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

No. 20-1410

(consolidated with No. 21-5261)

In the Supreme Court

of the United States

XIULU RUAN AND SHAKEEL KAHN,

Petitioners,

v.

UNITED STATES OF AMERICA,

Respondent.

On Writs of Certiorari to the

United States Courts of Appeals

for the Eleventh and Tenth Circuits

BRIEF OF ANMOL SINGH KAMRA

AS AMICUS CURIAE

IN SUPPORT OF PETITIONERS

PETER GOLDBERGER

Counsel of Record

PAMELA A. WILK

50 Rittenhouse Place

Ardmore, PA 19003

(610) 649-8200

peter.goldberger@verizon.net

i

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES .................................... ii

INTEREST OF THE AMICUS CURIAE................... 1

INTRODUCTION AND SUMMARY

OF ARGUMENT .................................................... 2

ARGUMENT FOR AMICUS ..................................... 6

A Subjectively Genuine Belief That the

Charged Distribution Was ―Within the Bounds

of Professional Practice‖ Is Inconsistent With

the Mens Rea Element of a Section 841(a)

Offense, and in the Case of a Non-Professional

May Be Predicated on a Sincere Belief That

the Pertinent Professional Was Acting in

Good Faith ............................................................. 6

CONCLUSION ......................................................... 15

ii

TABLE OF AUTHORITIES

Page(s)

Cases

Cheek v. United States, 498 U.S. 192 (1991) .......... 12

Clark v. Arizona, 548 U.S. 735 (2006) ...................... 3

Direct Sales Co. v. United States,

319 U.S. 703 (1943) .............................................. 11

Dixon v. United States, 548 U.S. 1 (2006) .............. 10

Elonis v. United States, 575 U.S. 723 (2015) ........... 8

Feola v. United States, 420 U.S. 671 (1975) .......... 11

Flores-Figueroa v. United States,

556 U.S. 646 (2009) ................................................ 7

Ingram v. United States, 360 U.S. 672 (1959) ........ 11

Kahler v. Kansas, 589 U.S. —,

140 S.Ct. 1021 (2020) ........................................... 10

Linder v. United States, 268 U.S. 5 (1925) ......... 9, 10

Liparota v. United States, 471 U.S. 419 (1985) ........ 7

Martin v. Ohio, 480 U.S. 228 (1987) ....................... 10

Morissette v. United States, 342 U.S. 246 (1952) ..... 8

Pinkerton v. United States, 328 U.S. 640 (1946) .. 4, 11

Ratzlaf v. United States, 510 U.S. 135 (1994) .......... 3

Rehaif v. United States, 588 U.S. —,

139 S.Ct. 2191 (2019) ............................................. 8

Rosemond v. United States, 572 U.S. 65 (2014) ..... 11

Staples v. United States, 511 U.S. 600 (1994) .......... 8

United States v. Bailey, 444 U.S 394 (1980) ............. 8

United States v. Lovern,

590 F.3d 1095 (10th Cir. 2009) .................. 4, 13, 14

iii

TABLE OF AUTHORITIES—continued

Page(s)

United States v. Moore, 423 U.S. 122 (1975) ........ 3, 6

United States v. Quinones,

635 F.3d 590 (2d Cir. 2011) ................................. 12

United States v. Vamos,

797 F.2d 1146 (2d Cir. 1986) ............................... 12

United States v. Voorhies,

663 F.2d 30 (6th Cir. 1981) .................................. 13

United States v. X-Citement Video, Inc.,

513 U.S. 64 (1994) .................................................. 8

Constitution, Statutes and Rules

18 U.S.C. § 2(a) .......................................................... 3

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

21 U.S.C. § 841(b) .................................................. 2, 6

21 U.S.C. § 846 ................................................ passim

21 U.S.C. § 885(a) ...................................................... 7

Controlled Substances Act of 1970 ............... 6, 10, 13

63 Pa.Stat. § 218.3 ..................................................... 4

63 Pa.Stat. § 422.13(f) ............................................... 4

21 C.F.R. § 1306.04(a) ............................................. 14

49 Pa.Code § 21.283 .................................................. 4

49 Pa.Code § 21.284b ................................................ 4

49 Pa.Code § 21.285 .................................................. 4

Other Authorities

1 WAYNE R. LAFAVE, SUBSTANTIVE CRIMINAL LAW

(3d ed. 2018) ............................................... 9, 10, 12

1 PAUL H. ROBINSON,

CRIMINAL LAW DEFENSES (1984) ................... 10, 12

iv

TABLE OF AUTHORITIES—continued

Page(s)

