Amicus Curiae Brief — Xiulu Ruan, Petitioner v. United States
Supreme Court briefDec 27, 2021
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Nos. 20-1410, 21-5261
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In The
Supreme Court of the United States
---------------------------------♦--------------------------------DR. XIULU RUAN,
Petitioner,
v.
UNITED STATES OF AMERICA,
Respondent.
---------------------------------♦--------------------------------SHAKEEL KAHN,
Petitioner,
v.
UNITED STATES OF AMERICA,
Respondent.
---------------------------------♦--------------------------------On Writs Of Certiorari To The
United States Courts Of Appeals For
The Tenth And Eleventh Circuits
---------------------------------♦--------------------------------AMICUS CURIAE BRIEF OF THE NATIONAL
ASSOCIATION OF CHAIN DRUG STORES
IN SUPPORT OF NEITHER PARTY
---------------------------------♦--------------------------------TORSTEN M. KRACHT
HUNTON ANDREWS KURTH LLP
2200 Pennsylvania Ave., NW
Washington, D.C. 20037
tkracht@HuntonAK.com
CAMERON L. DAVIS
HUNTON ANDREWS KURTH LLP
500 W. 5th Street, Suite 1350
Austin, TX 78701
cdavis@HuntonAK.com
TREVOR S. COX
Counsel of Record
HUNTON ANDREWS
KURTH LLP
951 E. Byrd Street
Richmond, VA 23219
Phone: (804) 788-7221
tcox@HuntonAK.com
Counsel for the National Association of Chain Drug Stores
================================================================================================================
COCKLE LEGAL BRIEFS (800) 225-6964
WWW.COCKLELEGALBRIEFS.COM
i
TABLE OF CONTENTS
Page
TABLE OF CONTENTS ......................................
i
TABLE OF AUTHORITIES .................................
iii
INTEREST OF AMICUS CURIAE ......................
1
INTRODUCTION AND SUMMARY OF THE
ARGUMENT.....................................................
3
ARGUMENT ........................................................
5
I.
II.
In interpreting § 1306.04(a) to determine
the scope of prescriber liability, the Court
should in no way undermine the knowledge requirement that protects pharmacists from unwarranted liability ...............
5
A. Reflecting the distinct roles of prescribers and pharmacists, § 1306.04
imposes liability only on pharmacists
who “knowingly” fill an illegitimate
prescription .........................................
6
B. The Court should not resolve these
cases in a way that undermines the
knowledge requirement for pharmacist liability ..........................................
9
Acting outside “the usual course of . . .
professional practice” means completely
abandoning professional obligations, not
merely failing to adhere to a professional
standard ..................................................... 13
A. The Court should confirm Moore’s determination of what constitutes acting
outside the usual course of professional practice ..................................... 14
ii
TABLE OF CONTENTS—Continued
Page
B. The Court should reject any interpretation of “usual course of . . . professional practice” that would expose
pharmacists to liability under 21 C.F.R.
§ 1306.06 for minor infractions or
mere non-compliance with professional
standards ............................................... 18
III.
The Court can adopt standards that allow
for punishment of wrongdoers while allowing pharmacists to practice their profession free from the unwarranted threat
of liability .................................................. 23
CONCLUSION..................................................... 25
iii
TABLE OF AUTHORITIES
Page
CASES
Gonzales v. Raich,
545 U.S. 1 (2005) ................................................. 5, 15
Linder v. United States,
268 U.S. 5 (1925) .....................................................22
Reasor v. Walmart Stores E., L.P.,
No. 3:19-CV-27-CRS, 2019 WL 5597302
(W.D. Ky. Oct. 30, 2019) ...........................................12
United States v. Bek,
493 F.3d 790 (7th Cir. 2007) .............................. 13, 17
United States v. Feingold,
454 F.3d 1001 (9th Cir. 2006) ..................................16
United States v. Kahn,
989 F.3d 806 (10th Cir. 2021) ..................................17
United States v. Moore,
423 U.S. 122 (1975) ......................................... passim
United States v. Naum,
832 F. App’x 137 (4th Cir. 2020),
petition for cert. filed (U.S. Apr. 22, 2021)
(No. 20-1480) ...........................................................16
United States v. Ruan,
966 F.3d 1101 (11th Cir. 2020) ................................17
United States v. Sabean,
885 F.3d 27 (1st Cir. 2018) ......................................16
iv
TABLE OF AUTHORITIES—Continued
Page
United States v. Tran Trong Cuong,
18 F.3d 1132 (4th Cir. 1994) ....................................16
United States v. Volkman,
797 F.3d 377 (6th Cir. 2015) ....................................16
STATUTES & ADMINISTRATIVE MATERIALS
21 C.F.R. § 1306.04 ............................................. passim
21 C.F.R. § 1306.05(a) ...................................................9
21 C.F.R. § 1306.06 ............................................. passim
21 U.S.C. § 801(1) ........................................................23
21 U.S.C. § 829 .............................................. 7, 8, 19, 20
21 U.S.C. § 841 .................................................... passim
21 U.S.C. § 842(a)(1) ............................................. 19, 20
21 U.S.C. § 842(c)(1) ....................................................19
21 U.S.C. § 842(c)(2) ....................................................19
22 TEX. ADMIN. CODE § 295.1 ......................................21
22 TEX. ADMIN. CODE § 295.9 ......................................21
Comments and Objections to Part 306,
36 Fed. Reg. 7776 (Apr. 24, 1971)..............................8
DEL. ADMIN. CODE § 2500-3.9 .....................................21
DEL. ADMIN. CODE § 2500-5.1.12.3 .............................21
DEL. ADMIN. CODE § 2500-15.0 ...................................21
v
TABLE OF AUTHORITIES—Continued
Page
Dispensing Controlled Substances
for the Treatment of Pain,
71 Fed. Reg. 52716 (Sept. 6, 2006) .............. 12, 23–24
Purpose of Issue of Prescription,
36 Fed. Reg. 4847 (Mar. 13, 1971) .............................8
OTHER AUTHORITIES
Compl., United States v. Chip’s Discount Drugs,
Inc., No. 2:20-cv-00010-LGW-BWC (S.D. Ga.
