Petition for Writ of Certiorari — Joel E. Miller, Petitioner v. United States

NO. ______

IN THE

SUPREME COURT OF THE UNITED STATES

JOEL E. MILLER,

Petitioner,

v.

UNITED STATES OF AMERICA,

Respondent.

On Petition for Writ of Certiorari to the

United States Court of Appeals for the Tenth Circuit

PETITION FOR WRIT OF CERTIORARI

VIRGINIA L. GRADY

Federal Public Defender

JOHN C. ARCECI

Assistant Federal Public Defender

Counsel of Record for Petitioner

633 17th Street, Suite 1000

Denver, Colorado 80202

(303) 294-7002

QUESTION PRESENTED

Because many controlled substances have medical uses, the Controlled

Substances Act (“CSA”) authorizes doctors and other medical practitioners to issue

prescriptions. But as this Court has explained, that authority obviously has limits.

Specifically, the CSA “bars doctors from using their prescription-writing

powers as a means to engage in illicit drug dealing and trafficking as conventionally

understood.” Gonzales v. Oregon, 546 U.S. 243, 270 (2006). A doctor, therefore, is

criminally liable for unlawfully distributing a controlled substance when acting as “a

drug ‘pusher,” and “not as a physician.” United States v. Moore, 423 U.S. 122, 126, 143

(1975).

The practice of instructing juries in the Tenth Circuit, however, blurs this clear

line between criminal and non-criminal conduct, and allows doctors and other medical

practitioners to be convicted of felony drug crimes based on malpractice, or even

mere disagreements about the appropriate standard of care.

The question presented is:

Whether the phrase “issued for a legitimate medical purpose by an individual

practitioner acting in the usual course of his professional practice,” as used in 21

C.F.R. § 1306.04 and routinely employed in jury instructions setting forth the

elements of an unlawful prescribing charge, must mean that a doctor has abandoned

medical practice and engaged in “illicit drug dealing and trafficking as conventionally

understood,” and whether juries must be so instructed in order to prevent criminal

conviction for malpractice or mere disagreements about the appropriate standard of

care?

i

TABLE OF CONTENTS

Page

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

TABLE OF CONTENTS ....................................................................................................... ii

TABLE OF AUTHORITIES ................................................................................................iv

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

OPINION BELOW .................................................................................................................1

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

FEDERAL PROVISIONS INVOLVED ............................................................................1

STATEMENT OF THE CASE .............................................................................................2

REASONS FOR GRANTING THE WRIT .....................................................................14

I.

The Tenth Circuit’s instructional practice fails to inform juries about the

clear line that Congress and this Court have drawn between a doctor’s

failure to adhere to a particular standard of medical care (a civil matter)

and a doctor’s complete abandonment of medical practice to engage in

drug dealing as conventionally understood (a criminal matter). .....................14

II. The Tenth Circuit’s practice criminalizes disputes about the proper

standard of care, and turns every physician who prescribes controlled

substances into a potential felon. ........................................................................18

III. Prosecutorial discretion is not an answer to this problem, and only this

Court’s intervention will ensure that juries are properly instructed about

when medical practitioners are criminally liable for prescribing controlled

substances. ..............................................................................................................21

IV. Properly instructing juries about what the government must prove to

establish medical practitioners’ criminal liability is an issue of increasing

national importance...............................................................................................25

CONCLUSION ......................................................................................................................29

ii

APPENDIX

Order and Judgment of the United States Court of Appeals for the Tenth

Circuit in United States v. Miller, 891 F.3d 1220 (10th Cir. June 6, 2018) .................. A1

District court’s oral ruling on jury instructions (November 2, 2015)...........................A15

Order of the United States Court of Appeals for the Tenth Circuit denying

petition for rehearing en banc (August 6, 2018) ........................................................A18

Letter from the Clerk of Court advising that application for extension of time in

which to petition for certiorari has been granted by Justice Sotomayor

(October 23, 2018)..........................................................................................................A19

Relevant statutes and regulations .......................................................................................A21

Relevant jury instructions given by the district court

(Instruction Nos. 16 & 20-A) .......................................................................................A24

Relevant defense and government proposed jury instructions .....................................A27

iii

TABLE OF AUTHORITIES

Page

Cases

Bond v. United States, 572 U.S. 844 (2014) .............................................................................24

Gonzales v. Oregon, 546 U.S. 243 (2006) ...........................................................................passim

Jin Fuey Moy v. United States, 254 U.S. 189 (1920) ......................................................... 15, 16

Linder v. United States, 268 U.S. 5 (1925) ..................................................................15, 16, 28

Marinello v. United States, 138 S. Ct. 1101 (2018) ..................................................................22

Maslenjak v. United States, 137 S. Ct. 1918 (2017) ................................................................23

McDonnell v. United States, 136 S. Ct. 2355 (2016) ................................................................23

United States v. Bartee, 479 F.2d 484 (10th Cir. 1973) ............................................................ 9

United States v. Behrman, 258 U.S. 280 (1922) .......................................................................16

United States v. Feingold, 454 F.3d 1001 (9th Cir. 2006) .......................................................23

United States v. Lovern, 590 F.3d 1095 (10th Cir. 2009) .................................................. 9, 10

United States v. Miller, 891 F.3d 1220 (10th Cir. 2018) .......................................................... 1

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

Webb v. United States, 249 U.S. 96 (1919) ..............................................................................16

Yates v. United States, 135 S. Ct. 1074 (2015) ........................................................................23

Statutes

18 U.S.C. § 3231 ........................................................................................................................1

18 U.S.C. § 3742 ........................................................................................................................1

iv

21 U.S.C. § 802.................................................................................................................. 1, 7, 8

21 U.S.C. § 822...................................................................................................................... 7, 8

21 U.S.C. § 829...................................................................................................................... 1, 7

