Alexander DeLuca,
M.D.
Addiction, Pain, & Public Health website
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PAIN WITHOUT TREATMENT, WRONG WITHOUT
REMEDY
Implications of the "Liberty" Interest in Medical
Treatment, and the Americans with Disabilities Act for the Rights of
Patients to Receive Pain Therapy with Controlled Substances
By William
E. Hurwitz, M.D., 1992.
This paper was submitted to the George
Mason Law Review in the author's first year of law school. It has remained
an unpublished work, until now, December 7, 2003.
[NOTE: This document has NOT yet been fully coded and is currently
incomplete. Latest revision: April 22, 2005]
"It is a disgraceful episode in the history of medicine that
doctors and scientists allowed themselves to join a mass hysteria which
confused the tremendous benefits of narcotics for the patient in pain with
the social abuse of the same compounds."
(1)
I. Introduction
A. The Clinical-Regulatory Problem
Chronic pain is a significant health problem. (2)
Yet many patients whose
condition is most severe find access to treatment is limited or simply
unavailable. (3)
Opioids
(4)
are the mainstay of management of severe pain,
(5 )
and
there are certain clinical circumstances in which there is simply no
effective alternative.
(6 )
Reluctance on the part of physicians to prescribe
adequate amounts of these medications results in needless pain and
suffering. The inadequacy of pain management has been extensively documented
and commented upon in the medical literature. ( 7) Its causes have been ascribed,
in part, to physician ignorance of proper therapy and fear of adverse
effects of opioid medications, including the fear of inducing addiction in
patients.
( 8) That these fears are not warranted has also been amply documented.
An additional substantial impediment to adequate pain treatment is physician
fear of regulatory scrutiny and sanction.
( 9) This fear is, unfortunately,
reinforced by the actions of state and federal regulatory authorities. In
view of the remote possibility of malpractice liability arising from
inadequate pain treatment,
( 10) there is, effectively, no counterbalancing
sanction for inadequate treatment of pain. This asymmetry in the legal risks
to doctors contributes to the wide-spread avoidance of the use of opioids in
community practice.
Top of Page
B. Approaches to a Legal Solution
The prescribing of controlled substances is constrained by a complex
regulatory structure involving the federal Drug Enforcement Administration,
its state counterparts, and state professional licensure and regulatory
bodies.
( 11) The right of patients to receive controlled substances which have
been approved for general medical use for the relief of pain depends not
only on an abstract legal right to treatment,
( 12) but on the availability
through the prescription, administration, or performance of a particular
treatment by a licensed physician. The situation of a pain patient wishing
to obtain adequate pain management is analogous to that of a woman seeking
to assert her right to birth control services. Both kinds of patients
require affirmative acts from willing physicians to obtain the desired
medical intervention.
Under Griswold, a regulatory agency's action against a physician's license
prompted by the physician's prescription of opioids for pain relief may
provide a physician standing to assert the right of his patients to
treatment.
( 13) There have been no reported cases, however, involving precisely
this circumstance. Why this is so is a matter of conjecture. Perhaps, in the
setting of a disciplinary hearing, the accused physician may consider it
more useful to present the medical condition of the patient warranting
treatment with opioids as evidence of the physician's bona fides, rather
than raise the issue of the patient's bona fides and right to treatment.
( 14)
Thus, as a practical matter, patients harmed by the chilling effect of drug
regulation are left with, at best, a limited opportunity to seek to
establish a legal right to treatment with controlled substances.
The inhibitory effect of the scheme of medical regulation on a patient's
access to pain medication is susceptible to legal challenge. This Comment
explores two possible bases for such a challenge. The first approach relies
on the line of cases in which the Supreme Court has supported protection of
personal autonomy and bodily integrity as a fundamental right under the
Fourteenth Amendment. The inclusion of the right to pain treatment under the
umbrella of fundamental rights would enable the Court to subject state
regulatory schemes to a "strict scrutiny" standard of review, with the
likely outcome of modification of the regulatory scheme to accommodate the
needs of pain patients.
The second approach to challenging state regulation relies upon the
Americans with Disabilities Act of 1990.
( 15)
This Comment will argue that pain
patients are protected as persons with disabilities entitled to appropriate
medical treatment and that the regulatory scheme, through its disparate
impact on their access to such treatment, violates the law. To set the stage
for these discussions, a brief review of the historical background of the
regulation of controlled substances is presented in the following section.