BERTRAND RUSSELL, HUMAN KNOWLEDGE:

ITS SCOPE AND LIMITS (1923, rev. 1948) ................ 9

Jonathan Wayne, The difference between belief and

knowledge (2017), available at

https://medium.com/perspectivepublications/the-differencebetween-belief-and-knowledge-cb909520a265/ (accessed

12/22/2021) ............................................................. 9

INTEREST OF THE AMICUS CURIAE

Amicus curiae is Anmol Singh Kamra, whose

conviction for conspiracy to violate the same statute

as is under consideration in these cases is presently

pending (mid-briefing) before the United States

Court of Appeals for the Third Circuit, at No. 211615.1

Kamra was 20 to 23 years old during the time

period underlying the charges in his case. A member

of India’s Sikh minority religious community, he was

born and grew up in New Delhi. Kamra moved to the

United States in 2010 at age 17 to attend college.

After transferring from another school, he received a

bachelor’s degree in business administration from

Philadelphia’s Drexel University in December 2013,

majoring in entrepreneurship and marketing. Beginning part-time as an unpaid Drexel undergraduate

studying business, and then as a full-time employee

in 2014 upon graduation, Kamra worked in various

positions at Campus Pharmacy, in the Drexel neighborhood. Following his college graduation, Kamra’s

principal responsibilities at the pharmacy included

organizing its ―mess‖ of business records, along

with marketing. He had no medical or formal

pharmacy education. Based solely on on-the-job

training, Kamra also sometimes served as a pharmacy ―tech,‖ a job which (in Pennsylvania at least)

Pursuant to Rule 37.6, amicus Kamra affirms that no

counsel for a party authored this brief in whole or in part

and that no person other than amicus and his family have

made a monetary contribution intended to fund its

preparation or submission. All parties have consented in

writing to the filing of this brief.

1

2

requires no particular credentials or licensure. As a

―tech,‖ Kamra received guidance from and performed

routine tasks for the registered pharmacists, such as

counting pills for bottling and waiting on customers.

Both petitioners in the cases before this Court

were licensed physicians. By filing this brief, amicus

seeks to ensure that in formulating a proper test for

―good faith‖ in criminal cases charging a defendant

with ―knowingly‖ dispensing or distributing a

controlled substance outside the ―usual course of

professional practice‖ and not for a ―legitimate

medical purpose‖ (or with conspiring to commit, or

with aiding and abetting that offense) the Court

takes account of the fact that some defendants

prosecuted for this offense are not themselves

physicians or pharmacists, or any other sort of

medical professional.

INTRODUCTION AND

SUMMARY OF ARGUMENT

The issue in this case is whether a court trying a

criminal case alleging the intentional distribution or

dispensing of a controlled substance, in violation of

21 U.S.C. § 841(a),(b) – or conspiracy to do so, in

violation of id. § 846 – should instruct the jury,

whenever the evidence warrants, and in what terms,

that the prohibited intent has not been proven if the

jury is left with reasonable doubt whether the

accused acted in ―good faith.‖

The statute provides that there is no guilt unless

the defendant acts outside of what is ―authorized by‖

3

subchapter I of chapter 13 of the Controlled

Substances Act and does so ―knowingly‖ and ―intentionally.‖ 21 U.S.C. § 841(a).2 What is ―authorized by

this subchapter,‖ the Court unanimously explained

in United States v. Moore, 423 U.S. 122 (1975), after

meticulously exploring the complex statutory

scheme, is drug distribution within the ―bounds of

professional practice.‖ Id. 142.

The proper answer to the first part of the

question presented – whether a ―good faith‖ instruction is needed in prosecutions for this offense – is

Yes. In other words, ―good faith,‖ properly defined, is

inconsistent with the mens rea for the § 841 and

related § 846 offenses, and juries need to be so

advised. That is, ―good faith‖ is not an affirmative

defense. Rather, it refers to evidence which may

serve, if credited by the jury, to negate what could

otherwise be proof beyond a reasonable doubt of an

offense element. Compare, e.g., Clark v. Arizona, 548

U.S. 735 (2006) (discussing evidence of insanity in

relation to mens rea elements). Only distribution

that is in fact ―outside the bounds‖ is penalized. But

even when distribution falls outside, a defendant

who does not ―know‖ or ―intend‖ this is not guilty. A

defendant who genuinely believes otherwise may

2 Although the statute reads ―knowingly or intentionally,‖ it

is universally read to mean ―knowingly and intentionally,‖

as the disjunctive reading is illogical, given that any

pertinent knowledge is necessarily included within intent.

