                    FOR PUBLICATION
  UNITED STATES COURT OF APPEALS
       FOR THE NINTH CIRCUIT

ANGEL MCCLARY RAICH; JOHN DOE,            
Number One; JOHN DOE, Number
Two,
              Plaintiffs-Appellants,
                                                No. 03-15481
                v.
ALBERTO R. GONZALES, Attorney                    D.C. No.
                                               CV-02-04872-MJJ
General, as United States Attorney
                                                  OPINION
General; KAREN TANDY,* as
Administrator of the Drug
Enforcement Administration,
             Defendants-Appellees.
                                          
         Appeal from the United States District Court
           for the Northern District of California
          Martin J. Jenkins, District Judge, Presiding

                   Argued and Submitted
            March 27, 2006—Pasadena, California

                      Filed March 14, 2007

       Before: Harry Pregerson, C. Arlen Beam,** and
               Richard A. Paez, Circuit Judges.

                Opinion by Judge Pregerson;
   Partial Concurrence and Partial Dissent by Judge Beam

   *Karen Tandy is substituted for her predecessor, Asa Hutchinson, as
Administrator of the Drug Enforcement Administration, pursuant to Fed.
R. App. P. 43(c)(2).
   **The Honorable C. Arlen Beam, Senior United States Circuit Judge
for the Eighth Circuit, sitting by designation.

                                3025
                     RAICH v. GONZALES                 3029


                        COUNSEL

Robert A. Raich, (briefed) Oakland, California and Randy E.
Barnett, (argued) Boston University School of Law, Boston,
Massachusetts, for the plaintiffs-appellants.

Mark T. Quinlivan, Assistant United States Attorney, Boston,
Massachusetts, for the defendants-appellees.
3030                  RAICH v. GONZALES
                         OPINION

PREGERSON, Circuit Judge:

   Plaintiff-Appellant Angel McClary Raich (“Raich”) is a
seriously ill individual who uses marijuana for medical pur-
poses on the recommendation of her physician. Such use is
permitted under California law. The remaining plaintiffs-
appellants assist Raich by growing marijuana for her treat-
ment.

   Appellants seek declaratory and injunctive relief based on
the alleged unconstitutionality of the Controlled Substances
Act, and a declaration that medical necessity precludes
enforcement of the Controlled Substances Act against them.
On March 5, 2003, the district court denied appellants’
motion for a preliminary injunction. We hear this matter on
remand following the Supreme Court’s decision in Gonzales
v. Raich, 125 S. Ct. 2195 (2005). For the reasons set forth
below, we affirm the district court.

                 STATUTORY SCHEMES

I.   The Controlled Substances Act

   Congress passed the Comprehensive Drug Abuse Preven-
tion and Control Act of 1970, Pub. L. No. 91-513, 84 Stat.
1236, to create a comprehensive drug enforcement regime it
called the Controlled Substances Act, 21 U.S.C. § 801-971.
Congress established five “schedules” of “controlled sub-
stances.” See 21 U.S.C. § 802(6). Controlled substances are
placed on a particular schedule based on their potential for
abuse, their accepted medical use in treatment, and the physi-
cal and psychological consequences of abuse of the substance.
See 21 U.S.C. § 812(b). Marijuana is a Schedule I controlled
substance. 21 U.S.C. § 812(c), Sched. I (c)(10). For a sub-
stance to be designated a Schedule I controlled substance, it
must be found: (1) that the substance “has a high potential for
                        RAICH v. GONZALES                        3031
abuse”; (2) that the substance “has no currently accepted med-
ical use in treatment in the United States”; and (3) that
“[t]here is a lack of accepted safety for use of the drug or
other substance under medical supervision.” 21 U.S.C.
§ 812(b)(1). The Controlled Substances Act sets forth proce-
dures by which the schedules may be modified. See 21 U.S.C.
§ 811(a).

   Under the Controlled Substances Act, it is unlawful to
knowingly or intentionally “manufacture, distribute, or dis-
pense, or possess with intent to manufacture, distribute, or
dispense, a controlled substance,” except as otherwise pro-
vided in the statute. 21 U.S.C. § 841(a)(1). Possession of a
controlled substance, except as authorized under the Con-
trolled Substances Act, is also unlawful. See 21 U.S.C.
§ 844(a).

II.   California’s Compassionate Use Act of 1996

   California voters passed Proposition 215 in 1996, which is
codified as the Compassionate Use Act of 1996
(“Compassionate Use Act”). See Cal. Health & Safety Code
§ 11362.5. The Compassionate Use Act is intended to permit
Californians to use marijuana for medical purposes by
exempting patients, primary caregivers, and physicians from
liability under California’s drug laws. The Act explicitly
states that its purpose is to

      ensure that seriously ill Californians have the right to
      obtain and use marijuana for medical purposes
      where that medical use is deemed appropriate and
      has been recommended by a physician who has
      determined that the person’s health would benefit
      from the use of marijuana in the treatment of cancer,
      anorexia, AIDS, chronic pain, spasticity, glaucoma,
      arthritis, migraine, or any other illness for which
      marijuana provides relief.
3032                  RAICH v. GONZALES
Id. § 11362.5(b)(1)(A). Another purpose of the Compassion-
ate Use Act is “[t]o ensure that patients and their primary car-
egivers who obtain and use marijuana for medical purposes
upon the recommendation of a physician are not subject to
criminal prosecution or sanction.” Id. § 11362.5(b)(1)(B). The
Compassionate Use Act strives “[t]o encourage the federal
and state governments to implement a plan to provide for the
safe and affordable distribution of marijuana to all patients in
medical need of marijuana.” Id. § 11362.5(b)(1)(C).

   To achieve its goal, the Compassionate Use Act exempts
from liability under California’s drug laws “a patient, or . . .
a patient’s primary caregiver, who possesses or cultivates
marijuana for the personal medical purposes of the patient
upon the written or oral recommendation or approval of a
physician.” Id. § 11362.5(d).

        FACTUAL & PROCEDURAL HISTORY

   Appellant Angel McClary Raich is a Californian who uses
marijuana for medical treatment. Raich has been diagnosed
with more than ten serious medical conditions, including an
inoperable brain tumor, a seizure disorder, life-threatening
weight loss, nausea, and several chronic pain disorders.
Raich’s doctor, Dr. Frank Henry Lucido, testified that he had
explored virtually every legal treatment alternative, and that
all were either ineffective or resulted in intolerable side
effects. Dr. Lucido provided a list of thirty-five medications
that were unworkable because of their side effects.

   Marijuana, on the other hand, has proven to be of great
medical value for Raich. Raich has been using marijuana as
a medication for nearly eight years, every two waking hours
of every day. Dr. Lucido states that, for Raich, foregoing mar-
ijuana treatment may be fatal. As the district court put it,
“[t]raditional medicine has utterly failed [Raich].” Raich v.
Ashcroft, 248 F. Supp. 2d 918, 921 (N.D. Cal. 2003).
                       RAICH v. GONZALES                      3033
   Raich is unable to cultivate marijuana for her own use.
Instead, Raich’s caregivers, John Doe Number One and John
Doe Number Two, cultivate it for her. They provide mari-
juana to Raich free of charge. They have joined this action as
plaintiffs anonymously in order to protect Raich’s access to
medical marijuana.

   This action arose in response to a law enforcement raid on
the home of another medical marijuana user, former plaintiff-
appellant Diane Monson.1 On August 15, 2002, Butte County
Sheriff’s Department deputies, the Butte County District
Attorney, and agents from the federal Drug Enforcement
Agency (“DEA”) came to Monson’s home. After DEA agents
took control of Monson’s six marijuana plants, a three-hour
standoff between state and federal authorities ensued. The
Butte County deputies and district attorney concluded that
Monson’s use of marijuana was legal under the Compassion-
ate Use Act. The DEA agents, after conferring with the U.S.
Attorney for the Eastern District of California, concluded that
Monson possessed the plants in violation of federal law. The
DEA agents seized and destroyed Monson’s six marijuana
plants.

