United States v. An Article of Drug . . . Bacto-Unidisk

PETITIONER:United States
RESPONDENT:An Article of Drug . . . Bacto-Unidisk
LOCATION:Stanley’s Home

DOCKET NO.: 343
DECIDED BY: Warren Court (1967-1969)
LOWER COURT: United States Court of Appeals for the Sixth Circuit

CITATION: 394 US 784 (1969)
ARGUED: Jan 23, 1969
DECIDED: Apr 28, 1969

Facts of the case

Question

Audio Transcription for Oral Argument – January 23, 1969 in United States v. An Article of Drug . . . Bacto-Unidisk

Earl Warren:

Number 343, United States versus an Article of Drug.

Mr. Wallace.

Lawrence G. Wallace:

Mr. Chief Justice and may it please the Court.

This case is here on a writ of certiorari to the United States Court of Appeals for the Sixth Circuit and it is an in rem seizure proceeding brought by the Government against an interstate shipment of five cases of antibiotic sensitivity discs bearing the trade name Bacto-Unidisk.

Counsel have asked the clerk to distribute a sample of the seized article to each member of the Court.

The Government’s libel alleged that the shipment violated Section 502 (l) of the Federal Food, Drug, and Cosmetic Act in that the Bacto-Unidisk was a drug within the meaning of the Act was composed in part of specified antibiotics and was neither certified nor exempted from certification pursuant to Section 507 of the Act.

And the amended answer by the claimant, Difco Laboratories, the manufacturer of the Bacto-Unidisk admits that the article is composed in part of the specified antibiotics and has neither been certified nor exempted from certification.

The claimant’s denial that the shipment violated the Act was based solely on the contention that the antibiotics certification requirements of the statute are inapplicable because the Bacto-Unidisk is not a drug within the meaning of the statute.

And the only issue in this case therefore is whether sensitivity testing discs such as the Bacto-Unidisk are drugs within the definition in Section 201 (g) of the Act which appears on page 2 of our brief.

This issue arises because Section 507 of the Act imposes the batch-testing certification requirement only on antibiotic drugs.

And these are to find in Section 507 by reference to the general term of drug which in turn is defined for purposes of the entire Act in Section 201 (g).

William O. Douglas:

Where is that 507?

Lawrence G. Wallace:

507 may appears on page 3 of our brief; that is the batch-testing requirement for antibiotic drugs.

And in the middle of page 4, the definition of antibiotic drugs is in terms of drug and that brings into play the general definition of drug in the statute as a whole.

William O. Douglas:

As I see 507, it talks about batches and drugs.

Lawrence G. Wallace:

That refers to production batches of —

William O. Douglas:

Where the certification of batches of drug.

Lawrence G. Wallace:

That is correct.

Each production batch has to be certified by taking a sample from that production batch in testing it to see that it has the proper characteristics of identity, strength, potency, etcetera, to assure its safety and efficacy of use, and that has to be done before that production batch of an antibiotic drug can be disseminated for use.

Now, the manner in which the Bacto-Unidisk and similar products are used in the course of antibiotic therapy is described in the opinion and findings of the District Court and in the printed enclosure which the claimant includes in each carton of Bacto-Unidisk and which appears in the record, and to which I shall refer later.

The discs are used in a screening test which in the words of the District Court serves as a guide to a medical doctor in his determination of the choice of antibiotic to prescribe for the patient.

This is accomplished by first drawing from the patient a specimen of affected body fluid which contains the infecting microorganism that is causing his illness.

Typically, this specimen is then taken to the hospital or other clinical laboratory and placed upon a culture medium in a small glass dish so called Petri dish where it is incubated for a period of hours to assure that the mature colonies of the principle infecting organism can be isolated from the specimen for use in the sensitivity test.

This so-called islet of the infecting microorganism is then applied upon a second culture medium in another Petri dish and the dry paper sensitivity discs, each of which has been impregnated with a certain quantity of a particular antibiotic are placed upon the surface of this freshly inoculated culture.

During the ensuing incubation period of 6 to 18 hours, the antibiotics disseminate outward forming circular zones around each of the small impregnated discs.

Can this be brought back by — (Inaudible)

Lawrence G. Wallace:

I don’t know the answer to that.

They cannot be bought until after they have been certified.

They cannot be marketed to anyone.

And as a practical matter, they’re used only in clinical laboratories.

(Inaudible)

Lawrence G. Wallace:

Well, that is correct.

That’s the way the Act is presently —

That’s the argument (Inaudible)

Lawrence G. Wallace:

Well, of course to my knowledge, they are not now being disseminated and this would be a prescription drug if our position is correct that they are drug within the meaning of the Act.

Of course, if they are not a drug, that would make a difference in answering that question.

Potter Stewart:

They are manufacturing and sold for use by clinical laboratories not by —

Lawrence G. Wallace:

That is correct.

Potter Stewart:

— individual people?

Lawrence G. Wallace:

They are not intended —

Potter Stewart:

And that’s what the law is, that’s what the product is, isn’t that correct?

Lawrence G. Wallace:

The product is intended for this testing use in laboratories and not to be ingested by individuals in anyway.

Now, as I say in the test, the antibiotics disseminate outward forming circular zones around each of these small impregnated discs and then if the infecting organism is sensitive to the antibiotic on a particular disc, its growth will be inhibited in the zone around back disc, leaving a clear circle, a so called “zone of inhibition” on the medium in the dish surrounding that particular discs.

