UNITED STATES v. RUTHERFORD
Legal provision: Federal Food, Drug, and Cosmetic, and related statutes
Argument of Wade H. McCree
Chief Justice Warren E. Burger: We'll hear arguments next in United States against Rutherford.
Mr. Solicitor General.
Mr. Wade H. McCree: Mr. Chief Justice and may it please the Court.
This case concerns a drug or group of drugs variously referred to in the record a Laetrile with a “capital L”, laetrile with the “lowercase l”, amygdalin and Vitamin B17.
Part of the problem with this case is the difficulty of distinguishing just which drug is referred to in a particular context.
Generically, this drug or group of drugs comprised a compound known as a cyanogenetic glucoside.
I understand glucoside to be one of a group of organic compounds found in the kernels and seeds of most fruit that hydrolyzed or breakdown to yield glucose which is a sugar, and in the case of a cyanogenic glucoside, hydrogen cyanide as well which of course is a poison.
Amygdalin is the name of a cyanogenic glucoside that is frequently used interchangeably with Laetrile either with the “capital L” or “small case l.”
One other definition might be useful, one of the chemical definitions of Laetrile or proper definitions of Laetrile has been -- was made in the administered of record as laevo-mandelonitrile-beta-glucuronoside.
I say all of that to suggest the origin of the name Laetrile.
Laevo is the first part which means left as I understand it from the Latin and mandelonitrile is the chemical and if we take lae from leavo and the trile from mandelonitrile, we have Laetrile, and this is the drug with which we are concerned today.
The left business, the Laevo is in contrast to dextro which would be the right rotation and it refers to the way these two drugs show up in polarized light.
The proponents of this drug Laetrile contends that it is a cancer cure and in some instances, a cancer preventive.
The process is change from time to time, but in short it appears to be the following.
It is the theory of the proponents that Laetrile releases hydrocyanic acid, which of course is a poison, and it does so in the presence of an enzyme that allegedly occurs in greater concentration in malignant cells than it does in normal cells.
And therefore, the malignant cells are destroyed by the action of this chemical.
The case comes before us is a consequence of a curious proceeding.
The Federal Food, Drug And Cosmetic Act prohibits the introduction of any new drug as defined in the statute into interstate commerce unless a new drug application, an NDA supported by appropriate evidence of the drug's safety and effectiveness has been approve by the Commissioner of the Food and Drug Administration who is the Secretary of Health, Education, and Welfare's designate, or unless the drug is exempted from the approval requirements by one of the Acts two grandfather provisions, one in 1938 and the other in 1962, both of which are still operative.
Because Laetrile had not been established as being entitled to grandfather status or is having meant the statutory requirements for approval as a new drug, the Food and Drug Administration brought a series of civil and criminal proceedings to prevent the introduction of Laetrile under various names into interstate commerce.
In March 1975, respondents brought a suit in the United States District Court for the Western District of Oklahoma to enjoin the Government from interfering with the sale and distribution to patient suffering from cancer of a substance known as B17, Laetrile and amygdalin.
The District --
Justice Potter Stewart: What was the status of the respondent?
What was their -- what conferred upon them standing to bring this suit?
Mr. Wade H. McCree: That's a question for which I haven't good answer if the Court please of the Government raise the question of the jurisdiction of the court and their standing, but it was decided adversely to the Government and it its present posture, we suggest that on a remand, there probably was jurisdiction.
But at this stage, I cannot answer you Mr. Justice Stewart.
Justice Potter Stewart: Are these -- the respondents' alleged in their complaint that they want to use it or that they move?
Mr. Wade H. McCree: They alleged that they wish to use it.
Justice Potter Stewart: They are not producers or sellers?
Mr. Wade H. McCree: They are not producers.
They alleged that they were patients suffering from cancer and that they were terminally ill cancer patients and they were later certified as a class consisting of terminally ill cancer patients and they wish access to the drug for their therapy to be administered to them by their physicians.
The District Court issued a preliminary injunction forbidding the Government from preventing the purchase in interstate movement of Laetrile for respondent Rutherford and the other members of the class who could show by affidavit that they were terminally ill with cancer.
On appeal by the Government, the Tenth Circuit upheld the granting of the injunction but instructed the District Court to remand the case to the Commission for the development of an administrative record adequate under the Administrative Procedures Act, addressing the issues first whether Laetrile is a new drug within the meaning of the Act, and second if so, whether it is exempt from the premarketing requirements because of either the 1938 or the 1962 grandfather clause.
Upon remand, the Commissioner initiated administrative proceedings to a federal register announcements seeking public comment, and the proceedings which included two days of oral presentation produced more than 400 submissions and more than 5,000 pages of testimony at the conclusion of which, the Commissioner concluded first that Laetrile is a broader generic term for a group of related compounds and that in its various forms, it is a new drug within the meaning of the Food and Drug Act, and that it was definitely toxic when taken orally, that it had not been adequately tested for safety, that is was not generally recognized among experts a safe for use in man, and that distribution prior to meeting the premarketing approval of the FDA would be unlawful unless it qualified for exempt status under either grandfather provision.
He concluded that it was not exempt under the 1938 exemption, grandfather exemption, or the 1962 because the drug that -- with which was she was concerned had not been used commercially under the same or similar label for therapeutic purposes before either the 1938 time or the 1962 time which would've permitted it to continue in commerce.
