Appendix — Privitera v. California

IN THE

Supreme Court of the Anite

OCTOBER TERM, 1978

ne, #871850

JAMES ROBERT PRIVITERA, JR.,

Petitioner,

Vv.

THE STATE OF CALIFORNIA,

Respondent.

APPENDICES TO

PETITION FOR A WRIT OF CERTIORARI

TO THE SUPREME COURT OF CALIFORNIA

DENNIS S. AVERY

350 Cedar Street

San Diego, California 92101

Telephone: (714) 239-0391

JERRY W. KANE

1800 Central Federal Tower

San Diego, California 92101

Telephone: (714) 238-1328

Counsel for Petitioner

INTERIM PRINTING & MAILING COMPANY

1108 West MORENA BOULEVARD, SAN DIEGO, CALIFORNIA 92110 — 275-3050

tt

APPENDIX A

A-1

IN THE SUPREME COURT OF

THE STATE OF CALIFORNIA

Crim. 20340

[Filed March 15, 1979]

| (HE PEOPLE OF THE STATE OF CALIFORNIA,

Plaintiff and Respondent,

Vv.

JAMES ROBERT PRIVITERA, JR., et al,

Defendants and Appellants

Under California Health and Safety Code

section 1707.1, it is a misdemeanor to

sell, deliver, prescribe or administer

any drug or device to be used in the

diagnosis, treatment, alleviation or cure

of cancer which has not been approved by

the designated federal agency (21 U.S.C.

§ 355) or by the state board (Health

& Saf. Code, § 1704).2/

LT

1/ Section 1707.1 provides: “The sale, of-

fering for sale, holding for sale, delivering,

| giving away, prescribing or administering of any

| drug, medicine, campound or device to be used

_ in the diagnosis, treatment, alleviation or cure

of cancer is unlawful and prohibited unless

(1) an application with respect thereto has

been approved under Section 505 of the Federal

Food, Drug and Cosmetic Act, or (2) there has

been approved an application filed with the

board setting forth: [4] (a) Full reports of

investigations which have been made to show

whether or not such drug, medicine, compound

or device is safe for such use, and whether

Such drug, medicine, compound or device is

effective in such use; [4] (b) A full list of

the articles used as components of such drug,

medicine, compound or device; [4] (c) a full

Statement of the composition of such drug,

medicine, campound or device; (d) A full

description of the methods used in, and the

facilities and controls used for, the manu-

facture, processing and packing of such drug,

medicine or compound or in the case of a device,

a full statement of its composition, properties

and construction and the principle or prin-

ciples of its operation; [{] (e) Such samples

of such drug, medicine, compound or device

and of the articles used as camponents of the

drug, medicine, compound or device as the

board may require; and [4] (f) Specimens

(End of fn. 1.)

A-3

Defendants James Robert Privitera, Jr.,

a medical doctor, William David Turner,

Phyllis Blanche Disney, Winifred Agnes

Davis, and Carroll Ruth Leslie were con-

victed by jury of the felony of con-

spiracy to sell and to prescribe an

unapproved drug--laetrile--intended for

the alleviation or cure of cancer. (Pen.

Code, § 182, subd. 1; Health & Saf.

Code, § 1707.1.) Davis and Turner were

also convicted of selling laetrile for

the alleviation or cure of cancer.

(Health & Saf. Code, & 1707.1.)

Viewed in the light most favorable to

the judgments (see People v. Reilly

(1970) 3 Cal.3d 421, 425), the evidence

amply supports the jury's conclusion

that defendants were involved in a com-

mon plan to import, prescribe, sell and

distribute laetrile (also referred to as

amygdalin or vitamin B-17) to cancer

patients. Dr. Privitera prescribed

laetrile for cancer patients and referred

his patients to Turner and Disney as sup-

pliers of laetrile. Disney referred

patients to Dr. Privitera for treatment.

Leslie and Disney worked as distribu-

tors in various residential areas. De-

A-4

fendants told prospective users that

laetrile is an effective treatment or

cure for cancer. Laetrile has not been

approved for that purpose by one of the

designated governmental agencies.

Defendants appeal on the ground that

the statute is unconstitutional. They

contend the right of privacy protected

by the federal and California Constitu-

tions includes a right to obtain lae-

trile or, more generally, a right of

access to drugs not recognized by the

government as effective. Fundamental

rights, defendants point out, may be

regulated only to the extent necessary

to achieve a compelling state interest.

Defendants argue the purported right to

obtain laetrile is fundamental and there-

fore the regulation challenged here must

be reviewed under the compelling state

interest standard. Section 1707.1 is

found to be unconstitutional, defend-

ants conclude, when measured against

that standard.

We hold the asserted right to obtain

drugs of unproven efficacy is not encom-

passed by the right of privacy embodied

in either the federal or the state Con-

A-5

stitutions. The appropriate standard of

review, therefore, is the rational basis

test, rather than the compelling state

interest test. We conclude section

1707.1 amply satisfies the applicable

standard by bearing a reasonable rela-

tionship to the achievement of the legi-

timate state interest in the health and

safety of its citizens.

THE UNITED STATES CONSTITUTION

The Supreme Court has held that regu-

lations limiting certain fundamental

rights may be justified only by a com-

pelling state interest (Kramer v. Union

Free School District (1969) 395 U.S.

621, 627; Shapiro v. Thompson (1969)

394 U.S. 618, 634; Sherbert v. Verner

(1963) 374 U.S. 398 406), and that

legislative enactments must be narrowly

drawn to express only the legitimate

state interest at stake (Griswold v.

Connecticut (1965) 381 U.S. 479, 485;

Aptheker v. Secretary of State (1964)

378 U.S. 500, 508; Cantwell v. Connecti-

cut (1940) 310 U.S. 296, 307-308). The

right of privacy, founded in the Four-

teenth Amendment's concept of personal

A-6

liberty and restriction upon state ac-

tion, has been declared a fundamental

right. (Roe v. Wade (1973) 410 U.S.

113, 152-155.) Thus, if the right of

privacy were implicated in this case

the challenged statute would, arguably,

be judged under the compelling state

interest standara.2/

However, a fundamental privacy right

is not at stake here. The interest de-

fendants allege is, apparently, "the

interest in independence in making

certain kinds of important decisions."

(Whalen v. Roe (1977) 429 U.S. 589,

599-600.) But the kinds of "important

decisions" recognized by the high

court to date as falling within the

right of privacy involve "matters relat-

ing to marriage, procreation, contracep-

tion, family relationships, and child

2/ However, as we shall see, even statutes

restricting exercise of a right found by the

United States Supreme Court to be a fundamental

privacy right are reviewed under the rational

ieee ee the danger to health is

Significant. (Roe v. Wade

113, 163.) , Supra, 410 U.S.

A-7

rearing and education'" (Whalen v. Roe,

supra, 429 U.S. at p. 600, fn. 26,

quoting Paul v. Davis (1976) 424 U.S.

693, 713), but do not include medical

treatment.

For this reason defendants' reliance

on Roe v. Wade, supra, 410 U.S. 113, is

misplaced. In that case a majority of

the high court held the decision to have

an abortion falls within the right of

privacy, a conclusion following from the

court's earlier decisions that acti-

vities relating to procreation (Skinner

v. Oklahoma (1942) 316 U.S. 535, 541-

542) and contraception (Eisenstadt v.

Baird (1972) 405 U.S. 438, 453-454) were

also protected by that right. (410 U.S.

at pp. 152-153.) However, emphasizing

that this privacy right is not absolute,

the court stated: "The Court's deci-

sions recognizing a right of privacy

also acknowledge that some state regula-

tion in areas protected by that right is

appropriate. As noted above, a State may

properly assert important interests in

safeguarding health, in maintaining

medical standards, and in protecting

potential life .... The privacy

A-8&

right involved, therefore, cannot be

said to be absolute." (410 U.S. at

pp. 153-154.)

Significantly, when danger to health

exists Roe v. Wade indicates that state

regulation shall be tested under the

rational basis standard. (410 U.S. at

p- 163.) Indeed, the high court held in

Roe v. Wade that a state may--without

encroaching upon any right of privacy--

further its important interest "in the

areas of health and safety" by requiring

abortions be performed at licensed in-

stitutions which “insure maximum safety

for the patient" and prohibiting per-

formance of abortion by a person not a

physician as defined by state law.

(410 U.S. at pp. 149, 150, 163-165.)

The lesson of Roe v. Wade for our case

is that a requirement that a drug be

certified effective for its intended use

is a reasonable means to "insure maxi-

mum safety for the patient."

In Planned Parenthood of Central

Missouri v. Danforth (1976) 428 U.S. 52,

the high court struck down a state pro-

hibition of a particular abortion pro-

A-9

cedure on the ground the prohibition did

not reasonably relate to preservation and

protection of maternal health. Signifi-

cantly, in discussing the validity of the

statutory prohibition of the medical

procedure, the court did not refer to any

constitutional considerations of privacy.

Rather the procedure was evaluated by

the court on the basis of medical evi-

dence of its safety and effectiveness

under the rational basis standard.

Planned Parenthood thus stands for the

proposition that although the decision

to have an abortion may be within the

constitutional zone of privacy deserving

the protection provided by the compelling

interest standard, the selection of a

particular procedure is a medical matter

to which privacy status does not attach

and which may be regulated by the govern-

ment, providing a rational basis for

such regulation exists.

Whalen v. Roe, supra, 429 U.S. 589

provides additional support for our con-

clusion that the appropriate standard

for reviewing section 1707.1 is the

rational basis test. In Whalen v. Roe

A-10

the high court upheld a New York

statute requiring that the patient's

name, address and age-~among other

information--be filed with the state

department of health whenever a

"Schedule II" drug is prescribed. 2/

Finding the state "had been unable to

demonstrate the necessity for the

patient-identification requirement on

the basis of its experience during the

first 20 months of administration of the

new statute," the district court held

that "the doctor-patient relationship

is one of the zones of privacy accorded

constitutional protection’ and that the

patient-identification provisions of the

Act invaded this zone with a ‘a need-

lessly broad sweep.'" (429 U.S. at

_3/ The New York statute classified poten-

tially harmful drugs in five schedules. Drugs,

such as heroin, which are highly abused and

have no recognized medical use, are in

schedule 1. Schedules II through V include

drugs which have a progressively lower po-en-

tial for abuse but also have a recognized

Take ica nek

re) itima

pp. 592-593.) ee Se

A-11

p. 596.) Rejecting the standard em-

ployed by the district court, the high

court reaffirmed that "State legisla-

tion which has some effect on individual

liberty or privacy may not be held un-

constitutional simply because a court

finds it unnecessary, in whole or in

part. For we have frequently recog-

nized that individual States have broad

latitude in experimenting with possible

solutions to problems of vital local

concern." (Id. at p. 597, fns. omitted.)

Although recognizing that, "[u] nques-

tionably, some individuals" concern for

their own privacy may lead them to avoid

or to postpone needed medical attention"

(id. at p. 602), the Supreme Court up-

held the patient-identification require-

ment under the rational basis test.

"The New York statute challenged in this

case represents a considered attempt to

deal with [a problem of vital local

concern]. It is manitestly the product

of an orderly and rational legislative

decision ... . There surely was

nothing unreasonable in the assumption

that the patient-identification require-

—

A-12

ment might aid in the enforcement of laws

designed to minimize the misuse of

dangerous drugs. For the requirement

could reasonably be expected to have a

deterrent effect on potential violators

as well as to aid in the detection or

investigation of specific instances of

apparent abuse. At the very least, it

would seem clear that the State's

vital interest in controlling the dis-

tribution of dangerous drugs would sup-

port a decision to experiment with new

techniques for control. For if an

experiment fails--if in this case ex-

perience teaches that the patient-

identification requirement results in

the foolish expenditure of funds to ac-

quire a mountain of useless information-—-

the legislative process remains avail-

able to terminate the unwise experiment.

It follows that the legislature's en-

actment of the patient-identification

requirement was a reasonable exercise of

New York's broad police powers." (Id.

at pp. 597-598.)

Finally, the high court reiterated:

"It is, of course, well settled that the

A-13

State has broad police powers in regulat-

ing the administration of drugs by the

health professions. Robinson v.

California, 370 U.S. [660], at 664-665;

Minnesota ex rel. Whipple v. Martinson,

256 U.S. [41], at 45; Barsky v. Board of

Regents, 347 U.S. 442, 449." (Whalen v.

Roe, supra, at p. 603, fn. 30.) Although

it had not done so, the court observed,

"the State no doubt could prohibit

entirely the use of particular Schedule

II drugs." (Id. at p. 603.) If the

state has the power to ban a drug with a

recognized medical use because of its

potential for abuse, then--given a ra-

tional basis for doing so--the state

clearly has the power to ban a drug not

recognized as effective for its intended

use.

The legitimate state interest expressed

in the challenged statute is set forth

in the legislative findings recited in

section 1700. "The effective diagnosis,

care, treatment or cure of persons

suffering from cancer is of paramount

public importance. Vital statistics in-

dicate that approximately 16 percent of

A-14

the deaths in the United States annual-

ly result from one or another of the

forms of cancer. It is established that

accurate and early diagnosis of many

forms of cancer, followed by prompt

application of methods of treatment’

which are scientifically proven, either

materially reduces the likelihood of

death from cancer or may materially

prolong the useful life of individuals

suffering therefrom. [4] Despite in-

tensive campaigns of public education,

there is a lack of adequate and ac-

curate information among the public

with respect to presently proven methods

for the diagnosis, treatment, and cure

of cancer. Various persons in this

State have represented and continue to

represent themselves as possessing

medicines, methods, techniques, skills,

or devices for the effective diagnosis,

treatment or cure of cancer, which

representations are misleading to the

public, with the result that large

numbers of the public, relying on such

representations, needlessly die of

cancer, and substantial amounts of the

A-15

savings of individuals and families

relying on such representations are need-

lessly wasted." (Health & Saf. Code,

§ 1700.)

These findings were recently echoed by

the Commissioner of the federal Food and

Drug Administration with specific refer-

ence to laetrile. "In the Commissioner's

opinion, the use of Laetrile in the

United States has become a genuine pub-

lic health problem. Increasingly,

doctors dealing with cancer patients are

finding that the patients are coming to

legitimate therapy too late, having de-

layed while trying Laetrile. It seems

clear that another substantial group of

persons afflicted with cancer is avoid-

ing effective therapy altogether and

using Laetrile instead. The question

has become one of life and death for

these patients and for others who may

be convinced to use Laetrile in the

future."» (42 Fed.Reg. 39769.)

The commissioner rendered his opinion

at the conclusion of a rulemaking pro-

ceeding undertaken in compliance with

the opinion of the court of appeals in

A-16

Rutherford v. United States (10th Cir.

1976) 542 F.2d 1137, and the order of the

district court in Rutherford v. United

States (W.D.Okla. 1977) 424 F.Supp. 105.

"Based upon a careful review of the ad-

ministrative record," the commissioner

found that "Laetrile is not generally

recognized by qualified experts as a

safe and effective cancer drug." (42

Fed.Reg. 39775.) The commissioner

further found laetrile does not qualify

for exemption from the new drug provi-

sion of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. § 301 et seq.)

by virtue of compliance with the 1962

grandfather clause of the act. (42 Fed.

Reg. 39795.) Distribution of laetrile

in interstate commerce, the commissioner

concluded, is thus illegal and subject

to regulatory activity by the Food and

Drug Administration.

Because of defendants' reliance on it,

subsequent developments in the Ruther-

ford case will now be considered.’ In

Rutherford v. United States (W.D.Okla.

1977) 438 F.Supp. 1287, the district

court set aside the commissioner's action

A-17

and enjoined federal authorities from

interfering with distribution of lae-

trile in interstate commerce or with

use of laetrile for the treatment of

cancer. The decision was based on two

grounds: First, contrary to the conclu-

sion reached by the commissioner, the

court held that laetrile is exempt from

the premarket approval requirement for

new drugs by virtue of compliance with

the 1962 grandfather clause. (438 F.

Supp. at pp. 1294-1298.) Second, con-

trary to the conclusion we reach today,

the court concluded the federal right

of privacy encompasses a "right to use

a nontoxic substance in connection with

one's own personal health-care." (Id.

at pw 430i.)

On appeal by the government, the court

of appeals addressed neither the grand-

father clause question nor the right of

privacy issue. Instead, the court

held that "the 'safety' and 'effective-

ness' terms used in the statute have no

reasonable application to terminally ill

cancer patients." "We are considering

only cancer patients who are terminally

A-18

ill and only their intravenous use of

Laetrile. Thus in this context, what

can ‘generally recognized' as 'safe'

and ‘effective’ mean as to such persons

who are so fatally stricken with a

disease for which there is no known

cure? What meaning can ‘effective'

have in the absence of anything which

may be used as a standard? Under this

record Laetrile is as effective as

anything else. What can ‘effective'

mean if the person, by all prevailing

standards. . . is going to die of can-

cer regardless of what may be done."

The permanent injunction granted by the

district court was continued but limited

only to permit procurement of intra-

venous injections of laetrile admin-

istered by a licensed medical practi-

tioner to persons who are certified by

a licensed medical practitioner to be

terminally ill of cancer in some form.

(Rutherford v. United States (10th Cir.

1978) F.2d (No. 77-2049; filed 10

July 1978) .) 4/

A-19

Defendants can take no comfort in the

court of appeals' decision for, unlike

Rutherford, this case is not an action

-

4/ On 22 January 1979 certiorari was granted

in Rutherford. (47 U.S.L.Week 3492, Dock.

No. 78-605.)

on behalf of the class of terminally ill

cancer patients. Whatever may be said in

favor of permitting "terminal" cancer

patients access to laetrile, there is no

indication in the record that defendants

sought to restrict their activities to

that class when prescribing, distribut-

ing and administering laetrile. Indeed,

the record reflects that Dr. Privitera

sometimes neither took a medical history

from nor personally examined the patients

for whom he prescribed laetrile. The lay

defendants, of course, were not qualified

to diagnose cancer, much less to deter-

mine whether a cancerous condition was

"terminal." )

Moreover, we are not prepared to re-

ject as unreasonable the explanation

given by the commissioner for the Food

and Drug Administration's refusal to

approve laetrile for use by “terminal”

5/

cancer patients.— The commissioner

5/ The court of appeals did not mention or

discuss the reasons given by the commissioner.