21 U.S.C. § 841(a) ............................................................................................ 1, 6, 9, 15, 7, 20

21 U.S.C. § 841(b)....................................................................................................................20

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

28 U.S.C. § 1291 ........................................................................................................................1

Regulations

21 C.F.R. § 1306.03 ...................................................................................................................1

21 C.F.R. § 1306.04 ............................................................................................ 1, 8, 9, 10, 11

Rules

Fed. R. App. P. 25 .....................................................................................................................6

Sup. Ct. R. 14.1(i)(vi) ...............................................................................................................10

Sup. Ct. R. 34.6 ..........................................................................................................................6

10th Cir. R. 25.5 .........................................................................................................................6

Other Authorities

Benjamin N. Cardozo, The Nature of the Judicial Process (1921) .................................23

CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016,

Morbidity and Mortality Weekly Report (MMWR), March 15, 2016 ..........................25

Centers for Disease Control and Prevention, et. al., Guideline for Prescribing

Opioids for Chronic Pain, J Pain & Palliat Care Pharmacotherapy, 2016,

Jun; Vol. 30(2) ......................................................................................................................25

v

K. Tate Chambers, A Primer on Investigating Doctors Who Illegally Prescribe Opioids,

66 U.S. Att’y Bull. (July 2018) ............................................................................................26

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 Am. J.L. & Med. 7 (2016) ..............................................................................................26

Lenny Bernstein, How many patients should your doctor see each day?, Washington Post,

May 22, 2014 ...........................................................................................................................3

Lenny Bernstein, White House opioid commission calls for wide-ranging changes to anti-drug

policies, Washington Post, Nov. 1, 2017 ............................................................................25

Merriam-Webster Online .......................................................................................................17

Michael Nedelman, Doctors increasingly face charges for patient overdoses, CNN,

July 31, 2017..........................................................................................................................26

Oyez.org, Oral Argument in United States v. Moore, 74-759 ..................................................22

Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV,

76 FR 77330-01 (noting effective date of January 11, 2012) .......................................... 7

U.S. Dep’t of Health and Human Services, Press Release, HHS Acting Secretary

Declares Public Health Emergency to Address National Opioid Crisis (Oct. 26, 2017) .........26

U.S. Dep’t of Justice, Press Release, Attorney General Sessions Announces New

Prescription Interdiction and Litigation Task Force (Feb. 27, 2018).......................................27

U.S. Dep’t of Justice, Press Release, Attorney General Sessions Announces Opioid

Fraud and Abuse Detection Unit (Aug. 2, 2017) ...................................................................27

vi

PETITION FOR A WRIT OF CERTIORARI

Petitioner, Joel E. Miller, respectfully petitions for a writ of certiorari to review

the order and judgment of the United States Court of Appeals for the Tenth Circuit

entered on June 6, 2018.

OPINION BELOW

The published decision of the United States Court of Appeals for the Tenth

Circuit, United States v. Miller, 891 F.3d 1220 (10th Cir. 2018), appears in the Appendix

at 1.

JURISDICTION

The United States District Court for the District of Colorado had jurisdiction

in this criminal action pursuant to 18 U.S.C. § 3231. The Tenth Circuit had

jurisdiction pursuant to 28 U.S.C. § 1291 and 18 U.S.C. § 3742. The circuit court

entered judgment on June 6, 2018, and it denied rehearing on August 6, 2018.

(Appendix at 1, 18.) Justice Sotomayor extended the time in which to petition for

certiorari by 60 days, to and including January 3, 2019. (Appendix at 19.) This Court

has jurisdiction pursuant to 28 U.S.C. § 1254(1).

FEDERAL PROVISIONS INVOLVED

The relevant statutory and regulatory provisions, including 21 U.S.C. §§ 802,

829, 841, and 21 C.F.R. §§ 1306.03, 1306.04, are included in the Appendix at pages

A21 to A23. See Sup. Ct. R. 14.1(f).

1

STATEMENT OF THE CASE

A. Dr. Miller ran a family medical practice in the small, rural community of

Craig, Colorado.

After completing his medical training and spending nearly a decade working

as a physician in Texas and along Colorado’s Front Range, Joel Miller moved to

Craig, Colorado in 2003, to follow his goal of becoming a small-town doctor. (V9 at

2774-75; 3362; V1 at 1014.) 1 He practiced medicine there for almost another

decade, first alongside a longtime family practitioner in town, and then, beginning

in 2008, in his own practice. (V9 at 2776-81.)

Craig is a small, rural community in the northwest corner of the state—“out in

the middle of nowhere,” in the words of one lifelong resident. (Id. at 2145.) It is a

hardscrabble town, driven by boom-and-bust industries like coal mining and ranching.

(Id. at 2006, 2063, 2140, 2176, 2394, 2456.) Like many rural communities, it has its

fair share of poverty. (Id. at 2111; V1 at 1015.)

By the time Dr. Miller opened his own practice, he was one of the few doctors

left in Craig. The doctor with whom he had worked retired (v9 at 2778-80), and the

recession had hit the area hard, leading other doctors to leave (id. at 2003-07). The

Citations are to the record on appeal in the Tenth Circuit and the page

number at the bottom, right-hand side of each page. The citations are provided for

the Court’s convenience in the event this Court deems it necessary to review the

record to resolve this petition. See Sup. Ct. R. 12.7.

1

2

small hospital in town was staffed with a rotating cast of practitioners, who many

residents resisted seeing, in part because they couldn’t provide continuing care. (Id.

at 704, 1011, 1459, 2206.) The nearest big city and the main referral area was

Grand Junction, Colorado, a city about 3 hours away in good weather, and

sometimes unreachable in winter. (Id. at 2005, 2174.)

