PLEASE TAKE NOTICE that on August 3, 2000, at 8:00 a.m., or as soon thereafter as it may be heard, plaintiffs will bring on for hearing their motion for summary judgment pursuant to Rule 56 of the Federal Rules of Civil Procedure.
Plaintiffs bring their motion on the ground that there is no genuine issue for trial and plaintiffs are entitled to entry of a final judgment in their favor as a matter of law.
This motion is based upon the accompanying memorandum of points and authorities, plaintiffs' Submission of Evidence on Summary Judgment, and such other and further matters as may be called to the attention of the Court at or before the hearing.
MEMORANDUM OF POINTS AND AUTHORITIES
INTRODUCTION AND SUMMARY OF ARGUMENT
Plaintiffs are a class of prominent and respected physicians and seriously ill patients. They seek an injunction protecting California physicians from threatened federal retaliation for providing candid advice to patients about the medical use of marijuana. This Court has previously issued a preliminary injunction, which provides plaintiffs with a certain measure of relief. Conant v. McCaffrey, 172 F.R.D. 681 (N.D. Cal. 1997). At a recent hearing, after three years of changing positions, the government all but stipulated to the terms of this preliminary injunction. The primary question for the Court now is how to frame a broader permanent injunction to remedy fully the government's violation of the First Amendment.
We emphasize at the outset that, as this Court has recognized, this case "is not about doctors prescribing, growing, or distributing marijuana." Conant, 172 F.R.D. at 686 (emphasis added). Rather, "this case is about the ability of doctors, on an individualized basis, to give advice and recommendations to bona fide patients suffering from serious, debilitating illnesses regarding the possible benefits of personal, medical use of small quantities of marijuana." Id. Such advice and recommendations have long been in the mainstream of U.S. medical practice.
Medical marijuana remained a quiet, little-noticed aspect of medical practice until measures legalizing medical use of marijuana qualified for the November 1996 ballot in California and Arizona. Medical marijuana then exploded into the public arena as a matter of significant controversy - both medical and, to a large degree, political. Federal officials (including the defendants in this suit) objected to the "message" sent by the California initiative and, after its approval by the voters, set out to stop physicians from engaging in speech with patients that would effectuate the initiative. The official government policy sought to suppress the "wrong" message through the threat of draconian punishments. Any physician who "recommended" the medical use of marijuana to a patient risked revocation of her prescription drug licenses, loss of Medicare/Medicaid provider status, and criminal prosecution. At least one California physician was investigated by the DEA for recommending medical marijuana in the short time between the government's announcement of its policy and this Court's entry of its preliminary injunction.
Defendants' threats against physicians have been effective. Physicians have censored medical advice they offer to their patients, refusing to provide guidance on the risks or benefits from medical marijuana even when it is the only medicine that the physician believes will be effective. This interference with the free flow of important information between physician and patient is a travesty of medical policy: patients are denied critical information; patients' trust in physicians is jeopardized; patients turn for information to unreliable sources such as the Internet; and health care for extremely ill patients, especially those with AIDS and cancer, is compromised for the sake of the government's political need to appear "tough on drugs."
The government's medical marijuana policy violates the First Amendment, which plainly applies to communications between physician and patient.(1) The government has adopted a policy that sweeps in both protected and unprotected speech in order to suppress a message with which it disagrees. The policy is unconstitutionally vague because a person of reasonable intelligence could not determine what speech is permitted. The physicians who are supposed to follow the policy are completely confused by what it prohibits, the government officials responsible for promulgating the policy do not know its meaning, and the lawyers responsible for defending the policy in this Court have given inconsistent answers as to its scope. The government's policy is more than simply vague and overbroad, however, it is an example of the most egregious kind of viewpoint discrimination.
The genuinely contested issue before this Court now is not liability, but how to frame a final injunction that will remedy defendants' violations of the First Amendment and provide the necessary breathing room for physicians to practice medicine without fearing investigation and prosecution if they provide candid advice and recommendations to patients about medical marijuana. In doing so, the Court does not write on a clean slate. Defendants' threats have intimidated physicians into self-censorship, and it is impossible to completely "unring the bell." What the Court can and should do, however, is provide physician members of the plaintiff class with clear protections by specifically enjoining the government from commencing, or threatening to commence, criminal or administrative proceedings against them for actions that form a normal part of medical practice: (1) discussing and providing recommendations concerning the risks and benefits of marijuana for a particular patient; (2) informing patients of the safest and most medically appropriate means of implementing a recommended treatment; (3) noting diagnosis and treatment information in a patient's chart; (4) providing letters at a patient's request to third parties confirming a patient's treatment or medical condition; (5) testifying in court concerning a patient's treatment or medical condition; and (6) verifying that the patient meets the elements of the medical necessity defense.
