Informed Consent and Medicolegal Problems
Jeffrey P. Phelan
Table Of Contents
Chairman, Department of Obstetrics and Gynecology, Citrus Valley Medical Center, West Covina, California; President and Director, Clinical Research, Childbirth Injury Prevention Foundations, Pasadena, California (Vol 1, Chap99)
PROFESSIONAL STANDARD VERSUS PATIENT-ORIENTED MATERIALITY STANDARD
THE REASONABLE DOCTOR STANDARD: MAJORITY VIEW
REASONABLE PATIENT STANDARD: MINORITY RULE
EXCEPTIONS TO INFORMED CONSENT
The medical professional liability crises of the 1970s and 1980s were nothing in comparison to the circumstances affecting physicians today.1 Contemporary physicians are confronted with society’s often inconsistent or conflicting demands, and simply the voracious greed of the plaintiff bar. At the same time, the public has demanded that health care practitioners be superbly trained, experienced, and currently competent, yet it has argued for defining health care downward through alternative providers, cost containment, and fee structuring, as well as cuts in medical education funding. In the process, there has been a desire for a return to the “old days of medicine,” when a reassuring physician with a good bedside manner was sufficient. Yet our better judgment prevails in favor of vigorous peer review, stringent credentialing, and continuing medical education.
Patient expectations have kept pace with developments in science, often interpreting the latest miracle of medicine, or the latest episode of ER on television, as the prevailing standard of care. Information about medicine and health has become a staple of consumer interest, yet the consumer is often inadequately prepared to appreciate the limitations of science despite its advances. Attorneys and others, ranging from economists to physicians, have contributed their own arguments for a level of performance that strains the capacity and, often times, the ability of the profession.
In reality, whatever the intended effect of a medical or surgical intervention, an unsatisfactory outcome has often resulted in the full use of one’s legal rights and remedies. Since the new millennium, professional liability insurance premiums for obstetricians and gynecologists have exponentially risen to a level where the amount spent on liability insurance alone often exceeds the earnings of 99.9% of American wage earners.1 As these premiums continue to rise, society must ask who benefits the most from an increase in insurance premiums? Is it society or is society also being victimized by the parasitic effects of litigation?
There is no question that physicians, as well as other professionals, should be accountable for their professional performance. Physicians have come a considerable distance since 1970 toward understanding and appreciating their professional liability and how to manage risk. Modern physicians have moved beyond certain arguments of the status quo to an acceptance of a balance of decision making in practice, and a new sharing with patients of information, concerns, ideas, and choices. This partnership has not yet extended to its fullest potential, wherein patients will equally share the ultimate responsibility for the consequences of decisions jointly made, but perhaps it has achieved a rough equity in allowing the patient a participatory role and, at the same time, affording the physician some protection from the consequences of a poor outcome.
The informed consent process epitomizes this sharing of information and represents a partnership between physician and patient.2 It is a process because no single event during its course can suffice to satisfy all its requirements. It is a process because it takes some time to share information, exchange queries and answers, to reflect and consider the alternatives, and to make a decision. Informed consent is a deliberative and interactive session.
Although the express purpose of informed consent is to provide an opportunity for patients to take an active role in their care and to allow them to participate meaningfully by being adequately informed, empirical evidence suggests that traditional roles in ultimate decision making remain largely unchanged, but are in the process of changing. A study of informed consent and cardiac surgery in 1986 revealed that, “patients…continued to yield this decision making to experts involved in rendering their clinical care.”3 Instead of patients valuing the process for the opportunity to participate in the decision-making process, they placed value on the physician’s expressed concern and communication. The physician, in turn, enjoyed some small measure of protection from liability. Therefore, “the patient and the surgeon each benefits from the law of informed consent, but not in the way it was intended.”
While societal thinking for the past several decades has been molded by the media and the plaintiff bar to believe that the world in which we live can be or is a no-risk bubble, the contemporary role of informed consent is also undergoing a transformation. The evolution of informed consent law as set forth in Table 1, and as noted by Trichter in 1980,4 intended a closer union between the patient and the doctor:
*This case has been decertified and has no precedential qualities but the facts are used to suggest a lack of informed consent.
Instead, informed consent is now shifting responsibility through procedural-based informed consent to the patient to assume the risk of procedures such as vaginal birth after cesarean5 (Table 2) and vacuum use6 during operative vaginal delivery (Table 3). While Trichter’s dream may, in part, have been realized, the net effect is that patients are assuming a greater role in accepting responsibility for their health care decisions.
VBAC, vaginal birth after cesarean
This proposed consent should be modified in keeping with the law of the reader’s state and after consultation with an attorney. (Line 7 refers to solely nontertiary facilities; This consent form has been modified from the original proposed consent. [Phelan, JP: OBG Manage 8:62, 1996]).
This proposed consent should be modified in keeping with the law of the reader’s state and after consultation with an attorney. (This consent form has been modified from the original proposed consent. [Phelan JP: OBG Management 11:65, 1999]).
There has been an evolution in theory surrounding informed consent, and it is reassuring to know that the roots of the expectations of physician and patient that form the foundation for informed consent date back to 1767.7 In Slater v. Baker & Stapleton,7 a plaintiff alleged negligence and a lack of informed consent for a surgical procedure. Most of such early cases, such as the Slater matter, were more about negligence than issues of informed consent, but the idea was established early in English common law (which is the basis for modern American jurisprudence) that a patient had certain rights that could not be violated by a physician.