Accordingly, Dr. Miller soon found himself running a vibrant general

practice, inheriting some patients from his prior stint, attracting new ones, and

ending up with around 2,500 patients whom he saw for a full panoply of medical

conditions. (V1 at 198; V9 at 1454, 2096.) 2 He was well-liked in Craig, and

regarded as a caring doctor, who never turned someone away because they couldn’t

pay or because they had complicated conditions or histories that required time to

manage. (Id. at 1497, 2001.) Indeed, the picture painted in the proceedings below

was that of a small-town doctor who took the time to listen to his patients, and

become involved not only in their care, but also their lives beyond the examination

room; he knew about their families, their troubles, and their lives, in addition to

This practice size was consistent with that for primary-care physicians at the

time. See, e.g., Lenny Bernstein, How many patients should your doctor see each day?,

Washington Post, May 22, 2014 (reporting on studies from 2012 and 2013

demonstrating average patient loads of approximately 2,300 patients for primary-care

physicians).

3

2

their illnesses. (V1 at 1015, 2917, 2152, 2133.) Many of his patients credited him

with saving their lives and those of their loved ones. (V9 at 2120, 2498.)

The principal reason most people go to see their primary-care provider is for

pain—something hurts, perhaps something minor like a sore throat, perhaps

something major like an injury from working in the mines or on the ranch. (V9 at

2764-65, 3120-22.) The vast majority of Dr. Miller’s patients were people he saw for

regular conditions or minor pain, some of whom might take a narcotic for just a short

period of time while they healed. (Id. at 3120-22.) He also saw some people with

chronic pain as a small part of his practice. (Id. at 2783.)

That he did so is unremarkable. There are millions upon millions of Americans

living with significant pain. (Id. at 2564.) But because there is a shortage of certified

pain management specialists across the country, primary care physicians such as Dr.

Miller shoulder most of the responsibility for managing patients’ pain. (Id. at 2004-05,

2567.) This is particularly true in rural communities like Craig, where access to such

specialists is further restricted by geography and economics. Indeed, the only regional

pain specialists, some of whom were up to three hours away in Grand Junction, either

focused on temporary interventions and not on patients requiring medication

management over the long-term (id. at 2004-05), or didn’t see Medicaid patients or

those lacking insurance, or didn’t take patients who had been treated extensively with

narcotics in the past (id. at 2181-82).

4

Treating chronic pain patients is extremely complex; they are genuinely sick

people afflicted by legitimately painful conditions, and often by mental illnesses as

well. (Id. at 2665-66, 2671.) Moreover, chronic pain tends to coincide with other

conditions, like anxiety and sleeplessness—indeed, if you’re in pain all the time, you’re

unlikely to be calm or sleep well. (Id. at 2060, 2597.) You’re also less likely to be able

to work, meaning such patients were often of limited means, and without private

insurance. In the words of the district court below, these were “scabrous, almost

impossible patients . . . the worst of the worst . . . the untouchables.” (Id. at 3396-97.)

But Dr. Miller saw them, even when others wouldn’t, and tried to do his best with

them. (Id. at 2016, 3027.)

Indeed, it bears stating directly that this is not the type of “pill mill” or “pain

clinic” case that have dominated headlines in recent years. Rather, Dr. Miller ran a

legitimate family medicine practice, and after a five-week jury trial, even the

government conceded that he helped many people in his practice. (V9 at 3223-25.)

Nevertheless, Dr. Miller eventually ended up in the government’s crosshairs,

accused of improperly prescribing controlled substances to a handful of the thousands

of patients that he saw, and of improperly billing government and private insurance

for those services. (V1 at 449-57.) The jury rejected the government’s theory of the

case, however, and acquitted Dr. Miller on all the financial counts; it split, however,

on 14 prescription drug counts, ultimately convicting him of seven counts of

5

unlawfully distributing a controlled substance. (V1 at 840.) One of these counts was

reversed by the district court after trial (v1 at 1198), and an additional conviction for

making a false statement to the DEA was reversed by the Tenth Circuit. (Appendix

at A10-A11.)

Thus, all that remains of the 35-count superseding indictment in this case are

six prescription drug convictions. Each concerns a single prescription written

between 2009 and 2012, to just five of Dr. Miller’s over 2,500 patients—those with

complex histories and conditions and whom the district court below described as “the

most needy and intractable.” (V9 at 3396-97.) The question presented encompasses

all of these remaining convictions, each charged as a violation of 21 U.S.C. § 841(a),

and which are, briefly recounted:

• Count 20 charged Dr. Miller with prescribing hydrocodone

(Schedule III) and zolpidem (Schedule IV) to L.D. 3 on March

3, 2009;

• Count 23 charged Dr. Miller with prescribing fentanyl

(Schedule II) to S.K. on April 12, 2010;

• Count 27 charged Dr. Miller with prescribing morphine

(Schedule II), oxycodone (Schedule II), and clonazepam

(Schedule IV) to C.M. on April 7, 2011;

Consistent with the practice in the proceedings below and the applicable

privacy redaction requirements, see Sup. Ct. R. 34.6, Fed. R. App. P. 25, 10th Cir. R.

25.5, initials of the patients in each count are used here and in the elements jury

instructions reproduced in the Appendix at A24.

6

3

• Count 28 charged Dr. Miller with prescribing oxycodone

(Schedule II) to L.W. on April 20, 2011;

• Count 31 charged Dr. Miller with prescribing both

hydrocodone (Schedule III) and zolpidem (Schedule IV) to

S.F. on December 22, 2011;

• Count 32 charged Dr. Miller with prescribing hydrocodone

(Schedule III), zolpidem (Schedule IV), and carisoprodol 4

(Schedule IV), again to S.F., on January 18, 2012.

B. Under the Controlled Substances Act, doctors and other medical

practitioners are authorized to issue prescriptions for controlled

substances, but that authorization is not a license “to engage in illicit

drug dealing and trafficking as conventionally understood.”

