Legal Issues in Palliative Care

INTRODUCTION

The miracles of modern medicine and modern technology have made it possible to maintain a human body’s vital functions through the use of life support equipment for a very long time. In an instance where there is hope of any type of recovery for a patient, this is wonderful. In an instance where there is no hope, it can raise issues that become both an ethical and legal quagmire. We are concerned here with the legal issues.

THE RIGHT TO DIE

As the prospect of being kept alive indefinitely, at least in the biological sense, became a reality, a new legal issue took front and center in the collective consciousness—the right to die. The issue brought with it a number of lawsuits. The first of these, Quinlan v New Jersey, involved a 21-year old New Jersey woman who went into a coma after swallowing a combination of alcohol and Valium in 1975.⁴² She was put on life support, but because of brain damage lapsed into a “vegetative state,”⁴³ which is defined by the National Institute of Neurological Disorders and Stroke (NINDS) as follows:

“A persistent vegetative state (commonly, but incorrectly, referred to as “brain-death”) sometimes follows a coma. Individuals in such a state have lost their thinking abilities and awareness of their surroundings, but retain non-cognitive function and normal sleep patterns. Even though those in a persistent vegetative state lose their higher brain functions, other key functions such as breathing and circulation remain relatively intact. Spontaneous movements may occur, and the eyes may open in response to external stimuli. They may even occasionally grimace, cry, or laugh. Although individuals in a persistent vegetative state may appear somewhat normal, they do not speak and they are unable to respond to commands.”

Ms. Quinlan’s parents requested that she be removed from the ventilator and allowed to die. The hospital refused, and the Quinlans sued. The case wound up going to the New Jersey Supreme Court, who made the following ruling in 1979:

“We herewith declare the following affirmative relief on behalf of the plaintiff. Upon the concurrence of the guardian and family of Karen, should the responsible attending physicians conclude that there is no reasonable possibility of Karen's ever emerging from her present comatose condition to a cognitive, sapient state and that the life-support apparatus now being administered to Karen should be discontinued, they shall consult with the hospital “Ethics Committee” or like body of the institution in which Karen is then hospitalized. If that consultative body agrees that there is no reasonable possibility of Karen's ever emerging from her present comatose condition to a cognitive, sapient state, the present life-support system may be withdrawn and said action shall be without any civil or criminal liability therefore on the part of any participant, whether guardian, physician, hospital or others. We herewith specifically so hold.”

There was no hope, and she was removed from the respirator. Ironically, she lived for several years in a nursing home in New Jersey where she died in June of 1985.

During the years in which the Quinlan Case was being decided, and probably in part because of the notoriety it received, the Living Will, which was first proposed by an attorney named Louis Kutner in a 1967 article in the Indiana Law Journal,⁴⁴ became a hot topic in medical care. Basically, a living will states the wishes of a person in the event that a decision must be made to continue or discontinue life-sustaining medical support in an emergency situation. In 1976 California became the first state to enact a Natural Death Act which gave legal standing to living wills and protected physicians from being sued for failing to treat incurable illnesses. Ten more states passed similar acts in that same year.⁴⁵ Since then, all of the states and the District of Columbia have enacted some sort of legislation recognizing advance directives, although the specific name by which advance directives are known and guidelines and restrictions for their use vary from state to state. It is therefore incumbent upon the physician to make sure he knows the specifics in each state in which he practices.

The American Cancer Society publishes a list of the elements that might be included in the legal definition of life-sustaining medical support⁴⁶ (see Fig. 7) but again, these definitions vary from state to state. Regarding other issues, such as feeding tubes, etc. the ACS adds:

“Nutrition/hydration (food and water) are not usually defined as life-sustaining unless they are provided by a feeding tube or intravenous line. Medications or procedures necessary to provide comfort or ease pain are not usually considered life-sustaining procedures but, rather, as comfort measures. In some states, tube feedings and intravenous fluids are considered comfort measures.”

Figure 7: Definition of Life-sustaining Medical Treatment

An interesting “test” of the strength of a person’s final wishes came in another landmark case, Cruzan v. Missouri, which revolved around the principle of the “right to die,” if it is the patient’s expressed wish, even in the absence of a formal document.