A-20

concluded: "[A]pproval of Laetrile re-

stricted to ‘terminal' patients would

lead to needless deaths and suffering

among (1) patients characterized as

*terminal' who could actually be helped

by legitimate therapy and (2) patients

clearly susceptible to the benefits of

legitimate therapy who would be misled

as to Laetrile's utility by the limited

approval program or who would be able

to obtain the drug through inevitable

leakage in any system set up to adminis-

ter such a program." (42 Fed.Reg.

39805.) Substantial evidence in the

administrative record appears to sup-

port the conclusion reached by the

, ass 6

commissioner. &/ Certainly the record in

($/ For example, with regard to the impos-

sibility of determining "who is terminal," the

commissioner cited Dr. Peter H. Wiernik,

Chief of the Clinical Oncology Branch of the

National Cancer Institute's Baltimore Cancer

Research Center, who stated "One major dif-

ficulty in making a particular chemical avail-

able for terminal patients only is that no one

can prospectively define the term 'terminal'

with any accuracy. A patient can be said to be

terminal only after he dies. Many patients who

are critically ill respond to modern day manage-

ment of cancer." This opinion was shared by

(Fn. 6 continued.)

A-21

this case does not inspire one with confi-

dence that advocates of laetrile would co-

operate with a regulation restricting it

to “terminal” cancer patients. In

studied defiance of current law,

Dr. Privitera prescribed and admin-

istered the drug as a cancer cure, ad-

vised his patients to discontinue con-

ventional treatment, and warned them

not to let their regular physicians

know they were taking laetrile.

In conclusion, we emphasize we are not

taking sides on the fiercely contested

medical questions regarding laetrile's

safety or efficacy as a cancer drug.

Laetrile advocates may yet be vindi-

cated in the court of scientific opin-

Dr. Joseph F. Ross, Professor of Medicine at

the University of California School of Medi-

cine at Los Angeles. Dr. Ross stated "(T]he

distinction of 'terminal' patients from

'non-terminal' may not be reliably determined

and an assumption that Laetrile may be given

to such patients with impunity may deprive

such patients of therapeutic measures which

could help them." As Helen Brown, Executive

Director of Cancer Control/Los Angeles, put it,

"No one knows if and when any patient is going

to die." (42 Fed.Reg. 39805.)

A-22

ion, for even as this is being written

the National Cancer Institute is seeking

approval from the Food and Drug Adminis-

tration to test laetrile on advanced

cancer patients. (Cancer Institute

Seeks to Test Laetrile, L.A. Times

(28 Sept. 1978) pt. I, p. 14, cols.

1-6.) Nor are we endorsing the deci-

sion the Legislature has made on the

basis of existing scientific evidence.

Whether cancer patients--especially

advanced cancer patients who have

unsuccessfully sought relief from con-

ventional therapy and who are fully

informed as to the consensus of scien-

tific opinion concerning the drug--

should have access to laetrile is clearly

a question about which reasonable per-

sons may differ. It is not our function

to render scientific or legislative

judgments. Rather, we must resolve a

narrow question: Does the challenged

legislation bear a reasonable relation-

ship to the achievement of the legiti-

mate state interest in the health and

safety of its citizens? We conclude

section 1707.1 does satisfy this

A-23

standard and that it therefore does not

encroach upon the fed-ral constitutional

cight of privacy.

THE STATE CONSTITUTION

Having determined the federal consti-

tutional right of privacy does not en-

compass a right of access to drugs of

unproven efficacy, we next determine

whether the voters of California in-

tended to create such a right in

November 1972 when they amended article

I, section 1 of our Constitution to

include among the various “inalien-

able" rights 7 "all people" the right

7

of "privacy."—

7/ Article I, section 1 (as reworded by

constitutional amendment in Nov. 1974) now

reads: "All people are by nature free and

independent , and have certain inalienable

rights. Among these are enjoying and de-

fending life and liberty, acquiring, possess~

ing, and protecting property, and pursuing

and obtaining safety, happiness, and privacy.

A-24

There is simply no evidence of such

intent. To the contrary, in White v.

Davis (1975) 13 Cal.3d 757, we ob-

served “the moving force behind the new

constitutional provision was a more fo-

cussed privacy concern, relating to the

accelerating encroachment on personal

freedom and security caused by increased

surveillance and data collection activity

in contemporary society. The new pro-

vision's primary purpose is to afford

individuals some measure of protection

against this most modern threat to per-

sonal privacy." (Id. at p. 774.) As we

further observed, "(t]he principal

objectives of the newly adopted provi-

sion are set out in a statement drafted

by the proponents of the provision and

included in the state's election bro-

chure," the beginning paragraphs of

which we then quoted: "'The prolifera-

tion of government snooping and data

collecting is threatening to destroy our

traditional freedoms. Government

agencies seem to be competing to compile

the most extensive sets of dossiers of

American citizens. Computerization of

A-25

records makes it possible to create

"cradle-to-grave" profiles of every

American. [4] At present there are

no effective restraints on the informa-

tion activities of government and busi-

ness. This amendment creates a legal

and enforceable right of privacy for

every Californian.' (Italics in the

original.)" (13 Cal.3d at p. 774.)

The election brochure argument by the

proponents of the provision "represents,

in essence, the only ‘legislative

history' of the constitutional amend-

ment available to us." (Id. at p. 775.)

In the absence of any evidence that the

voters in amending the California

Constitution to create a right of pri-

vacy intended to protect conduct of the

sort engaged in by defendants, we have

no hesitation in holding that section

1707.1 does not offend that constitu-

tional provision.

FAILURE TO PRESERVE

SEARCH AND SEIZURE ISSUE

Defendants finally contend that the

trial court erred in denying their mo-

tion to suppress certain evidence ob-

A-26

tained on execution of a telephonic

search warrant.

Subdivision (b) of section 1528 of the

Penal Code provides in pertinent part

that a magistrate may orally authorize a

peace officer to sign the magistrate's

name on a duplicate original search

warrant. Defendants argue that at-

tempted action under this provision

failed here because the person author-

ized to sign the magistrate's name--a

federal customs service special agent--

was not a "peace officer" under

California law.

The People correctly respond that

defendants are precluded from raising

this issue by their failure to preserve

it by appropriate objection below.

"(T]he general rule [is] that questions

relating to the admissibility of evi-

dence will not be reviewed on appeal in

the absence of a specific and timely

objection in the trial court on the

ground sought to be urged on appeal.

(See Evid. Code, § 353; People v.

Welch (1972) 8 Cal.3d 106, 114-115;

People v. De Santiago (1969) 71 Cal.2d

A-27

18, 22.) The contrary rule would de-

prive the People of the opportunity to

cure the defect at trial and would

"permit the defendant to gamble on an

acquittal at his trial secure in the

knowledge that a conviction would be

reversed on appeal.' (Coy v. Superior

Court (1959) 51 Cal.2d 471, 473.)"

(People v. Rogers (1978) 21 Cal.3d

542, 548.)

The reason for the rule is well illu-

strated here. While conceding a federal

customs agent is not, per se, a "peace

officer" under California law (see Pen.

Code, § 7, subd. 8, and § 830 et seq.),

the People suggest Agent Nadel may never-

theless have acquired such status by

process of cross-deputization. As the

issue was not raised below, the People

had no occasion to pursue the point and,

therefore, defendants may not raise it

now.

We have considered defendants' re-

maining contentions and find them to

lack merit.

The judgments of conviction are

affirmed.

WE CONCUR:

TOBRINER, J.

MOSK, J.

RICHARDSON, J.

MANUEL, J.

A-28

CLARK, J.

A-29

PEOPLE v. PRIVITERA

DISSENTING OPINION BY BIRD, C.J.

I respectfully dissent.

I do not question for a moment that

the effective treatment of persons suf-

fering from cancer is a matter of para-

mount public importance. However, we

are dealing here with a disease whose

causes and treatment continue to baf-

fle the medical community. Among

physicians and scientists themselves

there remains legitimate dispute as to

what is truly an effective program of

treatment for cancer. So long as there

is no clear evidence that laetrile is

unsafe to the user, I believe each in-

dividual patient has a right to obtain

the substance from a licensed physician

who feels it appropriate to prescribe

it to him.

Cancer is a disease with potentially

fatal consequences; this makes the

choice of treatment one of the more

important decisions a person may ever

make, touching intimately on his or her

A-30

being. For this reason, I believe the

right to privacy, recognized under both

the state and federal Constitutions, pre-

vents the state from interfering with a

person's choice of treatment on the sole

grounds that the person has chosen a

treatment which the state considers

"ineffective."

The right of privacy is a concept of

as yet undetermined parameters. Justice

Staniforth's opinion for the Court of

Appeal in this case provides as decent

a map through this difficult terrain

as I believe is available. For this

reason, I herewith reprint his

opinion. *

"Under California Health and Safety

Code section 1707.1,2/ it is a mis-

demeanor to sell, deliver, prescribe

Or administer any drug or device to be

1/ Health and Safety Code section 1707.1

provides:

"The sale, offering for sale, holding

for sale, delivering, giving away, prescrib-

ing or administering of any drug, medicine,

(Fn. continued)

* See page 2a for conment.

A-31

(Fn. 1 continued)

campound or device to be used in the diagnosis,

treatment, alleviation or cure of cancer is un-

lawful and prohibited unless (1) an applica-

tion with respect thereto has been approved

under Section 505 of the Federal Food, Drug

and Cosmetic Act [21 USCS § 355], or (2)

there has been approved an application filed

with the board setting forth:

"(a) Full reports of investigations

which have been made to show whether or not

such drug, medicine, compound or device is

safe for such use, and whether such drug,

medicine, compound or device is effective in

such use;

"(b) A full list of the articles used

as components of such drug, medicine, compound

or device;

"(c) A full statement of the camposi-

tion of such drug, medicine, campound or device;

"(d) A full description of the methods

used in, and the facilities and controls used

for, the manufacture, processing and packing of

A-32

* Since Justice Staniforth wrote the opinion

which I am setting forth here, the case of

Rutherford v. United States has continued its

way through the courts. In 1977 the Federal

Drug Administration held administrative proceed-

ings and determined that laetrile was a "new

drug," and that it should not receive agency

approval, since the drug was not proven "safe

and effective" in the treatment of cancer. The

case then returned to federal district court,

where the judge set aside the Federal Drug

Administration determination and enjoined the

agency from interfering with the use of laetrile

by terminally ill cancer patients. (Ruther-

ford v. United States (W.D. Okla. 1977) 438 F.

Supp. 1287, 1301.) On appeal, the Tenth Cir-

cuit Court of Appeals affirmed. The court

noted: "We are considering only cancer

patients who are terminally ill... . ([I]n

this context, what can ‘generally recognized'

as ‘safe and effective’ mean as to such persons

who are so fatally stricken with a disease for

which there is no known cure? What meaning

can ‘effective’ have in the absence of anything

which may be used as a standard?" (Rutherford

v. United States (10th Cir. 1978) F.2d -)

On Monday, January 22, 1979, the United States

Supreme Court agreed to hear the Rutherford

case. (See Los Angeles Times, Monday,

January 22, 1979, p. 1.)

A-33

used in the diagnosis, treatment, al-

leviation or cure of cancer which has not

been approved by the designated federal

agency (21 U.S.C.S. § 355) or by a state

board (Health & Saf. Code, § 1704).

Defendants, James Robert Privitera,

Jr., a medical doctor, William David

Turner, Phyllis Blanche Disney, Winifred

Agnes Davis, and Carroll Ruth Leslie, were

convicted by jury of a felony, conspiracy

to sell, to prescribe, an unapproved

drug, laetrile, intended for the al-

leviation or cure of cancer. (Pen.

(Fn. 1 continued)

such drug, medicine or compound or in the case

of a device, a full statement of its camposi-

tion, properties and construction and the

principle or principles of its operation;

"“(e) Such samples of such drug, medi-

cine, compound or device and of the articles

used as components of the drug, medicine, car

pound or device as the board may require; and

"(£) Specimens of the labeling and

asvertising proposed to be used for such drug,

medicine, campound or device."

PU NLIT FATE ON ot mmwan ne

A-34

Code, § 182, subd. 1; Health & Saf. Code,

§ 1707.1.) Davis and Turner were con-

victed of selling laetrile to be used

for the alleviation or cure of cancer

(Health & Saf. Code, § 1707.1.)

We view the evidence in the light most

favorable to the judgments. (People v.

Reilly, 3 Cal.3d 421, 425 [90 Cal.Rptr.

417, 475 P.2d 649].) The defendants

were involved in a common plan to im-

port, distribute and prescribe laetrile

(also referred to as amygdalin or vita-

min B-17) to cancer patients. Defendants

Turner and Davis were importers and chief

suppliers of the drug. Defendants Leslie

and Disney worked as the distribution

network in various residential areas.

Dr. Privitera prescribed amygdalin for

cancer victims (or to undercover state

agents represented to be cancer victims).

Dr. Privitera referred patients to Turner

and Davis to buy the amygdalin; Disney

referred patients to Dr. Privitera for

treatment.

The defendants told the prospective

users of the drug that amygdalin was an

effective treatment or cure for cancer.

A-35

Substantial evidence supports the jury

finding of a common plan or agreement to

supply and prescribe amygdalin as a can-

cer cure. lLaetrile has not been

"approved" by a designated governmental

agency.

I

Contentions of the Parties --

Factual and Legal

Dr. Privitera contends that California

Health and Safety Code section 1707.1 is

an unconstitutional invasion of the can-

cer victim's right to obtain and use

amygdalin in violation of rights

guaranteed by the United States Consti-

tution, Amendments I, IV, V, VI, VII,

VIII, and XIV, and California Constitu-

tion, article I, sections l, 7, 7 (a) and

15. This, he asserts, is an invasion of

the patient's right of privacy, his or

her right to be left alone in choice

of orthodox versus unorthodox treat-

ment of cancer. As a corollary and

necessary concommitant of the right of

privacy of the patient, Dr. Privitera

argues that the constitutional protec-

|

|

|

A-36

tion accorded the cancer victim's right

to utilize amygdalin in a program of nu-

tritional therapy extends to physicians

willing to administer the drug and to

persons willing to supply the drug for

the cancer victim's use. Argues

Dr. Privitera: "The protection of con-

stitutional guarantees of privacy and

personal liberty, therefore, extends not

only to the patient pursuing a course

of nutritional therapy but to the phy-

Sician who prescribes and administers

the therapy and to the person who fur-

nishes the essential components.”

Dr. Privitera does not challenge the

validity of the general or specific

regulatory laws to the extent they pro-

hibit the advertisement of amygdalin as

a cure for cancer (Health & Saf. Code,

§ 1714); or require amygdalin be labeled

in accordance with state law and regu-

lations (Health & Saf. Code, § 26463);

or impose standards on the manufacturing

and packing of amygdalin to insure

quality and prevent adulteration or de-

terioration, or the prohibition of the

sale of amygdalin to members of the

A-37

general public for the purpose of treat-

ing cancer by persons other than li-

censed physicians (Health & Saf. Code,

§ 26400 et seq.). (Health & Saf.

Code, §§ 1704, 26670, 1707.1, 1709;

17 Cal. Admin. Code, § 10400.1.)

Rather, Dr. Privitera's challenge is

directed to those laws, specifically

the one of which he is convicted, inso-

far as they prohibi€ a duly licensed

physician from administering amygdalin

to cancer patients and which prohibit

its sale to either licensed physicians

or persons who have obtained prescrip-

tions from a licensed physician.

(Health & Saf. Code, §§ 1700-1721.)

According to Dr. Privitera, this

right of choice of medical treatment is

a fundamental right of the individual

and regulations limiting this right may

be justified only by "compelling state

interests"; the legislative enactments

which seek to regulate or control in

the areas of such fundamental rights

must be narrowly drawn to protect only

the legitimate state interests at stake.

The specific drug here supplied or

prescribed is a substance known as

A-38

amygdalin, also known as laetrile, and

also known as vitamin B-17. Amygdalin

is a by-product of apricot pits. The

substance has been the subject of wide-

spread public dispute as to its efficacy

for the treatment of cancer. Orthodox

medicine, as represented by the American

Cancer Society, places it in the area

of nostrums. Its proponents vary in

their claims from that as a cure for

cancer or as simply a nutritional aid

causing the patient to gain weight, have

a better appetite, and a better emotion-

al outlook. It is generally conceded

that amygdalin is nontoxic; it does not

fall within the general ban of drugs

which are toxic, habit forming, addic-

tive, or otherwise distort reality.

Coventional medicine regards the

"evidence," “proof," of the curative

effect of amygdalin as anecdotal in

nature and contends the drug has never

been established by scientific method-

Ology to have any effect whatsoever

upon either the cure or retardation of

cancer growth. Despite the pros and

cons of the experts in the field of

= 39

medicine, and Sites from nonmedical

fields taking side on this issue, can-

cer victims in large numbers have

sought the relief, whatever its nature,

which is available from the use of this

drug. Where, as in Mexico and in West

Germany, the drug is available through

doctors and clinics, cancer victims,

able to travel, seek out and obtain the

treatment.

Dr. Privitera points out that many

cancer victims have investigated and

evaluated the merits of surgery, radia-

tion therapy or chemotherapy with the

aid of competent medical advice and have

made the highly personal decision [that]

the benefits from such therapy [are] not

sufficient to justify the risks which

include disfigurement, debilitation,

and accelerated death and for this reason

have chosen to seek amygdalin as a treat-

ment; other cancer victims have been

advised that their condition is hopeless,

their case is terminal and as a last re-

sort before certain death, seek amygdalin.

