Opposition — Seelig v. United States

FIDED

AUG2 9 1980

No. 80-23 WOH. IUIDAYG, JPR, CUE

Iu the Supreme Court of the Hnited States

OCTOBER TERM, 1979

RICHARD SEELIG, TERRY HAWKINS AND

DONALD PRIMMER, PETITIONERS

Vv.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS FOR

THE SIXTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

WADE H. McCreg, JR.

Solicitor General

PHILIP B. HEYMANN

Assistant Attorney General

VINCENT L. GAMBALE

Attorney

Department of Justice

Washington, D.C. 20530

(202) 633-2217

In the Supreme Court of the Hnited States

OCTOBER TERM, 1979

No. 80-23

RICHARD SBEELIG, TERRY HAWKINS AND

DONALD PRIMMER, PETITIONERS

Vv.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS FOR

THE SIXTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

QUESTIONS PRESENTED

1. Whether petitioners were properly prosecuted under

21 U.S.C, 841(a)(1) for violating regulations promulgated

by the Attorney General under the Controlled Substances

Act, 21 U.S.C. 801 et seq.

2. Whether a government witness was improperly

allowed to testify as to legal conclusions.

TABLE OF CONTENTS

Page

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TABLE OF AUTHORITIES

Cases: ;

United States v. Barron, 594 F. 2d 1345,

cert. demied, 441 U.S. O51 wc ceeeeeeeeeeeeseees 6

United States v. Davis, 564 F. 2d 840,

cert. demied, 434 U.S. LOIS woo etesteeeeeees 7

United States v. Dunbar, 590 F. 2d 1340 ........... 6-7

United States v. Green, 511 F. 2d 1062,

cert. demied, 423 U.S. LOB] wo... eeseeseeeeeeeees 5

United States v. Grimaud, 220 U.S. 506 ........... 2, 6

United States v. Pastor, 557 F. 2d 941 ........ccccseeeee 7

United States v. Roya, 574 F. 2d 386 ..........ccccceeeee 7

Statutes and regulations:

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Miscellaneous:

H.R. Rep. No. 91-1444, 9lst Cong., 2d Sess.

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Physicians Desk Reference (34th ed.

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OPINION BELOW

The opinion of the court of appeals (Pet. App. 19a-36a)

is reported at 622 F. 2d 207.

JURISDICTION

The judgment of the court of appeals was entered on

May 8, 1980. Mr. Justice Stewart extended the time for

filing a petition for a writ of certiorari to and including

July 7, 1980, and the petition was filed on that date. The

jurisdiction of this Court is invoked under 28 U.S.C.

1254(1).

STATEMENT

Following a jury trial in the United States District

Court for the Southern District of Ohio, petitioners, three

registered pharmacists, were convicted on multiple

misdemeanor counts of selling four-ounce bottles of

cough medicine containing codeine (a schedule V

controlled substance) to the same person within a 48-hour

period, in violation of 21 U.S.C. 841(a)(1) and 21 C.F.R.

1306.32(b), and on multiple felony counts of refilling

prescriptions for Valium and Darvon (schedule IV

controlled substances) without physician authorization,

in violation of 21 U.S.C. 84l(a)(l1) and 21 C.F.R.

1306.22(a) and 1306.23.' Petitioners Seelig and Hawkins

were each sentenced to three-year terms of imprisonment,

suspended in favor of three years’ probation, and to fines

totaling $10,000. Petitioner Primmer received the same

sentences, except that his fines amounted to $5,000 (Pet.

App. 43a-44a). On appeal, the court of appeals found the

‘Petitioner Seelig was convicted on 19 misdemeanor counts and

eight felony counts (Pet. App. 39a). Petitioner Hawkins was

convicted on six misdemeanor counts and seven felony counts (id. at

4la). Petitioner Primmer was convicted on 18 misdemeanor counts

and five felony counts (id. at 43a).

l

2

evidence sufficient to sustain petitioners’ convictions, but

it remanded for a new trial on the ground that the trial

judge erred in admitting certain evidence auu in giving

certain instructions to the jury (Pet. App. 19a-36a).

The trial evidence showed that petitioners Seelig and

Hawkins were co-owners of Seelig Pharmacies, Inc.,

which operated two retail drugstores in Columbus, Ohio.

All three petitioners are registered pharmacists who

worked in those stores. The pharmacies’ record books for

April and May 1978, which were obtained in connection

with a DEA audit, showed “repeated occasions where

more than four ounces of [codeine-based cough medicine]

was sold to the same person within a 48 hour period”

(Pet. App. 35a-36a). Five customers, including two

undercover police officers, testified that they had made

such purchases, including repeat purchases in the same

store on the same day (Il Tr. 25-37, 61-77, 88-105).