   Fearing raids in the future and the prospect of being
deprived of their medicinal marijuana, Raich, Monson, and
the John Doe plaintiffs sued the United States Attorney Gen-
eral and the Administrator of the DEA in federal district court
on October 9, 2002. The suit sought declaratory and injunc-
tive relief. Specifically, plaintiffs-appellants argued: (1) that
the Controlled Substances Act was unconstitutional as applied
to them because the legislation exceeded Congress’s Com-
merce Clause authority; (2) that through the Controlled Sub-
stances Act, Congress impermissibly exercised a police power
that is reserved to the State of California under the Tenth
Amendment; (3) that the Controlled Substances Act unconsti-
  1
   Plaintiff-Appellant Monson withdrew from this action on December
12, 2005.
3034                  RAICH v. GONZALES
tutionally infringed their fundamental rights protected by the
Fifth and Ninth Amendments; and (4) that the Controlled
Substances Act could not be enforced against them because
their allegedly unlawful conduct was justified under the com-
mon law doctrine of necessity.

   On October 30, 2002, the plaintiffs-appellants moved for a
preliminary injunction. On March 4, 2003, the district court
denied the motion by a published order. See Raich v. Ashcroft,
248 F. Supp. 2d 918. The district court found that, “despite
the gravity of plaintiffs’ need for medical cannabis, and
despite the concrete interest of California to provide it for
individuals like them,” the appellants had not established the
required “ ‘irreducible minimum’ of a likelihood of success
on the merits under the law of this Circuit.” Id. at 931.

   On December 16, 2003, we reversed and remanded this
matter to the district court to enter a preliminary injunction.
See Raich v. Ashcroft, 352 F.3d 1222, 1235 (9th Cir. 2003).
We held that the plaintiffs-appellants had demonstrated a
strong likelihood of success on the merits of their claim that
the Controlled Substances Act, as applied to them, exceeded
Congress’s Commerce Clause authority. See id. at 1234. We
did not reach plaintiffs-appellants’ remaining arguments in
favor of the preliminary injunction. See id. at 1227. The Gov-
ernment timely petitioned the Supreme Court for a writ of cer-
tiorari. The Supreme Court granted certiorari on June 28,
2004. See Ashcroft v. Raich, 542 U.S. 936 (2004).

   On June 6, 2005, the Supreme Court vacated our opinion
and held that Congress’s Commerce Clause authority includes
the power to prohibit purely intrastate cultivation and use of
marijuana. See Gonzales v. Raich, 125 S. Ct. at 2215. The
Court remanded the case to us to address plaintiffs-
appellants’s remaining legal theories in support of a prelimi-
nary injunction. See id. On remand, Raich renews her claims
based on common law necessity, fundamental rights protected
by the Fifth and Ninth Amendments, and rights reserved to
                        RAICH v. GONZALES                       3035
the states under the Tenth Amendment. She also argues for
the first time that the Controlled Substances Act, by its terms,
does not prohibit her from possessing and using marijuana if
permitted to do so under state law. We have jurisdiction over
this interlocutory appeal under 28 U.S.C. § 1292(a)(1).

        STANDING & STANDARD OF REVIEW

   [1] To satisfy the requirements of constitutional standing,
“the plaintiff must have suffered, or be threatened with, an
actual injury traceable to the defendant and likely to be
redressed by a favorable judicial decision.” Mujahid v. Dan-
iels, 413 F.3d 991, 994 (9th Cir. 2005) (citing Spencer v.
Kemna, 523 U.S. 1, 7 (1998)). Furthermore, the injury must
be: (1) concrete and particularlized, and (2) actual or immi-
nent, not conjectural or hypothetical. See United States v.
Antelope, 395 F.3d 1128, 1132 (9th Cir. 2005).

   [2] We are convinced that the requirements of constitu-
tional standing have been met here.2 Although Raich has not
suffered any past injury, she is faced with the threat that the
Government will seize her medical marijuana and prosecute
her for violations of federal drug law. The threat posed by
deprivation of her medical treatment is serious and concrete:
Raich’s doctor testified that foregoing medical marijuana
treatment might be fatal. The threat is not speculative or con-
jectural: DEA agents previously seized and destroyed the
medical marijuana of former plaintiff-appellant Diane Mon-
son. Monson’s withdrawal from this action does not change
the fact that DEA agents have — and may again — seize and
destroy medical marijuana possessed by gravely ill Califor-
nians, including Raich. Finally, it is clear that Raich’s threat-
ened injury may be fairly traced to the defendants, and that a
favorable injunction from this court would redress Raich’s
threatened injury.
  2
   We also note that the Supreme Court did not question constitutional
standing in this case. See Gonzales v. Raich, 125 S. Ct. 2195.
3036                    RAICH v. GONZALES
   A district court’s decision regarding preliminary injunctive
relief is subject to limited review. See Harris v. Bd. of Super-
visors, 366 F.3d 754, 760 (9th Cir. 2004). The court should
be reversed only if it abused its discretion or based its deci-
sion on an erroneous legal standard or on clearly erroneous
findings of fact. See id. A preliminary injunction must be sup-
ported by findings of fact, reviewed for clear error. See Haw-
kins v. Comparet-Cassani, 251 F.3d 1230, 1239 (9th Cir.
2001). The district court’s conclusions of law are reviewed de
novo. See Brown v. Cal. Dep’t of Transp., 321 F.3d 1217,
1221 (9th Cir. 2003).

                         DISCUSSION

   “The standard for granting a preliminary injunction bal-
ances the plaintiff’s likelihood of success against the relative
hardship to the parties.” Clear Channel Outdoor, Inc. v. City
of Los Angeles, 340 F.3d 810, 813 (9th Cir. 2003). We have
two different criteria for determining whether preliminary
injunctive relief is warranted. “Under the traditional criteria,
a plaintiff must show (1) a strong likelihood of success on the
merits, (2) the possibility of irreparable injury to [the] plaintiff
if preliminary relief is not granted, (3) a balance of hardships
favoring the plaintiff, and (4) advancement of the public inter-
est (in certain cases).” See Save Our Sonoran, Inc. v. Flowers,
408 F.3d 1113, 1120 (9th Cir. 2005) (internal quotations omit-
ted). We also use an alternative test whereby a court may
grant the injunction if the plaintiff demonstrates either: (1) a
combination of probable success on the merits and the possi-
bility of irreparable injury, or (2) that serious questions are
raised and the balance of hardships tips sharply in his favor.
See id.

   The two alternative formulations “represent two points on
a sliding scale in which the required degree of irreparable
harm increases as the probability of success decreases. They
are not separate tests but rather outer reaches of a single con-
tinuum.” Baby Tam & Co. v. City of Las Vegas, 154 F.3d
                          RAICH v. GONZALES                         3037
1097, 1100 (9th Cir. 1998) (internal quotation marks and cita-
tions omitted).

I.   Common Law Necessity

   Raich first argues that she has a likelihood of success on
the merits of her claim that the common law doctrine of
necessity bars the federal government from enforcing the
Controlled Substances Act against her medically-necessary
use of marijuana.3 Raich avers that she is faced with a choice
of evils: to either obey the Controlled Substances Act and
endure excruciating pain and possibly death, or violate the
terms of the Controlled Substances Act and obtain relief from
her physical suffering.