In America, this evolution continued and became more specific in the case of Mohr v. Williams,8 wherein a surgeon was given consent to operate on the patient’s right ear. Finding the left ear in greater need of attention, the surgeon instead operated on the left ear, apparently with skill and success, but notably without permission. It was considered an assault and battery, and for many years, cases involving similar circumstances were treated as batteries, or “unauthorized touchings.”9
Modern American law (see Table 1) on informed consent found its first articulation in 1914, when the eloquent and famous Justice Cardozo, in Schloendorff v. Society of New York Hospital10 stated, “every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”
Although the early cases in this field were the stepchildren of the quasi-criminal writ of trespass and the tort of battery, informed consent has evolved through the long and tortuous common law tort of negligence. Although there are numerous detailed legal reasons for this evolution, the most common sense reason is probably the connotation of battery being an intentional, unconsented touching versus the unintentional aspect of the common law tort action of negligence.
Although rarely filed as a complaint against a physician, informed consent per se has become an increasingly more significant issue in a malpractice claim. Rather than filing a complaint against the clinician on the basis of improper informed consent, informed consent is now threaded throughout the trial to weave the physician’s alleged failure to give the patient the right to choose a “less riskier course of action.” Thus, it is on this basis that procedural-based informed consent will be used more frequently and, in the process, will become an increasingly greater bar to potential claims.
Historically, the term informed consent was first used in a 1957 California case, Salgo v. Leland Stanford University.11 In that case, the patient was diagnosed with arteriosclerosis of the abdominal aorta. After the negligent performance of a translumbar aortogram, the patient became paralyzed from the waist down. The patient sued for the negligent performance of the procedure and the failure to explain the procedure and its attendant risks. In deciding the matter on behalf of the patient, the court ruled that “full disclosure of facts necessary to a proposed procedure or operation [and] the extent of the risks involved,” should be explained to the patient. Thus, California physicians after Salgo appeared to have a duty of minimal disclosure. After the Salgo decision, little attention was brought to the case. However, in 1960, informed consent skyrocketed into the American consciousness. Within 3 days of each other, Natanson v. Kline12 and Mitchell v. Robinson13 rocked the American medical establishment.
The former case, Natanson v. Kline,12 stemmed from a radiotherapy case in Wichita, Kansas. In this case, after a mastectomy for breast cancer, the patient suffered chest wall injuries from cobalt therapy used to reduce the risk of cancer recurrence. After hearing all the evidence, the trial court found in favor of the defendant. On appeal, there were two aspects to the negligence alleged: one carried several allegations of improper radiation therapy and the second involved the failure to warn Mrs. Natanson that the radiation therapy could have significant side effects. During the trial, Mrs. Natanson and her husband indicated they had been given no warning. The medical record indicated nothing, and the doctor did not remember. The trial judge refused to give a broad instruction on the failure to warn to the jury as requested by the plaintiff. The Kansas Supreme Court held, on appeal, that the broad instruction should have been given, and the court returned the case for retrial. This opinion and an additional opinion secondary to a request for rehearing marked the genesis as well as the prominence of the doctrine of informed consent.
Here, the Kansas Supreme Court pointed out that the Natanson case was “…not an action for assault and battery, where a patient has given no consent to the treatment.” Rather, Dr. Kline was acting in good faith, did not intend Irma Natanson harm, and had her permission. Thus, contrary to the traditional assault and battery case where the defendant is acting out of malice, Dr. Kline was attempting to confer a benefit (reduce Irma Natanson’s risk of breast cancer recurrence with radiation therapy) with her consent. But, here, the “…nature and consequences of the risks of the treatment were not properly explained to her.” This relates directly to whether the physician has obtained the informed consent of the patient prior to rendering treatment.
Moreover, the Kansas Supreme Court held that Dr. Kline had an obligation as a reasonable and prudent physician “to disclose and explain to the patient in language, as simple as necessary, the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body.” Moreover, the court held that if treatment was given without the consent of the patient, “…the physician was guilty of malpractice no matter how skillfully the treatment may have been administered.”
Thus, Natanson moved informed consent away from the concept of battery to one of negligence. But, where was the link to her injury or proximate cause? In informed consent cases, the issue is frequently whether the plaintiff would have chosen a different course of treatment if s/he had been adequately informed. In Natanson, there was no evidence that Mrs. Natanson would have chosen an alternative therapeutic approach or none at all. Thus, a physician would be subject to liability “if he makes no disclosure of significant facts within his knowledge which are necessary for the basis of an intelligent consent by the patient to [the proposed treatment].”
The Natanson decision also created confusion because the standard of disclosure was the “reasonable and prudent doctor” and that the violation of this duty, the failure to disclose, was a proximate cause of the injury. The court, in essence, had not increased the patient’s right to self-determination but instead imposed a more detailed duty of disclosure on the reasonable physician. This was offset, however, by the “reasonable physician standard” as an indicator of adequate disclosure. This has resulted in the use of expert testimony to establish the standard for disclosure.
In summary, the Kansas Supreme Court held that “the physicians must advise the patient [of] the nature of the proposed treatment and any hazards known to the physician.” This decision also alluded to the issues of assumption of the risk, the later to be termed “therapeutic privilege exception,” and the determination of the adequacy of informed consent by expert medical testimony.
The second important opinion, Mitchell v. Robinson,13 was handed down by the Missouri Supreme Court shortly after the Natanson opinion and confused the need for expert medical testimony. In this opinion, the case was not over the need for or the amount of informed consent. The plaintiff explicitly denied receiving any information regarding the hazards of shock therapy and, in contrast, the defendant doctors indicated they had provided it. In these circumstances, the court held that it was up to the jury to decide whom to believe and that this did not require expert medical testimony. This opinion provided the basis for interpretation (misinterpretation) that in cases of informed consent expert medical testimony was not necessary, even to determine the extent of disclosure required.