He concluded that the distribution of Laetrile in interstate commerce is in violation of the Food, Drug, and Cosmetic Act and subject to regulatory action.
Chief Justice Warren E. Burger: Mr. Solicitor General, what evidence did the District Court have before it as a basis for a finding that this was nontoxic?
Mr. Wade H. McCree: If the Court please, the District Court when it initially granted the injunction, I had no evidence before it except --
Chief Justice Warren E. Burger: But he did make a finding that it was nontoxic, did he not?
That's my impression from your -- the summary of your argument or part of your brief.
Mr. Wade H. McCree: Well, the matter went back to the District Court from the administrative hearing and do I understand your inquiring about the second time the District Court looked at it the first time?
Chief Justice Warren E. Burger: That wasn't clear from what I read whether it was the second time or the first time.
At anytime, what evidence did the District Court have of this drug, this material being nontoxic?
Mr. Wade H. McCree: It's my understanding that the District Court did not take evidence in this matter, but relied on the administrative record that was made.
Chief Justice Warren E. Burger: But he did make a finding that it was nontoxic?
Mr. Wade H. McCree: He made a finding when he reviewed this administrative record that I've just related, which is the next step in the proceeding and what the District Court did was to sustain the Commissioner's conclusion that Laetrile was a new drug.
He agreed that it was not exempt under the 1938 grandfather clause, but he concluded that it was exempt under the 1962 grandfather clause, and in doing so, we contend improperly reviewed the evidence that was before the Commissioner, and that was properly within the jurisdiction of the Commissioner to make findings.
And then, he did a curious thing which we contend also was in error.
He held that the Food and Drug Administration had offended that constitutional right to privacy by denying the right to use a nontoxic substance in connection with one's own personal health.
Despite his find -- the Commissioner's finding that Laetrile has a known toxicity when taken orally and that it -- the testing is insufficient to determine its toxicity in any form.
Justice William H. Rehnquist: Well, isn't there an additional curiosity about the District Court's constitutional holding and that he'd already found that it was covered by the grandfather clause in 1962 so it didn't have to reach that question?
Mr. Wade H. McCree: Mr. Justice Rehnquist, we agree that it was a quite unnecessary finding for the District Court to make.
But the District Court did this nevertheless.
The Government appealed it again to the Tenth Circuit and the Tenth Circuit without addressing the grandfather ground or the constitutional ground on which the District Court relied held as a matter of law that the safety and effectiveness terms used in the statute have no reasonable applications to terminally ill cancer patients, and that the Food And Drug Administrator had erroneously applied the Act to these persons.
Nevertheless, it modified the District Court's injunction to limit the use to intravenous injections administered by licensed medical practitioner and only to person certified by a licensed medical practitioner to be terminally ill of cancer in some form, and he directed the Food and Drug Administration to promulgate regulations within this limitation as if the drug was found by the Commission to be safe and effective for the terminally ill cancer patients.
And the matter is before this Court on the writ of certiorari.
We submit that the following questions are presented.
First, whether the safety and effectiveness requirements of the Federal Food and Drug and Cosmetic Act applied to drugs intended for use by the terminally ill which is the issue on which the Court of Appeals decided the matter.
We submit further that if the Court decides that question as we think it should, it would want to consider the two grounds found by the District Court for enjoining the interstate distribution of the drug, and therefore, it would consider whether the judgment of the Court of Appeals barring application of the Act to interstate distribution of the drug for intravenous administration to terminally ill patients is sustainable on the grounds that Laetrile is exempt because of the premark -- from the premarketing requirements because of the 1962 grandfathers clause, and finally, whether the judgment of the Court of Appeals is sustainable underground that the prohibition of the interstate distribution violates a constitutional right to privacy.
I'd like to address the first question now if I may.
Justice Byron R. White: Those last two are really questions for your opposition to propose and I --
Mr. Wade H. McCree: Indeed they are, but he --
Justice Byron R. White: And they have I take it.
Mr. Wade H. McCree: And he's entitled to urge the Court to sustain the judgment on those alternative grounds and --
Justice Byron R. White: And he has presented them?
Mr. Wade H. McCree: And he has presented them, yes sir.
The -- we submit that the Court of Appeals is misconstrued the statute in holding that the safety and effective requirements of the Act do not apply to terminally ill persons.
In the first place, the Act makes no such exception.
There's no language in the Act that says that it does not apply to terminally ill persons and the legislative history does not support this exception that's contended for.
The Food and Drug Administration has consistently administered the Act without recognizing any such exception and the Congress has indicated its acquiescence in the adminis -- the way the Act has been administered because on at least two occasions, it has amended the Act without changing the construction that the Commission placed upon the statute.
We further submit that there's no reliable means of identifying the class except in retrospect.
The administered record teaches that cancer is a disease about which very little is known, that it frequently goes into spontaneous remission for reasons not understood, and that a person designated is terminally ill may surprise his physician by outliving the prognosis that he makes at the time the designation is indicated.
We also suggest that a drug can be unsafe for a dying person contrary to the decision of the Court of Appeals if it poses a risk of shortening the life of the terminally ill person or if it poses the risk of aggravating the symptoms experienced by the so-called terminally ill person.