Nancy Cruzan, a 33-year old woman from Missouri, was in a “vegetative state” as the result of being injured in an automobile accident. She was dependent not on a respirator, but on a feeding tube. After she had been in the vegetative state for four years with no sign of recovery, her parents requested that the feeding tube be removed because their daughter would not have wanted to live in her current state, and had said so in a conversation with a roommate. Hospital personnel refused and the Cruzans filed a lawsuit. Thus began another long court battle, this one going all the way to the United States Supreme Court.

In July 1988, a circuit court judge ruled that Nancy’s parents, as her legal guardians and acting according to her wishes, could order her feeding tube removed. The Attorney General of Missouri appealed the decision on behalf of the state, arguing that the testimony of her roommate did not constitute clear and convincing evidence, and further that preserving Ms. Cruzan’s life took legal precedence over her right to refuse life-saving measures. The Missouri Supreme Court agreed and reversed the lower court’s ruling, stating that “The state’s interest in life is unqualified.”⁴⁷

The Cruzans appealed to the US Supreme Court. The case was argued December 6, 1989 and decided June 25, 1990.⁴⁸ In a 5-4 ruling, the first time the US Supreme Court had ruled on an end-of-life case, the Missouri Supreme Court decision was upheld based on the state’s contention that clear and convincing evidence had not been presented. Chief Justice Rehnquist wrote for the majority:

“Petitioner Nancy Beth Cruzan was rendered incompetent as a result of severe injuries sustained during an automobile accident. Co-petitioners Lester and Joyce Cruzan, Nancy's parents and co-guardians, sought a court order directing the withdrawal of their daughter's artificial feeding and hydration equipment after it became apparent that she had virtually no chance of recovering her cognitive faculties. The Supreme Court of Missouri held that, because there was no clear and convincing evidence of Nancy's desire to have life-sustaining treatment withdrawn under such circumstances, her parents lacked authority to effectuate such a request. We granted certiorari, 492 U.S. 917 (1989), and now affirm.”

Writing for the minority, Justice Brennan posed the question:

“Is there any reason to suppose that a state is more likely to make the choice that the patient would have made than someone who knew the patient intimately? To ask this is to answer it.”⁴⁹

This case received widespread national notoriety, and as a result another witness who could testify to Ms. Cruzan’s wishes regarding being kept alive in a vegetative state came forward. This time Missouri accepted this as “clear and convincing evidence” and finally, in December of 1990 Ms. Cruzan’s feeding tube was removed. Twelve days later, on December 26, 1990, Ms. Cruzan was declared dead.

FEDERAL LAWS AND RULINGS

Up until the 1960’s, a person was considered dead when her heart quit beating and she quit breathing. However, in response to rapid changes in available treatment, and the advent of the heart transplant, in 1968 an ad hoc committee of Harvard Medical School offered a new definition of death—brain death.⁵⁰ Since then, all standards for brain death have been based on this definition. The committee stated that:

“Our primary purpose is to define irreversible coma as a new criterion for death. There are two reasons why there is need for a definition: 1) Improvements in resuscitative and supportive measures have led to increased efforts to save those who are desperately injured. Sometimes these efforts have only partial success so that the result is an individual whose heart continues to beat but whose brain is irreversibly damaged. The burden is great on patients who suffer permanent loss of intellect, on their families, on the hospitals, and those in need of hospital beds already occupied by those comatose patients. 2) Obsolete criteria for the definition of death can lead to controversy in obtaining organs for transplantation.”

As each state was creating its own laws to govern “brain death,” the Federal government, along with medical facilities and medical schools all struggled to create a universal definition of death. That finally happened in the 1980’s when the Uniform Determination of Death Act (UDDA) was proposed (see the “Ethics” section and Appendix I). It was ultimately adopted by all 50 states and includes the following language:

“An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.”

