IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
------
KIYOSHI KUROMIYA, et al
:
CIVIL ACTION
:
v.
: NO. 98-CV-3439
:
THE UNITED STATES OF AMERICA :
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March 3, 1999
Philadelphia, Pennsylvania
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MOTION TO DISMISS
BEFORE: HONORABLE MARVIN KATZ, S.J.
APPEARANCES:
for the Plaintiffs: HIRSCH & CAPLAN PUBLIC INTEREST LAW FIRM
BY: LAWRENCE ELLIOTT HIRSCH, ESQ.,
1735 Market Street
Philadelphia, PA 19103
MICHAEL D. CUTLER, ESQ.,
46 Kenwood street
Brookline, MA 02146-2413
GATEWOOD GALBRAITH, ESQ.,
P.O. Box 1438
Lexington, KY 40588
WILLIAM G. PANZER, ESQ.,
370 Grand Avenue, Suite 3
Oakland, CA 94610
for the Defendant: ARTHUR R. GOLDBERG, ESQ.,
KARYN A. TEMPLE, ESQ.,
United States Department of Justice
901 E Street N.W.
Washington, DC 20044
for the Defendant: DANIEL DORMONT, ESQ.,
United States Department of Justice
Reported by: Joel
Gerstenfeld, C.S.R.
Official Court Reporter
1234 U.S. Courthouse
Philadelphia, PA 19106
Proceedings recorded by mechanical stenography;
transcript produced by dictation.
The publication of this proceeding is furnished by the Hirsch & Caplan Public Interest Law Firm and Fairlaw.org. Inquiries about the content and context may be addressed to:
Lawrence Elliott Hirsch, Esq.
Tel: (215) 496-9530; Fax: (215) 496-9532
E-mail: actionclass@fairlaw.org
THE COURT: Good morning,
everybody. I will be glad to hear both sides on the motion.
Actually, we should start with the Government,
if that is agreeable.
MR. GOLDBERG: Thank you, your Honor.
My name is Arthur Goldberg. I represent the United States. This is our
Motion to Dismiss the plaintiffs' Complaint in this matter.
Your Honor, plaintiffs seek to have this Court
announce an unprecedented and totally unfounded Constitutional right for a purported class
of 97 million people to use marijuana for various ailments, ranging from AIDS to itching
disorders to wound care. No court in this country has come anywhere close to
suggesting that such a right exists under the Constitution, and this Court should not do
so here this morning. Rather, the Court should dismiss the Complaint now because
plaintiffs have failed to state a claim upon which relief can be granted for any of the
theories in their Complaint. They've got a Commerce Clause claim. They've got
a Fifth Amendment due process equal protection claim, a Ninth Amendment claim which
appears to be some sort of fundamental right and a Tenth Amendment claim suggesting that
this is a matter reserved only for the States and not for the Federal Government.
But first let me point out a procedural matter.
And that is that our motion is effectively unopposed here this morning. We've
twice moved to dismiss the plaintiffs' Complaint, once last summer of their first amended
Complaint, your Honor granted them an opportunity to amend it. They filed a second
amended Complaint which in all significant respects was identical to the first amended
Complaint.
And they've not opposed our second motion to
dismiss either. Whether it's an inability, unwillingness for some belief that their
quest is righteous, it's really immaterial. They haven't opposed our motion.
And for this reason alone under the local rules of this Court our motion ought to be
granted and their Complaint ought to be dismissed.
We've cited cases in your recent submission
that shows that the Courts in this District and in the circuit are not hesitant to dismiss
a Complaint for failure to follow the local rules.
THE COURT: May I get the benefit of your
advocacy on a particular issue? In your motion you attach a letter from a physician
addressed to, I believe, Congressman Hamburg.
MR. GOLDBERG: That's right.
THE COURT: And other materials that raise
issues about whether the Compassionate Use Program was efficacious or deleterious.
If I get involved in those particular issues,
is there a factual issue that's raised? Your papers are not in affidavit form.
And I take it there are eight people who do receive marijuana under the
Compassionate Program?
MR. GOLDBERG: Seven or eight.
THE COURT: Seven or eight to this point,
and what is the viability of the equal protection claim that the Government is providing
to those seven or eight but not to others?
