II. The Parties' Requests for Relief
A. Plaintiffs' Application for Preliminary Injunction
In their Application for Preliminary Injunction, Plaintiffs
assert that the federal policy is unconstitutional for several
reasons. First, Plaintiffs state that the federal policy violates
patient and physician First Amendment rights because the speech
at issue (prescription, recommendation, and scientific
consultation) is fully protected. Therefore, Plaintiffs argue,
the federal policy is an unconstitutional prior restraint, an
unconstitutional content-based suppression of protected speech,
and is unconstitutionally overbroad.
Second, Plaintiffs argue that the federal policy violates the
Tenth Amendment because it causes all states to be "effectively
coerced and cajoled into aiding federal authorities in the
apprehension and prosecution of those who violate the [federal]
[p]olicy." Application Prelim. Inj. at 18.
Third, Plaintiffs assert that the federal policy violates the
Ninth Amendment by violating the unenumerated rights of
physicians to recommend and prescribe needed treatment to a
seriously or terminally ill patient, as well as the rights of
patients to receive such treatment.
Fourth, Plaintiffs argue that the federal policy violates the
Commerce Clause. Plaintiffs assert that because neither
intrastate recommendation and prescription of marijuana, nor the
cultivation, growth, or use of medicinal marijuana substantially
affects the channels or instrumentality of interstate commerce,
it is beyond the power of Congress or administrative agencies to
regulate such activity.
Fifth, Plaintiffs argue that the federal policy violates the
Administrative Procedures Act (APA) because it imposes two rules
of general applicability, thus final rules, without providing
adequate notice and opportunity for public comment.
Finally, Plaintiffs argue that the federal policy exceeds
ONDCP's statutory authority. The federal policy announces that
physicians who prescribe or recommend marijuana under state law
will have their DEA prescription drug licenses revoked and their
participation in Medicare and Medicaid prohibited. Plaintiffs
assert that neither the CSA nor the Social Security Act provide
the Federal government with the authority to revoke licenses or
participation in Medicare and Medicaid based upon a
recommendation or prescription for medical marijuana in
accordance with state law.
B. Defendants' Motion to Dismiss
In their Motion to Dismiss, Defendants assert several
arguments. First, they state that Plaintiffs' claims are not
appropriate for judicial resolution at this time because
Plaintiffs lack standing and their claims are not ripe for
judicial review. Defendants also note that none of the federal
agency Defendants has taken any final agency action affecting the
Plaintiffs. In addition, Defendants assert that the DEA has the
authority to revoke a doctor's registration to dispense
controlled substances for violations of the CSA.
Defendants also claim that the federal policy is fully
consistent with the First Amendment, and does not violate the
Ninth or Tenth Amendments. Moreover, because the federal policy
is a "statement of agency policy," it is exempt from the notice
and comment requirements for rulemaking under the APA. Finally,
Defendants argue that Plaintiffs are not entitled to a
preliminary injunction because they are not likely to succeed on
the merits, and
the balance of equitable factors weighs against enjoining
enforcement of the CSA, a statute Congress enacted to protect the
public health and safety.
In their Motion to Dismiss, Defendants argue that Plaintiffs
lack standing to bring this suit because federal law does not
prohibit a physician from merely discussing the risks and
benefits of medical marijuana use with a patient. In addition,
Defendants note that the Department of Justice (DOJ) has not
threatened to bring charges against doctors or scientists for
engaging in discussions about medical marijuana. Thus, Defendants
argue, in the absence of a "credible and immediate" threat of
prosecution, Plaintiffs do not have standing to bring this case.
Defs.' Mot. Dismiss at 8.
Plaintiffs challenging a statute or policy in federal court
must demonstrate that they have or will sustain some immediate
injury from the challenged statute or official conduct. See
O'Shea v. Littleton, 414 U.S. 488, 494, 94 S.Ct. 669, 38 L.Ed.2d
674 (1974). However, "[b]ecause of the sensitive nature of
constitutionally protected expression, [the Supreme Court has]
not required that all of those subject to overbroad regulations
risk prosecution to test their rights. For free expression — of
transcendent value to all society, and not merely to those
exercising their rights — might be the loser." Dombrowski v.
