criminality
and prescribing negligence. Although a few courts have
claimed legitimate medical purpose and usual course
of professional practice are interchangeable, see, e.g.,
United States v. Nelson, 383 F.3d 1227, 1231 (10th Cir.
2004) (explaining that it is “difficult to imagine circumstances in which a practitioner could have prescribed
controlled substances within the usual course of medical practice but without a legitimate medical purpose”
as well as the reverse), that claim is contrary to common sense and a fair reading of the CSA and 21 C.F.R.
§ 1306.04. Unlike the Nelson court, very few practitioners have trouble distinguishing these. John J. Mulrooney II & Katherine E. Legel, Current Navigation
Points in Drug Diversion Law: Hidden Rocks in Shallow, Murky, Drug-Infested Waters, 101 MARQ. L. REV.
333, 389 (2017) (“The two bases may be . . . co-morbidly
present, but that does not support the proposition that
the phrases are interchangeable.”). Because the standard of care is increasingly used as a proxy for the
“usual course” standard, a mistaken or even somewhat
9
careless prescriber could only be saved from criminal
sanction because of her legitimate medical purpose.
Second, courts extended some version of the good
faith defense to practitioners, whether measured by a
subjective standard, United States v. Sabean, 885 F.3d
27 (1st Cir. 2018); United States v. Rosenberg, 585 F.3d
355, 357 (7th Cir. 2009); United States v. Feingold, 454
F.3d 1001 (9th Cir. 2006), or a so called “objective”
standard,9 United States v. Volkman, 797 F.3d 377, 387
(6th Cir. 2015); United States v. Hurwitz, 459 F.3d 463,
479 (4th Cir. 2006); United States v. Vamos, 797 F.2d
1146 (2d Cir. 1986). The defense is a critical way to distinguish criminal from civil liability. See, e.g., United
States v. McIver, 470 F.3d 550, 560 (4th Cir. 2006) (good
faith is a “plainspoken method of explaining a critical
difference between the two standards”).
Third, the difference between the standard for civil
negligence and that for criminal liability was acknowledged and emphasized by the courts. See Dineen & DuBois at 31–34; Volkman, 797 F.3d at 387 (practitioner
cannot be convicted merely for “carelessness or negligence or foolishness”). There was general agreement
that the “standard for criminality is at least two steps
beyond that which would satisfy the breach requirement in malpractice: from a mistaken doctor (one
breach in otherwise careful practice) to a bad doctor
(pattern indicating carelessness) to a criminal doctor
9
Objective good faith may be an oxymoron. Deborah Hellman,
Prosecuting Doctors for Trusting Patients, 16 GEO. MASON L. REV.
3 (2009).
10
(pattern indicating knowledge or intention to violate
law),” Dineen & DuBois at 32, although other scholars
have been long concerned about the conflation of those
standards. 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).
Those concerns about conflation have come to fruition
in the Fourth, Tenth, and Eleventh Circuits.
II.
The Erosion of Standards and the Risks of
Harm
What little consistency once existed, however, is
waning quickly. Several circuits have substantially
eroded the standards for a practitioner’s conviction
and available defenses under Section 841. There are
especially concerning erosive trends in the Fourth,
Tenth, and Eleventh Circuits, where courts have endorsed convictions for prescribing “outside the usual
course of professional practice.” Full stop. Those circuits have eliminated any consideration of legitimate
medical purpose and an effective good faith defense.
The Ruan Petition details the path of the Eleventh
Circuit, which has collapsed the meaning of good faith
into compliance with the standard of care over the
last decade. Petition at 23–27; United States v. Ruan,
966 F.3d 1101 (11th Cir. 2020), petition for cert. pending, 17-12653 (Apr. 7, 2021). The Fourth Circuit also
recently departed from the precedent in Hurwitz
and eliminated the legitimate medical purpose
11
requirement. United States v. Naum, 832 Fed. App’x
137 (4th Cir. 2020) (unpublished) petition for cert.
pending, 20-4133 (Apr. 22, 2021) (declaring irrelevant
that the prescriptions were for a legitimate medical
purpose, the patients’ legitimate treatment needs, and
the lack of profit motive because departure from the
usual course of practice was enough).