Top of Page
II. Historical Background and Regulatory Dilemma
The federal regulatory scheme for controlled substances prescribed in the
practice of medicine has been predicated upon the perceived clarity of the
distinction in clinical practice between proper use and abuse. Harrison
Narcotics Act
( 16) established the pattern of the regulation of opioids from the
time of its passage in 1914 until it was replaced by the Controlled
Substances Act of 1970.
( 17)
The Harrison Act required individuals involved in
the commercial distribution of opioids to register with the government and
to pay a federal tax. Federal registration pursuant to the Harrison Act
entitled the registrant to obtain special order forms required for
commercial transactions involving these products; transactions involving
opioids by non-registrants were prohibited.
The Harrison Act did not purport to regulate the practice of medicine, and
excluded from its purview "the dispensing, or distribution of [opioids] to a
patient by a physician... in the course of his professional practice
only." But under the common assumptions of that time, drug dependence was
equated with addiction, and the maintenance of a drug-dependent person was
considered beyond the scope of professional practice. In the first case in
which the Supreme Court was called upon to apply the Act to a physician
issuing prescriptions for morphine "for the purpose of providing the user
with morphine sufficient to keep him comfortable by maintaining his
customary use," the Court responded, "[T]o call such an order for the use of
morphine a physician's prescription would be so plain a perversion of
meaning that no discussion of the subject is required."
The language in Webb implied that the distribution of opiates to maintain
opiate-dependent patients, even in the context of the bona fide exercise of
medical judgment, was not "in the course of professional practice" and,
therefore, was unlawful. This position was subsequently incorporated in the
first Treasury Regulations implementing the Harrison Act , as well as
numerous state statutes. The attitude reflected in the Court's holding has
continued to dominate the culture of drug enforcement.
Under the apparently self-evident conventional understanding reflected in
Webb, patients who required prolonged use or higher than normal doses of
narcotics were considered addicts, regardless of the clinical circumstances
giving rise to the use of these medications. Physicians who prescribed
narcotics in this way were considered guilty of prescribing excessive
amounts of controlled substances, which was deemed to constitute
malpractice. The Regulations of the Arkansas State Medical Board, for
example, define malpractice to include: The prescribing of excessive amounts
of controlled substances to a patient including the writing of an excessive
number of prescriptions for an addicting or potentially harmful drug to a
patient. Consistent with the Supreme Court's ruling that "no discussion of
the subject is required," courts and regulatory agencies have felt no
obligation to articulate any standard for permitted use of controlled
substances for greater than de minimis amounts of opioids in pain therapy.
Leonard v. Arkansas State Medical Board was an appeal from a professional
disciplinary action against a physician based on allegations of "prescribing
excessive amounts of controlled substances." This case is illustrative of
the conventional regulatory practice. The suspension of the physician's
license was affirmed on appeal solely on the basis of statistical evidence
that his prescription of controlled substances exceeded the norm in his
community by 50-75%, in spite of the absence of "proof, or allegation, that
he prescribed any drug for any purpose other than treatment of symptoms of
patients." This calculation was made without reference to the diagnoses of
the patients under treatment and without evidence of any actual harm to his
patients. All of the State's expert witnesses testified to the danger of
drug addiction and as to their opinion that controlled substances should
only be used for short periods of time in extreme clinical circumstances.
The hostile attitude of members of boards of medicine to the aggressive use
of narcotics in the management of pain has been documented, as has the
inhibitory effect of the current regulatory scheme on the "appropriate"
management of pain. The term "appropriate" is, of course, judgmental.
Although there is strong support in the medical community that pain should
be minimized, there is no consensus as to whether this goal warrants 1) the
almost inevitable creation of the physiological dependence on opioids that
accompanies chronic administration, 2) the possible creation of
psychological dependence (also referred to as "addiction"), and 3) the
probable escalation of dosage that accompanies the development of tolerance.
These issues are not different in kind than the customary weighing of
benefit against risk occasioned by the choice of any medication or medical
procedure. What is novel about the choice of narcotics as therapeutic agents
is the presumed incapacity of patients and their physicians to make a
rational therapeutic decision, insofar as "addicted" individuals are thought
to succumb to their cravings and to lose their power of self-control. From a
broader social policy perspective, the risks of a less restrictive use of
opioids are 1) the promotion of addiction in opioid-treated patients, and 2)
the diversion of opioids from legitimate channels to the illicit market.