Taking the ―or‖ literally renders the statute’s ―intentionally‖

option surplusage, a construction that is to be eschewed.

Ratzlaf v. United States, 510 U.S. 135, 140–41 (1994)

(applying this principle to construction of mens rea element).

4

have made a mistake of fact, but based on their ―good

faith‖ state of mind cannot be convicted.

In addressing the second aspect of the question –

the proper contours of ―good faith‖ in this context –

the Court should bear in mind that while the two

petitioners happen to be physicians, individuals

other than medical doctors can be and routinely are

prosecuted under these statutes. Those defendants

may be charged under various theories of direct and

vicarious criminal liability, such as conspiracy (21

U.S.C. § 846), aiding and abetting (18 U.S.C. § 2(a)),

and the so-called ―Pinkerton doctrine.‖3 The

defendants so charged may be pharmacists, who

have professional training and licensure obligations

with respect to controlled substances. But a

defendant may also be a nurse, or a physician’s

assistant.4 Or the accused may be a lay person,

ranging from untrained pharmacy techs (like amicus

Kamra5) to anyone who assumed a role in the

charged distribution or conspiracy (anything from

3 See Pinkerton v. United States, 328 U.S. 640 (1946).

4 Depending on state law, the nature of such a defendant’s

licensure, and the terms of their employment, such a person

may or may not have independent authority to write

prescriptions for and to dispense controlled substances. See,

e.g., 63 Pa.Stat. § 218.3; 49 Pa.Code § 21.283, 21.284b,

21.285 (prescription authority and requirements for Certified Registered Nurse Practitioners); compare 63 Pa.Stat.

§ 422.13(f); 49 Pa.Code § 18.152(a)(2) (physician assistant).

5 Some states apparently require pharmacy technicians to be

registered with a regulatory body. See United States v.

Lovern, 590 F.3d 1095, 1106 (10th Cir. 2009) (Kansas). Not

so, in Pennsylvania.

5

creating fraudulent

delivering packages).

prescriptions

to

knowingly

To ensure fairness to all defendants charged in

these cases, and more important to enforce the statutory mens rea requirement, the Court should hold

that the jury must be instructed to acquit defendants

as to whom the evidence gives rise at least to

reasonable doubt that they harbored a subjectively

honest belief that the distribution at issue was

―outside the bounds of professional practice.‖ The key

to ―good faith‖ is the honesty of each particular

defendant’s subjective belief, not its objective

reasonableness. The latter is merely evidence

bearing on the former.

A jury’s finding of guilt based on a lack of ―good

faith‖ might arise from the defendant’s own actions

or from the defendant’s knowledge of the doctor’s,

pharmacist’s, or some other person’s intentions. Any

proper instruction on this point must advise the jury

to consider all the relevant facts and circumstances,

including the particular defendant’s own pertinent

education and training (or lack thereof), and that

person’s role in relation to any licensed professionals

involved in the case.6 For lack of a proper ―good

6 At amicus Kamra’s own trial, the court delivered a ―good

faith‖ instruction that failed to distinguish between the

knowledge expected of professionals and the situation of a

non-professional (such as a pharmacy tech) who must

necessarily rely on the guidance of professionals (such as a

pharmacist and/or doctor). The judge rejected, in Kamra’s

case, a request to charge the jury to acquit if it harbored a

reasonable doubt that the non-professional acted in the

genuine belief, even if unreasonable, that the doctor’s actions

6

faith‖ jury instruction at trial in the cases before the

Court, the judgments of the courts of appeals as to

both petitioners should be reversed.

ARGUMENT FOR AMICUS CURIAE

A Subjectively Genuine Belief that the

Charged Distribution Was “Within the

Bounds of Professional Practice” Is Inconsistent with the Mens Rea Element of a

Section 841(a) Offense, and in the Case of a

Non-Professional May Be Predicated on a

Sincere Belief that the Pertinent Professional Was Acting in Good Faith.

The offense described in 21 U.S.C. § 841(a)

requires the government to prove that the defendant

acted ―knowingly‖ and ―intentionally.‖ The statute

makes it unlawful (and subsection 841(b) declares

that unlawful conduct to be a felony offense) to

distribute a controlled substance ―[e]xcept as authorized by this subchapter.‖ In United States v. Moore,

423 U.S. 122 (1975), this Court carefully analyzed

subchapter 13.I. of the Controlled Substances Act of

1970 to reach the conclusion that what is ―authorized‖ by that part of the Act is drug distribution

within the ―bounds of professional practice.‖ Id. 142.