But in the zones around the discs containing an antibiotic to which the microorganism is resistant, the islet will grow leaving little are no clear area.

From the presence or absence of these zones of inhibition around the various discs, the microbiologist advices the physician which of the antibiotics appear to be effective and which appear to be ineffective against the infecting microorganism.

This report is then used by the physician as a guide in selecting an antibiotic for treatment of his patient’s infection.

And these discs are quite widely used; this record shows there is testimony that the volume of discs sensitivity testings is approximately 5,000 per month in one Chicago hospital.

It is —

William O. Douglas:

Antibiotics, in the —

Lawrence G. Wallace:

They are impregnated on each of the small circular discs.

William O. Douglas:

Not by the doctor, but in the —

Lawrence G. Wallace:

In the manufacture’s laboratories and the manufacture of them.

The discs as you have it has already impregnated with the various antibiotics labeled around the edge and with the one sulfur.

William O. Douglas:

Are those antibiotics that are produced by the manufacturer, are they subject to the testing in the batches of drugs in 507?

Lawrence G. Wallace:

Not unless the discs are drugs and the use in the discs is the use as a drug.

Otherwise, there would be no batch-testing whatsoever if these antibiotics required under the statute.

Unless, they happen to commingled with antibiotic powders that are going to be disseminated for use directly on patients in which case, they would’ve been tested that in that form.

But the batch-testing requirement does require testing of each form of the antibiotic as it’s prepared for use because of the peculiar scientific problems of change in the antibiotic from one form to another.

It is clear then that these discs contain antibiotic substances which in the words of the statute are chemical substances which are produced by a microorganism and which have the capacity to inhibit or destroy other microorganisms.

And it is equally clear that the use of the sensitivity discs in medical practice is dependent upon the purported capacity of the antibiotics impregnated on the discs to function as antibiotics to actually inhibit or destroy the growth of microorganisms.

Lawrence G. Wallace:

In this respect, the discs differ from medical books or the Petri dishes in the laboratory or other articles that may also be used as a guide to therapy.

Now, for more than 20 years, Congress has recognized in Section 507 of the Act and in its successive amendments that because of the peculiar scientific properties of these biologically produced antibiotic drugs, special quality control of procedures must be required to assure their scientific reliability or in the words of the statute to ensure their safety and efficacy of use.

Section 507 therefore, requires that before it is disseminated each production batch of antibiotic drugs must be tested and certified pursuant to regulations promulgated by the Secretary of Health, Education, and Welfare to assure that the drugs have such characteristics of identity, strength, quality and purity as to ensure their safety and efficacy of use.

At first, antibiotics intended only for laboratory use in sensitivity testing were exempted by regulation from the batch-testing requirement.And that exemption applied to commercial sensitivity discs such as the Bacto-Unidisk which came in to use in the 1950’s as the number of antibiotics began to proliferate.

The exemption of sensitivity discs from the certification requirement was terminated in a rule making proceeding in 1960 in which regulations were adopted to require their batch certification.

This is discussed in our brief.

The order adopting the regulations recited that following numerous complaints by the medical profession, hospitals, and laboratory technicians, the Food and Drug Administration made an extensive survey of the condition surrounding the production and marketing of discs and found them unreliable in their statements of potency with resulted impairment of their safety and efficacy.

It was therefore deem in the words of the order vital for the protection of the public health to adopt the regulations requiring their batch certification.

The question in this case then is whether the Secretary correctly interpreted statute as authorizing the application of the batch-testing requirement to antibiotic sensitivity discs which brings us back to the interplay of definitions in the statute.

The District Court was of the view that a literal reading of the Act’s definition of drug on page 2 of our brief and particularly the language in subpart (B) of the definition, articles intended for use in the diagnosis cure mitigation treatment or prevention of disease.

The District Court was of the view that this language clearly has application to the sensitivity discs.

But despite this and despite the fact that drugs are contained in the article again in the words of the District Court, the District Court decided that the Act should not be interpreted as including sensitivity discs as drugs because no part of this article is administered to man or other animals either internally or externally, and its sole function is to provide medical doctors with information for use by them as guidelines.

The Court of Appeals affirmed the holding that sensitivity discs are not drugs within the meaning of the statute expressing the view that the discs only aid to physician to determine what antibiotics to use for the cure mitigation or treatment of the patient’s disease and in the words of the court that it was not the legislative intent to apply the phrase intended for use in the cure, mitigation, treatment, etcetera, in such an indirect manner.

Neither court cited any legislative history in support of its interpretation of the statutory definitions.

We believe first that it is clear on this record and in the District Court’s findings that batch-testing of antibiotics sensitivity discs serves the congressional purpose expressed in Section 507 of assuring the safety and efficacy of antibiotic therapy.

The role of the discs in therapy is adequately described in the claimant’s own printed enclosure package in the cartons of that to Bacto-Unidisks which is reproduced in our appendix on page 182.

We can look at the first paragraph there.

It says that Bacto sensitivity discs and Bacto-Unidisk, only the latter are involved here, are standardized to paper discs containing known amounts of the more commonly employed antibiotics, etcetera.

They are recommended as a rapid practical clinically accurate and inexpensive means of determining the relative sensitivity of microorganisms to these therapeutic agents.

