Spring 2004
O'Shaughnessy's
Journal of the California Cannabis Research Medical
Group
|
The Legal Status of Medical
Marijuana
By Alice Mead
“Medical marijuana” —the name itself is heavily laden with innuendo. “Marijuana” is
actually slang for Cannabis sativa, the plant’s proper name. It was used pejoratively
during the early 1900s when the public came to associate the plant’s recreational
use with ethnic and racial minorities, against whom discrimination and antipathy
were widespread.
For thousands of years around the world, Cannabis sativa has been used as a
medicine. The plant contains approximately 60 cannabinoids, primarily tetrahydrocannabinol
(THC), which is psychoactive, and cannabidiol (CBD), which is not. The plant
also contains hundreds of other substances, such as flavonoids and terpenes,
many of which may have therapeutic potential in their own right. Supporters
of natural cannabis medicines believe that the various elements of the cannabis
plant work in synergy with one another to mitigate the side effects of THC
and to enhance the plant’s therapeutic effectiveness.
The federal government contends that suffering patients already have legal
access to a cannabinoid-containing medicine. Although a pharmaceutical product
containing pure synthetic THC —Marinol—is available by prescription, many patients
have expressed dissatisfaction with its mode of action. Because of its oral
dosage form and its metabolism within the body, the medicine does not take
effect for a significant period of time. Patients cannot adjust or “titrate” the
dose to achieve symptom relief without experiencing excessive psychoactive
effects. Moreover, patients suffering from nausea and vomiting may not be able
to take a medicine in capsule form. Therefore, this option is an illusory one
for many patients.
Cannabis and Federal Law
In the U.S., a complex patchwork of federal and state laws determines whether,
and when,
a psychoactive substance with abuse potential can be made available
for general medical use. The federal Controlled Substances Act (CSA)
and the Food, Drug and Cosmetic Act (FDCA) are the two primary statutes
that govern this field. The CSA has five “schedules” into which a psychoactive
substance is placed, depending on its acknowledged medical usefulness,
on the one hand, and dependence-producing potential, on the other.
Cannabis is located in Schedule I, the most restrictive schedule, having
been placed there by Congress when the CSA was first enacted in 1970.
Under the CSA, products containing Schedule I substances are not available
for general prescriptive use. Rather, such substances can be used only within
the context of a federally-approved research study. A Schedule I substance
has
1) a high potential for abuse;
2) no “currently accepted medical use in treatment” in the US;
3) a lack of accepted safety for use under medical supervision.
By contrast, a Schedule II substance, such as OxyContin, can be prescribed
by physicians, although it still “has a high potential for abuse” —indeed,
its abuse “may lead to severe psychological or physical dependence.” However,
it does have a currently accepted medical use. 21 USC sec. 812(b).
How to Escape Schedule I
In an attempt to reschedule cannabis, advocacy groups have on several occasions
initiated a special petition procedure by which a substance can be transferred
to another schedule or removed from the schedules altogether.1 These rescheduling
efforts have spanned several decades, but the Drug Enforcement Administration,
the Department of Health and Human Services, and the courts have ultimately
rejected them.2
A new petition, filed in 2002, is currently pending. Because Schedule I status
impedes research —which has been particularly true in the case of cannabis— there
are no data from large “controlled clinical trials” sufficient to satisfy the
exacting criteria for a prescription medicine. And the DEA has clearly stated
that, however widespread, “anecdotal evidence” is not adequate to meet the
CSA’s requirement of “accepted medical use.”
FDA approval esssentially constitutes “acceptable
medical use”
If a specific cannabis-based product were to be approved by the Food
and Drug Administration (FDA)—which approval essentially constitutes “accepted
medical use”— that product would become available for prescription.
However, while research is well underway in the UK, there appears to
be no pharmaceutical company in the U.S. that is developing a whole
plant, cannabis-based medicine as a prescription product.
The availability of herbal cannabis as an actual prescription medicine in the
U.S. is therefore uncertain. The federal government has clearly indicated that
medicinal cannabis will be judged by the rigorous criteria to which other investigational
products are subject. Therefore, such a medicine would have to be cultivated,
formulated, and tested in accordance with strict regulatory standards. Furthermore,
even if one specific product were to achieve such approval, smokable cannabis
itself and other unrefined cannabis-containing products would remain in Schedule
I, just as Marinol is in Schedule III, while all other forms of THC remain
in Schedule I.