Twelve years later, Canterbury v. Spence14 brought into question the sufficiency of a doctor’s disclosure to a paralyzed laminectomy patient. There, Jerry Canterbury consulted Dr. William Spence regarding severe pain between his shoulder blades. After an inconclusive x-ray, Dr. Spence recommended a myelogram, a procedure in which dye is injected in the spinal column. This dye study suggested an abnormality, a filling defect, in the spine at the fourth vertebrae of the chest. To determine the cause of the defect, a laminectomy was recommended. After the surgery and also a fall, Jerry Canterbury complained that he could not move his legs and had trouble breathing. Paralysis was confirmed clinically and Dr. Spence reoperated to relieve the pressure on the spinal cord. Subsequently, Jerry Canterbury regained control over his muscles but suffered permanent bladder dysfunction.
At issue was whether Dr. Spence should have disclosed the “one percent” risk of paralysis to Jerry Canterbury. Dr. Spence contended that the “communication of that risk to the patient is not good medical practice because it might deter patients from undergoing needed surgery and might produce adverse psychological reactions which preclude the success of the operation.”
However, the court concluded that “true consent to what happens to one’s self is the informed exercise of a choice and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.” Because the patient is dependent on his or her physician, “the requirement of reasonable divulgence by [the] physician to [the] patient to make such a decision possible” when “…the exigencies of reasonable care call for it.” Thus, the patient, not the physician, has the prerogative to determine his or her own course of care so long as there is “…some familiarity with the therapeutic alternatives and their hazards.”14
But does that mean “full” disclosure or something less than that? After all, it seems unrealistic to expect professionals to disclose “all risks” of an intended therapeutic approach. At the same time, “the patient’s right of self decision shapes the boundaries of the duty to reveal.”
In that holding, the California Supreme Court backed away from reasonable patient tests where “all risks potentially affecting the decision must be [disclosed]” to one in which the extent of disclosure would be one in which “…the patient would deem it significant to his decision.” This means that the scope was limited to material risks that a “…reasonable person in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.”
However, the physician did not need to disclose items of which people of average sophistication were aware, already knew, or were not material to the patient’s decision. However, the physician decision to withhold information for medical reasons must be carefully circumscribed.
Canterbury grounds the physician disclosure requirements into negligence on the basis of a duty to warn of foreseeable risks. For example, “due care normally demands that the physician warn the patient of any risk to his well being which contemplated therapy may involve” and that the duty to warn is “surely a facet of due care.” Moreover, Canterbury symbolizes “…respect for the patient’s right of self determination on a particular therapy…” and demands a legal rather than a physician standard.
In California, the Cobbs15 court acted similarly and drew on the foundational elements of informed consent and the disparity between the doctor and the patient (Table 4). As such, the Cobbs court imposed an “overall obligation to the patient of reasonable disclosure of available choices with respect to proposed therapy and of the dangers inherent and potentially involved in each.” Moreover, Cobbs,15 as well as Canterbury,14 fell short of full disclosure. Instead, physician disclosure did not extend to all possible complications nor include “minor risks inherent in common procedures” such as drawing blood. But, disclosure included those procedures “…which involve a known risk of death or bodily harm.” Thus, a physician has a duty to disclose the potential for death, serious harm and possible complications. The scope is measured by the patient’s need; and, the test for determining that need is the materiality to the patient’s decision.
Subsequent to the Cobbs15 decision, Truman16 extended the scope of adequate informed consent to include informed refusals. In the Truman case, a wrongful death action was brought by the decedent’s sons for the failure to disclose the risk of not undergoing a Pap smear. In that case, Dr. Thomas advised Mrs. Truman of the need for a Pap smear to check for cervical cancer. But he did not advise her of the dangers of not having the test. She subsequently developed cervical cancer and died. In the appellate court ruling for the plaintiff, the court held that Dr. Thomas was obligated to provide the patient “…with all the information material to her decision.” While the Truman matter symbolizes the requirement to inform the patient of the consequences of her refusal, this case also moved informed consent from surgical procedures or the operating room to nonoperative procedures and outpatient care.
The creation of a guarantor, the nurse, for informed consent in the Campbell17 decision markedly altered the course of informed consent. There, the court imposed a duty on Pitt County Memorial Hospital under the corporate negligence theory to insure a patient’s informed consent prior to a medical procedure.
In that case, Margaret Campbell was admitted to Pitt County Memorial Hospital for the delivery of her footling breech pregnancy. Five weeks prior to admission, she had been advised by her doctor of the baby’s position and that if it remained breech, her baby would be delivered by cesarean. When she presented in labor, a partner of her doctor and the labor and delivery nurses of the hospital knew of the footling breech presentation. In fact, Mrs. Campbell notified the nurse of the baby’s presentation, and an x-ray ordered by the doctor confirmed it. The x-ray findings were also confirmed by a vaginal examination. The health care providers did not disclose this fact or its significance to Mr. or Mrs. Campbell. While the labor and delivery nurse did express some of her concerns to the obstetrician, she did not contact her immediate supervisor or the chairperson when the obstetrician failed to address these concerns.
During the course of vaginal delivery, the cord became entangled. As a result, the baby allegedly became severely asphyxiated and developed cerebral palsy requiring constant care and supervision. At trial, the plaintiff presented evidence that “the obstetricians and labor and delivery nurses were aware of the higher risks of vaginal delivery for a baby in a footling breech position and, …[that] the cord entanglement and asphyxia could have been avoided by a cesarean.”
Under the doctrine of corporate negligence, the North Carolina court held that the defendants “did have a legal duty to ensure that plaintiffs informed consent to a vaginal delivery of a footling breech baby had been obtained prior to delivery.” In deciding the case, the court relied on the expert testimony of a perinatal nurse, and found that the physician had the responsibility to explain the risks of alternative procedures and that the nurse was responsible for ensuring that the patient had been given an explanation. While the Campbell case has been decertified (has no precedential qualities), the facts of this case are often used to show a lack of informed consent.