Another important piece of Federal legislation, the “Patient Self-Determination Act”⁵¹ (PSDA), was proposed in 1990, and went into effect in December of 1991. The PSDA establishes strict guidelines that all health care facilities receiving Medicare and Medicaid payments must follow:

• Provide written information to patients about their right to make decisions concerning treatment by completing advance directives
• Ensure compliance with the requirements of state law
• Maintain written policies and procedures with respect to advance directives
• Document in the individual’s medical record whether or not the individual has executed an advance directive
• Educate their staff and the communities they serve about state law governing advance directives
• Not condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive.

It is interesting to note the final guideline, in which it is pointed out that a patient does not have to have an advance directive. That is because it is sometimes not possible for patients to execute a final directive, or they choose not to, and treatment cannot be withheld.

As laws have evolved, so have advance directives and the legal issues surrounding them.

LEGAL CONSIDERATIONS IN ADVANCE DIRECTIVES

An advance directive only becomes a factor when a patient is no longer able to speak for herself, whether through illness, an accident, or the loss of mental competency. The patient always has a right to change her mind and rescind the advance directive. In some states, the patient can do this verbally, but it is much better for the physician if the patient executes the new order in writing.

The best policy for the physician is to encourage all patients to execute an advance directive, not just those with terminal illnesses. While this obviously helps the physician protect himself legally, it also helps the patient remain in charge of her life under all medical circumstances and avoid the possibility that she and her loved ones will become embroiled in a long, drawn out court battle. That is what happened in Florida to a woman named Terri Schiavo.

In 1990, when she was only 26 years old, Ms. Schiavo collapsed and as a result suffered massive brain damage. According to her doctors she is in a Persistent Vegetative State, which in Florida is defined as a complete lack of awareness and a complete inability to interact.⁵² Ms. Schiavo did not have a living will or any other type of advance medical directive. Although she does not require life-support equipment for her heart and breathing, she does require a feeding tube. A couple of years after her collapse, her husband, Michael Schiavo, petitioned the Florida Court for permission to remove his wife’s feeding tube, stating that she had expressed on more than one occasion that she would never want to live if she had to be dependent on machines to survive. The court granted his petition, but his in-laws, Ms. Schiavo’s parents, filed an action to stop the removal. The court battle of Schiavo v Florida went on for several years, but finally Mr. Schiavo prevailed, and his wife’s feeding tube was removed October 15, 2003. Six days later, October 21, Governor Jeb Bush intervened and ordered that her feeding tube be reinserted. As of the end of 2004, that stay was still in effect, and Ms. Schiavo remained on nutritional life support.

Governor Bush was quoted as saying,

“The conflict among family members over the best interests of this young woman has made us all acutely aware that uncertainty in these situations can, and does, compound the tragedy,” he said. “I hope all Floridians, and any others who have followed this case, will ensure their best interests are clearly documented in a living will or other directive to spare their families a similar anguish.”⁵³

Physicians in Florida appeared to share that sentiment in a poll that was conducted by Medscape between October 31 and November 8, 2003.⁵⁴ (see Fig. 8) The poll asked how the controversy regarding Terri Schiavo had affected the advice given to patients regarding advance directives. Overwhelmingly, the physicians responded that they were now more likely to recommend an advance directive or living will.

The Florida State Legislature also responded to the Terri Schiavo lawsuit. In 1999 the state made several changes in the statutes that govern life-support, or “life-prolonging” procedures, stating that beginning October 1, 1999, life prolonging procedures may also be withheld or withdrawn from a person who is suffering from an end stage condition.⁵⁵ An “end stage condition” means an irreversible condition that is caused by injury, disease, or illness which has resulted in progressively severe and permanent deterioration, and for which, to a reasonable degree of medical probability, treatment of the condition would be medically ineffective.

Figure 8: Post-Schiavo Poll Among Florida Physicians

The Florida definition of “life prolonging procedures” means any medical procedure, treatment, or intervention that:

1. uses mechanical or other artificial means to sustain, restore, or replace a spontaneous vital function, and
2. when applied to a patient in a terminal condition, serves only to prolong the dying process, and
3. artificially provides sustenance and hydration.

