Background

Rarely does a week pass without at least one account in the popular press of a medical error with devastating consequences for a patient and his or her family. Not all of them receive as intense media scrutiny as the young transplant recipient at Duke Medical Center who died as a consequence of the failure of the transplant physician to confirm compatibility between donor and recipient.

Several years ago, the Institute of Medicine published a report entitled To Err Is Human: Building a Safer Health System, in which it was asserted that between 44,000 and 98,000 Americans die each year as a result of medical errors. Shortly after the report was published, critics began to challenge the data in widely read medical journals such as JAMA, in turn leading to defenses of the data in the same journals by those involved in the original report. And so the controversy continues.

The Joint Commission for the Accreditation of Health Care Organizations (JCAHO) also weighed in by promulgating a new standard for the "Patient Rights and Organizational Ethics" chapter of its Accreditation Manual for Hospitals, providing that: "Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." At first glance, this standard appears to be nothing more than confirmation of a principle set forth in the American Medical Association Code of Medical Ethics, i.e., "A physician shall deal honestly with patients and colleagues, and strive to expose those physicians deficient in character or competence, or who engage in fraud or deception." The Ethics Manual of the American College of Physicians (ACP) is even more specific and on point, providing that physicians should disclose to patients information about errors of procedure or judgment if such information is material to the patient's well-being.

There are at least two dimensions to this component of medical ethics and professionalism. The first pertains to the ethical obligation of the physician to possess and consistently demonstrate the requisite clinical competencies. The second pertains to the ethical obligation to be honest with patients about all matters relevant to their medical condition and treatment. Our primary focus here will be the latter. We will also leave to another opportunity the difficulty in reaching consensus on what constitutes a medical error and in allocating responsibility among health care professionals and organizational or institutional systems that impact the quality of patient care. Similarly, we will leave to another discussion whether the duty to disclose extends to cases in which there has been a medical error without an adverse impact upon the patient — the "no harm, no foul" idea. Finally, we will also need to defer the intriguing question of whether the ACP's limitation of the duty to disclose to those situations in which the patient's well-being requires that he or she be informed of an error sets the threshold of disclosure so high that it would rarely, if ever, be incumbent upon a physician to do so.

Question: If the doctrine of informed consent relates to patient participation in the choice of treatment, how can it create a duty to disclose medical error?

Staunch advocates of truth telling in medical practice, who consider honesty and full disclosure essential features of the virtuous physician, insist that physicians must apprise their patients of any medical error that has had an adverse impact. The ethical obligation of the physician to be candid with patients is broader than the doctrine of informed consent. It arises out of the fiduciary nature of the physicianpatient relationship, which is one of trust and confidence. Such relationships require honesty and forthrightness on the part of those who enter into them. Duplicity, deception, or nondisclosure of information that is integral to the relationship is deemed to be inherently pernicious regardless of when it may occur.

Question: Why must physicians shoulder a responsibility that would compel them to act against their professional interest and perhaps the financial well being of their families?

Discussion of the purported duty of physicians to disclose medical error reveals less than a clear consensus as to what the professional obligation entails. Two arguments in particular have been consistently put forward in order to justify the nondisclosure of medical error to patients. The first relates directly to the malpractice implications of medical error, and suggests a sort of Fifth Amendment right against selfincrimination on the part of physicians. No one, so the argument runs, even the professional in the fiduciary relationship of physician and patient, should be under an ethical obligation to engage in self-incrimination and thereby provide a potential adversary with the informational basis for initiating legal proceedings that are (at least in the eyes of physicians) essentially punitive in nature.

The second argument is based upon a less selfserving and, indeed, purportedly beneficent purpose. According to this argument, disclosure to a patient that an adverse outcome was or may have been the product of a medical error will increase the patient's anxiety and stress, as well as undermine the trust that is essential to the therapeutic relationship. Since an ancient axiom of the medical profession has been "primum non nocere" (first do no harm), nondisclosure of medical error should be seen as consistent with this axiom. This argument draws to some extent upon one of the well-recognized exceptions to the doctrine of informed consent — the so-called "therapeutic privilege." According to this exception, if a physician, in the exercise of sound professional judgment, reasonably believes that the disclosure of certain information to a patient poses a risk of significant harm (to the patient, not the physician), that information can be withheld. One can also readily discern how invoking a variation on the therapeutic privilege in circumstances of medical error plays into a potential "escape clause" in the ACP language by asserting that such a disclosure would not promote, but rather undermine the patient's well-being.

In view of the survey data indicating the overwhelming preference of patients to be informed of medical errors affecting their care, the only basis for insisting that nondisclosure of error is truly motivated by beneficence toward the patient rather than protection of the physician, would be that physicians know better than patients what is in their (the patient's) best interest. One of the central features of the paradigm shift from the paternalistic to the shared decision making paradigm for the physician-patient relationship was the recognition that harm is a value-laden concept. Ultimately, it must be the patient as autonomous person, and not the physician, who is the arbiter of what constitutes harm to them.

Question: What typically happens to the conscientious physician who follows such ethical admonitions to disclose their mistakes to patients?

Qualitative studies and much anecdotal evidence indicate that it is more often the effort to conceal medical error, rather than the timely, candid, yet sensitive disclosure of it, that is more likely to precipitate malpractice litigation. Patients who are conscientiously and compassionately advised by their physicians that a medical error has occurred, even when the consequences of the error are significant, appreciate the candid disclosure and are much less likely to sue than are those patients who are kept in the dark. Patients, or in the cases in which medical error has caused or contributed to the patient's death, family members who subsequently learn that medical error has been "covered up" are the most likely to initiate malpractice litigation. A reason often cited by medical malpractice plaintiffs for the filing of such suits is that patients or families were desperately searching for "answers" to persistent questions that had gone unanswered by those responsible for providing care. Another prominent motivating factor for such lawsuits is to send a message to health care professionals that practices, procedures, or policies may need to be changed so that other patients will not be harmed in the same way. Thus disclosure of medical error should be accompanied, when appropriate, by reasonable assurances to the patient or family that remedial measures will be undertaken in order to reduce the likelihood of similar problems in the future.

A prominent example of the benefits of a policy of disclosing medical error to patients or their families is the Veterans Affairs Medical Center in Lexington, Kentucky, which has attributed a marked reduction in malpractice claim totals in large measure to a policy of prompt disclosure of medical error, along with appropriate apologies, waiver of costs, and payment for injuries resulting from the error.

Question: What is the policy of the UC Davis Health System on this issue?

Faculty members and leaders of the Health System are actively involved in initiatives to minimize medical errors. It is the policy of the Health System's risk management office to candidly discuss medical errors with patients and families.