Is there a rational basis for the distinction
that does not involve the factual issue of the kind that the physician explained to
Congressman Hamburg?
MR. GOLDBERG: Well, let me just explain,
your Honor. As we pointed out in our brief, we did attach that material. And
we think it's appropriate on a Motion to Dismiss when plaintiff refers to this program and
with nothing else it's in their Complaint, that we can then attach publicly available
materials to sort of add an explanation to the program that the plaintiffs refer to in the
Complaint. We think that's appropriate, that does not create a factual issue, it
does not somehow undermine our Motion to Dismiss.
And if the Court says, well that, you may then,
that converts your Motion to Dismiss into a motion for summary judgment, we don't
necessarily agree with that. But even if it were, there's been no opposition to our
motion for now summary judgment. There are no factual disputes, and I don't think
there are any contested facts with regard to this program. The material we provided
simply gave the explanation why this progam was terminated. Now --
THE COURT: I'm sorry, go ahead.
MR. GOLDBERG: I will try to answer the
second part of your Honor's question.
THE COURT: Go ahead.
MR. GOLDBERG: But I would be happy to --
THE COURT: No, no, please.
MR. GOLDBERG: Okay. With respect to
the equal protection argument they make with respect to this program, they made two
separate arguments. They make one with respect to this program, that it somehow
violates their rights to equal protection because the Government has refused to revive or
expand this program that was discontinued in 1992, and there are seven or eight people now
in the program, and at its maximum there were 15 people, I believe, in the program.
But first of all, because we're not dealing
with a fundamental right, we're not dealing with some sort of suspect classification such
as racial discrimination or gender discrimination.
As the Court is well aware, this decision is
judged on a rational basis test. The Supreme Court has said that the Court must
reject these sorts of claims so long as there's any reasonably conceivable state of facts.
THE COURT: Explain to me what, I agree,
the rational basis test.
MR. GOLDBERG: Okay.
THE COURT: Explain to me the rational
basis.
MR. GOLDBERG: I think I ought to do that.
This may be a long-winded answer, but I want the Court to get the full benefit of
all the thinking that goes into this answer. I want to just kind of go through the
history of this program.
In May of 1978 a Mr. Randall who apparently had
glaucoma filed a suit in District Court for the District of Columbia asking that Court to
declare unconstitutional certain Federal laws and regulations that govern the use of
marijuana in research programs. Apparently he had previously been in a program, a
research program and had been receiving marijuana by volunteering to be a patient in a
study that was being conducted for the FDA, the Food and Drug Administration's
regulations.
Those studies were originally controlled in
terms of patients' ability to take marijuana, to take it at home. I think they
probably were not allowed to take it at home, they had to take it in some sort of
laboratory setting. And Mr. Randall objected to those limitations and sought an
injunction ordering the Government to provide him with marijuana based upon his own
doctor's prescription so he could then, I guess, decide how much and when to use it on his
own. A month after that suit was filed, it was settled. And those settlement
papers we appended to our Motion to Dismiss. And the settlement enabled Mr. Randall
to use marijuana as part of what the FDA calls an investigational new drug program, I
refer to it as IND program.
That's a program that allows individuals whose
physicians think they will benefit from an unapproved drug, a drug that's not yet been
approved by the FDA, allows them to receive these drugs under a physician's supervision
and care. So, he started on that program.
The original commitment by the Government was
to allow it up to two years. Apparently it was extended.
Between 1978 when Mr. Randall started in that
program and 1992 the FDA ordered single patient IND status for marijuana to a total of 15
patients.
In 1991 the FDA reviewed this program and
decided it was not a good idea. In 1992 the Government ceased allowing new patients
into the program, but it didn't terminate those who were already in. There were a
whole lot of applications that had been approved. People were waiting to get into
the program. The Government said we're not going to allow any of these new people
in. And then the question was, what do we do about the 15 people we've already got
in that program? The Government decided we're not going to cut them off. We're
going to keep them in the program. But at the same time we're going to advise them
that we've concluded that this is not a beneficial therapy for them and we're going to
encourage them to look into alternative therapies.