Feb. 12, 2020)...........................................................11
Compl., United States v. Howen, No. 1:21-cv00106-DAB-SAB (E.D. Cal. Jan. 26, 2021) .............11
Compl., United States v. Ridley’s Family Markets, Inc., No. 1:20-cv-00173 (D. Utah Dec. 4,
2020) .................................................................. 10, 19
Compl., United States v. Seashore Drugs, Inc.,
No. 7:20-cv-207 (E.D.N.C. Oct. 30, 2020) ................19
Compl., United States v. Shaffer Pharmacy, No.
3:21-cv-00022-JZ (N.D. Ohio Jan. 6, 2021) .............11
Compl., United States v. Walmart Inc., No. 1:20cv-01744-CFC (D. Del. Dec. 22, 2020) ......... 11, 19, 20
Compl., United States v. WeCare Pharmacy,
LLC, No. 8:21-cv-00188-MSS-AEP (M.D. Fla.
Jan. 26, 2021) ..........................................................11
First Amended Compl., Fuog v. CVS Pharmacy,
Inc., No. 1:20-cv-00337-WES-LDA (D.R.I.
Aug. 26, 2020) ..........................................................12
vi
TABLE OF AUTHORITIES—Continued
Page
Mem. in Opp’n to Def.’s Mot. to Dismiss, United
States v. Ridley’s Family Markets, Inc., No.
1:20-cv-00173-TS-JCB (D. Utah Mar. 8, 2021) .......11
NACDS.org Staff, Americans’ Trust in Pharmacists Should Speak Volumes to Government,
NACDS Says, https://www.nacds.org/news/
americans-trust-in-pharmacists-should-speakvolumes-to-government-nacds-says/ ................24–25
Wis. Pharmacy Examining Bd., Administrative
Warning, Division of Legal Services and Compliance Case No. 17 PHM 095 (Dec. 6, 2018) .........12
1
INTEREST OF AMICUS CURIAE1
Pharmacists play a critical role in our nation’s
healthcare system, daily ensuring that, among other
things, millions of patients receive the medicines they
need as well as instructions for safely using them.
Whether in independent pharmacies or chain drug
stores, pharmacists and their employers share the
same mission when it comes to prescribed treatment:
to deliver to patients the medicines that licensed practitioners have determined they need.
The National Association of Chain Drug Stores
(NACDS) is a leading organization supporting pharmacies in promoting and fulfilling that mission. A
non-profit, tax-exempt organization incorporated in
Virginia, NACDS represents traditional drug stores,
community pharmacies, supermarkets, and mass merchants with pharmacies. NACDS chain members operate over 40,000 pharmacies and employ nearly 3
million individuals, including 155,000 pharmacists; its
80 chain member companies include regional chains,
with a minimum of four stores, and national companies.
NACDS continually strives to help its members
to maintain and enhance the safe care of patients
who rely on pharmacists’ training, judgment, and
1
No party’s counsel authored any part of this brief or made
a monetary contribution intended to fund the preparation or submission of this brief. No person other than amicus, its members,
or its counsel contributed money intended to fund the brief ’s
preparation or submission. All parties have provided written consent to the filing of this brief.
2
professionalism. That care depends on pharmacists’
ability to understand their obligations when filling
prescriptions for controlled substances. NACDS members seek to deliver that care and practice their profession under clear and consistent rules, without
regulatory uncertainty, and free from the threat of severe penalties just for doing their jobs. To that end,
NACDS regularly files amicus briefs in cases that have
the potential to alter or clarify pharmacists’ obligations.
Kahn v. United States (No. 21-5261) and Ruan v.
United States (No. 20-1410) are such cases. Although
they concern the scope of physicians’ potential liability
for prescribing medications in violation of the Controlled Substances Act (CSA), the manner in which the
Court decides the questions presented could—directly
or indirectly—affect the scope of pharmacists’ potential liability for dispensing medications in violation of
the CSA.
While NACDS takes no position on Petitioners’ ultimate culpability under 21 U.S.C. § 841(a), it does
have a strong interest in the Court’s proper interpretation of that statute and the regulations implementing the CSA. Key among those regulations is 21 C.F.R.
§ 1306.04(a), which places primary “responsibility for
the proper prescribing and dispensing of controlled
substances” on the “prescribing practitioner,” but also
imposes a “corresponding responsibility” on the pharmacist who fills the prescription.