   The necessity defense “traditionally covered the situation
where physical forces beyond the actor’s control rendered
illegal conduct the lesser of two evils” and the actor had no
“reasonable, legal alternative to violating the law.” United
States v. Bailey, 444 U.S. 394, 410 (1980); see also 2 Wayne
R. LaFave, Substantive Criminal Law § 10.1 at 116 (2d ed.
2003 & Supp. 2005). As we have recognized,

     In some sense, the necessity defense allows us to act
     as individual legislatures, amending a particular
     criminal provision or crafting a one-time exception
     to it, subject to court review, when a real legislature
     would formally do the same under those circum-
     stances. For example, by allowing prisoners who
     escape a burning jail to claim the justification of
     necessity, we assume the lawmaker, confronting this
     problem, would have allowed for an exception to the
     law proscribing prison escapes.
   3
     We address Raich’s necessity claim before her constitutional substan-
tive due process claim because “an Act of Congress ought not be con-
strued to violate the Constitution if any other possible construction
remains available.” Gilmore v. California, 220 F.3d 987, 998 (9th Cir.
2000) (quoting NLRB v. Catholic Bishop, 440 U.S. 490, 500 (1979)).
3038                        RAICH v. GONZALES
United States v. Schoon, 971 F.2d 193, 196-97 (9th Cir.
1991).

   The Supreme Court has recognized that a common law
necessity defense exists even when a statute does not explic-
itly include the defense. See Bailey, 444 U.S. at 425 (Black-
mun, J., dissenting) (having “no difficulty in concluding that
Congress intended the defenses of duress and necessity to be
available” to prison escape defendant); id. at 415 n.11 (Rehn-
quist, J., majority opinion) (noting that the majority’s “princi-
pal difference with the dissent, therefore, is not as to the
existence of [the necessity] defense but as to the importance
of surrender as an element of it”).4

  A.     Whether Raich Satisfies the Requirements of the
         Common Law Necessity Defense5
  4
    Dicta in a recent Supreme Court decision questioned the ongoing vital-
ity of common law necessity defense. The majority in United States v.
Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483, 490 (2001)
(“Oakland Cannabis”), stated that “it is an open question whether federal
courts ever have authority to recognize a necessity defense not provided
by statute.” But the majority ultimately conceded that the “Court ha[d] dis-
cussed the possibility of a necessity defense without altogether rejecting
it.” Id. (citing Bailey, 444 U.S. at 415). Three Justices filed a separate con-
currence in Oakland Cannabis, noting that “the Court gratuitously casts
doubt on ‘whether necessity can ever be a defense’ to any federal statute
that does not explicitly provide for it, calling such a defense into question
by a misleading reference to its existence as an ‘open question.’ ” Id. at
501 (Stevens, J., concurring) (quoting majority opinion) (emphasis in orig-
inal). “[O]ur precedent has expressed no doubt about the viability of the
common-law defense, even in the context of federal criminal statutes that
do not provide for it in so many words.” Id. (citing Bailey, 444 U.S. at
415).
   We do not believe that the Oakland Cannabis dicta abolishes more than
a century of common law necessity jurisprudence. See, e.g., Regina v.
Dudley & Stephens, 14 Q.B.D. 273 (1884).
   5
     As the Supreme Court did in Oakland Cannabis, we first address the
underlying principles of the common law necessity defense, and then turn
to the defense’s relationship to the Controlled Substances Act and the
relief sought. See, e.g., Oakland Cannabis, 532 U.S. at 490-95.
                          RAICH v. GONZALES                         3039
   [3] Here, although we ultimately conclude that Raich is not
entitled to injunctive relief on the basis of her common law
necessity claim, we briefly note that, in light of the compel-
ling facts before the district court, Raich appears to satisfy the
threshold requirements for asserting a necessity defense under
our case law. We have set forth the following general stan-
dards for a necessity defense:

      As a matter of law, a defendant must establish the
      existence of four elements to be entitled to a neces-
      sity defense: (1) that he was faced with a choice of
      evils and chose the lesser evil; (2) that he acted to
      prevent imminent harm; (3) that he reasonably antic-
      ipated a causal relation between his conduct and the
      harm to be avoided; and (4) that there were no other
      legal alternatives to violating the law.

United States v. Aguilar, 883 F.2d 662, 693 (9th Cir. 1989).

   We first ask whether Raich was faced with a choice of evils
and whether she chose the lesser evil. Raich’s physician pres-
ented uncontroverted evidence that Raich “cannot be without
cannabis as medicine” because she would quickly suffer “pre-
cipitous medical deterioration” and “could very well” die. If
Raich obeys the Controlled Substances Act she will have to
endure intolerable pain including severe chronic pain in her
face and jaw muscles due to temporomandibular joint dys-
function and bruxism, severe chronic pain and chronic burn-
ing from fibromyalgia that forces her to be flat on her back
for days, excruciating pain from non-epileptic seizures, heavy
bleeding and severely painful menstrual periods due to a uter-
ine fibroid tumor, and acute weight loss resulting possibly in
death due to a life-threatening wasting disorder.6 Alterna-
  6
    This litany of ailments makes no mention of the fact that Raich was
confined to a wheelchair before she found effective pain management in
marijuana, which restored her ability to walk. The seriousness of her con-
ditions cannot be overemphasized: in 1997, the extreme physical and psy-
3040                       RAICH v. GONZALES
tively, Raich can violate the Controlled Substances Act and
avoid the bulk of those debilitating pains by using marijuana.
The evidence persuasively demonstrates that, in light of her
medical condition, Raich satisfies the first prong of the neces-
sity defense.

   [4] We next ask whether Raich is acting to prevent immi-
nent harm. All medical evidence in the record suggests that,
if Raich were to stop using marijuana, the acute chronic pain
and wasting disorders would immediately resume. The Gov-
ernment does not dispute the severity of her conditions or the
likelihood that her pain would recur if she is deprived of mari-
juana. Raich has therefore established that the harm she faces
is imminent.

   [5] Prong three asks whether Raich reasonably anticipated
a causal connection between her unlawful conduct and the
harm to be avoided. We believe that Raich’s belief in the
causal connection is reasonable. Here, Raich’s licensed physi-
cian testified to the causal connection between her physical
condition and her need to use marijuana. The Government did
not dispute this medical evidence. Because Raich has clearly
demonstrated the medical correlation, she has satisfied prong
three.7

chological pain led Raich to attempt suicide. We are mindful that “extreme
pain totally occupies the psychic world” and that “in serious pain the
claims of the body utterly nullify the claims of the world.” Seth F.
Kreimer, The Second Time as Tragedy: The Assisted Suicide Cases and
the Heritage of Roe v. Wade, 24 Hastings Const. L.Q. 863, 895 & n.157
(1997) (citations omitted). Raich has shown remarkable fortitude in pursu-
ing this action to vindicate the rights of the infirm despite her precarious
physical condition.
   7
     The causal connection prong limits the danger that a medical necessity
exception could open the floodgates to widespread exceptions to the Con-
trolled Substances Act. A marijuana “necessity” claimant absolutely must
present, as Raich has, testimony that the allegedly unlawful action was
taken at the direction of a doctor.
                           RAICH v. GONZALES                           3041
   [6] Finally, we ask whether Raich had any legal alternatives
to violating the law. Dr. Lucido’s testimony makes clear that
Raich had no legal alternatives: Raich “has tried essentially
all other legal alternatives to cannabis and the alternatives
have been ineffective or result in intolerable side effects.”
Raich’s physician explained that the intolerable side effects
included violent nausea, shakes, itching, rapid heart palpita-
tions, and insomnia. We agree that Raich does not appear to
have any legal alternative to marijuana use.8

   [7] Although Raich appears to satisfy the factual predicate
for a necessity defense, it is not clear whether the Supreme
Court’s decision in United States v. Oakland Cannabis Buy-
ers’ Cooperative forecloses a necessity defense to a prosecu-
tion of a seriously ill defendant under the Controlled
Substances Act. 532 U.S. 483, 484 n.7 (2001). Similarly,
whether the Controlled Substances Act encompasses a legisla-
tive “determination of values,” id. at 491, that would preclude
a necessity defense is also an unanswered question. These are
difficult issues, and in light of our conclusion below that
Raich’s necessity claim is best resolved within the context of
a specific prosecution under the Controlled Substances Act,
where the issue would be fully joined, we do not attempt to
answer them here.
  8
    The Government suggests that certain federal programs exist which
might allow Raich to obtain marijuana lawfully. See, e.g., 21 U.S.C.
§ 823(f) (authorizing the Secretary of Health and Human Services to per-
mit medical practitioners to design and implement research protocols
using Schedule I substances, including marijuana, on a case-by-base
basis). Amici curiae American Civil Liberties Union Foundation and Mar-
ijuana Policy Project and Rick Doblin, Ph.D make abundantly clear that
this is not a tenable “alternative.” The program is highly restricted and has
not accepted new medical marijuana patients since 1992.
3042                  RAICH v. GONZALES
  B.   Whether a Viable Necessity Defense Gives Raich a
       Likelihood of Success on the Merits on this Action for
       Injunctive Relief

   Irrespective of the compelling factual basis for Raich’s
necessity claim, whether Raich has a likelihood of success on
the merits in this action for injunctive relief is a different
question. We conclude that Raich has not demonstrated that
she will likely succeed in obtaining injunctive relief on the
necessity ground.

