Kuromiya v. U.S.

78 F.Supp.2d 367

Kiyoshi KUROMIYA, et al., Plaintiffs, v. The UNITED STATES of America, Defendant.

Civil Action No. 98-3439.

United States District Court, E.D. Pennsylvania.

December 1, 1999.

Lawrence Elliott Hirsch, Hirsch & Caplan Public Interest Law Firm, Philadelphia, PA, for plaintiffs.

Arthur R. Goldberg, Gail R. Levine, Karyn A. Temple, Dept. of Justice, Civil Division, Washington, DC, Daniel Dormont, Office of Chief Counsel, Drug Enforcement Administration, Washington, DC, for defendant.

MEMORANDUM & ORDER

KATZ, Senior District Judge.

A group of approximately 160 plaintiffs has raised an equal protection challenge to the administration of a government program by which eight individuals receive marijuana to treat various ailments. Plaintiffs contend that they are similarly situated to those individuals and that the government has acted unconstitutionally in denying them access to the same program.¹ The time for discovery has now concluded, and the government's motion for summary judgment is before the court. As the government had a rational basis for its decision not to supply marijuana to the plaintiffs through the compassionate use program, the court must grant the government's motion.

I. Background

The compassionate use program was established in 1978 to settle a civil lawsuit. Initially, only one individual, Robert Randall, received marijuana from the government for treatment of his glaucoma. See Def. Ex. 3 at 3 (Mem. from Assistant Secretary of Health James Mason describing program's origin); see also Def. Ex. 5 (legal documents describing circumstances by which Randall would receive marijuana without legal consequences). The government subsequently agreed to supply medical marijuana to several other individuals through the same mechanism. See Def. Ex. 3 at 3-4.²

The beginnings of this program may be distinguished from the ordinary processes by which most drugs are approved for experimental use. The Food and Drug Administration (FDA) does provide a mechanism known as the treatment IND³ by which drugs that are under clinical investigation may be distributed to patients for whom no alternative drug or therapy is available. See 21 C.F.R. § 312.34(a). However, the compassionate use program did not comply with the requirements of a treatment IND. See 21 C.F.R. § 312.34(b)(1);⁴ Def. Ex. 1 ¶¶ 3-6 (noting distinctions between compassionate use program and treatment INDs). Rather, the marijuana program may more appropriately be described as a "single patient IND," in which the drug was simply distributed to certain individuals. As described by the government,

Single patient INDs cannot establish the scientific efficacy of new drugs; nor are they intended to permit the widespread distribution of unapproved drugs. The INDs are not conducted in controlled clinical settings, nor are they blinded or closely monitored by FDA or the clinical investigators. Thus, reports resulting from single patient INDs are merely anecdotal, and are not designed in a manner to provide the type of scientific data necessary to establish the safety and efficacy of a new drug.

Def. Ex 1 ¶ 5 (Aff. of Dr. Cynthia McCormick⁵). Moreover, the government apparently never conceded formally that marijuana was effective in treating the symptoms of those individuals who were receiving it.

This anomalous status ultimately contributed to the termination of the compassionate use program. In 1989, applications began to increase from fewer than five a year to a high of approximately forty applications following Mr. Randall's work with advocacy organizations to expand the single patient IND. See Def. Ex. 1 ¶ 7; Def. Ex. 3 at 4; Def. Ex. 6 at 1; but see Plf. Ex. 2 at 30 (government response to interrogatory stating that a total of 63 individuals applied for single patient INDs between 1978 and the present). The government apparently attempted to dissuade Mr. Randall from these efforts and informed him of the methods by which a larger-scale IND that might lead to useful findings could be initiated. See Def. Ex. 6.

The government also, however, decided to reevaluate the program as a whole. As Dr. McCormick explained the situation,

[A]s I understand it, [this expansion] threatened the availability of marijuana for future single patient INDs and other research projects. In 1991, FDA sought assistance from the Department of Health and Human Service, Public Health Service, in dealing with the increasing number of single patient INDs. This led to a review of the INDs by Assistant Secretary for Health, Dr. James O. Mason.

Def. Ex. 1 ¶ 7. Dr. Louis Sullivan, the Secretary for Health & Human Services, eventually approved Dr. Mason's recommendations that the program end except for those patients already receiving marijuana. See Def. Ex. 4 at 27-28.

