Brief for the Respondents in Opposition — Raladam Co. v. United States

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x

INDEX

Page

Opinions below. - - ‘ “5 ‘ 1

Jurisdiction : ‘ 1

Questions presented - 2

Statute involved_ 2

Statement 3

Argument 7

Conclusion 15

CITATIONS

Cases:

Federal Security Administrator v. Quaker Oats Company, 318

y.. 8. 218... 13

Gibbons v. Ogden, 22 U. 8. 1 12

McDermott v. Wisconsin, 228 U.S. 115- 8, 12

United States v. Carolene Products Co., 304 U.S. 144 12

United States v. Coca Cola Co., 241 U.S. 265- - 13

United States v. Darby, 312 U. 8. 100 : 12

United States v. Lexington Mill and Elevator Company, 232

1s, Beeeuwaases ; : 13

Weeks v. United States, 245 U.S. 618 —.-- ae 11

Statutes:

Food and Drugs Act of 1906, 21 U.S. C., 1934 ed., 1 et

seq_- aie casa oe 8, 9, 12,13

Federal Food, Drug, and Cosmetie Act (Act of June 25,

1938, c. 675, 52 Stat. 1040, 21 U. &. C. 301 et seq... |

See. 201 (n).. -..-+ 3

Sec. 304 (a) --- ves . 2

OR; Die scones wo : ; <i a

Miscellaneous:

S. Rep. No. 646, 74th Cong., Ist sess., pp. 7-8__- 9

(1)

606431—- 44--—1

Inthe Supreme Court of the United States

OcrosER TERM, 1944

No. 316

RaLApAM COMPANY, AS CLAIMANT OF 62 PACKAGES,

More or Less, OF MarMoLa Prescription TAs-

LETS, PETITIONER

v.

Unirep States OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED

STATES CIRCUIT COURT OF APPEALS FOR THE SEVENTH

CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINIONS BELOW

The opinion of the circuit court of appeals

(R. 1353-1359) is reported at 142 F. (2d) 107.

The memorandum opinion of the district court

(R. 1298-1315) is reported at 48 F. Supp. 878.

JURISDICTION

The judgment of the circuit court of appeals

was entered May 4, 1944 (R. 1360). The petition

for a writ of certiorari was filed August 3, 1944.

The jurisdiction of this Court is invoked under

(1)

eT RE ON AT ee ee ad Fi ye Ping aba? SiS RY SX

eae SEN

2

Section 240 (a) of the Judicial Code, as amended

by the Act of February 13, 1925.

QUESTIONS PRESENTED ©

The principal questions presented are:

1. Whether a drug is misbranded within the

meaning of Section 502 (j) of the Federal Food,

Drug, and Cosmetic Act, if, when used in ac-

cordance with the directions contained in its label-

ing, it endangers public health, even though the

labeling contains no false or misleading statement.

2. If so, whether the Act is unconstitutional as

an interference with the practice of self-medica-

tion and as lacking an ascertainable standard for

determining when a drug is misbranded.

3. Whether the evidence is sufficient to sustain

the findings of the trial judge, coneurred in by

the circuit court of appeals, that petitioner’s

product was dangerous to health when used in the

dosage, and for the duration of time, prescribed

in its labeling, and, therefore, was misbranded

under Section 502 (j) of the Federal Food, Drug,

and Cosmetic Act.

STATUTE INVOLVED

The Federal Food, Drug, and Cosmetic Act

(Act of June 25, 1938, ¢. 675, 52 Stat. 1040, 21

U.S. C. 301 et seq.), provide in part:

* * * * *

Src. 304. (a) Any article of food, drug,

device, or cometic that is adulterated or

misbranded when introduced into or while

3

in interstate commerce, * * * shall be

liable to be proceeded against while in in-

terstate commerce, or at any time there-

after, on libel of information and con-

demned in any district court of the United

States within the jurisdiction of which the

article isfound: * * *.

* * * * *

Sec. 502. A drug or device shall be

deemed to be misbranded

* * * * *

(j) If it is dangerous to health when used

in the dosage, or with the frequency or

duration prescribed, recommended, or sug-

gested in the labeling thereof.