Informed consent was jolted once again in Moore v. UCLA.18 Here, the Moore case broadened the scope of informed consent by imposing on California physicians the obligation to disclose matters unrelated to the patient’s health but those related to the physician’s economic or research interests that may affect the doctor’s judgment.
In that case, John Moore underwent treatment for leukemia at University of California at Los Angeles Medical Center (UCLA). There, his doctor confirmed the diagnosis of leukemia and later recommended that Moore’s spleen be removed “…to slow down the progress of the disease.” For purposes of continued care, John Moore, a Seattle, Washington, resident, was advised by his doctor that follow-up procedures could only be done at UCLA. Throughout this period of time, Moore’s doctor and his associates “…were actively involved in a number of activities which they concealed from [Moore]…[such as]…conducting research on Moore’s cells…planning to benefit financially and competitively [from the use of the cells] and…[without requesting] his permission.”
In deciding in favor of John Moore, the California Supreme Court recognized that “…a reasonable patient would want to know whether a physician has an economic interest that might affect a physician’s professional judgment.” After all, “…a sick patient deserves to be free of any reasonable suspicion that [a] doctor’s judgment is influenced by a profit motive.”
What impact, if any, will this broadened disclosure requirement have on physician health care providers? More important, what constitutes a “conflicting loyalty”? Does this include disclosure of physician-owned hospitals, physician owned medical groups, consulting positions with pharmaceutical or health care corporations, and the acceptance of material intended for educational purposes such as textbooks, tapes, or lectures? Under these circumstances, when is the duty to disclose extinguished? For example, does a textbook accepted some 20 years earlier from some now-forgotten pharmaceutical company while in medical school and before one is a licensed physician need to be disclosed to each and every patient? What if the doctor attends a conference sponsored by a medical company? Should the very fact that the doctor or nurse attended the conference or accepted the book need to be disclosed?
In establishing this broad disclosure requirement, the California Supreme Court inferred that excessive disclosure could be avoided where the “…disclosure [goes]…beyond that required within the medical community,” the interest is not material, the risks are remote, and the issue is “…not central to the decision to administer or reject [a] procedure.” But, when a physician is seeking a patient’s consent, it is the patient’s prerogative not the physicians to determine the ultimate direction of his or her health care. Thus, in the situation of conflicting loyalties, the physician must “…disclose personal interest unrelated to the patient’s health…that may affect his [or her] professional judgment.”18
|PROFESSIONAL STANDARD VERSUS PATIENT-ORIENTED MATERIALITY STANDARD|
Although the Natanson12 court held that giving no information at all was negligence as a matter of law, the court still retained the potential of a professional standard negating that position. Not until the Canterbury14 decision in 1972 did the participatory model, or patient-oriented material standard, gain recognition. In such a jurisdiction, the undisclosed risk must materialize and it must be shown that the nondisclosure caused the injury. Therefore, although the patient does not have to produce expert testimony, the patient must show that, had the disclosure been made, she would not have proceeded with the medical treatment.
Thus, the existence of a duty on the part of physicians to inform the patients of the inherent risks of a proposed treatment and its downstream consequences is acknowledged. But, two prevailing views as to the yardstick of this duty have developed (Table 5).
Reasonable doctor standard
The disclosure of those risks that other physicians practicing under the
same or similar circumstances would consider necessary to tell the patient.
Reasonable patient standard
What would a prudent person in the patient’s position have done
if adequately informed of all significant perils?
|THE REASONABLE DOCTOR STANDARD: MAJORITY VIEW|
Measured by Customary Disclosure Practices of Physicians
The majority of the courts that deal with the issue of informed consent have based the duty to inform on whether it was the custom of physicians practicing in the community to make that particular disclosure.19 According to the court, the Canterbury rule would require doctors to spend too much time covering every aspect of a proposed treatment. The questions of whether a doctor is negligent in failing to inform the patient of possible consequences of an operation is to be determined according to the general practice customarily followed by the medical profession.19
This particular disclosure was considered the majority and preferable view. Under the majority view, the physician need not disclose the risks of infection, for example, if it is something known to any person of “ordinary sophistication” or to satisfy the patients’ need to know. At the same time, information promulgated by a group of doctors such as the American College of Obstetricians and Gynecologists (ACOG) or a hospitals’ department of obstetrics and gynecology could satisfy the reasonable doctor’s disclosure requirements.
|REASONABLE PATIENT STANDARD: MINORITY RULE|
Disclosure of the Risk of Treatment is Measured by What a Reasonable Patient Would Want to Know
The Canterbury court defined a risk as material, “…when a reasonable person in what the physician knew or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego therapy.” Though a physician may not know with complete “exactitude” what the patient would consider important to his or her decision, the physician should be able to sense how the reasonable patient would expectably react given certain information. The physician can accept this burden because he is in a superior position to look into the patient’s background and current condition.
The reasonable patient standard15 is thus grounded in the concept that differences exist between the doctor and patient (see Table 4). For example, “patients are generally persons unlearned in the medical sciences and therefore, except in rare cases, …the knowledge of patient and physician are not in parity…” Second, “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…” Third, the patient’s consent to treatment, to be effective, must be an informed consent. Fourth, the patient being unlearned in medical sciences, has an abject dependence on and trust in his physician for the information on which he relies during the decisional process, thus raising an obligation in the physician that transcends arms-length transactions.