Bacto sensitivity discs are especially valuable in selecting the drug effective against chronic or persistent infections, refract to age of primary therapy.

The testimony in the case explained that the test is medically important because there are various strains of the same general group or type of infecting organisms such as Staphylococcus, and there are differences among these strains in their sensitivities and resistances to various antibiotics.

The claimant argues that it is somehow significant that treatment with an antibiotic frequently as began before the results of the test are known, but that does not disprove that the discs play an important role in antibiotic therapy.

The testimony unequivocally shows consistently with the claimant’s printed representations that as a result of the test with the discs, the treatment is sometimes switched from one antibiotic to another, and this is particularly true in the critical situations in which a patient is not responding to the primary therapy.

We’ve collected those references on page 23 of our brief.

In other factual consideration that it is important to this point in my argument also is indicated in the claimant’s printed enclosure in the Bacto-Unidisk this time on page 185 of the appendix.

The little chart in the middle of that page shows that a difference in the concentration or potency of the antibiotic on the disc can make a difference as to whether a zone of inhibition will appear at all in the test and not merely a difference in the size of the zone.

Because of this, discrepancies in discs potencies can cause misleading test results and lead the physician to proscribe the wrong antibiotic for this patient.

This was explained at the trial in the testimony of Dr. Joseph Turin, Chief of the Bacteriology section of the laboratory in Henry Ford Hospital in Detroit on page 83 of your printed appendix.

After complaining of the discrepancy, his hospital had found in discs prior to the certification requirement, Dr. Turin explained in the last two paragraphs on page 83, there’s a possibility of having too low of potency in that discs, too low of concentration in which case the organism would tend to be reported out as being a resistant one or being more resistant than if the true potency were in the discs.

And on the other hand, you might have too high of potency which means that you would report a sensitive organism which in fact might not be in that very sensitive category.

Lawrence G. Wallace:

So, it might be an error in either direction which would give us false readings and we would be giving misinformation to the clinician and he in turn obviously being unaware of this situation as we would be would not treat the patient properly.

Therefore, we feel that we can’t take this chance of using discs that are not certified.

It to us is a real hazard.

Additional testimony to the same effect to summarize on page 27 of our brief, the point is that the whole legislative purpose reflected in the batch-testing requirement of Section 507 and brought out in the legislative history reviewed in our brief.

The purpose of trying to assure that patients will get the therapeutic benefit intended when physicians prescribe antibiotic drugs for them can be defeated regardless of how pure and potent the pills capsules or injections administered to the patients maybe if because of faulty discs, the wrong antibiotics are administered to.

We believe that a proper respect for the congressional judgment requires that the issue of interpreting the statutory definitions in this case be approached with this background in mind.

When this consideration is combined with the general principle that the Food, Drug and Cosmetic Act is broadly construed in according to its purpose to protect the public health, we think it is clear first that the use of the discs shown in this record is a used in the treatment of disease within the meaning of the statutory definition of drug.

The claimant argues that the use of the discs in the course of the patient’s treatment is too indirect to use to be considered a use in the treatment of disease within the statutory definition.

But this would mean that the discs are neither drugs nor devices within the meaning of the Act since the definition of device used as precisely the same statutory language.

And since the Act’s protections against adulteration or misbranding apply only to drugs and devices, the result would be that the public would be utterly unprotected against any kind of mislabeling or adulteration of the discs.

There would be no statutory recourse for example, even if the discs were being marketed with every antibiotic on them falsely labeled.

Nothing in the statutory language or in the legislative history requires a session absurd result which would so seriously endanger the public health.

The more substantial interpretive question presented by this case in our view is the problem of distinguishing the statutory definitions of drug and device on pages 2 and 3 of our brief.

Their terms insofar as pertinent here are almost identical and yet the two definitions are expressly mutually exclusive.

The District Court recognized this problem and undertook to solve it by limiting the statutory term drug to what it believe to be the common medical usage of the word drug outside the statute as articles administer to man or other animals either internally or externally.

We believe that this is where the District Court went wrong because this is inadequate as an approach to the interpretation of this complex technical regulatory scheme for the protection of the public health in which the Congress has provided its own definition of the term drug for the purposes of the Act.

It is a statutory term of art to be interpreted in a manner to effectuate the objectives of the statute.

In our view, Securities and Exchange Commission against Ralston Purina Company in volume 346 U.S. is the exemplary opinion of this Court which illuminates the proper approach to interpreting such a provision of a regulatory statute, so as to accomplish the congressional purpose.

There, in interpreting the statutory exemptions from registration for a private offering of stock, this Court held that because it was the congressional purpose to exempt transactions as to which there was no practical need for the statute’s application, the interpretation of the exemption should turn on whether the particular class of person’s affected needs the protection of the Act.

Applying this standard, the Court held that the company’s offering of treasury stock to its key employees was a public offering subject to the provisions of the security’s Act because in the words of the court, the employees had not been shown to be able to defend for themselves.

The same basic approach was recently taken by the Court of Appeals for the Second Circuit in distinguishing between the definitions of drug and device in the statute before us.

In the case of AMP Incorporated against Gardner which is cited in our brief and in which this Court denied certiorari in number 86, this term.

The Court there look to the practical consequences in terms of the Act’s differences in the requirements imposed upon drugs and devices to determine whether the particular article there at issue should be classified as one or the other.

And the practical consequences of that difference in classification are restricted to a very few provisions of the statute.