Now, what the Government concluded is that
there are two reasons for this decision: One, it was bad medical and scientific practice,
and two, it was bad public health policy.
In terms of the medical scientific aspect the
people who looked at this progam determined that smoked marijuana was at bottom harmful to
people, particularly people who are seriously ill to begin with.
THE COURT: Where is that in the record?
Where do I look for that?
MR. GOLDBERG: It's in the materials that
we appended to our Motion to Dismiss. There are statements there about the
Government concluding that this is bad medical practice and bad public policy.
THE COURT: But they are not, for one
thing, in affidavit form, right?
MR. GOLDBERG: That's right. But
this again, we think these things can be subsumed into the pleadings and dealt with as
part of the pleadings in this case. This is not a record review case, your Honor.
This is not an Administrative Procedure Act challenge. This is a straight
Constitutional challenge at which at this point we're testing the sufficiency of the
allegations in the plaintiff's Complaint.
THE COURT: But if as you say the
Government terminated the program because it was not beneficial or if it was deleterious,
am I required then to give the other side an opportunity to examine whether there are
facts that would support that as a rational decision? It has to be a rational
decision.
MR. GOLDBERG: Not at this point because,
your Honor, the Court can conclude that there is a reasonably conceivable set of facts
would show there's a reasonable basis, and at that point I think that's the end of the
inquiry.
If I may proceed, you know, they conclude that
there are chemical components in marijuana that could cause lung problems, particularly
people with cancer who are prone to lung infections to begin with. There was no
evidence, and all of this, in this material that's appended to our motion, no evidence to
smoke marijuana was any better than other available therapies. And at this point in
the late '80's and early '90's, people have concluded that Marinol was going to be, which
contains the active ingredient THC from marijuana, it was going to be useful as an
alternative therapy.
In terms of public health, these same officials
looked at the program and said this is not providing any scientifically valid evidence
that marijuana is going to be beneficial. This was not a controlled laboratory
study. You had a variety of patients with a variety of different conditions being
treated by different doctors, taking different doses of marijuana in uncontrolled
settings. And the experts who looked at this said, this is not the way to conduct
any kind of valid scientific study to determine whether this drug is going to be safe and
effective.
So, in short, those are the reasons. They
are contained in these materials. And they, I think, clearly show there's a rational
basis for these conclusions.
Now, in terms of why they didn't shut everybody
off of the program and kept this handful of people in there, again the Government had made
a commitment to these people and decided in exercise of some judgment that is we have two
alternatives. We can tell these people they can't use it anymore, or we can let them
continue, but at the same time tell them we don't think this is good for you and we would
like to encourage you to, you know, use alternative therapies such as Marinol.
THE COURT: May I ask, how does the
program work for the small group? Is there a department or an agency or a person who
administers it, or what happens to these seven or eight people?
MR. GOLDBERG: I'm not sure exactly which
agency. It might be the Food and Drug Administration that was running it. I'm
really not sure. And if it's not set forth in that attachment to our Motion to
Dismiss, I think it was the FDA, but I'm not a hundred percent certain.
THE COURT: And there's no medical
supervision? In other words, the doctor doesn't examine the people?
MR. GOLDBERG: Well, the individual doctor
is responsible for supervising the patient's, his patient's use of the drug. But
there's no control, there's no Government official controlling this study. They're
relying on the indivdual doctors.
THE COURT: And the Government does what?
It sends the marijuana to the physician?
MR. GOLDBERG: Yes, the Government
supplies the marijuana to the physician.
THE COURT: To the physician in a
specified quantity?
MR. GOLDBERG: Well, that's the point.
I think it was up to the individual physician to specify to the patient how much
the patient was going to use. Again, that just shows how sort of freewheeling and
unscientific the program was.
And again, you know, these are hard decisions
that Government officials have to make.
THE COURT: Suppose it wasn't marijuana.
Let's just say it was food stamps or some other benefit like that. Could the
government just provide the food stamps to seven or eight people and not others?