Pfister, 380 U.S. 479, 486, 85 S.Ct. 1116, 14 L.Ed.2d 22 (1965).
Plaintiffs have noted that the federal policy, and thus, the CSA,
has had a chilling effect — that doctors and researchers have
been fearful of discussing the potential benefits of medical
marijuana with their colleagues and patients. While these
Plaintiffs have not been prosecuted by the government for such
actions, their fear of potential sanctions is both credible and
immediate. Therefore, this Court finds that there is enough at
stake here to determine that Plaintiffs have standing to
challenge the federal policy as it relates to enforcement of
provisions of the CSA.
However, as noted above, part of the federal response involves
the exclusion of physicians prescribing or recommending medicinal
marijuana from participation in the Medicare and Medicaid
programs. In the most recent Conant court decision, on facts
nearly identical to those in the present case, the court noted
[the federal policy] stated only that the government
"will send a letter" that "will outline the authority
of the Inspector General for HHS to exclude specified
individuals or entities from participation in the
Medicare and Medicaid programs." Such a letter has
never been prepared or released. The parties can only
speculate as to what such a letter would contain, and
what effect it would have on plaintiffs. The [federal
policy] alone does not amount to a specific threat.
This factor is fatal to plaintiffs' challenge of the
Medicare/Medicaid policy. "Unadorned speculation" is
"insufficient to invoke federal judicial power."
Whitmore v. Arkansas, 495 U.S. 149, 158, 110 S.Ct.
1717, 109 L.Ed.2d 135 (1990).
Conant v. McCaffrey, 2000 WL 1281174, *9 (N.D.Cal. 2000).
Defendants do not discuss the Medicare/Medicaid issue at all in
their briefs. It is therefore unclear to the Court whether
Defendants intend to proceed in this area or not. Because of the
lack of a credible or immediate threat of exclusion from the
Medicare and Medicaid programs, Plaintiffs lack standing to bring
a challenge to that portion of the federal policy.
Defendants also argue in their Motion to Dismiss that
are not ripe. Ripeness requires a court "to evaluate both the
fitness of the issues for judicial decision and the hardship to
the parties of withholding court consideration." Texas v. United
States, 523 U.S. 296, 300-301, 118 S.Ct. 1257, 140 L.Ed.2d 406
(1998) (quoting Abbott Laboratories v. Gardner, 387 U.S. 136,
149, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)). Plaintiffs argue that
the federal policy is content based and unconstitutional. This is
a purely legal question, where no future development of a factual
record is necessary, and is thus fit for judicial review. See
Time Warner Entertainment Co., L.P. v. Federal Communications
Commission, 93 F.3d 957, 974 (D.C.Cir. 1996). Further,
Plaintiffs have provided affidavits from physicians that describe
the chilling effect that the uncertainty regarding the federal
policy has had on their speech, as discussed supra. The
hardship to the Plaintiffs of withholding resolution on the
merits is clear. Plaintiffs' challenge to the federal policy is
C. Statutory and Regulatory Framework
The CSA criminalizes the use, possession, or distribution of
certain controlled substances and establishes five schedules of
controlled substances. 21 U.S.C. § 801-812. Schedule I drugs
have a high potential for abuse, no currently accepted medical
value in the United States, and a lack of accepted safety for use
under medical supervision. 21 U.S.C. § 812(b)(1). Schedule II
drugs have a high potential for abuse, a currently accepted use
in treatment or a currently accepted medical use with severe
restrictions, and abuse of the drug may lead to severe
psychological or physical dependence. 21 U.S.C. § 812(b)(2).
Marijuana is a Schedule I controlled substance. 21 U.S.C. § 812
Moreover, there are provisions in the CSA by which the Attorney
General (AG) may change a designation of a controlled substance —
either move it up, down, or off of the schedules.
21 U.S.C. § 811. Under these provisions, certain factors are considered,
including the risk to public health of decriminalization.