Therefore, now a person executing a living will or other advance directive in the state of Florida will have to specifically request that sustenance and hydration be provided.

Informed Consent
Every state has its own particular rules and regulations regarding advance directives. While most are very similar, it is still important to know exactly what the guidelines are in the state that governs a patient’s advance directive, so you can make sure she is completely informed. Informed consent is crucial when a patient executes an advance directive because it comes into play in life and death matters. The patient must be made to understand exactly what medical treatment will be provided, and what medical treatment will not be provided, and what criteria will be used to determine when the final provisions of the directive will be undertaken. Of course, a patient must be of legal age and mentally competent for the advance directive to be valid.

In order to make clear what the patient wants, and to make clear to the patient exactly what she is requesting, following are recommendations for questions that the physician should ask a patient who wants to execute an advance directive:⁵⁶

• Do you want to be resuscitated if your heart stops?
• Do you want to be put on a ventilator that will breathe for you if you can't breathe for yourself?
• If you are unable to enjoy life, do you want to be given antibiotics if you become infected, or just care that will make you comfortable?
• Are there other circumstances in which you would want to be given comfort care only?
• Would you want to be kept alive by a feeding tube and intravenous (IV) fluids if you have no hope of recovery?
• Do you want to state some general principles and then trust your health care proxy to make specific decisions?

A signed consent form should be included in the patient’s record, along with a copy of the advance directive. There are many different forms available for living wills and other advance directives. Included as Appendix K is a form that may be used in California. Appendix L, Resources, provides access to a Website containing links to all state forms.

The physician should also know whether or not a patient must be referred to an attorney or other legal resource to execute a valid advance directive. Again, this information is governed by state legislatures, so be sure to know the exact requirements of the state governing the advance directive. Even if it is not a requirement, it is not a bad idea to suggest that the patient be fully informed of all the legal consequences of her advance directive, and how they impact her family.

If the physician is not present when all the ramifications of an advance directive are explained to the patient, he should speak to the patient about it as soon as possible so he has first hand knowledge of what the patient does, or does not, understand. If there are any gray areas, they should be cleared up and a new consent specifically addressing those areas should be executed and signed by the physician, the patient, and appropriate witnesses.

Every member of a palliative care team should be advised of all the stipulations of each individual’s advance directive. If the patient goes into a facility, or enters into hospice care either at home or in a facility, a copy of the advance directive should be given to the care givers, and the recipient should sign and date an acknowledgement of receipt.

When the time comes to honor whatever the patient’s wishes are, the attending physician is the final authority; however, the physician should consult with the other members of the team before reaching a final decision, because if the consensus agrees with him that death is imminent, he must comply with the advance directive.

Complying with an Advance Directive
There are various elements that might be involved when a patient has requested that no extraordinary measures be taken, depending on the patient’s individual wishes. Some of the most common are:

• DNR (Do Not Resuscitate)
• Removal or refusal of life-support equipment
• Refusal of nutrition and fluids
• Adequate medication to stop all pain

Do Not Resuscitate (DNR) Instructions
Generally speaking, a DNR order only applies to cardiopulmonary resuscitation. It is usually issued when a person is terminally ill, and death is expected. It is also commonly issued when a patient is in advanced old age.

The DNR should spell out exactly what is included. Just because someone has issued a DNR does not mean that she does not want to receive other life-saving procedures. The DNR should also be fully explained to the patient’s family or caregivers.

Occasionally a member of the patient’s family will insist that resuscitation be tried, even if the medical team has informed them that it is futile. In that instance the person objecting should be treated with patience and compassion, but the written request of the patient must be honored.

Removing or Withholding Life-Support Equipment
If the patient’s advance directive includes removing life-support equipment, or not using it at all, again this request must be respected. It is important that the physician does not avoid using these devices because he is afraid of legal consequences. In palliative treatment, removing a patient from life-support at her express wish is both ethical and legal. As with the DNR, the patient’s family and caregivers must be fully apprised of the patient’s wishes so they will know what steps will, or will not, be taken.