MR. GOLDBERG: Well, it's interesting that
your Honor raised that point because there is a case, Dandridge v. Williams which is an
old case in 1969. And I think it dealt either with food stamps or with AFDC
benefits. I know it was a HHS run program and there's a very, I think, important
point made by the Supreme Court in that case. And it says:
If the classification has some reasonable
basis, it does not offend the Constitution simply because is not made with mathematical
nicety or because in practice it results in some inequality, the problems of Government
are practical ones and may justify, if they do not require, rough accommodations that may,
the Supreme Court said, sometimes appear to be illogical and appear to be unscientific.
But if we're not talking about a fundamental right that's all the Government need
to do.
And let me point out there's another case that
I think is important on this point. And this case which is not cited in our brief,
it's Steffan v. Perry from the D.C. Circuit at 41 F.3d 677 on pages 684 and 685, 1994.
This was a question of whether or not the Naval
Academy could dismiss someone who was a homosexual. And it was a case of rational
basis review on a equal protection claim. And the D.C. Circuit said this rational
basis review is not a license for Courts to judge the wisdom, fairness or logic of these
legislative or regulatory choices. The Government has no obligation, and this is
really relevant to this point in this case, the Government has no obligation to produce
evidence to sustain the rationality of a regulatory classification. Because a
classification neither involving fundamental rights nor proceeding along suspect lines is
accorded a strong presumption of validity, the burden is on the one attacking the
governmental arrangement to negative every conceivable basis which might support it,
whether or not the basis has a foundation in the record. And the Court went on to
say this presumption of regularity and rationality applies to administrative and
regulatory schemes and decisions as well as legislative. It's exactly what we have
here, your Honor.
THE COURT: May I ask in that case, the
Steffan v. Perry, how did that come up procedurally? Was that on a motion to dismiss
or motion for summary judgment or what?
MR. GOLDBERG: I frankly don't know.
It was one or the other, but I really don't know.
THE COURT: And what was the holding
actually?
MR. GOLDBERG: The holding was that there
was a rational basis.
THE COURT: For?
MR. GOLDBERG: For dismissal of this
individual from the Naval Academy.
So, again we have provided ample information
here from which I think the Court can conclude that there was a rational basis for the
Government's decision in this regard.
THE COURT: May I ask, is the Government's
documentation about this particular Compassionate Access Program centered in one place?
Is there a person in the Government who is familiar with its operation and its
history?
MR. GOLDBERG: It may not be one person.
It may be somebody at the FDA. It may also include some people at the
National Institute of Health.
THE COURT: I take it that the physician
who wrote the letter that you attached is familiar with it?
MR. GOLDBERG: I think, yes, it's either
from NIH or FDA.
THE COURT: It's Assistant Secretary of
Health?
MR. GOLDBERG: Here, here it is, Assistant
Secretary of HHS. He was above both NIH and FDA. They're both components of
HHS.
Your honor, I really think that I've covered
everything I want to cover with respect to the equal protection claim regarding the
termination of this program.
There is a second equal protection claim that
the plaintiffs have. And that is the claim that, as best I can decipher it, they
appear to be complaining that there's an equal protection denial because marijuana is
listed as a Schedule I drug under the Controlled Substances Act. But Marinol, which
is available through prescriptions, is a Schedule II drug. And again this only has
to pass the rational basis test in order to be sustained.
And it's clear that Marinol has gone through
the proscribed testing and evaluation under the FDA's procedures. And it's been
concluded that it has a lower potential for abuse and it has some efficacious uses and
therefore, it's been approved by the Food and Drug Administration.
Marijuana, on the other hand, has been
determined to be a drug that's highly susceptible to abuse and has no acceptable medical
uses, and therefore it has been and remains a Schedule I --
THE COURT: People, people, there can't be
any exclamations from the audience or reaction. You have to remain silent in the
courtroom.
MS. CANNISTRACI: I'm sorry.
MR. GOLDBERG: In any event, marijuana is
a Schedule I drug. There's a rational basis for its categorization as a Schedule I
drug. And we don't think there's any substance to this aspect of plaintiffs' equal
protection claim as well as the other aspects.
I would like to, your Honor delved into the
equal protection aspect. First, I would like to, if your Honor is interested, to go
also over the commerce clause Tenth Amendment and Ninth Amendment issues, but --
THE COURT: I really don't think for my
research that's necessary.