Dr. Privitera contends many concerned

cancer victims, competent and responsible

A-40

adults, seek and use amygdalin as a food

substance to ameliorate the horrifying

fhysical wasting away of the body

(cachexia) which accompanies cancer.

Thus they seek amygdalin not only for

its possible cancer curative benefits,

but also for its known nutritional bene-

fits. Cancer victims cannot be certain

amygdalin will either cure or control

cancer but they believe, based upon the

anecdotal, personal experience approach,

the drug provides relief from the ter-

rible pain, mental malaise, the emo-

tional depression and weight loss which

mark the progression of their disease.

The People assert, contrary to

Dr. Privitera's contentions, not a

Single accredited medical school in the

State of California teaches amygdalin

might be effective in the controlling or

curing of cancer. Further the use of

amygdalin as a form of nutritional

therapy is officially regarded by the

State Départment of Health, the Calif-

Ornia Medical Association, the National

Cancer Institute and a great block of

practicing physicians, to be of no value

A-41

whatsoever in the controlling or curing

of cancer.

Dr. Privitera specifically contends

section 1707.1 of the Health and Safety

Code is unconstitutional. It is a

denial of one aspect of individual

"liberty" protected by the due process

of the Fourteenth Amendment.

The patient, he asserts, has a right

of “privacy" or “a guarantee of certain

areas or zones of privacy." This is the

individual right of independence in

making certain kinds of important de-

cisions. The very nature of the rela-

tionship, the act to be performed, the

decision to be made, precludes unjusti-~

fied state presence. It is "the right

of the individual to be free in action,

thought, experience and velief from

governmental compulsion." (Kurland,

The Private I, University of Chicago

Magazine 7, 8, Autumn 1976.) It is that

right voiced by Justice Brandeis in his

dissent in Olmstead v. United States,

277 U.S. 438, 478 [72 L.Ed. 944,’ 956,

48 S.Ct. 564, 572, 66 A.L.R. 376] "the

right to be let alone", "the right most

A-42

valued by civilized men."

Historically this right of privacy was

first articulated as a constitutional

right in Griswold v. Connecticut, 381

U.S. 479 [14 L.Ed.2d 510, 85 S.Ct. 1678],

a decision holding unconstitutional a

Statute prohibiting the use of contra-

ceptives. However, the recognition of

the existence, innate in every human

being, of a zone of privacy is older

than the Bill of Rights, older than our

political parties, older that the state's

concern with the nature of treatment to

be received by cancer-ridden patients.

It is in the nature of man that such

right exists.

This principle, now of constitutional

dimension, has been embraced by many de-

cisions in a variety of situations. 2/

2/ In Morris L. Ernst's and Alan U. Schwartz's

Privacy: The Right To Be Left Alone (The Mac

Millan Co. 1963), the history and broad sweep of

this doctrine is documented. Samuel D. Warren

and Louis D. Brandeis, in The Right to Privacy

(1890) , 4 Harvard Law Review 193, state: "..

it has been found necessary from time to time to

define anew the exact nature and extent of such

protection."

A-43

(See In re Lifschutz, 2 Cal.3d 415, G32.

fn. 12 [85 Cal.Rptr. 829, 467 P.2d 557,

44 A.L.R.3da 1], and Roe v. Wade, 410 U.S.

113, 151-153 (35 L.Ed.2d 147, 175-177,

93 S.Ct. 705, 726).) This concept, when

placed in the doctor-patient relation-

ship is the “right to decide independ-

ently, with the advice of his physician,

to acquire and to use needed medication."

(Whalen v. Roe, 429 U.S. 589, 603 [51

L.Ed.2d 64, 75, 97 S.Ct. 869, 876, 878];

Doe v. Bolton, 410 U.S. 179, 197 [35

L.Ed.2d 201, 215-216, 93 S.Ct. 739,

750].) In re Lifschutz, supra, 2 Cal.3d

415, 431, 432, makes this profound in-

sight concerning Griswold: "Indeed,

the decision's concern for valued as-

pects of individual privacy may ulti-

mately aid in protecting man from the de-

humanization of an everencroaching

technological environment."

The People concede, as they must, the

fact, the existence of this expanding

and as yet judicially unmeasured con-

cept of individual privacy. However,

they contend the State of Califor..ia has

the broad power to establish and enforce

A-44

standards of conduct within its borders

ralative to health. This is a vital as-

pect of its police power. Within its

ambit is the authority of the state to

regulate the delivery of health services.

(Barsky v. Board of Regents, 347 U.S.

442, 449 [98 L.Ed. 829, 74 S.Ct. 650,

654]; People v. Nunn, 46 Cal.2d 460,

469 [296 P.2d 813].)

This broad premise authorizes the in-

vasion of the doctor-patient zone of

privacy by the state to prohibit the

doctor prescribing certain species of

drugs. (Blinder v. Division of Narcotic

Enforcement, 25 Cal.App.3d 174 [101

Cal.Rptr. 635].) The People point to

Whalen v. Roe, supra, 429 U.S. 589, 603,

fn. 30 [51 L.Ed.2d 64, 75, 97 S.Ct. 869,

878], and Paris Adult Theatre I v.

Slaton, 413 U.S. 49, 65, 67 [37 L.Ed.2a

446, 461-463, 93 S.Ct. 2628], in support

of this broad position.

The People concede any exercise of

police power, depends in the first in~

Stance upon an articulated public in-

terest in the activity to be regulated

and second, the means used must be rea-

A-45

sonably necessary for the accomplishment

of that public purpose. (Goldblatt v.

Hempstead, 369 U.S. 590, 594, 595 [8

L.Ed.2d 130, 133-135, 82 S.Ct. 987,990].)

At the heart of the People's defense of

Health and Safety Code section 1707.1 is

the premise, Legislature declared ,2/ that

3/ Health and Safety Code section 1700 pro-

vides:

"The effective diagnosis, care, treatment

or cure of persons suffering fram cancer is of

paramount public importance. Vital statistics

indicates that approximately 16 percent of the

total deaths in the United States annually re-

sult from one or another of the forms of cancer.

It is established that accurate and early diag-

nosis of many forms of cancer, followed by

prompt application of methods of treatment which

are scientifically proven, either materially re-

duces the likelihood of death from cancer or

may materially prolong the useful life of in-

dividuals suffering therefrom.

"Despite intensive campaigns of public

education, there is a lack of adequate and ac-

curate information among the public with re-

spect to presently proven methods for the

diagnosis, treatment, and cure of cancer. Vari-

ous persons in this State have represented and

continue to represent themselves as possessing

medicines, methods, techniques, skills, or de-

vices for the effective diagnosis, treatment,

or cure of cancer, which representations are

(Fn. 3 continued.)

A-46

early and accurate diagnosis of cancer

materially reduces the likelihood of

death, prolongs useful life; where false

Or misleading representations are made

to the public, large numbers rely upon

(Fn. 3 continued.)

misleading to the public, with the result that

large numbers of the public, relying on such

representations, needlessly die of cancer, and

substantial amounts of the savings of in-

dividuals and families relying on such repre-

sentations are needlessly wasted.

"It is, therefore, in the public interest

that the public be afforded full and accurate

knowledge as to the facilities and methods for

the diagnosis, treatment, and cure of cancer

available in this State and that to that end

there be provided means for testing and investi-

gating the value or lack thereof of alleged

cancer remedies, devices, drugs, or compounds,

and informing the public of the facts found,

and protecting the public fran misrepresenta-

tion in such matters.

"The importance of continuing scientific

research to emmy the cause or cure of can-

cer is recogniz , and the department shall

administer this chapter with due regard for

the importance of bona fide scientific re-

search and the clinical testing in hospitals,

clinics, or similar institutions of new

drugs or compounds."

A-47

such falsities, and needlessly die of

cancer.

The People contend the California

Legislature in enacting the statutory

scheme made this implicit finding:

Ineffective cancer remedies are more

hazardous to the patient than the

state sanctioned alternatives. (Health

& Saf. Code, § 1700.)

Concerning the efficacy of amygdalin,

this court, this opinion, does not

enter that fray. The effectiveness of

amygdalin as a cure for cancer or as a

nutritional aid with general health

giving benefits, is not, as a matter of

law, an issue when the charge is a vio-

lation of Health and Safety Code section

1707.1. The issue here is human liberty.

Can the informed cancer-ridden patient

be limited in choice of treatment re-

ceived from a state licensed physician

to "state sanctioned alternatives" ?~'

To resolve these contra-poised conten-

tions we must carefully analyze the na-

ture of the right protected.

4/ People v. Privitera, 55 Cal.App.3d Supp.

39 (128 Cal.Rptr. 151).

A-48

II

The Patient's Right to Privacy

The challenge of Dr. Privitera to

Health and Safety Code section 1707.1

resolves itself, upon analysis, into

two separate and distinct areas of

claimed constitutional rights; there is

the right of privacy of the patient to

choose or reject his or her own treat-

ment, Orthodox or unorthodox, approved

Or unapproved by the state. The second

contention is bifaceted: Dr. Privitera

asserts (1) a derivative right -- equal

in stature to that of his patient, and

(2) the doctor's independent right to

practice medicine generally and to pre-

scribe medicine, use procedures, without

unreasonable government restrictions.

We examine’ first the right of the

patient and determine this right is of

such fundamental nature its free exer-

cise may be impinged upon or forbidden

only by such state interest as may be a

"compelling interest."

The "fundamental" nature of this right

derives from its source. It flows from

i

A-49

the very nature of man. Justice Brandeis

in Olmstead v. United States, supra, 277

U.S. 438, 478 [72 L.Ed. 944, 956, 48

S.Ct. 564, 572], stated: “The makers of

our Constitution undertook to secure

conditions favorable to the pursuit of

happiness. They recognized the signifi-

cance of man's spiritual nature, of his

feelings and of his intellect. They knew

that only a part of the pain, pleasure

and satisfactions of life are to be found

in material things. They sought to pro-

tect Americans in their beliefs, their

thoughts, their emotions and their sen-

sations. They conferred, as against the

government, the right to be let alone --

the most comprehensive of rights and the

right most valued by civilized men. To

protect that right, every unjustifiable

intrusion by the government upon the

privacy of the individual, whatever the

means employed, must be deemed a viola-

tion... ." (Italics added.)

Judge Cardozo in Schloendorff v.

Society of New York Hospital, 211 N.Y.

125 {105 N.E. 92, at page 93] stated:

“Every human being of adult years and

A-50

sound mind has a right to determine what

shall be done with his own body; ...."

The right to control one's own body is

not restricted to the wise; it includes

the “foolish” refusal of medical treat-

ment. Nor is this right limited in its

recognition to any single segment of the

political, economic, or social thought

spectrum. In commenting upon Justice

Brandeis' most valued of rights, that

right to be left alone, now Chief

Justice Burger, in his dissent in

Application of President & Directors

of aCe eae Vek. 331 F.2d 1010, at

page 1017, stated: "Nothing in this

utterance suggests that Justice Brandeis

thought an individual possessed these

rights only as to sensible beliefs,

valid thoughts, reasonable emotions,

or well-founded sensations. I sug-

gest he intended to include a great

many foolish,.unreasonable and even

absurd ideas which do not conform,

Such as refusing medical treatment even

at great risk."

Without specific reference to a consti-

tutional basis, the right to choose what

A-51

may be a suicidal medical course has been

upheld. In Erickson v. Dilgard, 44 Misc.

2a 27 [252 N.¥.S.2d 705, 706] a New York

court sustained the unwilling Jehovah's

Witness' objection to a needed blood

transfusion despite risk of death.

The court there said at page 706:

". . . it is the individual who is the

subject of a medical decision who has

the final say and that this must neces~-

sarily be so in a system of government

which gives the greatest possible pro-

tection to the individual in the

furtherance of his own desires.”

For analogy we look to the very heart

of this right of choice of medical pro-

cedures, the right to beget or not to

beget a child. In the case of Griswold

v. Connecticut, supra, 381 U.S. 479 the

Supreme Court held unconstitutional a

Connecticut statute prohibiting the use

of contraceptives. Following Griswold a

series of United States Supreme Court

cases have attempted to ascertain the

boundaries of this aspect of privacy.

The outer limits have not yet been de-

termined. However, it is made clear by

th

A-52

decision that unjustified government

interference with personal decisions

". »« « relating to marriage, Loving v.

Virginia, 388 U.S. 1, 12 (1967); pro-

creation, Skinner v. Oklahoma, 316 U.S.

535, 541-542 (1942); contraception,

Eisenstadt v. Baird, 405 U.S. at 453-

454 id., at 460, 463-465 (White, J.,

concurring in result); family relation-

ships, Prince v. Massachusetts, 321 U.S.

158, 166 (1944); and child rearing and

education, Pierce v. Society of Sisters,

268 U.S. 510, 535 (1925), Meyer v.

Nebraska, supra“ (Roe v. Wade, supra,

410 U.S. 113, 152-153 [35 L.Ed.2d 147,

177, 93 S.Ct. 705, 726]) violate this

concept.

Roe v. Wade, supra, 410 U.S. I13 dealt

specifically with the ‘rights to deter-

mine one's-own medical treatment. The

United States Supreme Court held that the

mother's constitutional right of privacy

was broad enough to encompass her deci-

sion whether to terminate her pregnancy

before 'the end of the first trimester of

pregnancy. Said the court at page 163

[35 L.Ed.2d at p. 182]: “With respect

A-53

to the State's important and legitimate

interest in the health of the mother the

‘compelling' point, in light of present

medical knowledge, is at approximately

the end of the first trimester."

(Roe v. Wade, supra, 410 U.S. 113, 163

(35 L.Ed. 2d 147, 182, 93 S.Ct. 705,

731).)

In the companion case, Doe v. Bolton,

supra, 410 U.S. 179 the United acne

Supreme Court held the statutes requir-

ing abortions to be conducted in hospi-

tals, or accredited hospitals, requiring

the interposition of a hospital abortion

committee and thus limiting abortions to

those circumstances was unconstitutional.

In vindicating the woman's right of

choice of medical care, the Supreme

Court stated: "The woman's right to re-

ceive medical care in accordance with

her licensed physician's best judgment

and the physician's right to administer

it are substantially limited by this

statutorily imposed overview." (Doe v.

Bolton, supra, 410 U.S. 179, 197 [35

L.Ed.2a 201, 216, 93 S.Ct. 739, 750).-)

To support its conclusion, the Supreme

A-54

Court examined the role of the licensed

physician, saying: "“If a physician is

licensed by the State, he is recognized

by the State as capable of exercising

acceptable clinical judgment. If he

fails in this, professional censure and

deprivation of his license are available

remedies. Required acquiescence by co-

practitioners has no rational connection

with a patient's needs and unduly in-

fringes on the physician's right to

practice. The attending physician will

know when a consultation is advisable --

the doubtful situation, the need for

assurance when the medical decision is a

delicate one, and the like. Physicians

have followed this routine historically

and know its usefulness and benefit for

all concerned. It is still true today

that '[{rJeliance must be placed upon the

assurance given by his license, issued by

an authority competent to judge in that

respect, that he [the physician] pos-

sesses the requisite qualifications.'

Dent v. West Virginia, 129 U.S. 114,

122-123 (1889). See United States v.

Vuitch, 402 U.S. at 71." (Doe v. Bolton,

ee

A-55

supra, 410 U.S. 179, 199-200 [35 L.Ed.2d

Sa SET, Fs. Sree. T39,° TS s9

In Whalen v. Roe, supra, 429 U.S. 589,

the United States Supreme Court con-

sidered the New York statutory require-

ments with respect to prescriptions for

“dangerous, legitimate" drugs. The

requirement in question was that of

notification. The court balanced the

invasion of the zone of privacy against

the public's right involved and con-

cluded that with respect to the particu-

lar type of drugs involved the statutes

were a reasonable exercise of the state's

broad police power. In so holding the

court discussed the right of an individu-

al to choice of treatment saying: "Nor

can it be said that any individual has

been deprived of the right to decide in-

dependently, with the advice of his

physician, to acquire and to use needed

medication. . . . Within dosage limits

which appellees do not challenge, the

decision to prescribe, or to use, is left

entirely to the physician and the pa-

tient." (Whalen v. Roe, supra, 429 U.S.

589, 603 [51 L.Ed.2d 64, 75-76, 97

S.Ct. 869, 878].)

A-56

Concerning the doctor's "right to

practice" Whalen points out: "The

appellee doctors argue separately that

the statute impairs their right to

practice medicine free of unwarranted

state interference. If the doctors'

claim has any reference to the impact

of the 1972 statute on their own pro-

cedures, it is clearly frivolous. For

even the prior statute required the

doctor to prepare a written prescription

identifying the name and address of the

patient and the dosage of the prescribed

drug. To the extent that their claim has

reference to the possibility that the

patients' concern about disclosure may

induce them to refuse needed medication,

: ; ; ‘

the doctors' claim is derivative from,

and therefore no stronger than, the

patients'. Our rejection of their

claim therefore disposes of the doctors'

as well." (Italics added; Whalen v.

Roe, supra, 429 U.S. 589, 604 [51

L.Ed.2d 64, 76, 97 S.Ct. 869, 879].)

Carey v. Populations Services Intern.,

oni ee. > 192 2.88.38 675, 97-6. Ct.

2010], examines the question involving

A-57

the availability of contraceptives to

minors. The Supreme Court held the right

to privacy in matters affecting procrea-

tion extends to minors as well as adults.

The California Supreme Court has set

forth as a "postulate" or "axiomatic"

the right to choose one's own "lawful"

treatment. In Cobbs v. Grant, 8 Cal.3d

229, at page 242 [104 Cal.Rptr. 505,

502 P.2d 1], the court, in determining

the duty of the physician to secure the

informed consent of the patient to treat-

ment, said: "Preliminarily we employ

several postulates. . .. The second

is that a person of adult years and in

sound mind has the right, in exercise

of control over his own body, to de-

termine whether or not to submit to law-

ful medical treatment.”