3
NACDS writes to explain how the Court’s construction of the relevant statutes and regulations may
affect pharmacists, and to assist the Court in reaching
correct interpretations that effectuate Congress’s intent to hold wrongdoers liable while avoiding the inadvertent or unwarranted imposition of liability.
---------------------------------♦---------------------------------
INTRODUCTION AND
SUMMARY OF THE ARGUMENT
As with most of its docket, the Court’s resolution
of the questions presented here could have an impact
far beyond the specific context in which these cases
arise. In particular, the Court’s interpretation of 21
C.F.R. § 1306.04—the regulation at the center of Petitioners’ good-faith defense—could have a potentially
sweeping effect on pharmacists and the practice of
pharmacy.
Section 1306.04(a) clarifies that an “effective” prescription is one issued “for a legitimate medical purpose” by a prescriber “acting in the usual course of his
professional practice.” In addition to establishing when
a prescriber may issue a prescription, § 1306.04(a) imposes liability on pharmacists for “knowingly filling” a
prescription that fails the regulation’s requirements. A
separate provision applicable to pharmacists, 21 C.F.R.
§ 1306.06, utilizes the same usual-course-of-professionalpractice language in identifying when a pharmacist
may fill a prescription for a controlled substance. How
the Court interprets and applies the language of
4
§ 1306.04(a) may well affect, in turn, how lower courts
and administrative agencies assess pharmacists’ alleged violations of § 1306.06.
In view of the potentially far-reaching consequences of the Court’s interpretation, this brief submits three points to assist in the Court’s resolution of
these cases.
First, § 1306.04(a) includes an important safeguard that recognizes the division of responsibility between physicians and pharmacists—that a pharmacist
may only be held liable if she “knowingly fill[s]” a “purported” prescription, i.e., a prescription that was not
written “in the usual course of professional treatment.”
21 C.F.R. § 1306.04 (emphasis added). This limitation
on liability reflects the very real constraints on a pharmacist presented with a facially valid prescription for
a controlled substance. Recent civil litigation and enforcement actions against pharmacists and pharmacies, however, have sought to sidestep that scienter
requirement and also to expand pharmacists’ liability
under § 1306.06. Mindful of those alarming efforts (albeit made in a context different from these cases),
NACDS urges the Court to avoid any interpretation
here that inadvertently would increase pharmacists’
exposure to unwarranted liability.
Second, in interpreting the meaning of the “usual
course of . . . professional practice,” the Court should
confirm what it stated more than forty years ago in
United States v. Moore, 423 U.S. 122 (1975): acting
outside “the usual course of . . . professional practice”
5
means completely abandoning one’s professional obligations, not merely failing to comply with a professional standard. Id. at 142–143. The Court should
decline to read “usual course of . . . professional practice” as requiring perfect compliance with all professional standards. Doing so would expose pharmacists
to unwarranted civil and criminal enforcement under
§ 1306.06 for even the most minor, unintentional deviation from the ideal standard of care.
Third, recognizing appropriate limits on the liability of pharmacists is consistent with Congress’s goal in
the CSA of punishing true wrongdoers “to conquer
drug abuse and to control the legitimate and illegitimate traffic in controlled substances.” Gonzales v.
Raich, 545 U.S. 1, 12 (2005).
---------------------------------♦---------------------------------
ARGUMENT
I.
In interpreting § 1306.04(a) to determine
the scope of prescriber liability, the Court
should in no way undermine the knowledge requirement that protects pharmacists from unwarranted liability.
Although these cases involve the liability of prescribing practitioners, NACDS is concerned that the
Court’s interpretation of “usual course” language in
§ 1306.04(a) could have an unintentional and inappropriate collateral impact on the scope of pharmacists’
liability. In considering the questions in this case, it is
important that the Court remain cognizant of the
6
different function performed by prescribers, on the one
hand, and pharmacists, on the other, and do nothing
either to undermine the protection from liability that
§ 1306.04(a)’s scienter requirement is meant to provide
to pharmacists, or to adopt an interpretation of “usual
course” that would improperly expand pharmacists’ liability under § 1306.06, where the same language appears. NACDS is especially wary of such unintended
results here because recent civil suits and enforcement
actions have intentionally sought to impose liability on
pharmacists based on similarly expansive and unwarranted readings of the regulations.
A. Reflecting the distinct roles of prescribers and pharmacists, § 1306.04 imposes liability only on pharmacists who
“knowingly” fill an illegitimate prescription.
Although § 1306.04(a) regulates both prescribers
and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill
sets, responsibilities, and workplaces from physicians,
pharmacists play a vital but distinct role in a patient’s
care. Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a
pharmacist relies on the physician’s assessment of the
patient’s needs. The pharmacist has neither examined
nor diagnosed the patient, and lacks the information
the physician has collected on the patient’s medical
7
situation, records, and history, including such things
as x-rays, ultrasounds, lab results, and treatment
plans.
The CSA recognizes pharmacists’ circumscribed
role in dispensing controlled substances. It provides
that pharmacists may not dispense Schedule II controlled substances “without the written prescription of
a practitioner,” 21 U.S.C. § 829(a), and that they risk
criminal and civil liability if they do, see id. §§ 841(a),
(c), 842. The CSA’s implementing regulations further
explain that a prescription for a controlled substance
“must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice.” 21 C.F.R. § 1306.04(a). The regulations separately provide that such a prescription
“may only be filled by a pharmacist, acting in the usual
course of his professional practice and either registered individually or employed” by a registered entity.