STATEMENT

Proceeding under Section 304 of the Federal

Food, Drug, and Cosmetie Act, the United States,

on April 11, 1939 (R. 1), filed a libel of infor-

mation in the District Court of the United States

for the Western District of Wisconsin, which was

amended on January 8, 1940 (R. 5), against ap-

proximately 62 packages of a drug product ealled

Marmola on the ground that it was misbranded

under Section 502 (j) of the Act* in that it was

‘The Government also proceeded under Section 502 (a)

and 201 (n) of the Act (21 U.S. C. 352 (a) and 821 (n)) and

the trial court based the decree of condemnation on these

sections as well as on Section 502 (j) (R. 13-26). The cir-

cuit court of appeals, however, relied solely upon Section

502 (j) in affirming the decree and petitioner’s contentions

are directed only to that provision. We, therefore, confine

our discussion to Section 502 (j), without, however, waiving

reliance on Sections 201 (n) and 502 (a).

4

dangerous to health when used as prescribed in

its labeling (R. 5-7). Petitioner intervened as

claimant (R. 3, 5) and the case was tried before

the court without a jury.

The Government’s libel of information was

based on the contention that the seized Marmola

Prescription Tablets were dangerous to health be-

‘ause each contained one-half grain of desiccated

thyroid (R. 13) * and the labeling of the product

directed that four tablets be taken each day over

a period of 60 to 90 days (R. 9). In support of

its claim that the taking of four Marmola tablets

each day was dangerous to health, the Govern-

ment’s proof showed that the consumption of two

grains of desiccated thyroid of the United States

Pharmacopoeia standard constitutes an overdose

for many persons. The proof in this respect may

be summarized as follows:

When the thyroid gland fails to produce a suffi-

cient amount of thryoxin, which is, or is contained

in, the hormone of the thyroid gland, a condition

known as hypothyroidism appears. This condi-

tion is made evident by such symptoms as thick-

ened and coarsened skin, falling hair, sluggishness

of mind and body, a puffy appearance due to a

mucoid deposit under the skin, and changes in the

2 It was stipulated at the trial that “the only ingredient of

Marmola Prescription Tablets that is involved in this action

is the 1% grain of Desiccated Thyroid contained in each

tablet” (R. 19).

9]

blood chemistry, and is accompanied by a de-

pression in the basal metabolic rate. CR. 39, 582-

584. 672-674, 690, 700-701, 781, 919.)

If the thyroid gland produces too much of its

hormone, a condition Known as hyperthyroidism

results. This disease is manifested by many signs

and symptoms, such as headaches, nausea, vomit-

ing, tachycardia, heart pains, palpitation of the

heart, sweating, nervousness, and sleeplessness.

In its severe stages, it is usually accompanied by

loss of weight. (R. 40, 584, 681, 692, 782-790.)

Hyperthyroidism does not cause organic or path-

ological changes but does induce misfunctions

which may be so severe as to cause death

(R. 930, 938, 939).

Desiccated thyroid is obtained from the thyroid

elands of food animals. When it is administered

to a human being it has the same effect as thyroxin

spontaneously produced; that is, if a person is

deficient in thyroxin the symptoms of hy pothy-

roidism will disappear as the dosage of desiccated

thyroid reaches the point where it replaces the

deficiency of the thyroxin, If, however, the dos-

age furnishes more thyroxin than is necessary to

maintain the normal functioning of the body, the

signs and symptoms of a spontaneous hyper-

thyroidism appear. (R. 47-48, 421, 587-588, 6TT-

681, 789-790, 806-807, 1163, 1188.)

Persons differ in their tolerance for the drug,

and the limit of tolerance can be determined only

6

by trial and error (R. 90, 247-250, 588-590, 991,

607-608, 637-638, 923-926). All persons who ob-

tain an overdose of desiccated thyroid develop the

well-recognized symptoms of hyperthyroidism.