In the last twenty years, the inhumanity of allowing patients to suffer pain
from terminal cancer has prompted a more liberal approach to the treatment
of such patients. No doubt, in the minds of many, the fact of expected death
alters the clinical calculus, even assuming a strong bias against dependence
and tolerance. Recently, in response to a growing recognition that acute
post-traumatic or post-operative pain are undertreated, the National Center
for Health Policy and Research issued its Clinical Practice Guideline for
the management of acute and post-operative pain, which endorses "an
aggressive approach to pain assessment and management."
The use of opioids in the treatment of chronic pain of non-malignant origin
remains controversial in clinical practice. While prominent experts advocate
the aggressive use of these medications in patients unresponsive to other
modalities, with the exception of those affiliated with medical centers
where academic prestige protects physicians from adverse regulatory
scrutiny, most physicians are inhibited in prescribing opioids by fear of
such scrutiny. Thus, the many chronic pain sufferers do not have access to
effective pain treatment.
"The course of professional practice" of leading practitioners who prescribe
opioids aggressively in the treatment of chronic pain makes it no longer
possible to maintain that proper use of even large amounts of opioids can be
readily distinguished from abuse and possible diversion on the mere basis of
the number of pills prescribed or the duration of use. Enforcement schemes
based on such simple criteria are more likely than not to target competent
physicians prescribing appropriate medication to medically deserving
patients, or to inhibit such prescribing altogether. Some states have
addressed this dilemma passing statutes explicitly authorizing the treatment
of intractable pain. Virginia's statute is typical:
In the case of a patient with intractable pain, an attending physician may
prescribe a dosage in excess of the recommended dosage of a pain relieving
agent if he certifies the medical necessity for such excess dosage in the
patient's medical record. Any person who prescribes, dispenses or
administers an excess dosage in accordance with this section shall not be
deemed to be in violation of the provisions of this title because of such
excess dosage, if such excess dosage is prescribed, dispensed or
administered in good faith for accepted medicinal or therapeutic purposes.
The deference by courts to administrative agencies responsible for
professional discipline, coupled with the bias reflected in the attitudes of
members of such agencies regarding the prescribing of opioids, afford scant
protection for the physician treating pain aggressively with opioids in
accordance with accepted professional, but not "community," standards. The
standard asserted by boards of medicine simply does not reflect the changing
academic understanding regarding the use of these medications. Under these
circumstances, peer review by boards of medicine, rather than affording due
process protection, undermines it.
Top of Page
III. The Supreme Court and Patient Autonomy
A. Substantive Due Process and Fundamental Rights
The United States Constitution proscribes government actions that deprive
persons of "life, liberty, or property" without due process of law. The
United States Supreme Court has established that due process "bars certain
arbitrary government actions regardless of the fairness of the procedures
used to implement them." The scope of judicial protection of life, liberty,
and property has been subject to varying judicial interpretation, however.
Those substantive rights that fall within the judicially recognized,
constitutionally protected sphere are referred to as "fundamental." The
Court imposes a standard of review, referred to as "strict scrutiny,"in
situations where state action infringes "fundamental rights." Under a strict
scrutiny standard of review, state action may be justified only by a showing
of a compelling state interest. "[A] governmental purpose to control or
prevent activities constitutionally subject to state regulation may not be
achieved by means which sweep unnecessarily broadly and thereby invade the
area of protected freedoms."
The Court has long recognized a fundamental right of patient autonomy in a
variety of clinical and procedural contexts, such as 1) the right to control
procreation, 2) the right to bodily integrity and freedom from intrusion, 3)
the right of mental patients and prisoners to refuse medication to treat
mental illness, and 4) the right to refuse medical treatment, even in the
context of expected death. The right of a patient with severe, chronic pain
to choose treatment with opioids is a logical application of the rights
articulated by the Court in the cases cited above.