MR. GOLDBERG: All right, thank you.
THE COURT: Thank you.
I'll be glad to hear the other side.
MR. HIRSCH: Good morning, your Honor.
THE COURT: Good morning, sir.
MR. HIRSCH: My name is Lawrence Hirsch
and I am counsel for the plaintiffs in this case. There are a number of plaintiffs
who have, Kiyoshi Kuromyia is sitting with me at counsel table. And there are, I
guess, approximately 50 or 60 plaintiffs in the courtroom. I wanted to know what
your Honor would like to do with respect to identification of these people for the record.
THE COURT: It isn't really necessary.
MR. HIRSCH: Not necessary?
THE COURT: It's a public proceeding.
I'll be glad to hear your legal argument on the motion.
MR. HIRSCH: Yes, your Honor. With
respect to the legal argument, the Government has taken the position since the first day
that this case started that there was no cause of action, that Congress has the right
under the commerce clause to pass the Controlled Substances Act which they did in 1970,
and that's the end of the issue, that's all your Honor has to look at. And they have
persisted in that type of argument from the start, they're wrong.
And it is obvious that their Motion to Dismiss
the Complaint based on Rule 12 is not consistent with our Rules of Civil Procedure in the
Federal system.
They attached for the Court's consideration
documentation. It was parsed, it was snipped, it was not really ample documentation.
For example, the materials that they included with respect to the Robert Randall
settlement with the Government were merely, I mean who could understand that? Who
could understand what the nature of Robert Randall's claims were against the Government of
the United States and other defendants? We don't know who the other defendants were.
We don't know what the issues in that case
were. We don't know what the settlement was. The settlement created a policy.
The settlement created some course of action that happened after that with respect
to medical marijuana.
Randall asserted a medical necessity position.
He said that he was entitled to marijuana from the Government because he was going
blind and from glaucoma and that he needed marijuana, that was the most efficacious
treatment for his condition and the Government gave it to him. After he struggled
and he litigated, they decided that Robert Randall would be the first person in the United
States to get Government supplied marijuana, marijuana grown on a Government farm in
Oxford, Mississippi.
Now, we have argued in the Complaint, among
other things, that when Randall got that deal with the Government, that that deal created
a policy, and that that deal recognized, that they didn't give Robert Randall new rights,
it restored and reinvested his fundamental rights.
And with respect to the portions of the record
that the Government included, they're inadequate. They don't tell anybody anything.
And their position that those papers and the papers that were trimmed from the
records of Health and Human Services, don't add anything to the picture either because
they are only part of what would be a voluminous record of whatever the actions were that
were taken by HHS. I --
THE COURT: May I interrupt you?
MR. HIRSCH: Yes, sure.
THE COURT: And ask, is it your position
that your clients are entitled to marijuana prescribed by a physician as a matter of law
or is it your position that there are facts in dispute which have to be resolved before
that question can be answered?
MR. HIRSCH: Well, there are facts that
have to be placed on the record for the Court's consideration in the context of a summary
judgment proceeding on both sides.
The record has to be there for this Court.
This is a case of judicial review of Congressional action.
THE COURT: What facts? That's what
I'm trying to get at.
MR. HIRSCH: Are the facts that I think
are important. You know, the first fact that I would look at was who is this person
that cut the policy off? Who elected this person? Where did he get his
authority from? Was it possible for him to do it? I mean, or did the
arrangement and the policy that came from it that was created by the Government in 1978,
who did that give the authority to? Why do we have a situation where Congress,
people in Congress are writing to Health and Human Services to some unelected,
unanswerable, I mean who does this person answer to and say, please restore this program,
please restore it because it's the right thing to do, it's the compassionate thing to do,
it's good medicine, it's good policy, do it.
Why does this Government get into a position
where somebody is making decisions? We have three people in this class action,
Jackie Rickert, Ladd Huffman and Ron Shaw, all of whom signed contracts with the
Government or were admitted into the program and were only awaiting the last thing, which
was the delivery of their marijuana, one person with serious multiple sclerosis, one
person with serious post-polio syndrome and one person with a rare bone tumor disease.