What, then, is the future —at least in the short term— for medicinal cannabis
in the U.S.? Cannabis dispensaries offer medicinal cannabis in various forms,
such as tinctures, candies, etc., and a number of patients are able to obtain
their medicine through home cultivation. Can this system flourish in some way
independent of the federal regulatory structure?
Exceptions to federal prohibition?
In 1998, the federal government filed a number of federal civil actions against
cannabis dispensaries in Northern California. The government contended that
the dispensaries were being conducted in violation of federal law, which
prohibits the sale, manufacture or distribution of cannabis. The federal
district court agreed and turned away a motion to modify its injunction to
allow the distribution of medicinal cannabis to seriously ill patients who
could show “medical necessity,” i.e., those who had tried all standard medications
without success and for whom medicinal cannabis was the only treatment that
alleviated their symptoms. The U.S. Court of Appeals for the Ninth Circuit
reversed, ruling that, notwithstanding the fact that cannabis is a Schedule
I drug under the federal CSA, there could be a medical necessity defense
to an action under the Act. 3
The U.S. Supreme Court granted certiorari and, in an 8-0 opinion (Justice
Breyer abstaining), the Court determined that there is no “medical
necessity” exception to the CSA’s statutory prohibitions against manufacturing
and distributing cannabis.4
The Court concluded that placement in Schedule I establishes that cannabis
has no medical benefits and cannot be used outside the confines of a federally-approved
research project. Five members of the Court went even further in dictum to
state that there should be no distinction drawn between the CSA’s prohibitions
against manufacturing and distributing and its other prohibitions, such as
possession for personal use. Therefore, it would appear that a medical necessity
exception to the CSA would also not be available in an action against a patient
for possession or cultivation for personal use.
However, the Court explicitly noted that it was not addressing the constitutional
issues, if any, that might be raised by the application of the CSA in such
cases. In the face of this apparent invitation, on remand a number of as-applied
constitutional arguments were presented. Furthermore, independent actions were
also filed, one by the Wo/man’s Alliance for Medical Marijuana, a cultivation
cooperative (that had been raided by the Drug Enforcement Administration),
joined in the suit by the governments of the county and city in which it is
located (Santa Cruz).5
Another was filed by Angel Raich and Diane Monson, individual patients seeking
declaratory and injunctive relief to establish their right to cultivate and
use medicinal cannabis free from interference or punishment by the federal
government.6 Raich v. Ashcroft, No. 03-15481 (9th Cir.).
There are two primary constitutional issues raised by these cases.
First, the proponents of medicinal cannabis contend that the federal
government lacks power under the Commerce Clause to regulate wholly
intrastate, noncommercial cultivation of medicinal cannabis. (Interestingly,
the FDCA regulates only misbranded or adulterated food and drugs that
move in interstate commerce, whereas the CSA purports to regulate the
use and distribution of controlled substances in both intrastate and
interstate commerce.7
Such challenges have been very difficult to mount in the past, but recent decisions
of the U.S. Supreme Court appear to have narrowed the reach of the Commerce
Clause. In United States v. Lopez, 8 the Supreme Court struck down the Gun-Free
School Zones Act of 1990 because
1) possessing a firearm within 1,000 feet of a school had nothing to do with
commerce or any sort of economic enterprise;
2) there was no requirement in the statute that the firearm possession actually
affect interstate commerce; and
3) there were no formal findings regarding the effect on interstate commerce
of the firearm possession.
Similarly, in United States v. Morrison9, the Court invalidated the civil remedy
established under the Violence Against Women Act because, despite Congressional
findings regarding the economic effect of gender-motivated crimes of violence,
the Court determined that intrastate violence against women is not economic
activity and does not “substantially affect” interstate commerce.
The Court of Appeals for the Ninth Circuit has very recently followed the high
Court’s lead
in this area. In United States v. McCoy10, the Ninth Circuit struck
down a statute prohibiting possession of child pornography produced
using materials that had traveled in interstate commerce, as applied
to simple possession of a photograph that had not traveled in interstate
commerce and was not intended for interstate distribution or economic
use. In light of these opinions, the Commerce Clause argument in the
medicinal cannabis cases may be credible and may have particular force
in the situation involving individual cultivation of cannabis for personal
medical use.