21 C.F.R. § 1306.06.
Consistent with the division of responsibility between prescribers and pharmacists, § 1306.04 limits
when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a
pharmacist knows a prescription is illegitimate:
The responsibility for the proper prescribing
and dispensing of controlled substances is
upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order
purporting to be a prescription issued not in
the usual course of professional treatment or
8
in legitimate and authorized research is not a
prescription within the meaning and intent of
section 309 of the Act (21 U.S.C. [§] 829) and
the person knowingly filling such a purported
prescription, as well as the person issuing it,
shall be subject to the penalties provided for
violations of the provisions of law relating to
controlled substances.
21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist
violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written “in the usual course of
professional treatment.” Ibid. (emphasis added).
These critical limitations on a pharmacist’s possible liability under § 1306.04 are no accident. They were
added to the regulation intentionally to avoid the unwarranted and counterproductive imposition of liability. When first proposed in 1971, the regulation lacked
the word “knowingly,” which would have allowed penalties for any “person filling [an illegitimate] prescription.” Purpose of Issue of Prescription, 36 Fed. Reg.
4847, 4948 (Mar. 13, 1971). Pharmacists protested
such an expansive rule, however, and during the comment period specifically “objected to the responsibility
placed upon a pharmacist under § [1306.04] to determine the legitimacy of a prescription.” Comments
and Objections to Part 306, 36 Fed. Reg. 7776, 7777
(Apr. 24, 1971). The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require
knowledge.” Ibid.
9
These limitations sensibly reflect the very real
constraints on pharmacists presented with prescriptions for controlled substances. To be sure, pharmacists
can do things like inspect prescriptions for indicia of
facial invalidity to determine if they can be filled—e.g.,
tampering, missing or incorrect information, a forged
signature, or a prescribing physician who is not
DEA-registered. See 21 C.F.R. § 1306.05(a). When presented with a facially valid prescription, however, a
pharmacist cannot be expected to second-guess the
prescriber’s medical judgment that the prescribed
medicine is appropriate, to interrogate the patient regarding whether they actually need the prescribed
medication, or to obstruct the patient’s care by withholding it. Indeed, none of the myriad state and federal
laws with which pharmacists must comply authorizes,
much less requires, pharmacists to supersede the medical judgment of the prescriber. The law should not unduly chill a pharmacist’s performance of her duties to
make medications safely available to patients who
need them. The knowledge requirement in § 1306.04
properly reflects this circumscribed role.
B. The Court should not resolve these
cases in a way that undermines the
knowledge requirement for pharmacist
liability.
In resolving the issues presented in these cases—
including whether a good-faith defense is available
to a practitioner charged with violating 21 U.S.C.
§ 841(a)—the Court should take care not to weaken the
10
knowledge requirement in § 1306.04, insofar as it applies to pharmacists. That requirement is a critical
safeguard against unwarranted liability, which could
unduly chill pharmacists from performing duties vitally important to public health.
This is no abstract concern. In recent enforcement
actions it has filed across the country, accusing pharmacists and pharmacies of unlawfully dispensing
medicines, the U.S. Department of Justice (DOJ) has
aggressively attempted to sidestep § 1306.04’s knowledge requirement. Citing pharmacists’ “corresponding
responsibility,” DOJ has argued that pharmacists are
liable for filling prescriptions that allegedly present socalled “red flags”—factors that do not necessarily bear
on a prescription’s facial validity but that, in DOJ’s
opinion, suggest the prescriber may have written it for
an illegitimate purpose. Under DOJ’s theory, the presence of one or more “red flags” not only proves that a
prescription is illegitimate but that a pharmacist who
fills it must be doing so “knowingly.”
The “red flags” advanced by DOJ include patients
seeking to fill “[n]ew prescriptions for controlled substances a patient has never received before”;2 certain
combinations of prescribed drugs;3 providing physician-ordered refills when “one to three days of supply
2
Compl. ¶ 79, United States v. Ridley’s Family Markets, Inc.,
No. 1:20-cv-00173-TS-JCB (D. Utah Dec. 4, 2020), ECF No. 2.
3
See, e.g., id. ¶¶ 68–72.
11
remained”;4 late filling of prescriptions;5 dispensing
the same medications “for the same patients over long
periods of time”;6 prescriptions for doses above “90
[morphine milligram equivalents]/day”;7 and prescriptions for more than one “[i]mmediate-release opioid[ ]
. . . sufficiently close in time that the supplies would
have overlapped.”8 Even though in many circumstances these supposed “red flags” have legitimate explanations (medical or otherwise), DOJ has gone so far
as to argue that the presence of one or more of these
elements is “near conclusive[ ] evidence of a prescription’s invalidity.”9 According to DOJ, when faced with a
prescription presenting one or more “red flags,” a pharmacist must identify each issue, take steps to resolve
it, and document in writing how it was resolved—no
matter how many times the same patient has presented the prescription. Until and unless each “red
flag” is resolved, DOJ says, a pharmacist must secondguess the prescription’s appropriateness, override the
4
Compl. ¶ 67, United States v. Shaffer Pharmacy, No. 3:21cv-00022-JZ (N.D. Ohio Jan. 6, 2021), ECF No. 1.
