Lead Opinion
Opinion
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).
Viewed in the light most favorable to the judgments (see People v. Reilly (1970)
Defendants appeal on the ground the statute is unconstitutional. They contend the right of privacy protected by the federal and California Constitutions includes a right to obtain laetrile 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 necessaiy to achieve a compelling state interest. Defendants argue the purported right to obtain laetrile is fundamental and therefore the regulation challenged here must be reviewed under the compelling state interest standard. Section 1707.1 is found to be unconstitutional, defendants conclude, when measured against that standard.
The United States Constitution
The Supreme Court has held that regulations limiting certain fundamental rights may be justified only by a compelling state interest (Kramer v. Union School District (1969)
However, a fundamental privacy right is not at stake here. The interest defendants allege is, apparently, “the interest in independence in making certain kinds of important decisions.” (Whalen v. Roe (1977)
Significantly, when danger to health exists Roe v. Wade indicates that state regulation shall be tested under the rational basis standard. (
In Planned Parenthood of Missouri v. Danforth (1976)
Whalen v. Roe, supra,
Although recognizing that, “[unquestionably, some individuals’ concern for their own privacy may lead them to avoid or to postpone needed medical attention” (id., at p. 602 [
Finally, the high court reiterated: “It is, of course, well settled that the State has broad police powers in regulating 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,
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 indicate that approximately 16 percent of the total deaths in the United States annually 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. [U] Despite intensive campaigns of public education, there is a lack of adequate and accurate 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
These findings were recently echoed by the Commissioner of the federal Food and Drug Administration with specific reference to laetrile. “In the Commissioner’s opinion, the use of Laetrile in the United States has become a genuine public health problem. Increasingly, doctors dealing with cancer patients are finding that the patients are coming to legitimate therapy too late, having delayed while trying Laetrile. It seems clear that another substantial group of persons afflicted with cancer is avoiding 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 proceeding undertaken in compliance with the opinion of the court of appeals in Rutherford v. United States (10th Cir. 1976)
Because of defendants’ reliance on it, subsequent developments in the Rutherford case will now be considered. In Rutherford v. United States (W.D.Okla. 1977)
On appeal by the government, the court of appeals addressed neither the grandfather clause question nor the right of privacy issue. Instead, the court held that “the ‘safety’ and ‘effectiveness’ terms used in the statute have no reasonable application to terminally ill cancer patients.” “We are considering only cancer patients who are terminally 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 cancer regardless of what may be done.” The permanent injunction granted by the district court was continued but limited only to permit procurement of intravenous injections of laetrile administered by a licensed medical practitioner 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)
Defendants can take no comfort in the court of appeals’ decision for, unlike Rutherford, this case is not an action 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, distributing 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 determine whether a cancerous condition was “terminal.”
Moreover, we are not prepared to reject as unreasonable the explanation given by the commissioner for the Food and Drug Administration’s refusal to approve laetrile for use by “terminal” cancer patients.
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 vindicated in the court of scientific opinion, for even as this is being written the National Cancer Institute is seeking approval from the Food and Drug Administration to test laetrile on advanced cancer patients. (Cancer Institute Seeks to Test Laetrile, L.A. Times (Sept. 28, 1978) pt. I, p. 14, cols. 1-6.) Nor are we endorsing the decision the Legislature has made on the basis of existing scientific evidence. Whether cancer patients—especially advanced cancer patients who have unsuccessfully sought relief from conventional therapy and who are fully informed as to the consensus of scientific opinion concerning the drug—should have access to laetrile is clearly a question about which reasonable persons 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 relationship to the achievement of the legitimate state interest in the
The State Constitution
Having determined the federal constitutional right of privacy does not encompass a right of access to drugs of unproven efficacy, we next determine whether the voters of California intended to create such a right in November 1972 when they amended article I, section 1 of our Constitution to include among the various “inalienable” rights of “all people” the right of “privacy.”
There is simply no evidence of such intent. To the contrary, in White v. Davis (1975)
The election brochure argument by the proponents of the provision “represents, in essence, the only ‘legislative history’ of the constitutional amendment available to us.” (Id., at p. 775.) In the absence of any evidence that the voters in amending the California Constitution to create
Failure to Preserve Search and Seizure Issue
Defendants finally contend that the trial court erred in denying their motion to suppress certain evidence obtained 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 attempted action under this provision failed here because the person authorized 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 evidence 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)
The reason for the rule is well illustrated 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 nevertheless have acquired such status by a 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’ remaining contentions and find them to lack merit.
Tobriner, J., Mosk, J., Richardson, J., and Manuel, J., concurred.