By providing for a bright-line rule in its final injunction, the Court can undo some of the damage that defendants have done to both the practice of medicine and to the Constitution.
BACKGROUND
I. Mainstream Clinicians And Researchers View Medical Marijuana As A Safe And Effective Treatment For Certain Patients.
Physician recommendations of medical marijuana have long been part of mainstream medical practice in the United States. See, e.g., Pls' Evid., Exh. 2 at 9.(2) Based on research and experience, physicians have concluded that marijuana is an appropriate treatment for certain patients. Marijuana, of course, is not approved for physician prescription. But physicians recommend treatments ranging from vitamins to chicken soup to red wine (for cardiac health), none of which are federally approved prescription medications.
The efficacy of marijuana in treating certain conditions has been recognized by the New England Journal of Medicine:
The advanced stages of many illnesses and their treatments are often accompanied by intractable nausea, vomiting, or pain. Thousands of patients with cancer, AIDS, and other diseases report they have obtained striking relief from these devastating symptoms by smoking marijuana.
Pls' Evid., Exh. 124. A 1990 Harvard survey of more than 2,000 oncologists found that forty-four percent had recommended marijuana to cancer patients undergoing chemotherapy to control nausea or lack of appetite. Doblin, et al., "Marijuana as Antiemetic Medicine: A Survey of Oncologists' Experiences and Attitudes," Journal of Clinical Oncology, vol. 9, no. 7 (July 1991), attached as Exh. A-23 to Declaration of K. Zeese, filed Feb. 14, 1997. A vast body of research supports the observations of clinicians concerning medical use of marijuana. See Declaration of K. Zeese and exhibits, filed Feb. 14, 1997.
Marijuana is an especially effective treatment of nausea and wasting in patients with cancer or AIDS. As Dr. Debasish Tripathy states: "The nausea and retching associated with chemotherapy [for cancer] are often disabling and intractable." Pls' Evid., Exh. 14 at 5; see also Pls' Evid., Exh. 10 at 6, 9; Pls' Evid., Exh. 2 at 6; Pls' Evid., Exh. 4 at 5. Retching, which can last for days after treatment, can literally tear the esophagus and fracture ribs. Vomiting results in severe fluid loss. Because of chemotherapy's side effects, many cancer patients eat almost nothing because they cannot stand the sight or smell of food. With each successive treatment, these patients lose weight and strength. See Pls' Evid., Exh. 14 at 5. Because of the severity of chemotherapy's side effects, some patients discontinue treatment, even though they know that ceasing treatment could lead to death. See Pls' Evid., Exh. 10 at 7; Pls' Evid., Exh. 14 at 13; Pls' Evid., Exh. 2 at 19; Pls' Evid., Exh. 4 at 10; Pls' Evid., Exh. 6 at 8. Patients who do not respond to conventional antiemetics (drugs intended to prevent nausea and vomiting) are particularly prone to abandon chemotherapy regimens. For some patients, antiemetics in pill form are literally impossible to swallow or ingest, for instance patients with cancer of the colon, stomach, throat or esophagus. See Pls' Evid., Exh. 14 at 6; Pls' Evid., Exh. 10 at 9. For these patients, medical marijuana can prove to be the only effective form of treatment. See Pls' Evid., Exh. 10 at 9.
Patients with AIDS, while benefitting tremendously from recently developed drug therapies, face a barrage of problems caused by those medicines. First, AIDS, and some of the medications often used to treat it, cause severe nausea, making it difficult to swallow and retain pills. Pls' Evid., Exh. 5 at 13. Patients are required to eat, both to prevent uncontrolled weight loss ("wasting syndrome") and because some pills must be taken on a full stomach. Id. at 14; see also Pls' Evid., Exh. 25 at 4. The nausea and vomiting can be so severe that Dr. Milton Estes observes that patients "have terminated potentially life-saving treatment because the side effects of their treatment seemed to them worse than the disease." Pls' Evid., Exh. 5 at 15; see also Pls' Evid., Exh. 6 at 8. Many AIDS patients are also beset by "wasting syndrome," a condition characterized by severe progressive weight loss and breakdown of muscle tissue. As AIDS patient Keith Vines explains, wasting syndrome can be devastating: "I lost more than 40 pounds of lean body mass. My bones became brittle and my joints, for lack of nourishment, ached with pain. I tried to stay fit by exercising regularly. But nothing seemed to stave off my progressive deterioration." Pls' Evid., Exh. 15 at 7. Dr. Marcus Conant explains that wasting syndrome leads to other complications and often death because it "undermines both the immune system generally and a patient's ability to withstand the effects of other therapies." Pls' Evid., Exh. 2 at 7; see also Pls' Evid., Exh. 6 at 20. For patients who do not respond to or tolerate conventional prescription drugs, marijuana can be the only treatment that will stimulate appetite and alleviate nausea and vomiting, "allowing the AIDS patient to recover lost body mass and become healthier." Pls' Evid., Exh. 2 at 10; Pls' Evid., Exh. 6 at 1, 14-15; Pls' Evid., Exh. 9 at 8; Pls' Evid., Exh. 13 at 6; Pls' Evid., Exh. 12 at 7.