Chief Justice Warren E. Burger: I suppose you're done to that if it had any tendency of risk of hastening death.
Mr. Wade H. McCree: And of course, if it was toxic, if it hastened death, it would be a fortiori that it would be unsafe for the terminally ill patient.
We also suggest that the drug is ineffective as well as unsafe if it does not produce the effects of prolong life or the (Inaudible) from pain that is claimed for.
And if it's ineffective, then we say the Court of Appeals was erroneous in its determination.
We also submit that the terminally ill have the same right to be protected from ineffective drugs just as other people have, and that the Tenth Circuit by substituting its judgment for that of the agency charge by Congress with the responsibility of keeping unsafe drugs out of the market place was an error and that this Court should reverse its judgment.
The grandfather's clause if I may pass to that and anticipate the argument that's in my brother's brief, that -- we submit and perhaps my brother will answer this that there's no claim that Laetrile was marketed commercially before 1962.
And of course to be within the grandfather's clause, the person contending the exemption must show commercial marketing.
And we submit that there was not and we submit that the brief that the administrative record is very clear about that.
The Commissioner also found that the composition of different substances referred to as Laetrile before and after 1962 very listed their formulations so that no one could state with certainty just what's subject had been grandfathered, and of course, there would be another for the grandfather's clause not to apply.
We also submit that the record supports the Commissioner's conclusion that the drug was not generally recognized as safe as required by Section 201 (p).
He found specifically that there was a hazard of cyanide poisoning and the record shows that when ingested orally, the drug has a very definite toxic effect and that there was insufficient testing of its consequences when taken by injections parenterally.
Justice Harry A. Blackmun: General McCree, in your view, who has the burden of proof on the grandfather clause issue?
Mr. Wade H. McCree: I would think the person who asserted the exemption would have the burden of proof.
Justice Harry A. Blackmun: Are there any cases that so hold?
Mr. Wade H. McCree: I can't think of a case it's specifically addresses that question.
But normally, a person claiming an exemption from a general rule in the ordinary theory of the allocation of burden would have to sustain it.
This case is curious in another respect.
It's not the typical food and drug case, and so the manner of burden -- who bears the burden, takes on an interesting aspect.
Here, we have patients contending that they have a right to use a drug, and it's not the typical case of the manufacturer of a drug seeking of clearance for it when he would understand what he had to show.
We think the contrary to the finding of a District Court that the Commissioner was extremely fair in the hearing that he conducted because he invited persons who were sponsors of the drug, who were not themselves cancer patients to present evidence and he consider their evidence in arriving at his conclusion.
We suggest that there's another reason why the grandfather's clause does not apply because the only labeling of the drug before 1962 was for investigational use only, and not for commercial use.
It was labeled to instruct physicians who were conducting experiments in its use and as such, it did not qualify for the grandfather's clause.
Finally, we say that the District Court employed an improper standard of review by overturning the Commissioner's findings of fact.
There was evidence to support every one of the Commissioner's findings.
We submit that it was his right to do this and that the District Court improperly evaded the province of the administered of agency in making these findings.
Finally, we would address the constitutional issue.
In the first place, we say that the asserted right of privacy which would give a terminal patient the right to use this drug is premised upon something that is not so.
It is premised on the unwarranted belief that Laetrile has been shown to be nontoxic.
And we submit that the record shows clearly that it is toxic.
And if it is, the entire premise for this determination is destroyed and the conclusion should fall.
Justice Byron R. White: Is that true if taken orally?
Mr. Wade H. McCree: It is certainly true taken orally and there is no adequate investigation of its consequences when taken by injection.
Justice Byron R. White: So, you can't say then that it's not toxic?
Mr. Wade H. McCree: You cannot say that it is not toxic.
Justice Byron R. White: Well, you can't say that it is either?
Mr. Wade H. McCree: That's correct.
But the conclusion --
Justice Byron R. White: And this Circuit's order is limited to intravenous?
Mr. Wade H. McCree: It is so limited and we suggest two things from that.
First, the limitation that was gratuitous indicates that the Court of Appeals recognized the toxicity when taken orally.
But we also suggest that it is his premise that a person has a constitutional right to use a nontoxic drug, and it would appeal then that if there is no evidence of toxicity or not, that his conclusion fails.
Particularly when the drug is shown to be toxic in one form and when it is clear that one of its components is a deadly poison, and no one knows whether it is released in the -- when taken parenterally, when injected instead of ingested.
We also suggest that this Court in discussing the right of privacy has not extended it beyond protecting the individual interest in making independent decisions in matters relating to marriage, procreation, family relationships, and childbearing and education.
In Whalen versus Roe, this Court in 429 U.S. page 600 in footnote 26 said expressly that the right to privacy did not extend to the drugs that were involved there that were subject to potential abuse.
It would also suggest that the court has made it clear that even in these protected areas, the right of a person not to be regulated might be restricted in the interest of protecting the health of the person concerned.
Now, we point to the abortion cases, the case that involved the saline amniocentesis method of abortion, where the court said that this wasn't the prohibition there wasn't to protect the health of the woman, but it was for a different purpose, and an improper purpose.
