SOUTHEAST TENNESSEE LEGAL SERVICES

 

 

Intense pain – not illness, injury, or even death -- may be a patient’s greatest fear. Relief from pain may be his or her greatest desire. Yet, morphine and other drugs  are administered less often and in smaller doses than sound medical practice would permit.

One of the reasons for this anomaly is that doctors fear professional sanctions and even criminal prosecution if they prescribe drugs that may be said to create addiction or hasten death. It is among the legal matters discussed in this memorandum, as follows:

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The Ethical Obligations of Physicians

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Standards for Accreditation of Health Care Organizations

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State Medical Board Guidelines

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The Medical Value of Narcotics

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The Principle of Double Effect

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State Regulation of Narcotics

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Criminal Prosecutions

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Guidelines for Prosecutors

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Intractable Pain Statutes

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Statutes that Protect the Elderly from Abuse and Neglect

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Civil Litigation

The Ethical Obligations of Physicians

The American Medical Association has concluded in its Code of Ethics  that "physicians have an obligation to relieve pain and suffering and to promote the dignity and autonomy of dying  patients in their care. This includes providing effective palliative treatment even though it may forseeably hasten death."[1] In other words, narcotics – more properly called opioids – can and must be used if they are the appropriate tools for the relief of the excruciating pain that can occur as life ends. 

Standards for Accreditation of Health Care Organizations

In 2001, the Joint Commission on Accreditation of Health Care Organizations issued new standards for pain management. 

Although the standards apply only to hospitals , nursing homes, HMOs and other organizations, they have the potential to drive the actions of state medical and nursing boards, federal agencies, and the courts. They suggest what is or should be the standard of care .

 Practice guidelines have been used in malpractice litigation as evidence of the standard of care in a number of cases.[2] For example, the Minnesota Supreme Court held that the trial court had erred by refusing to admit into evidence the Joint Commission’s guidelines on administering anesthesia.[3]  

State Medical Board Guidelines  

About half of state medical boards have established guidelines  regarding pain management, but they take divergent approaches. To promote consistency in state medical policy, the Federation of State Medical Boards adopted in May 1998 its Model Guidelines for the Use of Narcotics for the Treatment of Pain.[4]  

It “encourages physicians to view effective pain management as part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness.” It then declares: “The Board will judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient’s pain….”  

If this standard becomes the prevailing one on a national basis, it has the potential of removing all but the most egregious cases from the sanctions of licensing boards.  

The Medical Value of Narcotics 

There is a point where only opioids can provide relief from acute and severe pain.[5] That point can vary from patient to patient and from time to time with the same patient. Therefore, over time and with careful attention to both the patient’s history of pain and the prior dosages to treat it, physicians adjust the amount of narcotics given to a patient.  

            This process produces effects that are widely misunderstood outside the medical profession. To understand them, one must attach medical explanations to the words commonly used to describe these effects.  

Addiction. In the words of physicians, tolerance occurs when a constant dose of a drug produces declining effects or when a higher dose is needed to maintain an effect. Physical dependence on opioids is characterized by a withdrawal effect following discontinuation of a drug. Such dependence is a common effect in chronic pain management, but it is not restricted to opioids. It happens to everyone who uses opioids for more than a few days. All it means is that they should never be stopped suddenly. Instead, they should be weaned over a few days. However, if they are stopped suddenly, a patient may have withdrawal , a very uncomfortable flu-like syndrome including muscle aches, nausea, diarrhea, and sometimes vomiting or even muscle spasms.

Neither physical dependence nor tolerance should be equated with addiction or substance abuse. Addiction is a psychological and behavioral syndrome characterized by the loss of control over drug use, by compulsive use, and by continued use despite harm.[6]   

In other words, opioids do not lead to addiction any more than liquor creates alcoholism. This is not to say that addiction should not be feared. But the risk of addiction pales in comparison to the other problems of a person who may be severely ill or dying. 