The federal Controlled Substances Act is likely
un-constitutional as applied to the intrastate, noncommercial cultviation,
possession and use of medicinal cannabis
On December 16, 2003, the United States Court of Appeals for the Ninth
Circuit ruled in one of these cases —Raich v. Ashcroft— that the
federal Controlled Substances Act is likely unconstitutional as applied
to the intrastate, noncommercial cultivation, possession and use of
medicinal cannabis, where that medical use has been recommended by
a physician. Under the court’s analysis, Congress has no jurisdiction
to regulate such activity under the Commerce Clause of the federal
constitution.
The Court remanded the case to the district court for entry of a preliminary
injunction against the federal government. The federal government unsuccessfully
sought rehearing and rehearing en banc. At t the time of this writing, the
cultivation and use of medicinal cannabis under such circumstances would seem
to be lawful under both state and federal law.11
Second, the medicinal cannabis cases contend that individual patients have
a fundamental right to rely on their physicians’ recommendation to use medicinal
cannabis, when it is the only medicine that has been demonstrated to alleviate
their suffering. This, then, is the “medical necessity” argument raised to
a constitutional level.
Past cases have generally found that there is no fundamental right to choose
an unapproved medicine.12 However, those opinions arose out of different factual
settings, and the specific question raised by the current cases was not directly
addressed. Indeed, in Carnohan, which rejected the plaintiff’s argument that
he had a fundamental right to obtain and use laetrile for the prevention of
cancer, the Court of Appeals stressed that it was not deciding whether the
plaintiff had “a constitutional right to treat himself with home remedies of
his own confection.”13 Again, patients who cultivate their own medicinal cannabis
or who obtain it from intrastate sources avowedly beyond the jurisdiction of
the FDA, may be able to distinguish their situation from those in Carnohan
and Rutherford.
Furthermore, the fundamental rights argument may have been bolstered by a recent
U.S. Supreme Court decision which may portend a loosening of the fundamental
rights doctrine’s narrowness. In Lawrence v. Texas,14 the Court found a Texas
statute criminalizing sexual relations between persons of the same sex to be
an unconstitutional restriction on liberty under the Due Process Clause of
the Fourteenth Amendment.
Thus far, federal district courts have rejected these arguments, but partially
(at least with regard to the Commerce Clause) because those courts perceived
themselves to be bound by prior Ninth Circuit precedent.15 The medicinal cannabis
cases were recently argued before two different panels of the Ninth Circuit,
and the parties are awaiting the panels’ rulings. It may be that the CSA does
not, after all, comprise a totally “closed” system for the distribution of
all controlled substances.
The Role of Proposition 215
Enacted by 56% of the electorate in November 1996, Proposition 215, or the
Compassionate Use Act, codified at Health & Safety Code section11362.5,
stands in stark contrast to the narrow constraints of federal law. Proposition
215 authorizes a seriously ill patient (and the patient’s “primary caregiver”),
who has the oral or written approval or recommendation of a physician, to
cultivate and/or possess cannabis for medical purposes. A recent California
Attorney General opinion states that the term “marijuana” in the initiative
includes concentrated cannabis, i.e., hashish.16
At first glance, one might think that the initiative must be inconsistent with
federal law and hence, under the Supremacy Clause, invalid. However, Proposition
215 merely abrogates the State’s own criminal laws prohibiting cultivation
and possession of cannabis, as they apply to qualifying patients/primary caregivers.
The State is unquestionably free to abolish its own laws without running afoul
of the Supremacy Clause. Nevertheless, although Proposition 215 is not itself
in conflict with federal law, patients, primary caregivers, cannabis dispensaries—and
in some cases, even physicians-who act in accordance with its text and purpose,
may still be at risk of federal prosecution or other sanction.
Prop 215’s Protections
Soon after enactment of Proposition 215, many commentators, as well as state
and local law enforcement personnel,
In many counties, patients who clearly possessed
physicians’ recommendations were arrested and forced to stand trial.
concluded that the initiative provided only an affirmative defense,
which the patient-defendant would have to raise at trial. Accordingly,
in many counties, patients who clearly possessed physicians’ recommendations
were arrested and forced to stand trial. Patients, by contrast, argued
that they were entitled to complete immunity from arrest and prosecution.
This uncertainty was finally resolved by the California Supreme Court in People
v. Mower .17 In Mower, the Court ruled that a patient may raise his/her status
as a patient or primary caregiver
1) as a basis for moving to set aside an indictment or information before trial
on the ground of the absence of reasonable or probable cause to believe that
he/she is guilty or
2) as an affirmative defense at trial. The Court further ruled that, although
the patient-defendant has the burden of proof regarding the facts of his/her
status, he/she need only raise a reasonable doubt as to his/her guilt, rather
than having to prove his/her status by a preponderance of the evidence. In
so doing, the Court also reaffirmed the validity and vitality of Proposition
215.