   [8] The necessity defense is an affirmative defense that
removes criminal liability for violation of a criminal statute.
See 2 LaFave, Substantive Criminal Law § 9.1(a) (2d ed.
2003 & Supp. 2005). Necessity is essentially a justification
for the prohibited conduct: the “harm caused by the justified
behavior remains a legally recognized harm that is to be
avoided whenever possible.” Paul H. Robinson, Criminal Law
Defenses § 24(a) (1984 & Supp. 2006-2007). A common law
necessity defense thus singles out conduct that is “otherwise
criminal, which under the circumstances is socially acceptable
and which deserves neither criminal liability nor even cen-
sure.” LaFave, Substantive Criminal Law § 9.1(a)(3) (2d ed.
2003 & Supp. 2005) (quotation omitted). The necessity
defense serves to protect the defendant from criminal liability.

   [9] Though a necessity defense may be available in the con-
text of a criminal prosecution, it does not follow that a court
should prospectively enjoin enforcement of a statute. Raich’s
violation of the Controlled Substances Act is a legally recog-
nized harm, but the necessity defense shields Raich from lia-
bility for criminal prosecution during such time as she
satisfies the defense. Thus, if Raich were to make a miracu-
lous recovery that obviated her need for medical marijuana,
her necessity-based justification defense would no longer
exist. Similarly, if Dr. Lucido found an alternative treatment
that did not violate the law — a legal alternative to violating
the Controlled Substances Act — Raich could no longer
                           RAICH v. GONZALES                           3043
assert a necessity defense. That is to say, a necessity defense
is best considered in the context of a concrete case where a
statute is allegedly violated, and a specific prosecution results
from the violation. Indeed, oversight and enforcement of a
necessity defense-based injunction would prove impractica-
ble: the ongoing vitality of the injunction could hinge on fac-
tors including Raich’s medical condition or advances in
lawful medical technology. Nothing in the common law or
our cases suggests that the existence of a necessity defense
empowers this court to enjoin the enforcement of the Con-
trolled Substances Act as to one defendant.

   [10] Because common law necessity prevents criminal lia-
bility, but does not permit us to enjoin prosecution for what
remains a legally recognized harm, we hold that Raich has not
shown a likelihood of success on the merits on her medical
necessity claim for an injunction.9

II.   Substantive Due Process

  Raich contends that the district court erred by failing to
protect her fundamental rights. Her argument focuses on
unenumerated rights protected by the Fifth and Ninth Amend-
ments to the Constitution under a theory of substantive due pro-
cess.10
  9
    We cannot ignore that the unusual circumstances of this case raise the
danger of acute preconviction harms. The arrest of Raich or her suppliers,
or the confiscation of her medical marijuana would cause Raich severe
physical trauma. Under the right circumstances, Raich might obtain relief
from the courts for preconviction harm based on common law necessity.
See generally Jones v. County of Los Angeles, 444 F.3d 1118, 1129-31
(9th Cir. 2006) (noting that constitutionally cognizable harm can occur “at
arrest, at citation, or even earlier,” and criticizing the government’s posi-
tion that “would allow the state to criminalize a protected behavior or con-
dition and cite, arrest, jail, and even prosecute individuals for violations,
so long as no conviction resulted”).
   10
      We refer to these claims together as the substantive due process claim.
3044                      RAICH v. GONZALES
  A.     Substantive Due Process, Generally

   [11] Although the Fifth Amendment’s Due Process Clause
states only that “[n]o person shall . . . be deprived of life, lib-
erty, or property, without due process of law,” see U.S. Const.
amend. V, it unquestionably provides substantive protections
for certain unenumerated fundamental rights.11 “The Due Pro-
cess Clause guarantees more than fair process, and the ‘lib-
erty’ it protects includes more than the absence of physical
restraint.” Washington v. Glucksberg, 521 U.S. 702, 719
(1997); see also Planned Parenthood of S.E. Penn. v. Casey,
505 U.S. 833, 847 (1992) (“It is tempting, as a means of curb-
ing the discretion of federal judges, to suppose that liberty
encompasses no more than those rights already guaranteed to
the individual against federal interference by the express pro-
visions of the first eight Amendments to the Constitution. But
of course this Court has never accepted that view.” (internal
citation omitted)). As Justice Harlan put it over forty years
ago:

       [T]he full scope of the liberty guaranteed by the Due
       Process Clause cannot be found in or limited by the
       precise terms of the specific guarantees elsewhere
       provided in the Constitution. This ‘liberty’ is not a
       series of isolated points pricked out in terms of the
       taking of property; the freedom of speech, press, and
       religion; the right to keep and bear arms; the free-
       dom from unreasonable searches and seizures; and
       so on. It is a rational continuum which, broadly
  11
     Although the Fifth Amendment’s Due Process Clause is applicable
here, cases finding substantive rights under the Fourteenth Amendment’s
Due Process Clause are equally relevant. See Troxel v. Granville, 530 U.S.
57, 65 (2000) (“We have long recognized that the Amendment’s Due Pro-
cess Clause, like its Fifth Amendment counterpart, guarantees more than
fair process. The Clause also includes a substantive component that pro-
vides heightened protection against government interference with certain
fundamental rights and liberty interests.” (emphasis added) (internal cita-
tion and quotation marks omitted)).
                      RAICH v. GONZALES                       3045
    speaking, includes a freedom from all substantial
    arbitrary impositions and purposeless restraints, and
    which also recognizes, what a reasonable and sensi-
    tive judgment must, that certain interests require par-
    ticularly careful scrutiny of the state needs asserted
    to justify their abridgment.

Poe v. Ullman, 367 U.S. 497, 543 (1961) (Harlan, J., dissent-
ing) (citations omitted); see also Casey, 505 U.S. at 849 (not-
ing that Justice Harlan’s position was adopted by the Court in
Griswold v. Connecticut, 381 U.S. 479 (1965)). These conten-
tions find support in the Ninth Amendment, which provides
that “[t]he enumeration in the Constitution, of certain rights,
shall not be construed to deny or disparage others retained by
the people.” U.S. Const. amend. IX.

  In Glucksberg, the Supreme Court set forth the two ele-
ments of the substantive due process analysis.

    First, we have regularly observed that the Due Pro-
    cess Clause specially protects those fundamental
    rights and liberties which are, objectively, “deeply
    rooted in this Nation’s history and tradition,” and
    “implicit in the concept of ordered liberty,” such that
    “neither liberty nor justice would exist if they were
    sacrificed.” Second, we have required in substantive-
    due-process cases a “careful description” of the
    asserted fundamental liberty interest.

Glucksberg, 521 U.S. at 720-21 (citations omitted).