In here, the concern if for the health would not be prohibited.
Also, we suggest that historically, the exercise of the police power to protect people from harmful drugs or improperly labeled drugs is far antedates the Constitution when the Constitution was adopted, this was a common practice.
In fact, we show in our appendix that it began in 1266, I guess that's 200 years after the Norman Conquest and continuously in Anglo-American history, public health has been protected.
I see the -- my time is nearly expired and I would like to reserve any remaining time I might have for rebuttal.
Chief Justice Warren E. Burger: Very well.
Justice John Paul Stevens: Mr. Solicitor General, may I ask you one question.
I read in the press that marijuana is very helpful in relieving pain in cancer patients.
Has the FDA ever addressed that question that arises with respect to marijuana?
Mr. Wade H. McCree: I'm not aware that a new drug application has been filed with the FDA for that.
Justice John Paul Stevens: I've been told that's used for that purpose.
Mr. Wade H. McCree: I've heard that, too.
Justice John Paul Stevens: Yes.
Mr. Wade H. McCree: And I think I have read too that experimental uses has been authorized and I think I read recently that someone who is authorized to use it experimentally have been arrested.
I think in one of the New England states for possessing marijuana that he said was furnished in were authorized by the Food and Drug Administration.
I'm not aware of any litigation.
Justice Lewis F. Powell: Had any state pass a right to that statute?
Mr. Wade H. McCree: I'm not aware of any right.
Justice Lewis F. Powell: A number of such statutes had been introduced in state legislatures.
Mr. Wade H. McCree: I am aware of that, but I'm not aware that any state has does this.
We point out in our reply brief that the only state that's addressed this question of the -- of a right to privacy challenged to self-medication is California in People versus Privitera, which was just decided March 15, 1979.
California found under both the federal and state constitution, no constitutionally protected right to take a particular drug, of course medication.
If I have a moment, I would like to reserve --
Argument of Kenneth Ray Coe
Chief Justice Warren E. Burger: Yes.
Mr. Kenneth Ray Coe: Mr. Chief Justice and may it please the Court.
I think initially it is incumbent upon me to discuss with you briefly the limitations that are imposed inherently in this case by the lower court's rulings.
This case applies only to a class of terminally ill cancers patients which are represented in this case by Mr. Glen Rutherford.
It applies only to the application of the substance known as Laetrile.
It applies to the intravenous application of that particular substance, and it applies to application of that substance only under the care of -- excuse me, by supervising doctor.
This case has nothing at all -- no content other than that what I've just discussed.
Now, the reason I mentioned that is because it has been asserted in the Government's brief to a large extent that this case Bowe (ph) is very ill for the Food and Drug Administration, and I just do not believe that is the case and I do not believe this case when you consider what is happening.
Initially, this case was brought in the United States District Court for the Western District of Oklahoma by several cancer patients who were desirous of using Laetrile were in the terminal state, and almost immediately died.
Mr. Rutherford was brought in as a replacement or supplemental plaintiff and at that point in time, we move the court for temporary injunction so that he wouldn't suffer the same fate as the original plaintiffs.
The District Court granted the injunction just as to Mr. Rutherford which decision of course was appealed to the Tenth Circuit Court of Appeals.
That Circuit made a determination that in fact Mr. Rutherford was entitled to the temporary injunction, but it did not appear to that court that the Food and Drug Administration had the sufficient record upon which to base its new drug determination.
So, the case was remanded back to the District Court and a hearing was held before that District Court.
At that point in time Judge Bohanon asked the attorneys for the Food and Drug Administration what administrative record had been compiled to determine that Laetrile was a new drug or that it was not grandfathered by provisions of the 62 Amendments or the 38 Amendments.
The Government Attorney stipulated in court at that time that's a matter of record that they had no record exclusive of one affidavit which had been prepared by a Food and Drug Administration medical doctor.
Judge Bohanon then remanded the case to the Food and Drug Administration so that the proper administrative record could be compiled upon which he can base some decision and the Tenth Circuit could base some decision as to authenticity of the administrator's findings.
The Food and Drug Administration then held its rule making proceeding, and we've contended throughout this litigation that the rulemaking proceeding that the FDA conducted was not proper under the circumstances.
Justice William H. Rehnquist: How did this case get to the District Court, Mr. Coe?
It was it -- I don't know, originally an application for administrative review?
Mr. Kenneth Ray Coe: No, Your Honor.
It was a complaint filed in the Unites States District Court for the Western District of Oklahoma on behalf of terminally ill cancer patients alleging that the Food and Drug Administration by virtue of the determination that Laetrile was a new drug, had effectively prohibited their use of the drug, and there is authority for that I believe that's Weinberger versus Hynson, Westcott & Dunning, that after the Food and Drug Administration had made its initial determination that a District Court made them review.
Justice Byron R. White: It was just an administrative.
Justice William H. Rehnquist: So, it wasn't the application or administrative review under the Heinemann?
Mr. Kenneth Ray Coe: Well, yes Your Honor, I guess you had to call that.
Justice Byron R. White: But it what forward just on the administrative record?
Mr. Kenneth Ray Coe: Your Honor, it's been backwards and forwards --
Justice Byron R. White: Yes, but I mean as it finally got to -- finally before Judge Bohanon, it -- he proceeded on the administrative record?