Because this is a physician-prescribing case, it has a unique legal posture under

federal drug law.

The Controlled Substances Act (CSA), of course, generally prohibits any

person from dispensing or distributing a controlled substance. See 21 U.S.C.

§ 841(a)(1). But because many of the controlled substances covered by the Act have

important medical uses, the Act exempts physicians and other medical “practitioners”

from this prohibition and authorizes them to write prescriptions for certain controlled

substances “in the course of professional practice.” 21 U.S.C. §§ 802(21), 829.

Carisoprodol was scheduled as a controlled substance only seven days prior to

the prescription charged in Count 32. See Schedules of Controlled Substances: Placement of

Carisoprodol Into Schedule IV, 76 FR 77330-01, at 77357 (noting effective date of

January 11, 2012).

4

7

For a physician’s controlled substance prescription to be lawful, two principal

things must be present.

First, the physician must register with the Attorney General. See 21 U.S.C.

§§ 802(21), 822(b); 21 C.F.R. § 1306.03. This requirement is not at issue, as Dr. Miller

was properly registered at all times relevant here.

Second, the physician must be acting as a physician, that is, “in the course of

professional practice.” 21 U.S.C. § 802(21). Regulations promulgated by the Attorney

General further provide that to be lawful, a prescription “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) (emphasis added). The regulation

does not define the terms “legitimate medical purpose” or “usual course of

professional practice,” nor does it provide any further explanation about the

differences between civil and criminal liability vis a vis failure to comply with a

particular standard of care.

As discussed in greater detail below, however, this Court has drawn that line,

clearly and consistently. That is, the CSA “bars doctors from using their prescriptionwriting powers as a means to engage in illicit drug dealing and trafficking as

conventionally understood,” Gonzales v. Oregon, 546 U.S. 243, 270 (2006), and that a

doctor, therefore, is criminally liable for unlawfully distributing a controlled substance

8

when acting as “a drug ‘pusher,” and “not as a physician.” United States v. Moore, 423

U.S. 122, 126, 143 (1975).

The Tenth Circuit employs the “legitimate medical purpose” and “usual course

of professional practice” language of § 1306.04(a) when instructing juries about the

elements the government must prove to convict a doctor for unlawful prescribing

(that is, for a violation of the common drug crime of distribution of a controlled

substance under 21 U.S.C. § 841(a)). But the Tenth Circuit also has directed district

courts not to further define these critical terms for the jury. Rather, the circuit has

concluded that the question of what constitutes the “usual course of professional

practice” in a § 841(a) prosecution (and, by implication, a “legitimate medical

purpose”) is a question of fact to be left to the jury. See United States v. Lovern, 590

F.3d 1095, 1101 (10th Cir. 2009) (citation omitted); United States v. Bartee, 479 F.2d

484, 488–89 (10th Cir. 1973).

Thus, juries in the Tenth Circuit are instructed, as the jury in Dr. Miller’s case

was, only that a physician is criminally liable for issuing a prescription for a controlled

substance if that prescription “was not for a legitimate medical purpose or was outside

the usual course of professional medical practice.” (V1 at 881.)

9

C. Consistent with circuit precedent, the district court declines to define for

the jury what it means for a prescription to be “issued for a legitimate

medical purpose by an individual practitioner acting in the usual course

of his professional practice,” or to otherwise delineate the line between

medical malpractice and criminal conduct.

There was no dispute at trial that the prescriptions in question were for

controlled substances and had been written by Dr. Miller, i.e., that he had

“distributed” or “dispensed” a controlled substance. The only issue was the exercise

of his professional judgment, and whether the prescriptions were written for a

“legitimate medical purpose” and within his “usual course of professional practice.”

Dr. Miller requested that the district court instruct the jury with definitions as a

matter of law for the terms “legitimate medical purpose” and “usual course of

professional practice” as used in 21 C.F.C. § 1306.04, and make clear that an

important line exists between civil medical malpractice and criminal conduct. (V9 at

3173-74; see also V1 at 640-42 (defense proposed jury instructions), 939 (renewed

argument in motion for a new trial).) 5

The district court declined to define these terms for the jury, however, or to

otherwise instruct the jury on how these phrases create a standard different from the

civil standards for medical malpractice. Instead, the court pointed to the Tenth

Circuit’s decision in Lovern as foreclosing that argument. The court noted that this

The pertinent instructions proposed by both Dr. Miller and the government

below appear in the Appendix at A27 to A36, as do the instructions ultimately given

by the district court (at A24 to A26). See Sup. Ct. R. 14.1(i)(vi).

10

5

authority “[c]ame as a surprise to me,” but because of it, the court had to “resist[] that

which is almost irresistible, which is to weigh in and provide the jury with definitions

as a matter of law.” (V9 at 3173-74; see also V1 at 1186-87.)

Without clarification for the jury, the disposition of this critical issue turned on

the testimony of dueling expert witnesses.

The government’s key expert witness was Dr. Theodore Parran, a physician

from Cleveland, Ohio, who worked at the medical school at Case Western and

practiced medicine with an emphasis in pain management and addiction. (V9 at 10971118.) At the time of this case, Dr. Parran previously had testified on behalf of the

government in approximately 50 to 60 criminal trials of physicians. (V9 at 1326-27.)

With respect to each of the drug counts, Dr. Parran opined, echoing the

language of 21 C.F.R. § 1306.04, that the prescriptions charged in each count were

“inconsistent with the usual course of medical practice” and “for other than a

legitimate medical purpose.” (Id. at 1142, 1150-51; 1185-87 (Prescription charged in

Count 20); 1192-94 (Counts 31, 32); 1224-25 (Count 23); 1238-40 (Count 27); 127677 (Count 28).)

