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Bast RC Jr, Kufe DW, Pollock RE, et al., editors. Holland-Frei Cancer Medicine. 5th edition. Hamilton (ON): BC Decker; 2000.

Cover of Holland-Frei Cancer Medicine

Holland-Frei Cancer Medicine. 5th edition.

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Chapter 75Legal Aspects of Cancer

, PA.

Today, the physician who works to diagnose or treat cancer has a difficult dilemma. The patients’ expectations regarding the discovery and cure of their disease often are at odds with the realities of cancer. 1 Patients are familiar with such wondrous advances as mammography, computed tomography (CT), magnetic resonance imaging (MRI), chemotherapy, and radiation therapy. As a result, they come to their physicians with the hope, and often the expectation, that they will be able to save them. Despite progress in the detection and treatment of cancer, this group of diseases, unfortunately, is often still beyond medicine’s reach. This “box” around the physician is further aggravated by the movement of medicine to the managed-care setting. Physicians are caught in a struggle to provide each patient with as much time and attention as possible, while also facing the realities of cost, care, reimbursement schedules, and a system that seems to discourage participation and follow-up by the specialist.

Nowhere is this dilemma reflected more clearly than in the statistics relating to medical malpractice claims brought against physicians. One reliable source of such statistics is the Physician Insurers Association of America, an organization that comprises professional liability insurers, owned or managed by physicians. This association has been engaged in a data-sharing project through which it has collected such statistics since 1985. As of December 1998, they had evaluated over 163,000 claims. 2 Of particular interest is the fact that when determining which patient conditions lead to the most claims being filed, cancer of the breast, of the bronchus and lung, and of the colon and rectum made the top-20 list. As might be expected, these were in the top-10 conditions resulting in the largest pay-outs by malpractice insurers. 2– 4 In fact, according to these studies, the top five misdiagnosed conditions were (1) breast cancer, (2) cancer of the bronchus and lung, (3) appendicitis, (4) acute myocardial infarction, and (5) ectopic pregnancy. 2– 4

The statistics are not all bad, however. Fully two-thirds of all malpractice claims brought against physicians are resolved without payment of any indemnity by the physician or carrier. Unfortunately, the other one-third result in significant indemnities and disruption to the life and practice of the physician. This chapter is designed to assist the physician whose practice involves the diagnosis and treatment of cancer to gain an understanding of the legal process as it relates to the commonly encountered problems in this field. With this understanding, it is hoped that the physician will be better able to avoid entanglements in the legal system and so devote himself or herself more fully to the patients.

This chapter begins by discussing the elements of a medical malpractice claim. It continues with a section on preventing the most commonly encountered problems for physicians who deal with cancer, and it concludes with sections on managed care as it affects the cancer specialist and the developing law regarding physician-assisted suicide and euthanasia.

Elements of Liability

In the United States judicial system, the same elements must be proven to establish a right to recovery, regardless of the nature of the claim. These are (1) that a duty existed which was breached, (2) that the breach caused an injury, and (3) that an injury, in fact, resulted. Despite the fact that these elements are the same for all claims, the necessary proof to establish each element in cases involving cancer may vary because of the particular characteristics of this area of medicine.

The Standard of Care

The first element, breach of duty, more commonly is referred to as failure to abide by the applicable “standard of care.” The first question this raises is: who establishes the standard of care? Because of the complexity of medicine, it is almost universally held that jurors may not create the standard to which doctors are held; rather, jurors must apply the standard that is recognized by the medical profession. This standard generally is established through expert medical testimony. Unfortunately, litigation often is seen as a battle of experts, wherein the jury is left to measure the credibility of two competing viewpoints. As might be expected, this at times leads to confusion in a juror’s mind. Medicine is not static, and the overlap between competing schools of thought or evolution from a prior practice to a more current approach creates a gray zone wherein most litigation of this nature occurs. The only remedy for the physician is to stay constantly informed about developing practice parameters and understand when to refer patients to those with greater expertise. If the physician elects to provide treatment in an area not usually managed by those with his or her training, the physician may be held to the standard of the specialist whose role has been assumed.

The question of who is qualified to act as an expert often creates intense argument at trial. It seems logical that an oncologist should be called to testify against an oncologist or a radiologist against a radiologist; however, this is not always the case. In most jurisdictions, if an expert can demonstrate an understanding of the appropriate standard of care, either through training, practice, or association with those in the field, he or she often is given the latitude to testify. It, then, is up to opposing counsel to assist the jury in weighing the credibility of this testimony by demonstrating any shortfalls that the individual may have in his or her understanding of the relevant medical practice. 5

In addition to the use of expert testimony, counsel often attempts to establish the standard of care by referring to general medical literature and practice parameters. For example, a joint effort by the American Colleges of Radiology, Surgeons, Pathologists, and the Society of Surgical Oncology has resulted in practice guidelines for breast conservation treatment, against which one’s actual practice may be measured. 6 Although most jurisdictions currently hold that such literature and guidelines, if established as authoritative, may be introduced as evidence for the standard of care, they are not considered to be dispositive of that issue. The usual practice is to preclude the introduction of such parameters to establish the standard but to allow it in cross-examination and impeachment of the opposing side’s expert. In this fashion, the jury has the benefit of the standards when measuring the testimony of an expert and may consider them as they deem appropriate. 7

A final point to consider is whether the standard of care is that of the physician’s own community or a more broadly based standard. In earlier times, the standard was that of each physician’s local community. This was necessitated by the often significant difference in facilities and equipment from one community to another and the rather laborious dissemination of medical information. With the advent of mass communication and educational techniques as well as the proliferation of technology to some of the most remote communities in the United States, the local standard recently has given way to a national standard of care. This is best evidenced by board examinations, which are national in scope. As a result, physicians can expect that the standard to which they must adhere will be that normally accepted in the country.