The Tenth Circuit had previously required proof
that a practitioner acted without a legitimate medical
purpose to convict. United States v. Varma, 691 F.2d
460, 462 (10th Cir. 1982) (holding that the prosecution
must show defendant “acted intentionally or knowingly and . . . prescribed the drug without a legitimate medical purpose and outside the usual course
of professional practice”) (emphasis added). In 2004,
however, the Circuit held that a “practitioner has unlawfully distributed a controlled substance if she prescribes the substance either outside the usual course
of medical practice or without a legitimate medical
purpose.” Nelson, 383 F.3d at 1232 (emphasis added)
(explicitly stating that the court was not “bound by the
language of Varma” and concluding that neither 21
C.F.R. § 1306.04(a) nor Moore required more). This
year, the Tenth Circuit constructively eliminated the
good faith defense and reaffirmed that the government
need not show that the defendant acted without a legitimate purpose to convict. Khan, 989 F.3d at 825–26
(rejecting a good faith defense as to deviations from the
usual course of professional practice, upon which a conviction may be based alone, and stating that “[u]nlike
other criminal offenses, good faith does not go to mens
12
rea for § 841 offenses involving practitioners” and that
“the only relevant inquiry . . . is whether a defendantpractitioner objectively acted within that scope, regardless of whether he believed he was doing so”)
(emphases added). Together, the Fourth, Tenth, and
Eleventh Circuits have effectively rewritten the CSA
as applied to practitioners, grounding criminal liability
in a mere departure from accepted medical practice.
III. Patient Harm is Predictable if the Standard
of Care is the Proxy for Criminal Liability
In negligence, standard of care is used to “scrutinize[e] . . . practice and treatment decisions” and
measure prevailing custom, with some allowance for
“respectable minority” views, Sandra H. Johnson,
Customary Standards of Care, 43 HASTINGS CTR. REP.
6, 9–10 (2013), but even this can suppress innovation
in medicine. Id. The dark side of standard of care as a
proxy in criminal prescribing cases is that fear of scrutiny pushes practitioners solidly to the “safe middle,”
at least for the practitioner, where adoption of new
practices dies. Id.
Even worse, the fear of criminal scrutiny, including the “penalties of the process,” Sandra H. Johnson,
Regulating Physician Behavior: Taking Doctors’ “Bad
Law” Claims Seriously, 53 ST. LOUIS U. L.J. 973 (2009),
drives some practitioners away from the patients most
in need of care. Kelly K. Dineen, Definitions Matter: A
Taxonomy of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce Patient Harm, 67 KS. L.
13
REV. 101, 1001–11 (2019) (describing the serious
harms and deaths from suicide and the shift to illicit
drugs after prescribers abandoned patients, abruptly
stopped, or rapidly tapered patients’ opioids out of fear
of legal scrutiny); Michael C. Barnes et al., Demanding
Better: A Case for Increased Funding and Involvement
of State Medical Boards in Response to America’s
Drug Abuse Crisis, 106 J. MED. REG. 3, 6–21, 8 (2020)
(“[I]nvestigating and prosecuting prescribers . . . has
compromised access to treatment for individuals with
legitimate medical needs. Enforcement efforts have
created a chilling effect on prescribers, . . . who are decreasing and altogether ceasing their prescribing out
of fear of investigation and prosecution.”).
The sequala of Harrison Narcotic Act enforcement
is illustrative of the harms that follow when the government uses a meat cleaver instead of a scalpel on
issues at the intersection of law and medicine. What
followed was a century-long segregation of addiction
care from medicine, which created a vacuum of care
and pushed people with substance use disorders from
doctors to drug dealers, Evan D. Anderson et al., 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
a substance use disorder lack access to evidence-based
care and continue to face stigma and discrimination in
every aspect of their lives. 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). Practitioners
14
remain unwilling to treat them for fear of scrutiny.
Nat’l Academies of Sciences, Medications for Opioid
Use Disorder Save Lives, 120–21 (2019) (“[T]he 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[.]”).
The rush to the middle and outright patient
abandonment has already happened in the treatment
of individuals with persistent pain. Dineen, Definitions
Matter. As the news of the opioid crisis proliferated
with a laser-like focus on prescription opioids for
chronic pain and the “bad” doctors who prescribed
them, law and policy actors enacted new restrictions,
enforcement, and administrative guidance. Id. The
Centers for Disease Control and Prevention (CDC)
recommendations to limit opioid prescribing were accorded the force of legal mandates and entities from
insurance companies to provider groups adjusted recommended prescribing parameters further downward
to ensure compliance. Id.
While some responded moderately, many practitioners involuntarily and inappropriately tapered
medications without consideration for the patient’s
well-being, causing needless suffering and death to
the point that the Food and Drug Administration
(FDA) and the CDC issued warnings. Christine Vestal,
Rapid Opioid Cutoff is Risky Too, Feds Warn, PEW (May
15
21, 2019), https://www.pewtrusts.org/en/research-andanalysis/blogs/stateline/2019/05/21/rapid-opioid-cutoffis-risky-too-feds-warn. Today, many practitioners
categorically refuse to treat patients with chronic
pain, while others simply stopped prescribing. Jackie
Yenerall & Melinda B. Buntin, Prescriber Responses
to a Pain Clinic Law: Cease or Modify?, 206 DRUG AND
ALCOHOL DEP. 107591, 1–4 (2020) (After state law
changes, 24% of prescribers stopped prescribing altogether, without regard for patient needs).