How could anybody shut these people out? It's not, is it up to, I mean were
they acting on behalf of the Executive? Were they acting on behalf of the lawmakers?
Who are they?
THE COURT: What would you do to ascertain
those facts if you had the opportunity?
MR. HIRSCH: Well, what I would do is get
the records, put on the record, that is the records from Health and Human Services, every
record that had to do with the Compassionate Access Program.
The Government has suggested in the papers that
they filed, in this policy report that was done in 1994, July, 1994, that the program was
closed because of the marijuana activists who were soliciting people because it now, by
that time it became easier to get into the program. There was a protocol that was
established, and the AIDS community was involved. There was an influx of people from
the AIDS community. And the Government says in its partial answer in these papers
that they attach that the government, they were afraid because of the influx of people
that the Government would not have enough capacity on their farm to supply the marijuana
to the people which is absolutely absurd.
Now, those types of things with respect to how
did those people get into the program? Why was there only in a course of 13 or 14
years 15 people in the entire United States that became entitled to legal marijuana?
THE COURT: Why isn't it rational to
continue the program as to those people who relied on it, be it seven or eight people --
MR. HIRSCH: Well --
THE COURT: -- terminate it as to others?
Why isn't the reliance interest sufficient to support the rationality of the
decision?
MR. HIRSCH: The decision by whom, your
Honor? Are you talking about the decision by the --
THE COURT: The Government to terminate
the program.
MR. HIRSCH: By some branch of the
Government to terminate the program?
THE COURT: Yes.
MR. HIRSCH: Beacuse, number one, it
wasn't rational. I mean it goes to the, you know, we have argued among other things
that the statutory framework is not consistent with Constitutional principles because,
number one, there was a prohibition without Constitutional amendment.
Number 2, that when the law was passed in 1970,
to replace the Cannibis Tax Act of 1937 that there was no rational basis for that and that
was arbitrary and inconsistent with the facts and inconsistent with medicine.
THE COURT: Has any Court ever --
MR. HIRSCH: No, sir.
THE COURT: Pardon?
MR. HIRSCH: No, sir.
THE COURT: No Court has ever accepted,
it's always been rejected, I take it?
MR. HIRSCH: Well, no, it has never been
litigated.
The issues that are raised in this case have
never been litigated before.
THE COURT: But wasn't there extensive
litigation about the FDA's putting marijuana as a Schedule I substance?
MR. HIRSCH: There's been some, there has
never been litigation that has been that it has gone the distance. There have been
some lower Court cases that have dealt with certain issues that involved marijuana, it
involved marijuana recreational use. This is the only case that squarely raises the
medical issue with respect to marijuana. This is it as far as I know.
And, you know, when the Government filed its
motions the second time around, now we knew that they were going to file a Motion to
Dismiss because they had indicated before that the second amended Complaint was even filed
that that's what they were going to do, they were going to maintain this position.
But this time they filed attachments to it for the Court's consideration. I don't
want to remark about that.
As your Honor can see from reading my
opposition that the very first thing that I did was I checked to see whether this Court
had ever ruled on fundamental issues involving 12(b)(6) and converstion of it to a Rule 56
motion. And I cited to this Court your Opinion in a case that had your identical
language in the case that deals with the Rule 12(b) and what happens if the Court is
presented with papers for consideration on a Motion to Dismiss, it is mandatory that it
become converted to a Rule 56 motion.
Now, the Government has made what I think is a
preposterous argument. They cite a case in the Third Circuit from a footnote called
Oshiver, that has nothing to do with this. It has to do with a plaintiff attaching
papers to his Complaint, and those papers being considered on a Motion to Dismiss.
This case is not that case. This case is
papers were filed. They were meager, and they tried to get the most mileage out of
them, but they were filed and for this Court's consideration. So this Court must as
a matter of law convert this, their motion to a Rule 56 motion.
I wanted to comment about the motion to strike
the file. I've worked on this case for about two-and-a-half years.
The first time I wrote the Complaint it took me
about, I don't know, maybe a month-and-a-half to write the Complaint and that was the
first amended Complaint.
Then I asked this Court for leave to amend
because I wanted to restyle the Complaint. I wanted to focus in, not so much on the
prohibition originally in the period of reefer madness back in the '30's that has lasted
up to this time. But I wanted to focus it specifically on the Controlled Substances
Act of 1970.