Marijuana is also an effective medication in the field of pain care. Chronic, persistent pain is a disabling and often life-threatening condition; thus alleviating pain is often a medical imperative. Pls' Evid., Exh. 23 at 6; Pls' Evid., Exh. 22 at 12. Marijuana is used as an adjuvant therapy to manage symptoms and side-effects and to augment other analgesics. Much like certain chemotherapy regimens and some AIDS medications, opioid analgesics - the standard treatment for chronic and severe pain - can induce nausea, vomiting, or retching, which in turn can lead to malnourishment, anorexia, wasting, and a general decline in patient health. Pls' Evid., Exh. 22 at 15-16; Pls' Evid., Exh. 23 at 10, 15-16; Pls' Evid., Exh. 24 at 6, 12. When patients do not respond to traditional antiemetics, pain specialists have found that marijuana often can provide "immediate relief with significantly fewer adverse effects." Pls' Evid., Exh. 22 at 19. Marijuana also functions as an analgesic or co-analgesic for many patients who do not respond to traditional pain therapies. Pls' Evid., Exh. 23 at 10-14; Pls' Evid., Exh. 22 at 20; Pls' Evid., Exh. 24 at 12; Pls' Evid., Exh. 25 at 15. In fact, marijuana "has the analgesic potential to notably lessen a pain patient's opiate intake and thereby reduce the unpleasant and possibly damaging side effects of long-term narcotic use." Pls' Evid., Exh. 23 at 19. Thus, both the British Medical Association and the Institute of Medicine (in a study commissioned by the White House Office of National Drug Control Policy) have recognized the important roles that cannabinoids, a group of compounds found in marijuana, can serve in treating pain. Pls' Evid., Exh. 23 at 10, 18; Pls' Evid., Exh. 22 at 20.
II. Defendants Have Issued Threats Against Physicians To Chill Their Speech About The Efficacy Of Medical Marijuana As A Treatment.
During several decades of widespread physician recommendations of medical marijuana, federal officials never prosecuted, revoked the prescription drug license of, or punished in any way a physician for recommending the use of medical marijuana. Until the weeks before the November 1996 elections, no federal official had even threatened such action.
Under pressure from Congress to "be doing something" about medical marijuana initiatives (Pls' Evid., Exh. 35 at 11:11), defendants sprang into action. Director of the Office of National Drug Control Policy, Barry McCaffrey, obtained reversal of the policy of prior Administrations - a policy he described as involving "sensitive federalism" concerns - requiring that "the federal government will make no representations on a state initiative." Pls' Evid., Exh. 98 at 2. Thus, Director McCaffrey urged the electorate to "vote 'no' to the drug legalizing Proposition 215." Pls' Evid., Exh. 64; see also infra at 24 (campaign activities of defendant McCaffrey and others).
In November 1996, however, California voters overwhelmingly approved Proposition 215. The legal change wrought was relatively modest: Proposition 215 confers a state law immunity from criminal prosecution for marijuana use or possession to seriously ill persons who have received the "recommendation" or "approval" of a physician for the medical use of marijuana. Pls' Evid., Exh. 48.(3) Federal officials initially responded with a two-fold message: marijuana use remained illegal under federal law and physician prescriptions of marijuana remained illegal under federal law. For instance, defendant McCaffrey stated during a television interview: "A physician who tries to prescribe a Schedule I drug, with or without these referendum in California or Arizona, is subject to prosecution under federal law -- and we will uphold the law." Pls' Evid., Exh. 63 at 2; see also Pls' Evid., Exh. 73; Pls' Evid., Exh. 80 at 5. But federal officials soon resolved to roll back Proposition 215 through a more comprehensive approach aimed at recommendations of medical marijuana, acting just as aggressively as they had in opposing the initiative. As Director McCaffrey put it, "we're not getting rolled on this." Pls' Evid., Exh. 75 at 7; see also infra at 25-26.