Mr. Kenneth Ray Coe: Yes, Your Honor.
Justice Byron R. White: No new evidence in the District Court?
Mr. Kenneth Ray Coe: No new evidence was heard.
The administrative record that was compiled which is ordered by the Tenth Circuit Court of Appeals was ordered to comply with the Administrative Procedure Act Section 554 sub (c).
Within that subsection, it requires that cross-examination be allowed to the proponents and to the other side in the case.
Now, the Food and Drug Administration selected the most informal proceeding of the variety of proceedings it could possibly hold, and in fact allowed witnesses to testify without the administration oath, or without the opportunity of cross-examination to determine the veracity of any of those witnesses.
Now, that was so even though the objection was made to the Hearing Examiner at that time to that particular type of proceeding.
Justice William H. Rehnquist: You said the Administrative Procedure Act prohibits that?
Mr. Kenneth Ray Coe: I'm sorry, Your Honor?
Justice William H. Rehnquist: You say that the Administrative Procedure Act prohibits that?
Mr. Kenneth Ray Coe: No, the Tenth Circuit Court of Appeals required that the FDA conduct the proceedings pursuant to 554 sub (c) of the Administrative Procedure Act.
Justice William H. Rehnquist: So that if you say that 554 sub (c) prohibited the sort of proceedings conducted by the Food and Drug Administration?
Mr. Kenneth Ray Coe: Actually, sir that refers you to 556 which grants the right of cross-examination.
Justice William H. Rehnquist: So, indirectly you say it that is -- what the FDA did here is prohibited by the Administrative Procedure Act?
Mr. Kenneth Ray Coe: By that and as it was espoused by the Tenth Circuit Court of Appeals.
Justice William H. Rehnquist: Well, you know I presume the Tenth Circuit has the right to construe the statute but not to impose its own requirements.
Mr. Kenneth Ray Coe: The FDA also has proceedings in which generally speaking when a court sends a case to it for review and generally speaking, those requirements are for a more formal type of hearings.
That's an addition to the requirements of the Tenth Circuit.
That was not amended in this case.
Now, the --
Justice William H. Rehnquist: Is that a part of the APA?
Is that part of the Administrative --
Mr. Kenneth Ray Coe: No, it's part of the regulations for the Food and Drug Act, I believe it's Section 1060 or 1080 of their procedure, left side in our brief, Your Honor.
At any rate, the FDA did hold its proceedings and the Commissioner did issue findings just as the Solicitor General advised the court.
This was then appealed to the District Court for the Western District of Oklahoma.
Judge Bohanon examined the entire administrative record, and based upon his review of that record made the determination that the entire proceedings were arbitrary capricious and abused of discretion and not in accordance with the law.
He based it upon several things.
First, he made the determination that the Food and Drug Administration by virtue of a notice published in the Federal Register espoused the same continuing view toward Laetrile as it had been espousing for many years since the 1950's, same entrenched position.
Justice William H. Rehnquist: Well what's the matter with that?
Justice Thurgood Marshall: It just could be correct.
Justice William H. Rehnquist: I mean there not just judges, they presumably have some right to decide what positions to take on things.
Mr. Kenneth Ray Coe: Your Honor, I think that that is exactly the point the judge was making.
The FDA has made its decision, has made its decision backed in 1950 before it had any administrative record whatsoever and continues to make the same.
He used that particular item to show that there was a lack of in depth fact-finding in the administrative proceedings.
Justice William H. Rehnquist: That they simply weren't open even to persuasion by new evidence?
Mr. Kenneth Ray Coe: I believe that what the court is trying to make, Your Honor.
The court decided as I have just previously said that the Food and Drug Administration Commissioner's decision should be set aside.
That was set aside.
It was set aside on two bases.
First of all, it was set aside on the basis that Laetrile is subject to an exemption by virtue of the 1962 grandfather provisions of the Act.
He also made the determination that it would not -- that should be set aside based upon the fact that a new violation of the right to privacy guaranteed with the Ninth Amendment of the Constitution.
Chief Justice Warren E. Burger: What was the evidence on its use before 1962?
Mr. Kenneth Ray Coe: Your Honor, there was substantial evidence on use prior to 1962.
The evidence of use prior to 1962 --
Chief Justice Warren E. Burger: Commercial use, commercial use and that's the requirement, isn't it?
Mr. Kenneth Ray Coe: The requirement is commercial use prior to 1962, Your Honor.
The Court cited and I believe its footnote 22, affidavits by Chauncey Lick and several other individuals as to commercial use prior to 1962.
Chief Justice Warren E. Burger: Well, do you need to stop to find it now?
Mr. Kenneth Ray Coe: At any rate Your Honor, the District Court found that it was used prior to 1962 that was used commercially.
The District Court found that the labeling was the same for all practical purposes as it was before that date.
The District Court found that it was not -- that it was safe and that it was nontoxic.
Now, that going into great detail on each and every one of those because the District Court's opinion sets it out in great detail and I've briefed it in my brief and the Government's brief did theirs.
The case law establishes that if there is a difference of opinion upon among experts, for instance such as -- as to safety, and this applies across the board I believe to the 1962 grandfather exemption.