Moreover, records of the pharmaceutical wholesalers

serving the Selig stores showed that the stores had

purchased unusually large amounts of codeine-based

cough preparations (Gov. Exhs. 215-217).

Petitioners’ records also showed that they had refilled

or renewed Valium and Darvon prescriptions without

authorization by the prescribing physician. While

petitioners presented testimony to show that they

routinely renewed prescriptions upon oral authorization

(Pet. 7), several prescribing physicians testified that “their

records failed to disclose oral authorizations for renewal

of prescriptions and that it was their practice to record

such oral authorizations” (Pet. App. 36a).

ARGUMENT

In United States v. Grimaud, 220 U.S. 506, 517-519

(1911), this Court held that a person may not be

prosecuted for violating an administrative regulation

3

unless the underlying statute authorizes criminal prosecu-

tion for such a violation. The court below properly

rejected petitioners’ contention (Pet. 8-18) that the

Controlled Substances Act provides no authority for

criminal prosecutions based on violations of the

regulations at issue here.? In an opinion upon which we

rely in the main, the court of appeals held (Pet. App. 23a):

The combination of [21 U.S.C.] §829(c) and §822(b)[>]

thus requires a person to dispense or distribute a

schedule V drug for a medical purpose and to be within

the authority of their registration as determined by the

Attorney General. Section 822(a) requires every person

who distributes or dispenses controlled substances to

register with the Attorney General. Section 821

authorizes the Attorney General to promulgate rules

and regulations relating to the registration and control

of the manufacture, distribution, and dispensing of

controlled substances. Section 871(b) authorizes the

2At the outset, we note that the petitioners are in essentially the

same position as if the district court had denied a motion to dismiss

this indictment. Petitioners have been granted a new trial and may be

acquitted. If petitioners are convicted, they wilt be free to raise this

issue at that time.

3Section 82%c) provides:

No controlled substance in schedule V which is a drug may be

distributed or dispensed other than for a medical purpose.

Section 822(b) provides:

Persons registered by the Attorney General under this sub-

chapter to manufacture, distribute, or dispense controlled

substances are authorized to possess, manufacture, distribute, or

dispense such substances (including any such activity in the

conduct of research) to the extent authorized by their

registration and in conformity with the other provisions of this

subchapter.

4

Attorney General to promulgate and enforce rules,

regulations, and procedures that he deems necessary

for the efficient execution of his functions.

Although Congress was not as clear in this statute as

in the one involved in Grimaud, this Court is satisfied

that the statute does expressly, albeit in a convoluted

fashion, provide that a violation of the promulgated

rules constitutes an unlawful act under the Controlled

Substances Act.[*]

The court also correctly observed (Pet. App. 23a-24a

n.1), that

[o]ther courts have had no problem finding defend-

ants guilty under 21 U.S.C. §841(a)(1) for violating

the regulations (primarily 21 C.F.R. $1306.04). See

United States v. Hayes, 595 F. 2d 258, 259 (Sth Cir.),

cert. denied, 100 S. Ct. 138 (1979); United States v.

Roya, 574 F. 2d 386, 390 (7th Cir.), cert. denied, 439

U.S. 857 (1978); United States v. Pastor, 557 F. 2d

930, 939 (2d Cir. 1977) United States v. Rosenberg,

515 F. 2d 190, 196-97 (9th Cir.), cert. denied, 423

U.S. 1031 (1975); United States v. Green, 511 F. 2d

1062, 1067-70 (7th Cir.), cert. denied, 423 U.S. 1031

(1975); United States v. Larson, 507 F. 2d 385, 386

(9th Cir. 1974); United States v. Bartee, 479 F. 2d

484, 488 (10th Cir. 1973).[>]

Petitioners attempt to avoid the weight of those

decisions with the observation (Pet. 12) that those

‘Section 841(aX(1) provides in relevant part:

(a) Except as authorized by this subchapter, it shall be

unlawful for any person knowingly or intentionally—{1) to

manufacture, distribute, or dispense, or possess with intent to

manufacture, distribute, or dispense, a controlled substance;

*_* *

5Petitioners do not contend that the decision below conflicts with

the decision of any other court of appeals.

5

prosecutions involved violations of 21 C.F.R. 1306.04,

while this case involves violations of 21 C.F.R. 1302.22,

1306.23 and 1306.32. Petitioners assert that 21 C.F.R.

1306.04 presents a special case because it merely “mimics

the statute” and does not “expand” the reach of the

statute. That contention is ill-founded because 21 C.F.R.