5
See, e.g., Compl. ¶ 72, United States v. Howen, No. 1:21-cv00106-DAB-SAB (E.D. Cal. Jan. 26, 2021), ECF No. 1.
6
Compl. ¶ 66, United States v. WeCare Pharmacy, LLC, No.
8:21-cv-00188-MSS-AEP (M.D. Fla. Jan. 26, 2021), ECF No. 1.
7
Compl. ¶ 75, United States v. Chip’s Discount Drugs, Inc.,
No. 2:20-cv-00010-LGW-BWC (S.D. Ga. Feb. 12, 2020), ECF No. 1.
8
Compl. ¶ 361, United States v. Walmart Inc., No. 1:20-cv01744-CFC (D. Del. Dec. 22, 2020), ECF No. 1.
9
Mem. in Opp’n to Def.’s Mot. to Dismiss at 5 (emphasis
added), 8, United States v. Ridley’s Family Markets, Inc., No. 1:20cv-00173-TS-JCB (D. Utah Mar. 8, 2021), ECF No. 31.
12
prescriber’s medical judgment, and refuse to fill it—or
else face the threat of liability.
There are many problems with DOJ’s “red flags”
theory. It has no basis in the CSA or its implementing
regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, caseby-case approach that pharmacists take when filling
prescriptions in favor of a categorical approach to culpability.10 And it traps pharmacists in an untenable position—either face liability under the CSA for filling a
facially valid prescription that raises a “red flag,” or
face state-based professional liability,11 and even civil
suits,12 for refusing to fill such a prescription.
But the critical point here is that § 1306.04 provides a protection for pharmacists that the Court
should not inadvertently eliminate: a pharmacist may
10
See Dispensing Controlled Substances for the Treatment of
Pain, 71 Fed. Reg. 52716, 52720 (Sept. 6, 2006) (noting that “each
case must be evaluated based on its own merits in view of the
totality of circumstances”).
11
See, e.g., Wis. Pharmacy Examining Bd., Administrative
Warning, Division of Legal Services and Compliance Case No. 17
PHM 095 (Dec. 6, 2018).
12
See, e.g., First Amended Compl. ¶ 2, Fuog v. CVS Pharmacy, Inc., No. 1:20-cv-00337-WES-LDA (D.R.I. Aug. 26, 2020),
ECF No. 6 (challenging “corporate wide discriminatory practices
in refusing to fill, without a legitimate basis, valid and legal prescriptions for opioid medication”); Reasor v. Walmart Stores E.,
L.P., No. 3:19-CV-27-CRS, 2019 WL 5597302, at *3 (W.D. Ky. Oct.
30, 2019) (defamation suit by physician asserting that “the failure
to fill his patient’s prescriptions necessarily imputed illegal conduct because pharmacists are required to fill prescriptions unless
the [p]harmacist has reason to know of some irregularity”).
13
only be held liable if the pharmacist “knowingly fill[s]”
a “purported” prescription. In other words, unless a
pharmacist subjectively knows that a facially legitimate prescription has been prescribed for illegitimate
reasons, the pharmacist should not face potential liability for dispensing medication based on that prescription. A strict adherence to this knowledge element
is critical to ensuring that pharmacists acting in good
faith are not punished for filling facially valid prescriptions written by licensed and registered prescribers—
punishment that, if rendered, would chill other pharmacists from performing their duties. In addressing
the related issues raised in these cases, the Court
should be careful not to undermine this important
safeguard.
II.
Acting outside “the usual course of . . .
professional practice” means completely
abandoning professional obligations, not
merely failing to adhere to a professional
standard.
The Court’s decision in these cases may also affect
the scope of pharmacists’ potential liability by how it
resolves the question of what it means for conduct to
fall outside “the usual course of . . . professional practice” for a physician. See, e.g., United States v. Bek, 493
F.3d 790, 798 (7th Cir. 2007) (“[T]o convict . . . a practitioner registered to distribute controlled substances,
of violating § 841(a)(1), the government must show
that he prescribed controlled substances outside ‘the
course of professional practice.’ ”). While this case
14
involves physicians, the Court’s interpretation of this
language will likely affect pharmacists, too.
The Court should answer that question by confirming what it stated in United States v. Moore, 423
U.S. 122, 124 (1975): a practitioner acts outside the
usual course of professional practice when he completely abandons his professional obligations—and
fails to act as a physician at all—not when he merely
fails to comply with any single professional standard.
A. The Court should confirm Moore’s determination of what constitutes acting
outside the usual course of professional practice.
This Court’s decision in Moore supports the plain,
narrow meaning of the phrase “usual course of . . . professional practice.” There, the Court held that a physician registered by the DEA could be prosecuted under
21 U.S.C. § 841 “when [his] activities fall outside the
usual course of professional practice.” Ibid. The Court
held that the evidence was sufficient to show that Dr.
Moore’s conduct “exceeded the bounds of ‘professional
practice’ ” because “[i]n practical effect, he acted as a
large-scale ‘pusher’ not as a physician.” Id. at 143. Dr.