That that is a fact question to be determine by the trial of fact.
In this case, Judge Bohanon was seating as both the trier of law and the trierl of fact.
Justice Thurgood Marshall: What facts did he have before him?
Mr. Kenneth Ray Coe: The facts he had before him were the facts --
Justice Thurgood Marshall: Was it administrative record, that's all?
Mr. Kenneth Ray Coe: That's all he had.
Justice Thurgood Marshall: When you say facts, don't you mean testimony?
Mr. Kenneth Ray Coe: Your Honor, in this case, I do mean testimony and --
Justice Thurgood Marshall: Well, what case that says -- what case that says that he looks at the administrative record droves out to finding of the administrative body and replaces it with his own?
Isn't that what was done here?
Mr. Kenneth Ray Coe: Your Honor, there is --
Justice Thurgood Marshall: Isn't that what was done here?
Mr. Kenneth Ray Coe: I'm sorry, Your Honor?
Justice Thurgood Marshall: Isn't that what was done here?
Mr. Kenneth Ray Coe: That he threw out the findings and superimposed his own.
Yes, Your Honor, that's exactly what he did.
Justice Thurgood Marshall: And the authority for that.
Mr. Kenneth Ray Coe: The authority for that are the cases which I've cited under that particular proposition on our brief.
First of all Your Honor, if I may address --
Justice Thurgood Marshall: Where did he get the fact that the law didn't apply to terminally ill people?
Where did he find that in the record?
Mr. Kenneth Ray Coe: Well Your Honor, he didn't find anything in the record, in the record that the law did not apply to terminally ill patients because that would have been (Voice Overlap) on his part.
Justice Thurgood Marshall: But where did he find it?
Where did he find it?
Mr. Kenneth Ray Coe: He determined -- well, as a matter of fact, I think it was the Tenth Circuit that actually made determination of such Your Honor.
The Tenth Circuit --
Justice Thurgood Marshall: Where did the Tenth Circuit find it?
Mr. Kenneth Ray Coe: I think they found that based along --
Justice Thurgood Marshall: You think?
You don't know, do you?
Mr. Kenneth Ray Coe: Your Honor, I know in my own mind.
Justice Thurgood Marshall: What do you think?
What do you think?
Mr. Kenneth Ray Coe: Alright, I think Your Honor that the Tenth Circuit found that the Act did not apply to terminally ill cancer patients because it would be ridiculous to apply the term efficacy to a terminally ill cancer patient.
Chief Justice Warren E. Burger: Why would it, aren't there pain relieving properties in some drugs that would be used on terminally ill patients?
Mr. Kenneth Ray Coe: Your Honor, many of the drugs that are used on terminally ill cancer patients do in fact have pain killing effects and generally speaking --
Chief Justice Warren E. Burger: Isn't that the function of this agency, this regulatory body to see that any pain relieving drugs are safe and meet all the other standards?
Mr. Kenneth Ray Coe: It is the duty of the Food and Drug Administration to fulfill its congressional mandate, and it is our position before the Court that the congressional mandate which added efficacy in particular to the Food and Drug Act which came out after the thalidomide tragedies does not have application to terminally ill cancer patients.
And the reasoning behind that is very simply that if in fact there were an effective cancer remedy, then you wouldn't have terminal cancer patients, they're be terminal from some other cause entirely.
And as long as you do not have an effective cancer remedy, that to require that of Laetrile is an absurd result from the Act.
Justice William H. Rehnquist: Well, what about the Chief Justice's question that even the terminally ill patient may need relief from symptomatic conditions, not a cure, perhaps not even remission relief from pain.
Mr. Kenneth Ray Coe: I certainly do not disagree with that.
I have no problem with that whatsoever --
Justice William H. Rehnquist: Do you think the Tenth Circuit would exempt that and say go down by a few grains of morphine if you feel you needed to relieve the pain?
Mr. Kenneth Ray Coe: The Tenth Circuit ruled strictly relative to Laetrile intravenous form.
I do not know what the Court will do in some other context.
Justice William H. Rehnquist: What's your position on that?
Mr. Kenneth Ray Coe: My position as it always has been is that we have terminal cancer patients desiring to use Laetrile.
This case is brought that particular issue before the court.
My position is that they should be allowed to use it.
Justice Thurgood Marshall: And that the Food and Drug Act doesn't apply to terminal patient?
Mr. Kenneth Ray Coe: That it does not apply to terminally ill cancer patients designed to use Laetrile under their physician's care.
Justice Byron R. White: What about Heroin?
Justice Thurgood Marshall: When and where do you get that from?
The statute doesn't say it.
Mr. Kenneth Ray Coe: Your Honor, the statute --
Justice Thurgood Marshall: The regulations don't say it.
Mr. Kenneth Ray Coe: Oh, I certainly agree with that.
Justice Thurgood Marshall: Well, did anybody see it before the Court in this case?
Mr. Kenneth Ray Coe: No.
Justice Thurgood Marshall: So it's brand new?
Justice Byron R. White: And you would say that same thing as -- about heroin or cocaine?
Mr. Kenneth Ray Coe: It is my -- no, I do not have a heroin or cocaine case, Your Honor, so I would not discuss that at all.
I do understand --
Justice Byron R. White: No, but you are saying it about oral -- about Laetrile taken orally.