Two grains of desiccated thyroid of United States

Pharmacopoeia standard * constitute overdosage

for many persons, that is, on such a daily dosage

a considerable proportion, even those who

are hypothyroid, will develop symptoms of

hyperthyroidism (R. 248, 402-404, 422, 444-446,

470-473, 562-565, 591, 638, 644, 652-653, 662-663,

790-792). These symptoms are not the reactions

of allergies or idiosyncrasies (R. 201-213, 496-

497).

Moreover, many persons, without realizing it,

are suffering from or are extremely susceptible to

an illness; that is, such pathological changes may

be occurring in their organs, or the reserves of

some organs may be so depleted, that these jrer-

sons cannot withstand extra strain (R. 49-51, ifi-

180, 484-485). In these persons, the inducing of

symptoms of hyperthyroidism accelerates the onset

of, or precipitates, the more serious stages of (lis-

eases which they may have or to which they may

be susceptible or prevents curative measures from

being effective (R. 389, 736-738). This is es-

pecially true of diabetes (R. 485-495, 497-498) and

’The desiccated thyroid used in petitioner's product pos-

sesses one and one-half times the potency of that made in

accordance with the standard of the United States Pharma-

copoeia (R. 18-19; see also R. 1357).

heart disease (R. 559-568, 642-643, 677-679, 692-

693). The indnuecd syinptoms of hyperthyroidism

also contribute to the precipitation of certam

functional diseases. such as amenhorrhea, Graves’

Disease, and psaychonenuroses CR. Ts8-789. 793-

798, 805-804 ).

On this evidence the trial court found, ationg

other things, that the desiccated thyroid contained

in petitioner’s tablets produces greater pliysto-

logical effects than the sare quantity prepared

according to the siandard of the United States

Pharmacopoeia (Fiuding 4. R. 1316), and that

CR. 1326):

21. The use of two grains of desiccated

thyroid daily without.amedical supervision

is dangerous to users.

22. The Marmola Prescription ‘Tablets,

When used as a treatment for obesity in

daily dosages of four tablets for the dura-

tion of time suggested in the labeling, are

danverous *o the health of users.

The trial court concluded as a matter of law (Con-

elusion 3, R. 1326) that the tablets were mis-

branded as alleged i the libel of information, and

entered a decree of condemnation (R. 1327-1528).

On appeal to the Cireuit Court of Appeals for

the Seventh Circuit the decree was affirmed (R.

1360).

ARGUMENT

1. Contrary to the basic premise of petitioner's

entire argument (Pet. 14-17, 24-49), neither the

606431—44—. 2

g

trial court nor the cireuit court of appeals hela

that Section 502 (j) of the Act is designed to put

an end to “the labeling of effective dosages of use-

* * *

ful drugs for self-medication” (Ce. g.,

Pet. 52) merely because of potential dangers

whieh may be inherent in the dig as such.

Rather, the courts held in plain and unambiguous

language confined to a single product, petitioner's,

that it is misbranded because when used in the

manner prescribed, suggested, and recommended

in its labeling, it endangers the public health,

even though the labeling contains no false or

misleading statement and contains the informa-

tion required by the other sections of the Act.

McDermott v. Wisconsin, 228 U. 8S. 115, 133,

upon which petitioner relies (Pet. 14-15, 20-21,

24, 57-59), was not concerned with a provision

such as Section 502 (j), and therefore does not

aid petitioner in any respect. In that case this

Court held invalid a State law the effect of which

was to cause the removal of a label that, in accord-

ance with the provisions of the Food and Drugs

Act of 1906 (21 U.S. C., 1934 ed., 1 et seq.), had

been properly placed on a food shipped in inter-

state commerce. The reason given by this Court

was that ‘‘the label is the means of vindication or

the basis of punishment in determining the char-

acter of the interstate shipment dealt with by

Congress.”” Likewise, in the present case the

label must be relied on to ascertain whether the

9

preseribed use of the product renders it dangerous

to the publie health.’