Notes
Section 1707.1 provides: “The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound 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
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 basis standard when the danger to health is significant. (Roe v. Wade, supra,
The New York statute classified potentially harmful drugs in five schedules. Drugs, such as heroin, which are highly abused and have no recognized medical use, are in schedule I. Schedules II through V include drugs which have a progressively lower potential for abuse but also have a recognized medical use. Schedule II includes the most dangerous of the legitimate drugs. (Id., at pp. 592-593 [51 L.Ed.2d at pp. 69-70].)
On 22 January 1979 certiorari was granted in Rutherford. (— U.S. — [
The court of appeals did not mention or discuss the reasons given by the commissioner.
For example, with regard to the impossibility 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 difficulty in making a particular chemical available 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 management of cancer.” This opinion was shared by Dr. Joseph F. Ross, professor of medicine at the University of California School of Medicine at Los Angeles. Dr. Ross stated “[T]he distinction of ‘terminal’ patients from ‘nonterminal’ 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 Helene 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.)
Article I, section 1 (as reworded by constitutional amendment in Nov. 1974) now reads: “All people are by nature free and independent, and have inalienable rights. Among these are enjoying and defending life and liberty, acquiring, possessing, and protecting property, and pursuing and obtaining safety, happiness, and privacy.”
Dissenting Opinion
I respectfully dissent.
I do not question for a moment that the effective treatment of persons suffering from cancer is a matter of paramount public importance. However, we are dealing here with a disease whose causes and treatment continue to baffle 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 individual 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 being. For this reason, I believe the right to privacy, recognized under both the state and federal Constitutions, prevents 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.
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 alleviation or cure of cancer. (Pen. Code, § 182, subd. 1; Health & Saf. Code, § 1707.1.) Davis and Turner were convicted 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,
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 cancer victim’s right to obtain and use amygdalin in violation of rights guaranteed by the United States Constitution, Amendments I, IV, V, VI, VII, VIII, and XIV, and California Constitution, article I, sections 1, 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 treatment of cancer. As a corollary and necessary concommitant of the right of privacy of the patient, Dr. Privitera argues that the constitutional protection accorded the cancer victim’s right to utilize amygdalin in a program of nutritional 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 constitutional guarantees of privacy and personal liberty, therefore, extends, not only to the patient pursuing a course of nutritional therapy but to the physician who prescribes and administers the therapy and to the person who furnishes the essential components.”
Dr. Privitera does not challenge the validity of the general or specific regulatory laws to the extent they prohibit the advertisement of amygdalin as a cure for cancer (Health & Saf. Code, § 1714); or require amygdalin be labeled in accordance with state law and regulations (Health & Saf. Code, § 26463); or impose standards on the manufacturing and packing of amygdalin to insure quality and prevent adulteration or deterioration, or the prohibition of the sale of amygdalin to members of the general public for the purpose of treating cancer by persons other than licensed physicians (Health & Saf. Code, § 26400 et seq.). (Health & Saf. Code, §§ 1704, 26670, 1707.1, 1709; Cal. Admin. Code, tit." 17, § 10400.1.)
Rather, Dr. Privitera’s challenge is directed to those laws, specifically the one of which he is convicted; insofar as they prohibit a duly licensed
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 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 widespread 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 vaiy 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 emotional outlook. It is generally conceded that amygdalin is nontoxic; it does not fall within the general ban of drugs which are toxic, habit forming, addictive, or otherwise distort reality. Conventional 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 methodology 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 medicine, and others from nonmedical fields taking side on this issue, cancer 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, radiation 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 treatment; other cancer victims have been advised that their condition is hopeless, their case is terminal and as a last resort before certain death, seek amygdalin.
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 California Medical Association, the National Cancer Institute and a great block of practicing physicians, to be of no value 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 clause 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 decisions. The very nature of the relationship, the act to be performed, the decision to be made, precludes unjustified 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 (Autumn 1976) U. Chic. Magazine 7.) It is that right voiced by Justice Brandeis in his dissent in Olmstead v. United States,
Historically this right of privacy was first articulated as a constitutional right in Griswold v. Connecticut,
This principle, now of constitutional dimension, has been embraced by many decisions in a variety of situations.