In the first memorandum to Dr. Sullivan, dated June 1991, Dr. Mason highlighted many of the issues that would play a part in the program's termination, including the difficulty of acquiring marijuana and the lack of useful results. See Def. Ex. 7 at 1-3. Dr. Mason stated that the "widespread use of marijuana for medical purposes, especially where alternative medications are available, is bad public policy and bad medical practice." Id. at 3. After discussing difficulties in actually bringing marijuana into the marketplace, Dr. Mason described various side effects and the lack of medical support for claims made by medicinal marijuana users. See id. at 3-4.

The second memorandum, dated January 31, 1992, includes Dr. Mason's recommendations, which were approved by Dr. Sullivan on March 4, 1992. See Def. Ex. 3 at 8. As Dr. Mason explained, his recommendations were "based on the premise that supplying marijuana to additional applicants was suspect on public health grounds, and, in the absence of a clear research protocol, raised concerns about [the government's] legal authority to distribute marijuana for this purpose." Id. at 1. After hinting at possible legal difficulties in continuing to supply marijuana, Dr. Mason stated that "[l]ittle or no useful data has been obtained" from the program and "there is consensus within the Public Health Service that the single-patient IND process would not yield useful data in the future that would resolve the remaining safety and effectiveness issues." Id. at 4. Dr. Mason then outlined the recommendations that were ultimately approved:

1. NIDA will continue to grow marijuana in amounts sufficient to fulfill the needs of PHS-approved research. New single patient INDs would not fall into this category.

2. PHS will continue to supply marijuana to the 13 patients currently receiving shipments. At the same time, PHS will aid and encourage the physicians of all patients to use alternative therapies.

3. NIH will work with its AIDS clinical trial network to design a protocol and begin a well-controlled clinical trial of Megace and Marinol, the most promising agents studied to date for HIV wasting-syndrome. The NIH study protocol is being developed and trials can begin in 3-6 months. Every effort will be made to enroll the patients of physicians with pending applications in this study as well as the ongoing Unimed study.

Id. at 4-5. The same memorandum explains that those individuals with pending applications would not receive marijuana. See id. at 8; see also Def. Ex. 8 (March 18, 1992, memorandum from Mason describing implementation of those steps); Def. Ex. 9 (March 20, 1992, memorandum from Mason describing final decision).

As the foregoing suggests, the question before the government was what to do with the individuals who were then receiving marijuana. At the time the program stopped accepting new applicants in March 1992, there were thirteen participants; presently, eight remain. See Def. Ex. 1 ¶ 11. The government's submissions reveal that it decided to permit those currently in the program to continue receiving marijuana (although they would be encouraged to utilize alternative therapies) and to terminate the program as those patients died or left the program voluntarily. See id. ¶ 9. As Dr. Mason explained, this decision would "in effect, extricate PHS from supplying marijuana through single-patient INDs by attrition[.]" Def. Ex. 3 at 6; see also Def. Ex. 9 at 1 (March 20, 1992, memorandum from Mason to FDA, NIH, and Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), stating that government would continue to provide marijuana to those currently receiving it in an effort to balance interests).

II. Discussion⁶

The government's submissions suggest at least four bases for the termination of the compassionate use program: bad public policy, bad medicine, a lack of marijuana for the remaining patients, and the existence of alternative treatments. The government explains its decision to continue providing marijuana only to the remaining individuals in the program as a means of balancing the government's desire to avoid distributing marijuana to increasing numbers of individuals with the interests of those who had already relied upon the drug. These justifications provide a rational basis for the government's decisions.⁷

As the court discussed previously, the classification in this case does not "burden[] a fundamental right" or "target[] a suspect class." Kuromiya, 37 F.Supp.2d at 727 (citations omitted). A classification that does not affect a fundamental right or a suspect class

cannot run afoul of the Equal Protection Clause if there is a rational relationship between the disparity of treatment and some legitimate governmental purpose. Further, a legislature that creates these categories need not actually articulate at any time the purpose or rationale supporting its classification. Instead a classification must be upheld against equal protection challenge if there is any reasonably conceivable state of facts that could provide a rational basis for the classification.

Heller v. Doe, 509 U.S. 312, 320, 113 S.Ct. 2637, 125 L.Ed.2d 257 (1993) ...