Moore “gave inadequate physical examinations or
none at all,” “ignored the results of the tests he did
make,” “did not give methadone at the clinic and took
no precautions against its misuse and diversion,” “did
not regulate the dosage at all,” and “did not charge
for medical services rendered, but graduated his fee
15
according to the number of tablets desired.” Id. at 142–
143.
Accordingly, the Court indicated, a practitioner
acts outside the usual course of professional practice
when he completely abandons his professional obligations, and fails to act as a physician at all. That the
Court intended this conclusion is apparent not only
from its appraisal of the evidence but also its observation about the congressional intent underlying the
CSA. The Court noted that § 841 prohibited “the significantly greater offense of acting as a drug ‘pusher,’ ”
id. at 138, and that, in enacting the CSA, “Congress
was particularly concerned with the diversion of drugs
from legitimate channels to illegitimate channels,” id.
at 135 (emphasis added); see also Gonzales, 545 U.S. at
12 (noting that one of the “main objectives of the CSA”
was to “control the legitimate and illegitimate traffic in
controlled substances”).
Thus, a prescriber would completely abandon his
professional obligations if he were to intentionally divert a controlled substance from a patient who needs a
prescription for pain management (a legitimate channel) to someone who uses a prescription to satisfy an
addiction (an illegitimate channel). By contrast, the
mere failure to comply with a professional or state-imposed standard—such as paperwork requirements—
would not rise to the same level. Nor would imposing
liability for such a minor failure serve the CSA’s purpose of effectively controlling drug manufacture, distribution, and dispensation.
16
Since Moore, some circuits have followed the
Court’s lead and construed conduct outside of “professional practice” to mean deliberate, egregious conduct
beyond the scope of a practitioner’s professional role.
See United States v. Feingold, 454 F.3d 1001, 1011 (9th
Cir. 2006) (interpreting § 1306.04 as “unquestionably
impos[ing] a higher burden on the government than
proving deliberate malpractice”); United States v. Tran
Trong Cuong, 18 F.3d 1132, 1137 (4th Cir. 1994) (reasoning that § 841 requires proof that physician’s “authority to prescribe controlled substances was being
used not for treatment of a patient, but for the purpose
of assisting another in the maintenance of a drug habit
or of dispensing controlled substances for other than a
legitimate medical purpose, i.e., the personal profit of
the physician”).13 But others have signaled that any departure from a professional standard—no matter how
slight, and without regard to whether the practitioner
has ceased to act as a physician at all—might be sufficient to establish guilt. See, e.g., United States v. Sabean, 885 F.3d 27, 45 (1st Cir. 2018) (reasoning that
13
See also, e.g., United States v. Volkman, 797 F.3d 377, 386
(6th Cir. 2015) (“In the past, we have endorsed a broad approach
to determining what conduct falls outside the accepted bounds of
professional practice so as to constitute a CSA violation, eschewing a preestablished list of prohibited acts in favor of a case-bycase approach.”); United States v. Naum, 832 F. App’x 137, 144
(4th Cir. 2020) (holding that an instruction “that the jury must
consider the totality of the circumstances in making its determination that Naum acted outside the scope of professional medical
practice was consistent with . . . our precedents” and noting favorably the court’s instruction that “violation of an applicable professional regulation alone, however, is not determinative”), petition
for cert. filed (U.S. Apr. 22, 2021) (No. 20-1480).
17
failing to adhere to a professional standard “is undeniably relevant”); Bek, 493 F.3d at 799 (approving jury
instruction to consider the norms of professional practice).
Neither the Tenth Circuit in Kahn nor the Eleventh Circuit in Ruan indicated what conduct constitutes action outside the scope of professional practice.
As the petitions stress, however, those Circuits do not
recognize a good-faith defense to a charge under the
“professional practice” prong of § 841(a). Instead, they
permit a conviction when a physician merely fails to
act in “accordance with the standards of medical practice generally recognized and accepted in the United
States.” United States v. Ruan, 966 F.3d 1101, 1167
(11th Cir. 2020); see United States v. Kahn, 989 F.3d
806, 825 (10th Cir. 2021) (“[T]he only relevant inquiry
under that second prong is whether a defendant-practitioner objectively acted within that scope, regardless
of whether he believed he was doing so.” (emphasis
added)).
The Court should reject such an expansive interpretation. If one can exceed the bounds of professional
practice merely by failing to adhere to any unspecified
professional standard, then any practitioner who accidentally or unknowingly makes even a small, ministerial mistake has broken the law and could find himself
the target of a government enforcement action, which
would proceed on a knowledge standard akin to strict
liability. Even the government has recognized that this
cannot be—in its opposition to the Ruan petition, it
conceded that the Section 841 standard is “higher than
18
the standard for civil liability on a medical-negligence
or medical-malpractice claim.” Br. for the United
States in Opp’n at 22, Ruan v. United States, No. 201410 (U.S. July 7, 2021). But the standard advanced by
the Tenth and Eleventh Circuits would collapse that
distinction. To avert that outcome, the Court should
confirm Moore’s conclusion that a practitioner acts outside the usual course of professional practice by completely abandoning professional obligations.
B. The Court should reject any interpretation of “usual course of . . . professional practice” that would expose
pharmacists to liability under 21 C.F.R.