The construction placed on Seetion 502 (7) bs

the courts below accords fully with the design of

Congress. The legislative history discloses that,

in enacting the section, it was intended to amplity

and extend the provisions of the Food and Drugs

Act of 1906 so as to close the channels of inter-

state commerce to a drug product which is danger

ous when used according to its labeling even

though it does not contain false or misleading

statements. This is set forth clearly in Senate

Report No. 646, 74th Cong., Ist sess., pp. 7-3,

accompanying S. 5, a precursor to the bill which

was enacted into law. The report stated:

-aragraph (b) defines a drug or device

as misbranded if it is dangerous to health

under the conditions of use prescribed in

its labeling or advertising. There are no

useful products which would be barred

from the market under this provision, since

labeling with proper directions for use

would remove any worth-while article from

this ban. Under the present law, which

* Petitioner erroneously conceives Section 502 to be a mis

labeling section in the ordinary sense of that term: that is,

the label itself must per se be false or misleading (see ¢. 7.,

Pet. 24, 26-28. 37). However, it is evident from those define.

tions of misbranding contained in the paragraphs of the sec

tion following paragraph (a) that a product may be mis-

branded even though its label is not false or misleading (see

Section 502 of the Act as copied at pp. 12-13 of the Appen

dix to the petition for a writ of certiorari).

10

contains no provision of this character,

there have come on the market a number

of dangerous drugs from the use of which

many authenticated cases of death and im-

pairment of health have been reported. Se

long as their labels bore no false or mis-

leading statements, the publie could not be

protected,

There are certain drugs whose em-

plovment is necessary in the treatment’ of

some diseases, Which none the less may

in very exceptional cases prove harmful to

persous to whom they are administered.

Their action ti such eireumstances is com-

parable to the allergie action of eggs and

other common foods, which was discussed in

connection with paragraph (a) of section

30L. It is not intended that this provision

should ban the sale of useful drugs of this

kind when they are appropriately labeled.

On the other hand, it is not intended that

the existence of these drugs shall constitute

a cloak under which may hide the manufae-

turers of unnecessary and dangerous me-

dieaments; or even necessary medicaments

with Improper or insufficient directions for

use that result in the injury of susceptible

persons in any considerable number of im-

stances even though most persons could use

them with safety. Much eritieism has been

launched at this provision on the ground

that it applies to innocuous drugs for whieh

extravagant therapeutic claims are made

and which thus indirectly impair the pa-

tient’s chance of recovery through his post-

11

ponement of proper methods of treatment.

The language does not relate to such prod-

ucts. It applies only to potent drugs which

are per se harmful unless — properly

administered.

Petitioner’s contention (Pet. 32-39) that the cir-

cuit court of appeals construed Section 502 (j) ina

manner inconsistent with the other subsections of

Section 502 is without merit, for it is based on

petitioner’s basic misapprehension that the court

predicated its decision on the assumption that the

subsection prevents the labeling and consumption

of desiccated thyroid. It is clear, however, that

the court did not so hold. What it did decide was:

that the drug, under the terms of Section 502 ()),

was misbranded because its labeling prescribed a

dosage which made the product dangerous to the

public health, notwithstanding that it may have

complied with the other subsections: and that a

drug, to escape being misbranded, must comply

with every provision of Section 502. This leads

to no inconsistency between the various provi-

sions of the section, which supplement rather than

conflict with each other. To offend against any

one of the subsections eonstitutes a misbranding,

whether it relates to informative labeling, the form

or fill of the container, or dangerous dosage. See

Weeks v. United States, 245 U.S. 618, 621.

2. Petitioner’s further contention (Pet. 50-58)

that, as construed by the cireuit court of appeals,

Section 502 (j) is unconstitutional as an unwar-

ara

12

ranted interference with the practice of self-

medication and because it contains no ascertain-

able standard for determining when a drug is

misbranded, is without merit.