Some pain relievers formerly were regulated but are now available over the counter in smaller doses than in prescription form. In either form, they often have limits on dosages, primarily because of the side effects. By contrast, physicians say that narcotics do not behave similarly. “The right amount of opioid medication is the amount that relieves your pain with minimal or tolerable effects. There is no usual dose…. Just as there is no usual dose, there is no maximum dose of opioids …. Also, there is no ceiling effect – no point when increasing the dose won’t work anymore to reduce the pain.”[7] 

Doctors believe that opioids in the class of morphine are safe, effective, and essential, especially when pain is severe.[8] To be effective, though, they must be available when and where patients need them and in adequate dosages. This presents an apparent conflict with state laws, criminal and civil, which may be administered on the mistaken notion that large dosages hasten death. 

        Hastening of Death. Two medical organizations issued a statement in 1996 that: “It is now accepted by practitioners of the specialty of pain medicine that respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naïve patient and is antagonized by pain.”[9] In short, they are not likely to hasten death. 

The Principle of Double Effect 

In deciding the assisted suicide cases,[10] the U.S. Supreme Court acknowledged the principle of double effect It means that medication administered for a primary purpose (control of pain) can have a secondary effect (the hastening of death). In other words, so long as the primary motivation is worthy, the undesirable consequence cannot be punished.  

State Regulation of Narcotics 

States regulate both the dispensing of narcotics and the licensing of physicians, pharmacies and nurses.  With such broad powers, they control not only the misuse of opioids but, while not necessarily meaning to do so, can frustrate the proper use of these drugs to relieve pain. The most debatable policies concerning the dispensing of opioids are: 

• Limits on the amount of narcotics that can be prescribed or dispensed at one time. 

• Limits on the number of days within which a prescription must be filled following its issuance, as little as three days. 

• Requirements that the physician issue prescriptions for opioids on government forms, often in triplicate, one copy of which becomes available to the state medical board.  

These regulations create subtle but widespread intimidation of physicians. Doctors fear that a disciplinary record is being accumulated against them if they prescribe in ways that anyone could question, even without a medical basis for an allegation.[11]  

Patients are affected too. When Texas adopted a multiple-copy program, prescriptions for opioids to control pain were cut by 43%.[12] While abuses may have been curbed, it seems just as likely that physicians opted for less effective management of pain in order to protect their licenses from challenge.  

Criminal Prosecutions 

The concerns of physicians about criminal charges are not frivolous. In a 1998 case[13] that concluded six years after the actions that were questioned, the Kansas Court of Appeals ordered the acquittal of a doctor, L. Stan Naramore. A jury had found him guilty of two crimes, sentencing him to five to 20 years in prison. The first was attempted murder of one patient in his treatment of her intractable pain. The other was second-degree murder in his decision to discontinue life-support for a different patient.

Although the state presented three experts to support its position, the defense had six witnesses who were at least as persuasive in concluding that proper medical procedures had been followed. The Court of Appeals set the convictions aside, noting that the evidence created more than a reasonable doubt of guilt.  More to the point, it found the doctor’s actions to be medically appropriate.  

Dr. Naramore is not the only physician to have been investigated or prosecuted. According to one survey, at least 13 physicians (other than Dr. Jack Kervorkian, who is widely known for his assistance to patients in committing suicide) have been investigated but not prosecuted. Six others have been indicted for murder, and there have been four trials so far. One resulted in an acquittal, another in a conviction overturned on appeal, a third in a conviction with an appeal pending, and the fourth in a hung jury. Two nurses have been investigated, and the trial of one was underway when the survey of cases was made. [14]  

Guidelines for Prosecutors 

In 2000, the Maryland Attorney General issued guidance to all local prosecutors in that state.[15] It recognized both the value of narcotics in relieving the pain of dying persons and the practical difficulty of establishing the wrongful intent that is a necessary ingredient of every crime. Its reasoning was two-fold.  

