cross petition — Rutherford v. United States

Supreme Court, U. &

ILED’

NOV @% 1978

COMTGHAEL naa JR., CLERK

Furthe Supreme Gourt of the Wnited States

OcTOBER TERM, 1978

78-763

RRR el era

GLEN L. RUTHERFORD, ET AL.,

Petitioners,

VERSUS

UNITED STATES OF AMERICA, ET AL.,

Respondents.

CROSS-PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE TENTH CIRCUIT

KENNETH COE, of the Firm

Looney, NICHOLS, JOHNSON & HAYES

219 Couch Drive

Oklahoma City, Oklahoma 73102

Counsel for Petitioners

November, 1978

EBB B BPP LP LLL LLL LL

UTTERBacK TYPESETTING CO.. 519 W. CaLiF.. CKLAHCMA City. PH 2285-0030

TABLE OF CONTENTS

PAGE

NE EE ENE I 1

JURISDICTION it hidbeedinntinttclonpdinclieaieteaamma a 2

QUESTIONS PRESENTED ex SO

CONSTITUTIONAL PROVISIONS 3

SERRE IE OE I Eee csnccsenenenstsicnceesunaapannsigs 4

STATEMENT OF THE CASE 5

REASONS FOR GRANTING THE CROSS-

oo 8 RE Re RET SO ae ek 9

CERTIFICATE OF SERVICE follows Cross-Petition

for Writ.

a

TABLE OF AUTHORITIES

Cases PAGE

Doe v. Bolton, 410 U.S. 179, 93 S.Ct. 739, 35 L.Ed.2d

201 (1973) .. pigeon esa eee aie 7

Roe v. Wade, 410 U.S. 113, 93 S.Ct. 705, 35 L.Ed.2d

147 (1973) .. a ee

Rutherford v. United States, 399 ) F.Supp 1208 ( W. D.

Cee, See 5

U. S. v. Republic Steel en: 362 U.S. 482, 80 S.Ct.

884, 4 L.Ed.2d 903 (1960) _.. oot ll Bias 0 9

United States Constitution

Amendment No. 5... Lee RY RS kee 3

yt FRE a POL EL ERE ais ine 3

Statutes

21 U.S.C. 321 (p) . 4

28 U.S.C. 1254(1) . 2

Drug Amendments of 1962, Sec. 107(c) (4), 76 Stat.

789 - saab : eh Sag ; 4

In the

Supreme Court of the United States

OctToBEerR TERM, 1978

La ieee

GLEN L. RUTHERFORD, Er AL.,

Petitioners,

VERSUS

UNITED STATES OF AMERICA, ET AL.,

Respondents.

CROSS-PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE TENTH CIRCUIT

This Cross-Petition is brought on behalf of the Plain-

tiffs below for a writ of certiorari to review the judgment

of the United States Court of Appeals for the Tenth Circuit.

The Opinion of the Court of Appeals from which the

Petition for Writ of Certiorari is requested is not yet re-

ported but is attached as Appendix A to the Petition for

Writ of Certiorari filed by the United States. The Opinion

of the District Court is reported at 438 F.Supp. 1287, and

is attached as Appendix D to the Petition for the Writ of

Certiorari of the United States. The decision of the Com-

missioner of the Food and Drug Administration is reported

wii

at 42 Fed. Reg. 39768 and is attached as Appendix L cf the

Petition for Writ of Certiorari of the United States. All

appendices of the Petition for Certiorari filed by the United

States are hereby adopted by reference for the purposes

of this Cross-Petition.

JURISDICTION

The judgment of the Court of Appeals (App. B, to

the Petition for Certiorari of the United States) was en-

tered on July 10, 1978. On August 4, 1978, the Court of

Appeals denied a Motion for Clarification or in the altern-

ative Petition for Re-Hearing filed by respondents on July

27, 1978 (App. C to the Petition for Writ of Certiorari of

the United States). The jurisdiction of this Court is in-

voked under 28 U.S.C. 1254(1).

QUESTIONS PRESENTED

I.

Does the denial of the right to use Laetrile by a

“terminal” cancer patient violate the constitutionally guar-

anteed right of privacy?

II.

Is Laetrile exempt from the Federal Food, Drug, and

Cosmetic Act requirements of “efficacy” by virtue of the

transitional provisions of the 1962 Amendments to the

Food, Drug and Cosmetic Act allowing certain drugs to

be exempted from the “efficacy” requirement if they were

generally recognized as safe prior to the 1962 Amendment?

—3—

ITI.

Do the safety and efficacy requirements of the Fed-

eral Food, Drug and Cosmetic Act apply to drugs intended

for use by the terminally ill?