Who Qualifies?
The ballot arguments and the text of the initiative indicate that the law was
intended to apply to seriously ill patients. Proposition 215 specifies a
number of serious diseases and conditions that are effectively presumed to
constitute “serious illness” for which treatment with medicinal cannabis
is appropriate —cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma,
arthritis and migraine. However, the Act is not limited only to these enumerated
conditions. Rather, the Act applies with equal effect to any seriously ill
patient if 1) the person suffers from “any other illness for which marijuana
provides relief” and 2) a physician has determined that the person’s health
would benefit from such a therapeutic option. The Act therefore has a broad
scope, enabling patients with a variety of conditions to qualify for its
protections.
Patients Obtaining Cannabis
Unfortunately, many patients are too ill to cultivate their own cannabis. Furthermore,
a patient’s “primary care-giver,” defined as the individual, designated by
patient, “who has consistently assumed responsibility for the housing, health,
or safety of that person,” may not be skilled enough (or have the space)
to manage a successful garden. However, Proposition 215 did not establish
any other distribution mechanism, potentially forcing patients to obtain
their medicine from the black market.
Recognizing this need, even before Proposition 215 was passed, a number of
dispensaries, then called “cannabis buyers clubs,” opened their doors. The
operator of the San Francisco Cannabis Buyers Club, Dennis Peron, was designated
by thousands of patients as the patients’ “primary caregiver.” However, a California
Court of Appeal determined that, under the circumstances of that case, the
operator did not meet the statutory criteria and therefore was not covered
by the Act.18 Hence, many cannabis dispensaries may be operating in violation
of both state and federal law.
Nevertheless, in some areas, such dispensaries —operating with the approval,
or at least without the objection, of local governments— have proliferated.
A small section of downtown Oakland has been denominated “Oaksterdam,” because
of the large number of dispensaries that flourish there. By contrast, in other
parts of the state, there are no dispensaries at all.
Even home cultivation, however, does not ensure that a qualifying patient (or
a primary caregiver) will not be arrested and even convicted under state law.
One of the most contentious issues has centered on the amounts —the weight
of dried herbal cannabis and/or the number of plants— that a patient or caregiver
can legitimately possess or cultivate. In some cases, law enforcement has contended
that the amount possessed or cultivated demonstrates that the cannabis was
intended for sale, rather than the patient’s personal use, in violation of
Health & Safety Code sections 11359-60. By contrast, patients seek to establish
that the amount was actually reasonable for the patient’s needs. Different
counties have promulgated “plant limit” guidelines, but these have not been
consistent across the state.
Furthermore, Proposition 215 did not exempt patients from the state criminal
law prohibitions against transporting cannabis. One California Court of Appeal
has suggested that a patient may lawfully transport cannabis if the method,
timing and distance of transportation are reasonably related to the patient’s
medical needs.19 However, more recently, another state appellate court construed
Trippet as applying only to “incidental transportation of marijuana from the
garden to a qualifying patient.”20 This narrow decision had the potential further
to complicate patients’ ability to obtain and carry cannabis medicines.
“Clarification” —SB 420
It became increasingly apparent that the interpretation and application of
Proposition 215 were not fulfilling—and in some ways were undermining—the
initiative’s purpose. However, under California law, an initiative cannot
be amended by statute, unless its language so permits,21 and Proposition
215 did not allow for such amendment. In 1999,
Attorney General Lockyer convened a Medical Marijuana Task Force to
draft guidelines to attempt to address the initiative’s implementation
problems. This effort resulted in a bill, SB 420, which, after four
years, was finally signed into law on October 13, 2003, by outgoing
Governor Davis. SB 420 adds Article 2.5, commencing with Section 11362.7,
to the Health and Safety Code.
SB 420 was intended, not to amend, but to “clarify the scope” of the initiative,
to “facilitate the prompt identification” of qualified patients and their designated
primary caregivers in order to avoid unnecessary arrest and prosecution of
these individuals, and to “provide needed guidance” to law enforcement officers.” It
also sought to “promote uniform and consistent application” of the act across
the state.