In fact, at the beginning when the definition’s first came into the statute, there was no difference in the regulation of drugs and devices at all.

In our own case, the only significance of the classification of the discs as either drugs or devices as if they are classified as drugs, the batch-testing requirements for antibiotic drugs will apply.

And otherwise, they will not.

The scientific qualities of antibiotics which led Congress to require batch-testing are the same whether the antibiotic is used for a pill for a hypodermic injection or is a test to determine what pill or injection to administer.

And as I have said, the record shows that the medical need for assurances to quality and potency exist whether the antibiotic is used on a disc or in a pill or injection.

And it is therefore manifest that the Secretary correctly interpreted the Act to reflect the legislative purpose in concluding that the discs are drugs under Section 201 (g) subject to the batch-testing requirements of Section 507.

Lawrence G. Wallace:

And accordingly, we ask that the contrary judgment of the Court of Appeals be reversed.

If I may, I’ll save any remaining time for rebuttal.

Earl Warren:

Mr. Williams.

Edward Brown Williams:

Mr. Chief Justice, may it please the Court.

The chief effort of the Government in its brief in this matter and in its argument has been to create the impression that all or most antibiotic therapy in the United States is based on the sensitivity disc test of which we are talking here today, and that unless this procedure, this testing procedure is controlled by the Government through certification of these discs that the public health will be endangered, patient’s lives will be in jeopardy.

I should come back to that, we shall show you can establish very simply that on the basis of the literature cited by the Government itself and on the basis of the testimony at the trial and the judge’s findings in the District Court that these efforts of the Government simply do not hold water.

They won’t stand up.

Earl Warren:

What do you mean if there is no danger?

Edward Brown Williams:

I mean that there is no danger and I mean that the extent of antibiotic of the basing of antibiotic therapy upon the disc test is far more limited than the Government would have us believe.

In fact, I might say right here since the question has arisen that in our brief, page 18, we refer to the figures of the medical market guide which show that in 1967, 77% of the antibiotic sold in that year were purchased on prescription or on, or by a physicians.

Now, it is obvious that only about 23% went to hospitals, which is the Government concedes are the place where these tests are made in the hospital laboratories.

As Dr. Keefer, a witness at the trial said, “I would say from the total number of infections that doctor see and treat, the sensitivity test is not used.”

It is not used for routine.

There’s a good reason; that is that the initial therapy with a wide- spectrum antibiotic which the doctor starts before the test is ever began, it takes 24 to 36 hours for the test, is ordinarily successful because of the doctor’s experience and the information he is able to draw from other sources.

It is after the fact that he looks at the test and as Dr. Keefer stated and the Court found, the test is used to confirm his judgment.

Now, I should like to make a few remarks if I may about some of the statements made by my friend here.

There was a trial in the District Court which lasted I believe three days.

There were a quite a number of distinguished witnesses.

They knew what they were talking about at least most of them did.

The findings were made.

They’ve been almost ignored by the Government in this case.

They are not clearly erroneous.

There’s no question about that and there’s been no contention as the equivocally arise.

Byron R. White:

They have to be?

Edward Brown Williams:

I think they have to be in order to be reversed.

I think that’s clear from your decisions.

Byron R. White:

All the findings with consist of —

Edward Brown Williams:

I’m talking about the finding, yes sir.

Byron R. White:

These all factual?

Edward Brown Williams:

No sir, it is not all the factual question.

Edward Brown Williams:

Now, on the question of the application of Section 507, the batch-testing provision of the Act, this doesn’t look like the sort of things which lends itself to description as a part of a batch.

To me, —

Earl Warren:

As a part of what?

Edward Brown Williams:

A part of a batch which is to be tested by the Government, the term “batch” to me Mr. Chief Justice set and it mean something with some homogenetic to it, and here we have a whole different, an entirely different sort of an article.

Here are eight different antibiotic substances on this article.

Thurgood Marshall:

The Government said each of those eight came from a “batch” envelop?

Edward Brown Williams:

Yes sir, they came from a batch which was manufactured by a company which manufactures antibiotics which are tested by the Government on Section 507.

They have been check-tested I doubt not because I can’t conceive of a company who manufactures antibiotics and sells them for medicines, manufacturing separate antibiotics for use on these discs; that just wouldn’t be good business.

Potter Stewart:

But if the only market for the manufacturer of the antibiotics were the maker of this Unidisk, then as I understand that 507 would not require batch-testing?

Edward Brown Williams:

If the only market was —

Potter Stewart:

That’s a complicated question, and perhaps I haven’t thought.

If — I understand that the maker of this product here in issue is not the manufacturer of these various antibiotics but gets them from somewhere else.

Edward Brown Williams:

That is correct.

Potter Stewart:

From another manufacturer.

Now, if this for the only customer of that manufacturer, then there would be no batch-testing required of that manufacturer under 507, is that right?

Edward Brown Williams:

Well, the Government —

Potter Stewart:

The manufacturer of antibiotics, it sells only to the makers of discs.

Edward Brown Williams:

The Government said it would require it because they consider this a drug, and since the antibiotic —

Potter Stewart:

Well, no, no, as I understand, if they consider this a drug?

Edward Brown Williams:

Yes sir, but they also would consider the antibiotic going into it a drug because it would be a component of the drug under the statute.

That would be the Government’s attitude as I understand it.

But they can speak for themselves only.