  The Supreme Court has a long history of recognizing
unenumerated fundamental rights as protected by substantive
due process, even before the term evolved into its modern
usage. See, e.g., Casey, 505 U.S. 833 (to have an abortion);
Roe v. Wade, 410 U.S. 113 (1973) (same); Eisenstadt v.
Baird, 405 U.S. 438 (1972) (to use contraception); Griswold,
381 U.S. 479 (to use contraception, to marital privacy); Lov-
3046                  RAICH v. GONZALES
ing v. Virginia, 388 U.S. 1 (1967) (to marry); Rochin v. Cali-
fornia, 342 U.S. 165 (1952) (to bodily integrity); Skinner v.
Oklahoma ex rel. Williamson, 316 U.S. 535 (1942) (to have
children); Pierce v. Society of Sisters, 268 U.S. 510 (1925) (to
direct the education and upbringing of one’s children); Meyer
v. Nebraska, 262 U.S. 390 (1923) (same). But the Court has
cautioned against the doctrine’s expansion. See Glucksberg,
521 U.S. at 720 (stating that the Court must restrain the
expansion of substantive due process “because guideposts for
responsible decisionmaking in this uncharted area are scarce
and open-ended” and because judicial extension of constitu-
tional protection for an asserted substantive due process right
“place[s] the matter outside the arena of public debate and
legislative action” (citations omitted)); Reno v. Flores, 507
U.S. 292, 302 (1993) (noting that “[t]he doctrine of judicial
self-restraint requires us to exercise the utmost care whenever
we are asked to break new ground in this field” (quoting Col-
lins v. Harker Heights, 503 U.S. 115, 125 (1992))).

   Bearing that rubric in mind, we consider Raich’s substan-
tive due process claim. In the present case, it is helpful to
begin with the second step — the description of the asserted
fundamental right — before determining whether the right is
deeply rooted in this nation’s history and traditions and
implicit in the concept of ordered liberty.

  B.   Breadth of the Fundamental Right

   [12] Glucksberg instructs courts to adopt a narrow defini-
tion of the interest at stake. See 521 U.S. at 722 (“[W]e have
a tradition of carefully formulating the interest at stake in
substantive-due-process cases.”); see also Flores, 507 U.S. at
302 (noting that the asserted liberty interest must be construed
narrowly to avoid unintended consequences). Substantive due
process requires a “careful description of the asserted funda-
mental liberty interest.” Glucksberg, 521 U.S. at 721 (quota-
tion and citations omitted).
                      RAICH v. GONZALES                    3047
   Glucksberg involved a substantive due process challenge to
Washington state’s ban on assisted suicide. See id. at 705-06.
The Court in Glucksberg rejected the suggestion that the
interest at stake was the “right to die” or “the right to choose
a humane, dignified death,” and instead held that the narrow
question before the Court was “whether the ‘liberty’ specially
protected by the Due Process Clause includes a right to com-
mit suicide which itself includes a right to assistance in doing
so.” Id. at 722-23.

   Another case that considered and rejected several asserted
fundamental rights involved unaccompanied alien juveniles
who are in the custody of immigration authorities. See Flores,
507 U.S. at 294. The Flores Court rejected the proposed fun-
damental right of “freedom from physical restraint” because
it was not an accurate depiction of the true issue in the case.
See Flores, 507 U.S. at 302. The Court also rejected the for-
mulation of the “right of a child to be released from all other
custody into the custody of its parents, legal guardian, or even
close relatives.” Id. Instead, the Flores Court examined the
narrow “right of a child who has no available parent, close
relative, or legal guardian, and for whom the government is
responsible, to be placed in the custody of a willing-and-able
private custodian rather than of a government-operated or
government-selected child-care institution.” Id.; see also Law-
rence v. Texas, 539 U.S. 558, 578 (2003) (recognizing nar-
rowly defined fundamental right to engage in consensual
sexual activity, including homosexual sodomy, in the home
without government intrusion).

  C.   Raich’s Asserted Fundamental Interest

   Raich asserts that she has a fundamental right to “mak[e]
life-shaping medical decisions that are necessary to preserve
the integrity of her body, avoid intolerable physical pain, and
preserve her life.” We note that Raich’s carefully crafted
interest comprises several fundamental rights that have been
recognized at least in part by the Supreme Court. See Law-
3048                       RAICH v. GONZALES
rence, 539 U.S. at 574 (recognizing that “the Constitution
demands [respect] for the autonomy of the person in making
[personal] choices”); Casey, 505 U.S. at 849 (noting impor-
tance of protecting “bodily integrity”); id. at 852 (observing
that a woman’s “suffering is too intimate and personal” for
government to compel such suffering by requiring woman to
carry a pregnancy to term).

   Yet, Raich’s careful statement does not narrowly and accu-
rately reflect the right that she seeks to vindicate. Conspicu-
ously missing from Raich’s asserted fundamental right is its
centerpiece: that she seeks the right to use marijuana to pre-
serve bodily integrity, avoid pain, and preserve her life.12 As
in Glucksberg, Flores, and Cruzan, the right must be carefully
stated and narrowly identified before the ensuing analysis can
proceed. Accordingly, we will add the centerpiece — the use
of marijuana — to Raich’s proposed right.13

   [13] Accordingly, the question becomes whether the liberty
interest specially protected by the Due Process Clause
embraces a right to make a life-shaping decision on a physi-
cian’s advice to use medical marijuana to preserve bodily
integrity, avoid intolerable pain, and preserve life, when all
other prescribed medications and remedies have failed.

  D.     Whether the Asserted Right is “Deeply Rooted in This
  12
      This degree of specificity is required. In Cruzan v. Director, Mo.
Dept. of Health, 497 U.S. 261 (1990), the Court declined to frame the right
as an unqualified right to die, and instead specifically construed the right
as a “constitutionally protected right to refuse lifesaving hydration and
nutrition.” Id. at 279.
   13
      We also find persuasive the suggestion of amicus curiae California
Medical Association and California Nurses Association: that the definition
incorporate reference to the fact that Raich seeks to establish this right “on
a physician’s advice.” We also think that resort to a Schedule I substance
should be a last resort, and therefore narrow the right by limiting it to cir-
cumstances “when all other prescribed medications have failed.”
                      RAICH v. GONZALES                    3049
       Nation’s History and Tradition” and “Implicit in the
       Concept of Ordered Liberty”

   We turn to whether the asserted right is “deeply rooted in
this Nation’s history and tradition,” and “implicit in the con-
cept of ordered liberty,” such that “neither liberty nor justice
would exist if they were sacrificed.” Glucksberg, 521 U.S. at
720-21.

   [14] It is beyond dispute that marijuana has a long history
of use — medically and otherwise — in this country. Mari-
juana was not regulated under federal law until Congress
passed the Marihuana Tax Act of 1937, Pub. L. No. 75-348,
50 Stat. 551 (repealed 1970), and marijuana was not prohib-
ited under federal law until Congress passed the Controlled
Substances Act in 1970. See Gonzales v. Raich, 125 S. Ct. at
2202. There is considerable evidence that efforts to regulate
marijuana use in the early-twentieth century targeted recre-
ational use, but permitted medical use. See Richard J. Bonnie
& Charles H. Whitebread, The Forbidden Fruit and the Tree
of Knowledge: An Inquiry into the Legal History of American
Marijuana Prohibition, 56 Va. L. Rev. 971, 1010, 1027, 1167
(1970) (noting that all twenty-two states that had prohibited
marijuana by the 1930s created exceptions for medical pur-
poses). By 1965, although possession of marijuana was a
crime in all fifty states, almost all states had created excep-
tions for “persons for whom the drug had been prescribed or
to whom it had been given by an authorized medical person.”
Leary v. United States, 395 U.S. 6, 16-17 (1969).

   [15] The history of medical marijuana use in this country
took an about-face with the passage of the Controlled Sub-
stances Act in 1970. Congress placed marijuana on Schedule
I of the Controlled Substances Act, taking it outside of the
realm of all uses, including medical, under federal law. As the
Supreme Court noted in Gonzales v. Raich, 125 S. Ct. at
2199, no state permitted medical marijuana usage until Cali-
fornia’s Compassionate Use Act of 1996. Thus, from 1970 to
3050                      RAICH v. GONZALES
1996, the possession or use of marijuana — medically or oth-
erwise — was proscribed under state and federal law.14

   Raich argues that the last ten years have been characterized
by an emerging awareness of marijuana’s medical value. She
contends that the rising number of states that have passed
laws that permit medical use of marijuana or recognize its
therapeutic value is additional evidence that the right is funda-
mental. Raich avers that the asserted right in this case should
be protected on the “emerging awareness” model that the
Supreme Court used in Lawrence v. Texas, 539 U.S. at 571.