The People concede, as they must, the fact, the existence of this expanding and as yet judicially unmeasured concept of individual privacy. However, they contend the State of California has the broad power to establish and enforce standards of conduct within its borders relative to health. This is a vital aspect 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,
This broad premise authorizes the invasion 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,
The People concede any exercise of police power, depends in the first instance upon an articulated public interest in the activity to be regulated and second, the means used must be reasonably necessary for the
At the heart of the People’s defense of Health and Safety Code section 1707.1 is the premise, Legislature declared,
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 violation 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 received from a
H
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 treatment, 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 prescribe 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 exercise 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 the very nature of man. Justice Brandeis in Olmstead v. United States, supra,
Judge Cardozo in Schloendorff v. Society of New York Hospital,
Without specific reference to a constitutional basis, the right to choose what may be a suicidal medical course has been upheld. In Erickson v. Dilgard,
For analogy we look to the very heart of this right of choice of medical procedures, the right to beget or not to beget a child. In the case of Griswold v. Connecticut, supra,
Roe v. Wade, supra,
In the companion case, Doe v. Bolton, supra,
To support its conclusion, the Supreme 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 copractitioners has no rational connection with a patient’s needs and unduly infringes 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 ‘[r]eliance must be placed upon the assurance given by his license, issued by an authority competent to judge in that respect, that he [the physician] possesses the requisite qualifications.’ Dent v. West Virginia,
In Whalen v. Roe, supra,
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 procedures, 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,
Carey v. Populations Services Intern.,
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,
Aden v. Younger,
“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 regulation 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 serious 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 quintessence in the Matter of Quinlan,
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. . . . [E]ven if it were to be regarded as homicide, it would not be unlawful.” (Matter of Quinlan, supra,
Ill
The Doctor’s Zone of Privacy
Dr. Privitera asserts a separate and distinct constitutionally protected right—a zone of privacy—to prescribe, to treat patients whether in the orthodox mode—free from unjustified state interference.
Whalen v. Roe, supra,
Doe v. Bolton, supra,
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 prescribed 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 put. The
Dr. Privitera’s right, in relation to the patient, has been viewed traditionally 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 rationality of the licensing scheme, such standards are generally upheld as reasonable and necessaiy means of protecting the public health.
The more recent cases hint at the more profound right in the doctor. It is postulated: There exists in the doctor licensed to practice medicine a right, constitutional in nature, as yet ill-defined, to treat and to treat by unorthodox modalities—as yet unapproved by the state board—an informed consenting patient.
Doe v. Bolton, supra,
Roe v. Wade, supra,
Reason, based on history, experience, supports the doctor’s premise. To require prior state approval before advising—prescribing-administering —a new treatment modality for an informed consenting patient is to suppress innovation by the person best qualified to make medical progress. The treating doctor, 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
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 referent is California law and the full panoply of rights Californians have come to expect as their due. Accordingly, decisions of the United States Supreme Court defining fundamental rights áre persuasive authority to be afforded respectful consideration, but are to be followed by California courts only when they provide no less individual protection than is guaranteed by California law.’ ” (Serrano v. Priest,
It is an “incontrovertible conclusion that the California Constitution is, and always has been, a document of independent force. Any other result would contradict not only the most fundamental principles of federalism
Article I of the state charter is the California Declaration of Rights. Its first section establishes certain inalienable rights: “All people are by nature free and independent and have inalienable rights. Among these are enjoying and defending life and liberty, acquiring, 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,
The California Supreme Court first addressed the significance of the new provision in White v. Davis, supra,
“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 histoiy” of the constitutional amendment available (id., at p. 775), and “California decisions have long recognized the propriety of resorting to such election brochure arguments as an aid in construing legislative measures and constitutional amendments adopted pursuant to a vote of the people.” (Id., at fn. 11.)
After review of the ballot statements in White v. Davis, supra,
The rights here relied upon by Privitera do not fall within that “more focused privacy concern” of White v. Davis, supra,
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 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 personalities, 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, Fourth, 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 tp privacy is much more than ‘unnecessary wordage.’ It is fundamental in any free society. Privacy is not now guaranteed by our State Constitution. This simple amendment will extend various court decisions on privacy to insure protection of our basic rights.” (Italics added.)
Like Brandéis, the people of California 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 emotions, our expressions, our personalities . . . ,”
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 modem surveillance and data-collecting activities. This state-protected right of privacy encompasses a fundamental 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 compelling need.
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 compelling state interest can justify intrusion 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 compelling state interest which overrides the rights so found?