Aden v. Younger, 57 Cal.App. 3d 662

[129 Cal.Rptr. 535], held unconstitu-

tional the provisions of Welfare and

Institutions Code section 5326.4 requir-

ing substantive review by a mecial com-

mittee of a voluntary, competent pa-

tient's consent to choice of electro-

shock treatment. It was an unjustified

A-58

infringment of the patient's right to

privacy. This court stated at page 684:

"Where informed consent is adequately

insured, there is no justification for

infringing upon the patient's right to

privacy in selecting and consenting to

the treatment. The state has varied

interests which are served by the regu-

lation of ECT, but these interests are

not served where the patient and his

physician are the best judges of the

patient's health, safety and welfare.

". . . Any possible need which exists

for the voluntary and competent patient

cannot prevail in the face of the seri-

ous infringement to the patient's right

to privacy as guaranteed by Roe v.

Wade, supra, 410 U.S. 113 and Doe v.

Bolton, supra, 410 U.S. 179." (Aden

v. Younger, supra, 57 Cal.App.3d 662,

684.)

This right of choice-of-medical-

treatment concept reached its quintes-

sence in the Matter of Quinlan, 70 N.J.

10 [355 A.2d 674]. The New Jersey

Supreme Court was called upon to deter-

mine whether the father, as guardian of

A-59

Karen Quinlan, a 2l-year-old giri exist-

ing in a "persistent vegetative state,"

could be authorized to discontinue the

extraordinary procedures sustaining the

daughter's vital processes. The first

question was: Did the comatose Karen

Quinlan or her father havea right of

choice to choose death or life? And

secondly, could the father, through the

court guardianship procedures, be

authorized on her behalf to make such a

choice. The court authorized, through

the father-guardian, the withdrawal of

the life support processes. The right

of privacy inherent in the exceptional

circumstances of that case authorized

the rejection of the life support sys~-

tems. Reasoned the court: "The claimed

interests of the State in this case are

essentially the preservation and sanctity

of human life and defense of the right of

the physician to administer medical treat-

ment according to his best judgment. In

this case the doctors say that removing

Karen from the respirator will conflict

with their professional judgment."

(Matter of Quinlan, supra, 70 N.J. 10

A-60

{355 A.2d 647, 663].)

Yet, the court affirmed Karen's right

to choice, had she been competent to

assert it, and authorized the father to

exercise it on her behalf: ". ..

there would be no criminal homicide in

the circumstances of this case. ...

even if it were to be regarded as homi-

cide, it would not be unlawful." (Matter

of Quinlan, Supra, 70 N.J. 10 [355 A.2d

647, 669-670].) Concerning the interests

of the state in preservation of human

health and life the court said: “We

have no hesitancy in deciding, in the

instant diametrically opposite case, that

no external compelling interest of the

State could compel Karen to endure the

unendurable, ... ." (Matter of

Quinlan, supra, 70 N.J. 10 [355 A.2d 647,

663] .)

III

The Doctor's Zone of Privacy

Dr. Privitera asserts a separate and

distinct constitutionally protected

right -- a zone of privacy -- to pre-

scribe, to treat patients whether in the

A-61

orthodox mode -- free from unjustified

state interference.

Whalen v. Roe, supra, 429 U.S. 589,

accepts as a premise the existence of

the right of the individual patient to

choose independently with the advice of

his physician to use or not to use a4

particular medication. Said the

Supreme Court at page 603 [51 L.Ed.2d

at p. 75): "Nor can it be said that

any individual has been deprived of the

right to decide independently, with the

advice of his physician, to acquire and

to use needed medication." However,

with respect to the doctor's right to

freedom to treat, to minister to the

sick, in Whalen v. Roe, supra, 429 U.S.

589, we have heretofore noted the Supreme

Court's determination the "doctors'

claim is derivative from, and therefore

no stronger than, the patients'."

Doe v. Bolton, supra, 410 U.S. 179,

however, speaks specifically of the

doctor's right to administer medical

care. Bolton involved a constitutionally

defective statute requiring the consent

of two state licensed physicians other

A-62

than the patient's own doctor before an

abortion could be performed as well as

advance approval of three members of the

hospital staff where the abortion was to

be performed. Concerning this statute

the Supreme Court said: "The woman's

right to receive medical care in accord-

ance with her licensed physician's best

judgment and the physician's right to

administer it are substantially limited

by this statutorily imposed overview."

(Doe v. Bolton, Supra, 410 U.S. 179, 197

(35 L.Ed.2d 201, 216, 93 S.Ct. 739 750];

italics added.)

Dr. Privitera additionally asserts an

independent right to treat, not derived

from or measured by his patient's right

of choice, without first obtaining

approval of the procedure or drug pre-

scribed from a governmental board. He

argues Health and Safety Code section

1707.1 invades this right. Again, as in

the right of the patient, the doctor's

asserted right must be first examined

to determine its nature and thereby

select the test, the degree of scrutiny

to which the state interference will be

A-63

put. The right found must be balanced

against the state -- the public interest

protected.

Dr. Privitera's right, in relation to

the patient, has been viewed tradition-

ally as a species of economic interest

rather than as "fundamental" akin to

the privacy right. If a rational basis

was found to support an encroachment,

the statute was sustained.

While a dispassionate reading of the

physician's licensing requirements raises

some question concerning the total ra-

tionality of the licensing scheme, such

standards are generally upheld as rea-

sonable and necessary means of protect-

ing the public health.

The more recent cases hint at the more

profound right in the doctor. It is pos-

tulated: There exists in the doctor

licensed to practice medicine a right,

constitutional in nature, as yet ill-

defined, to treat and to treat by un-

orthodox modalities -- as yet unapproved

by the state board -- an informed con-

senting patient.

Doe v. Bolton, supra, 410 U.S. 179,

A-64

200 [35 L.Ed.2d 201, 217, 93 S.Ct. 739,

751], states if a physician is licensed

by the state he is recognized by the

state as capable of expressing accept-

able clinical judgment. I£ he fails

in this, professional censure and depri-

vation of his license are remedies avail-

able and "reliance must be placed on the

assurance given by his license ... that

he possesses the requisite qualifica-

tions.”

Roe v. Wade, supra, 410 U.S. 113, 163

(35 L.Ed.2d 147, 183, 93 S.Ct. 705, 732],

states concerning the termination of

pregnancy during the first trimester:

- « - the attending physician, in

consultation with his patient, is free

to determine, without regulation by

the State, that in his medical judg-

ment, the patient's pregnancy should

be terminated." (Italics added.)

Reason based on history, experience,

Supports the doctor's premise. To re-

quire prior state approval before

advising -- prescribing-administering --

a new treatment modality for an informed

consenting patient is to suppress in-

A-65

novation by the person best qualified to

make medical progress. The treating doc-

tor, the clinician, is at the cutting edge

of medical knowledge.

To require the doctor to use only

orthodox "state sanctioned" methods

of treatment under threat of criminal

penalty for variance is to invite a

repetition in California of the Soviet

experience with "Lysenkoism. "=/ The

mention of a reqvirement that licensed

doctors must prescribe, treat, within ,

5/ Soviet geneticist T.D. Lysenko, contro-

versial dictator of "communistic" biology

during the Stalin period, stultified the

science of genetics in the U.S.S.R. for at

least a generation. He imposed the "state

sanctioned alternative," the curious idea that

environmentally acquired characteristics of an

organism could be transmitted to the offspring

through inheritance. Thus, the Stalinist

concept of ideological conformity politically

implanted in genetics paralyzed this imr

portant branch of Soviet science.

A-66

"state sanctioned alternatives" raises

the spector of medical stagnation at

best, statism, paternalistic Big Brother

at worst. It is by the alternatives to

orthodoxy that medical progress has been

made. A free, progressive society has

an enormous stake. sin recognizing and

BRT > IR this right of the physi-

cian.—

6/ Lest the reader suspect these conclusions

are alarmist, without relevance to here and now

reference is made to Drug Regulation and

Innovation ~~ Empirical Evidence and Policy

Options, by Henry G. Grabowski (1976). This

is a summary of studies made -- cost versus

benefit analysis of the effects of the 1962

amendment which clothed the Federal Drug

Administration with the authority to test new

drugs for their "effectiveness" before permit-

ting general prescription and use.

One study surveyed was that by Sam Peltz-

man. He researched the effect of the 1962

amendment on drug innovation: "In effect,

Peltzman's +» « » Suggests that the rate of in-

novation in the post-amendment period is more

eg eee Ae eee amend-

; Did the Federal Drug Administration ef-

fectively weed out ineffective drugs? Peltzman's

study shows: ". . . analysis of evaluations by

medical experts suggests that the proportion of

ineffective drugs has remained roughly the same

(Fn. 6 continued.)

A-€7

(Fn. 6 continued.)

in the pre-1962 and post-1962 periods. Given

that the rate of new drug introductions was more

than halved in the post-amendment period, his

analysis therefore suggests that a large de-

cline took place in effective drugs." (Italics

added. )

The conclusion reached by Professor

Grabowski: "A consistent finding is that

regulation has had a significant negative effect

on the rate of innovation. While each of the

individual studies has shortcomings, taken to-

gether they would seem to provide considerable

support for the hypothesis that regulation has

been one of the principal factors responsible

for the observed decline in innovation."

Professor Grabowski's study shows: "An

indication of the change is the decline in dis-

covery and development of new chemical entities

by U.S. firms -- an initial decline from more

than one-third of worldwide introductions in

the year before the 1962 amendments to the Food,

Drug, and Cosmetic Act to less than one-quarter

of the total in 1963 . . . and unfortunately,

exports of pharmaceuticals as a share of U.S.

exports have declined by one-third since the

1950s."

(Fn. 6 continued.)

A-68

(Fn. 6 continued.)

Decline in innovation is bad enough yet

che giliebn*e tiene hits ak Ree enone: |

According to Professor Grabowski: "One of the

bitter ironies of this situation is that the

1962 amendments were spurred by an alarm over

the safi of new drugs -- by the fears

crea by the thalidomide incident. The

irony lies in the fact that the 1972 amendments

are keeping off the market new drugs that are

safer than the drugs they would replace. Pro-

fessor William Wardell's study of the lags in

the introduction of new drugs in the United

States cites, as one example, the five-year

delay in the appearance on the U.S. market of

a benzodiaze-pine hypnotic. If it had been

available in the United States as it was in

Great Britain during those five years, Pro-

fessor Wardell estimates that 1,200 lives would

have been saved.5/"

"S/ William M. Wardell, ‘Therapeutic

Implications of the Drug lag,' Clinical

Pharmacology and Therapeutics, vol. 15, no. 1

(January 1974), p. 83." (Henry G. Grabowski,

Drug Regulation and Innovation -—- Empirical

Evidence and Policy Options, p. 2.)"

A-69

IV

The Right of Privacy --

Article I, Section 1, of the

California Constitution

Thus far we have considered only the

specific guarantees of the federal bill

of rights and the emanations formed

therefrom in concluding fundamental

rights are encroached by section 1707.1

However: "'{I]n the area of fundamental

civil liberties -- which includes...

all protections of the California

Declaration of Rights -- we sit...

subject only to the qualification that

our interpretations may not restrict

the guarantees accorded the national

citizenry under the federal charter.

In such constitutional adjudication, our

first reference is California law and the

full panoply of rights Californians

have come to expect as their due. Ac-

cordingly, decisions of the United

States Supreme Court defining fundamental

rights are’ persuasive authority to be

afforded respectful consideration, but

are to be followed by California courts

only when they provide no less indivdual

A-70

protection than is guaranteed by California

law.'" (Serrano v. Priest, 18 Cal.3d 728,

764, (135 Cal.Rptr. 345, 557 P.2d 929]

quoting People v. Longwill, 14 Cal.3d 943,

951, fn. 4 [123 Cal.Rptr. 297, 538 P.2d

753).) (See also People v. Disbrow, 16

Cal.3d 101, 114-115 [127 Cal.Rptr. 360,

545 P.2d 272]; People v. Norman, 14 Cal.

3d 929, 939 [123 Cal.Rptr. 109, 538 P.2d

237); People v. Brisendine, 13 Cal.3d

528, 548-552 [119 Cai.Rptr. 315, 531

P.2d 1099]; Burrows v. Superior Court,

13 Cal.3d 238, 245-246 [118 Cal.Rptr.

166, 529-P.2d 590); Mandel v. Hodges,

54 Cal.App.3d 596, 615-617 [127 Cal.

Rptr. 244]; State v. Kaluna, 55 Hawaii

361 (520 P.2d 51, 58-59]; Baker v. City

of Fairbanks, 471 P.2d 386, 401-402; see

generally Note, Project Report: Toward

an Activist-Role for State Bills of

Rights (1973) 8 Harv.Civ.Rights -- Civ.

Lib.L.Rev. 271; Falk, Foreword: The

State Constitution: A More than

"Adequate" Nonfederal Ground (1973) 61

Cal.L.Rev. 273; Note, Rediscovering the

California Declaration of Rights (1974)

26 Hastings L.J. 481.)

A-71

It is an "incontrovertible conclusion

that the California Constitution is, and

always has been, a document of independ-

ent force. Any other result would con-

tradict not only the most fundamental

principles of federalism but also the

historic bases of state charters."

(People v. Brisendine, supra, 13 Cal.3d

528, 549-550.) We therefore must evalu-

ate the rights infringed by section

1707.1 in light of our own Constitution.

Article I of the state charter is the

California Declaration of Rights. Its

first section establishes certain inalien-

able rights: "All people are by nature

free and independent and have inalien-

able rights. Among these are enjoying

and defending life and liberty, acquir-

ing, possessing and protecting property,

and pursuing and obtaining safety,

happiness, and privacy." (Italics

added.) "The [federal] Constitution

does not explicitly mention any right of

privacy." (Roe v. Wade, supra, 410 U.S.

113, 152 (35 L.Ed.2d 147, 176, 93 S.Ct.

705, 726].) Neither did the California

Constitution. However, "[i]n November

A-72

1972, the voters of California speci-

fically amended article I, section 1 of

our state Constitution to include among

the various ‘inalienable’ rights of

‘all people’ the right of ‘privacy.'"

(White v. Davis, 13 Cal.3d 757, 773

[120 Cal.Rptr. 94, 533 P.2d 222]).)

The California Supreme Court first ad-

dressed the significance of the new pro-

vision in White v. Davis, supra, 13 Cal.

3d 757, 773-776. In that case the com-

plaint asserted certain government sur-

veillance and data-gathering activities

abridged students' and teachers' con-

stitutional right of privacy. In re-

versing a judment entered upon the

sustaining of a general demurrer, the

court concluded the activities chal-

lenged did fall within the aegis of

article I, section l. The court

"intimate[d] no opinion as to the

resolution of the ultimate constitu-

tional question after trial" (White

v. Davis, supra, 13 Cal.3d 757, 776),

and did not purport to sketch "the full

contours of the new constitutional pro-

vision." {Id., at p. 773.) Neverthe-

A-73

less, we are aided by its observations

and analysis.

"The principal objectives of the newly

adopted provision are set out in a

statement drafted by the proponents of

the provision and included in the state's

election brochure." (Id., at p. 774.)

This statement represents, in essence,

the only "legislative history" of the

constitutional amendment available

(id., at p- 775), and "California de-

cisions have long recognized the pro-

priety of resorting to such election

brochure arguments as an aid in con-

struing legislative measures and con-

stitutional amendments adopted pur-

suant to a vote of the people." (Id.,

at fn. 11.)

After review of the ballot statements

in White v. Davis, supra, 13 Cal v3: 757,

the Supreme Court concluded: "Although

the general concept of privacy relates,

of course, to an enormously broad and

diverse field of personal action and

belief, the moving force behind the new

constitutional provision was a more

focussed privacy concern, relating to

A-74

the accelerating encroachment on personal

freedom and security caused by increased

surveillance and data collection ac-

tivity in contemporary society. The new

provision's primary purpose is to afford

individuals some measure of protection

against this most modern threat to per-

sonal privacy." (Id., at pp. 773-774.)

The rights here relied upon by Pri-

vitera do not fall within that "more

focused privacy concern" of White v.

Davis, supra, 13 Cal.3d 757; but

rather relates to the "enormously

broad and diverse field of personal be-

lief and action." The state here does

not seek to surveil or collect data

about laetrile users or distributors.

It seeks to circumscribe an even more

profound compelling interest, that

right which is but an "outward mani-

festation of the inward domain of the

consciousness," the right to be left

alone.

To find the legislative intent of the

people of the State of California in

enacting the amendment to article I,

section 1, we look to the language of

"

A-75

the election brochure which extends

beyond data collection into the broader

area of freedom of personal action and

belief. The argument in favor of the

amendment stated:

"The right of privacy is the right to

be left alone. It is a fundamental and

compelling interest. It protects our

homes, our families, our thoughts, our

emotions, Our expressions, Our person-

alities, our freedom of communion, and

our freedom to associate with the people

we choose.

"The right of privacy is an important

American heritage and essential to the

fundamental rights guaranteed by the

First, Third, Fourt, Fifth and Ninth

Amendments to the U.S. Constitution.

This right should be abridged only when .

there is compelling public need."

(Italics added.)

The proponents of the amendment further

stated (in rebuttal): "The right to

privacy is much more than ‘unnecessary

wordage.' It is fundamental in any

free society. Privacy is not now guar-

A-76

anteed by our State Constitution. This

simple amendment will extend various

court decisions on privacy to insure

protection of our basic rights."

(Italics added.)