First, the use of opioids does not necessarily cause death. It  “usually occurs with the acute administration of morphine to an opioid-naive patient. Rarely, patients being treated chronically with opioids develop respiratory depression ...[16] Therefore, suspicion of  misconduct should not be based solely on the level of opioids in the blood.  

Second, even if respiratory depression from the use of narcotics becomes a cause of death, that secondary effect, though it may be foreseeable, is not a crime when the primary intent is to provide comfort care in accord with medical guidelines.  

The opinion concludes that a physician “who prescribes or administers opioids for the purpose of relieving pain or other symptoms, following appropriate medical practice in terms of titration and documentation, is not guilty of criminal homicide, even if the patient dies during the course of treatment.”  

Intractable Pain Statutes 

At least 15 states have enacted laws intended to protect physicians, nurses and pharmacists when narcotics are used for the treatment of pain. So far, their impact is uncertain. Some contain emphatic statements of the value of opioids in the relief of pain. Others have rigid definitions of what is the nature and degree of the pain that is covered by them.  

These laws have the virtue of allowing physicians to direct treatment for the alleviation of pain or discomfort at all times even if it would hasten death.[17] Virginia’s statute is even more expansive, covering also the risk of addiction.[18] 

However, they often define “intractable pain” as that “which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts....”[19] (emphasis added). Each of the italicized phrases creates problems in practical application.  

The definition adds unnecessary obligations to use efforts to find other possible forms of relief or cure. Tylenol™ can help to some degree and in some cases. But must it be tried unsuccessfully, and for how long, in situations when medical studies and a physician’s judgment call instead for morphine? A patient could be in a great deal of pain for a very long time while these questions are answered. 

Until recent years, it has been difficult to say what is the generally accepted course of medical practice concerning the use of narcotics for dying patients. The common denominator has been recognition of the value of opioids but a pervasive unwillingness in practice to use them. With the AMA statements and the pain management standards of the Join Commission as guidance, general acceptance may no longer be an issue.    

Statutes that Protect the Elderly from Abuse and Neglect  

Laws of this type carry a variety of sanctions ranging from criminal penalties to punitive damages to injunctions and compensatory damages.  They may also permit a successful claimant to receive reimbursement of his or her own attorney fees. As a result, they are potentially powerful tools in the hands of the elderly.  

A critical feature of them is the definition of “abuse or neglect" and in particular whether it includes the failure to manage pain properly.  

Civil Litigation 

In a 1990 North Carolina case,[20] a jury awarded $15 million in damages because pain was not treated appropriately. The patient had been admitted to the nursing home with prostate cancer that had metastasized to his left femur and to his spine. He was not expected to live more than six months. His physician prescribed morphine every three hours as needed for pain. However, a nurse employed by the nursing home considered the patient addicted to morphine. Without the consent of the physician, the nurse substituted a mild tranquilizer and delayed or withheld the administration of opioids. The parties to the lawsuit later agreed not to appeal and settled the matter for a lesser sum. 

A Georgia case[21] recognizes that pain management is an integral component of appropriate medical care. In it, a quadriplegic who could not breathe on his own sought court approval for withdrawal of a ventilator. The Georgia Supreme Court affirmed his right to refuse medical treatment. Importantly, it also said that  “his right to have a sedative (a medication that in no way causes or accelerates death) administered before the ventilator is disconnected is a part of his right to control his medical treatment.”

In 2001, a California jury held a doctor liable for under-treating pain.[22] The jurors found an internist responsible for elder abuse and recklessness and awarded a dying patient's family $1.5 million. The family said that the painkillers the patient received were only a fraction of the normal dosage. The damages were later reduced to $250,000 by the trial judge.

[1]  AMA Council on Ethical and Judicial Affairs, Code of Medical Ethics, 1998, Sec. 2.20, 46.