   The Lawrence Court noted that, when the Court had
decided Bowers v. Hardwick, 478 U.S. 186 (1986), “[twenty-
four] States and the District of Columbia had sodomy laws.”
Lawrence, 539 U.S. at 572. By the time a similar challenge
to sodomy laws arose in Lawrence in 2004, only thirteen
states had maintained their sodomy laws, and there was a
noted “pattern of nonenforcement.” Id. at 573. The Court
observed that “times can blind us to certain truths and later
generations can see that laws once thought necessary and
proper in fact serve only to oppress.” Id. at 579.

   Though the Lawrence framework might certainly apply to
the instant case, the use of medical marijuana has not obtained
the degree of recognition today that private sexual conduct
had obtained by 2004 in Lawrence. Since 1996, ten states
other than California have passed laws decriminalizing in
varying degrees the use, possession, manufacture, and distri-
bution of marijuana for the seriously ill. See Alaska Stat.
§ 11.71.090; Colo. Rev. Stat. § 18-18-406.3; Haw. Rev. Stat.
§ 329-125; Me. Rev. Stat. Ann. tit. 22, § 2383-B; Mont. Code
  14
    The mere enactment of a law, state or federal, that prohibits certain
behavior does not necessarily mean that the behavior is not deeply rooted
in this country’s history and traditions. It is noteworthy, however, that
over twenty-five years went by before any state enacted a law to protect
the alleged right.
                          RAICH v. GONZALES                         3051
Ann. § 50-46-201; Nev. Rev. Stat. § 453A.200; Or. Rev. Stat.
§ 475.319; R.I. Gen. Laws § 21-28.6-4; Vt. Stat. Ann. tit. 18,
§ 4474b; Wash. Rev. Code § 69.51A.040. Other states have
passed resolutions recognizing that marijuana may have thera-
peutic value, and yet others have permitted limited use
through closely monitored experimental treatment programs.15

   [16] We agree with Raich that medical and conventional
wisdom that recognizes the use of marijuana for medical pur-
poses is gaining traction in the law as well. But that legal rec-
ognition has not yet reached the point where a conclusion can
be drawn that the right to use medical marijuana is “funda-
mental” and “implicit in the concept of ordered liberty.” See
Glucksberg, 521 U.S. at 720-21 (citations omitted). For the
time being, this issue remains in “the arena of public debate
and legislative action.” Id. at 720; see also Gonzales v. Raich,
125 S. Ct. at 2215.

   [17] As stated above, Justice Anthony Kennedy told us that
“times can blind us to certain truths and later generations can
see that laws once thought necessary and proper in fact serve
only to oppress.” Lawrence, 539 U.S. at 579. For now, federal
law is blind to the wisdom of a future day when the right to
use medical marijuana to alleviate excruciating pain may be
deemed fundamental. Although that day has not yet dawned,
considering that during the last ten years eleven states have
legalized the use of medical marijuana, that day may be upon
us sooner than expected. Until that day arrives, federal law
does not recognize a fundamental right to use medical mari-
  15
    While these lesser endorsements of medical marijuana are relevant,
they cannot carry the same weight as legislative enactments that fully
decriminalize the use of medical marijuana. As the Lawrence Court con-
sidered the number of states that retained laws that prohibited sodomy, so
too must we consider the number of states that continue to prohibit medi-
cal marijuana.
3052                       RAICH v. GONZALES
juana prescribed by a licensed physician to alleviate excrucia-
ting pain and human suffering.16

III.    Tenth Amendment

   Third, Raich contends that the Controlled Substances Act
infringes upon the sovereign powers of the State of California,
most notably the police powers, as conferred by the Tenth
Amendment. The district court found that, as a valid exercise
of Congress’s Commerce Clause powers, the Controlled Sub-
stances Act could curtail the states’ exercise of their police
powers without violating the Tenth Amendment. See Raich v.
Ashcroft, 248 F. Supp. 2d at 927. The district court further
held that the Controlled Substances Act regulates individual
behavior and does not force the state to take any action. Id.

   [18] The Tenth Amendment reads, in its entirety: “The
powers not delegated to the United States by the Constitution,
nor prohibited by it to the States, are reserved to the States
respectively, or to the people.” U.S. Const. amend. X. Police
power is unquestionably an area of traditional state control.

       Throughout our history the several States have exer-
       cised their police powers to protect the health and
       safety of their citizens. Because these are primarily,
       and historically, . . . matter[s] of local concern, the
   16
      Because we find no fundamental right here, we do not address
whether any law that limits that right is narrowly drawn to serve a compel-
ling state interest. See Flores, 507 U.S. at 301-02. We note, however, that,
a recent Supreme Court case suggests that the Controlled Substances Act
is not narrowly drawn when fundamental rights are concerned. See Gon-
zales v. O Centro Espirita Beneficente Uniao do Vegetal, 126 S. Ct. 1211,
1221-23 (Feb. 21, 2006) (observing that “mere invocation of the general
characteristics of Schedule I substances, as set forth in the Controlled Sub-
stances Act, cannot carry the day,” and that the government had presented
no evidence that narrow exceptions to the Schedule I prohibitions would
undercut the government’s ability to effectively enforce the Controlled
Substances Act).
                          RAICH v. GONZALES                          3053
       States traditionally have had great latitude under
       their police powers to legislate as to the protection of
       the lives, limbs, health, comfort, and quiet of all per-
       sons.

Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996) (internal
citations and quotation marks omitted). The Compassionate
Use Act, aimed at providing for the health of the state’s citi-
zens, appears to fall squarely within the general rubric of the
state’s police powers.

   Generally speaking, however, a power granted to Congress
trumps a competing claim based on a state’s police powers.
“The Court long ago rejected the suggestion that Congress
invades areas reserved to the States by the Tenth Amendment
simply because it exercises its authority under the Commerce
Clause in a manner that displaces the States’ exercise of their
police powers.” Hodel v. Va. Surface Mining & Reclamation
Ass’n, 452 U.S. 264, 291 (1981); see also United States v.
Jones, 231 F.3d 508, 515 (9th Cir. 2000) (“We have held that
if Congress acts under one of its enumerated powers, there
can be no violation of the Tenth Amendment.”).

   [19] The Supreme Court held in Gonzales v. Raich that
Congress acted within the bounds of its Commerce Clause
authority when it criminalized the purely intrastate manufac-
ture, distribution, or possession of marijuana in the Controlled
Substances Act. See 125 S. Ct. at 2215. Thus, after Gonzales
v. Raich, it would seem that there can be no Tenth Amend-
ment violation in this case. Raich concedes that recent
Supreme Court decisions have largely foreclosed her Tenth
Amendment claim, and she also concedes that this case does
not implicate the “commandeering” line of cases.17
  17
     The commandeering cases involve attempts by Congress to direct
states to perform certain functions, command state officers to administer
federal regulatory programs, or to compel states to adopt specific legisla-
tion. See, e.g., Printz v. United States, 521 U.S. 898, 935 (1997); New
3054                       RAICH v. GONZALES
   The Supreme Court’s recent decision in Oregon v. Gon-
zales, 126 S. Ct. 904 (Jan. 17, 2006) is not to the contrary. In
that case, the Court invalidated an Interpretive Rule issued by
the Attorney General on the basis of statutory construction,
not on the basis of constitutional invalidity under the Tenth
Amendment. See id. at 925. Because the Attorney General’s
Rule was “incongruous with the statutory purposes and
design” of the Controlled Substances Act, the Rule had to be
nullified. Id. at 921 (emphasis added). Although Oregon v.
Gonzales undoubtedly implicates federalism issues, its hold-
ing is inapposite to Raich’s Tenth Amendment claim.