Planned Parenthood of Southeastern Pennsylvania v. Casey is the most recent
affirmation of the "fundamental right" of a woman to terminate her pregnancy
before fetal viability. The opinion recognized this right as a substantive
component of the liberty interest protected by the Due Process Clause of the
Fourteenth Amendment. The Court quoted Justice Brandeis: "[I]t is settled
that the due process clause of the Fourteenth Amendment applies to matters
of substantive law as well as to matters of procedure. Thus all fundamental
rights comprised within the term liberty are protected by the Federal
Constitution from invasion by the States."
In defining the scope of "a realm of personal liberty which the government
may not enter," the Court explicitly rejected a restriction on the scope of
liberty to the Bill of Rights or the practices of the States contemporaneous
with the adoption of the Fourteenth Amendment, and looked to the application
of "reasoned judgment," guided by "the balance which our nation, built upon
postulates of respect for the liberty of the individual, has struck between
that liberty and the demands of organized society."
The Court explained the inclusion of personal decisions relating to
marriage, procreation, contraception, family relationships, child rearing
and education as within the purview of constitutional protection by noting
that these "matters, involving the most intimate personal choices a person
may make in a lifetime, choices central to personal dignity and autonomy,
are central to the liberty protected by the Fourteenth Amendment." The Court
noted that a woman's "suffering is too intimate and personal for the State
to insist, without more, upon its own vision of the woman's role, however
dominant that vision has been in the course of our history and our culture."
Finally, the Court viewed its holding to be but an extension of its reading
of Roe "as a rule of personal autonomy and bodily integrity, with doctrinal
affinity to cases recognizing limits on governmental power to mandate
medical treatment or to bar its rejection."
B. The Implications of Casey for Pain Therapy
The reasoning in Casey supports the right of patients to receive the
prescription of approved medications to consenting patients by licensed
physicians in accordance with professionally accepted norms of clinical
practice. First, the right to obtain an abortion is analogous to the
right to obtain medication to relieve pain, insofar as both are actively
sought interventions that require the cooperation of a physician. It would
be inconsistent for a Court which views the right to obtain an abortion as
an extension of the rule of personal autonomy and bodily integrity not to
accord a similar right to a patient seeking to treat illness.
Second, in spite of the its acknowledgment that abortion is "fraught
with consequences for others," the Court relies upon the intimate and
personal nature of a woman's suffering implicated in decisions regarding
procreation as justifying a boundary beyond which the state may not intrude.
But certainly disease, and the pain and the intimations of mortality that
accompany it, are no less intimate and personal, no less a context in which
one defines "one's own concept of existence, of meaning, of the universe,
and of the mystery of human life" that the Court finds to be "at the heart
of liberty."
The connection between pain, death, and life's meaning is underscored by the
fact that the desire to avoid pain and suffering often provides the
motivation for "rational suicide." To deny a patient relief of chronic pain
may, in some instances, effectively condemn that patient to death. The
overwhelming duty of a physician confronted with a suicidal patient is to
take steps to prevent suicide, which, in this circumstance, might be simply
to provide more effective pain relief. In this factual setting, the
distinction between life and liberty is more form than substance, and the
Due Process guarantee might reasonably be called upon to vindicate both
rights.
Third, Casey restricts the State's right to interfere unduly with a
patient's access to a medical procedure. "Only where state regulation
imposes an undue burden on a woman's ability to make this decision does the
power of the State reach into the heart of the liberty protected by the Due
Process Clause." As applied to the regulation of abortion, "[a] finding of
an undue burden is a shorthand for the conclusion that a state regulation
has the purpose or effect of placing a substantial obstacle in the path of a
woman seeking an abortion of a nonviable fetus." This test calls for a
quasi-empirical analysis to determine the probability that a regulation will
discourage an otherwise willing woman from obtaining an abortion. Although
the term "substantial obstacle" is left undefined, a regulation which makes
an activity protected by the right illegal would clearly pose such an
obstacle. In the context of pain management, those statutes and regulations
which penalize the prescribing of opioids for the treatment of chronic pain
would probably be seen as imposing an "undue burden" on patient access to
treatment.