Patients with pain, addiction, or both desperately
need appropriate care and treatment. Patient abandonment will grow more widespread as practitioners
avoid legal scrutiny. Progress in medical care in these
areas will be stymied until the regulation of the medical practice is returned to the province of the states
except in cases in which a practitioner is acting without a legitimate medical purpose and outside the
course of professional practice.
IV. Criminalizing Negligent Prescribing Improperly Intrudes on the States’ Power to
Regulate Medical Practice
The federal cases that construe Section 841(a)(1)
in a manner that criminalizes negligent prescribing
raise serious federalism concerns. The regulation of
medical practice has long been the purview of the
states under their reserved 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
16
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 federal-state balance-of-power
norms are central to our dual sovereignty structure
of government. Those core norms cannot be fundamentally altered by either a federal law enforcement
agency’s policy decision to target the distribution of
specific controlled substances or extra-textual judicial
supposition. 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.”); Bond v. United States, 572 U.S. 844,
857–60 (2014) (refusing to interpret a statute in a way
that would upset the usual balance of federal and state
powers absent a clear statement from Congress). Instead, any construction of the CSA that would permit
the federal government to intrude on a state’s right to
regulate medical practice must be grounded in “a clear
indication that Congress intended that result.” Solid
17
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.”); see also Medtronic,
Inc. v. Lohr, 518 U.S. 470, 475 (1996).
The federal courts’ application of the clear statement canon in cases involving “Congressional regulation of core state functions” has been characterized
as a “super-strong rule” of statutory construction
that carries more force than a traditional presumption. 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 to alter the usual constitutional
balance . . . we will interpret a statute to preserve rather than destroy the States’ substantial sovereign
powers.”) (quotation marks and citations omitted); Cal.
Div. of Labor Standards Enforcement v. Dillingham
Constr., N.A., Inc., 519 U.S. 316, 325 (1997) (“[W]here
federal law is said to bar state action in fields of traditional state regulation, . . . we have worked on the assumption that the historic police powers of the States
were not to be superseded by the Federal Act unless
that was the clear and manifest purpose of Congress.”)
(citation and quotation marks omitted); Gregory v.
Ashcroft, 501 U.S. 452, 460 (1991) (Congress’s authority to preempt state law “in areas traditionally
18
regulated by the States” is “an extraordinary power in
a federalist system” that “we must assume Congress
does not exercise lightly.”).
The federal courts also apply the rule of lenity, a
“time-honored interpretive guideline,” when construing an ambiguous criminal statute. United States v.
Kozminski, 487 U.S. 931, 952 (1988). As this Court has
explained:
when a choice has to be made between two
readings of what conduct Congress has made
a crime, it is appropriate, before we choose the
harsher alternative, to require that Congress
should have spoken in language that is clear
and definite. We should not derive criminal
outlawry from some ambiguous implication.
United States v. Universal C.I.T. Credit Corp., 344 U.S.
218, 221–22 (1952). The CSA, however, is not ambiguous.
CSA Section 841(a)(1) cannot be interpreted as
criminalizing negligent prescribing because the statute is bereft of any indication—clear or otherwise—
that Congress intended to grant a federal law enforcement agency such sweeping authority over the practice
of medicine. In fact, the statutory text makes clear that
Congress intended to leave the regulation of medical
practice to the states. Consistent with that proposition,
this Court has already determined that the CSA does
not include a clear statement of Congressional intent
for the DOJ or DEA to regulate the practice of medicine beyond illicit drug trafficking and profiteering:
19
[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).
Gonzales clarifies that Congress knows how to set
federal standards of medical practice in the context of
prescribing and has expressly done so in one—and only
one—arena: opioid use disorder (OUD) treatment. Id.
at 271 (holding that 42 U.S.C. § 290bb-2a is the only
area 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 Evan D.
Anderson et al. at 98. (“Despite the longstanding norm
of federal noninterference in medicine, it is clear that
the federal government can regulate medical practice
if it makes its intention to do so clear and unambiguous.”). Congress, of course, did not leave the regulation
of OUD treatment standards to law enforcement—it
expressly delegated that authority to the Department
of Health and Human Services (HHS). 42 U.S.C.
20
§ 290bb-2a (“The Secretary . . . after consultation with
the Attorney General . . . shall determine the appropriate methods of professional practice in the medical
treatment.”).