Mr. Kenneth Ray Coe: No, we're just discussing the intravenous --
Justice Byron R. White: I know, but I thought my brother Rehnquist asked you about -- wouldn't you take the same position with respect to Laetrile taken orally?
Mr. Kenneth Ray Coe: I would take the same position.
Justice Byron R. White: Yes, yet the Court didn't decide that did it?
Mr. Kenneth Ray Coe: The Tenth Circuit did not decide that.
Justice Byron R. White: Yes, but you would take the position with respect to the oral ingestion as Laetrile but not heroin, even though it's a terminally ill cancer patient who wants it.
Mr. Kenneth Ray Coe: It is my understanding totally outside of anything I know from this case that in England, heroin and some other opiates are being used for terminally ill cancer patients and the reason it's being used is because they determine that there's nothing that can be done to help them and it will take them off some of the really mind-deadening drugs.
So, to that extent --
Justice Byron R. White: I suggest you stay with microphone, sir.
Mr. Kenneth Ray Coe: I'm sorry.
Justice Byron R. White: When you answer questions.
Mr. Kenneth Ray Coe: I would like to address if I may next the constitutional aspect in this particular case.
The lower court, the District Court found that to deny the use of Laetrile to terminally ill cancer patients violated their right to privacy.
The Tenth Circuit Court of Appeals did not rule upon this issue and as the court has been informed neither did it rule upon the issue of the grandfather clause.
As to the constitutional issue, the argument, the decision of the District Court was made that the -- this Court's decision in Roe versus Wade and likewise in Doe versus Bolton both abortion cases justified the extension of a right to privacy to a healthcare context.
Now, as we've briefed, it is the position of the respondents that the intent and spirit of both Doe versus Wade and Roe versus Bolton established that they are in healthcare context.
For instance, the health of the mother in Doe versus White as mentioned over and over again, and in Doe versus Bolton, Justice Douglas of course, Mr. Justice Douglas in his concurring opinion enumerated the right to careful one's own health as a fundamental right.
It is our position that if in fact the right to healthcare to make a determination as to the care of one's own body under medical supervision is a fundamental right in fact then the petitioner -- well, the respondents in this case plaintiffs below have a right to use Laetrile under the court's orders and within the court's limitations as they previously been enunciated.
Now, in order to overcome this, the Food and Drug Administration must establish a compelling state interest.
And in this case, that compelling state interest has been enunciated as more of a desire to maintain a system than to reach the merits of the issues.
Justice John Paul Stevens: Mr. Coe, you seem to concede that the constitutional right would not exist without the doctor's supervision or do you?
The only constitutional right to take this drug in a particular way of a doctor supervises.
Mr. Kenneth Ray Coe: Your Honor, I have only argued within that context because that is within the context of the lower court's decision and outside of that, I don't think --
Justice John Paul Stevens: If you acknowledge that the state can impose a regulatory control for the safety even if the terminally ill of cancer patient by saying the doctor has to supervise it, why would not the Constitution also give the state the power to say well, certain kinds of drugs, heroin, marijuana, whatever it might be, Laetrile, cannot be use for these people.
What's the difference between a flat rule against a particular kind of drug and the condition that the doctor approved of it in terms of constitutional terms?
Mr. Kenneth Ray Coe: I think it's somewhat analogous to the decision in Roe versus White in which this Court made the determination that during the first trimester of pregnancy, because of the facts and circumstances produced that there was no justification for a compelling state interest, and therefore, then abortion may be have without any interest to the state at all.
And then after that particular point in time, the compelling state interest came into play.
And I think in this case, it's the same thing.
In this case, if you have a patient who is not terminal, who is not been diagnosed as such by his doctor, and to be lead away from possibly useful orthodox therapy to Laetrile --
Justice John Paul Stevens: Just assuming the first of my question, they had been diagnose as terminally ill by the doctor, but then the question is do they -- why did they need doctor supervision to take the drug any more than they need?
Why is that anymore acceptable than FDA prove of the particular drug to be taken?
Mr. Kenneth Ray Coe: Your Honor, that is a -- that was a decision rendered by the Tenth Circuit that they have to have medical care.
I personally and the patients in this case are of the opinion that they should be subject to medical care because they're on very bad condition, they need continuing supervision.
Now as to what actual legal effect that has, as to the constitutional --
Justice John Paul Stevens: What if they live -- what if Oklahoma had a state rule that said that be a doctor be guilty of malpractice if he prescribe Laetrile because I have not been approved by the FDA?
Would that -- I suppose such a rule would be unconstitutional in your view.
Mr. Kenneth Ray Coe: Yes, Your Honor.
Justice John Paul Stevens: Yes.
Mr. Kenneth Ray Coe: As a matter of fact, Oklahoma is one of the 19 states I believe that has now legalizing this Laetrile.
The decision of the District Court is relation to the constitutional issue has been pretty well explained up to this point.
Basically, it is the right to privacy as enunciated Roe versus Wade, Doe versus Bolton, the fact that there is no compelling state interest when the case is considered in the terms of terminal cancer patients who have been declared by their doctors to past the stage where they going through death's door.
In their application, in their instance, there's no possible application of a compelling Government interest that could have an effect.