Causation

To impose liability, not only must there be a breach of the appropriate standard of care, but that breach must be causally related to an injury. In legal terminology, the term proximate cause generally is used. This was discussed most eloquently by a prominent legal scholar who wrote:

In a philosophic sense, the consequences of an act go forward to eternity, and the causes of an event go back to the dawn of human events and beyond. But any attempt to impose responsibility on such a basis would result in infinite liability for all wrongful acts, and would “set society on edge and fill the courts with endless litigation.” As a practical matter, legal responsibility must be limited to those causes which are so closely connected with the result and with such significance that the law is justified in imposing liability. Some boundary must be set to liability for the consequences of an act, upon the basis of some social idea of justice or policy. 8

In applying this concept, most jurisdictions now require proof that “but for” the act, the injury would not have occurred. This test is explained most clearly in jury instructions such as the following:

Negligence is a legal cause of injury if it directly in a natural and continuous sequence produces or contributes substantially to producing such injury, so that it can reasonably be said that but for the negligence, the injury would not have occurred. 9

When following this instruction, a jury could not impose liability in most instances, unless it determined that the act had probably (interpreted as a greater than 50% chance) caused the injury. Cancer cases, however, present a complicating factor that recently led to the application by some courts of a more inclusive test. This has occurred because of the nature of the disease itself. In many cases, a patient may have started out with a less than 50% chance of survival. Although negligence may have occurred, there was never a greater than 50% chance that the patient would survive. As a result, some jurisdictions have allowed recovery for a “lost chance of survival,” regardless of how small the chance was initially. 10 Courts that continue to follow the traditional approach opine that lowering the standard would require health-care providers to defend claims arising out of inevitably unfavorable results. Those that follow the more expansive approach rationalize their view by asserting that recovery is not based on the fact that the act caused death but rather that it caused a decreased opportunity for survival. An example of the application of this expanded rule occurred in a 1988 case, 11 in which a man sought medical therapy for gastric difficulties. Although he was suffering from gastric cancer at the time, it was not diagnosed, and he died 18 months later. The testimony at trial was that he had only a 30% chance of cure at the outset. In considering this, the court noted that medical science has given patients real chances to recover, sometimes only a small chance, but still a chance, in circumstances that used to be hopeless. When patients go to the doctor with serious illnesses, they expect to have those chances that medical science has provided. 12

Even though it could not be said in this circumstance that the failure to diagnose caused the death, it did in the court’s opinion decrease the chance of survival, which was compensable.

Damages

The final element establishing liability is damages. In other words, if the act fell below the acceptable standard, it must have resulted in an injury or loss. Such damages are uniformly divided into compensatory and punitive. Compensatory damages are those meant to compensate an individual for a loss and are measured by the value of that loss. Punitive damages, however, have no relationship to the loss but are intended simply to punish or deter conduct that society deems to be outrageous. As might be expected, the type of act that is necessary to support this form of compensation is significantly greater than simple negligence, and it generally requires that the act be so wanton or reckless as to be considered intentional. Such is seldom seen in these cases.

Compensatory damages, on the other hand, have seen expanded application in litigation involving cancer. One example is the recovery that was allowed for “lost chance of survival” discussed earlier. Fortunately, a number of courts adopting this more inclusive test tend to ameliorate the rather harsh result that occurs when compensation is allowed and there was never a probability of survival. They accomplish this by limiting the amount recovered to less than the value of all damages that flowed from the death. For example, if a 30% loss in the chance for survival occurred, the injured party may only be entitled to recover 30% of all damages related to the patient’s death. 13, 14

Some courts also have expanded the traditional concept of mental anguish in cancer cases. One example occurred in a case where a patient was referred to an oncologist to discuss chemotherapy after a mastectomy for breast cancer. 15 A recommendation was made to use chemotherapy, thereby increasing her chances of avoiding a recurrence of the cancer. The patient agreed, and a dose of Cytoxan calculated by the physician’s nurse was administered. The calculation turned out to be in error and, in fact, called for five times the appropriate dose. Although the calculation was checked by the physician, the error was not caught. On a return visit to the physician’s office, the patient explained that she had become extremely ill and did not wish to continue the chemotherapy. The overdosing was discovered at that time. Unfortunately, the medication had damaged the patient’s bone marrow. The cancer ultimately did return and, because of the bone marrow impairment, could not be treated by chemotherapy. At trial, the patient was unable to demonstrate that the Cytoxan was related in any way to the recurrence of the cancer. However, the court found that her mental anguish could reasonably have been increased by the knowledge that her plight was now hopeless in that she could no longer be treated with chemotherapy for this condition.

In most circumstances, there must be some physical injury or impact causing mental anguish before a court will allow a claim for mental anguish, however it is described. This helps to discourage fraudulent claims. In the case discussed herein, there was a physical injury (i.e., damage to the bone marrow) from which the emotional distress arose. There have, however, been exceptions to this general rule. Although not universally recognized, one such exception has been noted in some jurisdictions where a diagnosis of cancer was made and no cancer actually existed, thus causing only emotional distress. A case where a dentist observed a lesion on the roof of a patient’s mouth is illustrative of this. 16 The dentist performed a biopsy, and although no cancer was noted in the specimen, the dentist referred the patient to an oral surgeon. The oral surgeon advised the patient that there was a 50% chance that she was suffering from lethal midline granuloma, a rapidly growing lesion that may result in death. Ultimately, it was determined that no cancer existed. The patient sought recovery for “cancer phobia.” The court noted there had been expert testimony that the dentist deviated from acceptable standards in telling the patient she had cancer when his own test results were negative. It was then reasoned that it was foreseeable to expect that a mistaken diagnosis of cancer would result in emotional harm to the patient.