The new law requires the California Department of Health Services to establish
a fee-based, voluntary identification card system. While the bill was moving
through the legislature, the Office of the Legislative Counsel determined that
a mandatory ID card system would have constituted an invalid amendment to Proposition
215.22
A “serious medical condi-dition” is one that “substantially
limits the ability of the person to conduct one or more major life
activities”
SB 420 sets forth a transparent process by which qualified patients and their
primary caregivers may obtain ID cards. It defines the concept of “serious
medical condition” to include any condition that “substantially limits the
ability of the person to conduct one or more major life activities as defined
in the Americans with Disabilities Act,” or which, “if not alleviated, may
cause serious harm to the patient’s safety or physical or mental health.”23
It also clarifies that a copy of the patient’s medical record shall constitute
the “written documentation” that a patient must submit in order to substantiate
his/her physician’s conclusion that he/she has a serious medical condition
and that the use of medicinal cannabis is “appropriate.” The ID cards will
actually be issued by the patient’s county health department.
Amongst other issues, SB 420 attempts to address, in a limited way, the “supply
problem.” Section 11362.775 recognizes the existence and legitimacy of collective
or cooperative cannabis cultivation projects, although those concepts are not
specifically defined in the text. It also explicitly permits a primary caregiver
to be designated by more than one patient, if all patients reside in the same
county as the primary caregiver, and allows the primary caregiver to receive
reimbursement for the expenses incurred in cultivation, as well as reasonable
compensation for his/her services.
Finally, the law sets forth specific amounts of dried herb and numbers of plants,
which are intended to protect patients against improper arrest and prosecution
and to provide guidance to the law enforcement sector.
What about the physicians?
Proposition 215 depends upon physicians for its effective
implementation. If a physician has not approved or recommended a patient’s
use of medicinal cannabis, the patient cannot claim the Act’s protections.
Recognizing the importance of the physician’s role, the electorate
sought to encourage physicians’ involvement by affording them explicit
protection against punishment or other sanction for having recommended
or approved medicinal cannabis: “Notwithstanding any other provision
of law, no physician in this state shall be punished, or denied any
right or privilege, for having recommended marijuana to a patient for
medical purposes.”
Thus far, this forceful language has not been sufficient to attract physicians
in significant numbers. Many physicians do not like the idea of “smoking a
medicine” and are further discomforted by the unstandardized nature of crude
herbal cannabis products; some are not informed enough to discuss —much less
recommend— medicinal cannabis; and still others are fearful of incurring punishment
from the state and/or federal governments.
Those fears, at least until very recently, may have been well-founded. Proposition
215, as a state law enactment, could not protect physicians from the wrath
of the federal government. Immediately upon Proposition 215’s passage, former
Attorney General Janet Reno, former drug czar Barry McCaffrey, and former DHHS
Secretary Donna Shalala publicly announced a federal “policy,” pursuant to
which physicians who recommended medicinal cannabis would be stripped of their
licenses to prescribe all controlled substances (a death knell for most physicians’ practices),
barred from MediCal and Medicare, and potentially subjected to criminal prosecution.
The federal government did not actually have to act on the threat. Indeed,
more than six years later, the Drug Enforcement Administration (DEA) has taken
action against only one physician —one who had not only issued many recommendations,
but was also cultivating cannabis, albeit for personal medical use. However,
the chill from that threat has hung heavy in the air all this time, deterring
most physicians from being willing even to discuss the subject with their patients.
Only recently, have physicians had reason to feel a measure of comfort (see
discussion below of the First Amendment).
Unfortunately, the paucity of physicians cannot be alleviated through the participation
of allied health practitioners, such as chiropractors. Proposition 215 repeatedly
states that only physicians may recommend medicinal cannabis. Therefore, although
other health professionals, such as nurse practitioners, might be willing to
enter the fray, the clear text of the Act precludes this option.
This physician scarcity has had two consequences. First, many patients have
been unable to obtain recommendations from their physicians, even though the
patients’ conditions might have been improved by the use of medicinal cannabis.
Faced with the risk of arrest and prosecution by state or local police, such
patients may have foregone the use of medicinal cannabis altogether.
Second, a small number of stalwart physicians rose to the occasion and initiated
a type of sub-specialty —evaluating patients to determine if treatment with
medicinal cannabis would be appropriate and, if so, approving/recommending
its use. These physicians in most cases did not serve as the primary treating
physician. For example, they did not establish a treatment plan for the patient’s
underlying medical condition. Rather, they confined their role to medicinal
cannabis assessment and recommendation. Many of them issued hundreds, even
thousands, of recommendations, sometimes traveling to rural areas where there
was not a single physician willing to recommend medicinal cannabis.