As we have pointed out, the decisions below did

not deal with the practice of self-medication as

such. They related only to a product which, on

the basis of the evidence before the courts, was

found to be dangerous to the public health when

taken in the manner recommended by the manu-

facturer. There can be no doubt of Congress’

power to prohibit the transportation of such an

article in interstate commerce.

ees

The power of Congress to regulate commerce “Is

complete in itself, may be exercised to its utmost

extent, and acknowledges no limitations, other

than are prescribed in the constitution.”’ Gibbons

v. Ogden, 22 U.S. 1, 196; United States v. Darby,

312 U. S. 100, 113, 114. The power may be exer-

cised to keep interstate commerce ‘free from

the transportation of illicit or harmful ar-

ticles, to make such as are injurious to the

publie health outlaws of such commerce and to

bar them from the facilities and _ privileges

thereof.’ McDermott v. Wisconsin, 228 U. 5.

115, 128. This Court has upheld the right of

Congress to close the channels of interstate com-

merece to a product found to be adulterated not-

withstanding the honesty of its label. United

States v. Carolene Products Co., 304 U.S. 144, 151.

And under both the Food and Drugs Act of 1906

13

and the Federal Food, Drug, and Cosmetic Act, it

has been held that the design of the statutes was

not confined to a requirement of truthful and in-

formative labeling. United States v. Coca Cola

Co., 241 U.S. 265, 277, 278; Federal Security Ad-

ministrator v. Quaker Oats Company, 318 U.S.

218, 230.

Nor is there wanting a reasonable standard

whereby the question of misbranding under the

section may be determined Whether a prescribed

use of a drug is dangerous to the public health is

as susceptible of proof as is the question whether a

product contains any added or deleterious sub-

stances which may render it injurious to health;

and compliance or noncompliance with either

standard is equally susceptible of determination.

In respect of the latter standard as contained in

Section 7 of the Food and Drugs Act of 1906

(21 U. 8. C., 1934 ed., 8), this Court found no

such difficulty as petitioner perceives. United

States v. Coca Cola Co., 241 U. 8S. 265; United

States v. Lexington Mill and Elevator Company,

232 U.S. 399.

3. There is no warrant for petitioner’s conten-

tion (Pet. 59-60) that the evidence is insufficient

to support the findings of the trial judge. The

evidence, summarized in the Statement, supra, pp.

4-7, shows that two grains per day of desiccated

thyroid of United States Pharmacopoeia standard

constitute an overdosage for many persons, even

‘ those who are hypothyroid; that the daily dosage

Sa aihae ed at

14

of desiccated thyroid prescribed in the labeling

of petitioner’s product was two grains; and that

the desiccated thyroid contained in petitioner’s

product produces greater physiological effects

than a similar amount prepared pursuant to the

United States Pharmacopoeia standard. No wit-

ness questioned the facts shown by the Govern-

ment’s evidence that an overdosage of desiccated

thyroid produces the symptoms of hyperthy-

roidism and that when such symptoms appear

diabetes, tuberculosis, and certain heart diseases

are aggravated; that an overdosage sometimes

causes amenorrhea; and that excessive thyroid

medication heightens and exaggerates existing ex-

cited and unstable mental, nervous, and emotional

states, which are precipitating factors of Graves’

Disease and psychoneuroses. As the court below

stated (R. 1358), ‘‘We think the evidence such as

to justify only the conclusion reached by the trial

court. We certainly are not justified in saying

that the finding is erroneous as a matter of law.

Admittedly, taking four tablets a day, is not dan-

gerous to the health of all users, since tolerance

for the drug varies; but the experience of various

witnesses, all of whom took tablets according to

the directions on the label, as well as the testi-

mony of a number of medical experts, inevitably

impel one to the finding that use of the tablets as

prescribed is dangerous to the health of the

ae

15

CONCLUSION

The decision of the circuit court of appeals is

_correct, the case presents no question of general

importance, and there is involved no conflict of

decisions. We respectfully submit, therefore,

that the petition for a writ of certiorari should

be denied.

CHARLES Fauy,

Solicitor General.

Tom C, CLaRK,

Assistant Attorney General.

VINCENT A. KLEINFELD,

Special Assistant to the Attorney General.

Irvine 8. SHAPIRO,

ee

AutvIN M. Lovervp,

Attorney, Federal Security Agency.

Aveust 1944.

U.S. GOVERNMENT PRINTING OFFICE: 1044

Bide N rer 74

eed wea THis RG