Such cases place the physician in an awkward circumstance. The physician cannot avoid the responsibility of communicating his or her opinion to the patient. If that communication is not based on sufficient information, however, it may be the basis for a cause of action and damages. The lesson is that when imparting the diagnosis of cancer, the physician should take reasonable steps to ensure that the diagnosis has a medical basis and include this in the discussion.

Preventing Legal Complications

A physician’s time is best spent in medical endeavors, and time taken away from these activities can only operate to the detriment of the public. Unfortunately, physicians today find themselves embroiled with the law to the extent that it often absorbs an inordinate amount of time and saps their enthusiasm for interaction with patients. For this reason, a physician should endeavor to understand the interface between the law and his or her practice. Once this is accomplished, especially in those areas that most commonly produce difficulties, the physician will find that time spent on the legal ramifications of medicine is sharply reduced. This section discusses the most commonly occurring difficulties for physicians whose practice includes cancer medicine.

The Doctor-Patient Relationship

It generally is acknowledged that a physician has no duty, absent constitutional or statutory requirements, to render care unless he or she has agreed to do so. This premise was brought to us through the common law and serves as a foundation of the United States jurisprudence. A physician may find, however, that he or she has created a doctor-patient relationship and thus is obligated to care for the patient, even when the physician had not thought that he or she had done so.

The most common manner in which the doctor-patient relationship is created is by express agreement. The physician simply agrees to render medical care and attention, and the patient consents to that relationship. Traditionally, this occurs when the patient presents himself or herself to the physician’s office or the physician consults on the patient while in a medical facility. This relationship also can arise, however, where a physician has contracted with an entity that provides medical care to a group of patients. For example, hospital by-laws often provide that a staff physician cover the emergency room on an on-call basis. This often is considered a contract between the physician and the hospital, and patients are considered to be third-party beneficiaries of this contract. As such, a patient who presents to the emergency room may claim the benefit of that contract. In other words, because the on-call physician has been contacted, he or she generally is responsible to make a determination as to whether further evaluation is required and, if so, to provide that evaluation until the patient either is stable or referred to another physician or entity. Without the contractual arrangement (in this instance, the by-laws) the duty does not exist.

A question that often arises with specialists is whether an appointment made by a patient to see the physician in and of itself creates a doctor-patient relationship. Generally, such a call only implies that the doctor has agreed the patient may come to the office so that he or she can determine whether they will enter into such a relationship. This can be altered, however, depending on the manner in which the appointment is made. Such a circumstance may arise where the patient provides his or her clinical history by phone to the doctor’s office and it is apparent he or she has an acute illness that requires urgent care. If an appointment is made in this circumstance, the lines blur as to whether there was an agreement to treat that illness. As such, it is better to go forward and commence the relationship, using a legally sufficient manner to terminate the relationship, when appropriate. Of course, the one exception to this is if the requested therapy is beyond the capabilities of the physician. In this circumstance, there is no obligation to treat, but the physician should assist in making arrangements for follow-up care with another physician.

Casual encounters are fraught with potential difficulties. Every physician has been in a situation where a friend or acquaintance asks for medical advice in an informal setting. This may be as innocent as asking the physician to look at an unusual mole or listen to a particularly bothersome cough. Although it is difficult to disengage from such conversations, this is the more prudent course. If one listens to such complaints and gives advice, it may be assumed that a doctor-patient relationship has been created; it is not necessary that compensation changes hands. The better course in such circumstances is to advise the patient that perhaps he or she should come to the medical office, or that of another physician, for a full evaluation of the difficulty.

Informal conversations with a patient generally are not considered in the same light as an informal conversation with another physician. Generally, when one physician informally discusses his or her patient with a second physician, and there is no agreement for the second physician to undertake care of the patient or provide a formal consult, no doctor-patient relationship has been created. 17 To hold otherwise would severely hamper the free flow of information between physicians. All physicians must have the opportunity to discuss with peers the conduct of their profession. This same circumstance applies when various cases are presented for educational reasons, whether in a school environment or hospital meeting (e.g., tumor boards). 18 This, however, must be clearly distinguished from a formal consultation. Such can occur face to face, through a note on the hospital chart, or by phone. The distinguishing line is that the physician consulted understands that he or she is being engaged to provide a professional opinion for the medical care and attention of a patient.

Another question that often is encountered by those who specialize in cancer therapy is whether the patient who once was seen by the physician can claim the benefit of that doctor-patient relationship for all time. In other words, does a relationship, once started, continue in perpetuity? In most areas of medical practice, the line is fairly clear. Once a patient begins treatment for an acute illness, the relationship between patient and physician continues until the illness subsides or one party withdraws from the arrangement in a legally appropriate manner. This line may not, however, be as clear when treating cancer, which has the potential for long-term therapy, follow-up, and recurrence. For this reason, it is imperative that the physician clarify his or her expected role with the patient. In the event there has been no understanding with regard to future care and the patient seeks care from the physician, the physician should make a determination as to whether an acute or unstable situation exists. If the patient is unstable, the appropriate course is to assist the patient in stabilizing and then to ensure that he or she is transferred to another physician if one does not wish to continue providing care.

Terminating the Doctor-Patient Relationship

Once the doctor-patient relationship has begun, a physician may not abandon the patient without incurring liability. Terminating the relationship usually requires either a mutual agreement of the parties, the patient deciding to withdraw from the physician’s care, or the physician making a unilateral decision to withdraw in a manner that complies with legal requirements.