The "undue burden" test is, in reality, a balancing test of the benefits and
harms to society and to individuals in one regulatory regime versus an
alternative. The current regulatory scheme governing opioids is designed to
achieve a social utility 1) by stemming the flow of prescription medication
to illegitimate purposes and 2) by preventing patients from becoming
addicted after medical exposure. A new regulatory standard allowing
physicians to provide more medication to "deserving" patients could increase
the opportunities for fraudulent diversion to non-medical use, as well as
increase the number of medically-induced addicts . Some studies suggest,
however, that what has been considered illegitimate is medically justifiable
use, and that the dimensions of the problem of diversion via prescription
fraud have been exaggerated. Given the speculative nature of the
cost-benefit calculus at this level of analysis and scant scientific support
for the proposition that medical prescribing contributes significantly
either to "street" addiction or drug diversion, a state might be hard
pressed to assert that such concerns should override a patient's interest in
relief of pain.
Finally, if a patient's liberty interest in pain therapy were subsumed in
the"fundamental right" to "personal autonomy and bodily integrity,"
Casey
would subject the regulation of the prescribing of opioids for pain to a
"strict scrutiny" standard of review. Accordingly, such regulation could be
"sustained only if drawn in narrow terms to further a compelling state
interest." Under such a standard, the regulatory scheme would need to be
carefully crafted to avoid its inhibitory effect and to protect patient
autonomy. Although a regulatory scheme, such as that upheld in Whalen v. Roe
(requiring triplicate prescription forms for Schedule II Controlled
Substances), might still prevail under strict scrutiny.
In sum, the reasoning and holding of Casey would appear to support the
inclusion of a patient's right to treatment with opioids within the
protection of the substantive component of the Due Process Clause of the
Fourteenth Amendment as a "fundamental right." Such inclusion would be
coherent with the principle of "personal autonomy and bodily integrity"
articulated in Casey and finds further support in the "intimate and personal
nature" of that sphere of personhood upon which the state may not lightly
intrude. The "undue burden" test articulated in Casey, as well as the
"strict scrutiny" standard of review, would subject regulations governing
the prescribing of opioids to a careful balancing of pubic benefits and
private costs and probably lead to a rejection of those statutes and
regulations which penalize the prescribing of opioids without reference to
clinical circumstances.
Top of Page
IV. The Americans with Disabilities Act and the Treatment of Pain
A. The Scope and Purpose of the ACT
The Americans with Disabilities Act of 1990 (ADA) is a "remedial statute,
designed to eliminate discrimination against the disabled in all facets of
society." Congress took note of the fact that "unlike individuals who have
experienced discrimination on the basis of race, color, sex, national
origin, religion, or age, individuals who have experienced discrimination on
the basis of disability have often had no legal recourse to redress such
discrimination." The ADA addresses the problems of the disabled due to
discrimination in employment under Title I, in the provision of services by
governmental entities under Title II, and in public accommodations and the
services provided by private entities under Title III.
Under Title II, discrimination is defined as follows:
No qualified individual with a disability shall, by reason of such
disability, be excluded from the participation in, be denied the benefits
of, or be subjected to discrimination by a department, agency, special
purpose district, or other instrumentality of a State or a local government.
Title II, Section 201 defines "qualified individual with a disability to
mean: The hypothetical standard suggested above is, of course, discriminatory
against all patients with a poor prognosis in spite of aggressive care.
Whether prognosis can be the legitimating principle of a clinical decision
to withhold treatment against the patient's (or her surrogate's) wishes is
the crux of the legal dilemma. The literal application of the ADA under a
disparate impact test suggests that "poor prognosis" alone could be
construed as a "disability" affording protection against less than
aggressive care, as the Baby K court concluded. Top of Page
an individual with a disability who, with or without reasonable
modifications to rules, policies, and practices… meets the essential
eligibility requirements for the receipt of services or the participation in
programs or activities provided by a department, agency… other
instrumentality of a State or a local government.
Under Title III, Section 302(a), discrimination has a more extensive
definition, but omits the requirement that an individual be "qualified:"
General Rule. No individual shall be discriminated against on the basis of
disability in the full and equal enjoyment of the goods, services,
facilities, privileges, advantages, and accommodations of any place of
public accommodation.
Under Section 302(b), this rule is elaborated as follows:
(i) Denial of participation. It shall be discriminatory to subject an
individual or class of individuals on the basis of a disability or
disabilities of such individual or class, directly, or through contractual,
licensing, or other arrangements, to a denial of the opportunity of the
individual or class to participate in or benefit from the goods, services,
facilities, privileges, advantages, and accommodations of an entity.
