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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 It has remained an unpublished work, until now, December 7, 2003.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.

 

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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.

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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.

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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.

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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:

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.

(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.
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.

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.

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.

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.

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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]

 

Dr. DeLuca's Addiction, Pain, and Public Health Website

Alexander DeLuca, M.D., FASAM

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Originally posted: 11/20/2003

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