   [20] We hold that Raich failed to demonstrate a likelihood
of success on her claim that the Controlled Substances Act
violates the Tenth Amendment. Accordingly, the district court
did not abuse its discretion in denying Raich’s motion for pre-
liminary injunction on that basis.

IV.    The Controlled Substances Act, By Its Terms

   Finally, Raich argues that the plain text of the Controlled
Substances Act does not prohibit her from possessing mari-
juana pursuant to a doctor’s order. She observes that the Con-
trolled Substances Act prohibits possession of a controlled
substance “unless such substance was obtained . . . pursuant
to a valid prescription or order, from a practitioner, while act-
ing in the course of his professional practice.” 21 U.S.C.
§ 844(a). The Controlled Substances Act defines “practition-
er” as “a physician . . . licensed, registered, or otherwise per-
mitted, by the United States or the jurisdiction in which he
practices . . . to distribute, dispense, [or] administer . . . a con-

York v. United States, 505 U.S. 144, 166 (1992). The Controlled Sub-
stances Act, by contrast, “does not require the [state legislature] to enact
any laws or regulations, and it does not require state officials to assist in
the enforcement of federal statutes regulating private individuals.” Reno
v. Condon, 528 U.S. 141, 151 (2000).
                           RAICH v. GONZALES                           3055
trolled substance in the course of professional practice.” Id.
§ 802(21). Raich contends that her doctor is a licensed physi-
cian who may, in the jurisdiction in which he practices,
administer controlled substances, including marijuana under
the Compassionate Use Act, pursuant to a valid prescription.
Accordingly, she argues that her possession of marijuana is
legal under the Controlled Substances Act.

   [21] Raich raises this argument for the first time in her
opening brief to our second review of her case. It is a long-
standing rule in the Ninth Circuit that, generally, “we will not
consider arguments that are raised for the first time on
appeal.” Smith v. Marsh, 194 F.3d 1045, 1052 (9th Cir. 1999).
That rule is subject to the exceptions that we may consider a
new issue if: (1) there are exceptional circumstances why the
issue was not raised in the trial court; (2) the new issue arises
while the appeal is pending because of a change in the law;
or (3) the issue presented is a pure question of law and the
opposing party will suffer no prejudice as a result of the fail-
ure to raise the issue in the trial court. See United States v.
Carlson, 900 F.2d 1346, 1349 (9th Cir. 1990).

   Raich does not address the waiver issue in her opening
brief, nor does she cite any relevant exception that might
apply to her argument. We observe that there do not appear
to be any exceptional circumstances concerning why Raich
did not raise the argument below, and that there has been no
change in the law relevant to this argument. Thus, Raich’s
only argument against waiver of this claim is that it is a purely
legal question, and that the Government will suffer no preju-
dice as a result of Raich’s failure to raise the issue below.18
  18
     We assess prejudice to a party by asking whether the party is in a dif-
ferent position than it would have been absent the alleged deficiency. See
Zhang v. Am. Gem Seafoods, Inc., 339 F.3d 1020, 1035 (9th Cir. 2003).
The rule “serves to ensure that legal arguments are considered with the
benefit of a fully developed factual record, offers appellate courts the ben-
efit of the district court’s prior analysis, and prevents parties from sand-
3056                      RAICH v. GONZALES
   Even if a case falls within one of the exceptions to waiver
enunciated in Carlson, we must “still decide whether the par-
ticular circumstances of the case overcome our presumption
against hearing new arguments.” Dream Palace, 384 F.3d at
1005. Although Raich’s Controlled Substances Act claim
appears to fall within the third exception, we conclude that
this claim is waived because of the “particular circumstances”
surrounding the claim.

   [22] Raich failed to raise this claim before the district court
and before this court in her appeal in Raich v. Ashcroft, 352
F.3d 1222. Furthermore, when we requested renewed briefing
for this appeal by our order of September 6, 2005, we directed
the parties to brief the “remaining claims for declaratory and
injunctive relief on the basis of the Tenth Amendment, the
Fifth and Ninth Amendments, and the doctrine of medical
necessity, as set forth in their complaint.” Raich v. Gonzales,
No. 03-15481 (9th Cir. Sept. 6, 2005) (order directing
renewed briefing). Because Raich did not raise this issue
below, and because our order instructed the parties to brief
only the three claims set forth above, we hold that Raich’s
claim based on the plain language of the Controlled Sub-
stances Act is waived. We express no opinion as to the merits
of that claim.

                          CONCLUSION

  We conclude that Raich has not demonstrated a likelihood
of success on the merits of her action for injunctive relief.
First, we hold that Raich’s common law necessity defense is
not foreclosed by Oakland Cannabis or the Controlled Sub-

bagging their opponents with new arguments on appeal.” Dream Palace
v. County of Maricopa, 384 F.3d 990, 1005 (9th Cir. 2004). It does not
appear that the Government has suffered any prejudice from Raich’s fail-
ure to raise this claim below: the Government is in the same position that
it would have otherwise been.
                       RAICH v. GONZALES                    3057
stances Act, but that the necessity defense does not provide a
proper basis for injunctive relief. Second, although changes in
state law reveal a clear trend towards the protection of medi-
cal marijuana use, we hold that the asserted right has not yet
gained the traction on a national scale to be deemed funda-
mental. Third, we hold that the Controlled Substances Act, a
valid exercise of Congress’s commerce power, does not vio-
late the Tenth Amendment. Finally, we decline to reach
Raich’s argument that the Controlled Substances Act, by its
terms, does not prohibit her possession and use of marijuana
because this argument was not raised below.

 Accordingly, the judgment of the district court is
AFFIRMED.



BEAM, Circuit Judge, concurring and dissenting:

   I concur in the result reached by the court in this case, more
particularly its holding that “Raich has not demonstrated a
likelihood of success on the merits of her action for injunctive
relief” and that the district court’s denial of an injunction
should be affirmed. I dissent from the court’s expansive con-
sideration of the doctrine of common law necessity as well as
from several of the factual findings and legal conclusions
applied to this issue and other claims before the court.

                        DISCUSSION

   We should decide only the case that is properly before us,
not any other, and we should leave for another day any claim
or issue not ripe for consideration. When we do otherwise, we
simply create obitur dictum. See, e.g., Carey v. Musladin, 127
S. Ct. 649, 655 (2006) (Stevens, J., concurring) (citing Sheet
Metal Workers v. EEOC, 478 U.S. 421, 490 (1986)).

  This case returns to us on remand from the Supreme Court.
But, the party that earlier supplied jurisdiction to the Supreme
3058                   RAICH v. GONZALES
Court and to this court, Diane Monson, has withdrawn. Ante
at 3033 n.1. Thus, the facts concerning Ms. Monson gener-
ously recited by the court are in no way relevant or material
to the issues now raised by Raich. Accordingly, the court
likely has no jurisdiction over any claim asserted by the plain-
tiffs in this appeal but most certainly no jurisdiction to decide
whether Raich may assert the doctrine of common law neces-
sity in a future criminal prosecution.

   At oral argument, counsel for the parties conceded that
there is not now pending nor has there ever been pending a
prosecution or even a threatened prosecution of Raich for pos-
session or use of personal amounts of medicinal marijuana.
Indeed, counsel for Raich acknowledged at oral argument
that, to his knowledge, there has never been a federal criminal
prosecution for simple possession or use of medicinal mari-
juana against anyone anywhere in California. Counsel for the
government likewise indicated a lack of knowledge of any
such prosecution and stated that it would be “incredibly
unlikely” that any such federal prosecution would ensue in the
future. So, the court’s statement, ante at 3035, that
“[a]lthough Raich has not suffered any past injury, she is
faced with the threat that the Government will seize her medi-
cal marijuana and prosecute her for violations of federal drug
law” is plainly not supported by the record.

