11.01 Double-Effect; Introduction

11.02 The Principle of Double-Effect

11.03 Historical/Religious Development

11.04 Ethical Considerations

11.05 Legal Considerations

11.06 Clinical Effects

11.07 Double-Effect Versus Euthanasia

11.01 Double-Effect; Introduction

Slowly in the course of a terminal illness the body weakens and its reserves dwindle. Frequently as this happens the mind becomes less active and less tormented -- more accepting of the reality of death. At the same time, pain and other symptoms may also decrease, and the last few days of life may be totally devoid of significant suffering up until the time, as usually happens, the patient falls into a deep sleep or coma which quietly precedes death.

At other times, however, death is not so benevolent. Pain and other symptoms like nausea and shortness of breath may continue and even get worse requireing increasing medical intervention to obtain relief. When this happens, physicians are forced to make a difficult decision -- as body strength falters it becomes less and less tolerant of high doses of drugs, but as pain and suffering increase, adequate treatment requires ever increasing amounts of medication. Eventually a point is reached at which further increases in drug dosages to adequately control pain or other symptoms may be beyond the limit of body tolerance and could easily result in death.

The question this dilemma raises is when does the known risk of death from giving medications sufficient to control symptoms become potential manslaughter if death should occur? This chapter on the theory of "double-effect" discusses this issue. In reading the chapter it is important to keep in mind the use of the double-effect theory almost always relates to a situation involving an end-stage terminal illness at a point in time when essentially everyone involved in the patientís care has accepted that death is no longer the patientís enemy, but would be a welcomed, if not sought after, event.

It is also well to keep in mind how common double-effect therapy is in the last few days of life. In the Netherlands, where euthanasia has been practiced openly for years, a recent very well researched report noted less than four percent of deaths occurred as a result of active euthanasia, but 17.5% were probably hastened by the giving of drugs to relieve terminal suffering.

11.02 The Principle of Double-Effect

"Double-effect" has been defined as "the administering of opioids or sedative drugs to relieve pain and suffering in a dying patient with the incidental consequence of causing either respiratory depression or extreme sedation or both, resulting in the patientís death."

For an action leading to a patientís death to be held to be both ethical and moral based on this concept, it must conform to the following four legal requirements:

1. the action itself must be good or indifferent;

2. the good effect and not the evil effect must be the one sincerely intended by the agent;

3. the good effect must not be produced by means of the evil effect; and,

4. there must be a proportionate reason for permitting the foreseen evil effect to occur.

Applying these requirements to the situation of the suffering, terminally ill patient:

1. the action must be undertaken with a reasonable chance of reducing pain and/or suffering;

2. the action must be primarily intended to relieve pain and suffering, not to produce death;

3. the action cannot be undertaken with the intent of producing death as a means of achieving relief from pain and suffering; and

4. there must be enough reason to undertake the action, such as increasing the dosage of morphine as needed to control pain, to risk the foreseeable chance of producing death.

The general principle of "double-effect" therapy was well summarized by Dr. Timothy Quill in a 1995 article in the Archives of Internal Medicine entitled "You Promised Me I Wouldn't Die Like This! A Bad Death as a Medical Emergency":

The doctrine of double effect relies on a sharp distinction between intentions and consequences. Interventions that are intended to have a "good" primary purpose, such as the relief of suffering, can be justified even if they have unintended "bad" consequences, such as contributing to a patient's death. Such bad effects can even be anticipated as long as they are not intended. This distinction has freed physicians to provide high doses of opioid analgesics to patients who are dying in pain, even if this intervention indirectly contributes to an earlier death. In practice, one can frequently find a pain regimen that provides sufficient relief without compromising the patient's consciousness of life span, but here again data are lacking. Double effect has recently been extended to treat patients who are tormented in dimensions other than pain. The primary intent of this intervention is to relieve suffering, and the sedated patient is then allowed to die of his or her disease, the barbiturates, pneumonia, and/or dehydration since he or she can no longer eat or drink. To remain within the confines of the double effect, death in these extreme circumstances may be foreseen, but must not be intended.

To keep double-effect therapy within medically accepted boundaries, one must be able to say the patient died from a disease and not from the intended effects of the medication. It must be a rational statement to say death occurred as the result of the combined physical effect of the disease process and the medications which were required to treat the disease.

Although double-effect therapy is often considered to be quite different than other therapies because of ethical and legal considerations, it is not very different medically. Whenever a medical intervention is undertaken, there is always some identifiable and foreseeable risk to the patient, and often at least a minimal risk to the patientís life. In every case, the physician is expected to evaluate the risks and benefits of treatment, to recommend a course of treatment, and to provide treatments chosen by the patient or a surrogate speaking for the patient.