As to people who have not been designated as terminal cancer patients, as to the those who not have some other help in the compelling state interest might come in and there is no problem in this particular case of rendering a decision to that effect.
I like to address the decision by the Tenth Circuit Court of Appeals before I finish if it please the Court.
Justice Harry A. Blackmun: Mr. Coe, at this point, you always spoken of the doctor.
Do you mean by that a medical physician, would it cover the chiropractor, an osteopath, a naturopath?
Mr. Kenneth Ray Coe: As a matter of fact, Your Honor, the District Court in one of its previous orders in which he instituted the affidavits system which is the system in which an individual to obtain Laetrile has to have an affidavit from his doctor to demonstrate the he has in fact a member of the class.
Judge Bohanon limited to medical doctors M.D.s.
Justice Harry A. Blackmun: What is your position?
Mr. Kenneth Ray Coe: And I do not -- that's my position Your Honor.
The Tenth Circuit's ruling which was made to a certain extent or completely without any authority and support of it made the determination that Laetrile should be used by terminally cancer patients and could be for the reason that the term “safe and effective” do not have any meaning to terminal cancer patients.
As to effective as I've already said, I certainly agree.
There is no efficacious treatment to cancer --
Chief Justice Warren E. Burger: Is the Act to the contrary?
Mr. Kenneth Ray Coe: I'm sorry, Your Honor?
Chief Justice Warren E. Burger: Is there a support in the Act for that?
Mr. Kenneth Ray Coe: That is does not apply?
Chief Justice Warren E. Burger: Yes.
Mr. Kenneth Ray Coe: There is no support in the Act itself or anything in the Act just flat out adds terms requirements for safety and efficacy.
The administrator -- the Commissioner of Food and Drugs just had to apply the Act and therefore has added administrative gloss to it.
But there's nothing in either the Act no where the administrative gloss which gives an exempt -- an exemption for terminally ill cancer patients with the exemption of common sense.
And I believe that what the Tenth Circuit was using when it made its decision.
Justice Byron R. White: You didn't -- this wasn't your position in the Tenth Circuit?
Mr. Kenneth Ray Coe: It was not.
The Tenth Circuit opinion found that safe and effective did not have meaning to terminal cancer patients.
Terminal, it is submitted to this Court does not have meaning or -- if efficacious does not have meaning to terminal cancer patients.
The term safety to terminal cancer patients can in effect have no more meaning than nontoxic, and I think the record amply demonstrates that Laetrile was nontoxic.
I think it demonstrates as nontoxic both as to liquid and to tablets.
But based upon the Tenth Circuit's opinion, their argument is made as this time that is nontoxic only as to the liquid form.
The record is replete with that.
The judges -- the lower court's decision is replete with that.
If there are no questions, I have no --
Justice Harry A. Blackmun: I think the Solicitor General -- part of it was to brief as to --
Justice John Paul Stevens: Mr. Coe, I have one other question, the constitutional argument.
You make the same argument for -- if -- would it apply equally to one who is not a terminally ill cancer patient?
Mr. Kenneth Ray Coe: No.
The reason I said it would not, Your Honor, is because in this particular -- in this particular instance, the state has a legitimate interest --
Justice John Paul Stevens: But if it's nontoxic --
Mr. Kenneth Ray Coe: I'm sorry?
Justice John Paul Stevens: But if it's nontoxic, they don't know why it would be equally.
Mr. Kenneth Ray Coe: I do not disagree and nor does this case disagree, nor does the lower court's opinion's disagree with the Act -- with the Food and Drug Act or the intent of it as to safety and efficacy.
The disagreement is that those two terms have been very rigidly structured by the Food and Drug Administration to not allow what should be a very obvious exclusionary reception from the Act.
In this case, we do not object to the fact that it is limited.
The plaintiff class is composed of terminally cancer patients and that is all the case before the Court.
Justice Potter Stewart: Of course, if it is under the 1962 grandfather clause, then it's permissible for use by anybody, isn't it?
Mr. Kenneth Ray Coe: That's correct, Your Honor.
Rebuttal of Wade H. McCree
Chief Justice Warren E. Burger: Very well.
Mr. Solicitor General, do you have anything further?
Mr. Wade H. McCree: I just have this Mr. Chief Justice in response to Mr. Justice Blackmun's question and I was unable to give him the citation.
In fact, I told him I wasn't aware of it.
On page 163-A of our petition for certiorari, we state that the court in Bentex Ulcerine held at 469 F. 2d at 878 that a party seeking to shows that a drug comes within the grandfather exemptions, “Must prove every essential fact necessary for invocation of the exception.”
Justice Thurgood Marshall: General, I got one question or rather I need some help.
On this limiting it to the terminally ill, why wouldn't that -- I'm not espousing this.
But couldn't an equity court as this Court was just drawn its ability to provide remedy?
Mr. Wade H. McCree: I think it could, but this is a constitutional determination that it may --
Justice Thurgood Marshall: That's worried me.
Mr. Wade H. McCree: Worries me, too.
Justice Thurgood Marshall: Okay.
Mr. Wade H. McCree: If it please the Court, the Government submits its case on its brief.
Chief Justice Warren E. Burger: Thank you gentlemen.
The case is submitted.