   Accordingly, I return to the issues of standing, ripeness and
justiciability advanced in my earlier dissent in this case. With
specific regard to the court’s lengthy discussion of and rulings
upon the doctrine of common law necessity, it is clear that

    “[W]here it is impossible to know whether a party
    will ever be found to have violated a statute, or how,
    if such a violation is found, those charged with
    enforcing the statute will respond, any challenge to
    that statute is premature.” Alaska Airlines, Inc. v.
    City of Long Beach, 951 F.2d 977, 986 (9th Cir.
    1991). To satisfy Article III’s standing requirements,
                      RAICH v. GONZALES                       3059
    a plaintiff must show that she has suffered a concrete
    and particularized injury in fact that is actual or
    imminent (not conjectural or hypothetical). Plaintiff
    must also show that the injury is fairly traceable to
    the challenged action of the defendant and that it is
    likely, as opposed to merely speculative, that the
    injury will be redressed by a favorable decision. Citi-
    zens for Better Forestry v. United States Dep’t of
    Agric., 341 F.3d 961, 969 (9th Cir. 2003).

Raich v. Ashcroft, 352 F.3d 1222, 1235-36 (9th Cir. 2003)
(Beam, J., dissenting).

   Here, as to Raich, there is no discrete, challenged action
from which an injury can fairly be traced. San Diego County
Gun Rights Committee v. Reno, 98 F.3d 1121, 1127 (9th Cir.
1996), requires Raich to show a specific threat of prosecution,
and she bears the burden of establishing that the statute in
question is actually being enforced. A specific warning of
prosecution may suffice, but “a general threat of prosecution
is not enough to confer standing.” Id. Accordingly, the appli-
cability, or not, of the doctrine of common law necessity is
not a justiciable issue on this record and Raich currently has
no standing to ask the court to consider the matter.

   Assuming for purposes of discussion that the bare question
of the viability of the doctrine is before us, I nonetheless
respectfully disagree with substantial portions of the court’s
analysis of the matter.

   The doctrine of common law (medical) necessity is an
affirmative defense assertable only in a criminal prosecution.
E.g., United States v. Arellano-Rivera, 244 F.3d 1119, 1125-
26 (9th Cir. 2001) (holding that “before a defendant may pre-
sent evidence of a necessity defense, his offer of proof must
establish that a reasonable jury could” ascertain all the ele-
ments of the defense) (emphasis added). After reference to
several measures of potential injury and harm to Raich almost
3060                      RAICH v. GONZALES
totally unrelated to a reasonably foreseeable criminal prosecu-
tion, the court ultimately recognizes the legal limitations of
the defense, but only after issuing what amounts to a lengthy
advisory opinion.

   Here we are engaged in the review of a civil proceeding
seeking declaratory relief and injunction, not a criminal adju-
dication. It is important to note that, contrary to the inference
of the court in its factual dissertation, there has been no “testi-
mony” in this case directly addressing the elements of this
defense. The evidentiary record, such as it is, was developed
in the district court through a request for a preliminary injunc-
tion under Rule 65 of the Federal Rules of Civil Procedure.
All facts recited by the court, some of which are admittedly
testimonial in nature, arise from written “declarations” pro-
vided by Raich, Monson, Dr. Lucido and Dr. Rose, Monson’s
physician, in support of the injunction request. Yet, every case
cited by the court concerning the viability of the doctrine and
its elements involves a criminal prosecution.1 The burden of
proof of such a defense lies with the defendant and involves
the following elements:

      As a matter of law, a defendant must establish the
      existence of four elements to be entitled to a neces-
      sity defense: (1) that he was faced with a choice of
      evils and chose the lesser evil; (2) that he acted to
      prevent imminent harm; (3) that he reasonably antic-
      ipated a causal relation between his conduct and the
      harm to be avoided; and (4) that there were no other
      legal alternatives to violating the law.

United States v. Aguilar, 883 F.2d 662, 693 (9th Cir. 1989).
  1
   See, e.g., United States v. Bailey, 444 U.S. 394 (1980) (discussing the
choice of two evils doctrine); United States v. Schoon, 971 F.2d 193 (9th
Cir. 1991) (giving the burning jail example); United States v. Aguilar, 883
F.2d 662 (9th Cir. 1989) (explaining the standards and elements of the
necessity defense).
                         RAICH v. GONZALES                        3061
   In this civil action, Raich is not presently in a posture to
address elements one, two and three and cannot establish ele-
ment four. She has not been faced with a “choice of evils,”
one of which could lead to a criminal prosecution. Nor has
she acted to prevent “imminent harm.” She has presented no
evidence of a tested, adversarial nature sufficient to establish
the causal relationship required by element three. And, she
has not established and probably cannot establish that she has
no legal alternative to violating the law.

   The court states that “Raich’s physician [Dr. Frank Lucido]
presented uncontroverted evidence that Raich ‘cannot be
without cannabis as medicine’ because she would quickly
suffer ‘precipitous medical deterioration’ and ‘could very
well’ die.” Ante at 3039 (emphasis added). This opinion evi-
dence is, of course, gleaned from a written declaration seek-
ing declaratory and injunctive relief while positing a very
speculative happenstance. The opinion is not the fruit of an
adversarial hearing involving the assertion of an affirmative
defense by a criminal defendant in a criminal prosecution
designed to test the admissibility and credibility of the pro-
posed evidence. But even if Raich “cannot be without canna-
bis as medicine,” as Dr. Lucido opines, cannabis (or its
synthetic equivalent) as medicine is lawfully available to
Raich through the prescription-dispensed drug Marinol.2 And,
newly crafted or presently existing drugs as yet untested by
Raich may become known or available prior to any prosecu-
tion. So Raich may well have a legal alternative to the viola-
tion of the drug control laws.

   I also cannot fully join the court’s analysis of United States
v. Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483
(2001), as set forth in its footnote 4. Ante at 3038. Although
  2
    The active ingredient in Marinol is synthetic delta-9-
tetrahydrocannabinol, a naturally occurring component of Cannabis sativa
L, the marijuana Raich says she now consumes. Physicians’ Desk Refer-
ence, 61st ed., 2007 at 3333.
3062                    RAICH v. GONZALES
I do not concede that the Supreme Court’s discussion in Oak-
land Cannabis is dicta, I do agree with the court’s conclusion
that the case does not abolish “common law necessity juris-
prudence.”

  Thus, while I do not concur in the court’s statement that
“Raich appears to satisfy the threshold requirements for
asserting a necessity defense under our case law,” ante at
3039, I do acknowledge that she certainly may be eligible to
advance such a defense to criminal liability in the context of
an actual prosecution.

   Finally, if I fully understand the majority’s approach, the
most troubling aspect of its opinion is that it purports to let
this court determine, on the evidence presented to the district
court at the Rule 65 hearing, that Raich, and anyone similarly
situated, is entitled to a medical necessity defense if crimi-
nally prosecuted in the future. I respectfully believe that this
turns applicable federal criminal procedure on its head. The
viability and applicability of this affirmative defense is a
mixed question of law and fact. Arellano-Rivera, 244 F.3d at
1125. In a criminal prosecution of Raich for possession and
use of marijuana for medicinal purposes, if it ever occurs, the
issue of the sufficiency of the evidence to submit this particu-
lar defense to a jury is a question of law for the federal trial
court. Id. The establishment of the factual elements of the
defense, if submitted, is for the jury (or other trier of fact). Id.
Imposition of this court’s rulings into a later prosecution
would improperly pretermit established criminal procedure.
Thus, the court’s medical necessity discussion is a wholly
speculative and possibly unconstitutional jurisprudential exer-
cise.

                         CONCLUSION

  Accordingly, for the above-stated reasons, I dissent from
portions of the court’s factual findings and legal conclusions
                      RAICH v. GONZALES                  3063
but concur in the denial of Raich’s request for injunction and
in the court’s affirmance of the district court.