This “legislative history” closely

parallels the thoughts -- uses the exact

words -- of Justice Brandeis in his

prescient dissent in Olmstead v. United

States, supra, 277 U.S. a38.2/

7/ As if he had this case in mind, Brandeis

insightfully cautioned: "Experience should

teach us to be most on our guard to protect

liberty when the government's purposes are

beneficent. Men born to freedom are naturally

alert to repel invasion of their liberty by

evil-minded rulers. The greatest dangers to

liberty lurk in insidious encroachment by

men of zeal, well-meaning but without under-

ing." (Olmstead v. United States,

supra, 277 U.S. 438, 479 [72 L.Ed. 944, 957,

48 S.Ct. 564, 572-573]; Brandeis, J.,

dissenting. )

A-77

Like Brandeis, the people of Calif-

ornia have recognized the right to be

left alone -- the right to be free in

the sphere of private action. It is

“fundamental.” It protects "our homes,

our families, our thoughts, our emo-

tions, our expressions, our personal-

ee.

8/ Philosopher John Stuart Mill in his

classic work On Liberty (George Routledge

1905) sets forth the philosophic underpinnings

for this recently enunciated right to be left

alone:

"(T]here is a sphere of action in which

society, aS distinguished from the individual,

has, if any, only an indirect interest; compre-

hending all that portion of a person's life and

conduct which affects only himself, or if it

also affects others, only with their free,

voluntary, and undeceived consent and partici-

pation. When I say only himself, I mean di-

rectly, and in the first instance; for what-

ever affects himself, may affect others

through himself; . . . . This, then, is the

appropriate region of human liberty. It com

prises, first, the inward domain of consciousness;

demanding liberty of conscience, in the most com

prehensive sense; liberty of thought and feeling;

absolute freedom of opinion and sentiment on all

subjects, practical or speculative, scientific,

moral, or theological. . . . Secondly, the

principle requires liberty of tastes and pur-

suits; of framing the plan of our life to suit

(Fn. 8 continued.)

A-78

Based upon the "legislative intent"

derived from the express language of the

election brochure we conclude a right, of

California constitutional dimension, was

enacted. This right is not just a shield

against threats to personal freedom posed

by modern surveillance and data collect-

ing activities. This state-protected

right of privacy encompasses a fundamen-

tal and compelling interest of the cancer

patient to choose or reject his or her

own medical treatment on the advice of a

licensed medical doctor. This right can

be abridged only where there is compell-

ing need.

(Fn. 8 continued)

our own character; of doing as we like, subject

to such consequences as may follow: without im

pediment fram our fellow-creatures, so long as

what we do does not harm them, even though they

should think our conduct foolish, perverse, or

ee

". . . The only freedom which deserves the

name, is that of pursuing our own good in our own

way, SO long as we do not attempt to deprive

others of theirs, or impede their efforts to ob-

tain it. Each is the proper guardian of his own

health, whether bodily, or mental and spiritual.

Mankind are greater gainers by suffering each

(Fn. 8 continued.)

A-79

V

The Nature of the State's Interest

We have established this premise: The

patient's and Dr. Privitera's rights of

privacy are of such magnitude only a com-

pelling state interest can justify in-

trusion in the patient-doctor treatment

setting. We now consider the strength

of that state interest. Does Health and

Safety Code section 1707.1 serve a com~

pelling state interest which overrides

the rights so found ?2/ Indeed, a state

has a profound interest in maintaining

medical standards and in protecting

health, life. This justifies the test~-

(Fn. 8 continued.)

other to live as seems good to themselves, than

by compelling each to live as seems good to

the rest."

Mill concludes “over himself, over his own

body and mind, the individual is sovereign.”

(Pp. 13-18.)

9/ John Stuart Mill, On Liberty, Supra, gives

substance to the concept of "compelling state

interest" when he asserts: ". . . one very

simple principle, as entitled to govern abso-

lutely the dealings of society with the in-

(Fn. 9 continued.)

A-80

(Fn. 9 continued.)

dividual in the way of compulsion and control

whether the means used be physical force in the

form of legal penalties, or the moral coercion

of public opinion. That principle is, that

the sole end for which mankind are warranted

0 0 a Eee

individually or collective] in interfering

with the of action of of their

Ee SSR eon that the only

‘for which can be ri ly exer-

ee

a sufficient warrant. He cannot rightfull

compelled to do or forbear because it willbe

better for him to do so, because it will make

him happier, because, in the opinions of others,

to do so would be wise, or even right. These are

good reasons for remonstrating with him, or

reasoning with him, or persuading him, or

entreating him, but not for compelling him, or

visiting him with any evil in case he do other-

wise. To justify that, the conduct fran

which it is desired to deter him, must be cal-

Culated to produce evil to some one els. The

only part of the conduct of any one, for which

he is amenable to society, is that which con-

cerns others. In the part which merely con-

cerns himself, his independence is, of right,

absolute. Over himself, over his own body and

mind, the individual is sovereign."

A-81

ing and licensing of doctors and the

limits on giving of medical advice by

qualified practitioners. The regula-

tion of pharmaceuticals, the licensing

requirements for pharmacists and other

dispensers of drugs are so authorized.

Harm to others is readily forseeable.

It is well settled the state has broad

police powers in regulating the adinin-

istering of certain types of drugs by

the health professions. (See Robinson

v. California, 370 U.S. 660, 664-665

[8 L.Ed.2d 758, 761-762, 82 S.Ct. 1417,

1419-1420]; Minnesota ex rel. Whipple v.

Martinson, 256 U.S. 41, 45 [65 L.Ed.

819, 822, 41 S.Ct. 425, 426]; Whalen v.

Roe, supra, 429 U.S. 589.)

The cases cited by the People in sup-

port of this unquestioned power of the

state uniformly involve drugs which are

narcotic, habit forming, toxic in

nature. For example, as noted in Whalen

v. Roe, supra, the New York Legislature

had enacted a statutory scheme regulat-

ing dangerous, legitimate, drugs such as

opium, cocaine, methadone. The state

could "prohibit entirely [their] use."

EE ———— ee eo vee eee

———

A-82

Therefore, the New York statute requir-

ing the doctor to furnish the state with

a copy of every prescription for such

drugs did not unconstitutionally deprive

a person of the right to decide independ-

ently with the advice of his physician to

acquire or to use needed medication.

In Minnesota ex rel. Whipple v. Martin-

son, supra, 256 U.S. 41, 45 [65 L.Ed.

819, 822, 41 S.Ct. 425, 426], the

Supreme -Court reiterated this premise

when examining a California statute

which regulated morphine stating:

"There can be no question of the

authority of the state in the exercise

of its police power to regulate the

administration, sale, prescription and

use of dangerous and habit-forming drugs,

such as are named in the statute. The

right to exercise this power is so mani-

fest in the interest of the public health

and welfare, that it is unnecessary to

enter upon a discussion of it beyond

Saying that it is too firmly estab-

lished to be successfully called in

question.”

In Blinder v. Division of Narcotic

A-83

Enforcement, supra, 25 Cal.App.3d 174,

181, the authority of the State of

California to regulate prescription by

a doctor of a narcotic, habit forming,

dangerous drug was vindicated. Plain-

tiff physician sought to prescribe the

use of methadone as a necessary and ef-

fective method for the treatment of nar-

cotic addiction. The statutes chal-

lenged by Dr. Blinder provided for

treatment of addicts at certain places

and specified periods of time and

limited use of methadone in the treat-

ment of other diseases. The court in

Blinder held the limitations upon the

prescription of methadone for treat-

ment of addicts (Health & Saf. Code,

§§ 11391 and 11395) were an appropriate

exercise of the police power of the

state and did not constitute a denial of

equal protection of law or constitute

cruel and unusual punishment. Concern-

ing the right of the doctor to practice

without state interference, Blinder v.

Division of Narcotic Enforcement, supra,

25 Cal.App.3d 174, at page 181, states:

“Tt is well established, moreover, that

a i le a ee ee oe ee

A-84

although the right to practice medicine,

like the right to practice any other pro-

fession, is a valuable property right

[citation], this right may not be ex-

ercised free of reasonable restrictions.

‘The state clearly has the power to

regulate professions in the interest of

public health, safety and welfare.'

(Citations.]" It should be noted in

Blinder, as in Whipple, as in Robinson,

and in Whalen v. Roe, supra, the drugs

subject to his broad police power are

drugs which are dangerous in the sense

that they are narcotic, habit forming,

hallucinatory or toxic. Their use or

misuse "concerns others." Laetrile is

not in this class. It is generally con-

ceded to be a harmless drug. Its al-

leged evil lies in its "ineffective"

treatment of cancer.

The sole case authority submitted for

the proposition that the state has the

right under its police power to inter-

fere in the doctor-patient relationship

where the drug prescribed is amygdalir

is People v. Privitera, 55 Cal.App.3d

Supp. 39 [128 Cal.Rptr. 151], where the

A-85

same Dr. Privitera was charged in the

Municipal Court of Los Angeles with a

series of misdemeanor violations of

section 1707.1 (here charged as the

substantive crime, the object of a felony

conspiracy). The trial court there

sustained defendant's demurrer on the

ground section 1707.1 was unconstitu-

tional. The Appellate Division of the

Superior Court of Los Angeles County re-

versed and denied section 1707.1 was

overbroad, arbitrary or unreasonable.

It was within the constitutional power

of the Legislature to prohibit the pre-

scription of amygdalin for cancer treat-

ment. For its authority the appellate

division relied upon the cases we cite

which warrant state intervention in the

doctor-patient area in the control, dis-

tribution, use of narcotics and other

dangerous drugs.

The Privitera court examined the pro-

cedure imposed by the Legislature for

the prior administrative determination

of whether the drug is recognized as

safe and effective. For approval

thereof, Privitera relies on the United

A-86 A-87

States Supreme Court in Weinberger v. as to authorize prohibition of all

Hynson, Westcott & Dunning, Inc., 412 treatment by physicians of cancer by

U.S. 609, 619 [37 L.Ed.2d 207, 217, 93 any modalities other than "state sanc~-

S.Ct. 2469, 2478], which held in passing tioned alternatives." Said People v.

upon the safety and efficacy of new drugs, Privitera, supra, 55 Cal.App. 3d Supp.

strict scientific standards must be em- 39, 52: “However, the California

ployed and not “anecdotal evidence in-

dicating that doctors 'believe' in the

efficacy of a drug." Concerning the

problem of whether the scientific and

medical authorities are in dispute

the appellate division stated: "'Where sanctioned alternatives. We believe such

finding to be reasonable. One desperate

for a cure but who seeks to avoid neces-

Legislature, in enacting the statutory

scheme of cancer regulations, made_

the implicit finding that alleged but

ineffective cancer remedies are more

hazardous to the patient than the state-

there is a genuine difference of medi-

cal opinion among the experts on the

question of whether a drug is generally

recognized as safe for the treatment of

a particular disease, it must be con-

cluded that the drug is not generally

recognized as safe for the use in the

treatment of that disease.' (United

States v. Article of Drug, etc. (N.D.

Ga. 1968) 294 F.Supp. 1307, 1311.)"

(People v. Privitera, Supra, 55 Cal.

App.3d Supp. 39, 51.)

The appellate division examined the

right of privacy question but found the

state interest to be of such magnitude

Sary surgery because it is disfiguring,

necessary radiation because it is de-

bilitating or necessary chemotherapy

because it is toxic, might in his ex-

tremity employ substances which are

represented to be both harmless and

curative. Knowing such propensity of

these seriously ill, the Legislature

exercised its police power to protect

its citizens from the allegedly easier

but fallacious cure." (Italics added.)

Reported cases specifically involving.

the authority, the right, of either the

A-88

federal government or state to penalize,

prohibit, amygdalin transportation, pos-

session or use are rare. In Rutherford

v. United States, 399 F.Supp. 1208, a

class action was brought by cancer vic-

tims seeking to compel the Federal Drug

Administration (FDA) to desist from pre-

cluding administration of amygdalin to

patients suffering from cancer. By

its nonaction, it was contended, the

FDA made amygdalin not available.

Rutherford sought medical advice in the

United States. He was advised of the

necessity of abdominal resection, re-

moval of his rectum. He rejected these

alternatives and sought laetrile treat-

ment at a medical clinic in Tijuana,

Mexico. There he was treated’ for a

period of weeks and was returned as

cured. He alleged without the con-

tinued use of the amygdalin he faced

the prospect of escalation of the car-

cinoma.

The district court in Rutherford v.

United States, supra, found that the

FDA, under 21 United States Code section

355, had: ". . . abdicated its duty to

A-89

make a clear determination of whether the

drug laetrile should or should not be

placed in commerce though the drug has

been in use for many years and thousands

of persons have been treated with st.”

The court further found that from the

records, testimony and exhibits that:

". . . laetrile is not lethal in any

sense of the word. It is not harmful

to the human body and when used in

proper amounts under proper control

and supervision can effect relief from

cancer disease to the satisfaction of

many who are privileged to use the same."

(Rutherford v. United States, supra, 399

F.Supp. 1208, 1212.) In view of this

failure of the Federal Drug Administra-

tion to act in accordance with the

constitutional intent, the court found

that Rutherford and others were wholly

without means or resources to comply

with the provisions of 21 United States

Code section 355 (b) ,22/ further that

10/ 21 United States Code section 355 pro-

vides in part: "(a) No person shall introduce

or deliver for introduction into interstate com

(Fn. 10 continued.)

A-90

each of them was denied "the freedom of

choice for treatment by laetrile to

alleviate or cure their cancer."

Basing its decision upon the Roe v.

Wade, supra, 410 U.S. 113, concept of

the right of privacy as one of the

rights formed by the emanations from

the guarantees of the Fifth and Four-

teenth Amendments, the court granted the

requested injunctive relief.

Rutherford was reviewed sub nomine

Stowe v. United States of America (10-

12-75) D.C. No. CIV-75-0218-B (10th

Cir.) .— The court of appeals de-

(Fn. 10 continued)

merce any new drug, unless an approval of an

application filed pursuant to subsection (b)

of this section is effective with respect to

such drug."

il/ Stowe was the original plaintiff in the

Rutherford case. He was a cancer patient and

died in the pending of the suit. Rutherford

and Mrs. Schneider filed further papers in the

proceedings. Mrs. Schneider, Rutherford's co-

plaintiff, died before the hearing on the

preliminary injunction which was issued by the

district court.

A-91

clined to review the district court's

rulings laetrile was an effective treat-

ment for cancer, was not toxic, and the

new drug application provision, 21

United States Code section 355(a), was un-

constitutional. Rather the court of

appeals confined itself to the issue

of whether the laetrile was a so-called

"new drug" requiring FDA approval. The

court of appeals held that the record

made before the trial court was not

sufficient but concluded the "prelim-

inary injunction granted by the district

court in this case should be

and the same is upheld." (Italics

added.)

After remand to the district court in

opinion filed January 4, 1977, it was

held: "In view, however, of the com-

plete absence of any good-faith agency

record in support of its position in this

case, as the record here is not merely

incomplete, but virtually nonexistent;

and in appreciation of the fact that de-

A-92

priving a terminally ill cancer patient

of a substance he finds therapeutic,

whether such benefit is physical or

psychological, creates the very risk

that irreparable injury might be sus-

tained.”

The district court injunction remains

in effect pending remand to the FDA.

In Carnohan v. United States of Amer-

ica, et al., United States District

Court, Southern District of California

(San Diego), Civil No. 77-0010-GT,

plaintiff was a terminal cancer patient.

He sought to enjoin the FDA's inter-

ference with his importation or inter-

state transportation Of amygdalin for his

Own consumption.

The court found Carnohan was receiv-

ing laetrile in Mexico, and in order to

receive the drug he must either choose

to live in Mexico or he must commute

daily for his treatment. The court

weighed its basic authority for the

issuance of injunctive relief against

the harm to the public that could pos-

Sibly occur by weakening laws calcu-

A-93

lated to prevent victimization of can-

cer victims by playing on their desperate

need. The court observed where a person

is terminally ill with cancer and un-

responsive to other treatments: ".. .

the public harm is considerably reduced.

Such a person would not be avoiding

other methods of treatment generally

[accepted] . .. ." Thereupon the court

enjoined the United States Customs Ser-

vice from interfering in Carnohan's

possession and moving in interstate com-

merce not in excess of a three-month

supply of laetrile pending completion

by the FDA of its study.

These judically carved out exceptions

to the federal prohibition against im-

portation or interstate transportation

of amygdalin rest upon an unarticulated

premise. No compelling state interest

required enforcement of the laetrile

ban in the recited circumstances.

vi

Conclusions

We turn now to the final, the pivotal

question: Does the imposition of crimi-~

A-94

nal sanction on the doctor for prescrib-

ing amygdalin as a cancer treatment for

an informed consenting cancer victim,

without first seeking governmental ap-

proval of its safety and effectiveness,

serve a compelling state interest?

The Legislature has found the state's

compelling interest derives from its

“interest” in the "effective diagnosis,

care, treatment or cure of persons suf-

fering from cancer." (Health & Saf.

Code, § 1700.) Further the Legislature

found: ". . . accurate and early diag-

nosis of many forms of cancer, followed

by prompt application of methods of

treatment which are scientifically

proven .. . reduces the likelihood of

death from cancer ... ." The People

argue these are compelling reasons to

deny cancer victims the prescriptions by

a doctor of as yet an unapproved drug.

Without question, Health and Safety

Code section 1707.1 is an attempt at

exercise of legislative power in the

area of public health to protect the

cancer victim. The legislative concern

expressed in section 1700 reflects a

A-95

well founded and appropriate concern for

misleading and false claims of cures for

cancer. The section states a truism when

it finds: "Various persons in this State

have represented and continue to repre~

sent themselves as possessing medicines,

. . . skills, .. . for the effective

diagnosis, treatment, or cure of cancer,

which representations are misleading to

the public, .. .- Mi

However, upon what factual basis duly

licensed doctors in the State of Calif-

ornia are chargeable, let alone found

guilty of the strictures made in the

legislative finding is not clear. Why

doctors, “recognized by the State as

capable of exercising acceptable

clinical judgment," are honored by being

encompassed within that invidious class

of "various persons" who "mislead" the

public is obscure. "The . . . suggestion

is necessarily somewhat degrading to

the conscientious physician, ..- - He,

perhaps more than anyone else, is know-

ledgeable in this area of patient care,

and he is aware of human frailty, - - -

and needs." (Doe v. Bolton, supra, 410

A-96

U.S. 1979, 196 [35 L.Ed. 2d 201, 215,

93 $.Ct. 739, 750) .)