Sir?

Hugo L. Black:

I wonder if you answer him now.

Potter Stewart:

Well, I think your answer make accepts you start it to say that you answer to another question, whether or not these had already been batch-tested before they were sold to the maker of the Unidisk and you said, well, you thought maybe or maybe not because probably a manufacturer would not differentiated his various antibiotics depending upon to whom he was going to sell them.

Edward Brown Williams:

I can’t conceive that he would.

Potter Stewart:

Well, what —

Edward Brown Williams:

I think they are check-tested by the Food and Drug Administration.

Hugo L. Black:

Can you tell me precisely what this thing does?

Edward Brown Williams:

I can try Your Honor.

Edward Brown Williams:

There are in the sensitivity testing procedure which is entirely —

Hugo L. Black:

Sensitivity to a drug?

Edward Brown Williams:

Yes sir.

In this testing procedure, which is entirely a laboratory operation never comes anywhere near the patient.

There are involved, this device here which is called the sensitivity disc both has an antibiotic substances on it.

A Petri plate upon which is deposited agar which is strict with an islet from the patient.

On top of the agar, with the islet in it is placed this discs —

Hugo L. Black:

What?

Edward Brown Williams:

This is placed to this disc.

Around the disc, if the antibiotic is sensitive to — if the organism from the patient is sensitive to the particular antibiotic in contact with it, there will be a zone of inhibition.

If it is not sensitive to it, there will no zone of inhibition.

Hugo L. Black:

Can you put over divide it?

Edward Brown Williams:

Sir?

Hugo L. Black:

Why do you say this is put?

Edward Brown Williams:

It’s put on an agar plate, glass or china plate in the laboratory.

Hugo L. Black:

Well, what does it contact with reference to the human being?

Edward Brown Williams:

It doesn’t.

The only thing it contacts is an islet which is taken from shall we say “urine” or sputum —

Hugo L. Black:

Let’s take it from the —

Edward Brown Williams:

— of the human being; that is correct.

That is correct.

Hugo L. Black:

Now, —

William J. Brennan, Jr.:

Well, in layman’s terms.

You take in some excretion from the body?

Edward Brown Williams:

Yes.

William J. Brennan, Jr.:

Apparently, it has some kind of infection in it.

The infection takes what a bacterial form or something like that, does it?

If an antibiotic is used this treatment, it will effect only bacteria, yes sir.

Right, and so, they take the fluid whatever it is; they put it in the dish?

Edward Brown Williams:

That is correct.

William J. Brennan, Jr.:

Whatever you call a dish, they isolate from it whatever the particular infection in it?

Edward Brown Williams:

The first step is the isolation, —

William J. Brennan, Jr.:

Isolation?

Edward Brown Williams:

— I think some 18 hours.

William J. Brennan, Jr.:

And then you put this thing in the dish itself don’t you this disc?

Edward Brown Williams:

You strict the agar on the plate of dish — with the islet.

William J. Brennan, Jr.:

Don’t strict me, will you?

They take this thing don’t they and they put it in some kind of a dish, is that right?

Edward Brown Williams:

I’m not sure we have never order that.

William J. Brennan, Jr.:

That’s what I want to get straight.

Edward Brown Williams:

The agar goes on the disc, they isolate from the patient goes on the agar — I mean, on the dish.

They isolate from the patient goes on the agar and the disc —

William J. Brennan, Jr.:

What’s the agar?

Edward Brown Williams:

It’s a growing medium, to grow —

William J. Brennan, Jr.:

I see.

Edward Brown Williams:

— the bacteria —

William J. Brennan, Jr.:

Right.

Edward Brown Williams:

— in the isolate.

William J. Brennan, Jr.:

Right.

Now, then these little pegs on this thing are already impregnated with various kinds of antibiotics, is that right?

Edward Brown Williams:

Yes.

William J. Brennan, Jr.:

And then there is some kind of attraction to the particular antibiotic which would be effective against this particular infection whatever it maybe, is that it?

Edward Brown Williams:

If the infection or the infectious strain —

William J. Brennan, Jr.:

Yes.

Edward Brown Williams:

— is sensitive to the antibiotic, —

William J. Brennan, Jr.:

Right.

Edward Brown Williams:

— there will be —

William J. Brennan, Jr.:

Sensitive, meaning that the antibiotic might clear it up?

Edward Brown Williams:

Might clear it up.

William J. Brennan, Jr.:

Right.

Edward Brown Williams:

You don’t know that it would because this is an in vitro-test and was transferred to the body it may act and how to do it.

William J. Brennan, Jr.:

But nevertheless, this is then the tell whom of the laboratory technician or the doctor?

Look this is the kind of antibiotic it would appear might be effective against this infection in this patient’s body, is that right?

Edward Brown Williams:

That is what the laboratory technician may tell the doctor.

He may say that since there a showing of sensitivity In Vitro that you might try this because it maybe effective In Vivo.

William J. Brennan, Jr.:

Right, and it may or may not work?

Edward Brown Williams:

It may or may not.

William J. Brennan, Jr.:

But the point is this disc is out of a case after it has performed that function?

Edward Brown Williams:

That is correct.

William J. Brennan, Jr.:

All right, and as I understand it from what at least what Mr. Wallace suggested to us; the antibiotics used to impregnate these little things on this disc are not taken from batches which have been certified, is that right?