The Questions on which this Court granted certiorari

in the present cases implicate first the question

whether the scienter element of the offense – and in

particular, its requirement that the offense be

in prescribing controlled substances were undertaken in

good faith as to the bounds of professional practice.

7

committed ―knowingly‖ – extends to the ―Except‖

clause. If it does, then a defendant’s subjectively

genuine belief necessarily precludes guilt.

Because the ―except‖ clause introduces and

precedes the section’s other terms, including the

mens rea provision, the structure and plain language

of the statute are frankly ambiguous ―as a matter of

ordinary English grammar‖ on the question whether

the ―knowingly or intentionally‖ requirement

attaches to the introductory exception clause. Cf.

Flores-Figueroa v. United States, 556 U.S. 646, 650

(2009) (―knowingly‖ ordinarily applies ―to all the

subsequently listed elements‖). But background principles of federal criminal law, as enforced by this

Court in its most analogous cases, show that it does.

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

(attaching scienter element to a statute’s ―in any

manner not authorized‖ requirement, wherein lay

the wrongfulness of the alleged conduct).

Nor does the statute’s related procedural provision addressing ―Exemptions and exceptions,‖ 21

U.S.C. § 885(a)(1), require any different interpretation of the underlying substantive issue.7 Rather, it

supports the conclusion that the negative of the

exception, when placed in issue, is an element of the

7 That statute provides, in pertinent part: ―(1) It shall not be

necessary for the United States to negative any ... exception

set forth in this subchapter in any ... indictment, ... or in any

trial ... under this subchapter, and the burden of going

forward with the evidence with respect to any such ...

exception shall be upon the person claiming its benefit.‖

8

offense. That statute provides that for an indictment

to be valid, the grand jury need not plead the

negative of the exception, nor must the government

prove the negative at trial unless the defendant first

goes forward with some evidence to place the

question of distribution in the course of medical or

professional practice in issue. By clear implication,

§ 885(a) suggests that where the defendant does

meet that initial ―burden of going forward,‖ the

ultimate burden of proof beyond a reasonable doubt

to negate the exception as an element of the offense

rests squarely upon the prosecution.

Because acting outside the scope of medical

practice (when placed in issue) is an element of the

offense, it is unsurprising that a mens rea of guilty

knowledge, at least, applies to that circumstance.

After all, the wrongfulness of the conduct at issue

resides solely in the circumstances encompassed by

the statutory exception. Practicing medicine or operating a pharmacy is not presumptively unlawful

conduct, to be engaged in only at one’s peril and

tolerated by society only in exceptional circumstances. There is nothing inherently antisocial about

a doctor’s or pharmacist’s dispensing or distributing

narcotics in the ordinary course of professional

practice. To the contrary. This Court’s cases therefore establish a strong presumption that the statute’s

mens rea requirement (at least ―knowingly‖) attaches

to the ―outside the course‖ element. See Rehaif v.

United States, 588 U.S. —, 139 S.Ct. 2191, 2195

(2019); Elonis v. United States, 575 U.S. 723, 737

(2015); United States v. X-Citement Video, Inc., 513

U.S. 64 (1994); Staples v. United States, 511 U.S. 600,

610–16 (1994); United States v. Bailey, 444 U.S 394,

9

406 n.6 (1980); Morissette v. United States, 342 U.S.

246 (1952).

When knowledge is an element of an offense, a

reasonable doubt about whether the defendant has

that knowledge necessarily requires acquittal. A

good faith (that is, genuine or sincere, not feigned)

belief in a set of facts or circumstances inconsistent

with any of the facts or circumstances of which the

statute requires knowledge necessarily defeats the

government’s attempt to prove such ―knowledge‖ – a

term which denotes, after all, a state of mind

combining belief (or at least awareness) with truth.8

This remains so even when that belief is mistaken.

See 1 WAYNE R. LAFAVE, SUBSTANTIVE CRIMINAL LAW

§ 5.6(b), at 535 (3d ed. 2018).

Even before Congress had expressly codified the

―as authorized‖ exception in the Controlled

Substances Act, this Court held under prior law that

a doctor’s ―good faith‖ belief – subjective but sincere

– that appropriate medical practice called for distribution of narcotics to a patient would preclude any

criminal conviction, even when the doctor failed to

write a prescription as required by law. See Linder v.