The legislative finding gives no hint

of what rational classification includes

medical doctors within the ambit of

quacks.

The doctor in California is licensed

to practice only after meeting long

rigid education, experience qualifica-

tions. He is bound by oath to preserve,

to. prolong, the life of his patient. He

is under a legal duty, under threat of

malpractice suit, to act in accordance

with the generally accepted standards

of medical practice in his community in

this state. He is required under threat

of malpractice to treat only after receiv-

ing the informed consent of the patient.

(Cobbs v. Grant, supra, 8 Cal.3d 229.)

These are the “rational means" society

through law has imposed to insure a

high standard of performance by the

California doctor. It follows after

such rigid standards are met, the matter

of choice of treatment of the informed

consenting patient becomes "a purely

medical determination, which is within

A-97

a doctor's professional judgment."

(Aden v. Younger, supra, 57 Cal.App.3d

662, 677.) “Reliance must be placed upon

the assurance given by his license,

that he possesses the requisite qualifica-

tions." (Dent v. State of West Virginia,

129 U.S. 114, 122-123 [32 L.Ed. 623, 626,

9 S.Ct. 231, 233).-)

Limiting this exercise of the doctor's

professional judgment on some vague susp1l-

cion that “various persons” in this state

are engaging in quackery does not follow

as a matter of logic.

The premise that "“yarious persons, ~~

con man, snake oil salesman, ~~ have made

or will make false and misleading repre-

sentations to the public concerning the

diagnosis, treatment and cure of cancer

certainly warrants, as rational means,

the law which prohibits and makes criminal

such acts. Health and Safety Code sec-

tion 1714 accomplishes this precise pur-

pose. It prohibits a false representa-

tion with intent to defraud of any de-

vice or substance or treatment as an

effective cure for cancer. Dr. Privi-

tera does not contest the appropriate-

A-98

ness of Health and Safety Code sec-

tion 1714 as it does fit the announced

legislative purpose.

We conclude the limitation upon the

right to prescribe, to treat, of the

doctor of section 1707.1 bears no

logical relationship to the expressed

-legislative purpose. A fortiori, if

there is a lack of reasonable relation-

ship between the end sought and the

means used, then certainly no compelling

state purpose is present. +2/

12/ Refusing enforcement of Health and Safety

Code section 1707.1 is totally compatible with

(1) campulsory vaccination, (2) fluoridation of

public water supplies, (3) requiring that cer-

tain drugs be available to the public on pre-

scription from a licensed doctor, and (4)

recognition of a compelling state interest in

the health of a prospective mother at approxi-

mately the end of the first trimester of preg-

nancy. (Roe v. Wade, supra, 410 U.S. 113.)

Philosopher Mill precisely located the line of

demarcation between the individual's control of

himself, his own body and mind, and the sover-

eignty, retained by the state saying “there

is a sphere of action in which society, as dis-

tinguished from the individual, has if any, only

an indirect interest." (John Stuart Mill,

On Liberty, supra.) The much quoted Hames’

observation that freedom of speech does not

(Fn. 12 continued.)

A-99

Dr. Privitera is charged under Health

and Safety Code section 1767.4. Tease

statute requires for its breach an in-

tent to prescribe the unauthorized drug

or medicine for treatment of cancer.

The efficacy of the treatment pro-

posed or medicine prescribed is not

an issue under this statute. The

truth or veracity of the representa-

tions, disclosures, discussions, made

in connection with the treatment, by

the doctor to the patient are not an

issue in a trial of charges made under

section 1707.1.

The criminal liability attaches be-

cause the doctor in the exercise of

his medical judgment has prescribed a

drug for treatment of cancer not yet

approved under section 505 of the

federal Food, Drug and Cosmetic Act or

(Fn. 12 continued)

encompass the right to shout fire in a crowded

theater rests upon the readily recognizable

danger to society and thus authorizes state

intervention. Roe v. Wade, supra, 410 U.S.

113, is a classic example of a Silent applica-

tion of the Mill reasoning by the United States

Supreme Court in delienating the line between the

mother's control over her own body and a public

interest when there is another life and being.

A-100

which has not yet received approval of

the state board. Whether the doctor

in his best medical judgment believes

he has a miracle drug, a food supple-

ment or a hope-giving placebo is not an

issue. The governmental agencies have

not given approval; therefore the doc-

tor cannot prescribe.

The patient's right to receive

medical care, and the doctor's right to

administer it are substantially limited

not because of some established defect

in the medication, some danger to the

public if this patient is so treated.

The doctor becomes a criminal because

the government agency has not given its

prior approval to the exercise of his

best medical judgment.

The statute must be measured against

the legislative purpose of frustrating

cancer quacks, and for the promotion

of the early effective care, diagnosis

and cure of cancer. Instead, the im-

mediate and most direct effect of the

prohibition of section 1707.1 is to chill,

to prevent, innovative treatment by a

licensed doctor, the person or in the

A-101

class of persons most likely to make the

hoped-for breakthrough against dreaded

cancer. How logically this threat to

the innovative physician will increase

early effective diagnosis and cure of

cancer is difficult to perceive.

People v. Privitera, Supra, 55 Cal.

App.3d Supp. 39 at page 52 of the sup-

plement makes the following remarkable

observation concerning that compelling

state interest which supports Health

and Safety Code section 1707.1:

"| ineffective cancer remedies are

more hazardous to the patient than the

state-sanctioned alternatives."

(Italics added.)

The Legislature has not made such an

express finding and if such finding

should be implied then it denies the

patient the exercise of one of his most

fundamental rights. He, instead, has

the choice of "state sanctioned" treat

ment by the doctor or no treatment from

the doctor at all. Again, if this be

the legislative purpose, it misses its

mark. Diminishing fraudulent cures,

SS ea

oO Life Sf

A-102

punishing quackery in cancer treatment,

is a laudible objective. The means

chosen by the Legislature is bureaucra-

tically predetermined treatment or none,

injected into a constitutionally pro-

tected area of privacy. This fundamental

right of privacy, this right to be left

alone, is "older than the Bill of Rights,

Older than our political systems." It

cannot be swept away, denied by the pro-

cesses of compelled acceptance of “state

sanctioned alternatives."

It may be conceded that the dangers of

treatment of cancer -- or of any serious

and disabling disease -- by nonlicensed

purveyor of medical services is fraught

with dangers to the public and properly

subject to legislative protection. Thus

the difficulty with the statute as here

applied is that it seeks to remedy the

danger (that of a licensed medical doc-

tor prescribing a treatment of a cancer

patient without first getting approval

of an administrative body) when that

danger is not yet shown to exist.

If it be conceded section 1707.1 would

theoretically assure some protection to

A-103

the public or that unfortunate portion

of the public who have cancer but

who have not yet heard of the need for

early treatment, by prohibiting the use

of amygdalin or any unapproved modality

by the licensed physician, yet under the

law of this state and the United States

any individual can possess, use, self-

treat, his condition, whatever it may

be, by use of amygdalin, es heart's

content without liability.— In effect

it turns the whole matter of treatment

13/ See Ellen S. Hodgson, infra, page 687,

footnote 240, pointing out this incongruity.

The smuggler of laetrile: oi a faced a

$10,000 fine and rig i op mage nace oust

maximum penalty impo or smugg

tient deos eee for resale in the United

States. See 18 U.S.C. § 545 (1970). That only

the supplier, not the possessor, Of laetrile is

subject to criminal prosecution is due to the

fact that the drug is not clasified as a

'controlled' substance -- like heroin or mari~

juana -- the possession of which 1s illegal.

However, because the FDA has not officially

recognized the drug as 'safe,' it cannot

be brought into the country or transported

across state lines."

A-104

back to the cancer patient himself if he

is unwilling to accept the "state sanc-

tioned alternatives."

We conclude not only is there no com-

pelling reason shown to override the

patient's or the doctor's fundamental

right of choice in the treatment set-

ting but that the statute when sought

to be applied to a licensed medical

doctor does not pass the test as a ra-

tional means of accomplishment of the

announced legislative purpose.

There remains one further concern.

The evidence in this case shows with-

out exception the cancer victims,

whether People's or defense's wit-

nesses, were knowledgeable persons

fully aware of the nature of the

"state sanctioned alternatives" be-

fore seeking treatment from

Dr. Privitera. Many were unwilling to

accept the orthodox alternatives;

many unwilling to accept the verdict of

"terminal." These are not wide-eyed

country bumpkins seeking to be conned.

The class actions filed against

governmental authorities to compell the

A-105

availability of the drug in question

illustrate the desperate seeking of the

cancer wietiee,20. We need cite only

one witness as a basis for a composite

picture: The patient is a "senior"

citizen with diagnosed cancer of the

prostate; treatment recommended --

prostate removal and castration; female

hormone treatment for the rest of his

life. The victim simply refused to

accept these alternatives and sought

amygdalin treatment.

The nineteen witnesses testifying for

Dr. Privitera conveyed a felt imminency

of death. One senses a mortal fear

of both the disease and the orthodox

alternatives. This is a desperate

utterly human seeking to avoid the

pain and to prolong life. These ele-

ments form the unspoken rationale of

the Rutherford and Carnohan decisions.

14/ See Ellen L. Hodgson, Restrictions on

Unorthodox Health Treatment in California:

A Legal and Economic Analysis, 24 UCLA L.

Rev. 647, 683, 689, for an excellent and ex-

haustive review of case and statutory law.

A-106

Matter of Quinlan, supra, 70 N.J. 10

{355 A.2d 647, 663], states the premise

eloquently: ". . . no external com-

pelling interest of the State could

compel Karen to endure the unendurable,

only to vegetate a few measurable months

with no realistic possibility of return-

ing to any semblance of cognitive or

Sapient life. We perceive no thread of

logic distinguishing between such choice

on Karen's part and a similar choice

which, under the evidence in this case,

could be made by a competent patient

terminally ill, riddled by cancer and

suffering great pain; such a patient

would not be resuscitated or put on a

respirator . . . anda fortiori would

not be kept against his will ona

respirator."

To these nineteen cancer victims the

enforcement of Health and Safety Code

section 1707.1, the denial to them of

medical treatment, albeit unorthodox,

albeit unapproved by a state agency,

must surely take on a Kafkaesque, a

nightmare, quality. No demonstrated

public danger, no compelling interest

Td et pea en ee ee

A-107

of the state, warrants an Orwellian ts

intrusion into the most private of

zones of privacy.

The state has in the name of pro-

tecting the cancer victim criminalized

the doctor who is willing to innovate,

willing to try an unapproved drug with

the consent of his patient. From the

terminal patient's viewpoint a new

depth of inhumanity is reached by a

broad sweep of this law so inter-

preted. No compelling interest of

the state requires Dr. Privitera's

19 cancer patients to endure the un-

endurable, to die, even forbidden

hope.

Health and Safety Code section 1707.1

as here sought to be applied invades

the patient's and the doctor's zone

of privacy without showing of external

compelling state interests in viola-

tion of the Fourteenth Amendment to

the federal Constitution and articles I,

section 1 of the California Constitution."

BIRD, C.J.

A-108

PEOPLE v. PRIVITERA

Crim. 20340

DISSENTING OPINION BY NEWMAN, J.

I join in the Chief Justice's dissent,

except that I would not rely on the

federal Constitution. What the majority

of my colleagues condone here is action

that appears to me to constitute cruel

and inhuman treatment. (Cf. diss. opn.

in Cramer v. Tyars, 23 Cal.3d 131, 151,

fn. 1. See too Rosenblatt, Health Care

Reform and Administrative Law: A

Structural Approach (1978) 88 Yale L.J.

243, 247 ["The Legal Structure of Health

Care Reform: Creating the Appearance of

Public Control"].)

By selective quotation the majority

opinion downgrades the right of privacy

in California, which “relates, of

course, to an enormously broad and di-

verse field of personal action and

belief ...." (White v. Davis (1975)

13 Cal.3d 757, 774.) What the Califor-

A-109

nia Constitution in article I, section

1, guarantees is an inalienable right

of “pursuing and obtaining safety, happi-

ness, and privacy." By no means do

those words merely mirror Unites States

Supreme Court opinions. In White v.

Davis, supra, Justice Tobriner's opin-

ion for a unanimous court noted approv-

ingly these statements from the official

election brochure that help illuminate

privacy's full scope: "'The right of

privacy is the right to be left alone.

It is a fundamental and compelling

interest. It protects our homes, our

families, our thoughts, our emotions,

our expressions, our personalities, our

freedom of communion and our freedom to

associate with the people we choose

. « « of (2G. at p. 774.) “The raght

of privacy is an important American

heritage and essential to the funda-

mental rights guaranteed by th First,

Third, Fourth, Fifth and Ninth Amend-

ments to the U.S. Constitution. This

right should be abridged only when there

is a compelling public need. .. .-

eS

ee

EP LANA RIPEN RET LOE, ET Baiiet Ltt

as.

EEE ELI AE LOE LO SIDED DTT NO NENA

A-110

In this case I detect no such need.

NEWMAN, J.

APPENDIX B

B-1

ORDER DENYING REHEARING

CLERK'S OFFICE, SUPREME COURT

4250 STATE BUILDING

San Francisco, Catirornia 94102

—_—APR 42-4979 ___

I have this day filed Order

mf or

\ aid

RS

we

In re:.._C2 22: No 20340

People

vs.

Privitera, Jr., et al.

Respectfully,

G. E. BISHEL

Clerk

65953.077 11-78 4m OSP

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APPENDIX C

Cc-1

STATE COURT OF APPEAL

FOURTH DISTRICT

STATE OF CALIFORNIA

Cr. 8323.

[Filed November 10, 1977]

THE PEOPLE OF THE STATE OF CALIFORNIA,

Plaintiff and Respondent,

Ve

JAMES ROBERT PRIVITERA, JR., et al,

Defendarts and Appellants

"under California Health and Safety

Code section 1707. 1,2/

demeanor to sell, deliver, prescribe

it is a mis-

or administer any drug or device to be

1/ Health and Safety Code section 1707.1

provides:

"The sale, orfering for sale, holding

for sale, delivering, giving away, prescrib~

ing or administering of any drug, medicine,

(Fn. continued)

C=-2

(Fn. 1 continued)

compound or device to be used in the diagnosis,

treatment, alleviation or cure of cancer is un-

lawful and prohibited unless (1) an applica-

tion with respect thereto has been approved

under Section 505 of the Federal Food, Drug

and Cosmetic Act [21 USCS § 355], or (2)

there has been approved an application filed

with the board setting forth:

"(a) Full reports of investigations

which have been made to show whether or not

such drug, medicine, compound or device is

safe for such use, and whether such drug,

medicine, compound or device is effective in

such use;

"(b) A full list of the articles used

as components of such drug, medicine, campound

or device;

"(c) A full statement of the camposi-

tion of such drug, medicine, compound or device;

"(a) A full description of the methods

used in, and the facilities and controls used

for, the manufacture, processing and packing of

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used in the diagnosis, treatment, al-

leviation or cure of cancer which has not

been approved by the designated federal

agency (21 U.S.C.S. § 355) or by a state

board (Health & Saf. Code, § 1704).

Defendants, James Robert Privitera,

Jr., a medical doctor, William David

Turner, Phyllis Blanche Disney, Winifred

Agnes Davis, and Carroll Ruth Leslie, were

convicted by jury of a felony, conspiracy

to sell, to prescribe, an unapproved

drug, laetrile, intended for the al-

leviation or cure of cancer. (Pen.

(Fn. 1 continued)

such drug, medicine or compound or in the case

of a device, a full statement of its composi-

tion, properties and construction and the

principle or principles of its operation;

“(e) Such samples of such drug, medi-

cine, compound or device and of the articles

used as components of the drug, medicine, cam

pound or device as the board may require; and

"(£) Specimens of the labeling and

asvertising proposed to be used for such drug,

medicine, campound or device."

C-4

Code, § 182, subd. 1; Health & Saf. Code,

§ 1707.1.) Davis and Turner were con-

victed of selling laetrile to be used

for the alleviation or cure of cancer

(Health & Saf. Code, § 1707.1.)

We view the evidence in the light most

favorable to the judgments. (People v.

Reilly, 3 Cal.3d 421, 425 [90 Cal.Rptr.

417, 475 P.2d 649].) The defendants

were involved in a common plan to im-

port, distribute and prescribe laetrile

(also referred to as amygdalin or vita-

min B-17) to cancer patients. Defendants

Turner and Davis were importers and chief

suppliers of the drug. Defendants Leslie

and Disney worked as the distribution

network in various residential areas.

Dr. Privitera prescribed amygdalin for

cancer victims (or to undercover state

agents represented to be cancer victims).

Dr. Privitera referred patients to Turner

and Davis to buy the amygdalin; Disney

referred patients to Dr. Privitera for

treatment.

The defendants told the prospective

users of the drug that amygdalin was an

effective treatment or cure for cancer.

<_-~— =

C-5

Substantial evidence supports the jury

finding of a common plan or agreement to

supply and prescribe amygdalin as a can-

cer cure. Laetrile has not been

“approved” by a designated governmental

agency.

I

Contentions of the Parties --

Factual and Legal

Dr. Privitera contends that California

Health and Safety Code section 1707.1 is

an unconstitutional invasion of the can-

cer victim's right to obtain and use

amygdalin in violation of rights

guaranteed by the United States Consti-

tution, Amendments I, IV, V, VI, VII,

VIII, and XIV, and California Constitu-

tion, article I, sections l, 7, 7(a) and

15. This, he asserts, is an invasion of

the patient's right of privacy, his or

her right to be left alone in choice

of orthodox versus unorthodox treat-

ment of cancer. As a corollary and

necessary concommitant of the right of

privacy of the patient, Dr. Privitera

argues that the constitutional protec-

C-6

tion accorded the cancer victim's right

to utilize amygdalin in a program of nu-

tritional therapy extends to physicians

willing to administer the drug and to

persons willing to supply the drug for

the cancer victim's use. Argues

Dr. Privitera: "The protection of con-

stitutional guarantees of privacy and

personal liberty, therefore, extends not

only to the patient pursuing a course

of nutritional therapy but to the phy-

sician who prescribes and administers

the therapy and to the person who fur-

nishes the essential components."