Edward Brown Williams:

Well, I would assume that they are from batches which have been tested by the Food and Drug Administration.

William J. Brennan, Jr.:

Well, I thought Mr. Wallace told us that’s one of the problems here.

Edward Brown Williams:

He did say that.

William J. Brennan, Jr.:

Yes, but what’s the record —

Edward Brown Williams:

I would assume differently.

William J. Brennan, Jr.:

Well, what’s the record show?

Edward Brown Williams:

There’s nothing in the record on that Your Honor.

Byron R. White:

Well, what is Government want to test the antibiotics?

Edward Brown Williams:

They want to test this disc.

Byron R. White:

So they want to — they don’t want just to test the batches of antibiotics that are used to impregnate this disc.

They want to take the completed discs and test them?

Edward Brown Williams:

That is correct, yes sir.

William J. Brennan, Jr.:

And that I take it with the idea, I think that’s what Mr. Wallace said that except as whatever is that impregnate these discs have gone through the certification procedures.

You can’t be sure that the role that this disc is supposed to perform can be properly performed.

Edward Brown Williams:

That is the position.

William J. Brennan, Jr.:

And at that then, may have a deleterious effect in consequence upon the patient who maybe treated by a result which because it’s not been impregnated were certified batches might come up with the wrong answer or no answer.

Edward Brown Williams:

That is the position of the Government.

Byron R. White:

But do they claimed that there’s something else that needs testing besides the antibiotics that are used to impregnated these discs?

Edward Brown Williams:

They claim —

Byron R. White:

There’s something else about disc —

Edward Brown Williams:

— should be tested.

Byron R. White:

I know but is there something that happens to the antibiotics because of contact with the disc which means that the discs themselves be impregnated this have to be tested?

Edward Brown Williams:

The Government I think they should be tested —

Byron R. White:

Or would they to be satisfied with having with testing the antibiotics used to impregnate the disc?

Edward Brown Williams:

The Government thinks they should be — the discs themselves should be tested because they have found that the public health in their mind will be endangered if they are not tested.

We have seen no evidence whatsoever of it and let me point this out now.

In six years since this litigation began in 1962 I believe or 61′, nobody has come up with the single instances of an erroneous result from a test due to a faulty disc, and in the 12 years —

Byron R. White:

Have they been in circulation?

Edward Brown Williams:

Sir?

Byron R. White:

Have they been in circulation?

Edward Brown Williams:

Yes sir.

Byron R. White:

Ever since the litigation —

Edward Brown Williams:

Oh!

Other discs which are being certified of the disc.

Byron R. White:

That’s a different question.

Edward Brown Williams:

That — I know but I’m going to — if you permit me sir.

In the 12 years pervious to certification, in those years, nobody came up with a single case of an erroneous interpretation of a sensitivity test due to a faulty disc.

Now, Dr. Turin as my friend said at the hearing — at the trial, stated the he felt there was a danger to public health involved.

He said that two or three times, he was asked on cross-examination if he had one single instance to which he could point to show that the public health was involved here.

He could not point to any.

Byron R. White:

Well, we suppose to second guess the agency on this kind of a judgment —

Edward Brown Williams:

Sir, it is not —

Byron R. White:

— public health is in danger or not now, do you really suggest that we —

Edward Brown Williams:

Well, Mr. Justice, they have made no — this is not a finding made by the agency which is binding on the courts.

I’m not asking any second guessing.

I’m asking that the evidence be look at.

It shows that there is no such public health problem.

And furthermore, the law is such that there is no basis in my opinion for a holding this article to be anything other than a drug.

Unless, possibly, it were regarded as a device because the definition involved reads in terms of treatment of substances intended for use in the treatment or diagnosis of diseases.

Now, it’s quite obvious that treatment means treatment of a patient and nobody can maintain that with the —

Byron R. White:

Well, what about diagnosis Mr. Williams?

Edward Brown Williams:

Well, diagnosis was practically abandoned by the Government in the lower court as a ground for its position.

They come back to it in the upper court, but Dr. Keefer made it quite clear and he was perhaps I should say the most distinguished witness at the trial, he made it quite clear that it cannot be a diagnosis of an infection without identification of the organism.

And obvious to the test does not identify the organism.

Byron R. White:

Did the agency make any — as the agency at any time made any findings with respect to why this disc qualified either under the treatment or the diagnosis?

Edward Brown Williams:

They made a legal conclusion in the proceeding which is been referred to when the — in the course of which the regulations were adopted.

They made a legal conclusion that the disc where drugs.

Byron R. White:

They didn’t say whether it was because of the treatment or diagnosis?

Edward Brown Williams:

I don’t recall that they did.

William O. Douglas:

Did they pass at all —

Edward Brown Williams:

But they have built in terms of diagnosis, excuse me sir.

William O. Douglas:

Did they pass it all of whether or not the device was — the disc was a device?

Edward Brown Williams:

So far as I know, that was not considered by the agency, it didn’t appear in the public proceeding.

William O. Douglas:

There’s been no ruling on that?

Edward Brown Williams:

No sir as far as I know.

Byron R. White:

I think the Government though all that concedes that the disc is also covered by the definition of device?

William O. Douglas:

The Government doesn’t even mentioned device as I read this brief.

Edward Brown Williams:

Well, I think the Government’s point was that the language of the device section and 201 (h) of its statute and the language of the disc of the drug Section 201 (g) of the statute are quite similar except in that 201 (g) excludes devices from a definition of drug.