The inevitable visibility of this group brought to the fore the meaning of
the immunity language contained in Proposition 215. The Medical Board began
to investigate these physicians, further deepening the intimidation of physicians
as a whole. Beleaguered, the physicians argued that “Notwithstanding any other
provision of law” established an absolute and unqualified immunity. However,
it is virtually impossible to believe that the electorate would have intended
such a result, which would protect even the most reckless, incompetent, or
avaricious physician from investigation and punishment. Hence, the question
seems to be what sort of “specialized” physician-patient relationship can meet
the standard of care embodied in California’s Business & Professions Code.
This must be decided with great care. It would be a great irony if a small
group of physicians, having thus far avoided the federal government’s scrutiny,
were now to be at risk of “unprofessional conduct” and subject to sanction
from their own medical board, essentially only because they recommended medicinal
cannabis.
So, threatened from both afar and at home, most physicians have been sitting
on the sidelines. But the United States Supreme Court recently handed them
a bit of good news.
The First Amendment
In 1997, shortly after the “federal threat” had been broadcast across the country,
a group of physicians and patients brought an injunctive action against the
federal government. The suit asserted that physicians had a First Amendment
right to discuss and advise their patients concerning medicinal cannabis. The
federal district court agreed, as did the Court of Appeals for the Ninth Circuit.24
The Ninth Circuit stated that the federal government cannot prosecute or otherwise
punish a physician merely because he/she has discussed and recommended the
use of medicinal cannabis. Indeed, the Court stressed, the federal government
cannot even initiate an investigation against a physician solely because the
physician gave such opinion unless the government in good faith believes that
it has substantial evidence that the physician has acted unlawfully. On October
14, 2003, the Supreme Court denied certiorari, rendering the Ninth Circuit’s
decision final. The victorious plaintiffs claimed that physicians could now
recommend medicinal cannabis without fear of federal intervention.
However, the victory was not quite so unqualified, and physicians’ freedom
of speech is still not without boundaries. Both the federal district court
and the Court of Appeals in the Conant case emphasized that, if a physician
steps out of his/her role as a medical adviser and issues a recommendation
for the sole purpose of assisting the patient to obtain cannabis, the physician
could be guilty of aiding and abetting, or conspiring in, a violation of federal
law. Such conduct would fall outside the First Amendment.
Confusion Over Terms
Regrettably, the term “recommendation” in Proposition 215’s text has caused
a huge amount of confusion. Since it is the “key’ that unlocks a patient’s
access to both Proposition 215’s protections and to cannabis dispensaries,
a physician’s advice has now come under close scrutiny by state and federal
governments. But the federal government has never before challenged a physician’s
right fully to discuss a potential treatment option. For example, if a pregnant
woman were heroin-dependent and could not find a space in a methadone maintenance
program, a physician could certainly advise the woman not to attempt to withdraw
from heroin during her pregnancy, since doing so could cause a miscarriage.
It would simply be good medical practice to provide such information and advice,
even though heroin, like cannabis, is a Schedule I substance.
Thus, before Proposition 215, everywhere in the United States a physician and
patient could freely discuss and consider the potential usefulness of any medication,
whether or not its use was off-label or even if the medication were not approved
in this country. As part of that discussion, the physician could give his/her
informed opinion as to whether or not it might be desirable for the patient
to pursue such a treatment wherever it was available. And, of course, in accordance
with the standard of care, the physician should document such a discussion
in the medical record.
Ironically, after Proposition 215, things were no longer so straightforward.
In order to understand why, one must examine the meaning of the term “recommendation” and
the functions that a recommendation can now serve.
The term “recommendation” is ambiguous because a recommendation can take several
forms. Ostensibly, the term “recommendation” or “approval” is just a type of
shorthand for the traditional process wherein a physician, when discussing
a medical treatment option with a patient, provides information and professional
advice. In general, such a “recommendation” would be given orally to the patient
and then documented in the medical record. Under California law, a patient
has a right to request a copy of his/her medical record and may do so for any
reason.25 See also the regulations promulgated pursuant to the Health Insurance
Portability and Accountability Act (HIPAA)26.
The physician may also embody his/her conclusions and advice in a separate
letter or other document. Giving such a separate letter is often what is meant
by the phrase “issuing a medicinal cannabis recommendation.” Providing such
separate documentation is not without precedent, particularly when the patient
is using a prescription medicine containing a controlled substance.