When defendants assembled a government Working Group to formulate a more comprehensive response to the Compassionate Use Act, they first considered a range of options: (1) filing a suit claiming that federal law preempts the Proposition; (2) initiating federal criminal prosecution of medical marijuana users; (3) supporting state and local arrests and contraband seizures based on violation of federal law; and (4) developing a strategy for taking action against physicians. Pls' Evid., Exh. 92 at 4-5. The preemption suit was ultimately abandoned as unlikely to succeed. Pls' Evid., Exh. 34 at 289:20 to 290:17; Pls' Evid., Exh. 119 at 5. Prosecution of medical marijuana users, who generally possess quantities of marijuana insufficient to warrant federal attention (Pls' Evid., Exh. 33 at 74:1-22) would divert resources from other drug enforcement areas, and was rejected absent special circumstances.(4) State and local arrests or seizures for medical marijuana violations were rejected by California officials, who felt bound to honor the vote. Pls' Evid., Exh. 34 at 301:14 to 303:19.
Given the infeasibility of all other proposals, the Working Group turned to taking action against physicians, and specifically to trying to suppress physician recommendations of medical marijuana by eliding the difference between recommendations and prescriptions. In particular, the inclusion of the term "recommend" in Proposition 215 prompted the Working Group to address that term. See Pls' Evid., Exh. 34 at 101:13 to 102:20. According to Director McCaffrey, resolving the distinction between "prescriptions" and "recommendations" was "really the heart and soul of" the issue. Pls' Evid., Exh. 34 at 91:7-14. Defendant McCaffrey understood that federal law prohibited physician prescriptions of marijuana (Pls' Evid., Exh. 34 at 88:10 to 89:17), but he was not sure of how to deal with physician recommendations. Pls' Evid., Exh. 34 at 90:15-20. As described by the convener of the Working Group, "at present appears a sizable faction [of the medical community] supports marijuana for the terminally ill, why? Tension between individual treatment issues and developing a common good public policy need to be resolved." Pls' Evid., Exh. 92 at 4. In the end, defendants resolved that tension by simply telling physicians it was illegal to recommend marijuana.
The notion of punishing physician "recommendations" directly contradicted DEA's interpretation of the federal statute it is charged with administering. In a letter to a member of Congress several months before passage of Proposition 215, Thomas Constantine, the Administrator of DEA, had explained that the Controlled Substances Act ("CSA") prevented physicians from dispensing or prescribing marijuana, but not recommending it:
Whether the proposed California referendum would permit a practitioner to act in contravention of Federal law, thereby putting his or her DEA registration in jeopardy is unclear. The referendum only authorizes a practitioner to "recommend" the use of marijuana by a patient. This is a term which is not found in the CSA, and is not defined in the referendum. The CSA controls the manufacture, distribution and dispensing (which includes prescribing) of marijuana by a registrant, and does not address merely recommending its use.
Pls' Evid., Exh. 51 at 3 (emphasis added). Administrator Constantine confirmed that his letter was based on research by the legal counsel for DEA, the agency with direct responsibility for enforcement and application of the statute analyzed in his letter. Pls' Evid., Exh. 33 at 220:19 to 221:2. Even after the Administration's policy was issued, Administrator Constantine could offer no explanation of the rationale for including "recommendations" in the policy. See Pls' Evid., Exh. 33 at 152:22 to 153-1.
Nonetheless, the Administration produced an official response that featured first and most prominently, a series of threats against physicians, including
a practitioner's action of recommending or prescribing Schedule I controlled substances [i.e., marijuana] is not consistent with the "public interest" (as that phrase is used in the Controlled Substances Act) and will lead to administrative action by the Drug Enforcement Administration to revoke the practitioner's registration.
Pls' Evid., Exh. 110 at 2 (emphases added). The Administration's policy also threatens to prosecute criminally those physicians who recommend medical marijuana, as well as to revoke their ability to receive Medicare and Medicaid reimbursement. Id. The purpose of the policy was to ensure that the California initiative does "not cause, not fuel, not communicate the wrong message to American youngsters," as defendant McCaffrey stated in the press conference announcing the government's response to the Act. Pls' Evid., Exh. 112 at 12. And, the critical component was threatening doctors. When asked on national television what the "main components" of the Administration's policy would be, Director McCaffrey stated that "the first we're going to do is we're going to remind doctors . . . ." Pls' Evid., Exh. 108 at 2; see also infra at 25.
Prior to the preliminary injunction in this case, federal authorities began to enforce the government's policy. Dr. Robert Mastroianni, a physician in Pollock Pines, California, became subject to investigation by DEA for having recommended medical marijuana to a seriously ill patient. On January 27, 1997, DEA agent William Davis presented Dr. Mastroianni with a copy of a written marijuana recommendation and announced that he was under investigation. See Pls' Evid., Exh.11 at 5. Agent Davis demanded answers to a number of questions regarding Dr. Mastroianni's medical practices, his recommendations of marijuana, and his familiarity with research on the medical efficacy of marijuana. Id., 8-9. DEA agents also requested to review Dr. Mastroianni's prescription records at a local pharmacy. Id., 7.
These threats against physicians for communicating their medical judgments to patients are truly unprecedented. According to Dr. Estes, "I have practiced medicine