The Canterbury court held that it was the physician’s duty to disclose material information and adopted the so-called objective test. The court defined material information as follows: “a reasonable person in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not forgo the proposed theory.” In other words, the objective test relies on whether a reasonable person (other than the plaintiff but of similar position) would have accepted the treatment had the risk been disclosed.
This rule imposes a heavy burden on physicians to disclose sufficient information to permit the patient the opportunity to make an informed decision. Procedurally, the decisional control is left with the patient and the physician is left with deciding what a reasonable patient would want to know. The Canterbury14 court accepted this fact and added that a physician “must make judgment in terms of materiality.”
In Cobbs v. Grant, the court used the patient-oriented materiality standard but apparently adopted the subjective test. Not only have the courts adopted two tests for this determination, but some courts have allowed a hybridization of the two. The effect is well stated by Riskin20:
What Must be Disclosed?
The current status holds that, absent exceptions, a patient must give consent for any treatment. This means that the physician has a duty to disclose certain information in order for that consent to be valid and that the duty to disclose is not limited to surgical procedures but is triggered by any fork in the health care road. The information to be disclosed includes (Table 6) but is not limited to the nature of the ailment; the nature of the proposed treatment; the probability of success; the alternative forms of treatment, including no treatment; and the risk of unfortunate results associated with the treatment. California physicians under the Moore rule, must also disclose items unrelated to a patient’s health, “whether research or economic, that could affect the physician’s decision” would need to be disclosed. Whether or not the disclosure is held adequate will be judged by different rules in different states.
This will depend upon the jurisdiction in which one practices.
*To the author’s knowledge this issue is limited to California physicians.
In states that use what is called the majority rule, the adequacy of the informed consent will be determined by a professional medical standard, either the customary disclosure practices of physicians, such as ACOG literature, or what a reasonable physician would disclose under the same or similar circumstances. In those states that use the minority rule, the courts have abandoned the professional standard in favor of the more liberal lay standard, which requires disclosure dependent on the informational needs of the patient. The physician need not divulge all risks but only those that are material to an intelligent decision on the part of the patient. Some courts invoke the objective test for determination of materiality (the informational needs of a reasonably prudent patient of the same or similar position), and others invoke the subjective test (the informational requirements testified to by the plaintiff patient). In order for there to be liability, it must be shown that an unidentified risk caused an injury and that had the patient known of that risk he or she would not have proceeded with the therapy. To give no information at all presents liability as a matter of law, and the liability of the informed consent doctrine can be present even when the procedure is performed without negligence.
Refinements of locally applicable law on informed consent continue daily. Therefore, physicians are advised to consult their attorneys or matters as to whether the professional standard or the patient-oriented materiality standard applies in a given state. Moreover, local nuances of informed consent process and documentation should be considered in the context of this broader discussion.
|EXCEPTIONS TO INFORMED CONSENT|
Traditionally, physicians have considered themselves most capable of making medical decisions for their patients. This logical but paternalistic attitude was not only accepted but also expected by our patients. The doctrine of informed consent has, in a pragmatic way, significantly altered this approach. It has taken medical decision-making away from the sole proprietorship of the physician and given an important role to the patient. Our courts have responded to this byproduct of society’s changing attitudes toward individualism and the right of self-determination.
This transition has been a difficult one, and because of the confusion surrounding it, the majority of medical practitioners have agonized with negativism over its appropriateness. As the profession grows through it, most of the concern has been generated by ignorance of the doctrine, the opportunity for abuse it affords the plaintiff’s bar, and the confusing application by the courts. Until recently, plaintiffs have won few cases that were based solely on the lack of informed consent,19 yet it has been listed as a technical allegation in the majority of initial pleadings. Most, if not all, physicians want to inform their patients and do so.
Mutual sharing of decision making by the physician and the patient has a positive side. Legally, with adequate disclosure, the physician is protected because the patient assumes the risk for the procedure or course of therapy. But disclosure does not confer absolute protection in the circumstances where a procedure is negligently performed. All physicians believe that the discussion with the patient fosters a much better rapport and understanding. Nevertheless, documentation of these discussions should be undertaken.
In balancing the decision-making equation, the courts have allowed certain exceptions to the informed consent doctrine. Under either the majority or minority rules, there are specific situations that make disclosure unnecessary. These are generally thought to exist and are listed in Table 7. Four particular categories, as defined by Meisel21 deserve further discussion: emergency, incompetence, waiver, and therapeutic privilege. Of practical significance to the physician, the ultimate decision as to whether the exception exists in any one case is with the trier of fact: jury or judge. This means that the jury or judge will decide whether the doctor satisfied the requirements of these informed consent exceptions.
In general, a physician may render care in an emergency without the informed consent of the patient. This exception seems logical and practical. The difficulty is in the definition of the term emergency. The court may find that an emergency existed but not define it, and, needless to say, the term encompasses a spectrum of definitions. Commonly, the Book of Approved Jury Instructions for each state will provide definitions. For example, in 1986 California22 defined an emergency as follows:
There is little doubt when the patient is conscious and the urgency of the treatment is so obvious that to delay it for the acquisition of informed consent would produce similar harm. There are similar situations where, although the patient’s consent can be acquired, full disclosure to the patient is not possible. Under these conditions, minimal disclosure may be used.
The emergency exception is used for the preservation or restoration of health or, sometimes, even life. It is an honest, pragmatic, and practical decision we make that, in reality, should rarely cause physicians a problem in the courtroom. Nevertheless, the emergency exception remains a factual issue for the jury or the trier of fact to decide.
Certain persons are incompetent to give their consent for medical treatment and, therefore, may be treated without it. The definition of incompetence is similar to but even more difficult to deal with than the definition of emergency. There is no single standard of incompetence. Numerous approaches have been taken by the courts. Meisel21 discusses a general incompetence threshold that encompasses four specific incompetency tests.