Dr. Privitera does not challenge the

validity of the general or specific

regulatory laws to the extent they pro-

hibit the advertisement of amygdalin as

a cure for cancer (Health & Saf. Code,

§ 1714); or require amygdalin be labeled

in accordance with state law and regu-

lations (Health & Saf. Code, § 26463);

or impose standards on the manufacturing

and packing of amygdalin to insure

quality and prevent adulteration or de-

terioration, or the prohibition of the

sale of amygdalin to members of the

C-7

general public for the purpose of treat-

ing cancer by persons other than li-

censed physicians (Health & Saf. Code,

§ 26400 et seq.). (Health & Saf.

Code, §§ 1704, 26670, 1707.1, 1709;

17 Cal. Admin. Code, § 10400.1.)

Rather, Dr. Privitera's challenge is

directed to those laws, specifically

the one of which he is convicted, inso-

far as they prohibit a duly licensed

physician from administering amygdalin

to cancer patients and which prohibit

its sale to either licensed physicians

or persons who have obtained prescrip-

tions from a licensed physician.

(Health & Saf. Code, §§ 1700-1721.)

According to Dr. Privitera, this

right of choice of medical treatment is

a fundamental right of the individual

and regulations limiting this right may

be justified only by "compelling state

interests"; the legislative enactments

which seek to regulate or control in

the”areas of such fundamental rights

must be narrowly drawn to protect only

the legitimate state interests at stake.

The specific drug here supplied or

prescribed is a substance known as

»

C-8

amygdalin, also known as laetrile, and

also known as vitamin B-17. Amygdalin

is a by-product of apricot pits. The

substance has been the subject of wide-

spread public dispute as to its efficacy

for the treatment of cancer. Orthodox

medicine, as represented by the American

Cancer Society, places it in the area

of nostrums. Its proponents vary in

their claims from that as a cure for

cancer or as simply a nutritional aid

causing the patient to gain weight, have

a better appetite, and a better emotion-

al outlook. It is generally conceded

that amygdalin is nontoxic; it does not

fall within the general ban of drugs

which are toxic, habit forming, addic-

tive, or otherwise distort reality.

Coventional medicine regards the

"evidence," "proof," of the curative

effect of amygdalin as anecdotal in

nature and contends the drug has never

been established by scientific method-

ology to have any effect whatsoever

upon either the cure or retardation of

cancer growth. Despite the pros and

cons of the experts in the field of

Cc-9

medicine, and others from nonmedical

fields taking side on this issue, can-

cer victims in large numbers have

sought the relief, whatever its nature,

which is available frem the use of this

drug. Where, as in Mexico and in West

Germany, the drug is available through

doctors and clinics, cancer victims,

able to travel, seek out and obtain the

treatment.

Dr. Privitera points out that many

cancer victims have investigated and

evaluated the merits of surgery, radia-

tion therapy or chemotherapy with the

aid of competent medical advice and have

made the highly personal decision [that]

the benefits from such therapy [are] not

sufficient to justify the risks which

include disfigurement, debilitation,

and accelerated death and for this reason

have chosen to seek amygdalin as a treat-

ment; other cancer victims have been

advised that their condition is hopeless,

their case is terminal and as a last re-

sort before certain death, seek amygdalin.

Dr. Privitera contends many concerned

cancer victims, competent and responsible

C-10

adults, seek and use amygdalin as a food

substance to ameliorate the horrifying

physical wasting away of the body

(cachexia) which accompanies cancer.

Thus they seek amygdalin not only for

its possible cancer curative benefits,

but also for its known nutritional bene-

fits. Cancer victims cannot be certain

amygdalin will either cure or control

cancer but they believe, based upon the

anecdotal, personal experience approach,

the drug provides relief from the ter-

rible pain, mental malaise, the emo-

tional depression and weight loss which

mark the progression of their disease.

The People assert, contrary to

Dr. Privitera's contentions, not a

single accredited medical school in the

State of California teaches amygdalin

might be effective in the controlling or

curing of cancer. Further the use of

amygdalin as a form of nutritional

therapy is officially regarded by the

State Department of Health, the Calif-

ornia Medical Association, the National

Cancer Institute and a great block of

practicing physicians, to be of no value

C-11

whatsoever in the controlling or curing

of cancer.

Dr. Privitera specifically contends

section 1707.1 of the Health and Safety

Code is unconstitutional. It is a

denial of one aspect of individual

"liberty" protected by the due process

of the Fourteenth Amendment.

The patient, he asserts, has a right

of "privacy" or “a guarantee of certain

areas or zones of privacy." This is the

individual right of independence in

making certain kinds of important de-

cisions. The very nature of the rela-

tionship, the act to be performed, the

decision to be made, precludes unjusti-

fied state presence. It is "the right

of the individual to be free in action,

thought, experience and belief from

governmental compulsion." (Kurland,

The Private I, University of Chicago

Magazine 7, 8, Autumn 1976.) It is that

right voiced by Justice Brandeis in his

dissent in Olmstead v. United States,

277 U.S. 438, 478 [72 L.Ed. 944, 956,

48 S.Ct. 564, 572, 66 A.L.R. 376] "the

right to be let alone", "the right most

C-12

valued by civilized men."

Historically this right of privacy was

first articulated as a constitutional

right in Griswold v. Connecticut, 381

U.S. 479 [14 L.Ed.2d 510, 85 S.Ct. 1678],

a decision holding unconstitutional a

statute prohibiting the use of contra-

ceptives. However, the recognition of

the existence, innate in every human

being, of a zone of privacy is older

than the Bill of Rights, older than our

political parties, older that the state's

concern with the nature of treatment to

be received by cancer-ridden patients.

It is in the nature of man that such

right exists.

This principle, now of constitutional

dimension, has been embraced by many de-

. . . . . . 2

cisions in a variety of situations.—

2/ In Morris L. Ernst's and Alan U. Schwartz's

Privacy: The Right To Be Left Alone (The Mac

Millan Co. 1963), the history and broad sweep of

this doctrine is documented. Samuel D. Warren

and Louis D. Brandeis, in The Right to Privacy

(1890), 4 Harvard Law Review 193, state: ".

it has been found necessary from time to time to

C-13

(See In re Lifschutz, 2 Cal.3d 415, 432,

fn. 12 [85 Cal. Rptr. 829, 467 P.2d 557,

44 A.L.R.3d 1], and Roe v. Wade, 410 U.S.

113, 151-153 [35 L.Ed.2d 147, 175-177,

93 S.Ct. 705, 726].) This concept, when

placed in the doctor-patient relation-

ship is the "right to decide independ-

ently, with the advice of his physician,

to acquire and to use needed medication."

(Whalen v. Roe, 429 U.S. 589, 603 [51

L.Ed.2d 64, 75, 97 S.Ct. 869, 876, 878];

Doe v. Bolton, 410 U.S. 179, 197 [35

L.Ed.2d 201, 215-216, 93 S.Ct. 739,

750].) In re Lifschutz, supra, 2 Cal.3d

415, 431, 432, makes this profound in-

sight concerning Griswold: "Indeed,

the decision's concern for valued as-

pects of individual privacy may ulti-

mately aid in protecting man from the de-

humanization of an everencroaching

technological environment."

The People concede, as they must, the

fact, the existence of this expanding

and as yet judicially unmeasured con-

cept of individual privacy. However,

they contend the State of California has

the broad power to establish and enforce

C-14

standards of conduct within its borders

ralative to health. This is a vital as-

pect of its police power. Within its

ambit is the authority of the state to

regulate the delivery of health servicefe

(Barsky v. Board of Regents, 347 U.S.

442, 449 [98 L.Ed. 829, 74 S.Ct. 650,

654]; People v. Nunn, 46 Cal.2d 460,

469 [296 P.2d 813].)

This broad premise authorizes the in-

vasion of the doctor-patient zone of

privacy by the state to prohibit the

doctor prescribing certain species of

drugs. (Blinder v. Division of Narcotic

Enforcement, 25 Cal.App.3d 174 [101

Cal.Rptr. 635].) The People point to

Whalen v. Roe, supra, 429 u.S. 589, 603,

fn. 30 [51 L.Ed.2d 64, 75, 97 S.Ct. 869,

878], and Paris Adult Theatre I v.

* Slaton, 413 U.S. 49, 65, 67 [37 L.Ed.2d

446, 461-463, 93 S.Ct. 2628], in support

of this broad position.

The People concede any exercise of

police power, depends in the first in-

stance upon an articulated public in-

terest in the activity to be regulated

and second, the means used must be rea-

C-15

sonably necessary for the accomplishment

of that public purpose. (Goldblatt v.

Hempstead, 369 U.S. 590, 594, 595 [8

L.Ed.2d 130, 133-135, 82 S.Ct. 987,990].)

At the heart of the People's defense of

Health and Safety Code section 1707.1 is

the premise, Legislature declared =! that

3/ Health and Safety Code section 1700 pro-

vides:

"The effective diagnosis, care, treatment

or cure of persons suffering from cancer is of

paramount public importance. Vital statistics

indicates that approximately 16 percent of the

total deaths in the United States annually re-

sult from one or another of the forms of cancer.

It is established that accurate and early diag-

nosis of many forms of cancer, followed by

prompt application of methods of treatment which

are scientifically proven, either materially re-

duces the likelihood of death from cancer or

may materially prolong the useful life of in-

dividuals suffering therefran.

"Despite intensive campai of lic

essen eid tee 1k Oe ania end an

curate information among the public with re-

spect to presently proven methods for the

diagnosis, treatment, and cure of cancer. Vari-

ous persons in this State have represented and

continue to represent themselves as possessing

medicines, methods, techniques, skills, or de-

vices for the effective diagnosis, treatment,

or cure of cancer, which representations are

(Fn. 3 continued.)

C-16

early and accurate diagnosis of cancer

materially reduces the likelihood of

death, prolongs useful life; where false

or misleading representations are made

to the public, large numbers rely upon

(Fn. 3 continued.)

that

‘na to the public, with the result

mise numbers of the public, pelying op SoC)

representations, needlessly die of cancer,

substantial amounts of the savings of in-

j i lic interest

"It is, therefore, in the pub “8

lic be afforded full and accura

Le ee to the facilities and methods for

“The importance of continuing scientific

research to determine the cause or cure Of cane

importance of bona fide scientific re-

a ech and the clinical testing in hospitals,

clinics, or similar institutions of new

drugs or compounds.

C-17

such falsities, and needlessly die of

cancer.

The People contend the California

Legislature in enacting the statutory

scheme made this implicit finding:

Ineffective cancer remedies are more

hazardous to the patient than the

state sanctioned alternatives. (Health

& Saf. Code, § 1700.)

Concerning the efficacy of amygdalin,

this court, this opinion, does not

enter that fray. The effectiveness of

amygdalin as a cure for cancer or aS a

nutritional aid with general health

giving benefits, is not, as a matter of

law, an issue when the charge is a vio-

lation of Health and Safety Code section

1707.1. The issue here is human liberty.

Can the informed cancer-ridden patient

be limited in choice of treatment re-

ceived from a state licensed physician

to "state sanctioned alternatives" ?2/

To resolve these contra-poised conten-

tions we must carefully analyze the na-

ture of the right protected.

4/ People v. Privitera, 55 Cal.App.3d Supp.

39 [128 Cal.Rptr. 151).

Cc-18

Il

The Patient's Right to Privacy

The challenge of Dr. Privitera to

Health and Safety Code section 1707.1

resolves itself, upon analysis, into

two separate and distinct areas of

claimed constitutional rights; there is

the right of privacy of the patient to

choose or reject his or her own treat-

ment, orthodox or unorthodox, approved

or unapproved by the state. The second

contention is bifaceted: Dr. Privitera

asserts (1) a derivative right -- equal

in stature to that of his patient, and

(2) the doctor's independent right to

practice medicine generally and to ee

scribe medicine, use procedures, without

| unreasonable government restrictions.

We examine first the right of the

patient and determine this right is of

such fundamental nature its free exer-

cise may be impinged upon or forbidden

only by such state interest aS may be a

"compelling interest." |

The "fundamental" nature of this right

derives from its source. It flows from

C-19

the very nature of man. Justice Brandeis

in Olmstead v. United States, supra, 277

U.S. 438, 478 [72 L.Ed. 944, 956, 48

S.Ct. 564, 572], stated: "The makers of

our Constitution undertook to secure

conditions favorable to the pursuit of

happiness. They recognized the signifi-

cance of man's spiritual nature, of his

feelings and of his intellect. They knew

that only a part of the pain, pleasure

and satisfactions of life are to be found

in material things. They sought to pro-

tect Americans in their beliefs, their

thoughts, their emotions and their sen-

sations. They conferred, as against the

government, the right to be let alone --

the most comprehensive of rights and the

right most valued by civilized men. To

protect that right, every unjustifiable

intrusion by the government upon the

privacy of the individual, whatever the

means employed, must be deemed a viola-

tion... ." (Italics added.)

Judge Cardozo in Schloendorff v.

Society of New York Hospital, 211 N.Y.

125 [105 N.E. 92, at page 93] stated:

“Every human being of adult years and

C-20

sound mind has a right to determine what

shall be done with his own body; .- - - ~

The right to control one's own body is

not restricted to the wise; it includes

the "foolish" refusal of medical treat-

ment. Nor is this right limited in its

recognition to any single segment of the

political, economic, or social thought

spectrum. In commenting upon Justice

Brandeis' most valued of rights, that

right to be left alone, now Chief

Justice Burger, in his dissent in

Application of President & Directors

of Georgetown Col. 331 F.2d 1010, at

page 1017, stated: "Nothing in this

utterance suggests that Justice Brandeis

thought an individual possessed these

rights only as to sensible beliefs,

valid thoughts, reasonable emotions,

or well-founded sensations. I sug-

gest he intended to include a great

many foolish, unreasonable and even

absurd ideas which do not conform,

such as refusing medical treatment even

at great risk."

Without specific reference to a consti-

tutional basis, the right to choose what

C-21

may be a suicidal medical course has been

upheld. In Erickson v. Dilgard, 44 Misc.

2d 27 [252 N.Y¥.S.2da 705, 706] a New York

court sustained the unwilling Jehovah's

Witness' objection to a needed blood

transfusion despite risk of death.

The court there said at page 706:

". . . it is the individual who is the

subject of a medical decision who has

the final say and that this must neces-

sarily be so in a system of government

which gives the greatest possible pro-

tection to the individual in the

furtherance of his own desires."

For analogy we look to the very heart

of this right of choice of medical pro-

cedures, the right to beget or not to

beget a child. In the case of Griswold

v. Connecticut, supra, 381 U.S. 479 the

Supreme Court held unconstitutional a

Connecticut statute prohibiting the use a

of contraceptives. Following Griswold a :

series of United States Supreme Court

cases have attempted to ascertain the

boundaries of this aspect of privacy.

The outer limits have not yet been de-

termined. However, it is made clear by sy

C-22

decision that unjustified government

interference with personal decisions

"| | relating to marriage, Loving v.

Virginia, 388 U.S. 1, 12 (1967); pro-

creation, Skinner v. Oklahoma, 316 U.S.

535, 541-542 (1942); contraception,

Eisenstadt v. Baird, 405 U.S. at 453-

454 id., at 460, 463-465 (White, J.,

concurring in result); family relation-

ships, Prince v. Massachusetts, 321 U.S.

158, 166 (1944); and child rearing and

education, Pierce v. Society of Sisters,

268 U.S. 510, 535 (1925), Meyer v.-

Nebraska, supra" (Roe v. Wade, supra,

410 U.S. 113, 152-153 [35 L.Ed.2d 147,

177, 93 S.Ct. 705, 726]) violate this

concept.

Roe v. Wade, supra, 410 U.S. 113 dealt

specifically with the rights to deter-

mine one's own medical treatment. The

United States Supreme Court held that the

mother's constitutional right of privacy

was broad enough to encompass her deci-

sion whether to terminate her pregnancy

before the end of the first trimester of

pregnancy. Said the court at page 163

[35 L.Ed.2d at p. 182]: "With respect

C-23

to the State's important and legitimate

interest in the health of the mother the

‘compelling’ point, in light of present

medical knowledge, is at approximately

the end of the first trimester."

(Roe v. Wade, supra, 410 U.S. 113, 163

[35 L.Ed. 2d 147, 182, 93 S.Ct. 705,

731).)

In the companion case, Doe v. Bolton,

supra, 410 U.S. 179 the United States

Supreme Court held the statutes requir-

ing abortions to be conducted in hospi-

tals, or accredited hospitals, requiring

the interposition of a hospital abortion

committee and thus limiting abortions to

those circumstances was unconstitutional.

In vindicating the woman's right of

choice of medical care, the Supreme

Court stated: "The woman's right to re-

ceive medical care in accordance with

her licensed physician's best judgment

and the physician's right to administer

it are substantially limited by this

statutorily imposed overview." (Doe v.

Bolton, supra, 410 U.S. 179, 197 [35

L.Ed.2d 201, 216, 93 S.Ct. 739, 750].)

To support its conclusion, the Supreme

C-24

Court examined the role of the licensed

physician, saying: “If a physician is

licensed by the State, he is recognized

by the State as capable of exercising

acceptable clinical judgment. If he

fails in this, professional censure and °

deprivation of his license are available

remedies. Required acquiescence by co-

practitioners has no rational connection

with a patient's needs and unduly in-

fringes on the physician's right to

practice. The attending physician will

know when a consultation is advisable --

the doubtful situation, the need for

assurance when the medical decision is a

delicate one, and the like. Physicians

have followed this routine historically

and know its usefulness and benefit for

all concerned. It is still true today

that '[rJeliance must be placed upon the

assurance given by his license, issued by

an authority competent to judge in that

respect, that he [the physician] pos-

sesses the requisite qualifications.'