On cross examination, however, Dr. Parran was unable to articulate where the

line fell between poor medical practice or malpractice, on the one hand, and criminal

conduct, on the other. (Id. at 1331-33.) The best he could explain was that it was a

matter of degree, and that “[t]he criminal standard . . . is much more stringent in

11

terms of the problematic behavior on the part of the doctor. That’s all I can tell you.”

(Id. at 1331.)

The defense presented expert testimony from Dr. Lynn Webster, a pioneer in

the field of pain medicine and a past president of the American Academy of Pain

Medicine. (Id. at 2522, 2530.) Like Dr. Parran, he too was qualified as an expert in,

inter alia, pain and addiction medicine. (Id. at 2540.)

Dr. Webster testified that, contrary to Dr. Parran’s opinion, each of the

individual controlled substances prescribed in the counts in question was for a

“legitimate medical purpose” and prescribed within the usual course of Dr. Miller’s

medical practice. (Id. at 2563, 2593-94, 2630-31; 2569-71, 2577-78 (Count 20); 2627,

2634-35, (Counts 31, 32); 2674-77 (Count 23); 2610 (Count 27); 2626 (Count 28).)

He also testified extensively regarding the difference between the standard of

criminal conduct as opposed to standards for malpractice, explaining the importance

of distinguishing between the two, and how in the former there is “no physicianpatient relationship” and simply “no standard of care . . . [y]ou’re not practicing

medicine.” (Id. at 2549-54.)

Finally, it also came out at trial that the prescriptions at issue in this case all

were filled by pharmacists, who have their own duty under the Controlled Substances

Act to only fill prescriptions that are for “a legitimate medical purpose.” (Id. at 107982, 1086-87, 1762-64.) Also disclosed was that many of Dr. Miller’s patients

12

continued to receive the same prescriptions they received from Dr. Miller after he

stopped seeing them. (Id. at 664-67, 1592, 2105-06, 2220-22, 2389-90, 2266.) This

was so, explained one doctor who inherited some of Dr. Miller’s patients after he was

forced to shutter his practice under the weight of the government’s investigation (id.

at 3095), because the prescriptions were for a legitimate medical purpose (id. at 200910). No pharmacist or other doctor was charged in relation to the prescriptions at

issue in this case. (Id. at 664-71; 2009-10.)

D. The Tenth Circuit recognizes Dr. Miller’s preserved challenge, but

declines to consider the issue en banc.

On appeal, Dr. Miller conceded that prior circuit precedent foreclosed the

instructional challenge presented in this petition. He acknowledged, therefore, that he

would need to present his claim to the en banc court and this Court for review.

(Opening Br. at 57-58.) In its published decision, the panel acknowledged Dr. Miller’s

preservation of this claim. (Appendix at A2 n.1, A14.)

The Tenth Circuit denied Dr. Miller’s petition for rehearing en banc on the

question presented (Appendix at 18), and this petition follows.

13

REASONS FOR GRANTING THE WRIT

I.

The Tenth Circuit’s instructional practice fails to inform juries about the

clear line that Congress and this Court have drawn between a doctor’s

failure to adhere to a particular standard of medical care (a civil matter)

and a doctor’s complete abandonment of medical practice to engage in

drug dealing as conventionally understood (a criminal matter).

By instructing juries in unlawful prescribing trials without defining the key

terms “legitimate medical purpose” and “usual course of professional practice,” and

without otherwise instructing about the line between criminal conduct and bad or

merely disputed medical practice, the Tenth Circuit is failing to enforce an important

line that Congress and this Court have drawn for nearly a century.

Most recently, in discussing the reach of the Controlled Substances Act

(“CSA”) in Gonzalez v. Oregon, this Court emphasized the Act’s narrow scope when it

comes to the practice of medicine. Specifically, the Court explained the CSA is a

statute concerned with combating recreational drug abuse, and not an attempt (or

authorization to the federal government) to regulate medical practice generally. 546

U.S. 243, 272 (2006). Indeed, this Court explained that the CSA draws a clear and

important line between criminal and non-criminal conduct:

The [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.

14

Id. at 269-70 (emphasis added).

This is the same line this Court drew over four decades ago in United States v.

Moore, the Court’s first—and only—case involving the prosecution of a physician

under the CSA for unlawfully distributing controlled substances.

In Moore, this Court held that physicians were not categorically exempt from

criminal prosecution under the CSA’s unlawful distribution provisions, i.e., 21 U.S.C.

§ 841(a). And criminal liability existed in Moore because the doctor “acted as a largescale ‘pusher’ not as a physician.” 423 U.S. 122, 143 (1975). Indeed, the doctor in

Moore conceded that he had not observed generally accepted medical practices, and in

fact demonstrably engaged in drug dealing as conventionally understood, “prescribing

as much and as frequently as the patient demanded . . . not charg[ing] for medical

services rendered, but graduat[ing] his fee according to the number of tablets desired.”

423 U.S. at 142-43.

This clear line—drug dealing as conventionally understood—is also the same

line that this Court drew a century ago in cases interpreting the 1914 Harrison Act,

the predecessor statute to the CSA, and in which this Court affirmed numerous

convictions where “[i]n reality, the doctor became party to sales of drugs.” Linder v.

United States, 268 U.S. 5, 20-22 (1925); see, e.g., Jin Fuey Moy v. United States, 254 U.S.

189, 194 (1920) (affirming conviction of doctor who prescribed large quantities of

morphine, where prescriptions were demonstrably just sales to drug addicts, where

15

doctor, inter alia, charged according to the amount of drugs “prescribed”); Webb v.

United States, 249 U.S. 96, 99 (1919) (affirming conviction where physician and

druggist conspired to sell large quantities of morphine under the guise of issuing

prescriptions); United States v. Behrman, 258 U.S. 280, 288-89 (1922) (affirming

conviction where physician “indiscriminate[ly] dol[ed] out narcotics” in such large

quantities to a known addict that the “so called prescriptions” could only be for drug

use or sale); compare with Linder, 268 U.S. at 22 (reversing conviction of a physician

because, unlike in Jin Fuey Moy, Webb or Behrman, the physician’s distribution of only a

small quantity of drugs did not give rise to such clear inference of unlawful actions

and failure to comply with professional standards).