I have said and we have argued that their
Motion to Dismiss or to strike the Complaint under Rule 8 is frivolous. There is no
basis. There is not one word that they can point to in that Complaint that says
anything that is redundant, that doesn't have meaning, that doesn't have relevance and
isn't spelled correctly and grammatically correct. And I don't think that this
Government should be raising that type of motion which are not favored by any Court.
You could read Wright & Miller and pick up its commentary on Rule 1 about how
proceedings are to happen in the Federal Court, Rule 8, Rule 8(f) --
THE COURT: I think I understand your
argument. I think I understand your argument on the Motion to Dismiss.
MR. HIRSCH: Yes.
THE COURT: To give you one last shot at
explaining to me with your advocacy, why isn't it rational to terminate the Compassionate
Access Program except for eight people who relied on it? Why isn't that a rational
distinction between those who relied on it by receiving the marijuana and those who have
not yet, granted there are three who applied, and whose applications were accepted, as you
say? Put aside the Government's papers.
MR. HIRSCH: I mean they say it's bad
medicine, and it's bad health policy.
THE COURT: Put that aside.
MR. HIRSCH: We say it's good medicine.
And it's not only irrational, it's arbitrary. It's arbitrary. We have a
person in the courtroom who is one of the legal recipients of marijuana, Elvy Musikka, who
was the third person in the United States to get it and she fought for it. And she
wants everybody else who has her condition to have it too. And it's not up to the
Government to say this is it, we're drawing the line right here, we've decided. Who
is we? Who decided that? Who gave the order to do that? Was it ever
considered in any type of judicial forum at work, any type of hearing forum?
Absolutely not. Everything has been done arbitrary. And the reason for that is
that this Government from 1978 has hidden this program. They have gone out of their
way to hide this program, not to let people know that it even existed. And they do
it even today in the materials that they promulgate to the public and the things that they
pass around.
THE COURT: I take it it doesn't exist
anymore.
MR. HIRSCH: Pardon me?
THE COURT: They are no longer accepting
applicants to the program I take it.
MR. HIRSCH: Yes, they have not accepted
any applicants for several years now.
Your Honor, I think I have said enough.
And what I would like to do is there are some lawyers who are joining the plaintiffs' law
team and I would just like to briefly introduce them to the Court. I don't have a
written pro hac vice motion for these people.
THE COURT: I will be glad to have you
introduce them. And then if you file whatever paper you wish to file, I would be
glad to.
MR. HIRSCH: Yes, thanks very much.
THE COURT: Sure.
MR. HIRSCH: I would like to introduce
Michael Cutler.
THE COURT: Mr. Cutler.
MR. CUTLER: Good morning, your Honor.
MR. HIRSCH: Who is from Boston,
Massachusetts.
Gatewood Galbraith.
MR. GALBRAITH: Good morning, your Honor.
THE COURT: Mr. Galbraith, good morning.
MR. HIRSCH: Who is also a plaintiff in
the case and he's from Kentucky.
And Mr. William Panzer.
THE COURT: Mr. Panzer.
MR. PANZER: Good morning, your Honor.
Mr. HIRSCH: Who's from California and has
been involved in the parallel litigation in some respects between the Government and the
cannabis issues in the State of California where in California as your Honor might be
aware they passed the law about medical marijuana. And after they did, the Federal
Governmet, Mr. Goldberg and others have been attempting to nullify the will of the people
in California by declaring that Federal prohibition is Federal prohibition, not one joint,
not one grain of grass will ever be sanctioned by the Federal Government, whether it comes
from the States or whether it comes from the Federal Government, it will never be
sanctioned.
Their settlement position was very, very clear,
no concessions. They will make no concessions.
And I'm happy to have these people joining me.
And I now thank your Honor for your attention. And speaking on behalf of all
the people in the courtroom that came from all over the place, I would like to thank you
for your courtoom staff for making the accommodations and so forth.
THE COURT: You're certainly welcome.
MR. HIRSCH: Thank you, your Honor.