§ 1306.06 for minor infractions or mere
non-compliance with professional standards.
Although the scope of liability imposed by 21
C.F.R. § 1306.06 is not expressly at issue in these cases,
any interpretation of the scope of “usual course of . . .
professional practice” in § 1306.04(a) directly implicates it. Employing the same critical language, that
regulation provides that a prescription “may only be
filled by a pharmacist, acting in the usual course of his
professional practice and either registered individually or employed” by a registered entity.
The proper interpretation of § 1306.04(a) will ensure that § 1306.06 cannot be used as an end-run
around the requirements in § 1306.04, and that pharmacists can continue to effectively serve patients and
the public health. Again, this is not an abstract
19
concern. Recently, DOJ has developed a web of theories
to impose liability on pharmacists under § 1306.06.
DOJ has contended that noncompliance with § 1306.06
establishes a violation of 21 U.S.C. § 842(a)(1)—subjecting a pharmacist to the civil penalty provision contained in § 842(c)(1)14 and, for knowing violations, the
criminal penalty provision contained in § 842(c)(2),15
regardless of whether the underlying prescription actually was invalid.16 DOJ also has argued that a pharmacist’s mere failure to comply with any relevant
state regulation or professional norm is sufficient to
show action outside the usual course of professional
practice, and therefore a violation of § 1306.06—a position indistinct from the Tenth and Eleventh Circuits’ “strict liability” approach to prosecutions under
the “professional practice” prong of § 841(a).17 And, as
14
See 21 U.S.C. § 842(c)(1)(A) (“any person who violates this
section shall . . . be subject to a civil penalty”).
15
See 21 U.S.C. § 842(c)(2) (knowing violation of § 842 may
be prosecuted criminally).
16
See Compl. ¶ 89, United States v. Walmart Inc., No. 1:20cv-01744-CFC (D. Del. Dec. 22, 2020) (“A person dispensing controlled substances not in compliance with any of the three requirements identified above [§ 1306.04(a)’s legitimate purpose
and professional practice requirements and § 1306.06’s professional practice requirement] violates 21 U.S.C. § 829 and thus 21
U.S.C. § 842(a)(1).”).
17
See Compl. ¶ 21, United States v. Seashore Drugs, Inc., No.
7:20-cv-207 (E.D.N.C. Oct. 30, 2020) (asserting that “acting in the
usual course of pharmacy practice includes compliance with all
relevant state laws and regulations”); Compl. ¶ 21, United States
v. Ridley’s Family Markets, Inc., No. 1:20-cv-00173 (D. Utah
Dec. 4, 2020) (alleging the “usual course of pharmacy practice includes compliance with all relevant state laws and regulations”).
20
discussed above, DOJ also has invoked professional
norms in pursuing the nebulous “red flags” theory of
liability.18
The Court should construe “professional practice,”
as used in both § 1306.04 and § 1306.06, to limit these
unwarranted threats of liability against pharmacists.
In particular, the Court should reject any definition of
“usual course of . . . professional practice” that would
allow pharmacists to be held liable or even prosecuted
for minor, technical, or unintentional violations under
§ 1306.06. DOJ’s contention that a pharmacist exceeds
the usual course of professional practice by failing to
comply with any professional standard sweeps far too
broadly. Perhaps most importantly, that interpretation
of § 1306.06—combined with DOJ’s view that all violations of § 1306.06 qualify as violations of 21 U.S.C.
§ 829 for purposes of civil penalties under 21 U.S.C.
§ 842(a)(1)—guts § 1306.04(a)’s scienter requirement.
If DOJ need only prove that a pharmacist made missteps in filling a prescription, then it will rarely if ever
have to meet the much higher burden of proving that
the pharmacist knowingly filled an invalid prescription.
That interpretation has other problems as well.
Among other things, it ignores the wide sweep of
standards to which pharmacists are subject: not only
federal and state controlled-substances laws, but a
18
See Compl. ¶ 88, United States v. Walmart Inc., No. 1:20cv-01744-CFC (D. Del. Dec. 22, 2020) (maintaining that identifying and resolving “red flags” is “a well-recognized responsibility of
a pharmacist in the professional practice of pharmacy”).
21
myriad of state-imposed professional obligations. For
example, Delaware regulates matters ranging from the
font size on signs posted in pharmacies, to how long
records of prescriptions must be retained, to requirements for automated pharmacy systems;19 Texas has
regulations that dictate how long a pharmacist has to
give notice of an address change;20 and other States
regulate a host of other incidents of pharmacy practice,
including continuing education requirements. Yet, under DOJ’s understanding of the “professional practice”
requirement, a pharmacist could face criminal prosecution for using the wrong font size on pharmacy signs
or for forwarding a new address a few days late. It
would be both alarming and incongruous for a pharmacist to face liability and penalties under the CSA for
alleged violations of state pharmacy law—all without
the involvement or professional judgment of the relevant state board of pharmacy.21
The CSA contains no language indicating that
Congress intended to impose criminal liability for failure to perfectly comply with professional norms in
every case, which is an impractical standard. Such
19
See 24 DEL. ADMIN. CODE § 2500-3.9, 5.1.12.3, 15.0.
See 22 TEX. ADMIN. CODE §§ 295.1, 295.9.