General incompetence speaks to the overall competency of a person as a person rather than as a patient. Some examples are persons with severe mental retardation, persons with severe psychiatric disorders, or persons intoxicated by drugs or alcohol. The more specific criteria for incompetence include a patient who makes no decision at all; one who makes a decision for irrational reasons; one who makes an irrational decision; or one who does not know, appreciate, or understand the elements of disclosure provided. Any of these may be cited to support a declaration of incompetency.
If a patient is incompetent under the general incompetence category, disclosure and consent would not be necessary. However, if the patient is not generally incompetent, he may still be incompetent in one of the more specific areas, making consent unnecessary; however, sufficient disclosure is still essential to determine whether a specific incompetence exists.
Most obstetrician-gynecologists have been confronted by the patient who states that she does not want to know about the risks; or the patient who, after being given adequate disclosure states that she wants the doctor to decide; or the patient who desires not to hear about the procedure and wants the doctor to do what is “best.” Can a physician, with any security, assume that these responses are valid and pursue the treatment without further disclosure? The answer is probably “yes” under certain circumstances.
Although there are few court precedents regarding this issue in informed consent cases, there is obvious legal logic to support it. One must first understand the meaning of waiver. In the well-known Miranda case,23 the court defined a waiver as a voluntary relinquishment of a known right. If a patient has a right to make an informed decision concerning her medical care, she should also be able to relinquish all or part of that right and, therefore, give up the right to be informed, to make the decision, or both. Furthermore, if the patient indicates that she will proceed regardless of what the physicians tells her, she has in essence waived her right to be informed.
There are two key issues in using this exception to the informed consent doctrine. First, the patient must relinquish the right voluntarily. While a physician would not likely use physical force to get a patient to relinquish this right, the courts might consider any evidence suggesting that the physician used persuasive methods as constituting involuntary relinquishment and, therefore, render the waiver invalid. Some examples are misrepresenting the risks, minimizing the risks, or suggesting to the patient that she does not want to know the risks.
The second element that could present a problem is that it must be a known right. We certainly do not want to find ourselves in the position of having to read a “Medical Miranda Card” to each patient, and legal scholars agree that would likely be counterproductive. If waiver is invoked as an exception, the physician must indicate in some fashion that it is the patient’s right to know and decide. Because it is the patient’s decision, her right of individualism and her self-determination are protected. Finally, documentation of the exchange is important.
In general, this exception applied to the nondisclosure of potential risks of a recommended procedure. Thus, the patient decides, for whatever reasons, that she does not want to be told or to make a decision. Under the therapeutic privilege exception, the physician decides that disclosure of the risks of the treatment would harm rather than benefit the patient. In Canterbury v. Spence,14 the court recognized this right in a rather restrictive way, indicating that the information may be withheld if it would upset the patient to a point where the patient could not make a rational decision. In Nishi v. Hartwell,24 the court in its recognition of therapeutic privilege emphasized the best interest of the patient and adopted a more liberal interpretation, stating, “a physician may withhold disclosure of information regarding any untoward consequences of a treatment where full disclosure will be detrimental to the patient’s total care and best interest.”
Although this exception to disclosure is frequently discussed, few cases have actually been decided by therapeutic privilege. In claiming the therapeutic privilege exception, the physician may still be required to disclose the nature of the treatment, its benefits and effects and alternatives. This exception needs to be well documented and supported at the time it is made. Although there are definitely times when such a decision is appropriate, defending therapeutic privilege retrospectively would be difficult. Because this decision is made solely by the physician, the court may view self-interest as an overriding factor.
In this discussion, we have traced the informed consent doctrine to its current state. The application of this information to the pragmatic practice of medicine becomes one of judgment. Unfortunately, only guidelines can be given because there are no absolutes.
In reality, the practicing obstetrician-gynecologist, with few exceptions, adequately discusses any procedure and obtains consent from the patient. The problem is seldom one of action. As is true in so many other areas of physicians’ exposure in litigation, it is proof or documentation of that action that causes the problem.
After analyzing the cases in which the informed consent issue has been significant, we can list the following areas that will cause problems for the physician: no disclosure of any kind documented; misrepresentation of the risks; no identification of a reasonable alternative; reliance on a general hospital form; absent or inadequate documentation; and alteration of records to include documentation. Each of these must be viewed as a jury views them, retrospectively. The physician’s record is his best witness and serves as a black box to explain what happened and when. If nothing is documented and there is disagreement about disclosure, the psychological, emotional advantage goes to the injured patient. That advantage is removed if the physician has taken the time to personally write a reasonable, not lengthy, record evidencing that:
Should a physician attempt to document all the possible risks and complications? Such documentation is impratical and may even be counterproductive. If a physician attempts to do so, the very complication the patient develops may be the one the physician forgot to write down, and if the physician’s list of complications is otherwise complete, it will be assumed that because he did not include the specific complication, he obviously did not discuss it.
Physicians often ask what to do when, after providing the patient with informed consent, the patient says, “What do you recommend?” Should the physician give his or her recommendation or let the patient decide on her own? Obviously either can be done, but in reality, the physician has already provided a recommendation when the options were explained to the patient. Notwithstanding, the life experiences of the physician are different than those of the patient and what the physician would decide in a given circumstance may not be the same as what the patient would decide.
For example, a pregnant woman comes into your office at 42 weeks’ gestation.25 Her prior obstetrical history is highlighted by the following: her first pregnancy resulted in a stillbirth at 43 5/7 weeks and her second pregnancy culminated in a cesarean for fetal distress at 43 3/7 weeks and resulted in a child with spastic quadriparesis and cortical blindness; this child is in a stroller in front of you.