For example, the California Pain Patient’s Bill of Rights, Health & Safety
Code sections 124960-61, allows patients to request documentation of their
physicians’ conclusion that opioid treatment is appropriate. One purpose of
such documentation is to provide evidence for law enforcement personnel, if
necessary, to establish that the patient’s use is legitimate.
Finally, a physician also might have occasion, if requested by a third party
(and permitted by the patient), to confirm the veracity of either the written
recommendation or the copy of the medical record.
A recommendation can also be issued for several reasons. First, the physician
may genuinely believe that the information and advice about the therapeutic
potential of medicinal cannabis will assist the patient in making medical decisions.
Or, as the Court of Appeals in Conant suggested, it might enable the patient
to enroll in a clinical trial, decide to obtain treatment abroad, or assist
the patient in seeking a change in the laws governing medicinal cannabis. A
physician who provides information and advice under such circumstances could
be said to have an “informational purpose.”
Second, a physician’s advice, whether contained in a copy of the medical record
or in a separate document, could also be issued with the intent and for the
sole purpose of enabling the patient to go to a cannabis dispensary to obtain
cannabis. Many dispensaries will not provide cannabis without such proof of
physician approval. This could be called the “procurement” purpose, and Conant
suggests that this would not enjoy First Amendment protection.
Third, a physician may provide a patient with written proof of the physician’s
opinion or recommendation in order to enable the patient 1) to obtain an identity
card through the State’s new certification program or, if the patient chooses
not to seek an ID card but is otherwise qualified under Proposition 215, 2)
to attempt to avoid arrest if the patient is discovered to be cultivating or
possessing cannabis. Furthermore, if arrested, a patient can use proof of a
physician’s recommendation or approval to prove before trial that he/she is
entitled to the protections of Proposition 215. This could be called a “defensive” purpose.
The Conant ruling indicates that a physician is protected by the First Amendment
if he/she provides a recommendation for an informational, and probably also
for a defensive, purpose. The “procurement” issue creates a grey area, though.
If a physician talks with a cannabis dispensary on the telephone to confirm
the legitimacy of a patient’s medical record, or writes a letter of recommendation
at the request of a patient who explicitly informs the physician that the patient
intends to go to a cannabis dispensary, has the physician crossed into forbidden
territory? Faced with that residual degree of uncertainty, some physicians
may still be reluctant to document their professional opinion. And without
proof of that opinion/recommendation, a patient is not protected under Proposition
215. Thus, the extent of Conant’s salutary effect remains to be ascertained.
Conant and the Medical Board
Conant v. Walters did not totally protect physicians against any risk of federal
sanctions. However, it did have a rather unexpected and, in some ways, even
more powerful impact on the ability of the state Medical Board to pursue “recommending” physicians.
In theory, the Conant ruling does not apply only to the federal government.
Since it is based on the First Amendment, the ruling also applies to any
state or local governmental entity, including the Medical Board,
The Conant ruling applies to any state or local
governmental entity, including the Medical Board, that may try to
investigate or restrict a physician merely for having recommended
cannabis.
that may try to investigate or restrict a physician merely for having recommended
cannabis.
This has some very interesting consequences. As noted above, the Conant decision
makes it clear that if a physician’s opinion or recommendation is offered for
the sole purpose of enabling a patient to obtain cannabis, it could constitute
aiding and abetting a violation of federal law and thus be stripped of constitutional
protection. This inquiry is rather straightforward from the federal government’s
perspective. It focuses only on the physician’s purpose, i.e., whether or not
the physician sought to aid and abet, not on the quality of the physician’s
patient care practices (although a truly “sham” practice could be evidence
of intent). Standard-of-care issues are the province of state medical boards.
However, in light of Proposition 215, a physician’s intent should not be the
primary focus of the Medical Board. Even if a physician actually intends to
assist a patient in obtaining cannabis (and so does not qualify for First Amendment
protection), Proposition 215 still immunizes the physician from punishment
or scrutiny under state law, unless there is good reason to believe that his/her
conduct falls beneath the standard of care.
The interplay of federal and state law becomes a bit complex at this point.