The cases cited by the People in support 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 regulating dangerous, legitimate, drugs such as opium, cocaine, methadone. The state could “prohibit entirely [their] use.” Therefore, the New York statute requiring
In Minnesota ex rel. Whipple v. Martinson, supra,
In Blinder v. Division of Narcotic Enforcement, supra,
The Privitera court examined the procedure 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 States Supreme Court in Weinberger v. Hynson, Westcott & Dunning, Inc.,
The appellate division examined the right of privacy question but found the state interest to be of such magnitude as to authorize prohibition of all treatment by physicians of cancer by any modalities other than “state sanctioned alternatives.” Said People v. Privitera, supra,
Reported cases specifically involving the authority, the right, of either the federal government or state to penalize, prohibit, amygdalin transportation, possession or use are rare. In Rutherford v. United States,
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 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 it.”
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,
Rutherford was reviewed sub nomine Stowe v. United States of America (10-12-75) D.C. No. CIV-75-0218-B (10th Cir.).
After remand to the district court in opinion filed January 4, 1977, it was held: “In view, however, of the complete 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 depriving a terminally ill cancer patient of a substance he finds therapeutic, whether such benefit is physical or psychological, creates the very real risk that irreparable injury might be sustained.”
The district court injunction remains in effect pending remand to the FDA.
In Carnohan v. United States of America, 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 interference with his importation or interstate transportation of amygdalin for his own consumption.
The court found Carnohan was receiving 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 possibly occur by weakening laws calculated to prevent
These judicially carved out exceptions to the federal prohibition against importation 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 criminal sanction on the doctor for prescribing amygdalin as a cancer treatment for an informed consenting cancer victim, without first seeking governmental approval 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 suffering from cancer.” (Health & Saf. Code, § 1700.) Further the Legislature found: “. . . accurate and early diagnosis 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 prescription 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 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 represent themselves as possessing medicines, . . . skills, ... for the effective diagnosis, treatment, or cure of cancer, which representations are misleading to the public,. . . .”
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 qualifications. 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 receiving the informed consent of the patient. (Cobbs v. Grant, supra,
Limiting this exercise of the doctor’s professional judgment on some vague suspicion that “various persons” in this state are engaging in quackery does not follow as a matter of logic.
The premise that “various persons,”—con man, snake oil salesman, —have made or will make false and misleading representations 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 section 1714 accomplishes this precise purpose. It prohibits a false representation with intent to defraud of any device or substance or treatment as an effective cure for cancer. Dr.
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 relationship between the end sought and the means used, then certainly no compelling state purpose is present.
Dr. Privitera is charged under Health and Safety Code section 1707.1. This statute requires for its breach an intent to prescribe the unauthorized drug or medicine for treatment of cancer. The efficacy of the treatment proposed or medicine prescribed is not an issue under this statute. The truth or veracity of the representations, 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 because 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 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 supplement or a hope-giving placebo is not an issue. The governmental agencies have not given approval; therefore the doctor 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
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 immediate 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 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,
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” treatment 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, punishing quackery in cancer treatment, is a laudible objective. The means chosen by the Legislature is bureaucratically predetermined treatment or none, injected into a constitutionally protected 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 processes 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 doctor 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 the public or that unfortunate portion of the public who have cancer but who have not yet heard of the need for early treatment,
We conclude not only is there no compelling reason shown to override the patient’s or the doctor’s fundamental right of choice in the treatment setting but that the statute when sought to be applied to a licensed medical doctor does not pass the test as a rational means of accomplishment of the announced legislative purpose.
There remains one further concern. The evidence in this case shows without exception the cancer victims, whether People’s or defense’s witnesses, were knowledgeable persons fully aware of the nature of the “state sanctioned alternatives” before 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 compel the availability of the drug in question illustrate the desperate seeking of the cancer victims.
The 19 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 elements form the unspoken rationale
To these 19 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 of the state, warrants an Orwellian intrusion into the most private of zones of privacy.
The state has in the name of protecting 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 interpreted. No compelling interest of the state requires Dr. Privitera’s 19 cancer patients to endure the unendurable, 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 violation of the Fourteenth Amendment to the federal Constitution and article I, section 1 of the California Constitution.
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 proceedings 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. (Rutherford v. United States (W.D.Okla. 1977)
Health and Safety Code section 1707.1 provides:
“The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound 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 [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 composition of such drug, medicine, compound or device;
“(d) A full description of the methods used in, and the facilities and controls used for, the manufacture, 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 principles of its operation;
“(e) Such samples of such drug, medicine, compound or device and of the articles used as components of the drug, medicine, compound or device as the board may require; and
“(f) Specimens of the labeling and advertising proposed to be used for such drug, medicine, compound or device.”
In Morris L. Ernst’s and Alan U. Schwartz’s Privacy: The Right To Be Left Alone (1962), the history and broad sweep of this doctrine is documented. Samuel D. Warren and Louis D. Brandéis, in The Right to Privacy (1890) 4 Harv. L. Rev. 193, state: “. . . it has been found necessary from time to time to define anew the exact nature and extent of such protection.”