Hugo L. Black:

Is subsiding being the drug?

Edward Brown Williams:

Yes sir.

Hugo L. Black:

Antibiotic could go?

Edward Brown Williams:

Yes sir.

William O. Douglas:

Well, in its advice you wouldn’t have batch-testing if it was a device?

Edward Brown Williams:

No, you would not have batch-testing but you could have control as we point out —

William O. Douglas:

Different kind?

Edward Brown Williams:

— in our brief of a different kind.

William O. Douglas:

Misbranding or —

Edward Brown Williams:

Yes.

William O. Douglas:

— possibly?

Edward Brown Williams:

Yes sir.

Edward Brown Williams:

We have pointed out in our brief that control —

William O. Douglas:

There is no — that issue of device is not here, I don’t find it in the Government’s contentions or have I misread the brief?

Edward Brown Williams:

It isn’t before the Court in my opinion sir.

William O. Douglas:

Court below didn’t pass on it.

Edward Brown Williams:

The court below said that if there was anything, it was probably a device because the only difference between a device and a drug is that a device is an apparatus or an instrument or a contragulants.

William O. Douglas:

But the agency didn’t rule that it was or was not a device?

Edward Brown Williams:

No, they rule it was a drug thereby excluding it from the definition of device.

Abe Fortas:

Mr. Williams, suppose these discs were made so that it was to be applied to the human body or therapeutic purposes exactly the same disc not to be applied to the human body or therapeutic purposes, were that be any doubt that it was a drug?

Edward Brown Williams:

No sir, there would be no doubt it was drug.

Abe Fortas:

Suppose, it were to be applied to the human body or diagnostic purposes, that is to say for the purpose let us say of finding out what sort of microorganism is causing the difficulty, is there any doubt that that would be a drug?

Edward Brown Williams:

If it were applied to the human body for diagnostic purposes?

No sir.

Abe Fortas:

So that the question here comes down to this as I understand it.

This disc is applied not to the human body, but it’s applied to a smear taken from the agar plate from a substance derived from the human body and it’s done in the laboratory and the question is, does that distinction remove it from the category of a drug?

Edward Brown Williams:

Yes sir, but I should like to stress Mr. Justice that treatment of a patient is the test of whether this is used in treatment and this there is no treatment of a patient by this device.

Secondly, it cannot be use in diagnosis because it does not identify the organism.

That is perfectly clear.

You can’t diagnose unless you know what the organism is.

Abe Fortas:

Well, in a sense it is viewed —

Edward Brown Williams:

Diagnosis is recognition of disease.

Abe Fortas:

Yes.

I’m sorry.

In a sense it is used in treatment in the sense that it is used for purpose of determining the antibiotic to be used in treatment.

And in that sense, I suppose it’s arguable in a way that it is used in treatment eventhough its one step removed.

Edward Brown Williams:

It is used very in a sense and to determine the antibiotic used in treatment on the certain circumstances.

Abe Fortas:

May I ask you this sir if you happen to know the various substances, spanes and what not that are used in the laboratory for the purpose of — for diagnostic purposes to determine what the microorganism is or what not.

Are those classified as drugs?

Edward Brown Williams:

No sir.

There are several hundred, maybe thousands of laboratory tools of this nature which are used in the industry and in clinical laboratories which have never been classified as drugs.

And if this is classified as a drug, I can see no alternative to classifying all of these other hundreds or thousands of articles —

Abe Fortas:

I suppose however, how about something like this if there is such thing.

Let us suppose that in the laboratory, there is used for purposes of application to human tissue.

Let’s say a tuberculin batch or what not.

Would that be classified as a drug?

But I’m saying I’m sure that if there were injected into the person in the treatment of one form of tuberculosis or another, it would be classified as a drug.

Does the fact that the substance is used solely in the laboratory remove it from that classification?

Edward Brown Williams:

I believe so under the statute Mr. Justice Fortas.

Abe Fortas:

You don’t know of any case is?

I do not happen to know of the case, but the line to be drawn here is whether or not it’s used in the treatment or diagnosis of the disease.

And further, —

Hugo L. Black:

Mr. Williams, I asked you a few moments ago if antibiotic is a drugs, you said yes.

Edward Brown Williams:

Yes sir.

Hugo L. Black:

You said sulfur diagi drug.

As I understand it, antibiotics would only need one of these (Inaudible) and sulfur diagi, why aren’t they drugs when they put on them as the same as they haven’t been put on them?

Edward Brown Williams:

I’ll tell you why sir.

They are not drugs because under the statutes, it is well establish, there’s no doubt whatsoever that an article is not a drug unless it is intended for use in the treatment or diagnosis or prevention or cure of disease.

Hugo L. Black:

Well, that drug is, isn’t it?

Edward Brown Williams:

This is not.

Hugo L. Black:

What?

Edward Brown Williams:

No.

Hugo L. Black:

I’m talking about this disc come from what the drug is going to put on.

Edward Brown Williams:

Well, this drug could — if this drug will use to wash a window, it certainly wouldn’t be —

Hugo L. Black:

Its still be a drug, wouldn’t it?

Edward Brown Williams:

No sir, not under the statute.

Hugo L. Black:

Is it drug?

Edward Brown Williams:

Not under the statute.

It might be a drug in some sense, but not under the statute..