21 U.S.C. § 811(b), (c). Individuals may petition the AG for
rescheduling of a controlled substance. 21 C.F.R. § 1308.43 et
seq . Plaintiffs' complaint does not challenge these provisions,
nor does it suggest that Plaintiffs have petitioned the AG to
Under the CSA, the federal government also has the authority to
register physicians and other manufacturers, distributors, and
dispensers of controlled substances, and to revoke those
registrations when certain conditions are not met, e.g., lack of
compliance with the requirements of a state medical licensing
board, or violations of federal drug laws. 21 U.S.C. § 821-824.
D. The First Amendment Issue
Plaintiffs allege that the federal policy violates the First
Amendment rights of patients, physicians, and researchers because
the speech at issue (prescription, recommendation, and scientific
consultation) is fully protected. First, Plaintiffs argue that
the federal policy is an unconstitutional prior restraint. The
Supreme Court has defined such restraints as "administrative and
judicial orders forbidding
certain communications when issued in advance of the time that
such communications are to occur." Alexander v. United States,
507 U.S. 544, 550 (1993), quoting M. Nimmer, Nimmer on Freedom
of Speech, § 4.03, p. 4-14 (1984) (emphasis in original).
Plaintiffs note that the federal policy does not fall within the
narrow class of cases, such as those involving restraints about
the disclosure of the position of military forces during wartime,
that are able to overcome the constitutional presumption against
prior restraints. See, e.g., New York Times Co. v. United
States, 403 U.S. 713, 91 S.Ct. 2140, 29 L.Ed.2d 822 (1971).
Therefore, Plaintiffs argue, the federal policy cannot stand.
Second, Plaintiffs assert that the federal policy is an
unconstitutional content-based restriction on speech because it
effectively prohibits physicians from communicating with their
patients, and researchers from communicating with physicians and
patients, about the benefits from use of medicinal marijuana.
Citing Texas v. Johnson, 491 U.S. 397, 109 S.Ct. 2533, 105
L.Ed.2d 342 (1989), Plaintiffs note that "the government may not
prohibit the expression of an idea simply because society finds
the idea itself offensive or disagreeable." Id. at 414, 109
S.Ct. 2533. Thus, plaintiffs argue, government restraints on
speech such as the federal policy should survive judicial review
only if they: 1) are based on a compelling state interest; and 2)
are narrowly tailored, choosing the least restrictive means to
further that interest. Sable Communications, Inc. v. FCC,
492 U.S. 115, 109 S.Ct. 2829, 106 L.Ed.2d 93 (1989). In the present
case, Plaintiffs argue that the government does not have a
compelling interest in regulating the communication among
physicians, patients, and researchers about intrastate use of
medicinal marijuana. Moreover, Plaintiffs assert that the federal
policy is not the least restrictive means — that other options,
including the limiting of interstate shipment of marijuana, would
be more narrowly tailored to achieve the government's goal of
prohibiting illicit interstate drug trade.
Finally, Plaintiffs argue that the federal policy is
substantially overbroad and has a chilling effect on
doctor-patient communication. Thus, Plaintiffs assert, there are
doctors, researchers, and patients who are not before the Court,
but who may benefit from prescription or recommendation of
medicinal marijuana. Moreover, Plaintiffs note that there are
physicians who are not before the Court who are afraid to
recommend or prescribe medicinal marijuana to their patients.
In their Motion to Dismiss, as well as in oral argument at a
hearing on the preliminary injunction, the Defendants have
attempted to clarify their position regarding Plaintiffs' First
Amendment concerns about the federal policy. During the hearing,
Defendants' counsel stated,
[t]he Federal Government has drawn a very clear line
here that doctors are permitted — nothing in Federal
law prevents doctors from discussing the possible
risks and benefits of marijuana, but the line is that
they cannot prescribe it, and they cannot recommend
it to patients.
Tr. at 11. Thus, under current law, doctors, patients, and
researchers may freely discuss the benefits and risks of the use
of marijuana without fearing that the federal government will
proceed against them with criminal, civil, or administrative