When making this determination, the circumstance that created the relationship must first be analyzed. If there was a contract to render care, the physician may not be able to withdraw. For example, as noted earlier, hospital staff by-laws create an obligation for an on-call specialist to attend when called by the emergency-room physician. Unless the by-laws provide a method in which this relationship may be avoided, the physician may have no choice but to attend. This does not, however, require that he or she continue to care for the patient. In such circumstances, the physician’s only obligation generally is to attend during the immediate and unstable condition. The patient then may be referred to another physician for follow-up care. Similarly, in the case of managed-care contracts, the physician may not be allowed to terminate the relationship with a patient unless he or she follows the prerequisites of those contracts.

In most circumstances, the physician may elect to terminate for any reason that does not violate federal or state laws (such as those that prohibit discrimination) or his own contract with a health-care entity. In doing so, however, there are general tenets that should be followed:

  • The physician should determine whether the patient’s condition requires immediate attention. If so, the patient should be stabilized before terminating the relationship.
  • The patient should be made aware of the nature of his or her illness and, if required, that follow-up care is necessary.
  • The patient should be notified by the physician of his or her intent to withdraw from care as of a specific date.
  • The patient should be made aware that the physician will cover the patient for emergencies up to the date set out in the previous tenet.
  • If the physician wishes to provide a specific referral, that may be accomplished. He or she is under no obligation to do so, however, and may instead refer the patient to the general medical community. In this circumstance, the physician should make the patient aware of the type of medical specialist to be sought and cover the patient for a reasonable time.
  • The patient also should be informed that he or she is entitled to a copy of his or her medical records and that such will be provided to the patient or, if the patient so prefers, to the subsequent treating physician on request. 19

These instructions may be given orally, but this should be followed by written ones. Perhaps the most practical method of documentation is simply to post a letter to the patient with this information to his or her last known address. As with all medical communications, the documents should be marked as personal and confidential and a copy kept with the chart.

Consent

It is axiomatic that touching an individual without consent is battery. If battery results, it is actionable. This theory of law generally has been applicable to the medical profession since the early 1900s; 20 however, in the field of cancer, there has been increasing confusion with regard to obtaining informed consent. In part, this results from the nature of the diseases themselves, the evolving therapies that are available, and the role of the physician both as a treater of the disease and a researcher. In this regard, many questions have arisen, such as how much information patients with incurable diseases really wish to know, and whether it is counterproductive to disclose dismal prognoses; whether statistical data on morbidity or mortality are irrelevant to the individual patient’s course; and whether the physician’s personal interest, either through research or otherwise, should be disclosed to the patient. This section discusses these and other questions and, hopefully, will be instructive to the physician in avoiding the pitfalls that have led to increased litigation.

As a starting point, it is necessary to understand that the basis for informed consent springs from four primary assumptions. These have been cogently outlined by an appellate court of California as follows:

  1. 1. …patients are generally persons unlearned in the medical sciences, and therefore, except in rare cases, courts may safely assume that the knowledge of patient and physician are not in parity.
  2. 2. …a person of adult years and in sound mind has the right, in the exercise of control over his own body, to determine whether or not to submit to lawful medical treatment.
  3. 3. …the patient’s consent to treatment, to be effective, must be an informed consent.
  4. 4. …the patient, being unlearned in the medical sciences, has an abject dependence upon and trust in his physician for the information upon which he relies during the decisional process, thus raising an obligation in the physician that transcends arms’ length transactions. 21

Applying these four assumptions requires an analysis of the following questions: Who has the duty to obtain the consent of the patient: Who has the right to give consent: What information must be imparted to form a basis on which consent may be predicated: and What exceptions exist to obtaining consent? Regarding the first question, it generally is accepted that the physician who performs the diagnostic procedure or therapy has the duty to obtain consent. Physicians may delegate the work that this responsibility entails to others, but they cannot avoid the responsibility itself. For example, a physician may allow a resident or office personnel to explain a procedure and its risks to the patient; however, if information is incorrectly imparted, the physician will bear the responsibility for failing to obtain informed consent. This does not suggest that physicians should not use assistants in the technical aspects of consent, such as having the forms signed. However, the physician should participate in the direct communication with the patient when the essential information is imparted.

Another area of concern is whether a referring physician or the referred physician has the duty to obtain the party’s consent. This may occur, for example, when a family-physician sends a patient to a surgeon or oncologist for treatment of cancer. Courts that have reviewed this issue generally find that the obligation to obtain informed consent rests with the specialist who is to perform the procedure or render the care. 22 This does not suggest that the referring physician should avoid discussion with the patient before referral. Rather, the referring physician should keep in mind that too detailed a discussion may confuse the patient, if conflicting information is provided by the specialist who is to render the care.

The second question in obtaining informed consent is, who has the right to give the consent? As a general rule, the competent adult whose health is at risk has the right to receive the information and provide consent. If this individual is not competent, however, then the physician must look to another. In those circumstances where a court has declared the individual to be incompetent and appointed another, this process is relatively easy. If the physician is unsure in this regard, he may contact the clerk of the local court, who will determine whether a guardian has been appointed. If the individual has not been declared to be incompetent but the physician nonetheless believes this may be the case, he or she has several options. The first, when time is not of the essence, is to advise the family that a judicial determination may need to be made and have them seek counsel for the appointment of an appropriate guardian. The second is to rely on consent of the next of kin; however, this is not universally accepted in that jurisdictions vary regarding who may consent under various circumstances. As a result, it is appropriate for the physician to consult legal counsel in this circumstance.