To effectuate the remedial purpose of the Act, Congress articulated its
intent "to invoke the sweep of congressional authority, including the power
to enforce the fourteenth amendment and to regulate commerce, in order to
address the major areas of discrimination faced day to day by people with
disabilities." Thus, the ADA supplements the substantive due process
protections afforded by the Fourteenth Amendment to disabled persons in a
broad range of circumstances involving their relationships with public and
private entities.
(ii) Participation in unequal benefit. It shall be discriminatory to afford
an individual or class of individuals, on the basis of a disability or
disabilities of such individual or class, directly, or through contractual,
licensing, or other arrangements with the opportunity to participate in or
benefit from a good, service, facility, privilege, advantage, and
accommodation that is not equal to that afforded to other individuals.
(iii) Separate benefit. It shall be discriminatory to provide an individual
or class of individuals, on the basis of a disability or disabilities of
such individual or class, directly, or through contractual, licensing, or
other arrangements with a good, service, facility, privilege, advantage, or
accommodation that is different or separate from that provided to other
individuals, unless such action is necessary to provide the individual or
class of individuals with a good, service, facility, privilege, advantage,
or accommodation, or other opportunity that is as effective as that provided
to others.
B. The Definition of Disability, Medical Discrimination, and Chronic Pain.
The ADA defines "disability" as "a physical or mental impairment that
substantially limits one or more of the major life activities... a record
of such an impairment; or being regarded as having such an impairment."
"Physical and mental impairment" is further defined to include, inter alia,
any physiological disorder or condition affecting the neurological system,
musculoskeletal system, or sense organs. Thus, severe chronic pain, or the
medical conditions which give rise to it, satisfy the legislative definition
of "disability."
However, the determination of discrimination under the ADA as it applies to
medical treatment of a disability is problematic. Imagine that a patient
suffers from a disease which might be characterized as a disability and for
which there is no effective treatment. As compared with non-disabled
individuals with treatable illnesses, the patient with the untreatable
condition suffers discrimination as defined under Section 302(b)(ii) insofar
as this patient is afforded an unequal benefit, i.e. no treatment. But, it
would be manifestly unfair to hold a physician liable under the ADA for his
failure to treat an untreatable disease. Under this analysis, the mere fact
of disparate impact on the basis of a disability should not constitute
discrimination under the ADA in the context of the provision of medical
services.
If the patient's entitlement is characterized as the right to whatever
professional services may appropriately be provided in his treatment, then
determination of discrimination may be predicated on a failure to conform to
the standard of care applicable to the condition. Thus, the patient in the
illustration above would not suffer discrimination as long as he receives
medical care appropriate to his condition.
This does not completely eliminate the legal dilemma, however, as the
standard of care "appropriate" for a particular condition may be a
reflection of impermissible discrimination. Imagine a patient infected with
the Human Immune-deficiency Virus (HIV), who would like a disfiguring scar
removed by a plastic surgeon. Assume for the purpose of this illustration
that, absent HIV infection, there would be no reluctance on the part of the
surgeon to perform the procedure. Under a standard of care that acknowledged
the risk of infection to medical personnel and declared that proper
treatment of HIV-infected individuals does not include elective plastic
surgery, the surgeon's refusal to perform the procedure would not constitute
discrimination under this construction of the ADA. However, this would
constitute discrimination under a "disparate impact" analysis pursuant to
Section 302(b)(i) as a denial of a benefit on the basis of a disability.
The relevant inquiry is whether the standard of care is itself a source of
impermissible discrimination--a "discriminatory standard" analysis. The
policy determination may turn on whether the standard has been promulgated
to protect the interests of the patient. What weight to accord protection of
the public health and of the interests of health care providers where they
come into conflict with the interests of the patient is a matter of public
policy and politics. The limits of political intrusion upon the rights of
patients is subject to the resolution of the Constitutional issue raised in
the previous section.
The rights of pain patients under the ADA may be subjected to both a
"disparate impact" and a "discriminatory standard" analysis. It is apparent
from the literature cited earier that pain is undertreated in a variety of
clinical contexts. For purposes of ADA analysis, it is useful to look at
pain along two diagnostic dimensions: 1) malignant versus non-malignant and
2) acute versus chronic.