United States, 268 U.S. 5, 18 (1925) (―[W]e cannot

possibly conclude that a physician acted improperly

8 A sincere attachment to a fact that is not actually true is

still a ―belief,‖ but it is not ―knowledge.‖ See, e.g., Jonathan

Wayne, The difference between belief and knowledge (2017),

available at https://medium.com/perspectivepublications/thedifference-between-belief-and-knowledge-cb909520a265/

(accessed 12/22/2021); BERTRAND RUSSELL, HUMAN KNOWLEDGE: ITS SCOPE AND LIMITS 109, 170–72 (1923, rev. 1948).

10

or unwisely or for other than medical purposes solely

because he has dispensed to [an addicted patient], in

the ordinary course and in good faith, four small

tablets of morphine or cocaine for relief of conditions

incident to addiction.‖). As the Linder Court emphasized, in explaining and limiting a number of prior

holdings, whether any given defendant will prevail of

course depends heavily on the particular facts of the

case. Id. 18–22.

The briefs for the petitioners ably and thoroughly

demonstrate that there is not the slightest reason to

believe that Congress intended to revoke Linder’s

―good faith‖ rule when enacting the present

Controlled Substances Act in 1970. That doctrine is

not any sort of ―affirmative defense‖ that the defendant must establish. Cf. Kahler v. Kansas, 589 U.S.

—, 140 S.Ct. 1021 (2020) (distinguishing between

insanity defense and evidence of mental condition

that may negate mens rea element); Dixon v. United

States, 548 U.S. 1 (2006) (discussing defense of

duress); Martin v. Ohio, 480 U.S. 228 (1987) (selfdefense). Rather, ―good faith,‖ as used in the present

context, is an application of the basic rule that a

defendant’s mistake of fact that negates the knowledge required as an element of the offense necessarily requires acquittal. LAFAVE, ante, § 5.6(b); 1

PAUL H. ROBINSON, CRIMINAL LAW DEFENSES § 62(b),

at 245–48 (1984). For all these reasons, the judgments of the courts of appeals in both petitioners’

cases rejecting or limiting a ―good faith‖ defense were

wrong, and must be reversed.

In writing its opinion, the Court must bear in

mind that many defendants prosecuted under 21

11

U.S.C. § 841 (or for conspiracy to violate that statute

in violation of id. § 846) where the ―course of

professional practice‖ exception has been placed in

issue are not themselves medical or pharmacy

professionals. Prosecutions of such persons depend

on various rules of vicarious or accessorial criminal

responsibility. All of those doctrines require proof, as

to each defendant, of at least the same level of mens

rea as is required for the principal defendant. See,

e.g., Feola v. United States, 420 U.S. 671, 686 (1975)

(conspiratorial liability, whether for conspiracy itself

under § 846 and for substantive offenses under the

Pinkerton theory, requires at least the same level of

scienter as the object offense); Rosemond v. United

States, 572 U.S. 65, 71 (2014) (aiding and abetting

requires proof of intent to commit principal offense).

And as this Court has iterated, ―without the knowledge, the intent cannot exist.‖ Ingram v. United

States, 360 U.S. 672, 678 & 680 (1959), quoting

Direct Sales Co. v. United States, 319 U.S. 703, 711

(1943).

Non-professionals (or allied professionals and

paraprofessionals) may have some knowledge of

medical practice norms, but unlike a doctor, are not

necessarily expected to. And such defendants may

well be dependent for any understanding they do

have, on the very doctors or pharmacists who are at

the center of the government’s case. If working with

a physician, they are expected to take direction and

not substitute their own judgment for the doctor’s.

The result of these realities cannot be that nonprofessionals have less recourse to a ―good faith‖

defense because they have no sound basis to form an

independent opinion whether a given distribution is

12

or is not within the bounds of professional practice.

Instead, the proper rule is that defendants who are

not themselves professionals of the pertinent kind,

but are charged with criminal liability for

distribution outside the bounds of professional

practice, are entitled to be acquitted if they believed

in good faith that the professional was acting

lawfully, including a belief that the professionals

themselves believed in good faith they were acting

within proper bounds.