Thus, in a sense, the principle of double-effect comes into play every time a clinician chooses an antibiotic or chemotherapy regimen and weights the desired outcome against predictable toxicity; every time a surgeon and patient discuss the pros and cons of extensive surgery, life-threatening or not. Looked at in reverse, double-effect therapy is no different from any other medical therapy, the only difference being it is undertaken in a situation in which the risk of death is high but the risk worth taking because death is close at hand and in the absence of symptom control, there will be no pleasure in life prior to its occurrence.

11.03 Historical/Religious Development

The concept of double-effect can be found in the writings of Hippocrates, but is generally traced back to Aristotle through the thirteenth century teachings of St. Thomas Aquinas who invoked the principle of double-effect to justify a killing in self-defense. In his discussion, Aquinas stated: "The act of self-defense may have two effects, one is the saving of one's life, the other is the slaying of the aggressor. Therefore, this act, since one's intention is to save one's own life, is not unlawful." If, however, the act was undertaken with the intention of taking the otherís life, the description of the act could no longer be one of "self-defense" but rather one of "killing." St. Thomas then went on to say that even if an individual foresees the appropriate force used in self-defense will definitely result in death, this would not imply the individual's intention, and therefore it would not be a killing.

More recently the Catholic Church has applied the concept of double-effect to medical care, the classic case being one in which a pregnant woman develops cancer of the uterus. In this situation the death of the unborn child resulting from the performance of a hysterectomy is held not to be a killing under the theory of double-effect as long as the four usual limitations are fulfilled. First, the action causing the dual effect must be good -- the removal of a cancerous uterus saves the life of the mother. Second, the good effect must not be obtained by means of the evil effect -- in this case, saving the mother is not the direct result of ending the life of the unborn child. Third, sufficient reason exists for permitting the unsought evil effect -- in this case, saving the life of the mother justifies the unavoidable death of the child. Fourth, the evil effect is not intended in itself, but is merely allowed as a necessary consequence of the good effect -- the object is not to kill the child but to save the mother.

In applying these principles to the question of double-effect therapy to the treatment of the terminally ill patient, the 1994 Catechism of the Catholic Church in ß 2279 reads:

Even if death is thought imminent, the ordinary care owed to a sick person cannot be legitimately interrupted. The use of painkillers to alleviate the sufferings of the dying, even at the risk of shortening their days, can be morally in conformity with human dignity if death is not willed as either an end or a means, but only foreseen and tolerated as inevitable. Palliative care is a special form of disinterested charity. As such it should be encouraged.

11.04 Ethical Considerations

The religious formulation of the rational for double-effect therapy is closely followed by medical ethicists, again listing the necessary limitations as requiring that (a) the action is good in itself; (b) the intention of the act to be solely to produce the good effect; (c) the good effect is not achieved through the bad effect; and (d) there be sufficient reason to permit the bad effect.

As in the religious considerations, the ethical validity of the principle of double-effect requires a close look to insure the proper primary intent of the action because of the ethically significant distinction between foreseeing a potential undesired effect and intending an unavoidable maleficent outcome.

This difference between intended and unintended but foreseen consequences of medical treatment was well addressed by the first Presidentís Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Deciding to Forego Life-Sustaining Treatment in 1983 which concluded the relevant moral issue "is whether or not the decisionmakers have considered the full range of foreseeable effects, have knowingly accepted whatever risk of death is entailed, and have found the risk to be justified in light of the paucity and undesirability of other options."

11.05 Legal Considerations

Theoretically, the "double-effect" doctrine may conflict with the usual legal definitions of reckless homicide or involuntary manslaughter, which could lead to prosecution of the physician if he or she was held to have consciously disregarded "substantial and unjustifiable risk to human life." Fortunately, the legal system in every state in America has refused to take this approach and has uniformly accepted the concept of double-effect therapy.

Some states, including Indiana, Iowa, Kentucky, Michigan, Minnesota, Ohio, Rhode Island, South Dakota, Tennessee and Washington specifically mention it in their statutes, while others, including Maine, New Mexico, South Carolina, and Virginia specifically permit patients to sign health-care directives in which they authorize pain treatment even if it hastens death. In the remaining states, the same acceptance of double-effect therapy as relieving physicians from prosecution has been routinely upheld, even in the case of Dr. Jack Kevorkian, whose lawyer argued his intent in assisting "his" patientís suicides was to relieve suffering -- death being a necessary collateral consequence.