Recognizing that federal law enforcement agencies lack the requisite scientific expertise to make medical determinations, Congress did not trust DOJ to
perform one of its core functions under the CSA—the
scheduling of controlled substances—without health
care agency oversight and approval. 21 U.S.C. § 811(b).
Even where the federal government’s regulatory
authority is at its apex in the context of OUD treatment regulation, this Court has expressly stated 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 so far outside the
usual course of professional practice that their behavior is akin to that of a “large-scale [drug] pusher, not as
a physician.” Moore, 423 U.S. at 342–43. The legislative
history that attends to the Narcotic Addict Treatment
Act (1974) (NATA), which amended the CSA to permit
HHS to regulate OUD treatment, is in accord. That
record demonstrates that the Senate Judiciary Committee 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) (emphasis added). The Committee also reported that NATA intended to “reaffirm
21
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 (emphasis
added). In other words, the purpose of the CSA was to
permit the federal prosecution of prescribers who operate as profiteering drug traffickers as traditionally
understood and, thus, beyond the bounds of professional practice. The statute was never intended to regulate the practice of medicine by criminalizing good
faith medical mistakes or mere deviations from the
standard of care. 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.”).
Indeed, the CSA states on its face that it is not intended to interfere with the practice of medicine as
regulated by the states. CSA Section 903 expressly provides that:
No provision of this subchapter shall be construed as indicating an intent on the part of
the Congress to occupy the field in which that
provision operates, including criminal penalties, to the exclusion of any State law on the
same subject matter which would otherwise
be within the authority of the State, unless
there is a positive conflict between that provision of this subchapter and that State law so
that the two cannot consistently stand together.
22
Id. § 903. The CSA also depends on state law to determine which medical professionals constitute “practitioners” acting “in the course of professional practice”
and, thus, are COR eligible. Id. § 823(f ) provides that
“[t]he Attorney General shall register practitioners . . .
if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he
practices”); id. § 802(21).
The CSA further compels the DOJ to defer to state
licensing authorities before the agency may deny, suspend, or revoke 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 that determination is “[t]he recommendation of the appropriate
State licensing board or professional disciplinary authority”). Consistent with the text and structure of the
CSA, Attorney General Janet Reno explained in a 1998
letter to the House Judiciary Committee Chairman
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).
Congress also refused to enact the Pain Relief
Promotion Act, which would have outlawed the controlled substances used in physician-assisted suicide
and, thereby, permitted a federal law enforcement
agency to regulate pain management medicine. S. Rep.
23
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.”). It practically strains credulity to contend that Congress would delegate medical practice regulation to a federal law enforcement
agency that has no pertinent medical or scientific expertise whatsoever.
Congress has even proscribed the federal agencies
with significant scientific and medical expertise from
interfering with state medical practice regulation. The
federal Food, Drug, and Cosmetic Act (FDCA) provides
that it should not “be construed to limit or interfere
with the authority of a health care practitioner to prescribe . . . 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) (“Defendants state[d] that
Congress has left the practice of medicine to the States
to regulate. FDA does not disagree with these principles.”). This express FDCA limitation is of significant
practical import. If the FDCA preempted the regulation of medical practice, prescribers would be stripped
of their traditional right to use approved drugs “off-label,” that is, for non-approved uses to best serve their
patients, a practice this Court has expressly endorsed.
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,
350 (2001) (holding that off-label use is an “accepted
24
and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the
practice of medicine”). The Social Security Amendments of 1954 also make clear that they are not intended to interfere with the states’ health-related
police powers. 42 U.S.C. § 416 (“Nothing in this title
shall be construed as authorizing the Commissioner of
Social Security . . . to interfere in any way with the
practice of medicine[.]”).
These federal statutory “hands-off ” approaches to
regulating medical practice acknowledge the traditional federal system in which states are the laboratories of inventive “social and economic experiments.”
New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932)
(Brandeis, J., dissenting) (“Denial of the right to experiment may be fraught with serious consequences. . . .
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.”). State heterogeneity in the realm of health
policy bolsters medical innovation and benefits public
health. Gregory, 501 U.S. at 458 (explaining that the
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”). All medical innovations are wrought from the
bold decisions of practitioners to deploy their extensive
25
training and expertise to pioneer new treatment approaches that may save lives, improve patients’ health,
or reduce their suffering. There is no federal statute
that indicates that Congress intended to authorize a
federal law enforcement agency to criminalize such
good faith yet mistaken attempts to revolutionize medical practice or simply best treat their patients.
---------------------------------♦---------------------------------
CONCLUSION
For the reasons stated in the Petition for Writ of
Certiorari and this brief, this Court should grant the
Petition.
Respectfully submitted,
JENNIFER D. OLIVA
Counsel of Record
Associate 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
26
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
May 7, 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.