Another question often raised in the diagnosis and treatment of cancer is, who has the authority to consent for a child? Parents generally hold this right, and the physician is justified in relying on them. As with other areas of the law, however, confusion may exist in certain circumstances. This most often occurs when the child (i.e., an individual under 18 years of age in most states) is mature. With greater frequency, courts are beginning to require that mature minors be involved in the decision-making process. 23 Unfortunately, no bright line exists by which a physician can judge this circumstance. Rather, if he or she believes that the minor is mature enough to understand the nature of the illness, the risks of providing or withholding therapy, and the likely results, then that minor should be involved in the process. Most cases that have addressed this area of the law have done so regarding children in their teenage years. Closely related to the circumstance of the mature minor is that of the emancipated minor. This generally is thought of as someone who is below the statutory age of adulthood but who, nonetheless, is living on his or her own and is self-sufficient. These minors usually are thought of as having the right to consent to their own care.

Once it has been determined which physician will obtain the consent and who has the right to give consent, the next concern is what information must be imparted. The consensus of most jurisdictions is that the following information 24 should be included in discussion with the patient:

  • Nature of the patient’s illness
  • Nature of the proposed therapy
  • Reasonable alternative therapies
  • Chance of success with the proposed therapies
  • Substantial risks inherent in the therapies
  • Risk of failing to undergo therapy for the illness

When considering the quantum of information to be contained in these categories, courts are divided along two tracks. The first is to measure the quantum of information that reasonable physicians would provide to their patients under the same or similar circumstances. The second is to consider what a reasonable patient would want to know in making his or her determination. 25 Regardless of which test is used, the best rule is for physicians to understand the information generally imparted by their peers and, additionally, to consider what they would like to know if in the patient’s position attempting to make the decision. This combination of considerations generally will lead to an appropriate disclosure.

In considering the required disclosure, physicians who work in this area should be aware of a developing line of cases that may expand the quantum of information to be disclosed. This is illustrated by a recent Florida case, where the question was whether a duty existed on the part of a surgeon to advise a couple that the wife’s condition (medullary thyroid carcinoma) could be inherited by her children. 26 Those courts that require such disclosures follow the line of cases imposing on psychiatrists a duty to warn certain individuals about a danger of harm from their patient 27 or to protect others from infectious diseases. 28 Although in the Florida case, the court declined to hold the physician liable for failing to inform the parents, the better rule would be to advise if such risks of inheritability exist. In deciding such questions, courts generally seek to determine whether an injury was foreseeable and the injured person was in the zone of risk. In the case of inheritable diseases, the risk would seem to be foreseeable, and the children certainly would seem to be in the zone of danger.

There are, of course, exceptions to obtaining consent. In the realm of diagnosis and treatment for cancer, however, these are less common. The first is the emergency circumstance. Obviously, the law allows one to act in an emergency, if time would not permit obtaining an appropriate consent; it is presumed that the patient would consent. The second, which occurs in the rarest of circumstances, is the therapeutic privilege. As one court explained:

…patients occasionally become so ill or emotionally distraught on disclosure as to foreclose a rational decision, or to complicate or hinder the treatment, or perhaps even to pose psychological damage to the patient. Where that is so, the cases have generally held that the physician is armed with a privilege to keep the information from the patient, and we think it clear that portents of that type may justify the physician in action he deems medically warranted. 29

Even in this circumstance, however, the best rule to follow is that if the patient is not to be provided information for therapeutic reasons, then his or her next of kin should be given the information and asked to provide consent for therapy.

Another line of cases examined whether physicians must disclose a personal interest when obtaining informed consent. Such interests may occur with research protocols, grants, and patents. The Supreme Court of California most recently addressed this issue; 30 in that circumstance, a patient was undergoing treatment for hairy-cell leukemia. Because of the patient’s particular blood type, the physicians were able, over a period of time, to develop a cell line from his blood that ultimately was patented by them. Unfortunately, they had neglected to tell the patient they were drawing blood from him for this purpose. In reviewing the matter, the court held that

  1. a physician must disclose personal interests unrelated to the patient’s health, whether for research or economic gain, that may affect the physician’s professional judgment; and
  2. a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of a fiduciary duty. 31

In reaching this conclusion, the court noted that there may be conflicting loyalties under these circumstances. Physicians who add their own economic or research interests to the balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefit to the patient. The possibility that an interest extraneous to the patient’s health has affected the physician’s judgment is something that a reasonable patient would want to know in deciding whether to consent to a proposed course of treatment. It is material to the patient’s decision and thus a prerequisite to informed consent. 32, 33

Finally, a question also has been raised as to the proper role of statistical data in describing to a patient risks that are inherent in his or her disease and the success of proposed therapies. Most recently, this was considered by the Supreme Court of California; 34 in this case, the patient was suffering from pancreatic cancer. Discussions were held with the patient concerning the use of a chemotherapy known as FAM (5-fluorouracil, Adriamycin, and mitomycin C) and radiation therapy. Apparently, this combination had shown some promise in treating pancreatic cancer in experimental trials at that time. (The patient’s care was rendered in 1980.) Neither the operating surgeon nor the treating oncologist, however, disclosed to the patient the high statistical mortality rate that was associated with pancreatic cancer. The patient later testified that had he known, he would have chosen to forgo this therapy and, thus, improve the quality of his life over the time remaining. In considering the matter, the court noted that statistics are inherently unreliable in predicting the fate of an individual patient. As such, the court refused to mandate that statistical data regarding the mortality rate of a given cancer be provided to a patient. In doing so, it did not preclude the physician from using this information; rather, it indicated that this question should be decided on a case-by-case basis, which might include statistical data depending on the circumstance. 35 Considering the state of the law, no specific rule can be fashioned. Rather, as noted, the physician must consider this for each patient. It would seem, however, that caution is warranted because such statistical data would seem to be relevant to most lay individuals.