Dent v. West Virginia, co i Pee ee

122-123 (1889). See United States v.

Vuitch, 402 U.S. at 71." (Doe v. Bolton,

C25

supra, 410 U.S. 179, 199-200 [35 L.Ed.2d

201, 217, .93.8.Ct. 739, 753) .-)

In Whalen v. Roe, supra, 429 U.S. 589,

the United States Supreme Court con-

sidered the New York statutory require-

ments with respect to prescriptions for

“dangerous, legitimate" drugs. The

requirement in question was that of

notification. The court balanced the

invasion of the zone of privacy against

the public's right involved and con-

cluded that with respect to the particu-

lar type of drugs involved the statutes

were a reasonable exercise of the state's

broad police power. In so holding the

court discussed the right of an individu-

al to choice of treatment saying: "Nor

can it be said that any individual has

been deprived of the right to decide in-

dependently, with the advice of his

physician, to acquire and to use needed

medication. .. . Within dosage limits

which appellees do not challenge, the

decision to prescribe, or to use, is left

entirely to the physician and the pa-

tient." (Whalen v. Roe, supra, 429 U.S.

589, 603 [51 L.Ed.2d 64, 75-76, 97

S.Ct. 869, 878].)

C-26

Concerning the doctor's "right to

practice" Whalen points out: "The

appellee doctors argue separately that

the statute impairs their right to

practice medicine free of unwarranted

state interference. If the doctors'

claim has any reference to the impact

of the 1972 statute on their own pro-

cedures, it is clearly frivolous. For

even the prior statute required the

doctor to prepare a written prescription

identifying the name and address of the

patient and the dosage of the prescribed

drug. To the extent that their claim has

reference to the possibility that the

patients' concern about disclosure may

induce them to refuse needed medication,

the doctors' claim is derivative from,

and therefore no stronger than, the

patients'. Our rejection of their

claim therefore disposes of the doctors'

as well." (Italics added; Whalen v.

Roe, supra, 429 U.S. 589, 604 [51

L.Ed.2a 64, 76, 97 S.Ct. 869, 879].)

Carey v. Populations Services Intern.,

S60. 7 Vee L.Ed.2d 675, 97 S.Ct.

SSS ee

2010], examines the question involving

C-27

the availability of contraceptives to

minors. The Supreme Court held the right

to privacy in matters affecting procrea-

tion extends to minors as well as adults.

The California Supreme Court has set

forth as a “postulate” or "axiomatic"

the right to choose one's own "lawful"

treatment. In Cobbs v. Grant, 8 Cal.3d

229, at page 242 [104 Cal.Rptr. 505,

502 P.2d 1], the court, in determining

the duty of the physician to secure the

informed consent of the patient to treat-

ment, said: "Preliminarily we employ

several postulates. . .. The second

is that a person of adult years and in

sound mind has the right, in exercise

of control over his own body, to de-

termine whether or not to submit to law-

ful medical treatment."

Aden v. Younger, 57 Cal.App. 3d 662

[129 Cal.Rptr. 535], held unconstitu-

tional the provisions of Welfare and

Institutions Code section 5326.4 requir-

ing substantive review by a mecial com-

mittee of a voluntary, competent pa-

tient's consent to choice of electro-

shock treatment. It was an unjustified

C-28

infringment of the patient's right to

privacy. This court stated at page 684:

“Where informed consent is adequately

insured, there is no justification for

infringing upon the patient's right to

privacy in selecting and consenting to

the treatment. The state has varied

interests which are served by the regu-

lation of ECT, but these interests are

not served where the patient and his

physician are the best judges of the

patient's health, safety and welfare.

“=. . Any possible need which exists

for the voluntary and competent patient

cannot prevail in the face of the seri-

ous infringement to the patient's right

to privacy as guaranteed by Roe v.

Wade, supra, 410 U.S. 113 and Doe v.

°

C-29

Karen Quinlan, a 2l-year-old girl exist-

ing in a “persistent vegetative state,"

could be authorized to discontinue the

extraordinary procedures sustaining the

daughter's vital processes. The first

question was: Did the comatose Karen

Quinlan or her father have a right of

choice to choose death or life? And

secondly, could the father, through the

court guardianship procedures, be

authorized on her behalf to make such a

choice. The court authorized, through

the father-guardian, the withdrawal of

the life support processes. The right

of privacy inherent in the exceptional

circumstances of that case authorized

the rejection of the life support sys-

tems. Reasoned the court: "The claimed

interests of the State in this case are

Bolton, supra, 410 U.S. 179." (Aden

v. Younger, supra, 57 Cal.App.3d 662, essentially the preservation and sanctity

. , pra, A °

684.) of human life and defense of the right of

This right of choice-of-medical- the physician to administer medical treat-

treatment concept reached its quintes- ment according to his best judgment. In

sence in the Matter of Quinlan, 70 N.J. this case the doctors say that removing

10 {355 A.2d 674]. The New Jersey

Supreme Court was called upon to deter-

mine whether the father, as guardian of

Karen from the respirator will conflict

with their professional, judgment."

(Matter of Quinlan, supra, 70 N.J. 10

C-30

[355 A.2d 647, 663] .)

Yet, the court affirmed Karen's right

to choice, had she been competent to

assert it, and authorized the father to

exercise it on her behalf: ". -

there would be no criminal homicide in

the circumstances of this case. .-

even if it were to be regarded as homi-

cide, it would not be unlawful.” (Matter

of Quinlan, supra, 76 4.0. 19 {395 A.2d

647, 669-670] .) Concerning the interests

of the state in preservation of human

health and life the court said: “We

have no hesitancy in deciding, in the

instant diametrically opposite case, that

no external compelling interest of the

State could compel Karen to endure the

unendurable, -. + + ." (Matter of

Quinlan, supra, 70 N.J. 10 [355 A.2d 647,

663] .)

Ii!

The Doctor's Zone of Privacy

Dr. Privitera asserts a separate and

distinct constitutionally protected

right -- a zone of privacy -- to pre~

scribe, to treat patients whether in the

C-31

orthodox mode -- free from unjustified

state interference.

Whalen v. Roe, supra, 429 U.S. 589,

accepts as a premise the existence of

the right of the individual patient to

choose independently with the advice of

his physician to use or not to use a

particular medication. Said the

Supreme Court at page 603 [51 L.Ed.2d

at p. 75]: "Nor can it be said that

any individual has been deprived of the

right to decide independently, with the

advice of his physician, to acquire and

to use needed medication." However,

with respect to the doctor's right to

freedom to treat, to minister to the

sick, in Whalen v. Roe, supra, 429 U.S.

589, we have heretofore noted the Supreme

Court's determination the "doctors'

claim is derivative from, and therefore

no stronger than, the patients'."

Doe v. Bolton, supra, 410 U.S. 179,

however, speaks specifically of the

doctor's right to administer medical

care. Bolton involved a constitutionally

defective statute requiring the consent

of two state licensed physicians other

C-32

than the patient's own doctor before an

abortion could be performed as well as

advance approval of three members of the

hospital staff where the abortion was to

be performed. Concerning this statute

the Supreme Court said: "The woman's

right to receive medical care in accord-

ance with her licensed physician's best

judgment and the physician's right to

administer it are substantially limited

by this statutorily imposed overview."

(Doe v. Bolton, supra, 410 U.S. 179, 197

[35 L.Ed.2d 201, 216, 93 S.Ct. 739 750];

italics added.)

Dr. Privitera additionally asserts an

independent right to treat, not derived

from or measured by his patient's right

of choice, without first obtaining °

approval of the procedure or drug pre-

scribed from a governmental board. He

argues Health and Safety Code section

1707.1 invades this right. Again, as in

the right of the patient, the doctor's

asserted right must be first examined

to determine its nature and thereby

select the test, the degree of scrutiny

to which the state interference will be

C-33

put. The right found must be balanced

against the state -- the public interest

protected.

Dr. Privitera's right, in relation to

the patient, has been viewed tradition-

ally as a species of economic interest

rather than as "fundamental" akin to

the privacy right. If a rational basis

was found to support an encroachment,

the statute was sustained.

While a dispassionate reading of the

physician's licensing requirements raises

some question concerning the total ra-

tionality of the licensing scheme, such

standards are generally upheld as rea-

sonable and necessary means of protect-

ing the public health.

The more recent cases hint at the more

profound right in the doctor. It is pos-

tulated: There exists in the doctor

licensed to practice medicine a right,

constitutional in nature, as yet ill-

defined, to treat and to treat by un-

orthodox modalities -- as yet unapproved

by the state board -- an informed con-

senting patient.

Doe v. Bolton, supra, 410 U.S. 179,

C-34

200 [35 L.Ed.2d 201, 217, 93 S.Ct. 739,

751], states if a physician is licensed

by the state he is recognized by the

state as capable of expressing accept-

able clinical judgment. If he fails

in this, professional censure and depri-

vation of his license are remedies avail-

able and "reliance must be placed on the

assurance given by his license . . . that

he possesses the requisite qualifica-

tions."

Roe v. Wade, supra, 410 U.S. 113, 163

[35 L.Ed.2d 147, 183, 93 S.Ct. 705, 732),

states concerning the termination of

pregnancy during the first trimester:

* . . the attending physician, in

consultation with his patient, is free

to determine, without regulation by

the State, that in his medical judg-

ment, the patient's pregnancy should

be terminated." (Italics added.)

Reason based on history, experience,

supports the doctor's premise. To re-

quire prior state approval before

advising -- prescribing-administering --

a new treatment modality for an informed

consenting patient is to suppress in-

C-35

novation by the person best qualified to

make medical progress. The treating doc-

tor, the clinician, is at the cutting edge

of medical knowledge.

To require the doctor to use only

orthodox "state sanctioned" methods ‘

of treatment under threat of criminal

penalty for variance is to invite a

repetition in California of the Soviet

experience with "Lysenkoism. ">! The

mention of a requirement that licensed

doctors must prescribe, treat, within

5/ Soviet geneticist T.D. Lysenko, contro-

versial dictator of “cammmistic" biology

during the Stalin period, stultified the

science of genetics in the U.S.S.R. for at

least a generation. He imposed the "state

sanctioned a)cernative, " the curious idea that

environmentally characteristics of an

organism could be transmitted to the offspring

inheritance. Thus, the Stalinist

concept of ideological conformity politically

implanted in genetics paralyzed this im

portant branch of Soviet science.

C-36

"state sanctioned alternatives" raises

the spector of medical stagnation at

best, statism, paternalistic Big Brother

at worst. It is by the alternatives to

orthodoxy that medical progress has been

made. A free, progressive society has

an enormous stake in recognizing and

protecting this right of the physi-

cian.—

6/ Lest the reader suspect these conclusions

are alarmist, without relevance to here and now,

reference is made to Drug Regulation and

Innovation -- Empirical Evidence and Policy

Options, by Henry G. Grabowski (1976). This

is a summary of studies made -- cost versus

benefit analysis of the effects of the 1962

amendment which clothed the Federal Drug

Administration with the authority to test new

drugs for their "effectiveness" before permit-

ting general prescription and use.

One study surveyed was that by Sam Peltz-

man. He researched the effect of the 1962

amendment on drug innovation: "In effect,

Peltzman's . . . suggests that the rate of in-

novation in the post-amendment period is more

than halved as a result of the 1962 amend-

ments."

Did the Federal Drug Administration ef-

fectively weed out ineffective drugs? Peltzman's

study shows: "... analysis of evaluations by

medical experts suggests that the proportion of

ineffective drugs has remained roughly the same

(Fn. 6 continued.)

C-37

(Fn. 6 continued.)

in the pre-1962 and post-1962 periods. Given

that the rate of new drug introductions was more

than halved in the post-amendment period, his

analysis therefore suggests that a large de-

cline Fook place in effective drugs." (Italics

The conclusion reached by Professor

Grabowski: “A consistent finding is that

regulation has had a significant negative effect

on the rate of innovation. While each of the

individual studies has shortcomings, taken to-

gether they would seem to provide considerable

support for the hypothesis that regulation has

been one of the principal factors responsible

for the observed decline in innovation."

Professor Grabowski's study shows: "An

indication of the change is the decline in dis-

covery and development of new chemical entities

by U.S. fimms -- an initial decline from more

than one-third of worldwide introductions in

ee ee a ero

Drug, Cosmetic Act to less than one-quarter

of the total in 1963 . . . and unfortunately,

as Professor Grabowski shows, a continued ero-

sion of U.S. leadership thereafter. We have

reached the point where innovations based on

discoveries by U.S. firms and institutions con-

stitute less than one-sixth of world-wide

introductions of new chemical entities . . . and

exports of pharmaceuticals as a share of U.S.

Seg Sere ee, ee

3.”

(Fn. 6 continued. )

C-38

(Fn. 6 continued.)

Decline in innovation is bad enough yet

the public's safety has not been enhanced.

Accerding to Professor Grabowski: "One of the

bitter ironies of this situation is that the

1 ee oetate

the safety of new drugs -- ears

created by the thalidomide incident. The

irony lies in the fact that the 1972 amendments

are keeping off the market new drugs that are

safer than the drugs they would replace. Pro-

fessor William Wardell's study of the lags in

the introduction of new drugs in the United

States cites, as one example, the five-year

delay in the appearance on the U.S. market of

a benzodiaze-pine hypnotic. If it had been

available in the United States as it was 1n

Great Britain during those five years, Pro-

fessor Wardell estimates that 1,200 lives would

have been saved.5/"

"S/ William M. Wardell, "Therapeutic

Implications of the Drug lag,' Clinical

Pharmacology and Therapeutics, vol. 15, no. 1

(January 1974), p. 83." (Henry G. Grabowska ,

Drug Regulation and Innovation -- Empirical

Evidence and Policy Options, p. 2.)"

C-39

IV

The Right of Privacy --

Article I, Section l, of the

California Constitution

Thus far we have considered only the

specific guarantees of the federal bill

of rights and the emanations formed

therefrom in concluding fundamental

rights are encroached by section 1707.1

However: "'[I]n the area of fundamental

Civil liberties -- which includes...

all protections of the California

Declaration of Rights -- we sit...

subject only to the qualification that

our interpretations may not restrict

the guarantees accorded the national

citizenry under the federal charter.

In such constitutional adjudication, our

first reference is California law and the

full panoply of rights Californians

have come to expect as their due. Ac-

cordingly, decisions of the United

States Supreme Court defining fundamental

rights are persuasive authority to be

afforded respectful consideration, but

are to be followed by California courts

only when they provide no less indivdual

Cc-40

protection than is guaranteed by California

law.'" (Serrano v. Priest, 18 Cal.3d 728,

764, [135 Cal.Rptr. 345, 557 P.2d 929]

quoting People v. Longwill, 14 Cal.3d 943,

951, fn. 4 [123 Cal.Rptr. 297, 538 P.2d

753].) (See also People v.- Disbrow, 16

Cal.3d 101, 114-115 [127 Cal.Rptr. 360,

545 P.2da 272]; People v. Norman, 14 Cal.

3a 929, 939 [123 Cal.Rptr. 109, 538 P.2d

237]; People v. Brisendine, 13 Cal.3d

528, 548-552 [119 Cal.Rptr. 315, 531

P.2da 1099]; Burrows v. Superior Court,

13 Cal.3da 238, 245-246 [118 Cal.Rptr.

166, 529-P.2d 590]; Mandel v. Hodges,

54 Cal.App.3d 596, 615-617 [127 Cal.

Rptr. 244]; State v- Kaluna, 55 Hawaii

361 [520 P.2da 51, 58-59]; Baker v. City

of Fairbanks, 471 P.2da 386, 401-402; see

generally Note, Project Report: Toward

an Activist Role for State Bills of

Rights (1973) 8 Harv.Civ.Rights -- Civ.

Lib.L.Rev. 271; Falk, Foreword: The

State Constitution: A More than

"Adequate" Nonfederal Ground (1973) 61

Cal.L.Rev. 273; Note, Rediscovering the

California Declaration of Rights (1974)

26 Hastings L.J. 481.)

C-41

It is an “incontrovertible conclusion

that the California Constitution is, and

always has been, a document of independ-

ent force. Any other result would con-

tradict not only the most fundamental

principles of federalism but also the

historic bases of state charters."

(People v. Brisendine, supra, 13 Cal.3d

528, 549-550.) We therefore must evalu-

ate the rights infringed by section

1707.1 in light of our own Constitution.

Article I of the state charter is the

California Declaration of Rights. Its

first section establishes certain inalien-

able rights: "All people are by nature

free and independent and have inalien-

able rights. Among these are enjoying

and defending life and liberty, acquir-

ing, possessing and protecting property,

and pursuing and obtaining safety,

happiness, and privacy." (Italics

added.) "The [federal] Constitution

does not explicitly mention any right of

privacy." (Roe v. Wade, supra, 410 U.S.

113, 152 [35 L.Ed.2d 147, 176, 93 S.Ct.

705, 726].) Neither did the California

Constitution. However, "[i]n November

C-42

1972, the voters of California speci-

fically amended article I, section 1 of

our state Constitution to include among

the various '‘inalienable' rights of

‘all people' the right of ‘privacy.'"

(White v. Davis, 13 Cal.3da. 757, 773

[120 Cal.Rptr. 94, 533 P.2d 2223'.2

The California Supreme Court first ad-

dressed the significance of the new pro-

vision in White v. Davis, supra, 13 Cal.

3d 757, 773-776. In that case the com-

plaint asserted certain government sur-

veillance and data-gathering activities

abridged students' and teachers' con-

stitutional right of privacy. In re-

versing a judment entered upon the

sustaining of a general demurrer, the

court concluded the activities chal-~

lenged did fall within the aegis of

article I, section 1. T

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