The term "malignant pain" refers to that pain resulting from cancer, and the
term "non-malignant pain" refers to pain resulting from other causes,
whether or not the underlying condition is associated with a shortened life
expectancy. As noted above, cancer pain is undertreated. There is a
well-accepted standard of care in the treatment of cancer pain to the effect
that the dose of medications, including opioids, should be inidividualized
to enable patients "to function as they choose and to die relatively pain
free." Under a disparate impact analysis, therefore, patients who are denied
such care for other than clinical reasons may be the victims of
discrimination under the ADA.
Pain patients without cancer are also denied such treatment. For the sake of
argument, let us assume that the standard of care applicable to such
patients is to withhold opioids, in spite of the lack of efficacy of
alternative treatments. In this circumstance, under the analytic framework
presented above, the demonstration of a disparate impact alone would not be
sufficient to assert an ADA violation. If, however, the standard of care can
be shown to rely upon considerations not relevant to the clinical
circumstances of such patients, such a standard might be deemed
discriminatory, entitling patients to treatment with opioids.
A similar analysis applies with respect to the distinction between "acute"
and "chronic" pain, where the term "acute" refers to a short course of
expected treatment following surgery or physical trauma. It is now almost
universally recognized that opioids may be used aggressively in the
treatment of "acute" pain. Again, patients with "acute" pain denied adequate
treatment could assert discrimination based on disparate impact. Assuming
that the standard of care for "chronic" pain patients denies them the
aggressive use of opioids, an alternative basis to challenge such a standard
as discriminatory is possible. There is no fixed definition delineating when
"acute" pain becomes "chronic." A patient may recover more or less quickly
after a surgical procedure or trauma. A standard of care predicated upon an
arbitrary time interval and unrelated to the clinical condition of the
patient must be arbitrary, hence discriminatory against those arbitrarily
denied continued pain medication.
In a recent case, a hospital sought a declaratory judgment as to its
obligations under the ADA in the care of a child born without a cerebral
cortex, a condition known as "anencephaly." In spite of the mother's wishes
to the contrary, the hospital wished to withhold ventilator support in the
event that the child stopped breathing, asserting the futility of such
efforts. The court held that
"the plain language of the ADA does not permit the denial of ventilator
services that would keep alive an anencephalic baby when those life-saving
services would otherwise be provided to a baby without disabilities... The
Hospital's reasoning would lead to the denial of medical services to
anencephalic babies as a class of disabled individuals. Such discrimination
against a vulnerable population class is exactly what the Americans With
Disabilities Act was enacted to prohibit."
In this case the court applied a "disparate impact" analysis, i.e. but for
the "disability" of anencephaly, the hospital would treat aggressively,
therefore, the hospital must treat aggressively in spite of the
"disability." The hospital could have asserted a "disparate impact" argument
for withholding respiratory support compatible with the ADA. To wit:
Whenever a patient, with or without a disability, is a candidate for
life-saving respiratory support, neutral considerations relating to the
expected outcome of aggressive therapy determine the decision; the disabling
condition, as such, is irrelevant to the medical decision to provide or
withhold treatment; therefore, as the rights of anencephalic children, as a
class, were not implicated, there would be no violation of the ADA.
C. The ADA and Illegal Drugs
The ADA makes explicit provisions regarding the illegal use of drugs and the
context in which such use limits rights under the Act. First, the ADA
excludes illegal drug use, per se, as a disability. However, such use "does
not include the use of a drug taken under supervision by a licensed health
care professional..." The Act includes within its purview "an individual
who... is erroneously regarded as engaging in [illegal] use, but is not
engaging in such use..." Insofar as patients who require opioids for the
treatment of pain are often "erroneously regarded as engaging" in illegal
use, the plain language of the Act appears to specifically protect such
patients from discrimination. The Act goes even further in stating that "an
individual shall not be denied health services...on the basis of the current
illegal use of drugs if the individual is otherwise entitled to such
services." The clear implication of this language is that even a known
addict with a painful condition should not be denied medication for pain
merely on the basis of his addiction, if a non-addict in similar clinical
circumstances would be so treated.