Because she was a post-dates and prior cesarean patient, she was given, at that time, the option of induction of labor with or without cervical ripening, an elective repeat cesarean and expectant management with fetal surveillance testing. In this case, the fetal surveillance testing was to be a nonstress test and amniotic fluid index measurements twice per week.
After explaining the options and their consequences, she said, quite emphatically, that, “I do not want any type of intervention prior to 44 weeks.” In the event of an adverse result it would be hard for her to argue that she did not understand the risks. After all, she had had a stillbirth and a brain-damaged infant. Nevertheless, physicians must navigate this minefield and, in essence, relinquish control and let the patient decide. In short order she decided in favor of twice per week testing. Approximately 10 days later, she delivered a healthy baby.
Even though this patient chose what many of us would consider the riskier road to travel in light of her history, this case, in reality, illustrates the value of informed consent and letting the patient decide her own health care. As noted in Logan v. Greenwich Hospital Association,26 “a physician’s duty is to advise patients of possible alternatives in obtaining informed consent to an operative procedure [and that would] require disclosure of a more hazardous alternative.”
In the Logan matter, Martha Logan was being followed by an internist for systemic lupus erythematosis (SLE). In October 1972, her internist advised her to undergo a percutaneous or closed renal biopsy to determine the extent of her lupus nephritis and that the procedure would be performed by the urologist. During the course of the fluoroscopically monitored renal biopsy, the gallbladder was perforated and subsequently required removal. Martha Logan was not advised of the riskier more hazardous procedure of open renal biopsy. On appeal, the Connecticut Supreme Court concluded that, “informed consent requires disclosure of a more hazardous alternative.”
The patient is competent
Following the reasoning of Logan, does it not also follow that obstetrical patients should also be offered the riskier and more hazardous procedure of an elective cesarean delivery? Here again, the options of vaginal birth or cesarean are available. The attendant risks of each option fall more heavily on the baby or the mother depending on the route of delivery chosen by the mother. In reality, informed consent is a process that empowers the patient to choose a route of delivery in keeping with her life experiences, just as the post-dates patient did or Martha Logan wanted to do and, by so doing, she thus assumes the risks, although riskier, of the route taken.26,27
When the patient signs out against medical advice (AMA), informed consent and timely documentation, once again, apply. As noted in the Truman case,16 each patient has a right to refuse medical therapy as long as she is sufficiently informed of the consequences of that refusal. Signing out AMA is, in many ways, the penultimate form of refusal. When this happens in an outpatient or inpatient setting, simply provide the patient with the consequences of leaving and document accordingly (Table 8). On the patient’s chart or the AMA form, be sure to document that she has been advised that leaving under these circumstances could result in death or permanent brain damage to her, and, if pregnant, to her baby. As part of the process, provide her with appropriate medications and follow-up.
As previously noted, the reasonable documentation approach certainly should cover almost all circumstances. Let us take the hypothetical case of a 32-year-old gravida 4, para 4 woman whose physician believes a total abdominal hysterectomy and a Marshall-Marchetti-Krantz may be necessary. The physician discusses the procedures with the patient and documents “risks such as hemorrhage, infection, fistula, and even death.” Let us assume that both procedures are indicated and then performed in a fashion commensurate with the standard of care. Let us further assume that the patient develops urinary bladder stones, and the primary allegation is lack of disclosure that this could happen. The physician claims he told the patient of this potential complication and the patient denies it. It is not specifically documented in the chart as a risk.
In a majority rule state, the plaintiff will have to provide expert medical testimony to show that the information provided and documented by the physician deviated from the standard of other similar professionals. The physician can defend with his own expert medical testimony, and the advantage rests significantly on the side of the physician. In addition, if the jury believes that this information deviated from the standard, liability would only exist if the patient could prove that she would not have proceeded with the operation had she known of the risk.
In a minority rule state, the physician is stripped of his expert medical witness defense, and the plaintiff does not have to provide expert medical testimony. She only has to show that the risk was material enough that, had she known, she would not have proceeded (subjective test), or had a reasonable person of similar position other than the patient known, she would not have proceeded (objective test). In either a majority or a minority rule state, it seems unlikely that a jury could be convinced that a person would consent to a procedure knowing she could develop a fistula or an infection, could hemorrhage or die, but would not proceed if she knew she might develop urinary bladder stones.
Another hypothetical case demonstrates a problem that has accounted for successful plaintiff decisions in informed consent allegations. A young woman of reproductive age has either a laparoscopy or exploratory laparotomy for a possible cyst, endometriosis, or possible chronic pelvic inflammatory disease. On viewing the pelvis, the gynecologist find that it is “socked in” and is convinced that the procedure of choice is a total abdominal hysterectomy with bilateral salpingo-oophorectomy. In the best interest of the patient, the physician performs the surgery. The patient awakens, shocked that she has lost her uterus and ovaries and, obviously, her reproductive and hormone function. In a future allegation, the patient claims that she had been given no indication that the more radical surgery would be performed in that setting. She indicates that even if it were the appropriate medical therapy for her disease she should have had the right to decide if she wanted it and, if so, when she wanted it. If there is no documentation on the chart that this possibility was discussed with the patient and if the physician cannot show an emergency existed to proceed without the patient’s consent, the patient will probably be successful in her claim. A court will rarely accept the defense that a relative emergency existed in that the procedure needed to be done and the physician did not wish to expose the patient to a second anesthetic. In the present atmosphere of liberal interpretation, the patient’s right to decide supercedes what the physician may perceive to be in the best interest of the patient.