CONSTITUTIONAL PROVISIONS

United States Constitution, Amendment No. 5:

“No person shall be held to answer for a capitol,

or otherwise infamous crime, unless on a presentment

or indictment of a Grand Jury, except in cases arising

in the land or naval forces, or in the militia, when

in actual service in time of war or public danger; nor

shall any person be subject for the same offense to

be twice put in jeopardy of life or limb; nor shall

be compelled in any criminal case to be a witness

against himself, nor be deprived of life, liberty or

property, without due process of law; nor shall priv-

ate property be taken for public use, without just

compensation.”

United States Constitution, Amendment No. 9:

“The enumeration in the Constitution, of certain

rights shall not be construed to deny or disparage

others retained by the people.”

initia.

STATUTORY PROVISIONS

21 U.S.C. 321 (p), provides in part:

“The term ‘new drug’ means — (1) Any drug * * *

the composition of which is such that such drug is

not generally recognized, among experts qualified by

scientific training and experience to evaluate the safety

and effectiveness of drugs, as safe and effective for

the use under the conditions prescribed, recommended,

or suggested in the labeling thereof, except that such

a drug not so recognized shall not be deemed to be

a ‘new drug’ if at any time prior to the enactment

of this Act it was subject to the Food and Drugs Act

of June 30, 1906, as amended, and if at such time its

labeling contained the same representations concern-

ing the conditions of its use * * *.”

Section 107(c) (4) of the Drug Amendments of 1962,

Pub. L. No. 87-781, 76 Stat. 789 (“1962 Grandfather

clause”), provides:

“In the case of any drug which, on the day im-

mediately preceding the enactment date [October 10,

1962], (A), was commercially used or sold in the

United States, (B) was not a new drug as defined by

Section 201 (p) of the basic Act as then in force [21

U.S.C. 231 (p)], and (C) was not covered by an ef-

fective [new drug] application under section 505 of

that Act [21 U.S.C. 355], the amendments to section

201 (p) made by this Act shall not apply to such drug

when intended solely for use under conditions pre-

scribed, recommended, or suggested in labeling with

respect to such drug on that day.”

ceili

STATEMENT OF THE CASE

This action was instituted by cancer patients on March

12, 1975, and seeks to prevent the Government from in-

terfering with the interstate sale or distribution of Laetrile

for use exclusively by “terminal” cancer patients. In an

Order entered August 14, 1975, and amended October 10,

1975, the District Court enjoined the Government from

preventing the purchase and subsequent interstate move-

ment of a limited quantity of Laetrile for Glen L. Ruther-

ford, one of the Plaintiffs. Rutherford v. United States,

399 F.Supp. 1208, 1215 (W.D. Okla. 1975).

This decision was appealed by the United States to

the Tenth Circuit Court of Appeals which upheld the in-

junction but reached the conclusion that the Federal Food

and Drug Administration probably had not developed a

sufficient administrative record on the subject of Laetrile

and ordered the District Court to remand the case to the

Food and Drug Administration if in fact the proper record

had not been developed.

At a subsequent hearing, the attorneys for the Food

and Drug Administration admitted that their record was

virtually non-existent and at that time, the District Court

remanded the action to the Food and Drug Administration

for proper administrative proceedings.

On remand to the Food and Drug Administration, an

administrative proceeding was conducted and the Commis-

sioner concluded as follows:

(a) That Laetrile is a “drug.”

(b) That Laetrile is a “new drug.”

salle

(c) That Laetrile did not satisfy the premarketing

approval requirements for new drugs.

(d) That there is an absence of scientifically sound

data upon which experts could base an opinion that

Laetrile is safe for use in man.

(e) That Laetrile did not meet the Statutory cri-

teria of either the 1938 or 1962 Grandfather Exemp-

tion.

(f) That Laetrile is not safe and effective.

The District Court in its review of the Commissioner’s

decision, sustained the portions of the Commissioner’s con-

clusion that Laetrile is not generally recognized as safe

and effective but determined that Laetrile would be ex-

empt from the Act’s premarketing approval requirements

by virtue of the 1962 Grandfather clause. The court fur-

ther concluded that to deny the Plaintiff’s use of a non-

toxic substance in connection with his own personal health

care offended the Constitutional right of privacy and ruled

that it would be unconstitutional to deny the use of Laetrile

to a “terminal” cancer patient.

This decision was appealed to the Tenth Circuit Court

of Appeals which ruled as a matter of law that the “safety”

and “effectiveness” requirements of the Statute as now

written, have no application to terminally ill cancer pa-

tients who desire to take the drug intravenously.

The court did not rule on either the 1962 “Grand-

father clause” exemption or upon the constitutional issue

. relied upon by the lower court.

The Appeals Court limited its ruling to “intravenous”

usage of Laetrilc and ignored any other form of usage of

the drug.

a

REASONS FOR GRANTING THE

CROSS-PETITION

In a well written and thoroughly researched opinion,

the United States District Court for the Western District

of Oklahoma examined the Commissioner’s conclusions and

found them wanting. The District Court ruled that Lae-

trile would be exempted from the efficacy requirements of

the Food, Drug and Cosmetic Act by virtue of its use prior

to 1962, and that the Commissioner’s finding that Laetrile

is a “new drug,” was “arbitrary, capricious and a abuse

of discretion.”