1306.04 “mimics the statute” no more than do the

regulations at issue here. Section 1306.04 provides that

prescription drugs may not be dispensed except for a

“legitimate medical purpose,” a standard that the

regulation also explains, and one that is not specifically

set out in the statute. To be sure, the regulations here set

more precise guidelines governing the dispensation of

controlled drugs.° But, as the Seventh Circuit said in

United States v. Green, 511 F. 2d 1062, 1070 (7th Cir.),

cert. denied, 423 U.S. 1031 (1975), in upholding a

conviction based on a violation of 21 C.F.R. 1306.04,

“more precise regulations are desirable as to what

physicians [or pharmacists] may or may not do” with

respect to the dispensation of controlled drugs.

621 C.F.R. 1306.32(b) provides in relevant part that “[nJjot more

than 24 dosage units [four ounces] of [codeine-based medicine] may

be dispensed at retail to the same purchaser in any given 48-hour

period.”

21 C.F.R. 1306.22(a) provides in relevant part that “[njo

prescription for [schedule IV drugs] shall be filled or refilled more

than 6 months after the date on which such prescription was issued

and no such prescription authorized to be refilled may be refilled

more than five times. * * * Additional [schedule 1V drugs] may only

be authorized by a prescribing practitioner through issuance of

*** a new and separate prescription.”

21 C.F.R. 1306.23 provides in relevant part that partial filling of a

prescription for a schedule IV drug is permissible providing “(a)

({ejach partial filling is recorded in the same manner as a refilling, (b)

{t]he total quantity dispensed * * * does not exceed the total quantity

prescribed, and (c) [n]Jo dispensing occurs after 6 months after the

date on which the prescription was issued.”

6

At all events, the statutory language and the legislative

history support the authority of the Attorney General to

promulgate regulations that “fill up the details” rather

than simply “mimic the statute,”’ and the power of

Congress to confer that authority is equally clear. As the

Court said in Grimaud, supra, 220 U.S. at 517:

From the beginning of the Government various

acts have been passed conferring upon executive

officers power to make rules and regulations—not for

the government of their departments, but for

administering the laws which did govern. None of

these statutes could confer legislative power. But

when Congress had legislated and indicated its will,

it could give to those who were to act under such

general provisions “power to fill up the details” by

the establishment of administrative rules and

regulations, the violation of which could be punished

by fine or imprisonment fixed by Congress, or by

penalties fixed by Congress or measured by the injury

done.

Moreover, the Attorney General’s unquestioned

authority to determine which drugs should be controlled®

underscores his attendant authority to promulgate

regulations, such as those at issue here, that merely set

guidelines for the lawful dispensation of drugs that he has

designated as controlled substances.

7See H.R. Rep. No. 91-1444, 91st Cong., 2d Sess. 38, 51 (1970) (the

statute “authorizes the Attorney General to promulgate rules and

regulations * * * relating to the registration and control of the

manufacture, distribution, and dispensing of substances covered by

the act *** and it authorizes him to promulgate rules and

regulations for the efficient execution of his functions under title Il

[of the act].”)

8See United States v. Barron, 594 F. 2d 1345, 1352-1353 (10th Cir.),

cert. denied, 441 U.S. 951 (1979); United States v. Dunbar, 590 F. 2d

7

Nor is there any merit to petitioners’ contention (Pet.

12-13) that 21 C.F.R. 1306.32 is arbitrary or “totally

unrelated to the notion of ‘medical purpose’ ” as that term

is used in 21 U.S.C. 829(c). The regulation merely reflects

the obvious fact that a person will rarely, if ever, have a

legitimate medical need to consume more than one four-

ounce bottle of codeine-based cough medicine within a

two-day period.’ Moreover, the trial evidence showed that

a substantial amount of the cough medicine dispensed by

petitioners was consumed not for medical purposes, but

for purposes of getting “high” (II Tr. 25-26).!°

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

WADE H. McCreEzE, JR.

Solicitor General

PHILIP B. HEYMANN

Assistant Attorney General

VINCENT L. GAMBALE

Attorney

AuGusT 1980

1340, 1342; United States v. Roya, 574 F. 2d 386, 392 (7th Cir. 1978);

United States v. Davis, 564 F. 2d 840, 843-844 (9th Cir. 1977), cert.

denied, 434 U.S. 1015 (1978); United States v. Pastor, supra, 557 F. 2d

930, 941 (2d Cir. 1977).

9FDA guidelines provide that the label on a four-ounce bottle of

codeine-based cough medicine may not recommend a maximum adult

dosage exceeding four ounces within a 48-hour period. See Physicians

Desk Reference 1444 (34th ed. 1980).

Petitioners’ unrelated contention (Pet. 18-27) that the district

court erred in allowing a DEA investigator “to testify as to his

personal opinion of the Federal Law” was properly rejected by the

court of appeals (Pet. App. 30a). In any event, that issue does not

warrant review because it relates to the specific content of a witness's

trial testimony, and petitioners have now been granted a new trial.