All told then, the line that Congress and this Court have drawn, clearly and

consistently for a century, is simple—it is ceasing to act as a physician, and instead

acting as a drug dealer, that causes a doctor to face federal criminal prosecution.

Anything else, a fortiori, falls elsewhere, as matters better suited to medical

malpractice proceedings or state medical board disciplinary or licensing actions, for

example. Cf. Gonzalez, 546 U.S. at 270-21 (noting traditional reservation to the states

of the regulation of the medical profession).

This simple line, however, is not being enforced in the charging of juries in the

Tenth Circuit, as typified by Dr. Miller’s trial below. Because telling juries that a

doctor must have acted with “a legitimate medical purpose” or within “the usual

16

course of professional practice” to escape criminal liability, is not at all the same thing

as telling them that criminal liability only attaches when a doctor abandons his or her

role as a physician to become a drug dealer as conventionally understood.

Indeed, the plain meaning of these instructional adjectives (“usual” and

“legitimate”) suggest liability based on something far broader, such as deviation from

a general standard of care. See, e.g., Merriam-Webster Online, legitimate, “4 :

conforming to recognized principles or accepted rules and standards”; usual, “1 :

accordant with usage, custom, or habit : normal; 2 : commonly or ordinarily used

followed his usual route; 3 : found in ordinary practice or in the ordinary course of

events : ordinary.”; cf. Gonzalez, 546 U.S. at 258 (“All would agree, we should think,

that the statutory phrase ‘legitimate medical purpose’ is a generality, susceptible to

more precise definition and open to varying constructions, and thus ambiguous in the

relevant sense.”).

Moreover, a “good faith” jury instruction, as was given here (v1 at 889), is no

answer to these concerns. That’s because that instruction simply re-incorporates the

very same terms, still without defining them. (See, e.g., V1 at 889 (“A physician does

not violate the law when he dispenses a controlled substance to a patient for a

legitimate medical purpose and in the usual course of professional medical practice. The term ‘good

faith’ means the honest exercise of good professional judgment about the medical

needs of a patient. Good faith requires conduct in accordance with what the

17

physician reasonably believed to be a legitimate medical purpose and in the usual course of

professional medical practice.”) (Emphasis added.).) That’s why Dr. Miller sought to have

the jury instructed with greater clarity about what is a “legitimate medical purpose” and

what counts as the “usual course of medical practice.” The failure to do so erases the

line that Congress and this Court have drawn, and, indeed, fails to instruct the jury

about what the government must prove to establish criminality, creating the very real

possibility of conviction on grounds broader than “drug dealing and trafficking as

conventionally understood.”

II.

The Tenth Circuit’s practice criminalizes disputes about the proper

standard of care, and turns every physician who prescribes controlled

substances into a potential felon.

By failing to define what is—and what is not—encompassed by the terms

“legitimate medical purpose” and “usual course of professional practice,” the Tenth

Circuit’s practice effectively criminalizes disputes about the proper standard of care.

After all, the crux of physician-prescribing cases is almost always going to be

the physician’s exercise of professional judgment—i.e., whether a physician acted with

a “legitimate medical purpose” and within the “usual course of professional practice.”

(Whether a prescription was written, and whether it was for a scheduled controlled

substance, are unlikely to be disputed elements.) But without clear definitions of what

those terms mean, the jury must rely largely, if not exclusively, on expert opinion.

This is deeply problematic.

18

For one thing, the government’s expert in this case, Dr. Parran, has testified on

behalf of the government at between 50 to 60 trials. That means that the

government, through continued reutilization of this expert, is effectively establishing a

de facto standard of care that medical practitioners around the country must follow.

Because any physician who does not adhere to Dr. Parran’s view of what constitutes a

“legitimate medical purpose” or the “usual course of professional practice” risks being

hauled into federal court and forced to explain his or her treatment decisions under

risk of criminal conviction and imprisonment—even if another expert sees no

problem. That is a troubling outcome, to say the least, and one that makes any doctor

prescribing controlled substances into a potential felon.

Unsurprisingly, this outcome is in tension with the limits on the federal

government’s ability to define standards for the proper medical care and treatment of

patients. As this Court explained in Gonzalez, the CSA evidences no Congressional

intent to permit the Attorney General to make such a general definition; in fact, to the

contrary, it affirmatively “conveys unwillingness to cede medical judgments to an

executive official who lacks medical expertise.” 546 U.S. at 265-66. There is no

reason why the government should be able to accomplish through the repeated use of

a single expert in criminal trials, that which it could never do by regulation. But that is

the practical effect of its action, and in a very real sense then, the government is

defining the scope of the very crime it is enforcing.

19

Also troubling is this expert’s failure to articulate any principle for

distinguishing between negligence or malpractice, on the one hand, and conduct that

is outside the “usual course of professional practice” and without “a legitimate

medical purpose,” i.e., criminal behavior, on the other. In the end, all Dr. Parran

could come up with was that it was a matter of degree, and that the criminal standard

was “much more stringent.” This lack of any meaningful distinction (to say nothing

of the vagueness of “stringen[cy]” as a measure to be employed in the criminal law) is

so problematic because bad and even outright wrong medical judgments may occur

within the usual course of a physician’s professional practice.