THE COURT: Mr. Goldberg, if you want the
last word, you're welcome to it.
MR. GOLDBERG: Thank you, your Honor, I'll
be very brief.
THE COURT: Sure.
MR. GOLDBERG: With the Court's indulgence
I just have a couple points to make.
This is a Motion to Dismiss, which as the Court
well knows for the purpose of the motion, accepts as true all of the factual allegations
contained in the plaintiffs's Complaint. That's the posture we're in.
There are ample factual allegations about Mr.
Randall, Mr. Randall's case, Mr. Randall's settlement in the Complaint. Clearly for
purposes of resolving this motion, no further information is needed about that.
And when the Court asked Mr. Hirsch what are
the facts he would like to put on the record here, his response was he wants to know who
the person was who cut the policy off, what enabled him to do it and who is he answerable
to? Those are not factual questions, your Honor. Those are legal questions.
And again under the law this decision was rationally based. It does not
matter who the person was. If the agency was responsible for running this program,
it had the authority to run it and had it had the authority to terminate it.
THE COURT: Which agency are you referring
to?
MR. GOLDBERG: I'm talking about the
overall agency is Health and Human Services. And again it was the FDA who made the
decision and possibly in consultation with NIH. But they're both arms of the
Department of Health and Human Services.
And again, I'm not going to repeat myself.
It was clearly a rational basis on which to make that decision.
And just finally, this is not a case where it
is incumbent upon the Government to submit an administrative record. It's perfectly
admissible and perfectly proper for us to do what we did, to submit these documents to
amplify the very allegations that were made in plaintiff's Complaint and explain to the
Court what this program was about.
THE COURT: But how can I consider those
documents that you submitted when they are not even in summary judgment form, they are not
even in affidavit form?
MR. GOLDBERG: We don't consider this as a
motion for summary judgment. These are publicly available documents which are
referred to in the plaintiff's Complaint. And we think that they can be read as part
of the plaintiff's pleadings and added to the facts asserted in the plaintiff's pleadings.
And even upon those facts we argue there is no legal basis for the claim and
therefore it must be dismissed.
THE COURT: What is the best argument that
you have against allowing limited discovery of whatever records there are that would
demonstrate, as you point out, as you argue, the rational basis for terminating the
Compassionate Access Program?
MR. GOLDBERG: There's no showing that
there are any facts in dispute at this point.
To the extent that the documents --
THE COURT: The question is whether it was
rational to terminate and limit it to the four or five.
What is the downside of allowing limited
discovery on that issue and see what the documents are that would show why the program was
terminated and why it's rational to continue it as to the four or five, but not others?
MR. GOLDBERG: The downside is I think
that what we submitted really summarizes the basis for a decision. There will not be
any other documents that can show anything else. And this at bottom a claim that has
no merit. And there is no point in letting this case proceed any further.
THE COURT: How long would it take to
figure out what other documents existed, original documents that would disclose the
rational basis for terminating the program and limiting it to the four or five who
received the marijuana?
MR. GOLDBERG: I frankly don't know.
I wouldn't think it would take that long, but I couldn't give the Court any kind of
an estimate.
THE COURT: Who would know?
MR. GOLDBERG: I could find out. I
mean I have to talk to my contact person at Health and Human Services, my agency counsel
there who is not here this morning. And there may be several people he would have to
consult with in order to figure out what the universe of material was. I don't think
it's very much.
I think as I have said we have given the
plaintiffs and the Court the basic documents that show what this decision was and why it
was made. I don't think there's going to be much else there.
THE COURT: How much time would it take
just to ascetain preliminarily what's there and how long would it take to pull it
together?
MR. GOLDBERG: I suppose it would take at
least a week, maybe 10 days to ascertain what's there. It might take a little longer
to pull it together.
THE COURT: Would you be kind enough just
to ascertain preliminarily what is there and how long it would approximately take to pull
it together?
MR. GOLDBERG: Right.
THE COURT: And perhaps let me know, with
a copy, of course, to the other sides.
MR. GOLDBERG: Sure.
THE COURT: Much appreciated.
MR. GOLDBERG: Thank you.
THE COURT: Thank you very, very much.
I appreciate the argument.
(Court adjourned.)