Nestled within the “unprofessional conduct” statutes is Business & Professions
Code section 2238, which provides: “A violation of any federal statute or regulation
or any of the statutes or regulations of this state regulating dangerous drugs
or controlled substances constitutes unprofessional conduct.” One might conclude,
therefore, that a physician acting with a “procurement” purpose would be subject
to sanction by the Medical Board. However, Proposition 215, which flatly protects
physicians from punishment under state law for having made a recommendation,
is a more recent and more specific enactment than Section 2238. Hence, its
provisions should prevail.
Of course, the Medical Board can have legitimate concerns. However, after Conant
and Proposition 215, such concerns should focus only on the quality of the
physician’s patient-care practices. The Medical Board should seek to investigate
a physician who has recommended medicinal cannabis, only if it in good faith
believes that it has substantial evidence that the physician has failed to
meet appropriate and relevant practice standards. But physicians’ freedom to
practice should be not be more circumscribed, nor more closely scrutinized,
in this area than in any other.
The Immediate Future
The next few years should bring further legal and scientific developments.
At present, 10 states have recently enacted statutes or initiatives authorizing
(to a greater or lesser extent) the use of medicinal cannabis. Other states
are considering the enactment of such laws. At some point, faced with a massive
insurrection at the state level, the federal government may back down. On
the other hand, as the past has indicated, unless there is widespread cooperation
and involvement from physicians, such laws will have incomplete implementation.
One thing cannot be denied. Thousands of patients believe that medicinal cannabis —not
a synthetic component—has provided them with inestimable, perhaps life-saving,
relief from their suffering. Surely our government can find a solution to this
problem —a solution that meaningfully addresses what is clearly a legitimate
demand for a medicine.
Alice Mead is a legal consultant whose clients include pharmaceutical
companies and healthcare organizations. This is a longer version
of a copyrighted article, reprinted with permission, that appeared
in California Lawyer, January 2004.
References
1. 21 U.S. Code, Section 811
2. See, 57 Fed. Reg. 10,499 (Mar. 26, 1992); Alliance for Cannabis Therapeutics
v. DEA, 15 F.3d 1131 (D.C.Cir. 1994); 66 Fed Reg. 20,038 (April 18, 2001);
Gettman v. DEA, 290 F.3d 430 (D.C.Cir. 2002).
3. U.S. v. Oakland Cannabis Buyers’ Cooperative (OCBC) (9th Cir. 1999) 190
F.3d 1109.
4. U.S. v. Oakland Cannabis Buyers’ Cooperative (2001) 532 U.S. 483, 149 L.Ed.2d
722.
5. Wo/Men’s Alliance for Medical Marijuana v. U.S. (No. 03-15062) (9th Cir.).
6. Raich v. Ashcroft, No. 03-15481 (9th Cir.).
7. Compare 21 USC sec. 331(a)-(d) with 21 USC sec. 801. )
8. 514 U.S. 549 (1995),
9. 529 U.S. 598 (2000),
10. 323 F.3d 114 (9th Cir. 2003),
11. Raich v. Ashcroft 2003 WL 22962231.
12. See, e.g., Carnohan v. United States, 616 F.2d 1120 (9th Cir. 1980) (per
curiam); United States v. Rutherford, 442 U.S. 544 (1979).
13. 616 F.2d at 1122.
14. Lawrence v. Texas, 539 U.S. ___, 123 S.Ct. 2472 (2003),
15. See, e.g., County of Santa Cruz v. Ashcroft, F.Supp. (N.D.Cal. 2003), WL
22024235; Raich v. Ashcroft, 248 F.Supp.2d 918 (N.D. Cal.2003).
16. Cal. Ops. Atty. Gen. No. 03-411 (Oct. 21, 2003).
17. (2002) 28 Cal.4th 457, 122 Cal.Rptr.2d 326.
18. Lungren v. Peron (1997)
59 Cal.App.4th 1383, 70 Cal.Rptr.2d 20.
19. People v. Trippet (1997)
56 Cal.App.4th 1532, 66 Cal.Rptr.2d 559.
20. People v. Young, (2001)
92 Cal. App. 4th 229, 111 Cal.Rptr.2d 726.
21. Cal. Const., Art. II, Sec. 10(c),
22. Office of the Legislative Counsel of California, “Medical Marijuana: Identification
Program (S.B.420),” #16771 (Aug. 20, 2003)
23. Section 11362.7(h)(12).
24. Conant v. Walters 309 F.3d 629 (9th Cir. 2002).
25. Health & Safety Code sec. 123100 et seq.
26. 45 C.F.R. sec, 164.524(a)(1).