Hugo L. Black:

Well, did it used in diagnostic, diagnostic purposes?

Edward Brown Williams:

No sir, it is not because it does not identify the organism and without identification of the organism, there cannot be diagnosis.

Hugo L. Black:

Do you know how much theory that when you do this, it does not give you a correct answer and you may give a man this drug on the false assumption that he does not sensitive to it.

Edward Brown Williams:

That is their contention and I obviously don’t have time to go into my argument, but it is quite clear from the literature and from the trial that there are so many built-in protections against the sort of thing the Government apparently feared that this is simply not going to occur.

The physician does not rely principally upon this test even if his initial therapy has not been successful.

A physician’s lye’s is principle — sir?

Hugo L. Black:

Whether it’s a little or much, I would not go to around it at all what they say is case.

Edward Brown Williams:

But what they say does —

Hugo L. Black:

Was involved here.

Edward Brown Williams:

In my opinion, it isn’t the case.

And I think —

Earl Warren:

It was the opinion of Dr. Turin, wasn’t it?

Edward Brown Williams:

Yes and I asked Dr. Turin for some kind of specifics on that point.

He could give me none.

Earl Warren:

Well, do we or should we wait until they know someone who has died from the use of this before?

Edward Brown Williams:

After 16 years Mr. Chief Justice, you would —

Earl Warren:

— file a judgment for the Government?

Edward Brown Williams:

After 16 years Mr. Chief Justice I should think that something would’ve occurred if that were going to.

Earl Warren:

Well, maybe you would think so, but the Government through its research might think differently and should we hazard to help for the public by saying this isn’t necessary?

Edward Brown Williams:

The Government through its research has come up with nothing.That’s demonstrated in our brief.

It was demonstrated at the trial, and it will appear from the literature cited by the Government itself.

Byron R. White:

Do you say that this disc is not a device either?

Edward Brown Williams:

I say that if it is anything, it’s a device.

Byron R. White:

Under the — (Voice Overlap) does it have to be one or the other either a drug or a device?

Edward Brown Williams:

No sir.

Byron R. White:

But do you say it’s neither or do you say its —

Edward Brown Williams:

I say it’s very realistically under the statute, is neither.

But if it’s anything, it comes more than here that being an apparatus or an instrument than it does to be —

Byron R. White:

What to be a device under the statute, it has to be used for the diagnosis or treatment of a disease just like the drug.

Edward Brown Williams:

That is correct.

And if it were used for that, then it would be more likely to be a device.

Byron R. White:

But you said if used for that sort, it can’t be either?

Edward Brown Williams:

That’s my position, yes sir.

Edward Brown Williams:

I would like to conclude by saying that the literature cited by the Government which is the all the record entirely was never even mentioned at the trial, shows clearly that if a laboratory as all good laboratories do sets up the proper standards of zone sizes for the various antibiotics that that laboratory and any other which does that will have no problem with the zone sizes is which seem to trouble the Government so.

That is very clear from many of the articles cited by the Government itself.

That is true regardless of whether there are certification and it might be added that even under the Government’s certification regulations, the claim potency, that is the potency claim on the label of the disc may vary from 67% to 150% in the device itself or the sensitivity disc itself.

In other words, you can be from 67% to 150% off and still get these discs certified.

In fact, as between the lowest and the highest disc being tested by the Government, you can go as far as 250% off.

Now, that kind of system is hardly conducive to the kind of outlaying a fear which the Government wants you.

I see my time is up.

Earl Warren:

Very well, you have a minute or two Mr. Wallace.

Lawrence G. Wallace:

Thank you.

I want to clarify that our position is that under the statute, it would be entirely for to or this if this disc is not a drug whether or not the powders put on the disc were batch-tested.

The statute would not require that they be batch-tested.

But our position goes beyond that we say that regardless of whether those powders were batch-tested, the disc itself needs to be batch-tested to assure that the proper potency and the proper amount of the powder is impregnated.

William J. Brennan, Jr.:

(Inaudible)

Lawrence G. Wallace:

I don’t believe I said in fact, but we have to assure that the proper amount is on each of these discs and that it will defuse properly for the test and that the labeling is correct on the disc that would not be accomplished by batch-testing of the powders themselves.

William J. Brennan, Jr.:

I gather that the Government does not claim that whatever it was use to impregnate was not batch-tested, indeed they may well hold.

Lawrence G. Wallace:

That maybe.

William J. Brennan, Jr.:

But that the Government feels nevertheless these should be given other test, is that right?

Lawrence G. Wallace:

The discs themselves are drugs subject to the batch-testing requirement; that is correct.

The paper and which these antibiotics are contained is merely there.

The container — the paper placed no part in the test.

It’s just a convenient way of getting these antibiotics into the culture that has been drawn from the patient.

And I think it should be properly look at that way.

We believe that it is correct to interpret this statute functionally so as to afford the public the protections of the statute that are scientifically pertinent to the characteristics of the article at issue and to the medical use for which it is intended.

Dr. Turin himself while he could not recall specific example did recall that a number of instances of false result have been brought to his attention by individuals in the Infectious Disease Department.

But in addition, there was no challenge made to the record that was developed in the rule making proceedings and which the Food and Drug Administration determined on the basis of complaints from laboratories that the discs had proved unreliable and that there was a medical scientific need for their batch-testing.

Thank you.

Earl Warren:

Very well.