Hearing on Government's Motion to Dismiss

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

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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.)