The question of double-effect therapy has produced some interesting comments in the legal literature. In a famous Dutch case referred to as the "Postma decision," the court found a woman guilty of killing her mother when doses of narcotic intended to relieve her pain were all given at once with the intent of causing her death even though the mother was terminally ill. The court said if the doses had been given as ordered to relieve pain and the mother had died, the woman would not have been guilty of any wrongdoing.

In the recent U.S. Supreme Court decisions involving physician assisted suicide, the Court clearly differentiated and essentially approved the double-effect principle noting "when a doctor provides aggressive palliative care; in some cases, painkilling drugs may hasten a patient's death, but the physician's purpose and intent is, or may be, only to ease his patient's pain."

The New York Task Force set up by then Governor Cuomo in a report under the title: "When Death is Sought," stated: "It is widely recognized that the provision of pain medication is ethically and professionally acceptable even when the treatment may hasten the patient's death, if the medication is intended to alleviate pain and sever discomfort, not to cause death."

Finally, the Select Committee On Medical Ethics of the British House of Lords addressed the question of the need to rely on physicians to determine the intent of giving medication with the following statement:

In the small and diminishing number of cases in which pain and distress cannot be satisfactorily controlled, we are satisfied that the professional judgment of the health care team can be exercised to enable increasing doses of medication (whether of analgesics or sedatives) to be given in order to provide relief, even if this shortens life. The adequate relief of pain and suffering in terminally ill patients depends on doctors being able to do all that is necessary and possible. In many cases this will mean the use of opiates or sedative drugs in increasing doses. In some cases patients may in consequence die sooner than they would otherwise have done, but this is not in our view a reason for withholding treatment that would give relief, as long as the doctor acts in accordance with responsible medical practice, with the objective of relieving pain or distress and with no intention to kill.

11.06 Clinical Effects

The acceptance of the concept of double-effect has freed physicians to provide high doses of narcotic pain relievers to patients who are dying in pain, even if this intervention indirectly contributes to an earlier death. In medical practice the physician can usually find a therapeutic pain-relief regimen which provides sufficient relief without compromising the patient's consciousness, but it is not always possible and it is certainly unpredictable. If the physician had reason to worry each time a large dose of narcotic was given to a weakened patient, his or her ability to control pain and other symptoms would be very compromised.

Although double-effect therapy is most frequently considered when dealing with pain, it has recently been extended to treat patients who are tormented in other dimensions as well. As long as the primary intent of the intervention is to relieve suffering, whether the suffering is in the form of pain, shortness of breath, nausea, or any other form, it doesnít matter. Morally, ethically, legally and medically, whether the patient dies of his or her disease, the medications, pneumonia, and/or dehydration since he or she can no longer eat or drink, it is considered to be death by natural causes. All that is required is that the physician remain within the confines of intending the relief of suffering and not death itself -- death in these extreme circumstances may be foreseen, but must not be intended.

11.07 Double-Effect Versus Euthanasia

Some commentators suggest double-effect theory is just a charade for euthanasia, used purely to legitimize the prevalent use of excessive morphine which is administered by physicians who know or suspect it will cause death. At times, as in the case of Dr. Kevorkian, it is hard to argue with this opinion, but many physicians say this is fine. They suggest that although they are antagonistic to legalizing euthanasia because of the potential for abuse, they like knowing if a patient is truly suffering, they do not have to worry even if they know the level of medication ordered will almost certainly result in the patientís death.

The same report of the House of Lords quoted above also addressed this problem saying:

Some witnesses suggested that the double-effect of some therapeutic drugs when given in large doses was being used as a cloak for what in effect amounted to widespread euthanasia and suggested that this implied medical hypocrisy. We reject that charge, while acknowledging that the doctor's intention, and evaluation of the pain and distress suffered by the patient, are of crucial significance in judging double effect. If this intention is the relief of severe pain or distress, and the treatment given is appropriate to that end, then the possible double effect should be no obstacle to such treatment being given. Some may suggest that intention is not readily ascertainable. But juries are asked every day to assess intention in all sorts of cases and could do so in respect of double effect if in a particular instance there was any reason to suspect that the doctor's primary intention was to kill the patient rather than to relieve pain and suffering. They would no doubt consider the actions of the doctor, how they compared with usual medical practice directed towards the relief of pain and distress, and all the circumstances of the case. We have confidence in the ability of the medical profession to discern when the administration of drugs has been inappropriate or excessive.

Table of Contents Introduction Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7
Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Chapter 13 Chapter 14 Chapter 15 Chapter 16 Chapter 17

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