The very fact that two credentialed experts viewed the evidence here so

differently—and as falling on different sides of the line—indicates precisely how fluid

and uncertain these concepts are, and why this Court’s articulation in Moore and

Gonzalez of where that line rests makes a great deal of sense. Moreover, if, as here,

two experts in pain medicine can’t agree on the proper standard of care for complex

patients, it seems hard to expect a rural family doctor to always strike the right

balance. But if those judgments fall along the wrong part of the government expert’s

stringency scale, that physician risks criminal prosecution and exposure to what this

Court recognized in Moore were “severe criminal penalties.” 423 U.S. at 135. 6

Indeed, depending on the controlled substance involved, the statutory

penalties can range from up to 10 to 20 years’ incarceration on each count. See, e.g., 21

U.S.C. §§ 841(a)(1), (b)(1)(C), (b)(1)(E). It does not take much imagination to

20

6

In contrast, explaining to juries that criminal prosecutions are not evaluating

malpractice, and that a doctor acts outside of “a legitimate medical purpose” and the

“usual course of professional practice” only when he becomes a drug “pusher”

engaging in drug dealing “as conventionally understood,” provides a clear and

meaningful benchmark to evaluate the expert testimony, and allows juries to serve as a

check against unbridled prosecution. But failing to expressly delineate these

boundaries risks sweeping up as criminals many physicians who are not engaged in

drug dealing as conventionally understood, including those who might just be bad

doctors, those who might just be negligent on a particular judgment, or even those

whose practice just isn’t in accord with the views of the government’s preferred

practice standard as described by the expert witness of its choosing.

III.

Prosecutorial discretion is not an answer to this problem, and only this

Court’s intervention will ensure that juries are properly instructed about

when medical practitioners are criminally liable for prescribing

controlled substances.

Failing to instruct juries about this clear line grants the government a

dangerously broad power to prosecute, and the exercise of prosecutorial discretion is

no answer to this concern.

envision how just a handful of contested prescriptions quickly could expose a doctor

to a potential sentence that effectively amounts to life incarceration. And if a patient

misuses a prescribed drug and death results, that physician also may be exposed to a

mandatory minimum sentence of 20 years, and up to a maximum of life, on one count

alone. See id.

21

As this Court recognized last term, “to rely upon prosecutorial discretion to

narrow the otherwise wide-ranging scope of a criminal statute’s highly abstract general

statutory language places great power in the hands of the prosecutor. Doing so risks

allowing ‘policemen, prosecutors, and juries to pursue their personal predilections,’

which could result in the nonuniform execution of that power across time and

geographic location.” Marinello v. United States, 138 S. Ct. 1101, 1108-09 (2018)

(quoting Smith v. Goguen, 415 U.S. 566, 575 (1974)).

The government once seemed to recognize the clear line between drug

“pushers” who engage in “drug dealing as conventionally understood” and disputes

about how to practice medicine. See, e.g., United States v. Moore, 74-759, Oral Argument

at 59:16 (describing prosecutions in which evidence of medical practitioners’ failure to

comply with usual course of professional practice was “completely blatant”); id. at

1:03 (explaining that “we have been able to distinguish what is legitimate and what is

not legitimate, and what is within the scope of legitimacy, and what is so far beyond the

pale that under no interpretation could it be considered legitimate medical practice within the course [of

professional practice].”) (Emphasis added.). 7 But like any principle, the government’s

view of its own discretion is not immune from “[t]he tendency . . . to expand itself to

Available at https://www.oyez.org/cases/1975/74-759. (All links last visited

January 3, 2019.)

22

7

the limit of its logic.” Benjamin N. Cardozo, The Nature of the Judicial Process 51

(1921).

Accordingly, it is unsurprising to witness a certain mission creep over time—

from the “completely blatant” drug dealing and undisputed failure to comply with

acceptable medical practice in Moore; to blatant “pill mill” operations and conduct

which even a defense expert concedes was outside the usual course of practice, see

United States v. Feingold, 454 F.3d 1001, 1005, 1011 (9th Cir. 2006); to increasingly

nuanced allegations of physician misconduct like that which split two undisputed

experts (as well as the jury) in this case.

In recent terms, however, this Court repeatedly has intervened to rein in the

government’s overly expansive interpretation and application of criminal statutes. See,

e.g., Maslenjak v. United States, 137 S. Ct. 1918, 1927 (2017) (rejecting government’s

broad interpretation of 18 U.S.C. § 1425(a), which would “give prosecutors nearly

limitless leverage” because “Congress . . . did not go so far as the Government

claims”); McDonnell v. United States, 136 S. Ct. 2355, 2367-68 (2016) (rejecting

government’s broad interpretation of 18 U.S.C. § 201(a)(3), which read statutory term

“official act” to “encompass nearly any activity by a public official,” and instead

“adopt[ing]d “adopt a more bounded interpretation of ‘official act’”); Yates v. United

States, 135 S. Ct. 1074, 1081 (2015) (plurality opinion) (rejecting government’s broad

interpretation of 18 U.S.C. § 1519, which read undersized fish as falling within phrase

23

“any record, document, or tangible object,” because it was an “unrestrained reading”)

(emphasis added); Bond v. United States, 572 U.S. 844, 857-61 (2014) (rejecting

government’s broad interpretation of 18 U.S.C. § 229(a)(1) and statutory

implementation of chemical weapons treaty as including local crime of poisoning a

romantic rival with small amounts of chemicals to develop an uncomfortable rash,

because such “boundless reading” would “dramatically intrude upon traditional state

criminal jurisdiction” and Congress gave no clear indication of an intent to reach such

local criminal conduct) (internal quotation marks and citation omitted).

It should do the same here to reestablish the line that Congress and the Court

have already drawn. Indeed, it has been nearly 45 years since this Court last reviewed

the federal government’s criminal prosecution of a physician for unlawfully

prescribing controlled substances in Moore. (Gonzalez, while important to this

question, arose as an action for injunctive relief by the State of Oregon and others

against an interpretive rule issued by the Attorney General indicating that physicians

who assisted the suicide of terminally ill patients under state law would be violating

the CSA, see 546 U.S. at 248, 254.) There is no substitute for reaffirming the line

between criminal and non-criminal conduct in an actual criminal prosecution, and this

case, with the issue squarely presented as an instructional challenge, presents a

compelling vehicle to do so.