A proper formulation of this rule does not

demand that a defendant’s understanding, in

addition to being sincere, must also be found to be

objectively ―reasonable.‖ Even unreasonable beliefs,

if genuinely held, in fact negate any mens rea of

knowledge (and thus also negate intent). See Cheek

v. United States, 498 U.S. 192, 203 (1991); LAFAVE,

supra, at 535–37; ROBINSON, supra, at 248–52.9 Of

course, a jury’s view of the reasonableness of the

defendant’s professed belief may bear significantly

on their assessment of the subjective sincerity of the

defendant’s claim and thus affect their willingness to

find reasonable doubt on the basis of good faith.

Cheek, 498 U.S. at 203–04. But reasonableness, per

se, is not a requirement of ―good faith,‖ when invoked

Were the rule otherwise, these authorities explain, the

mens rea would be reduced to the level of negligence or

perhaps recklessness.

9

13

as a mistake-of-fact defense negating a requirement

of knowledge.10

There is a paucity of case law in the Circuits

addressing the proper application of this standard to

defendants who are not doctors or pharmacists, or

who are complete non-professionals. But those courts

which focus on the point have distinguished the

standard governing physicians, pharmacists and

other medical professionals from that applicable to

lay persons charged with similar offenses. For

instance, in United States v. Lovern, 590 F.3d 1095

(10th Cir. 2009), two defendants – an experienced

pharmacist, and a computer technician with no

medical education or any prior experience in the

medical or pharmaceutical fields – were convicted of

conspiracy to distribute controlled substances along

with substantive distribution offenses under the CSA

related to their employment by an online pharmacy.

In an opinion by then-Judge Gorsuch, the panel

10 The Circuits that have layered a ―reasonableness‖ require-

ment onto their ―good faith‖ rulings appear to justify the

result on public policy grounds, without adequately

premising those decisions on either statutory language or

criminal law principles. E.g., United States v. Quinones, 635

F.3d 590, 594–95 (2d Cir. 2011) (―While those who assist

practitioners in distributing controlled drugs clearly cannot

be held to the standard of a reasonable practitioner, they are

not free to unreasonably rely on the judgment of their

employers.‖); United States v. Vamos, 797 F.2d 1146, 1152–

54 (2d Cir. 1986); United States v. Voorhies, 663 F.2d 30, 34

(6th Cir. 1981) (approving instruction as to physician defendant that incorporated objective standard of reasonable

belief).

14

upheld the conviction of the pharmacist, but reversed

the technician’s for insufficient evidence that he

knew the doctor or pharmacists for whom he worked

were acting outside the usual course of professional

practice or without a legitimate medical purpose. Id.

1104–09. The court relied heavily on the defendant’s

lack of relevant education and training, and the

paucity of even circumstantial evidence that he had

the requisite knowledge.

The Lovern court reversed the untrained

assistant’s conviction despite the fact that the

district court had instructed the jury that (a) the

government had to prove that a defendant had acted

―other than in good faith for a legitimate medical

purpose and in the usual course of professional

practice‖ and (b) that ―[i]n determining whether or

not a defendant acted in good faith‖ the jury should

consider, inter alia, ―any evidence pertaining to the

particular position held by the defendant and

whether the defendant had any specialized training

or knowledge concerning the usual course of medical

practice.‖ Id. 1111 (dissent). The Tenth Circuit

majority contrasted the legal ―duty on pharmacists‖

under the CSA regulations ―not to knowingly fill

prescriptions issued outside the usual course of

medical practice. See 21 C.F.R. § 1306.04(a).‖ Id.

1102. Thus, Lovern implicitly recognized that the

good faith standard applicable to lay defendants

cannot be too demanding.

For these reasons, supplementing the presentations made in the petitioners’ principal briefs, the

judgments of the courts below should be reversed. In

framing its opinion, the Court should be attentive to

15

the circumstances of defendants charged under 21

U.S.C. § 841(a) with distribution or dispensing of a

controlled substance outside the course of professional practice (or under id. § 846 with conspiracy),

who are not themselves doctors or pharmacists. In

sum, such defendants charged under these statutes

must be acquitted if the jury, upon all the evidence,

is left with a reasonable doubt whether the defendant actually (that is, in ―good faith‖) believed that

the professional in question was acting in the good

faith belief that the distribution occurred within the

proper bounds of professional practice.

CONCLUSION

The judgments of the courts of appeals should be

reversed.

Respectfully submitted.

PETER GOLDBERGER

Counsel of Record for

amicus curiae Kamra

PAMELA A. WILK

50 Rittenhouse Place

Ardmore, PA 19003

(610) 649-8200

peter.goldberger@verizon.net

December 2021