As might be expected, some of the more traditional concepts of informed consent (e.g., which physician has the duty to obtain consent and which individual may provide consent) are remaining relatively static. With the development of new therapies, methods for measuring the success of those therapies, and participation of physicians in research, however, an evolution is occurring in the quantum of information that is expected to be imparted to the patient. As a result, legal counsel should be sought if confusion exists in the mind of the practitioner.

For Whose Acts Must the Physician Respond?

It generally is appreciated that physicians are responsible for their own acts and must answer if these are not within the acceptable standard of care. In this age of increased specialization and use of allied health professionals, however, physicians may find themselves responsible for the acts of numerous others. The first such category is the physicians’ or their professional associations’ employees and agents. The law has taken note of the fact that employees may not be able to respond adequately in damages for professional acts; as a result, the burden has been shifted to the employer, for public reasons. This does not mean that the employee escapes liability, only that the employer shares in that liability and may be held accountable.

This general rule of liability has been expanded to several other circumstances. Apparent agency has been found to exist where there was no actual employment or agency relationship but a provider (physician or hospital) created a circumstance in which it appeared that such existed. For this to occur, it must appear to the public that the provider has held out an individual so that a patient could reasonably believe that the individual was the agent or employee of the provider and further that the patient relied, to his or her detriment, on that representation. This theory most frequently has been applied to hospitals, where it often is held that they are responsible for the acts of emergency room physicians, pathologists, and radiologists who the public believed were employees of the hospital. Regarding physicians, there are circumstances where independent laboratory, pharmaceutical, or other medical services may be performed on the physician’s premises. In this circumstance, the public may reasonably believe that these are employees or agents of the physician, and responsibility may be established. To avoid this circumstance, the physician must make it clear, through signs and other disclosures, that these services are not being rendered by his or her employees or agents but are independent of the physician’s practice.

Another expansion of the physician’s or the professional association’s liability has been brought under the theories of “borrowed servant” and “captain of the ship.” Under the borrowed-servant theory, it generally is held that if a physician uses the employee of another, such as a hospital nurse, intern, or resident, that person may become his or her servant for the purpose of the endeavor. This generally requires that the physician directly supervise the other individual in the manner in which the act is to be performed. For example, when a physician uses a rounding nurse or surgical assistant and, in detail, directs the acts of that individual, responsibility may be attached. It generally would not cover, however, the circumstance where orders are left for nurses, residents, or interns, which they then carry out on their own with the medical training available to them. 36 In that this line often is gray, the only advice for the practicing physician is to understand that a borrowed-servant relationship may be found to exist and to exercise prudence when directing the acts of those working with him or her.

The captain-of-the-ship doctrine really is an expansion of the borrowed-servant rule. It was first enunciated in Pennsylvania in 1949, 37 and it has been fairly restricted to operating room circumstances, where it has been held in various states that the surgeon is responsible for everyone within the room. Fortunately, with the advent of various specialties, each specialist has come to be responsible for his or her own acts, and the doctrine has seen decreasing application by the courts. 38

Physicians who practice cancer medicine may face another question as to whether they are responsible for the acts of other specialists to whom they refer patients for consultation or therapy. In this regard, it generally has been held that once a referral is made, if there has not been negligence in selecting the other physician (i.e., selecting someone when it is known that he is incompetent), then the initial physician will not be responsible for the acts of the other specialist.

The Physician as an Expert Witness

The system of United States jurisprudence that currently is used to resolve disputes in medical management is adversarial. Each side presents its point of view, supported by those with experience in the appropriate medical endeavor. These experts may, and often do, have opposite views. It then is within the province of the jury to attempt to resolve the dispute.

For as long as this system continues, it is essential that physicians who do qualify as having sufficient training and experience agree to review these matters and provide testimony, where appropriate. If this does not occur, data may be presented to the jury which are not correct, thus resulting in an unjust result. This discussion focuses on the physician’s role in this crucible of competing viewpoints.

A common question is whether a treating physician can be compelled to provide testimony. The judicial system allows either side to subpoena treating physicians to render their thoughts regarding the medical aspects of the case. The American Medical Association Council on Ethical and Judicial Affairs has supported this view in its Code of Medical Ethics. In so doing, the Council notes that although a physician should not become an advocate or partisan in legal proceedings, he or she has an ethical obligation to assist in the administration of justice by providing testimony regarding a patient, when requested. 39 This does not, however, open the floodgate to any question an attorney may seek to ask of the treating physician. Rather, physicians generally are allowed to limit their testimony to their own care and treatment as well as their thoughts regarding the prognosis for the patient. In most circumstances, they are not compelled to render expert opinions on hypothetical facts presented by either side, nor are they compelled to render testimony as to whether another physician deviated from the acceptable standard of care. They may elect to participate in this fashion but, as noted, generally are not compelled to do so.

The hypothetical expert is in a different category. This individual usually is retained by one side or the other because of a special expertise to comment on one or more aspects of the litigation (i.e., standard of care, proximate cause to injury, injuries suffered by the patient). If the physician elects to participate in this fashion, it should be with the full understanding that absent some advanced limitation, he or she will be expected to review the materials submitted as well as render testimony in discovery depositions and subsequently in a court proceeding. This is a significant commitment, and it should not be undertaken unless the physician is willing to complete the work once accepted. Otherwise, an unjust result may occur because one side or the other is deprived of necessary testimony.