Two other potential problems can be illustrated with this second hypothetical patient. If the patient is not a minor and this more radical therapy has not been discussed with her, it is false to assume that intraoperatively her husband or a close relative can give informed consent for her unless she has so indicated. Pragmatically, the physician may have some psychological advantage by producing a relative’s consent, but legally, relatives do not have the authority. This means that consent is limited to the person undergoing treatment and no other person can consent for that person absent a judicial determination of incompetence. In a nonemergency situation, it is best to stop, discuss the problem with the patient as soon as possible, and plan to proceed at a later time.
The second false assumption is that the hospital consent form provides the authority to proceed and removes liability from the physician and the hospital. For example, the broad statement on the hospital form may give consent for diagnostic laparoscopy and possible exploratory laparotomy. Unless it can be specifically documented that the physician discussed what was meant by possible exploratory laparotomy, this form will be of little help. The form gives the false impression that the patient cannot bring an action because the form indicates that the hospital and physicians are not liable for any injury resulting therefrom. The physician needs to remember that it is generally held that no one can sign away the right for a future tort action.
Litigation based on informed consent has shifted its focus to vaginal birth after cesarean (VBAC) and operative vaginal delivery with vacuum or forceps, but some forms of litigation remain within the public eye. For example, frequent allegations continue to be made relating to tubal ligation, and, more specifically, to the nondisclosure of the risk of future pregnancies, and, the other is the prenatal identification of anomalous or potentially anomalous infants. Putting aside the moral issue of therapeutic abortion, the current climate indicates that the at-risk patient has the right to be informed about available state-of-the-art testing and about procedures for management of her pregnancy or future pregnancies. What she does with that information is her decision, but it does not waive her right to know—only the patient herself can do that.
VBAC has become a household word and a litigation target as well. Prior to 1996, there were already rumblings in the legal community that informed consent was the way to attack the “VBAC problem.” Prior VBAC patients with uterine ruptures were questioning the adequacy of their informed consent and stating that, “had I known that my uterus could rupture and hurt or kill my baby, I would not have done it.” But, as time went on, this issue became subsumed under the expanding role of elective cesareans and the right to decide in favor of a cesarean in the absence of an obstetrical indication.
In relatively short order, two cases5,28 rocked the national obstetrical community. Both cases involved women undergoing a VBAC who requested a cesarean during labor. When the cesareans were requested, the physicians conducted clinical evaluations and found no indication, absent the history of a prior cesarean, to perform the cesareans. As such, the labors continued. Later, both women sustained a uterine rupture and a their children suffered brain damage. In both cases, the courts decided that the expressed desire for a repeat cesarean by these women constituted withdrawal of the prior consent and a new informed consent was required for the labor to continue.
As an outgrowth of these VBAC cases and, for that matter even before they appeared, procedural-based informed consent, as noted in Tables 2 and 3, was becoming an integral part of our contemporary practice of obstetrics. As noted, in the proposed VBAC informed consent (see Table 2), the focus is on the patient and the risks to her and her baby. Upon initialing each line and signing the consent form, she acknowledges and assumes those risks.
This informed consent process and use of the form as outlined in Table 2 should be initiated at the first prenatal visit and, once again, on admission to the hospital. If she expresses a desire for a cesarean during labor, reconsent her with the form. If she chooses a cesarean, a cesarean should be done.
One issue that is not covered in the proposed VBAC consent form is the issue of physician presence. Some believe and others do not that the obstetrician should be immediately available during a VBAC. This split of opinion relates primarily to the issue of uterine rupture. Because the incidence of intrapartum fetal distress is not substantially different, the question remains whether the physician needs to be “readily” or “immediately” available for a laboring VBAC patient. Regardless of one’s position, the department of obstetrics/gynecology for each facility should decide whether or not the physician’s presence is required during a VBAC. This should also be included in the consent form. Regardless of the route taken, the department of obstetrics/gynecology should have the VBAC consent form reviewed by an attorney before implementation.
As VBAC informed consent litigation has risen exponentially, vacuum-related litigation pertaining to the alleged negligent use of the vacuum or the lack of informed consent has similarly increased. As noted in Table 3, the proposed vacuum consent attempts to address these concerns in a laboring patient. Admittedly, informed consent during labor would be fraught with concerns that the patient was potentially under the influence of narcotics or severe pain. Thus, consenting under these circumstances would be arguably difficult, and, perhaps insufficient.
In the case of vacuum or forceps use or for that matter route of delivery, a reasonable alternative would be to review with the patient the various options of delivery such as vacuum or forceps during her prenatal care. As part of that process, consider the development of a form for her to review and sign. By so doing, one removes the potential issues of duress or coercion out of the informed consent arena. The end result will be that the patient is better informed and less willing to seek legal redress.
Thus, it is easy to understand why the medical profession has overreacted to the informed consent doctrine. The courts have been less than clear on its application. With the trend to the minority rule and particularly the subjective test, physicians’ exposure is somewhat increased. However, regardless of which rule is in effect, it is our opinion that the commonsense approach to informed consent is the only practical one that will work and with which physicians can live. The informed consent doctrine provides a modicum of protection for the physician based on the assumption of risk by the patient, but it does not protect if negligence occurs.
There are no absolutes that always apply (Table 9). Each jurisdiction is different, and there are always multiple variables in a given lawsuit that can affect the outcome. If we practice good, current obstetrics and gynecology, if we remember that the patient should play a significant role in decisions about her own health, and if we document in a reasonable manner, we should dispel our irrational fear regarding the informed consent process and be able to proceed with our professional endeavors.
1. Nations obstetrical care endangered by growing liability crisis: ACOG announces “Red Alert” status where care is most at risk. Washington, D.C, American College of Obstetricians and Gynecologists, News Release, May 6 2002