Health and Safety Code section 1700 provides:
“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 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.
“Despite intensive campaigns of public education, there is a lack of adequate and accurate 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 savings of individuals and families relying on such representations 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 investigating 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 from misrepresentation in such matters.
“The importance of continuing scientific research to determine the cause or cure of cancer is recognized, and the department shall administer this chapter with due regard for the importance of bona fide scientific research and the clinical testing in hospitals, clinics, or similar institutions of new drugs or compounds.”
People v. Privitera,
Soviet geneticist T. D. Lysenko, controversial 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 important branch of Soviet science.
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 permitting general prescription and use.
One study surveyed was that by Sam Peltzman. He researched the effect of the 1962 amendment on drug innovation: “In effect, Peltzman’s . . . suggests that the rate of innovation in the post-amendment period is more than halved as a result of the 1962 amendments.”
Did the Federal Drug Administration effectively 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 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 decline 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 together 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 discovery 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, as Professor Grabowski shows, a continued erosion of U.S. leadership thereafter. We have reached the point where innovations based on discoveries by U.S. firms and institutions constitute less than one-sixth of worldwide introductions of new chemical entities . . . and exports of pharmaceuticals as a share of U.S. exports have declined by one-third since thp 1950s.”
Decline in innovation is bad enough yet the public’s safety has not been enhanced. According to Professor Grabowski: “One of the bitter ironies of this situation is that the 1962 amendments were spurred by an alarm over the safety of new drugs—by the fears created by the thalidomide incident. The irony lies in the fact that the 1962 amendments are keeping off the market new drugs that are safer than the drugs they would replace. Professor 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 benzodiazepine hypnotic. If it had been available in the United States as it
"’William M. Wardell, ‘Therapeutic Implications of the Drug Lag,’ Clinical Pharmacology and Therapeutics, vol. 15, no. 1 (January 1974), p. 83.” (Grabowski, Drug Regulation and Innovation—Empirical Evidence and Policy Options, p. 2.)
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 understanding.” (Olmstead v. United States, supra,
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 distinguishedfrom the individual, has, if any, only an indirect interest; comprehending 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 participation. When I say only himself, I mean directly, and in the first instance; for whatever affects himself, may affect others through himself; . . . This, then, is the appropriate region of human liberty. It comprises, first, the inward domain of consciousness; demanding liberty of conscience, in the most comprehensive 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 pursuits; of framing the plan of our life to suit our own character: of doing as we like, subject to such consequences as may follow: without impediment from our fellow-creatures, so long as what we do does not harm them, even though they should think our conduct foolish, perverse, or wrong. . . .
“. . . 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 obtain it. Each is the proper guardian of his own health, whether bodily, or mental and spiritual. Mankind are greater gainers by suffering each 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.)
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 absolutely the dealings of society with the individual 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, individually or collectively, in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be 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 otherwise. To justify that, the conduct from which it is desired to deter him, must be calculated to produce evil to some one else. The only part of the conduct of any one, for which he is amenable to society, is that which concerns others. In the part which merely concerns himself, his independence is, of right, absolute. Over himself, over his own body and mind, the individual is sovereign.”
21 United States Code section 355 provides in part: “(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) of this section is effective with respect to such drug.”
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 coplaintiff, died before the hearing on the preliminary injunction which was issued by the district court.
Refusing enforcement of Health and Safety Code section 1707.1 is totally compatible with (1) compulsory vaccination, (2) fluoridation of public water supplies, (3) requiring that certain drugs be available to the public on prescription from a licensed doctor, and (4) recognition of a compelling state interest in the health of a prospective mother at approximately the end of the first trimester of pregnancy. (Roe v. Wade, supra,
See Ellen S. Hodgson, infra, page 687, footnote 240, pointing out this incongruity. The smuggler of laetrile: “. . . faced a $10,000 fine and five-year prison sentence—the maximum penalty imposed for smuggling an illegal drug intended 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 classified as a ‘controlled’ substance—like heroin or marijuana—the possession of which is 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.”
See Hodgson, Restrictions on Unorthodox Health Treatment in California: A Legal and Economic' Analysis, 24 UCLA L.Rev. 647, 683, 689, for an excellent and exhaustive review of case and statutory law.
Dissenting Opinion
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. dis. opn. in Cramer v. Tyars,
Appellants’ petitions for a rehearing were denied April 12, 1979. Bird, C. J., and Newman, J., were of the opinion that the petitions should be granted.