Once a physician has elected to participate, it is incumbent on him or her to request of the attorney submitting materials those documents that are required for testimony. The treating physician may need no more than his or her own records; however, the hypothetical expert is in a different circumstance. In most instances, the expert’s review should consist of the medical records of the treating physicians, hospitalization records, and deposition testimony of the various treating physicians and the patient. Although some physicians elect to forgo the testimony and base their opinions solely on the records, they should nonetheless review this testimony before appearing in court. Failing to do so subjects their opinion to an attack on credibility in that they may not have considered all of the relevant facts. In addition to a review of pertinent medical records and depositions, an expert should review his or her own medical literature on the subject in question. In today’s arena of computer-assisted litigation, both sides may avail themselves of Medline searches and often start with a search of all published literature by experts retained in the matter. This does not suggest that a physician’s opinions may never change once published. However, the physician should be aware of his or her prior thoughts so that an adequate explanation of his or her current thinking, aside from all the literature, can be given. Most experts who are adequately trained and experienced may not find it necessary to conduct a general review of all the literature. This is a matter of personal preference and usually will not affect the case one way or the other. The only exception is that if a physician does consider a particular author, text, or journal article as being authoritative on a point, then that physician should review the same and be prepared to explain his or her own opinions if they diverge from those contained in that literature.

Managed Care

As the transition to managed care continues, there is an increasing risk that patients may not receive the care they had expected or is required, and that this disenchantment will be directed not only at the managed care entity but at the physician tasked with providing the care. As an independent contractor rendering care pursuant to such plans, physicians may not be exempt from liability and may find themselves named as defendants in malpractice cases, when the basis for the patient’s current problems actually stem from the plan’s procedures. Unfortunately, under current law, it is extraordinarily difficult to sue most managed-care organizations. They generally enjoy protection from lawsuits under the Federal Statute known as the Employee Retirement Income Security Act (ERISA). 40 Pursuant to this Act, the Managed Care Plan must be sued in Federal, not State, Court. Once in Federal Court, plaintiffs are only allowed to recover for the actual benefit they have been denied under the Plan as opposed to consequential damages, such as lost wages, future medical care and/or pain and suffering. Recently, there has been a significant effort to amend this act to allow lawsuits directly against health maintenance organizations for the recovery of consequential damages. 41 Sensing the political consensus that is forming in the United States for some type of reform, both the Republicans and Democrats have begun to fashion bills that would, in some way, impose accountability upon managed-care organizations. On the one side is a desire to protect the supposed cost efficiency of these plans, while on the other is a focus on physician and patient rights. 42 As of the spring of 1999, no bill had successfully negotiated its way to the President’s desk, although it is anticipated that eventually some reform will occur.

As the right to sue evokes, there are traps that the physician should consider. The first of these is the manner in which these plans fund physicians. Utilizing a combination of capitation and the distribution of risk pool funds, an impression is given that by avoiding the use of hospitalization, specialists, or expensive diagnostic tests, a provider may benefit in a tangible way. At least one Court has ruled that the existence of such plans must be disclosed to the patient. 43 If allowed in evidence, the appearance of impropriety may be sufficient to persuade a jury, when the issue is whether a physician should have used a specialty referral or diagnostic procedure. There is no golden rule to assist the physician in avoiding this difficulty, other than to be steadfast in exercising appropriate medical judgment. In other words, the physician must be vigilant in ensuring that he or she continues to use the health-care system appropriately and not distinguish in any fashion between those patients who are part of a managed-care program and those who are not.

The issue of referrals creates an additional difficulty. In most circumstances, physicians have established a referral pattern on the basis of their comfort with the experience of the physicians to whom they refer patients. Under many managed-care programs, the choice of referrals is limited. In fact, the physician may not be acquainted with those listed by the managed-care entity. The preferred course for physicians to avoid difficulty in this circumstance is to become familiar with at least some of the physicians listed on the provider panel. If this is not possible, the physician should tell the patient, before a referral, that he or she does not know the qualifications of a panel member. The patient can then can make a personal determination whether to rely on the managed-care entity’s certification of these physicians or to seek further advice.

Another common difficulty that managed care exacerbates is the potential for misunderstanding who is to monitor the patient. Managed-care entities using the “gatekeeper” system create a circumstance in which patients are referred back and forth between physicians as authorization is required for further diagnostic studies or care. To avoid patients falling through the proverbial “crack,” it is incumbent on both the primary-care physician and the specialist to ensure that the patient is being followed up by one or the other. The best mechanism is for the physicians to correspond and, in that correspondence, set out their understanding with regard to who has the responsibility for follow-up. In addition, patients should be made aware of how the referral system works and be instructed regarding their obligation to return to whichever physician is mandated under the system, if they require further care. This conversation should be documented in the physician’s medical record.

Recently, litigation has focused on the physician’s duty to advocate on behalf of the patient. 44 Although this area of the law is evolving, there already has been discussion suggesting that physicians will be under an increasing duty to seek approval for the medical attention they think is appropriate when the managed-care entity initially denies coverage. Of course, the extent to which a physician must go will vary under the circumstances. However, it seems clear that if coverage is denied and the physician believes this is inappropriate, he or she should at least follow the appellate procedure of the managed-care plan. Whether this is simply a phone conversation with a medical director or further written documentation on the need for care, as noted, depends on the circumstances. Most plans understand their own liability for refusing to authorize care that is strenuously recommended by a physician. As a result, advocacy often will inure to the patient’s benefit. An example of this in the middle 1990s was seen in litigation involving high-dose chemotherapy with autologous bone marrow transplantation for stage IV metastatic breast cancer. A number of managed-care plans throughout the country routinely denied this coverage, stating that it was experimental and, therefore, not authorized. There were, however, a number of court decisions indicating that this was not experimental therapy but rather within the mainstream of cancer treatment. 45 Such advocacy on behalf of the patient cannot help but inure to the patient’s benefit and, perhaps, change industry-wide perceptions as to what care is covered.