The lower court found that the evidence in the ad-

ministrative record established conclusively that Laetrile

was “generally recognized” as safe among qualified experts

prior to 1962 and therefore, qualified for the “grandfather

clause exemption.”!

However, the most compelling reason for granting this

Cross-Petition for Certiorari is the failure of the Tenth

Circuit Court of Appeals to rule upon the Constitutional

issues raised in a lower court’s decision.

The District Court’s opinion was grounded upon the

“right to privacy” guaranteed by the United States Con-

stitution and in particular, the case of Roe v. Wade, 410

U.S. 113, 152, 93 S.Ct. 705, 726, 35 L.Ed.2d 147 (1973).

Reference was also made to the case Doe v. Bolton, 410

U.S. 179, 213, 93 S.Ct. 739, 758, 35 L.Ed.2d 201 (1973)

(concurring opinion of Justice Douglas), in which Justice

1 Most particularly see footnotes 23 and 24 of the District Court's

Opinion.

alin

Douglas affirmed the right to privacy as encompassing the

“freedom to care for one’s heaith and person.”

The District Court affirmed that the right of terminal

cancer patients to utilize Laetrile falls within the “right

to privacy” and vacated the Commissioner’s Order.

The Court of Appeals decision expressly declined to

rule on the Constitutional issue of right to privacy which

was a partial basis for the ruling by the District Court.

Nor did the court rule upon the exemption of Laetrile

from the requirements of the Food, Drug and Cosmetics

Act by virtue of the transitional provision of the 1962

amendment to that Act, often referred to as the “grand-

father clause.”

Additionally, the Court of Appeals decision is incon-

sistent within itself in that it ruled that “intravenous” Lae-

trile could be used by terminal cancer patients but failed

to make any determination on other forms of Laetrile.

Laetrile therapy includes treatment with the liquid

form of the drug initially, but later the liquid is either

supplemented or combined with the tablet form.

As the Government points out in its Petition for Cer-

tiorari to this Court, the Tenth Circuit Court of Appeals

did not rule upon either of the two issues decided by the

lower court but instead ruled that the terms “safe” and

“effective” have no real meaning for a terminal cancer

patient and, therefore, that the act does not apply to their

usage of Laetrile.

Although the Circuit Court tacitly accepted the con-

stitutional conclusion reached by the lower court in its

Be SES

findings that “safe” and “effective” had no application to

terminal cancer patients, the court did not firmly rule on

the issue.

If, in fact, the reasoning of the Court of Appeals holds

true, that the safety and efficacy requirements have no

application to terminal cancer patients using Laetrile, then

it must logically apply acrcss the board to both liquid and

tablet forms.

The Appellate decision reads as though the sole issue

brought before it were the parenteral use of Laetrile and

that no argument had ever been made for usage of the

tablet form. Such is far from the truth. Neither the FDA

nor the Plaintiffs in this action have ever made any dis-

tinction between the two forms. The FDA has continu-

ously been opposed to any usage of Laetrile while the

Plaintiff class has continually been in favor of usage of

both types.

The Court of Appeals failure to explain its ‘imited

ruling and the fact that the ruling is inconsistent within

itself is sufficient grounds to justify this Court’s granting

of the Cross-Petition for Certiorari. The public importance

of the questions presented herein justify the granting of

a Writ of Certiorari, U.S. v. Republic Steel Corp., 362 U.S.

482, 80 S.Ct. 884, 4 L.Ed.2d 903 (1960).

Respectfully submitted,

KENNETH COE, of the Firm

Looney, NICHOLS, JOHNSON & HAYES

219 Couch Drive

Oklahoma City, Oklahoma 73102

Counsel for Petitioners

November, 1978

CERTIFICATE OF SERVICE

I, KENNETH COE, a member of the Bar of the Su-

preme Court of the United States, do hereby certify that

Service of the foregoing Cross-Petition for Writ of Cer-

tiorari to the United States Court of Appeals for the Tenth

Circuit has been made on the required parties by deposit-

ing three (3) copies of same in the United States Mail

with first class postage prepaid, to each of the following:

William S, Price, Assistant U. S. Attorney, Federal Court

House, Oklahoma City, Okla, 73102; Eugene M. Pfeifer,

Food & Drug Administration, 5600 Fishers Lane, Rock-

ville, Md. 20852; Julian Green, U. S, Customs Service,

Regional Commissioner of Customs, 500 Dallas—Suite 1240,

Houston, Tex. 77002; Wade H. McCree, Jr., Solicitor Gen-

eral of the United States, Washington, D.C. 20530, and

Barry Grossman, Catherine G. O'Sullivan, Peter L. De La

Cruz, Department of Justice, Washington, D.C, 20530, this

day of November, 1978.

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