21
Whether or not DOJ would likely pursue an enforcement
action based on such trivial conduct is irrelevant—that there is
even an actionable possibility demonstrates why creating federal
liability for departing from state regulations and professional
norms is an inherently flawed approach. The Court need not wait
until a pharmacist-defendant appeals from a conviction based on
this standard to understand now the problems such an interpretation poses.
20
22
failures do not implicate Congress’s stated concerns regarding drug diversion, and the Court’s discussion in
Moore throws cold water on such a conclusion. See
Moore, 423 U.S. at 143. Moreover, as Professors Oliva
and Dineen correctly observe in their amicus brief in
support of Dr. Ruan’s petition, see Br. of Amici Curiae
Profs. of Health Law & Policy in Supp. of Pet’r at 15–
25, Ruan v. United States, No. 20-1410 (U.S. May 7,
2021), construing the CSA to criminalize negligent
medical conduct plainly invades an area of the law long
reserved to the States (regulating medical malpractice), triggering significant federalism concerns, see
Linder v. United States, 268 U.S. 5, 18 (1925).
Accordingly, the Court should define what constitutes conduct outside the “usual course of . . . professional practice” consistent with its interpretation in
Moore. This would appropriately limit efforts to impose
federal civil and criminal liability against pharmacists
(whether based on state-imposed professional requirements, “red flags,” or other nebulous standards of practice), and would allow pharmacists to serve their
patients without fear that any minor misstep could
lead to crushing sanctions.
23
III. The Court can adopt standards that allow
for punishment of wrongdoers while allowing pharmacists to practice their profession free from the unwarranted threat
of liability.
Proper interpretations of the relevant statutes
and regulations will allow true wrongdoers to be held
liable without preventing pharmacists from practicing
their profession, serving their patients, or filling facially valid prescriptions free from anxiety that they
will later be found to have violated federal law.
First, the goal of holding wrongdoers accountable is hardly compromised by the requirement that a
pharmacist may be held liable only if the pharmacist
“knowingly fill[s]” a prescription that was not written “in the usual course of professional treatment.”
§ 1306.04 (emphasis added). Pharmacists who lack
knowledge of a prescription’s illegitimacy should not
face potential criminal or civil liability, and the Court
should refrain in these cases from adopting any interpretation that suggests otherwise. Indeed, the contrary
interpretation would have dire consequences. Lowering or eliminating a prosecutor’s burden to demonstrate knowledge could well have the effect of chilling
pharmacists from filling controlled-substance prescriptions—including facially valid ones—thereby depriving patients of medicines they need. See, e.g., 21
U.S.C. § 801(1) (recognizing that many drugs subject
to the CSA “have a useful and legitimate medical purpose and are necessary to maintain the health and
general welfare of the American people”); 71 Fed. Reg.
24
at 52719–20 (recognizing DEA’s own “obligation to ensure that there is no interference with the dispensing
of controlled substances to the American public in accordance with the sound judgment of their physicians”).
Second, reiterating the Court’s conclusion in
Moore that practitioners act outside the “usual course
of . . . professional practice” when they completely
abandon their professional role will ensure that egregious conduct will continue to be punished without
creating crippling consequences for slight missteps. It
also would give pharmacists the clarity they need to
perform their important functions. By contrast, interpreting “professional practice” to require compliance
with all professional standards would improperly subject pharmacists to substantial civil liability or even
criminal sanctions for simple mistakes, creating confusion and uncertain legal risks for pharmacists; chill
pharmacists in the practice of their profession, threatening patients with loss of access to necessary medications; and have the baneful effect of driving
pharmacists from the profession altogether.
In sum, the expansive interpretation proposed by
DOJ would undermine the CSA by threatening the
vital role that pharmacists play in our nation’s
healthcare system. Pharmacists, who are widely trusted
as acting in good faith,22 should only face CSA liability
22
Pharmacists are consistently ranked among the most honest and ethical professionals. See NACDS.org Staff, Americans’
Trust in Pharmacists Should Speak Volumes to Government, NACDS
25
when they knowingly abandon those responsibilities,
not when they strive to comply with them.
---------------------------------♦---------------------------------
CONCLUSION
In resolving the questions raised in this case, the
Court should not ignore the potential impact its rulings may have on pharmacists, nor should it construe
the CSA and its implementing regulations in any way
to undercut the protections they provide pharmacists
from unwarranted liability.
Respectfully submitted,
TORSTEN M. KRACHT
HUNTON ANDREWS KURTH LLP
2200 Pennsylvania Ave., NW
Washington, D.C. 20037
tkracht@HuntonAK.com
CAMERON L. DAVIS
HUNTON ANDREWS KURTH LLP
500 W. 5th Street, Suite 1350
Austin, TX 78701
cdavis@HuntonAK.com
TREVOR S. COX
Counsel of Record
HUNTON ANDREWS
KURTH LLP
951 E. Byrd Street
Richmond, VA 23219
Phone: (804) 788-7221
tcox@HuntonAK.com
Counsel for the National Association of Chain Drug Stores
DECEMBER 2021
Says, https://www.nacds.org/news/americans-trust-in-pharmacistsshould-speak-volumes-to-government-nacds-says/ (last visited
Dec. 22, 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.