Withdrawing Life Support/Physician-Assisted Suicide and Euthanasia

Tracing the origin of laws pertaining to suicide is not an easy task; however, it does appear that some of the earliest writings on the subject appeared in Roman law. That body of law did not prohibit suicide, but it did enact a forfeiture of property by those who committed suicide to avoid criminal punishment. 46 This seems to have been picked up in early English law. The writings by Bracton in the 1200s summarized the law as follows:

  • If a man has slain himself after having committed a felony, and for the purpose of evading the punishment therefore, his lands escheat and his chattels are forfeited.
  • If he has brought death on himself “without any cause, through anger or ill will, as when he wished to hurt another, and could not fulfill what he wished,” he is likewise to be punished with escheat of lands and forfeiture of goods.
  • If he commits suicide from “weariness of life or impatience of pain,” his lands descend to his heir and his chattels only are to be confiscated.
  • If he was insane when he did the act that caused his death, or if he did it by accident, he is to be held guiltless and forfeits nothing. 47

The law of the United States has its roots in the early English common law. As a result, this early treatment of suicide found its way into the criminal law of this country. It is now common to find statutes which not only prohibit suicide but impose penalties on those who aid another in the act of service. 48

A distinction, however, has been drawn between the withdrawal/withholding of life support and physician-assisted suicide and euthanasia. The prior is considered to be passive in nature in that it simply allows nature to take its course. The latter two categories, however, are considered to be active, in that they involve the participation of a physician either in prescribing medication or using medical devices to cause death.

Since the early 1970s, there has been a great deal of judicial and legislative attention focused on how to deal with the patient, and those who assist the patient, in the withdrawal and/or withholding of life support. The seminal case was that of the New Jersey Supreme Court involving Karen Quinlan. 49 This started a line of decisions that brought us to the U.S. Supreme Court decision in Cruzan. 50 The effect of these decisions has been to recognize the right of patients to refuse medical treatment even to the extent of withholding and/or withdrawing life support, including artificial nutrition and hydration. Additionally, the courts that have considered the matter have held that the right should not be diminished upon the incompetence of the individual. As a result, substitute decision makers are allowed when the patient is no longer able to make the decision.

Having decided the issue of withdrawal/withholding of life support, the Supreme Court, in 1997, turned its attention to physician-assisted suicide. It did so by reviewing the laws of Washington and New York states which prohibited physician-assisted suicide. The question raised was whether this was a right protected by the United States Constitution. The Court ruled that there was no Constitutional right to physician-assisted suicide or euthanasia. It did, however, leave undisturbed its earlier ruling protecting the right to refuse care and for withdrawal of life support. 51

These rulings did not end the issue of physician-assisted suicide or euthanasia for all time. Rather, as noted by one of the justices, the Court has left the matter to the “laboratory” of the states to allow each to address the issue within the context of that state’s Constitution and legislative enactments. It should be noted that some state Constitutions are worded in such a fashion that protection might be afforded for assisted suicide. In addition, there is apparently no prohibition to a state enacting its own laws for or against physician-assisted suicide. One potentially negative effect of these decisions is that we may now have a myriad of laws forming a patchwork quilt across the United States addressing this issue from different perspectives.

The first successful legislation legalizing physician-assisted suicide came in Oregon in 1997. 52 The Oregon initiative was most likely successful because of its limited scope. It applied to patients with less than 6 months to live and was further limited in that it allowed only prescriptions of lethal drugs. The Oregon Statute provides the following:

An adult who is capable, is a resident of Oregon, has been determined by the attending physician and consulting physician to be suffering from a terminal disease, and who has voluntarily expressed his or her wish to die, may make a written request for medication for the purpose of ending his or her life in a humane and dignified manner in accordance with this Act. Some of the safeguards included the following:

  • The initial request for drug prescriptions had to be in writing and witnessed by two individuals concurring that the patient was competent.
  • At least two physicians had to concur that the patient was suffering from a terminal illness and was likely to die within 6 months.
  • In the event the patient was thought to be suffering from a psychiatric disorder, the patient would have to be referred for counseling.
  • Records had to be maintained and submitted annually to the Health Division of the state for review.
  • Two oral requests were required, separated by at least 15 days, before a physician could accept the written request. Once accepted, the prescription could not be filled for 48 hours after the written request. 53

The constitutionality of the Oregon initiative was challenged, but the Statute withstood attack. Following that, it was submitted to the voters a second time and reaffirmed by 60%.

Interestingly, we now have one full year of data to review with regard to this Statute. 54 During the year, 23 persons who received prescriptions or medications were reported, as required, to the Oregon Health Division; 15 died after taking lethal medications, 6 died from underlying illnesses, and 2 were alive as of January 1, 1999. The median age of the 15 patients who died after taking the legal medications was 69 years; 8 were male and all 15 were Caucasian. Thirteen of the 15 patients had cancer. 54

It was also noted that, when compared with a control group, …the decision to request and use their prescription for lethal medication was associated with a concern of a loss of autonomy or control of bodily functions, not with fear of intractable pain or concern about financial loss. In addition, we found that the choice of physician-assisted suicide was not associated with level of education or health insurance. 54

Although the database available to date is small, it seems to be pointing in a direction that would alleviate two major fears: first, that there would be a rush toward utilization of this form of physician assistance; and second, that it would in some way be disproportionately chosen by or forced on terminally ill patients who are poor, uneducated, uninsured, or fearful of the financial consequences of their illness. There does not seem to be evidence supporting these fears from the data collected. 55 However, the caveat is that the database is small and the time over which this Statute has been in effect is relatively short. These issues will require continuing evaluation.

The issue of physician-assisted suicide and euthanasia remains in flux and will likely see continuing attention on a state-by-state basis. The only area that is fixed relates to a patient’s right to refuse care and/or life support. These concepts have found federal Constitutional protection for state legislatures and courts, and as a result, the only role for crafting guidelines which protect both the physician and the patient while preserving the right.

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