D. The ADA and the Regulation of Medical Practice
Title II of the ADA provides that "no qualified individual with a disability
shall… be subjected to discrimination by [a public] entity." "The term
'qualified individual with a disability' means an individual with a
disability who, with or without reasonable modifications to rules, policies,
or practices… meets the essential eligibility requirements for the receipt
of services… provided by a public entity." "Public entity" in this
subchapter includes "any department, agency… or other instrumentality of a
State… or local government." And the ADA explicitly abrogates state immunity
under the Eleventh Amendment:
In any action against a State for a violation of the requirements of this
chapter, remedies (including remedies both at law and in equity) are
available for such a violation to the same extent as such remedies are
available for such a violation in an action against any public or private
entity other than a State.
Whether a patient's treatment by a state-licensed physician is the "receipt
of services" provided by the state, and thus enables the patient to be
considered a "qualified individual" under this subchapter, has not yet been
fully adjudicated. A recent case in Alabama suggests that the denial to a
patient of access to the services of a licensed provider through the
application of state licensure provisions would entitle the patient to
protection under the ADA.
The Alabama Department of Public Health refused to extend the license to
operate an assisted living facility on the grounds that the facility was
caring for residents with Alzheimer's disease whose medical requirements
were greater than those permitted by Alabama regulations. The Department
made the facility's expulsion of these residents a condition of licensure.
The residents sued the Department, alleging that enforcement of the
regulations violated their rights under the ADA. In permitting the suit to
proceed, the court implicitly recognized a colorable claim by the residents
against the Department. A pain patient, the license of whose physician is
threatened as a result of his treatment, would be in an analogous position
to the residents with Alzheimer's Disease and would be entitled to relief
under the ADA.
Assuming that a patient has standing as a "qualified individual" to sue a
state licensure authority, a claim may be asserted upon either of two
theories: denial of meaningful access or intentional discrimination. Proof
of denial of meaningful access requires a showing that, because of a
disability, the claimant cannot derive a benefit from a public program
sufficiently like the benefit accorded to people without the disability.
The most logical criterion from a clinical point of view for the
meaningfulness of access would be the efficacy of treatment. A court might
rely, however, on a more mechanical measure of access such as the amount or
type of medication allowed. Such a rule has the virtue of administrative
simplicity, however, it ignores the variability of medication requirements
among patients with similar conditions. Assume, for example, that diabetic
patients may require over 100 units of insulin daily, although many will be
adequately treated with a much lower dose. A state policy which limited
treatment to only 20 units per day, regardless of the resulting blood sugar,
would appear to deny "meaningful access" to those requiring the higher dose.
Once denial of meaningful access is established, the court must balance the
cost of modification of the rules, policies, or practices against the
benefits expected to accrue to the disabled claimants. This is referred to
as "the reasonable accommodations test." This test requires a balancing of
the cost and benefits of an alternative regulatory standard.
A claim may also be asserted alleging "intentional discrimination" based
upon "improper criteria" that unnecessarily exclude qualified individuals. A
regulatory policy that failed to distinguish pain patients from addicts or
that relied on the number of pills prescribed or the duration of therapy as
the basis for sanction, without regard for the attendant clinical
circumstances, might be illustrations of "improper criteria."
Section 102(b)(4) of the ADA defines as within the scope of discrimination
"excluding or otherwise denying… benefits to a qualified individual because
of the known disability of an individual with whom the qualified individual
is known to have a relationship or association." Section 502 of the ADA also
makes it "unlawful to coerce, intimidate, threaten, or interfere with any
individual . . . on account of his or her having aided or encouraged any
other individual in the exercise or enjoyment of, any right granted or
protected" by the Act. Accepting for the sake of argument that a physician
has a legal duty under the ADA to provide adequate treatment to his patients
with chronic pain, under these provisions, a physician could assert a claim
against a state for disciplinary action against his license prompted by his
use of opioids in the treatment such patients.
V. Conclusion
This Comment has argued that the right of patients to choose treatment with
opioids for chronic pain is within the sphere of medical autonomy
constitutionally protected as a "fundamental right" deserving the highest
standard of judicial scrutiny. It has also argued that the ADA supplements
the Fourteenth Amendment rights and confers a cause of action on those whose
right to pain treatment has been denied, as well as on those physicians
whose treatment of such patients has resulted in disciplinary action against
them.
[END]
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Dr. DeLuca's Addiction, Pain, and Public Health Website |
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| Alexander DeLuca, M.D., FASAM |
Originally posted: 11/20/2003 |
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All Email to: adeluca@doctordeluca.com |
Most recently
revised: 4/22/2005 |
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