Refusal of Nutrition and Fluids
Removing sustenance is highly controversial. As seen in the Schiavo case, it is sometimes difficult to ascertain whether or not a person is truly in a persistent vegetative state without hope of recovery. In this instance, the wisest course is to discuss with the family and caregivers a timeline that will allow the patient sufficient time to show signs of recovering, and if hope for recovery is still non-existent at the end of that time, to move forward and comply with the patient’s wishes. Here again, this element of the advance directive should be discussed and fully understood by the patient and all other concerned parties. As with all other aspects of an advance directive, state guidelines regarding the medical criteria for a diagnosis of persistent vegetative state must be followed explicitly.

Adequate Medication to Stop All Pain
This is an area that is fraught with pitfalls. A patient requests adequate medication to prevent pain. What if that means there is a risk of overdose and death? Supposedly, a physician is legally protected if he is following the patient’s advance directive, but there can be a fine line between stopping pain, and assisting suicide. And physician-assisted suicide is expressly prohibited in all states except Oregon.

Even if state law protects a physician, there are instances of federal authorities trying to arrest physicians. Arrest warrants have been issued for several doctors in Oregon. These warrants have not been honored because of the ongoing legal battles between the state and federal attorneys general. So far, the US Supreme Court has upheld the Oregon laws, but there is still no absolute, final resolution.

Once again—make certain that the family and other caregivers understand the express wishes of the patient. Make certain that any advance directive concerning pain medication has been transferred to any facility or hospice organization caring for the patient. If you have a concern, discuss that concern with the ethics committee of the facility, or with the risk manager. Then, if there is consensus that pain medication must be increased, even if it hastens death, proceed.

Fully informing the patient’s family of the patient’s wishes—and the patient’s right to make those decisions—well in advance of any end-of-life action, or inaction cannot be overemphasized. Follow up any conversations with the family in writing, and put a copy of the document in the patient’s file. The only person likely to file a complaint is a relative or friend. If there is good documentation every step of the way, there is very little chance of the complaint going very far.

Refusing to Obey an Advance Directive
If it has been determined that a patient has no hope of recovery, refusing to obey an advance directive is medical battery, just as any touching without the patient’s permission is medical battery. The physician would be subject to both criminal prosecution as well as a malpractice action. However, an advance directive does not have to be enforced until and unless the physician has determined that the patient is dying. And although a family member, or other person acting on behalf of the patient, may request that the advance directive be put into place, it is up to the physician to make the final decision. Following is an actual case:

A 77-year old man with a history of failing health was taken into the emergency room because of a stroke. He was not conscious and appeared to be in a coma. He was put on life-support. When his wife, who is his power of attorney for health care matters came into his room after he was admitted, she said that it was his wish not to be on life support. The physician simply said, “he’s not dying,” and therefore the patient remained on life support, including a feeding tube. When the patient regained consciousness he requested that the feeding tube be removed, but his wife informed him that he would not be able to take his pain medication without his tube, so it remained. Subsequently the patient has made some strides toward recovery. He uses a walker, can now eat and is learning to talk, again. Although a complete recovery seems unlikely, the patient is able to enjoy a decent quality of life.⁵⁷

In this case the wife was completely cooperative. Had she not been cooperative and in fact insisted that the tubes be removed, the physician still had not only the right but the legal obligation to pursue a ruling from the administration of the facility in which the patient was being treated because the patient’s need for life-support appeared to be only temporary. However, if the patient took a turn for the worse and it appeared the reliance on life support would be permanent, the advance directive would become effective.

SUMMARY

Certain areas of palliative care will always require the physician to use his best judgment — and there is always the possibility that someone will disagree with that judgment, or challenge it. End-of-life care is an extremely emotional topic. It is critically important to respect the wishes of the patient, but equally important to respect the feelings of family and friends. The best advice for any physician is, don’t try and make all the decisions alone. Consider every aspect of what is best for the patient, and if necessary consult with other members of the health care team before taking final action. It is also critically important to document all the facts involved, and all the options considered prior to taking that final action. If there are any questions after the fact, that documentation will provide the answers in a timely manner. It might also help discourage any thoughts of litigation.

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