24

IV.

Properly instructing juries about what the government must prove to

establish medical practitioners’ criminal liability is an issue of increasing

national importance.

Finally, this is an important time for this Court to intervene and require juries

to be instructed more clearly about when a physician is criminally liable for

prescribing a controlled substance.

In the years since the prescriptions in this case were written back in 2009-12,

the national attention on the use, and misuse, of opioids and other prescription drugs

has exploded. See, e.g., Lenny Bernstein, White House opioid commission calls for wideranging changes to anti-drug policies, Washington Post, Nov. 1, 2017 (recounting national

attention on prescription drug abuses). The government’s response to the crisis has

varied.

In 2016, the Centers for Disease Control and Prevention published a guideline

for prescribing opioid pain medications in primary care settings. See Centers for

Disease Control and Prevention, et. al., Guideline for Prescribing Opioids for Chronic Pain, J.

Pain & Palliative Care Pharmacotherapy, 2016, Jun; Vol. 30(2):138-40; 8 CDC Guideline

for Prescribing Opioids for Chronic Pain – United States, 2016, Morbidity and Mortality

Weekly Report (MMWR), March 15, 2016. 9 And in 2017, the Acting Secretary of

Available at https://www.ncbi.nlm.nih.gov/pubmed/27301691;

https://www.tandfonline.com/doi/full/10.3109/15360288.2016.1173761.

8

9

Available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.

25

Health and Human Services declared the national opioid abuse epidemic a public

health emergency, and the President established a commission to study the problem

and make recommendations. See, e.g., U.S. Dep’t of Health and Human Services,

Press Release, HHS Acting Secretary Declares Public Health Emergency to Address National

Opioid Crisis 10; Ex. Order 13784 (March 29, 2017) (establishing Presidential

Commission).

But the government has also responded by prosecuting doctors. See, e.g.,

Michael Nedelman, Doctors increasingly face charges for patient overdoses, CNN, July 31, 2017

(reporting that “[b]etween 2011 and 2016, the number of doctors punished by the

DEA jumped more than five times”); 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 Am. J.L. & Med. 7, 36 (2016) (suggesting that “[t]here are

some indications that law enforcement scrutiny of physicians has grown recently in

reaction to the rise in prescription drug abuse”).

And there is every indication that such prosecutions will continue apace, with

the Department of Justice identifying such cases as a high priority area. See K. Tate

Chambers, A Primer on Investigating Doctors Who Illegally Prescribe Opioids, 66 U.S. Att’y

Bull. (July 2018) at 19-32 (recounting efforts to make the “overprescribing of opioids

Available at https://www.hhs.gov/about/news/2017/10/26/hhs-actingsecretary-declares-public-health-emergency-address-national-opioid-crisis.html.

10

26

by health care professionals a top priority of the Department of Justice,” and

providing guidance on such prosecutions); 11 see also U.S. Dep’t of Justice, Press

Release, Attorney General Sessions Announces Opioid Fraud and Abuse Detection

Unit (Aug. 2, 2017); 12 U.S. Dep’t of Justice, Press Release, Attorney General Sessions

Announces New Prescription Interdiction and Litigation Task Force (Feb. 27,

2018). 13

Accordingly, the federal courts are likely to continue to see many cases

involving physicians charged with unlawfully prescribing controlled substances.

Instructing juries with greater specificity, uniformly across the country, will ensure

that they can adequately distinguish well-meaning but mistaken doctors (and even bad

doctors) from drug dealers. Doing so would have no impact on the government’s

efforts to shut down problematic “pill mills” and “pain clinics” that are medical

practices in name only, or to prosecute doctors “who sold drugs, not for legitimate

purposes, but ‘primarily for the profits to be derived therefrom.’” Moore, 423 U.S. at

135 (quoting legislative history of the Controlled Substances Act, H.R. Rep. No. 911444 at 10). But such instructional clarity will help to stave off the government’s

11

Available at https://www.justice.gov/usao/page/file/1083791/download.

Available at https://www.justice.gov/opa/pr/attorney-general-sessionsannounces-opioid-fraud-and-abuse-detection-unit.

12

Available at https://www.justice.gov/opa/pr/attorney-general-sessionsannounces-new-prescription-interdiction-litigation-task-force.

27

13

mission creep and prevent criminalizing disputes about the proper exercise of medical

judgment, holding the line of criminal liability where Congress and this Court have

sensibly set it, at those who “engage in illicit drug dealing and trafficking as

conventionally understood.” Gonzalez, 546 U.S. at 270.

***

The line that Congress and this Court have drawn has been clear and consistent

for a century: a doctor violates federal drug laws and becomes criminally liable when

he engages in “illicit drug dealing and trafficking as conventionally understood,”

Gonzalez, 546 U.S. at 272, acts as a “‘pusher and not a physician,’ Moore, 423 U.S. 143,

and “[i]n reality, . . . bec[o]me[s] party to sales of drugs,” Linder, 268 U.S. at 20. The

instructional practice in the Tenth Circuit erases this clear line, and countenances

criminal conviction for medical malpractice or mere disputes about the appropriate

standard of care. This Court’s intervention is necessary to reaffirm the line and

ensure that juries are properly instructed.

28

CONCLUSION

For the foregoing reasons, the petition for a writ of certiorari should be

granted.

Respectfully submitted,

VIRGINIA L. GRADY

Federal Public Defender

/s/ John C. Arceci

JOHN C. ARCECI

Assistant Federal Public Defender

Counsel of Record

633 17th Street, Suite 1000

Denver, Colorado 80202

(303) 294-7002

January 3, 2019

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