[2]  Davenport v. Ephraim McDowell Memorial Hospital, Inc., 769 S.W.2d 56 (Ky. App. 1988) (a publication of the American Society of Post Anesthesia Nurses entitled “Guidelines for Standards of Care and Management Standards in Post Anesthesia Care Unit”); Thornton v. Mahan, 423 So.2d 181 (Ala. 1982) (a dental pamphlet evidencing attitudes of that profession toward use of the method employed by a dentist); and Stone v. Proctor, 131 S.E.2d 297 (N.C. 1963) (“Standards of Electroshock Treatment” of the Committee on Therapy, approved by the American Psychiatric Association).

[3]  Cornfeldt v. Tongen, 262 N.W. 2d 684, 703 (Minn. 1977).

[4] Federation of State Medical Boards of the United States, Inc. http://www.fsmb.org.

[5] Enck, Robert E. The Medical Care of Terminally Ill Patients, Baltimore: Johns Hopkins, 1994, 96-8.

[6]  Field, Marilyn J. and Cassell, Christine K., eds., Approaching Death: Improving Care at eh End of Life, Washington: National Academy Press, 1997, 193; Lynn Joanne and Harrold, Joan, Handbook for Mortals: Guidance for People Facing Serious Illness, New York: Oxford, 1999, 80.

[7]  Lynn and Harrold, 77.

[8]  Agency for Health Care Policy and Research, U.S. Dept. of Health and Human Services. Clinical Practice Guideline Number 9: Management of Cancer Pain. Rockville, MD: AHCPR Publication No. 94-0592, 1994.

[9]  The Use of Opioids for the Treatment of Chronic Pain: A Consensus Statement from American Academy of Pain Medicine  and American Pain Society , 1996.

[10] Vacco v. Quill, 521 U.S. 793, (1997); Washington v. Glucksberg, 521 U.S. 702 (1997).

[11] Von Roenn, Jamie H., Cleeland, Charles S., Gonin, Rene, Hatfield, Alan K., and Pandya, Kishan J. Physician Attitudes and Practices in Cancer Pain Management: A Survey from the Eastern Cooperative Oncology Group. Annals of Internal Medicine 119:121, 1993; Joranson, David E. and Gilson, Aaron M. Improving Pain Management Through Policy Making and Education for Medical Regulators. Journal of Law, Medicine & Ethics 24: 344, 1996.

[12] Sigler, Katherine A., Guernsey, Brock G., Ingrim, Naomi B., Buesing, Amy S., Hokanson, James, Galvan, Eustacio, and others. Effect of a Triplicate Prescription Law on the Prescribing of Schedule II Drugs. American Journal of Hospital Pharmacy 41:108, 1984.

[13] State of Kansas v. Naramore, 965 P.2d 211(Kan. App. 1998).

[14] Alpers, Ann. Criminal Act or Palliative Care: Prosecutions Involving the Care of the Dying. Journal of Law & Medical Ethics. 26:308, 1998.

[15] Curran, Jr., J. Joseph, Maryland Attorney General. Letter to all State Attorneys. August 24, 2000.

[16] Enck, 105.

[17] Del. Code Ann. tit. 16, § 25050; Me. Rev. Stat. Ann. tit. 18-A, § 5-804; N.M. Stat. Ann. §24-7A-4; and Vt. Stat. Ann. tit. 18, § 5253.

[18] Va. Code Ann. § 54.1-2984.

[19]  Tex. Rev. Civ. Stat. Tit. 71 Art. 4495c, § 2(3).

[20] Hillhaven is Ordered to Pay $15 Million to Ex-Patient’s Estate. Wall Street Journal, November 26, 1990.

[21]  State v. McAfee, 385 S.E.2d 651 (Ga. 1989).  

[22]  Bergman v. Eden Medical Center, No. H205732-1 (Sup. Ct.  Alameda Co., Calif.)

 

Copyright 2003 by Whitney Durand. Used with permission.